Multifunctional radiofrequency ablation system for treating breast lesion

Abstract

The invention discloses a multifunctional radiofrequency ablation system for treating breast lesions, which comprises a radiofrequency host, an ablation electrode, a pumping device and a controller, the radiofrequency host is electrically connected with the controller, both the ablation electrode and the pumping device are electrically connected with the radiofrequency host, and the pumping device is communicated with the ablation electrode; the ablation electrode comprises a needle rod assembly and a handle assembly, a first channel is formed in the needle rod assembly, a second channel communicated with the first channel is formed in the handle assembly, and a quick-release connecting piece communicated with the second channel is arranged outside the handle assembly. The device integrates the five functions of radiofrequency ablation, cyst fluid suction, sampling biopsy, smoke exhaust and flushing, cyst fluid suction, sampling biopsy, flushing operation and inner cyst wall ablation in the normal saline environment are achieved through the ablation electrode, instruments do not need to be replaced repeatedly in the ablation process, smoke generated in the ablation process can be exhausted, and the ablation efficiency is improved. And the operation efficiency and the ablation accuracy are effectively improved.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a multifunctional radiofrequency ablation system for treating breast lesions. Background Technology

[0002] Breast lesions refer to abnormal changes in breast tissue, broadly classified into benign and malignant categories. Common benign lesions include breast hyperplasia (related to endocrine disorders), breast cysts (fluid-filled cystic structures), and breast fibroadenomas (common in young women), most of which can be observed or treated surgically. Malignant lesions are primarily breast cancer, requiring diagnosis through imaging and pathology, and necessitating comprehensive treatment. In the treatment of breast cysts, the traditional approach is mechanical surgical removal. While effective, this method is invasive, has drawbacks such as significant trauma, a long recovery period, and potential scarring. In recent years, radiofrequency ablation, as a minimally invasive and precise treatment method, has gained widespread attention and application. This technique uses high-frequency current to generate heat within local tissue, causing coagulative necrosis of cells in the target area, thereby achieving the therapeutic goal. For the ablation treatment of breast cysts, existing ablation instruments cannot handle multiple lesions, requiring switching between multiple instruments, which increases the difficulty and duration of the operation. Furthermore, existing ablation techniques cannot operate in a saline environment, thus failing to ablate the inner cyst wall. Instead, they rely on highly destructive ablation to radiofrequency destroy both the target tissue and normal tissue, causing unnecessary tissue damage and thus having certain limitations. Summary of the Invention

[0003] The purpose of this invention is to provide a multifunctional radiofrequency ablation system for treating breast lesions, thereby addressing the aforementioned problems in the prior art.

[0004] To achieve the above objectives, the present invention adopts the following technical solution: a multifunctional radiofrequency ablation system for treating breast lesions, comprising a radiofrequency host, an ablation electrode, an aspiration device, and a controller. The radiofrequency host is electrically connected to the controller. The ablation electrode and the aspiration device are both electrically connected to the radiofrequency host. The aspiration device is connected to the ablation electrode. The aspiration device is used to draw out the cyst fluid from the cyst through the ablation electrode. The aspiration device is also used to introduce saline or drugs into the cyst through the ablation electrode. The ablation electrode includes a needle rod assembly and a handle assembly. The needle rod assembly has a first channel inside, and the handle assembly has a second channel inside that communicates with the first channel. The handle assembly has a quick-release connector outside that communicates with the second channel, and the quick-release connector is connected to the extraction device.

[0005] As an optional implementation of the above technical solution, the needle rod assembly includes an inner tube and an outer tube. The first channel is provided inside the inner tube, and the outer tube is sleeved on the outside of the inner tube. An insulating component is provided between the outer tube and the inner tube. Both the outer tube and the inner tube are connected to the radio frequency host via cables.

[0006] As an optional embodiment of the above technical solution, the inner tube has an annular mounting groove on its surface, and the outer tube is installed in the annular mounting groove and the two are kept insulated by an insulating component.

[0007] As an optional embodiment of the above technical solution, the insulating component includes an insulating tube and an insulating ring. The insulating tube is sleeved between the inner tube and the outer tube, and the insulating ring is disposed at the end of the insulating tube, with both sides of the insulating ring abutting against the inner tube and the outer tube, respectively.

