CN113456210A - Three-dimensional tumor thermal ablation instrument and control method thereof - Google Patents

Three-dimensional tumor thermal ablation instrument and control method thereof Download PDF

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CN113456210A
CN113456210A CN202010240187.8A CN202010240187A CN113456210A CN 113456210 A CN113456210 A CN 113456210A CN 202010240187 A CN202010240187 A CN 202010240187A CN 113456210 A CN113456210 A CN 113456210A
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temperature
heating device
tumor
temperature value
measuring needle
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韩俊霞
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/01—Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00642—Sensing and controlling the application of energy with feedback, i.e. closed loop control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00714—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/0072—Current
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature

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Abstract

A three-dimensional tumor thermal ablation instrument and a control method thereof. The tumor heating instrument mainly heats the tumor by a heating device, simultaneously monitors the temperature change of normal tissues around the tumor by a temperature measuring needle, controls the heating temperature by a controller, simultaneously monitors the temperature value of the normal tissues, does not damage the normal tissues while inactivating the tumor, and treats the tumor.

Description

Three-dimensional tumor thermal ablation instrument and control method thereof
Technical Field
The invention relates to a machine for treating solid tumors and a control method thereof. The apparatus is suitable for the treatment of benign and malignant solid tumors.
Background
The most critical of the current factors affecting the hyperthermia of tumors is the heating technology, and the ideal heating requires that 100% of the tumor tissue be heated above its killing temperature and maintained for a certain period of time to destroy the focal tissue, but at the same time avoid the damage of the normal tissues or organs around the tumor due to overheating (physics of tumor hyperthermia, p4, liu jing, physical and chemical institute of the chinese academy of sciences, 2008.5).
In order to obtain a desired tumor hyperthermia effect, the following conditions must be satisfied when heating: firstly, tumor cells begin to die when heated to 40-43 ℃; the normal tissue cells are heated to 45-47 ℃ and then die (Roemer, 1999); secondly, the temperature of the heated target tissue area is monitored and controlled in real time and instantly, so that a treatment implementer can see the temperature distribution and change in the body of a patient at any time, and the degree of control over the treatment accuracy is improved (tumor thermotherapy technology and clinical practice, P107. Liujia, Hunan province, Hospital of tumor radiotherapy department, Thermothers-room, 2009.8); and the temperature of normal tissues around the tumor must be kept below 45 ℃ (Physics of tumor thermotherapy, P4 Liu Jing, physical and chemical institute of Chinese academy of sciences, 2008.5).
Disclosure of Invention
The invention aims to provide a solid tumor treatment instrument and an operation method thereof. In order to overcome the current situations that the temperature measurement of a thermotherapy device is inaccurate and the poor treatment result caused by heating is estimated due to radiation generated by improper heating modes in various tumor thermotherapy at present, the invention provides a solid tumor treatment instrument and an operation method thereof, which can provide accurate, real-time and controllable required temperature for tumors.
In the following description, reference is made to the accompanying drawings that are not necessarily drawn to scale, but that are shown without departing from the spirit and scope of the invention. The description is not intended to limit the contents of the following examples.
An apparatus useful for treating solid tumors, a three-dimensional tumor thermal ablation apparatus, comprising: the front end of a heating device (2) with a temperature sensor is completely closed, the shell (21) is made of heat conducting materials, and an internal heater (22) and the temperature sensor (23) are respectively led out of the heating device through leads (25, 26) and then are fixed on one end head; the front end of a temperature measuring needle (3) with a temperature sensor (32) can be closed, the shell (31) is made of heat conducting material, and the temperature sensor (32) in the shell is fixed on one end head after being led out of the heating device through a lead (34); the controller (1) can control and display the temperature value of the heating device (2), can monitor and display the temperature value of the temperature measuring needle (3) and can provide direct current; the heating device (2) and the temperature measuring needle (3) are connected with the control instrument (1) through a lead.
In some embodiments of the invention, the housing (21) of the heating device is a metallic heat conducting material, a non-metallic heat conducting material.
In some embodiments of the invention, the front end (211) of the heating device is part of the housing (21) and is shaped as a sharp shape, a spherical shape, a planar shape, a curved shape, a combination of a planar and circular arc shape, a combination of a planar and inclined plane shape, or a combination of a planar and curved plane shape.
In some embodiments of the invention, the heater (22) of the heating device is connected with the outer shell (21) without clearance, and the heater (22) is connected with the outer shell (21) through a heat conducting material.
In some embodiments of the invention, the housing (31) of the temperature probe is a metal heat conducting material, a non-metal heat conducting material.
