Ablation needle puncture system based on bioelectrical impedance

Abstract

The application discloses an ablation needle puncture system based on bioelectric impedance, and relates to the technical field of biomedical engineering. The system comprises a puncture assembly, an electric impedance measurement assembly and an ablation needle catheter. An operating rod is arranged in the hollow cavity of the puncture needle body, and an ablation needle guide accessory is arranged on the operating rod. The electric impedance measurement assembly is used for measuring the electric impedance information of the tissue around the puncture needle body, and judging the target tissue section where the lesion is located according to the electric impedance information. After the lesion section is determined, the position of the ablation needle guide accessory is adjusted through the operating rod, so that the outlet of the ablation needle guide accessory corresponds to the lesion section. The distal end of the ablation needle catheter is provided with a flexible section. The side wall of the puncture needle body is provided with an ablation needle hole. After the ablation needle catheter is inserted through the guide accessory, the ablation needle catheter is inserted into the lesion section through the ablation needle hole, and ablation is started after the puncture is in place. The application can accurately identify and locate the lesion, guide the ablation needle catheter to enter the target tissue section where the lesion is located to perform ablation, and reduce the operation difficulty.

Description

Technical Field

[0001] This invention relates to the field of biomedical engineering technology, and in particular to an ablation needle puncture system based on bioelectrical impedance. Background Technology

[0002] Interventional ablation is a minimally invasive treatment method. Guided by imaging equipment, an ablation needle is inserted through the skin into the diseased tissue. Physical or chemical methods are then used to directly destroy the diseased tissue, causing necrosis and achieving the therapeutic goal. It is widely used in oncology, cardiovascular diseases, and other fields. Current interventional ablation methods primarily involve percutaneous puncture to enter the target tissue. During the puncture procedure, the surgeon needs to precisely locate and identify the target tissue. Traditional image-guided techniques (such as ultrasound, CT, DSA, MRI, etc.) may be limited by issues such as radiation risks, poor real-time performance, and insufficient tissue identification accuracy.

[0003] In recent years, bioimpedance technology has developed rapidly. Bioimpedance measurement technology has been widely applied in basic and clinical sciences. By extracting the magnitude and phase angle of biological tissue signals, and utilizing the different conduction and impedance characteristics of current in structures, components, and biological health conditions such as skin, muscle, fat, bone, and tumors, the tissue state can be clearly assessed. Specifically, bioimpedance measurement technology can be used to measure the impedance value of biological tissue in the puncture site, and the clinical state of the organism can be analyzed from the measurement results, and the physiological state of the biological tissue can also be inferred. For example, Chinese patent application CN202411708739.8 provides a bioimpedance-based puncture surgery tissue identification system, including a dual-electrode impedance needle for real-time acquisition of electrical signal data; a feedback display device, which integrates a trained random forest model to process the electrical signal data and obtain classification results; and a multi-frequency bioimpedance analyzer to display the real-time acquired waveforms and the classification results of the random forest model. The dual-electrode impedance needle includes a needle tube structure and an electrode structure located at the head of the needle tube structure. The needle tube structure, from the inside out, includes an outer needle tube, an insulating layer, and an inner needle core. The electrode structure, from the inside out, includes an excitation electrode layer, an insulating layer, and a measuring electrode layer. The excitation electrode layer is connected to an external excitation electrode cable, and the measuring electrode layer is connected to an external measuring electrode cable. The outer needle tube is connected to the measuring electrode layer, and the inner needle core is connected to the excitation electrode layer. This technical solution measures the electrical impedance value of biological tissue in the puncture area by setting electrodes on the needle tube of the puncture needle. The clinical state of the organism is then analyzed based on the measurement results, and the physiological state of the biological tissue is inferred, thereby identifying the type of biological tissue during the puncture process.

[0004] For example, Chinese patent ZL202510423223.7 provides a puncture device and system with hematoma monitoring function. The device includes: an epidural puncture needle, including a needle body and a needle hub; an epidural catheter for entering the epidural lumen through the epidural puncture needle; the front end of the epidural catheter is an insertion section, which is inserted longitudinally along the epidural lumen after entering it, and an impedance measurement structure is provided corresponding to the insertion section to measure the impedance value around the insertion section and transmit it to an impedance analyzer; the impedance analyzer is used to receive the aforementioned impedance value and assess whether there is a hematoma in the epidural lumen based on the change in impedance information. The above solution is based on bioelectrical impedance measurement technology, which utilizes the characteristic that the impedance of biological tissue changes when its state changes. It can sensitively, timely, and accurately identify the risk of epidural hematoma occurrence and development, thereby helping to improve the quality of clinical medical safety and improve the perioperative prognosis of patients.

[0005] Based on the need for precise identification and localization of target tissue lesions in interventional ablation therapy, this invention provides a new solution that can accurately identify lesions (such as tumors) and locate their positions, and facilitates the introduction of ablation needle catheters, according to the aforementioned bioelectrical impedance measurement technology. Summary of the Invention

[0006] The purpose of this invention is to overcome the shortcomings of existing technologies and provide an ablation needle puncture system based on bioelectrical impedance analysis. The ablation needle puncture system provided by this invention includes a puncture assembly, an impedance measurement assembly, and an ablation needle catheter for ablation. The rigid puncture needle body has a hollow cavity, within which an operating rod is disposed, and an ablation needle guide accessory is disposed on the operating rod. The impedance measurement assembly is used to measure the impedance information of the tissue surrounding the puncture needle body and to determine the target tissue segment where the lesion is located based on the impedance information. After determining the target tissue segment where the lesion is located, the position of the ablation needle guide accessory is adjusted via the operating rod so that the outlet of the guide accessory corresponds to the target tissue segment where the lesion is located. A flexible section is provided at the distal end of the ablation needle catheter. An ablation needle hole is provided on the side wall of the puncture needle body. After the ablation needle catheter is inserted through the ablation needle guide accessory, it pierces into the target tissue segment where the lesion is located through the ablation needle hole. After the puncture is completed, ablation is initiated. This invention can accurately identify and locate lesions (such as tumors). At the same time, the ablation needle catheter is guided into the target tissue segment where the lesion is located through the ablation needle guide accessory for ablation, which reduces the difficulty of surgical operation.