[0008] As an optional implementation of the above technical solution, the end of the inner tube is provided with a pointed portion.

[0009] As an optional implementation of the above technical solution, the quick-release connector includes a quick-release connector head and a connecting tube. One end of the connecting tube is disposed on the handle assembly and communicates with the second channel, and the other end of the connecting tube is connected to the quick-release connector head.

[0010] As an optional implementation of the above technical solution, the aspiration device includes an aspiration pump, a delivery pipeline, and a storage container. The aspiration pump is disposed on the delivery pipeline and is electrically connected to the radio frequency host. One end of the delivery pipeline is connected to a quick-release connector, and the other end of the delivery pipeline is detachably connected to the storage container. When aspirating cystic fluid, the aspiration pump introduces the cystic fluid from the cyst into the storage container through the ablation electrode. When injecting saline or rinsing the lesion, the storage container is replaced with a saline bottle or a drug bottle, and the aspiration pump introduces the saline or drug from the saline bottle or drug bottle into the cyst through the ablation electrode.

[0011] As an optional implementation of the above technical solution, it also includes a flexible sampling biopsy needle, which is used to pass through the quick-release connector, the second channel and the first channel in sequence to reach the sampling point of the lesion tissue for sampling.

[0012] The beneficial effects of this invention are as follows: This invention provides a multifunctional radiofrequency ablation system for treating breast lesions, which integrates five functions: radiofrequency ablation, cyst fluid aspiration, sampling biopsy, fume exhaust, and flushing. It achieves cyst fluid aspiration, sampling biopsy, flushing, and ablation of the inner cyst wall in a saline environment through ablation electrodes. Moreover, it does not require repeated instrument changes during the ablation process and can exhaust the fumes generated during the ablation process, effectively improving surgical efficiency and ablation accuracy. Attached Figure Description

[0013] Figure 1 This is a schematic diagram of the structure of a multifunctional radiofrequency ablation system according to one embodiment of the present invention; Figure 2 This is a schematic diagram of the ablation electrode structure in one embodiment of the present invention; Figure 3 yes Figure 2 Enlarged view of the middle section; Figure 4 yes Figure 2 Enlarged view of section II; Figure 5 This is a diagram showing the usage status of the flexible sampling biopsy needle in one embodiment of the present invention.

[0014] In the diagram: 1-RF host; 2-ablation electrode; 3-aspiration device; 4-controller; 5-flexible sampling biopsy needle; 2.1-Needle bar assembly; 2.2-Handle assembly; 2.1.1-Inner tube; 2.1.2-Outer tube; 2.1.3-Insulating tube; 2.1.4-Insulating ring; 2.2.1-Cable; 2.2.2-Connecting tube; 2.2.3-Quick-release connector; 3.1-Suction pump; 3.2-Transfer pipeline; 3.3-Storage container. Detailed Implementation

[0015] like Figures 1-5 As shown, this embodiment provides a multifunctional radiofrequency ablation system for treating breast lesions, which integrates five functions: radiofrequency ablation, cyst fluid aspiration, sampling biopsy, fume exhaust, and flushing. Through the ablation electrode 2, it realizes cyst fluid aspiration, sampling biopsy, flushing, and ablation of the inner cyst wall in a saline environment. Moreover, it does not require repeated instrument replacement during the ablation process and can exhaust the fume generated during the ablation process, effectively improving the efficiency and accuracy of the operation.

[0016] like Figure 1 As shown, this multifunctional radiofrequency ablation system includes a radiofrequency host 1, an ablation electrode 2, an aspiration device 3, and a controller 4. The radiofrequency host 1 is mainly responsible for generating and regulating the radiofrequency energy required for treatment. The ablation electrode 2 is mainly responsible for performing puncture, energy release, and providing a channel. The aspiration device 3 is mainly responsible for fluid aspiration and injection. The system controller 4 serves as the control core, monitoring and coordinating the normal operation of each unit. The radiofrequency host 1 is electrically connected to the controller 4, and the ablation electrode 2 and the aspiration device 3 are both electrically connected to the radiofrequency host 1, enabling control of treatment parameters and auxiliary operations.