In some embodiments of the invention, the front end (311) of the temperature probe is part of the housing (31) and is shaped as a sharp shape, a spherical shape, a planar shape, a curved shape, a combination of a planar and circular arc shape, a combination of a planar and inclined surface shape, or a combination of a planar and curved surface shape.
In some embodiments of the invention, the temperature sensor (32) of the temperature measuring needle is connected with the outer shell (31) without clearance, and the temperature sensor (32) is connected with the outer shell (31) through a heat conducting material.
In some embodiments of the invention, the wires (25, 26) of the heating device may be connected directly to the control unit, by means of which the heating temperature value of the heating device may be changed and displayed on the control unit.
In some embodiments of the invention, the lead (34) of the temperature probe may be connected directly to the controller, which may read and display the temperature value of the temperature probe.
In some embodiments of the invention, a method of controlling a three-dimensional tumor thermal ablation instrument: the controller can set the optimal temperature value of the temperature measuring needle; operating the heating device to be placed at the optimal position inside the tumor; operating the temperature measuring needle at the good tissue position on the outer edge of the tumor as a temperature measuring position; the controller is operated to send an instruction to the heating device to heat the tumor, and when the temperature of the tumor rises to a certain temperature value, the temperature value sensed by the temperature measuring needle is higher than the body temperature of a human body; when the temperature value monitored by the temperature measuring needle reaches the optimal temperature value of the temperature measuring needle set by the controller, the controller can record the temperature value of the heating device at the moment, and the constant temperature value of the heating device can be ensured through the control of the controller; the effects of tumor ablation and inactivation can be achieved through heating for a certain duration.
In some embodiments of the invention, the thermometry locations include any good tissue location anywhere within the tumor, within 10mm near the outer edge of the tumor geometry.
In some embodiments of the invention, the temperature measuring needle acts on the tissue near the tumor, the temperature value of the temperature measuring needle is monitored in real time through the whole process of the instrument, and the final stable temperature value is in the range of 40-45 ℃.
In some embodiments of the invention, the heating device acts on the position of the patient needing treatment, and the temperature value of the heating device is controlled by the control instrument to be kept between 43 and 70 ℃.
In some embodiments of the invention, the temperature of the heating device can be controlled within a range of 43-70 ℃, and according to different conditions, the heating device can fix a temperature value to heat the tumor at a constant temperature, and can also change the required temperature value in real time to heat the tumor.
In some embodiments of the invention, the heating device continues to heat for a time period in the range of 20 minutes to 90 minutes.
In some embodiments of the invention, the temperature measuring needle monitors the relationship between the temperature and the temperature of the heating device, and is characterized in that: the temperature measuring needle does not reach or exceed the range of 40-45 ℃, the heating device can correspondingly adjust the temperature according to the controller, and finally, tumor treatment can be carried out within the range of 43-70 ℃ no matter constant temperature heating or variable temperature heating is carried out.
In some embodiments of the invention, the number of the heating devices and the temperature measuring needles is characterized by: the number of the heating devices is not limited to 1 heating device corresponding to 1 temperature measuring needle, and includes 1 heating device corresponding to a plurality of temperature measuring needles, and also includes a plurality of heating devices corresponding to a plurality of temperature measuring needles.
The invention has the beneficial effects that:
1. because the temperature of normal tissue can be monitored by the instrument and the temperature of the normal tissue is in a safe range of 40-45 ℃, the instrument can inactivate tumors on the premise of not damaging the normal tissue.
2. Because the instrument can simultaneously use a plurality of heating devices which independently work to carry out tumor treatment, the instrument can realize the complete and seamless conformal heating treatment of tumor tissues of tumors with any shapes.
3. Because the temperature of the apparatus for inactivating the tumor is between 43 and 70 ℃, and the apparatus belongs to the low-temperature treatment range of the tumor, the apparatus can ensure that the tumor does not have carbonization points in the heating process, thereby avoiding various postoperative complications.
4. Clinical experiments show that the instrument has direct and obvious ablation effect on solid tumors, and can play a role in improving the immunologic function through thermal therapy stimulation.
Drawings
FIG. 1: schematic representation of tumor treatment method;
FIG. 2: structure diagram of heating device;
FIG. 3: a temperature measuring needle structure diagram;
FIG. 4: a thermal field schematic diagram of a single heating device;
fig. 5-fig. 18: after the three-dimensional tumor thermal ablation instrument is used for treatment, clinical pathological pictures are taken;
FIG. 19: clinical evaluation of general surgical chief of China people liberation military general Hospital on the three-dimensional tumor thermal ablation instrument;
FIG. 20: clinical evaluation of the oncology department chief and chief of the first subsidiary hospital of Harbin medical university on a three-dimensional tumor thermal ablation instrument;