[0007] To achieve the above objectives, the present invention provides the following technical solution: A bioelectrical impedance-based ablation needle puncture system, the system comprising: A puncture assembly for puncturing into target tissue includes a puncture needle body and a needle hub. The rigid puncture needle body has a hollow cavity, in which an operating lever is provided, and an ablation needle guide accessory is provided on the operating lever. The electrical impedance measurement component, which is set corresponding to the puncture needle body, is used to measure the electrical impedance information of the tissue surrounding the puncture needle body, and to determine the target tissue segment where the lesion is located based on the electrical impedance information; after determining the target tissue segment where the lesion is located, the position of the ablation needle guide accessory on it is adjusted by the operating lever so that the outlet of the guide accessory corresponds to the target tissue segment where the lesion is located. The ablation needle catheter used for ablation has a flexible segment at its distal end; the side wall of the puncture needle body is provided with an ablation needle hole. After the ablation needle catheter is inserted through the ablation needle guide accessory, it punctures the target tissue segment where the lesion is located through the ablation needle hole, and ablation is initiated after the puncture is in place.

[0008] Furthermore, the impedance measurement component includes an excitation electrode, an electrical stimulation unit, a measurement circuit unit, and an impedance analysis unit. The excitation electrode is connected to the electrical stimulation unit and the measurement circuit unit, and the electrical stimulation unit and the measurement circuit unit are connected to the impedance analysis unit. The excitation electrode includes an adjustable electrode and a fixed electrode. The adjustable electrode is installed in the hollow cavity, and an electrode hole is provided on the side wall of the hollow cavity corresponding to the adjustable electrode. The adjustable electrode can extend out of the hollow cavity or retract into the hollow cavity through the electrode hole. There are multiple fixed electrodes, which are arranged on the puncture needle body to form a fixed electrode array. The electrical stimulation unit is used to apply a current signal to the target tissue through the excitation electrode; wherein, a pair of excitation electrodes is formed by an adjustable electrode and a fixed electrode in the fixed electrode array to apply the current signal. After the measurement segment corresponding to the pair of excitation electrodes is completed, the next fixed electrode is replaced to form an excitation electrode pair with the adjustable electrode, and the current signal is continued to be applied. The measurement circuit unit is used to measure the voltage signal between a pair of excitation electrodes when a current signal is applied to the target tissue by a pair of excitation electrodes, wherein a measurement section is formed between the pair of excitation electrodes; The impedance analysis unit is used to calculate and store the impedance value corresponding to the current measurement segment based on the aforementioned current signal and real-time voltage signal; and to determine the tissue segment where the lesion is located based on the impedance value of each measurement segment.

[0009] Furthermore, the operating lever includes a lever body and an ablation needle guide accessory, the ablation needle guide accessory being arranged along the axial direction of the lever body; After the operating rod enters the hollow cavity through the needle seat, the lower end of the rod body can be driven to connect with the adjustable electrode. When the operating rod is rotated, the adjustable electrode is driven to extend or retract from the electrode hole, thereby extending out of the hollow cavity or retracting into the hollow cavity. When the adjustable electrode extends out of the electrode hole, a measurement section is formed by the adjustable electrode and the fixed electrode in the fixed electrode array. After determining the tissue segment where the lesion is located, rotate the operating lever to drive the adjustable electrode to retract from the aforementioned electrode hole; at this time, pull the operating lever to adjust the position of the ablation needle guide accessory on it, so that the outlet of the guide accessory corresponds to the ablation needle hole of the target tissue segment where the lesion is located.

[0010] Furthermore, a mounting base is provided in the hollow cavity, and a transverse track is provided on the mounting base. The adjustable electrode is mounted on the transverse track, and the adjustable electrode has a rack segment in the middle. A gear is provided at the lower end of the rod body, and the teeth of the gear mesh with the teeth of the rack segment of the adjustable electrode. When the gear meshes with the adjustable electrode rack section, rotating the operating lever causes the lower gear to rotate, driving the rack to move along the transverse track, thereby driving the rack to move linearly to extend or retract from the electrode hole.

[0011] Furthermore, an operating knob is provided at the top of the needle seat of the puncture assembly. The operating knob has a through hole for the operating rod to pass through, and a rod connector is provided on the through hole. The operating rod and the operating knob are connected or separated through the rod connector. When the operating lever is connected to the operating knob, rotating the operating knob will cause the operating lever to rotate synchronously; the operating knob and / or the outer periphery of the operating knob are provided with rotation indicator marks to indicate the rotation angle.