[0017] The aspiration device 3 is connected to the ablation electrode 2. The aspiration device 3 is used to draw out the cystic fluid from the cyst through the ablation electrode 2. The aspiration device 3 is also used to introduce saline or medication into the cyst through the ablation electrode 2. This invention enables cyst ablation in a saline environment. Because cyst lesions are hollow and lack tissue fluid, conventional electrodes cannot ablate them. By directly injecting an appropriate amount of saline into the cyst using the ablation electrode 2, selective radiofrequency ablation of the cyst wall is achieved in a saline environment, thereby achieving the goal of minimally invasive and precise treatment.

[0018] like Figure 2 As shown, in this embodiment, the ablation electrode 2 includes a needle rod assembly 2.1 and a handle assembly 2.2. The needle rod assembly 2.1 has a first channel inside, and the handle assembly 2.2 has a second channel communicating with the first channel inside. The handle assembly 2.2 has a quick-release connector communicating with the second channel on the outside. The needle rod assembly 2.1 is mounted on the handle assembly 2.2. The needle rod assembly 2.1 has a slender structure for puncture and has a through first channel inside. The handle assembly 2.2 is easy for doctors to hold and has a second channel communicating with the first channel inside. The handle assembly 2.2 has a quick-release connector on the outside, which communicates with the second channel and is used to quickly connect and disconnect the delivery tubing 3.2 of the aspiration device 3. Cyst fluid inside the cyst can enter the aspiration device 3 through the second channel, the first channel, and the quick-release connector to achieve cyst fluid drainage. The aspiration device 3 can also introduce external saline or drugs into the cyst through the ablation electrode 2 to achieve cyst wall flushing and ablation of the inner cyst wall in a saline environment.

[0019] Specifically, the quick-release connector includes a quick-release connector 2.2.3 and a connecting tube 2.2.2. One end of the connecting tube 2.2.2 is mounted on the handle assembly 2.2 and communicates with the second channel. The other end of the connecting tube 2.2.2 is connected to the quick-release connector 2.2.3. The quick-release connector 2.2.3 is used to connect with the extraction device 3 to facilitate the assembly and disassembly of the ablation electrode 2 and the extraction device 3.

[0020] like Figure 3 and Figure 4As shown, in one specific embodiment, the needle rod assembly 2.1 includes an inner tube 2.1.1 and an outer tube 2.1.2. The inner tube 2.1.1 has a first channel inside and a pointed end for easy puncture. The outer tube 2.1.2 is sleeved outside the inner tube 2.1.1, and an insulating component is provided between the outer tube 2.1.2 and the inner tube 2.1.1. Both the outer tube 2.1.2 and the inner tube 2.1.1 are connected to the radiofrequency host 1 via a cable 2.2.1. The ablation electrode 2 adopts a dual-electrode structure, with both the outer tube 2.1.2 and the inner tube 2.1.1 being conductive and connected to the radiofrequency host 1 via the cable 2.2.1. The insulating component between the outer tube 2.1.2 and the inner tube 2.1.1 allows both the outer tube 2.1.2 and the inner tube 2.1.1 to ablate the capsule wall, increasing the ablation range of the capsule wall.

[0021] Specifically, an annular mounting groove is formed on the surface of the inner tube 2.1.1, and the outer tube 2.1.2 is installed in the annular mounting groove and kept insulated from each other by an insulating component. The insulating component includes an insulating tube 2.1.3 and an insulating ring 2.1.4. The insulating tube 2.1.3 is fitted between the inner tube 2.1.1 and the outer tube 2.1.2, and the insulating ring 2.1.4 is located at the end of the insulating tube 2.1.3, with both sides of the insulating ring 2.1.4 abutting against the inner tube 2.1.1 and the outer tube 2.1.2 respectively, maintaining the insulation between the inner tube 2.1.1 and the outer tube 2.1.2. This ensures that both the outer tube 2.1.2 and the inner tube 2.1.1 can ablate the capsule wall, making the overall operation more convenient and faster.