FIG. 21: a three-dimensional tumor thermal ablation instrument clinical experiment report participating unit;
FIG. 22: list of clinical laboratory staff;
FIG. 23: the opinion of clinical trial management department of researchers and clinical trial institutions;
Detailed Description
The heating device leads 25 and 26 are connected with the controller, the temperature measuring needle lead 34 is connected with the controller, the controller is powered on, and the next operation can be carried out after the controller displays that the temperature value of the heating device is stable.
Further, the heating device 2 acts on the corresponding position of the patient.
The heating device body is a metal heat conducting housing 21 with a sharp front end 211 that an operator can insert directly into a patient's tumor. The heater 22 is arranged at the front end inside the heating device, is led out of the heating device through a lead 25 and is connected to the controller. The inside of the heating device is also provided with a temperature sensor 23, the heating device is led out through a lead 26 and is connected to the controller, and the temperature value monitored by the temperature sensor 23 in real time can be transmitted to the controller. The tail of the heating device is provided with a handle 24, which is convenient for the operator to operate.
Further, the temperature measuring needle 3 acts on the good tissue immediately outside the tumor margin. The temperature probe body is a metal shell 31, and an operator can directly insert the sharp front end 311 of the temperature probe into the tumor edge of a patient. A temperature sensor 32 is arranged in the temperature measuring needle, the temperature measuring needle is led out through a lead 34 and is connected to the controller, and the temperature value monitored by the temperature sensor 32 in real time can be transmitted to the controller.
Further, the operation of the heating device and the temperature probe has been completed, as shown in fig. 1.
The controller can set the optimal temperature value of the temperature measuring needle; the operation controller can send an instruction to the heating device to heat the tumor, and when the temperature of the tumor rises to a certain temperature value, the temperature value sensed by the temperature measuring needle is higher than the body temperature of a human body; when the temperature value monitored by the temperature measuring needle reaches the optimal temperature value of the temperature measuring needle set by the controller, the controller can record the temperature value of the heating device at the moment, and the temperature value of the heating device can be ensured to be constant through the control of the controller.
Each path of heating measurement and control device works independently and supplies power independently; the stabilized direct current output by the controller is within a safety range of 36V.
Fig. 4 shows the principle of the thermal field of a single heating device. After the heating device 2 intervenes in a human body, a thermal field is formed around the heating device due to the heating effect of the heating device and is gradually expanded, the temperature at the heating device is highest, the temperature is lower towards the periphery, and the temperature is balanced in a slope type with the inside higher and the outside lower through a certain time. Here, the temperature of the heating device determines the range of the heating radius 41.
Example one
Malignant tumor treatment by using line three-dimensional tumor thermal ablation instrument
Under-lens observation (HE staining), necrosis and degeneration are more remarkable, the glandular epithelial cell nucleus in the degeneration area is elongated, the chromatin is fuzzy, and the transition is continued with the necrosis area (figure 5, derived from the pathological morphology report of the clinical test).
In part, poor adhesion, with interstitial fibroplasia (fig. 6, from the pathomorphological report of this clinical trial).
The perivascular degeneration is obvious, the cellular chromatin is fuzzy, and the cells are lumpy (figure 7 and figure 8, which are derived from the pathological morphology report of the clinical test).
Necrosis is complete far away from the vascular region, the contour of the glandular cavity is visible, the cell nucleus disappears, eosinophilic red is addicted, and the cell ghost is distinguishable (fig. 9, fig. 10, fig. 11 and fig. 12, which are derived from the pathological morphology report of the clinical test).
The necrotic regions were characterized by vasodegeneration, thickening of the individual vessel walls, and lumen occlusion (fig. 13 and 14, derived from the pathomorphological report of this clinical trial).
In some cases, lymphoblastic and plasma cell infiltrates were observed around the residual tumor, the degenerative and necrotic regions (fig. 15, fig. 16, fig. 17 and fig. 18, derived from the pathomorphological report of the clinical trial), and no neutrophil infiltrates were observed.
By comparing the pathological morphology of the ablation group, the benign ablation group and the malignant ablation group directly cause degeneration and necrosis of glandular epithelium and stroma in different degrees due to thermal reaction; the degree of lymphocyte and plasma cell infiltration is more obvious in part of cases than that in an untreated group, and particularly, cancer tissue necrosis and degeneration, interstitial vascular wall necrosis and vascular occlusion are more obvious in a malignant group after treatment by a three-dimensional tumor thermal ablation instrument (derived from a pathological morphology report of the clinical test).
The embodiments of the present invention are preferred embodiments of the present invention, and the scope of the present invention is not limited by these embodiments, so: all equivalent changes made according to the structure, shape and principle of the invention are covered by the protection scope of the invention.