[0012] Furthermore, the electrical impedance analysis unit is configured as follows: Obtain the impedance value of the current measurement section and determine whether the impedance value of the current measurement section exceeds the preset normal tissue impedance standard; If the electrical impedance exceeds the preset standard for normal tissue, a lesion is determined to exist in the measurement segment; Continue to determine whether the measurement section is the smallest measurement section unit; If the determination is yes, the measurement segment is taken as the target tissue segment where the lesion is located, and the smallest measurement segment unit and the corresponding impedance value are stored. If the determination is negative, after obtaining the number of the smallest measurement segment units contained in the measurement segment, and combining the historically stored smallest measurement segment units and electrical impedance value information, determine which smallest measurement segment unit in the measurement segment is the target tissue segment where the lesion is located, and store the smallest measurement segment unit and the corresponding electrical impedance value.

[0013] Furthermore, multiple fixed electrodes are arranged in a row along the axial direction of the puncture needle body, with different distances between the fixed electrodes at different heights and the adjustable electrodes, thus forming measurement sections of different ranges.

[0014] Furthermore, the puncture needle body is provided with two rows of fixed electrodes, which are located on both sides of the puncture needle body and are symmetrically arranged. Each row of fixed electrodes includes multiple fixed electrodes arranged at intervals. There are two electrode holes, which are arranged in the same row as the fixed electrodes on both sides. Depending on the rotation direction of the operating lever, the adjustable electrode can extend or retract from both sides of the puncture needle body through the two electrode holes.

[0015] Furthermore, the puncture needle body is provided with N columns of fixed electrodes, where N is an integer greater than or equal to 2; each column of fixed electrodes is evenly distributed on the puncture needle body, and each column of fixed electrodes includes multiple fixed electrodes arranged at intervals. There are N electrode holes, which are arranged in the same row as N columns of fixed electrodes. The adjustable electrode is installed in the hollow cavity through a rotating structure. When the rotating structure is driven to rotate, the adjustable electrode is driven to rotate so that it corresponds to an electrode hole. When the operating rod is rotated, the adjustable electrode is driven to extend or retract from the aforementioned electrode hole.

[0016] Furthermore, the ablation needle catheter is provided with an ablation element, which is an ablation fluid delivered from a discharge fluid port for delivery, or the ablation element is an energy delivery element; The puncture needle body is provided with a first scale mark to indicate the puncture depth; The control lever is provided with a second scale mark to indicate the insertion depth of the control lever; The front end of the ablation needle guide accessory is a pre-bent structure; or, the front end of the ablation needle guide accessory is provided with an adjustment section to adjust the bending angle between the front end and the main body section.

[0017] Compared with the prior art, this invention, by adopting the above technical solution, has the following advantages and positive effects: The ablation needle puncture system provided by this invention includes a puncture assembly, an impedance measurement assembly, and an ablation needle catheter for ablation. The rigid puncture needle body has a hollow cavity, in which an operating rod is provided, and an ablation needle guide accessory is provided on the operating rod. The impedance measurement assembly is used to measure the impedance information of the tissue surrounding the puncture needle body, and to determine the target tissue segment where the lesion is located based on the impedance information. After determining the target tissue segment where the lesion is located, the position of the ablation needle guide accessory is adjusted by the operating rod so that the outlet of the guide accessory corresponds to the target tissue segment where the lesion is located. A flexible section is provided at the distal end of the ablation needle catheter. An ablation needle hole is provided on the side wall of the puncture needle body. After the ablation needle catheter is inserted through the ablation needle guide accessory, it pierces the target tissue segment where the lesion is located through the ablation needle hole. After the puncture is in place, ablation is initiated. This invention can accurately identify and locate lesions (such as tumors). Simultaneously, the ablation needle catheter is guided by an ablation needle guide accessory to the target tissue segment containing the lesion for ablation, reducing the difficulty of the surgical procedure. Furthermore, the puncture system can perform ablation operations on multiple lesions scattered around the puncture area with a single puncture, minimizing the number of punctures and effectively reducing the pain and damage caused to the patient by multiple punctures, as well as shortening the operation time. Attached Figure Description

[0018] Figure 1 This is a schematic diagram of the ablation needle puncture system provided in an embodiment of the present invention.

[0019] Figure 2 This is a schematic diagram of the wire arrangement of the excitation electrode provided in an embodiment of the present invention.

[0020] Figure 3 This is a schematic diagram of the operating lever provided in an embodiment of the present invention.

[0021] Figure 4 This is a schematic diagram illustrating the leftward lateral movement of the adjustable electrode driven by the operating lever, as provided in an embodiment of the present invention.

[0022] Figure 5 This is a schematic diagram illustrating the rightward lateral movement of an adjustable electrode driven by a joystick, as provided in an embodiment of the present invention.

[0023] Figure 6 This is a schematic diagram of the ablation needle hole corresponding to the lesion segment of the ablation needle guide accessory provided in an embodiment of the present invention.

[0024] Explanation of reference numerals in the attached figures: 10 puncture systems; Puncture assembly 100, puncture needle body 110, needle tip 111, electrode hole 112, ablation needle hole 113, needle seat 120, hollow cavity 130, operating rod 140, rod body 141, gear 1411, ablation needle guide accessory 142, front end 1421, operating knob 150. The impedance measurement assembly 200 includes an excitation electrode 210, an adjustable electrode 211, a rack segment 2111, a fixed electrode 212, a wire 213, an electrical stimulation unit 220, a measurement circuit unit 230, and an impedance analysis unit 240. 300 ablation needle catheter. Detailed Implementation

[0025] The bioelectrical impedance-based ablation needle puncture system disclosed in this invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be noted that the technical features or combinations of technical features described in the following embodiments should not be considered isolated; they can be combined with each other to achieve better technical effects. In the accompanying drawings of the following embodiments, the same reference numerals appearing in each drawing represent the same features or components, which can be applied to different embodiments. Therefore, once an item is defined in one drawing, it does not need to be further discussed in subsequent drawings.

