Radiofrequency ablation system with hemostatic function

Abstract

The application discloses a radiofrequency ablation system with hemostatic function, which comprises a sleeve, a radiofrequency ablation electrode assembly and a generator; the sleeve is an active device and is connected with a first port of the generator through a transmission line; an electric signal emitted by the first port controls the temperature of the outer surface of the sleeve; the radiofrequency ablation electrode assembly is connected with a second port of the generator through a transmission line; a signal emitted by the second port controls radiofrequency energy and / or microwave energy emitted by the radiofrequency ablation electrode assembly; the radiofrequency ablation electrode assembly comprises a radiation zone needle, an electrode and a first section which are sequentially connected; the radiofrequency ablation system with hemostatic function has an ablation form; in the ablation form, the first section of the radiofrequency ablation electrode assembly is sleeved in the sleeve, and the radiation zone needle and the electrode extend out of the sleeve. The application creates a new design by actively using the sleeve, allows the sleeve to inject medicine, and uses the sleeve as a hemostatic tool when the hemostatic function works, so that the needle bleeding problem of ablation is avoided.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, in particular to a radiofrequency ablation system with hemostatic function. BACKGROUND

[0002] Radiofrequency ablation is a new minimally invasive treatment technology for solid tumors in recent years, which can make patients avoid the pain of surgery, and has the advantages of high curative effect, small trauma, less pain, fast recovery, no sequelae, no risk, wide indications, etc. compared with traditional treatment. It is praised as green treatment technology by domestic and foreign experts.

[0003] At present, after completing lesion ablation, when the radiofrequency ablation needle is pulled out, the parenchymal organs subjected to radiofrequency ablation often have bleeding, and there is still a lack of effective hemostatic method. In addition, if the tumor subjected to radiofrequency ablation is a malignant tumor, the tumor may be taken out along the needle path when the biopsy needle is withdrawn, resulting in tumor cell spread.

[0004] The existing radiofrequency ablation system only has ablation function, and in the process of clinical use, there is no overall solution for the application of combined treatment with drugs such as chemotherapy in the clinic. There are the following problems:

[0005] 1. Multiple manufacturers' instruments are used, increasing the complexity of operation.

[0006] 2. Multiple manufacturers' instruments increase the cost of product use in the clinic.

[0007] 3. The passive instrument for single chemotherapy drug injection has the risk of needle tract bleeding and lesion metastasis when used in the clinic. SUMMARY

[0008] In view of the above defects of the prior art, in order to solve at least one of the above problems, the present application discloses a radiofrequency ablation system with hemostatic function, comprising a sleeve, a radiofrequency ablation electrode assembly and a generator; the sleeve is an active device, connected with a first port of the generator through a transmission line; the temperature of the outer surface of the sleeve is controlled by the electric signal emitted from the first port;

[0009] The radiofrequency ablation electrode assembly is connected with a second port of the generator through a transmission line; the radiofrequency energy and / or microwave energy emitted by the radiofrequency ablation electrode assembly is controlled by the signal emitted from the second port;

[0010] The radiofrequency ablation electrode assembly comprises a radiation zone needle head, an electrode and a first section connected in sequence; the radiofrequency ablation system with hemostatic function has an ablation form; in the ablation form, the first section of the radiofrequency ablation electrode assembly is sleeved in the sleeve, and the radiation zone needle head and the electrode extend out of the sleeve.

[0011] In one embodiment, the radiofrequency ablation system with hemostatic function further has an injection mode; in the injection mode, injection liquid is administered through the sleeve.

[0012] In one embodiment, the first section of the radiofrequency ablation electrode assembly is a double-layer tube, i.e. comprising an inner tube and an outer tube; the inner tube is sleeved in the outer tube; the generator is a radiofrequency and / or microwave energy generator.

