Interventional ablation puncture system and puncture auxiliary device of ablation needle

Abstract

The invention discloses an interventional ablation puncture system and a puncture auxiliary device of an ablation needle, and relates to the technical field of biomedical engineering. The interventional ablation puncture system comprises an ablation needle and a puncture guide device; the ablation needle comprises a puncture needle, a handle and an indicating needle; the puncture guide device comprises a light source emitter, the light source emitter comprises an indication light source used for indicating the correct puncture direction of the ablation needle, and the indication light source is used for emitting ray beams to irradiate the indication needle; the visual positioning mark is arranged on the pointer, the visibility of the visual positioning mark can be enhanced when the visual positioning mark is irradiated by the ray beam emitted by the indicating light source, and whether the actual puncture direction of the ablation needle is matched with the correct puncture direction or not is indicated through the visual positioning mark on the pointer. The ablation needle can directly and rapidly guide the puncture direction of the ablation needle, assists a doctor in rapidly judging the puncture direction, and has the advantages of being simple in structure, convenient to operate, convenient, fast and flexible.

Description

Technical Field

[0001] This invention relates to the field of biomedical engineering technology, and in particular to an interventional ablation puncture system and a puncture auxiliary device for the ablation needle. Background Technology

[0002] With the rapid development and widespread adoption of imaging technology and minimally invasive interventional devices, interventional ablation therapy has become one of the most important clinical treatments for oncology. Interventional ablation therapy is a minimally invasive treatment method that, guided by imaging equipment (such as ultrasound, CT, DSA, MRI, etc.), inserts an ablation needle through the body surface into the diseased tissue. It then directly destroys the diseased tissue through physical or chemical means, causing necrosis and thus achieving the therapeutic goal. It is widely used in fields such as oncology and cardiovascular diseases.

[0003] Commonly used interventional ablation treatments include radiofrequency ablation (RFA), microwave ablation (MWA), cryoablation, laser ablation, pulsed electric field ablation (PFA), and chemical ablation (injection of chemical substances). For example, taking microwave ablation for thyroid tumor treatment, a microwave ablation needle typically consists of an ablation needle tip, an ablation tube, and a handle. An insulator is placed between the ablation needle tip and one end of the ablation tube. The other end of the ablation tube is connected to the head of the handle, and the other end of the handle is connected to the microwave ablation device (or microwave therapy device); see also Figure 1 As shown, during ablation needle puncture, the insertion point, direction, and depth are determined under ultrasound guidance to ensure the needle tip is located in the center of the tumor (or the planned ablation area). After the ablation needle is placed, the microwave ablation device is activated for microwave ablation. After ablation, the needle tract is coagulated upon needle withdrawal to prevent bleeding. After ablation treatment, CDFI or contrast-enhanced ultrasound can be used to assess the necrosis of the lesion. Due to the inherent limitations of interventional ablation therapy—each interventional ablation needle can only kill tumor cells in a limited area—multiple needle insertions are required when the tumor is large or multiple tumors are discretely distributed. To kill tumor cells as accurately as possible without damaging or minimizing damage to the patient's important physiological tissues (such as blood vessels and nerves), it is necessary to plan the puncture path (including needle insertion position, puncture angle, and puncture depth) in advance and conduct preoperative assessment and verification of the expected ablation area. Currently, puncture path planning in clinical practice still mainly relies on the experience of physicians. Physicians usually need to plan the puncture path based on the static 3D data collected before the operation (such as the patient's CT scan imaging data or MRI magnetic resonance imaging data), and then the staff will perform manual puncture.

[0004] The traditional operating methods described above have the following drawbacks: 1. The accuracy of puncture planning is difficult to meet clinical needs, especially when the matching between the acquired static 3D images and the actual location of the tumor is not intuitive enough. Manual path planning relies heavily on the physician's operational experience, making it difficult to guarantee the accuracy and reliability of the planning. 2. After determining the needle insertion position (usually marked on the patient's skin), the doctor performs the puncture according to the puncture angle and depth provided by the plan. The direction and depth of the puncture are judged and controlled by the physician based on experience, resulting in low operational accuracy (especially when the angle between the puncture path and the cross-section of the patient's CT scan image is large). A single puncture is generally unsuccessful, and sometimes a single treatment requires ten or even dozens of punctures. The puncture efficiency is low, causing significant pain and damage to the patient, and the operation time is long, resulting in high labor intensity for the staff. 3. After the ablation needle is inserted into the human body, for deep tumors, a CT scan may be required to analyze whether the ablation needle has been inserted in place (deep tumors are difficult to locate accurately with ultrasound, and traditional metal needles may heat up, shift, or even damage the equipment under the strong magnetic field of MRI). If the ablation needle is not inserted in place, it will be pulled out and inserted again, and then another CT scan will be performed to determine whether the puncture is in place. Frequent CT scans increase the patient's risk of radiation exposure.