[0026] It should be noted that the structures, proportions, sizes, etc., illustrated in the accompanying drawings are merely for illustrative purposes and to aid those skilled in the art in understanding and reading the invention. They are not intended to limit the conditions under which the invention can be implemented. Any modifications to the structure, changes in proportions, or adjustments to size, provided they do not affect the effectiveness or purpose of the invention, should fall within the scope of the technical content disclosed in the invention. The scope of the preferred embodiments of the present invention includes other implementations, wherein functions may be performed not in the order stated or discussed, including substantially simultaneously or in reverse order, depending on the functions involved. This should be understood by those skilled in the art to which the embodiments of the present invention pertain.

[0027] Techniques, methods, and apparatus known to those skilled in the art may not be discussed in detail, but where appropriate, such techniques, methods, and apparatus should be considered part of the specification. In all examples shown and discussed herein, any specific values ​​should be interpreted as merely exemplary and not as limitations. Therefore, other examples of exemplary embodiments may have different values.

[0028] In the description of the embodiments of this application, " / " means "or", and "and / or" is used to describe the relationship between related objects, indicating that there can be three relationships. For example, "A and / or B" means: A and B exist alone, B exists alone, and A and B exist simultaneously. In the description of the embodiments of this application, "multiple" refers to two or more. Example

[0029] See Figure 1 As shown, this invention provides an ablation needle puncture system based on bioelectrical impedance, which can accurately identify and locate relevant lesions in the target tissue after puncture based on the preliminary location of the target tissue lesion determined by imaging technology, and then perform ablation treatment.

[0030] The puncture system 10 includes a puncture assembly 100, an impedance measurement assembly 200, and an ablation needle catheter 300.

[0031] The puncture assembly 100 is used to puncture into target tissue. The target tissue is tissue containing lesions (such as tumors), for example, where the preliminary locations of multiple lesions in the target tissue have been determined using imaging technology. The puncture assembly 100 may include a rigid puncture needle body 110 and a needle hub 120. The puncture needle body 110 has a through-hole hollow cavity 130, and its front end is a puncture needle tip 111, which may be a multi-faceted puncture body. The puncture needle body 110 may be made of materials such as alloy or stainless steel, and its surface is insulated. Based on the preliminary locations of multiple lesions in the target tissue, a puncture path is planned, and the puncture needle body is inserted into the target tissue.

[0032] An operating rod 140 is provided in the hollow cavity 130. The distal end (or tail end) of the operating rod 140 is located in the hollow cavity, and the proximal end (or head end) of the operating rod 140 extends out of the needle seat 120.

[0033] An ablation needle guide accessory is provided on the operating lever 140. Specifically, the operating lever 140 may include a lever body 141 and an ablation needle guide accessory 142, which is arranged along the axial direction of the lever body.

[0034] The impedance measurement component 200 is set corresponding to the puncture needle body 110 and is used to measure the impedance information of the tissue surrounding the puncture needle body 110, and to determine the target tissue segment where the lesion is located based on the impedance information.

[0035] After determining the target tissue segment where the lesion is located, the position of the ablation needle guide attachment 142 can be adjusted via the operating lever 140—for example, by pulling the operating lever 140 to move the ablation needle guide attachment 142 up and down, so that the outlet of the ablation needle guide attachment 142 corresponds to the target tissue segment where the lesion is located. In specific implementation, the ablation needle guide attachment 142 can adopt a tubular structure with a through central lumen to guide the ablation needle catheter 300 into place.

[0036] The ablation needle catheter 300 is used for ablation. The distal end of the ablation needle catheter 300 has a flexible section, allowing it to bend (flexibility refers to the ability of the component to bend under external force). In this embodiment, the side wall of the puncture needle body 110 has an ablation needle hole 113. After the ablation needle catheter 300 is inserted through the ablation needle guide accessory 142, it pierces the target tissue segment where the lesion is located through the ablation needle hole 113. Ablation is initiated after the puncture is completed.

[0037] In this embodiment, preferably, the ablation needle catheter 300 is entirely made of a flexible, bendable structure. It should be noted that although the ablation needle catheter can be bent under external force, it still possesses a certain degree of rigidity, allowing it to penetrate the target tissue for ablation. As an example, and not a limitation, when the ablation element is a radiofrequency element, the ablation needle catheter is a flexible ablation electrode. The body of the flexible ablation electrode can be made of a material with moderate rigidity and good conductivity, including alloys (shape memory alloys, etc.), semiconductor materials, composite materials, etc., which will deform under external force and return to its original shape after the external force is removed.

[0038] An ablation element is provided at the distal end of the ablation needle catheter 300. The ablation element is a fluid that delivers ablative fluid from a discharge fluid port for delivery, or it is an energy delivery element. In this embodiment, the ablation element may be a radio frequency (RF) element, a microwave element, a cryogenic element, an ultrasonic element, an electrocautery element, or a heating element, as needed.

[0039] Preferably, the outer surface of the puncture needle body 110 may be provided with a first scale mark to indicate the puncture depth; and the outer surface of the operating lever 140 may be provided with a second scale mark to indicate the insertion depth of the operating lever.

