Biopsy device with ablation electrode

Abstract

The biopsy device with the ablation electrode comprises a biopsy tool, a biopsy channel, an ablation main machine and the ablation electrode, the biopsy tool is located in the biopsy channel, the ablation electrode comprises an electrode needle and a handle, the handle is connected to the ablation main machine through a connecting line, and the ablation main machine is connected with the biopsy channel. The biopsy channel is parallel to the electrode needle, and a temperature measuring probe is arranged on the outer wall of a front end opening of the biopsy channel. After the biopsy tool finishes collecting focus tissues, the focus tissues contaminated at the front end of the biopsy device can be ablated under the action of the active ablation electrode, the passive puncture tool is combined with the active ablation electrode needle technology, a local ablation function is added in a conventional biopsy process, and the biopsy efficiency is improved. By accurately controlling the ablation temperature at the front port of the biopsy channel, the problem of transfer planting of tissues around a puncture port can be thoroughly solved.

Description

Technical Field

[0001] The utility model relates to the field of medical instruments, in particular to a disposable biopsy device with a radio frequency or microwave ablation function, and specifically to a biopsy device with an ablation electrode. Background Art

[0002] There are two commonly used tools in clinical practice. One is an active electrode needle system with ablation, which includes an energy generator with microwave or radio frequency function and a disposable electrode needle with ablation function. The other is a disposable biopsy brush or disposable biopsy forceps, which is used for biopsy tissue sampling under channels such as laparoscopes or bronchoscopes.

[0003] Existing disposable biopsy forceps or disposable biopsy brushes usually include the following steps during use: puncture, taking pathological tissue, and withdrawing the needle. Therefore, there is a risk of implantation and metastasis at the biopsy site during use. A meta-analysis included 8 studies on needle biopsy for suspected hepatocellular carcinoma. The analysis estimated that the total risk of tumor cells implanting through the needle tract was 2.7%. The utility model aims to solve the problem of needle tract implantation. Existing biopsy tools are mainly passive in form. Through structural material optimization, the detection rate is improved and the implantation rate is reduced. However, the technical principle determines that traditional passive biopsy tools cannot completely solve the problem of metastasis and implantation. Conventional biopsy tools, according to the existing use environment, are prone to carry out tumors and other malignant cells and transfer them to non-lesion areas along the needle tract, causing metastasis and implantation, endangering the patient's health.

[0004] The Chinese invention patent (authorization announcement number CN102626329B) discloses a radiofrequency ablation negative pressure automatic biopsy gun, which includes a set of negative pressure automatic biopsy needles and radiofrequency ablation needles, and the two share an outer sleeve system. The difference between the device and the utility model is that the biopsy device of the device is a negative pressure biopsy needle with a hollow structure, and the device does not have any temperature measurement control device, and the radiofrequency ablation electrode needle is not equipped with a control system, which cannot achieve the purpose of low-power ablation and precise ablation.

[0005] The Chinese utility model patent (CN211934280U) discloses an integrated ablation needle and ablation system, including a cannula and an electrode needle movably installed in the cannula, the needle shaft has a sampling slot near the needle tip, and the cannula moves axially relative to the needle shaft to expose or cover the sampling slot. The difference between this device and the present utility model is that the device is mainly used in the ablation process, and the purpose of adding a biopsy function to the integrated ablation needle is to perform a biopsy sampling operation on the ablation site after the ablation treatment is completed. The biopsy function is a means of assisting ablation treatment. However, the present utility model is mainly used for biopsy sampling, and the purpose of adding the ablation function is to prevent needle tract implantation during the withdrawal of the biopsy tool. Therefore, the real-time low-power precision ablation of the ablation system of the present utility model is different from the system of this device. Utility Model Content

[0006] In view of the above-mentioned defects of the prior art, the utility model provides a biopsy device with an ablation electrode. After the biopsy tissue sampling is completed, before or after the biopsy device is withdrawn, the ablation electrode releases energy to fully ablate the surface of the biopsy tool in contact with the tumor tissue, thereby achieving the purpose of killing the metastatic tissue.