[0013] In one embodiment, further comprising a biopsy needle; the biopsy needle comprises a biopsy section and a second section connected to each other; the radiofrequency ablation system with hemostatic function further has a biopsy mode; in the biopsy mode, the second section of the biopsy needle is sleeved in the sleeve, while the biopsy section extends out of the sleeve.

[0014] In one embodiment, further comprising a handle; the sleeve head of the sleeve is sleeved on the handle; in the biopsy mode, the second section of the biopsy needle is connected to the handle; the handle controls the movement of the biopsy needle in the sleeve.

[0015] In one embodiment, further comprising a handle; the sleeve head of the sleeve is sleeved on the handle; in the ablation mode, the first section of the radiofrequency ablation electrode assembly is connected to the handle; the handle controls the movement of the radiofrequency ablation electrode assembly in the sleeve.

[0016] In one embodiment, under the control of the electrical signal emitted by the first port, the temperature of the outer surface of the sleeve is 45-80℃.

[0017] In one embodiment, under the control of the electrical signal emitted by the first port, the temperature of the outer surface of the sleeve is 50-75℃.

[0018] In one embodiment, the radiofrequency ablation system with hemostatic function further has an injection mode, a biopsy mode and a hemostatic mode; in the injection mode, injection liquid is administered through the sleeve; in the biopsy mode, the second section of the biopsy needle is sleeved in the sleeve, while the biopsy section extends out of the sleeve; in the hemostatic mode, the temperature of the outer surface of the sleeve is 45-80℃; the ablation mode, the injection mode, the biopsy mode and / or the hemostatic mode can be switched as needed.

[0019] In one embodiment, the switching sequence between the ablation mode, the injection mode, the biopsy mode and / or the hemostatic mode comprises the following a-n cases:

[0020] a. first switching from the ablation mode to the injection mode, then to the biopsy mode, and finally to the hemostatic mode;

[0021] b. first switching from the ablation mode to the biopsy mode, then to the injection mode, and finally to the hemostasis mode;

[0022] c. first switching from the ablation mode to the injection mode, and finally to the hemostasis mode;

[0023] d. first switching from the ablation mode to the biopsy mode, and finally to the hemostasis mode;

[0024] e. first switching from the biopsy mode to the injection mode, then to the ablation mode, and finally to the hemostasis mode;

[0025] f. first switching from the biopsy mode to the ablation mode, then to the injection mode, and finally to the hemostasis mode;

[0026] g. first switching from the injection mode to the ablation mode, then to the biopsy mode, and finally to the hemostasis mode;

[0027] h. first switching from the injection mode to the biopsy mode, then to the ablation mode, and finally to the hemostasis mode;

[0028] i. first switching from the injection mode and the biopsy mode to the ablation mode, and finally to the hemostasis mode;

[0029] j. first switching from the injection mode and the ablation mode to the biopsy mode, and finally to the hemostasis mode;

[0030] k. first switching from the hemostasis mode and the ablation mode to the biopsy mode, and finally back to the hemostasis mode;

[0031] l. first switching from the hemostasis mode and the biopsy mode to the ablation mode, and finally back to the hemostasis mode;

[0032] m. first switching from the hemostasis mode and the ablation mode to the biopsy mode, then to the injection mode, and finally back to the hemostasis mode;

[0033] n. first switching from the hemostasis mode and the biopsy mode to the ablation mode, then to the injection mode, and finally back to the hemostasis mode.

[0034] In one embodiment, the generator has a temperature monitoring function, which can dynamically monitor the temperature of the needle of the biopsy needle.

[0035] In one embodiment, the power required by the radiofrequency ablation electrode assembly is not higher than 50 W, which is provided by the generator.

[0036] The present application relates to:

[0037] 1) An active biopsy electrode needle system with ablation function, which includes a radio frequency (microwave) energy generator and a disposable electrode needle with ablation function.

[0038] Radio frequency (microwave) generator: An energy transmitter used for ablation, typically high-power radio frequency (microwave) energy.