[0022] like Figure 1 As shown, in one specific embodiment, the aspiration device 3 includes an aspiration pump 3.1, a delivery pipeline 3.2, and a storage container 3.3. The aspiration pump 3.1 is mounted on the delivery pipeline 3.2 and is electrically connected to the radio frequency host 1. The liquid inside the aspiration pump 3.1 and the delivery pipeline 3.2 are isolated from each other to prevent leakage and contamination of the liquid in the delivery pipeline 3.2. One end of the delivery pipeline 3.2 is connected to a quick-release connector, and the other end is detachably connected to the storage container 3.3. When aspirating cyst fluid, the aspiration pump 3.1 introduces the cyst fluid from the cyst into the storage container 3.3 through the ablation electrode 2. When injecting saline or rinsing the lesion, the storage container 3.3 is replaced with a saline bottle or a drug bottle, and the aspiration pump 3.1 introduces the saline or drug from the saline bottle or drug bottle into the cyst through the ablation electrode 2.

[0023] Aspiration pump 3.1 is connected in series with delivery line 3.2 and its suction operation is controlled by radio frequency host 1. The suction device 3 has two working modes: In aspiration mode, delivery line 3.2 is connected to storage container 3.3, and aspiration pump 3.1 can be started to draw out and store the cyst fluid in the cyst through ablation electrode 2, realizing the cyst fluid aspiration function; In injection mode, storage container 3.3 is replaced with saline bottle or drug bottle, and aspiration pump 3.1 can inject saline or drugs into the cyst to realize cyst wall flushing operation and cyst wall ablation in saline environment.

[0024] like Figure 5 As shown, in one specific embodiment, the multifunctional radiofrequency ablation system further includes a flexible sampling biopsy needle 5. The flexible sampling biopsy needle 5 is used to sequentially pass through the quick-release connector, the second channel, and the first channel to reach the lesion tissue sampling point for sampling. When a biopsy is required, the quick-release connector 2.2.3 is quickly separated from the delivery tubing 3.2. The flexible sampling biopsy needle 5 passes through the quick-release connector 2.2.3, the second channel of the connecting tube 2.2.2, and the first channel, then exits from the inner tube 2.1.1 and reaches the lesion, allowing the physician to complete the tissue sampling biopsy along the same puncture path.

[0025] This invention's multifunctional radiofrequency ablation system integrates five functions: radiofrequency ablation, cyst fluid aspiration, sampling biopsy, fume extraction, and flushing. During ablation, the operator inserts the ablation electrode 2 into the cyst under image guidance. When sampling biopsy is required, a flexible sampling biopsy needle 5 is used to reach the lesion for sampling. When cyst fluid aspiration and fume extraction are required, the aspiration pump 3.1 enters aspiration mode, drawing out the cyst fluid and fumes from the cyst through the ablation electrode 2 and storing them in the storage container 3.3. When radiofrequency ablation is required, the storage container 3.3 is replaced with a saline bottle, and the aspiration pump 3.1 enters injection mode, injecting saline into the cyst to ablate the cyst wall using the ablation electrode 2. When flushing is required, the storage container 3.3 is replaced with a drug bottle, and the aspiration pump 3.1 enters injection mode, injecting the drug into the cyst to flush the cyst wall.

[0026] Compared with the prior art, the present invention has the following advantages: 1. It achieves precise ablation of the inner capsule wall, avoiding damage and destruction of normal tissue, improving the precision of the surgery, and reducing the patient's recovery time; 2. It integrates multiple functions, simplifies surgical procedures, greatly improves surgical efficiency, and enhances surgical safety; 3. It reduces complex and cumbersome procedures involving multiple consumables, thereby enhancing the economic value of health products.

[0027] In the description of this invention, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. They can refer to fixed connections, detachable connections, or integral connections; they can be mechanical or electrical connections; they can be direct connections or indirect connections through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art will understand the specific meanings of these terms in this invention. Furthermore, the specific features and structures described in the embodiments are included in at least one implementation method. Those skilled in the art can combine features from different implementation methods without contradiction. The scope of protection of this invention is not limited to the specific implementation methods described above. Based on the basic technical concept of this invention, implementation methods that can be conceived by those skilled in the art without creative effort are all within the scope of protection of this invention.