[0040] To guide the tip of the ablation needle catheter 300 smoothly through the ablation needle hole 113 on the side wall of the puncture needle body 110, the tip of the ablation needle guide accessory 142 can be a pre-bent structure, or the tip of the ablation needle guide accessory 142 can be provided with an adjustment section to adjust the bending angle between the tip of the accessory and the main body section.

[0041] When adjusting the bending angle of the front end of the ablation needle guide accessory 142, the angle at which the front end (distal end) of the ablation needle catheter 300 is inserted into the tissue can also be adjusted by adjusting the adjustment section.

[0042] In one embodiment, the adjusting section can be a self-bending and deformable sleeve structure, with the front end of the ablation needle catheter 300 passing through the adjusting section. The bending deformation of the adjusting section achieves the bending deformation of the front end of the ablation needle catheter 300. Specifically, the adjusting tube can be a fluid-fillable microchannel structure (the front end of the ablation needle catheter 300 passes through the lumen of the adjusting tube), and the bending deformation of the adjusting tube is controlled by changing the fluid filling amount of the adjusting section through a fluid delivery pump and a fluid suction pump; alternatively, the adjusting tube can be a shape memory alloy that responds to temperature (the front end of the ablation needle catheter 300 passes through the lumen of the adjusting tube), and the bending deformation of the adjusting section is controlled by changing the temperature of a portion of the adjusting tube through a temperature controller; alternatively, the adjusting tube can be an electroactive polymer component (the front end of the ablation needle catheter 300 passes through the lumen of the adjusting tube), which can contract or expand under the electrical excitation of the electro-excitation part to produce asymmetrical deformation, thereby causing the adjusting tube to bend and deform. In this embodiment, the impedance measurement component 200 may specifically include an excitation electrode 210, an electrical stimulation unit 220, a measurement circuit unit 230, and an impedance analysis unit 240. The excitation electrode 210 protrudes from the outer surface of the puncture needle body for better impedance measurement. The excitation electrode 210 can be connected to the electrical stimulation unit 220 and the measurement circuit unit 230 via wires, and the electrical stimulation unit 220 and the measurement circuit unit 230 are connected to the impedance analysis unit 240.

[0043] Specifically, the excitation electrode 210 may include an adjustable electrode 211 and a fixed electrode 212, see [reference needed]. Figure 2 As shown. The adjustable electrode 211 is installed in the hollow cavity 130. Corresponding to the adjustable electrode 211, an electrode hole 112 is provided on the side wall of the hollow cavity 130. The adjustable electrode 211 can extend out of the hollow cavity or retract into the hollow cavity through the electrode hole 112. In the initial state, the adjustable electrode 211 is housed in the hollow cavity; when it is necessary to measure the impedance, the adjustable electrode 211 is driven to extend out of the hollow cavity to form an outwardly convex electrode. There are multiple fixed electrodes 212, which are arranged on the puncture needle body 110 to form a fixed electrode array.

[0044] The electrical stimulation unit 220 is used to apply a current signal to the target tissue surrounding the puncture needle body through the excitation electrode 210. Specifically, an excitation electrode pair can be formed by the adjustable electrode 211 and one of the fixed electrodes 212 in the fixed electrode array to apply the current signal. After the measurement segment corresponding to this pair of excitation electrodes is completed (during measurement, the excitation electrode is also the measurement electrode), the next fixed electrode can be replaced to form an excitation electrode pair with the adjustable electrode to continue applying the current signal. In other words, during measurement, the adjustable electrode remains active, while only one fixed electrode is active at any given time, ensuring that only one pair of excitation electrodes is active at any given time.

[0045] The measurement circuit unit 230 is used to measure the voltage signal between a pair of excitation electrodes when a current signal is applied to the target tissue by the pair of excitation electrodes, forming a measurement segment between the pair of excitation electrodes. It is understood that, based on the adjustable electrodes, different fixed electrodes are selected as excitation electrodes in the fixed electrode array, resulting in different corresponding measurement segments.

[0046] The impedance analysis unit 240 is used to calculate and store the impedance value corresponding to the current measurement segment based on the aforementioned current signal and real-time voltage signal; and to determine the tissue segment where the lesion is located based on the impedance value of each measurement segment.

[0047] Specifically, the electrical impedance analysis unit 240 may include an electrical impedance calculation subunit and a lesion segment analysis subunit.

[0048] The impedance calculation subunit is configured to: acquire the measured voltage drop V and the injected current I, calculate the resistance R=V / I according to Ohm's law, and use the calculated value R as the impedance value of the current measurement section.

[0049] The lesion segment analysis subunit is configured to: acquire the impedance value of the current measurement segment; determine whether the impedance value of the current measurement segment exceeds a preset normal tissue impedance standard (usually an impedance range, which can be set by the system or the user); if it exceeds the preset normal tissue impedance standard, determine that a lesion exists in the measurement segment; otherwise, determine that no abnormality is detected in the measurement segment; if a lesion exists in the measurement segment, continue to determine whether the measurement segment is the smallest measurement segment unit; if yes—that is, if the measurement segment is the smallest measurement segment unit—the measurement segment is taken as the target tissue segment where the lesion is located, and the smallest measurement segment unit and the corresponding impedance value are stored; if no—that is, if the measurement segment is not the smallest measurement segment unit—the number of smallest measurement segment units contained in the measurement segment is acquired, and combined with the historically stored smallest measurement segment units and impedance value information, determine which smallest measurement segment unit in the measurement segment is the target tissue segment where the lesion is located, and store the smallest measurement segment unit and the corresponding impedance value.