[0039] Radio frequency energy module: This module is integrated into the radio frequency or microwave ablation generator and is used to connect to the cannula for active needle tract hemostasis.

[0040] 2) Disposable radiofrequency ablation electrode.

[0041] This invention relates to an electrode needle design for use in percutaneous, laparoscopic, or bronchoscopic channels with a biopsy tool (such as a brush or biopsy needle) channel (i.e., a cannula).

[0042] 3) Disposable ablation channel (i.e. cannula) with needle channel hemostasis function for injectable drugs.

[0043] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0044] 1. A groundbreaking design that activates the external channel (i.e., the cannula) allows for drug injection when the cannula is not connected to the main unit and is in a passive state. When connected to the main unit and in an active state, the cannula is used for hemostasis, thus avoiding needle tract bleeding during ablation. The generator controls the temperature of the cannula's outer surface, ensuring that bleeding points near the cannula are at an optimal coagulation temperature, accelerating coagulation and achieving timely hemostasis.

[0045] 2. The active radiofrequency cannula combined with radiofrequency (microwave) ablation electrodes and a biopsy needle in this invention enables ablation surgery to address biopsy needs that traditional single ablation techniques cannot meet. Simultaneously, because the biopsy needle is positioned inside the cannula, after the biopsy is taken and the needle is withdrawn, the surrounding tissue brought out with the biopsy needle enters the cannula. Under controlled cannula temperature, residual tumor cells inside the cannula are inactivated, thus preventing tumor cells from metastasizing to other sites with the withdrawn biopsy needle, thereby avoiding the risk of needle tract metastasis and seeding.

[0046] 3. If necessary, the procedure can be modified by injecting the medication first through a cannula, which helps reduce the carbonization area during the ablation process.

[0047] 4. Simplified surgical procedure: Based on the radiofrequency ablation platform, it integrates multiple technologies (drug injection, biopsy, hemostasis), making the use of instruments more standardized, the safety of the surgery higher, and the success rate higher.

[0048] This invention combines a traditional passive puncture tool with an active cannula, adding a crucial design element of active cannula wall heating (45-80℃) for hemostasis to the conventional radiofrequency ablation procedure. Temperature control is implemented during ablation and biopsy, effectively resolving the technical problem of tissue around the puncture site being transferred to other sites during needle withdrawal, i.e., needle tract transfer and implantation. In this invention, the electrode needle is designed with a smaller outer diameter to achieve precise ablation. Precise temperature control is a key design focus for the ablation electrode and the development of the built-in system. Based on advancements in microwave and radiofrequency ablation technologies, algorithm optimization allows for more precise output power from the ablation unit, achieving low-power output.

[0049] The following will further explain the concept, specific structure, and technical effects of the present invention in conjunction with the accompanying drawings, so as to fully understand the purpose, features, and effects of the present invention. Attached Figure Description

[0050] Figure 1 This is a schematic diagram of the structure of a radiofrequency ablation system with hemostatic function according to a specific embodiment of the present invention;

[0051] Figure 2 This is a partial structural diagram of a radiofrequency ablation system with hemostasis function in the ablation mode according to a specific embodiment of the present invention;

[0052] Figure 3 This is a schematic diagram of the sleeve and generator involved in a specific embodiment of the present invention;

[0053] Figure 4 This is a schematic diagram of the structure of the radiofrequency ablation electrode assembly and handle involved in a specific embodiment of the present invention;

[0054] Figure 5 This is a flowchart illustrating a usage scenario of the radiofrequency ablation system with hemostasis function involved in this invention.

[0055] The accompanying figure is labeled as follows:

[0056] Radiation zone needle 1, radiofrequency ablation electrode assembly 2, outer tube 3, inner tube 4, handle 5, generator 6, first port 7, second port 8, sleeve 9, electrode 10, and sheath 11. Detailed Implementation

[0057] To make the technical means, inventive features, objectives, and effects of the invention readily understandable, the invention is further illustrated below with reference to specific figures. However, the invention is not limited to the embodiments described below.