Claims

1. A multifunctional radiofrequency ablation system for treating breast lesions, characterized in that, The device includes a radio frequency host (1), an ablation electrode (2), a suction device (3), and a controller (4). The radio frequency host (1) is electrically connected to the controller (4). The ablation electrode (2) and the suction device (3) are both electrically connected to the radio frequency host (1). The suction device (3) is connected to the ablation electrode (2). The suction device (3) is used to draw out the cyst fluid in the cyst through the ablation electrode (2). The suction device (3) is also used to introduce saline or drugs into the cyst through the ablation electrode (2). The ablation electrode (2) includes a needle bar assembly (2.1) and a handle assembly (2.2). The needle bar assembly (2.1) has a first channel inside. The handle assembly (2.2) has a second channel inside that communicates with the first channel. The handle assembly (2.2) has a quick-release connector outside that communicates with the second channel. The quick-release connector is connected to the suction device (3).

2. The multifunctional radiofrequency ablation system for treating breast lesions according to claim 1, characterized in that, The needle bar assembly (2.1) includes an inner tube (2.1.1) and an outer tube (2.1.2). The first channel is provided inside the inner tube (2.1.1). The outer tube (2.1.2) is sleeved on the outside of the inner tube (2.1.1). An insulating component is provided between the outer tube (2.1.2) and the inner tube (2.1.1). Both the outer tube (2.1.2) and the inner tube (2.1.1) are connected to the radio frequency host (1) through a cable (2.2.1).

3. The multifunctional radiofrequency ablation system for treating breast lesions according to claim 2, characterized in that, The inner tube (2.1.1) has an annular mounting groove on its surface, and the outer tube (2.1.2) is installed in the annular mounting groove and the two are kept insulated by an insulating component.

4. The multifunctional radiofrequency ablation system for treating breast lesions according to claim 3, characterized in that, The insulating assembly includes an insulating tube (2.1.3) and an insulating ring (2.1.4). The insulating tube (2.1.3) is sleeved between the inner tube (2.1.1) and the outer tube (2.1.2). The insulating ring (2.1.4) is disposed at the end of the insulating tube (2.1.3), and the two sides of the insulating ring (2.1.4) abut against the inner tube (2.1.1) and the outer tube (2.1.2) respectively.

5. The multifunctional radiofrequency ablation system for treating breast lesions according to claim 3, characterized in that, The inner tube (2.1.1) has a pointed end.

6. The multifunctional radiofrequency ablation system for treating breast lesions according to claim 1, characterized in that, The quick-release connector includes a quick-release connector (2.2.3) and a connecting tube (2.2.2). One end of the connecting tube (2.2.2) is disposed on the handle assembly (2.2) and communicates with the second channel, and the other end of the connecting tube (2.2.2) is connected to the quick-release connector (2.2.3).

7. The multifunctional radiofrequency ablation system for treating breast lesions according to claim 1, characterized in that, The aspiration device (3) includes an aspiration pump (3.1), a delivery pipeline (3.2), and a storage container (3.3). The aspiration pump (3.1) is installed on the delivery pipeline (3.2) and is electrically connected to the radio frequency host (1). One end of the delivery pipeline (3.2) is connected to a quick-release connector, and the other end of the delivery pipeline (3.2) is detachably connected to the storage container (3.3). When aspirating cyst fluid, the aspiration pump (3.1) introduces the cyst fluid in the cyst into the storage container (3.3) through the ablation electrode (2). When injecting saline or rinsing the lesion, the storage container (3.3) is replaced with a saline bottle or a drug bottle, and the aspiration pump (3.1) introduces the saline or drug from the saline bottle or drug bottle into the cyst through the ablation electrode (2).

8. The multifunctional radiofrequency ablation system for treating breast lesions according to claim 1, characterized in that, It also includes a flexible sampling biopsy needle (5), which is used to pass through the quick-release connector, the second channel and the first channel in sequence to reach the lesion tissue sampling point for sampling.

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