[0050] As an example, and not a limitation, the measurement sections corresponding to the current adjustable and fixed electrodes include three minimum measurement section units—for example... Figure 2 Electrodes T and M3 (with a fixed spacing d between adjacent excitation electrodes, corresponding to the minimum measurement segment unit) are designated as L1 (measurement segment from electrode T to electrode M1), L2 (measurement segment from electrode M1 to electrode M2), and L3 (measurement segment from electrode M2 ​​to electrode M3), respectively. If the impedance R3 of the measurement segment of electrodes T and M3 is too high (abnormal), the impedance values ​​of the historically stored L1 minimum measurement segment unit (determined by the measurement result R1 of electrodes T and M1 as a pair of measurement electrodes) and L2 minimum measurement segment unit (determined by combining the measurement result R2 of electrodes T and M2 as a pair of measurement electrodes and the measurement result R1 of electrodes T and M1 as a pair of measurement electrodes) are considered. If the impedance R3 of the L1 and L2 minimum measurement segment units is too high (abnormal), the impedance values ​​of the L1 and L2 minimum measurement segment units are considered to be abnormal. If all impedance values ​​are normal (within the preset standard), it can be directly determined that there is a lesion in the L3 minimum measurement segment unit. If at least one of the impedance values ​​of the L1 and L2 minimum measurement segment units is determined to be abnormal, the impedance value R of the L3 minimum measurement segment unit can be determined first based on the values ​​of R3, R2, and R1. Then, the impedance value R is compared with the standard impedance value of the minimum measurement segment unit. If it exceeds the standard value, it is determined that there is a lesion in the L3 minimum measurement segment unit; otherwise, it is determined to be normal.

[0051] Furthermore, the size of the lesion area can be determined based on the abnormal proportion of the impedance index (the impedance value of the current measurement segment minus the median of the normal impedance standard corresponding to the segment, and then divided by the median of the normal impedance standard), and the determination result can be sent to the associated user terminal for output.

[0052] In this embodiment, after the operating rod 140 enters the hollow cavity 130 via the needle seat 120, the lower end of the rod body 141 can be driven to connect with the adjustable electrode 211. (See [reference needed]) Figure 3 As shown. At this time, rotating the operating lever 140 can drive the adjustable electrode 211 to extend or retract from the electrode hole, thereby extending out of the hollow cavity or retracting into the hollow cavity. When the adjustable electrode 211 extends out of the electrode hole, a measurement section is formed by the adjustable electrode 211 and the fixed electrode 212 in the fixed electrode array.

[0053] After identifying the tissue segment where the lesion is located, the operating lever 140 can be rotated to retract the adjustable electrode from the aforementioned electrode hole. Then, the operating lever can be pulled to adjust the position of the ablation needle guide attachment 142 thereon.

[0054] In this embodiment, preferably, a mounting base may be provided in the hollow cavity 130, and a transverse track is provided on the mounting base. The adjustable electrode 211 is mounted on the transverse track, and the adjustable electrode 211 has a rack segment 2111 in the middle. A gear 1411 is provided at the lower end of the rod body 141, and the teeth of the gear 1411 mesh with the teeth of the adjustable electrode rack segment 2111.

[0055] When gear 1411 meshes with adjustable electrode rack section 2111, rotating the operating lever causes the lower gear to rotate, driving the rack to move along the transverse track, thereby driving the rack to perform linear motion to extend or retract from the electrode hole. See also Figure 4 The illustration shows an example where the adjustable electrode 211 is driven to move to the left when the operating lever 140 is rotated in the forward direction. See also... Figure 5 As shown, this illustrates the scenario where the adjustable electrode 211 is driven to move to the right when the operating lever 140 is rotated in the reverse direction.

[0056] Optionally, to improve the connection stability between the lower end of the operating lever and the adjustable electrode, a limiting ring is installed at the distal end of the hollow cavity. The limiting ring is located below the adjustable electrode, and its inner diameter is slightly larger than the outer diameter of the lever body 141, and it has a bottom. The lower end of the lever body extends beyond the gear 1411 (the gear 1411 can be nested around the lever body and held fixed to it by compression or snapping). This lower end can be inserted into the limiting ring, and the bottom of the limiting ring restricts the insertion depth of the operating lever. When the lower end of the lever body is inserted into the limiting ring, the gear meshes with the adjustable electrode. When the operating lever is rotated, the limiting ring restricts the rotation of the lever body.

[0057] In a preferred embodiment of this example, an operating knob 150 may also be provided at the top of the needle hub 120 of the puncture assembly. (Continuing to the previous section...) Figure 1 As shown, the operating knob 150 may have a through hole for the operating lever to pass through. A lever connector is provided on the through hole, which enables the connection or separation of the operating lever and the operating knob 150. As an example, and not a limitation, the lever connector may be an arc-shaped groove located at the edge of the through hole. The inner diameter of the arc-shaped groove matches the outer diameter of the operating lever, allowing the operating lever to be inserted into the groove and locked in place, thus completing the connection. When it is necessary to remove the operating lever, it can be pulled out of the groove.

[0058] When the operating lever is connected to the operating knob, the user can rotate the operating knob to drive the operating lever to rotate synchronously. Preferably, the operating knob and / or its periphery can also be provided with rotation indicator marks to indicate the rotation angle.