[0058] It should be noted that the structures, proportions, sizes, etc., illustrated in the accompanying drawings of this specification are only used to complement the content disclosed in the specification for those skilled in the art to understand and read, and are not intended to limit the conditions under which the present invention can be implemented. Therefore, they have no substantial technical significance. Any modifications to the structure, changes in the proportions, or adjustments to the size, without affecting the effects and objectives that the present invention can produce, should still fall within the scope of the technical content disclosed in the present invention.

[0059] Example 1

[0060] Figures 1-4 This embodiment illustrates a radiofrequency ablation system with hemostasis and drug injection functions. The system includes a cannula 9, a radiofrequency ablation electrode assembly 2, a biopsy needle, a handle 5, and a generator 6. The generator 6 is a radiofrequency and / or microwave energy generator containing a radiofrequency module for needle tract ablation.

[0061] The radiofrequency ablation electrode assembly 2 is connected to the second port 8 of the generator 6 via a transmission line; the signal emitted from the second port 8 controls the radiofrequency energy and / or microwave energy emitted by the radiofrequency or microwave ablation electrode assembly 2. The radiofrequency ablation electrode assembly 2 includes a radiation zone needle 1, an electrode 10, and a first segment connected in sequence.

[0062] The radiofrequency ablation system with hemostasis function has ablation mode, injection mode, biopsy mode, and hemostasis mode. In ablation mode, the first segment of the radiofrequency ablation electrode assembly 2 is fitted inside the cannula 9, while the radiating area needle 1 and electrode 10 extend out of the cannula 9. In injection mode, the injection solution is administered through the cannula 9. The biopsy needle includes a biopsy section and a second section connected to each other. In biopsy mode, the second section of the biopsy needle is fitted inside the cannula 9, while the biopsy section extends out of the cannula 9. In hemostasis mode, the cannula 9 is connected to port 7 in the generator via an external transmission line, allowing it to operate actively, with an external surface temperature of 45-80℃, 50-75℃, 55-75℃, 60-70℃, 55℃, or 65℃. The ablation mode, injection mode, biopsy mode, and / or hemostasis mode can be switched as needed.

[0063] The first section of the radiofrequency ablation electrode assembly 2 is a double-layer tube, consisting of an inner tube 4 and an outer tube 3. The inner tube 4 is fitted inside the outer tube 3.

[0064] Sleeve 9 is an active device, connected to the first port 7 of generator 6 via a transmission line. The electrical signal emitted from the first port 7 controls the temperature of the outer surface of sleeve 9. The temperature controlled by the electrical signal is 45-80℃, 50-75℃, 55-75℃, 60-70℃, 55℃, or 65℃.

[0065] The sheath 11 of the cannula 9 is fitted onto the handle 5. In biopsy mode, the second section of the biopsy needle is connected to the handle 5; the handle 5 controls the movement of the biopsy needle within the cannula 9. In ablation mode, the first section of the radiofrequency ablation electrode assembly 2 is connected to the handle 5; the handle 5 controls the movement of the radiofrequency ablation electrode assembly 2 within the cannula 9. The handle 5 is a fixed handle.

[0066] Example 2

[0067] In this embodiment, the switching order between ablation mode, injection mode, biopsy mode and / or hemostasis mode includes the following an possibilities:

[0068] a. First switch from ablation mode to injection mode, then to biopsy mode, and finally to hemostasis mode;

[0069] b. First switch from ablation mode to biopsy mode, then to injection mode, and finally to hemostasis mode;

[0070] c. First switch from ablation mode to injection mode, and finally to hemostasis mode;

[0071] d. First switch from ablation mode to biopsy mode, and finally to hemostasis mode;

[0072] e. First switch from biopsy mode to injection mode, then to ablation mode, and finally to hemostasis mode;