[0007] After the biopsy tool has finished collecting the lesion tissue, the utility model can ablate the lesion tissue contaminated at the front end of the biopsy device through the action of the active ablation electrode. Since radio frequency or microwave ablation is performed by high-temperature heating to thermally coagulate and ablate the tissue, the amplitude and process of temperature rise directly affect the ablation effect of the contaminated area at the front end of the biopsy tissue channel. The utility model combines the passive puncture tool with the active ablation electrode needle technology, adds a local ablation function to the conventional biopsy process, controls the temperature at the ablation site, and can ablate the tissue around the puncture site through precise temperature control, and solves the technical problem of transfer implantation by ablating and thermally coagulating the contaminated contact surface of the biopsy tool port.

[0008] In order to solve the above technical problems, the utility model adopts the following technical solutions:

[0009] On the one hand, the utility model provides a biopsy device with an ablation electrode, including a biopsy tool, a biopsy channel, an ablation host, and an ablation electrode. The biopsy tool is located inside the biopsy channel. The ablation electrode includes an electrode needle and a handle. The handle is connected to the ablation host through a connecting line. The biopsy channel is in a parallel position with the electrode needle. The outer wall of the front port of the biopsy channel is provided with a temperature measuring probe, which can measure the temperature of the ablation electrode at any time. The temperature measuring point at this place (the outer wall of the front port of the biopsy channel) is designed based on the characteristics of the tissue when the temperature is higher than 55°C, and the cell denaturation immediately occurs, so as to design the temperature control threshold (higher than 55°C) and high temperature duration (determined according to the ablation characteristics). The application scenario of this place is to prevent implantation, because after the sampling is completed, the tool is easy to bring the diseased tissue at the sampling site along the needle channel to the place where the needle channel passes in the process of withdrawing from the human tissue. This design is to ablate and heat-coagulate the contaminated area near the diseased tissue in the tool through temperature control, and heat-coagulate before withdrawing the needle, thereby solving the problem of needle channel implantation. For the ablation range, the thermal coagulation area is important. The temperature measurement point (where the temperature measurement probe is set on the outer wall of the front port of the biopsy channel) is located at the front end of the contaminated area. The margin of the safety margin is determined by the duration of high temperature. The margin will ensure that the contaminated tissue close to the diseased area is completely ablated, thereby achieving the purpose of accurately controlling hemostasis and preventing metastasis. The biopsy device with ablation electrodes described in the utility model combines the ablation electrode with the biopsy channel.

[0010] In the above-mentioned biopsy device with ablation electrode, the biopsy tool can be detachably placed in the biopsy channel, and the ablation electrode can be detachably placed in the biopsy channel. The outer diameter of the ablation electrode is relatively thin, and it can penetrate into the biopsy channel to ablate the front end of the biopsy channel.

[0011] In the above-mentioned biopsy device with ablation electrode, the biopsy tool is a biopsy brush or a biopsy forceps.

[0012] In the above-mentioned biopsy device with ablation electrodes, a built-in system is installed in the ablation host, and the built-in system includes a temperature detection module and a power output module. The maximum output power of the ablation host is 100W, and the temperature is automatically adjusted by the system according to actual use during the ablation process. The ablation host is a microwave ablation host or a radiofrequency ablation host.

[0013] On the other hand, a biopsy method using the biopsy device with ablation electrodes comprises the following steps:

[0014] Step 1, connecting the ablation electrode to the ablation host through a connecting line and turning it on, and using the biopsy tool to perform biopsy sampling;

[0015] Step 2, withdrawing the biopsy tool with the sample collected from the biopsy channel, away from the biopsy channel port;

[0016] Step 3, pushing the electrode needle of the ablation electrode to the port position of the biopsy channel, turning on the ablation mode of the ablation host, starting the temperature measuring probe, and transmitting the measured temperature to the built-in system of the ablation host;

[0017] Step 4: After ablation is completed, the system is shut down and the needle is withdrawn.