[0059] In one embodiment of this invention, the fixed electrode array on the puncture needle body 110 is arranged in a column. In this case, multiple fixed electrodes are arranged at intervals along the axial direction of the puncture needle body to form a column. The distance between the fixed electrodes at different heights and the adjustable electrodes is different, thereby forming measurement segments of different ranges. Preferably, each adjacent electrode (including the adjustable electrode and the fixed electrode) uses the same interval value d, where d is the length of the smallest measurement segment unit. See [reference needed]. Figure 6 As shown. The electrical impedance analysis unit can determine the tissue segment where the lesion is located, i.e., the lesion segment, based on the electrical impedance values ​​of each measurement section. This is an example, not a limitation; for instance, the determined tissue segment where the lesion is located is... Figure 6 The section between the fixed electrodes N1 and N2 (the smallest measurement section unit) can be adjusted by the operating lever to position the ablation needle guide accessory 142 so that the outlet of the ablation needle guide accessory 142 corresponds to the ablation needle hole 113 of the target tissue section where the lesion is located. Then, the ablation needle catheter can be inserted into the hollow cavity through the ablation needle guide accessory 142 and then pierced into the lesion section through the ablation needle hole 113.

[0060] The ablation pinhole 113 is disposed between two adjacent electrodes in the axial direction. Preferably, the ablation pinhole 113 is disposed at the midpoint of the two adjacent electrodes in the axial direction.

[0061] In another embodiment of this invention, the puncture needle body 110 may also be provided with two rows of fixed electrodes. The two rows of fixed electrodes are located on both sides of the puncture needle body and are symmetrically arranged (the two rows of fixed electrodes are arranged at 180 degrees in the circumferential direction). Each row of fixed electrodes may include multiple fixed electrodes arranged at intervals. Preferably, each adjacent electrode (including adjustable electrodes and fixed electrodes) adopts the same interval value d, where d is the length of the smallest measurement segment unit.

[0062] At this time, the puncture needle body has two electrode holes—a left electrode hole and a right electrode hole. These two electrode holes are arranged in the same row as the fixed electrodes on both sides. Depending on the rotation direction of the operating lever, the adjustable electrode can extend or retract from the left and right sides of the puncture needle body through the left and right electrode holes, respectively. The adjustable electrode can be extended from the left or right electrode hole by rotating the operating lever clockwise or counterclockwise.

[0063] In another embodiment of this invention, the puncture needle body 110 may be provided with N columns of fixed electrodes, where N is an integer greater than or equal to 2; each column of fixed electrodes is evenly distributed on the puncture needle body (in the circumferential direction, for example, when N=4, the four columns of fixed electrodes are arranged at a 90-degree angle in the circumferential direction), and each column of fixed electrodes may include multiple fixed electrodes arranged at intervals, and the number of fixed electrodes in each column of fixed electrodes is the same.

[0064] At this time, there are N electrode holes on the puncture needle body, and the N electrode holes are arranged in the same row as N columns of fixed electrodes. The adjustable electrode is installed in the hollow cavity through a rotating structure. When the rotating structure is driven to rotate, it drives the adjustable electrode to rotate, so that it corresponds with an electrode hole. When the operating rod is rotated, it drives the adjustable electrode to move laterally to extend or retract from the aforementioned electrode hole.

[0065] The edges of the electrode holes and ablation electrode holes on the puncture needle body are rounded edges to avoid forming a cutting edge.

[0066] In the above description, the disclosure of this invention is not intended to limit itself to these aspects. Rather, within the scope of the objectives of this disclosure, components can be selectively and operationally combined in any number. Furthermore, terms such as “comprising,” “encompassing,” and “having” should be interpreted by default as inclusive or open-ended, rather than exclusive or closed, unless explicitly defined as such. All technical, scientific, or other terms are to be understood by those skilled in the art, unless defined as such. Public terms found in dictionaries should not be interpreted in the context of the relevant technical documents in an overly idealistic or impractical manner, unless explicitly defined as such in this disclosure. Any modifications or alterations made by those skilled in the art based on the foregoing disclosure are within the scope of the claims.

Claims

1. A bioelectrical impedance-based ablation needle puncture system, characterized in that... include: A puncture assembly for puncturing into target tissue includes a puncture needle body and a needle hub. The rigid puncture needle body has a hollow cavity, in which an operating lever is disposed. The operating lever includes a lever body and an ablation needle guide accessory, which is disposed along the axial direction of the lever body. An ablation needle hole is disposed on the side wall of the puncture needle body. The device includes an impedance measurement component with an excitation electrode, which is positioned corresponding to the puncture needle body. It measures the impedance information of the tissue surrounding the puncture needle body and determines the target tissue segment where the lesion is located based on the impedance information. The excitation electrode includes an adjustable electrode and a fixed electrode. The adjustable electrode is installed in a hollow cavity, and an electrode hole is provided on the side wall of the hollow cavity corresponding to the adjustable electrode. There are multiple fixed electrodes, which are arranged on the puncture needle body to form a fixed electrode array. After the operating rod enters the hollow cavity through the needle seat, the lower end of the rod body can be driven to connect with the adjustable electrode. When the operating rod is rotated, the adjustable electrode is driven to extend or retract from the electrode hole, thereby extending out of the hollow cavity or retracting into the hollow cavity. When the adjustable electrode extends from the electrode hole, a measurement segment is formed by the adjustable electrode and the fixed electrode in the fixed electrode array. Different measurement segments are formed between different fixed electrodes and the adjustable electrode. After determining the target tissue segment where the lesion is located, the operating lever is rotated to drive the adjustable electrode to retract from the aforementioned electrode hole. At this time, the operating lever is pulled to adjust the position of the ablation needle guide accessory on it so that the outlet of the guide accessory corresponds to the ablation needle hole of the target tissue segment where the lesion is located. The ablation needle catheter used for ablation has a flexible segment at its distal end. After being inserted through the ablation needle guide accessory, the ablation needle catheter is inserted into the target tissue segment where the lesion is located through the ablation needle hole, and ablation is initiated after the puncture is completed.