[0073] f. First switch from biopsy mode to ablation mode, then to injection mode, and finally to hemostasis mode;

[0074] g. First switch from injection mode to ablation mode, then to biopsy mode, and finally to hemostasis mode;

[0075] h. First switch from injection mode to biopsy mode, then to ablation mode, and finally to hemostasis mode;

[0076] i. First switch from injection and biopsy methods to ablation methods, and finally to hemostasis methods;

[0077] j. First switch from injection and ablation modes to biopsy mode, and finally to hemostasis mode;

[0078] k. First switch from hemostasis mode and ablation mode to biopsy mode, and finally back to hemostasis mode.

[0079] l. First switch from hemostasis mode and biopsy mode to ablation mode, and finally back to hemostasis mode.

[0080] m. First, switch from hemostasis mode and ablation mode to biopsy mode, then to injection mode; finally, return to hemostasis mode.

[0081] n. First, switch from hemostasis mode and biopsy mode to ablation mode, then to injection mode; finally, return to hemostasis mode.

[0082] The rest is the same as in Example 1.

[0083] Example 3 Workflow

[0084] Figure 5 The flowchart of the radiofrequency ablation system with hemostasis function in Embodiment 1 is shown in one application scenario. This example illustrates how the radiofrequency ablation system with hemostasis function of the present invention works. The application scenario is not limited to this. Figure 5 As shown.

[0085] S1. Connect the cannula and radiofrequency ablation electrode assembly of the radiofrequency ablation system with hemostasis function to the generator (i.e., connect the radiofrequency electrode with the cannula to the main unit). The cannula is connected to the first port of the generator through a transmission line (i.e., cannula connected to port one), and the radiofrequency ablation electrode assembly is connected to the second port of the generator through a transmission line (i.e., radiofrequency electrode connected to port two).

[0086] S2. Set the system to ablation electrode working mode. In ablation electrode working mode, the system is in ablation state during step S4.

[0087] S3. Secure the cannula and electrode (i.e., the radiofrequency ablation electrode assembly) and place it into the target ablation area.

[0088] S4. Perform ablation.

[0089] S5, Ablation complete.

[0090] S6. Exit the ablation electrode retention channel.

[0091] S7. Select the system mode and set it to needle tract hemostasis mode. In needle tract hemostasis mode, the system is in hemostasis state as described in step S10.

[0092] S8. Using the reserved channel (i.e. cannula), inject the required medication or perform procedures such as biopsy (i.e., the system needs to be in injection or biopsy mode).

[0093] S9. After completing the drug injection or biopsy, remove the biopsy tools (i.e., biopsy needles).

[0094] S10, press the start button to use the channel (i.e., cannula) to complete needle tract hemostasis and withdraw the needle (i.e., cannula).

[0095] The preferred embodiments of the present invention have been described in detail above. It should be understood that those skilled in the art can make numerous modifications and variations based on the concept of the present invention without creative effort. Therefore, all technical solutions that can be obtained by those skilled in the art based on the concept of the present invention through logical analysis, reasoning, or limited experimentation on the basis of existing technology should be within the scope of protection defined by the claims.

Claims

1. A radiofrequency ablation system with hemostatic function, characterized in that, It includes a cannula, a radiofrequency ablation electrode assembly, a biopsy needle, and a generator; the cannula is an active device and is connected to a first port of the generator via a transmission line; the electrical signal emitted from the first port controls the temperature of the outer surface of the cannula; The radiofrequency ablation electrode assembly is connected to the second port of the generator via a transmission line; the signal emitted from the second port controls the radiofrequency energy and / or microwave energy emitted by the radiofrequency ablation electrode assembly; the biopsy needle includes a biopsy section and a second section connected to each other; The radiofrequency ablation electrode assembly includes a radiation zone needle, an electrode, and a first segment connected in sequence; the radiofrequency ablation system with hemostasis function has an ablation mode, a biopsy mode, and a hemostasis mode; in the ablation mode, the first segment of the radiofrequency ablation electrode assembly is fitted inside the cannula, while the radiation zone needle and the electrode extend out of the cannula; in the biopsy mode, the second segment of the biopsy needle is fitted inside the cannula, while the biopsy section extends out of the cannula; in the hemostasis mode, the temperature of the outer surface of the cannula is 45-80℃; the ablation mode, the biopsy mode, and / or the hemostasis mode can be switched as needed.