[0018] In step 3 of the above method, the ablation temperature and ablation time of the ablation electrode are set by the system, and the ablation temperature range is 50-75°C. This range is related to the instruments used in actual applications. For example, for thicker 13G and 14G tools, a 10mm single-sided safe thermal coagulation zone is usually required after sampling, and the required time and temperature are higher. In this way, a higher temperature value such as 65°C or 60°C is required, which is determined based on experimental results and lasts longer. Some tools, such as thinner 17G and 18G tools, require a safe thermal coagulation range of only 2mm, so the temperature control is 55°C, the outer temperature range of the thermal coagulation range is 2mm, and the duration is also shorter.

[0019] Compared with the prior art, the utility model has the following beneficial effects:

[0020] After the biopsy tool has finished collecting the lesion tissue, the utility model can ablate the lesion tissue contaminated at the front end of the biopsy device through the action of the active ablation electrode. The utility model combines the traditional passive puncture tool with the active ablation electrode needle technology, adds a local ablation function to the conventional biopsy process, and can completely solve the problem of tissue transfer and implantation around the puncture port by accurately controlling the ablation temperature at the front port of the biopsy channel. Accurately controlling the ablation temperature at the front port of the biopsy channel means real-time detection of the temperature at the location through the temperature measuring probe at the location, and controlling the safety boundary range of the expansion through temperature control, and specifically achieving accurate thermal coagulation through the high temperature threshold and high temperature duration. In the utility model, the electrode needle is designed with a thinner outer diameter, which can achieve the purpose of precise ablation; the temperature measuring probe can detect the temperature on the outer wall of the front port of the biopsy channel in real time, so that when the biopsy tool is withdrawn and the missed biopsy cells are accumulated at the front port of the biopsy channel, the temperature at the temperature measuring probe can be heated by the active ablation electrode to reach the set temperature to ablate and kill the biopsy cells accumulated at the front port of the biopsy channel, completely solving the problem of tissue metastasis and implantation around the puncture site.

[0021] The concept, specific structure and technical effects of the present invention will be further described below in conjunction with the accompanying drawings to fully understand the purpose, characteristics and effects of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 This is a schematic diagram of the assembly structure of the biopsy tool and the biopsy channel of the embodiment of the utility model;

[0023] Figure 2 This is a schematic diagram of a biopsy channel in an embodiment of the utility model;

[0024] Figure 3 It is a schematic diagram of the assembly structure of the ablation electrode and the biopsy channel according to an embodiment of the utility model.

[0025] The reference numerals are as follows:

[0026] Biopsy channel 1, biopsy tool 2, electrode needle 3, handle 4, temperature measuring probe 5. DETAILED DESCRIPTION

[0027] In order to make the technical means, creative features, objectives and effects of the utility model easier to understand, the utility model is further described below with reference to specific diagrams. However, the utility model is not limited to the following implementation cases.

[0028] It should be noted that the structures, proportions, sizes, etc. illustrated in the drawings in this specification are only used to match the contents disclosed in the specification so that people familiar with this technology can understand and read them. They are not used to limit the conditions under which the present utility model can be implemented, so they have no substantive technical significance. Any structural modification, change in proportional relationship or adjustment of size should still fall within the scope of the technical contents disclosed in the present utility model without affecting the effects and purposes that can be achieved by the present utility model.

[0029] like Figures 1 to 3 As shown, a biopsy device with an ablation electrode includes a biopsy channel 1, a biopsy tool 2, and an electrode needle 3 fixed on a handle 4, and the handle 4 is connected to the ablation host through a connecting line. The biopsy tool 2 can be movably inserted into the biopsy channel 1, and the electrode needle 3 has a smaller outer diameter and can also be movably inserted into the biopsy channel 1. The temperature measuring probe 5 is arranged at the front end of the biopsy channel 1.