2. The ablation needle puncture system according to claim 1, characterized in that, The measurement assembly further includes an electrical stimulation unit, a measurement circuit unit, and an electrical impedance analysis unit. The excitation electrode is connected to the electrical stimulation unit and the measurement circuit unit, and the electrical stimulation unit and the measurement circuit unit are connected to the electrical impedance analysis unit. The electrical stimulation unit is used to apply a current signal to the target tissue through the excitation electrode; wherein, a pair of excitation electrodes is formed by an adjustable electrode and a fixed electrode in the fixed electrode array to apply the current signal. After the measurement segment corresponding to the pair of excitation electrodes is completed, the next fixed electrode is replaced to form an excitation electrode pair with the adjustable electrode, and the current signal is continued to be applied. The measurement circuit unit is used to measure the voltage signal between a pair of excitation electrodes when a current signal is applied to the target tissue by a pair of excitation electrodes, wherein a measurement section is formed between the pair of excitation electrodes; The impedance analysis unit is used to calculate and store the impedance value corresponding to the current measurement segment based on the aforementioned current signal and real-time voltage signal; and to determine the tissue segment where the lesion is located based on the impedance value of each measurement segment.

3. The ablation needle puncture system according to claim 1, characterized in that, The hollow cavity is provided with a mounting base, and the mounting base is provided with a transverse track. The adjustable electrode is mounted on the transverse track, and the adjustable electrode has a rack segment in the middle. The lower end of the rod body is provided with a gear, and the teeth of the gear mesh with the teeth of the rack segment of the adjustable electrode. When the gear meshes with the adjustable electrode rack section, rotating the operating lever causes the lower gear to rotate, driving the rack to move along the transverse track, thereby driving the rack to move linearly to extend or retract from the electrode hole.

4. The ablation needle puncture system according to claim 1, characterized in that, An operating knob is provided at the top of the needle seat of the puncture assembly. The operating knob has a through hole for the operating rod to pass through. A rod connector is provided on the through hole. The operating rod is connected or separated from the operating knob through the rod connector. When the operating lever is connected to the operating knob, rotating the operating knob will cause the operating lever to rotate synchronously; the operating knob and / or the outer periphery of the operating knob are provided with rotation indicator marks to indicate the rotation angle.

5. The ablation needle puncture system according to claim 2, characterized in that, The electrical impedance analysis unit is configured as follows: Obtain the impedance value of the current measurement section and determine whether the impedance value of the current measurement section exceeds the preset normal tissue impedance standard; If the electrical impedance exceeds the preset standard for normal tissue, a lesion is determined to exist in the measurement segment; Continue to determine whether the measurement section is the smallest measurement section unit; If the determination is yes, the measurement segment is taken as the target tissue segment where the lesion is located, and the smallest measurement segment unit and the corresponding impedance value are stored. If the determination is negative, after obtaining the number of the smallest measurement segment units contained in the measurement segment, and combining the historically stored smallest measurement segment units and electrical impedance value information, determine which smallest measurement segment unit in the measurement segment is the target tissue segment where the lesion is located, and store the smallest measurement segment unit and the corresponding electrical impedance value.

6. The ablation needle puncture system according to claim 2, characterized in that, Multiple fixed electrodes are arranged in a row along the axial direction of the puncture needle body. The distance between the fixed electrodes and the adjustable electrodes at different heights is different, thus forming measurement sections of different ranges.

7. The ablation needle puncture system according to claim 2, characterized in that, The puncture needle body is provided with two rows of fixed electrodes, which are located on both sides of the puncture needle body and are symmetrically arranged. Each row of fixed electrodes includes multiple fixed electrodes arranged at intervals. There are two electrode holes, which are arranged in the same row as the fixed electrodes on both sides. Depending on the rotation direction of the operating lever, the adjustable electrode can extend or retract from both sides of the puncture needle body through the two electrode holes.

8. The ablation needle puncture system according to claim 2, characterized in that, The puncture needle body is provided with N columns of fixed electrodes, where N is an integer greater than or equal to 2; each column of fixed electrodes is evenly distributed on the puncture needle body, and each column of fixed electrodes includes multiple fixed electrodes arranged at intervals. There are N electrode holes, which are arranged in the same row as N columns of fixed electrodes. The adjustable electrode is installed in the hollow cavity through a rotating structure. When the rotating structure is driven to rotate, the adjustable electrode is driven to rotate so that it corresponds to an electrode hole. When the operating rod is rotated, the adjustable electrode is driven to extend or retract from the aforementioned electrode hole.

9. The ablation needle puncture system according to claim 1, characterized in that, The ablation needle catheter is provided with an ablation element, which is an ablation fluid delivered from a discharge fluid port for delivery, or the ablation element is an energy delivery element; The puncture needle body is provided with a first scale mark to indicate the puncture depth; The control lever is provided with a second scale mark to indicate the insertion depth of the control lever; The front end of the ablation needle guide accessory is a pre-bent structure; or, the front end of the ablation needle guide accessory is provided with an adjustment section to adjust the bending angle between the front end and the main body section.

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