2. The radiofrequency ablation system with hemostatic function as described in claim 1, characterized in that, The radiofrequency ablation system with hemostasis function also has an injection mode; in the injection mode, the injected drug is administered through the cannula.

3. The radiofrequency ablation system with hemostatic function as described in claim 1, characterized in that, The first segment of the radiofrequency ablation electrode assembly is a double-layer tube, namely, an inner tube and an outer tube; the inner tube is sleeved inside the outer tube; the generator is a radiofrequency and / or microwave energy generator.

4. The radiofrequency ablation system with hemostatic function as described in claim 1, characterized in that, It also includes a handle; the end of the cannula is fitted onto the handle; in the biopsy configuration, the second section of the biopsy needle is connected to the handle; the handle controls the movement of the biopsy needle within the cannula.

5. The radiofrequency ablation system with hemostatic function as described in claim 1, characterized in that, It also includes a handle; the end of the cannula is fitted onto the handle; in the ablation mode, the first segment of the radiofrequency ablation electrode assembly is connected to the handle; the handle controls the movement of the radiofrequency ablation electrode assembly within the cannula.

6. The radiofrequency ablation system with hemostasis function as described in claim 1, characterized in that, Under the control of the electrical signal emitted from the first port, the temperature of the outer surface of the sleeve is 50-75℃.

7. The radiofrequency ablation system with hemostatic function as described in claim 1, characterized in that, The radiofrequency ablation system with hemostasis function also has an injection mode; in the injection mode, the injected drug is administered through the cannula; the ablation mode, the injection mode, the biopsy mode and / or the hemostasis mode can be switched as needed.

8. The radiofrequency ablation system with hemostasis function as described in claim 7, characterized in that, The switching order between the ablation mode, the injection mode, the biopsy mode, and / or the hemostasis mode includes the following (a) scenarios: a. First switch from the ablation mode to the injection mode, then to the biopsy mode, and finally to the hemostasis mode; b. First switch from the ablation mode to the biopsy mode, then to the injection mode, and finally to the hemostasis mode; c. First switch from the ablation mode to the injection mode, and finally to the hemostasis mode; d. First switch from the ablation mode to the biopsy mode, and finally to the hemostasis mode; e. First switch from the biopsy mode to the injection mode, then to the ablation mode, and finally to the hemostasis mode; f. First switch from the biopsy mode to the ablation mode, then to the injection mode, and finally to the hemostasis mode; g. First switch from the injection mode to the ablation mode, then to the biopsy mode, and finally to the hemostasis mode; h. First switch from the injection mode to the biopsy mode, then to the ablation mode, and finally to the hemostasis mode; i. First switch from the injection mode and the biopsy mode to the ablation mode, and finally to the hemostasis mode; j. First switch from the injection mode and the ablation mode to the biopsy mode, and finally to the hemostasis mode; k. First switch from the hemostasis mode and the ablation mode to the biopsy mode, and finally return to the hemostasis mode; l. First, switch from the hemostasis mode and the biopsy mode to the ablation mode, and finally return to the hemostasis mode; m. First, switch from the hemostasis mode and the ablation mode to the biopsy mode, then to the injection mode; finally, return to the hemostasis mode. n. First, switch from the hemostasis mode and the biopsy mode to the ablation mode, then to the injection mode; finally, return to the hemostasis mode.

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