Claims (10)

1. A three-dimensional tumor thermal ablation instrument comprising:
the front end of the heating device (2) with a temperature sensor (23) is completely closed, the shell (21) is made of heat conducting materials, and the internal heater (22) and the temperature sensor (23) are respectively led out of the heating device by leads (25, 26) and then are fixed on one end head;
the shell (21) is made of a metal heat conduction material and a non-metal heat conduction material;
the front end (211) is a part of the housing (21) and has a sharp shape, a spherical shape, a planar shape, a curved shape, a combined shape of a plane and a circular arc, a combined shape of a plane and an inclined plane, and a combined shape of a plane and a curved surface;
the temperature sensor (23) is connected with the outer shell (21) without clearance, and the temperature sensor (23) is connected with the outer shell (21) through a heat conduction material;
the front end of a temperature measuring needle (3) with a temperature sensor (32) can be closed, the shell (31) is made of heat conducting material, and the temperature sensor (32) in the shell is fixed on one end head after being led out of the heating device through a lead (34);
the shell (31) is made of a metal heat conduction material and a non-metal heat conduction material;
said front end (311) is part of said housing (31) and is shaped as a sharp shape, a spherical shape, a planar shape, a curved shape, a combination of a planar and circular arc shape, a combination of a planar and inclined surface shape, a combination of a planar and curved surface shape;
the temperature sensor (32) is connected with the outer shell (31) without gaps, and the temperature sensor (32) is connected with the outer shell (31) through heat conduction materials.
The controller (1) can control and display the temperature value of the heating device (2), can monitor and display the temperature value of the temperature measuring needle (3) and can provide direct current;
the leads (25, 26) can be directly connected to the control instrument, and the heating temperature value of the heating device can be changed by the control instrument and displayed on the control instrument;
the lead (34) can be directly connected to the controller, and the controller (1) can read and display the temperature value of the temperature measuring needle;
the heating device (2) and the temperature measuring needle (3) are connected with the controller (1) through leads.
2. A method of controlling a three-dimensional tumor thermal ablation instrument: the controller can set the optimal temperature value of the temperature measuring needle; operating the heating device to be placed at the optimal position inside the tumor; operating the temperature measuring needle at the good tissue position on the outer edge of the tumor as a temperature measuring position; the controller is operated to send an instruction to the heating device to heat the tumor, and when the temperature of the tumor rises to a certain temperature value, the temperature value sensed by the temperature measuring needle is higher than the body temperature of a human body; when the temperature value monitored by the temperature measuring needle reaches the optimal temperature value of the temperature measuring needle set by the controller, the controller can record the temperature value of the heating device at the moment, and the constant temperature value of the heating device can be ensured through the control of the controller; the effects of tumor ablation and inactivation can be achieved through heating for a certain duration.
3. The thermometric location of claim 10, wherein: including anywhere on the tumor, within 10mm near the outer edge of the tumor geometry.
4. The optimal temperature value of the temperature measuring needle according to claim 10, wherein: the temperature measuring needle acts on the tissue near the tumor, the temperature value of the temperature measuring needle is monitored in real time through the whole process of the instrument, and the final stable temperature value is in the range of 40-45 ℃.
5. Temperature value of the heating device according to claim 10, characterized in that: the heating device acts on the position of a patient needing treatment, and the temperature value of the heating device is controlled to be kept between 43 and 70 ℃ through the control instrument.
6. The constant temperature value of claim 10, wherein: the temperature of the heating device can be controlled within the range of 43-70 ℃, and according to different conditions, the heating device can fix a temperature value to heat the tumor at constant temperature and can also change the required temperature value in real time to heat the tumor.
7. A time as set forth in claim 10, wherein: the time is in the range of 20 minutes to 90 minutes.
8. The temperature-sensing needle of claim 10, which monitors the temperature relationship with the heating device, wherein: the temperature measuring needle does not reach or exceed the range of 40-45 ℃, the heating device can correspondingly adjust the temperature according to the controller, and finally, tumor treatment can be carried out within the range of 43-70 ℃ no matter constant temperature heating or variable temperature heating is carried out.
9. The number of heating devices and temperature probes according to claim 10, wherein: the number of the heating devices is not limited to 1 heating device corresponding to 1 temperature measuring needle, and includes 1 heating device corresponding to a plurality of temperature measuring needles, and also includes a plurality of heating devices corresponding to a plurality of temperature measuring needles.
10. The three-dimensional tumor thermal ablation instrument can stimulate the organism to recognize immunity and kill cancer cells.
CN202010240187.8A 2020-03-30 2020-03-30 Three-dimensional tumor thermal ablation instrument and control method thereof Pending CN113456210A (en)

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