[0030] When in use, the biopsy sampling operation is first performed. The biopsy tool 2 is first inserted into the biopsy channel 1 to perform the tissue sampling operation. Then the biopsy tool 2 with the biopsy tissue at the front end is withdrawn from the biopsy channel 1. The biopsy sample at the front end of the biopsy tool 1 can be processed. Then the ablation operation is performed. The ablation host is started, and the electrode needle 3 is inserted into the biopsy channel 1. After the electrode needle 3 reaches the front end of the biopsy channel 1, the host system starts to run and the ablation operation is performed. The temperature probe 5 transmits the ablation temperature to the ablation host in real time, and the operator can grasp the ablation temperature in real time. After the ablation is completed, the front end position of the biopsy channel 1 will no longer carry the tissue of the lesion after the ablation operation. At this time, the needle withdrawal operation is performed, which greatly reduces the risk of needle tract implantation.

[0031] This embodiment will solve the problem of metastasis caused by the puncture process by making a single channel compatible with the biopsy tool 2 and the ablation electrode needle 3. By placing a temperature measuring probe 5 near the sampling point (here, on the outer wall of the front port of the biopsy channel 1) and controlling the safety boundary covering the sampling point through the duration of the temperature threshold, precise hemostasis, ablation and thermal coagulation can be achieved. This design is only used to ablate tumor cells attached to the puncture needle and is suitable for use with a biopsy tool, not for ablation treatment.

[0032] The host is a radio frequency or microwave energy generator. Since the electrode needle 3 only needs to ablate the residue caused by the biopsy, the power required is relatively low, so the output power range of the generator is usually not higher than 20W. The host system of the generator includes a temperature monitoring function, which can dynamically monitor the temperature of the biopsy needle through the temperature measuring probe 5, mainly used to control the range of the safety boundary, which is achieved by setting the threshold and controlling the high temperature time. When the temperature reaches the required temperature and is maintained for a certain period of time according to the system setting, the system is shut down and the needle can be safely withdrawn.

[0033] The utility model optimizes the algorithm to make the power output of the system more accurate. Through low power output and thinner outer diameter of the ablation electrode needle, the purpose of accurate ablation can be achieved. The utility model combines the traditional passive puncture tool with the active ablation electrode needle technology, adds local ablation and temperature control to the conventional biopsy process, and can completely solve the problem of tissue transfer and implantation around the puncture site, which is beneficial to the health of patients.

[0034] The preferred specific embodiments of the utility model are described in detail above. It should be understood that ordinary technology in the field can make many modifications and changes according to the concept of the utility model without creative work. Therefore, any technical solution that can be obtained by a technician in the technical field based on the concept of the utility model through logical analysis, reasoning or limited experiments on the basis of the existing technology should be within the scope of protection determined by the claims.

Claims

1. A biopsy device with an ablation electrode, characterized in that: It includes a biopsy tool, a biopsy channel, an ablation host, and an ablation electrode. The biopsy tool is located inside the biopsy channel. The ablation electrode includes an electrode needle and a handle. The handle is connected to the ablation host through a connecting line. The biopsy channel is parallel to the electrode needle. A temperature measuring probe is provided on the outer wall of the front port of the biopsy channel. The biopsy tool can be detachably placed in the biopsy channel, and the ablation electrode can be detachably placed in the biopsy channel.

2. The device according to claim 1, characterized in that The biopsy tool is a biopsy brush or a biopsy forceps.

3. The device according to claim 1, characterized in that The ablation host is installed with a built-in system, and the built-in system includes a temperature detection module and a power output module.

4. The device according to claim 3, characterized in that The maximum output power of the ablation host is 100W.

5. The device according to claim 4, characterized in that The ablation host is a microwave ablation host or a radiofrequency ablation host.

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