[0005] To address the aforementioned shortcomings, existing technologies offer various puncture path planning schemes or puncture surgical robot solutions for precise positioning of ablation puncture planning and operation. For example, Chinese patent ZL201910220801.1 discloses a CT-guided method for planning puncture paths in liver tumor thermal ablation treatment, including: automatically segmenting and visually reconstructing the skin, liver, liver tumor, and key abdominal anatomical structures based on the patient's abdominal CT images in three dimensions; and selecting feasible puncture (needle insertion) areas within the bounding box of the patient's abdominal CT images based on multiple strong clinical constraints. This method can automatically and in real-time plan the puncture path required for thermal ablation treatment using a computer-aided planning system, providing it to staff for puncture operations. It effectively solves the problem of relying on doctors for manual puncture path planning, but still suffers from the latter two shortcomings. For example, Chinese patent application CN202411834653.X discloses a robotic end effector for puncture intervention, including a clamping module and a guide needle module. The clamping module includes a mounting body, a development board, a connector, a rotation drive mechanism, a gripper, an ultrasonic probe, and an electromagnetic sensor. The guide needle module includes a guide rail, a slider, and various displacement drive mechanisms for the guide needle. The coordinate system of the entire system is unified, and an electromagnetic-visual registration method is used for calibration. Surgical planning is performed after a preoperative CT scan of the patient's affected area, and the results are calculated using a constraint positioning algorithm. Upon reaching the target pose, the rotational drive mechanism rotates the guide needle to select a non-coplanar puncture channel path. The displacement drive mechanism moves the guide needle to adjust the insertion angle. Real-time ultrasound images are used to monitor the puncture process and target information. This surgical robot can plan the puncture path before surgery, enabling it to automatically and accurately align itself using a spatial constraint positioning algorithm based on the planned information. Then, the end effector can select a non-coplanar puncture channel path, and real-time ultrasound images are used to monitor the puncture process and target information during surgery. However, surgical robots are expensive, with high costs for consumables and maintenance. Furthermore, ultrasound image navigation during surgery is insufficient for accurately locating deep tumors. If MRI navigation is used instead of ultrasound navigation, the limitations of direct electromagnetic motor drive in MRI environments, leading to lower robot control precision, need to be addressed. Additionally, the high cost and low availability of MRI-compatible ablation needles and artifact issues must be resolved. Furthermore, the long MRI scan time prolongs the surgery, increasing the risk of anesthetic complications and infection for patients.

[0006] On the other hand, for interventional procedures, existing technologies offer convenient and cost-effective auxiliary positioning solutions to help operators determine the puncture location and angle. Common examples include using a self-made grid for puncture location, a protractor for measuring the puncture angle, and a laser beam to indicate the puncture direction (using an indicator beam parallel or perpendicular to the puncture needle). These methods require operators to accurately observe and judge relevant spatial information—such as whether the puncture needle is parallel or perpendicular to the beam. However, in interventional ablation procedures, the ambient lighting conditions in the operating room can interfere with the operator's observation and judgment, making it difficult for them to make accurate judgments and thus affecting the accuracy and efficiency of ablation needle puncture. Summary of the Invention

[0007] The purpose of this invention is to overcome the shortcomings of existing technologies and provide an interventional ablation puncture system and an auxiliary device for ablation needle puncture. The interventional ablation puncture system provided by this invention is suitable for scenarios where ablation needle puncture is performed manually. It includes an ablation needle and a puncture guide. The ablation needle is manually held, and the puncture guide includes a light guiding component with a light source emitter. The light source emitter includes an indicator light source for indicating the correct puncture direction of the ablation needle. The indicator light source emits a beam of light to illuminate the indicator needle. Simultaneously, the indicator needle is provided with a visual positioning mark, which enhances visibility when illuminated by the beam of light emitted from the indicator light source. The visual positioning mark on the indicator needle indicates whether the actual puncture direction of the ablation needle matches the aforementioned correct puncture direction. Thus, this invention can directly and quickly guide the puncture direction of the ablation needle, assisting physicians in quickly determining the puncture direction. It has the advantages of simple structure, convenient operation, and flexibility, and compared to existing technologies, it can effectively reduce the number of repeated punctures.

[0008] To achieve the above objectives, the present invention provides the following technical solution: An interventional ablation puncture system, the system comprising: An ablation needle includes a puncture needle, a handle, and an indicator needle, wherein the indicator needle is arranged parallel to the puncture needle or is arranged on the reverse extension line of the puncture needle; A puncture guide includes a light guiding assembly, the light guiding assembly including a light source mounting bracket and a light source emitter, the light source emitter including an indicator light source for indicating the correct puncture direction of the ablation needle, the indicator light source being used to emit a beam of light to illuminate the indicator needle; The indicator needle is equipped with a visual positioning mark, which enhances visibility when illuminated by the beam of light emitted by the indicator light source. The visual positioning mark on the indicator needle indicates whether the actual puncture direction of the ablation needle matches the aforementioned correct puncture direction.

[0009] Furthermore, the visual positioning mark adopts a reflective unit, and the surface of the reflective unit is provided with retroreflective material; When illuminated by the indicator beam of the indicator light source, the light is reflected by the retroreflective material, which enhances the visibility of the positioning mark.

[0010] Furthermore, the visual positioning mark adopts a photoluminescent unit, and a photoluminescent material is disposed on the surface of the photoluminescent unit. The indicator beam emitted by the indicator light source contains light components that can be absorbed and illuminated by the photoluminescent material, which makes the indicator beam distinguishable from ambient light. Under the illumination of the indicator beam of the indicator light source, the photoluminescent unit material absorbs light components of a specific wavelength and then radiates light of different wavelengths to make the location mark visible, thereby enhancing the visibility of the location mark.

[0011] Furthermore, the visible positioning marks on the indicator needle are multiple, and the ray beam emitted by the indicator light source is configured to have a certain width such that: When the actual puncture direction of the ablation needle matches the aforementioned correct puncture direction, the X-ray beam can completely cover all the visual positioning marks on the indicator needle so that the visual positioning marks are fully displayed; when the actual puncture direction of the ablation needle deviates from the aforementioned correct puncture direction, the X-ray beam cannot cover all the visual positioning marks on the indicator needle so that the visual positioning marks are not fully displayed; the matching is indicated by whether the visual positioning marks on the indicator needle are fully displayed.

[0012] Furthermore, the needle body of the indicator needle adopts a gradient structure, and the cross-section of the needle body gradually thickens from the front end to the rear end. The ray beam emitted by the indicator light source irradiates from the front end to the rear end of the needle body, and the irradiation surface can completely cover the rear end cross-section of the needle body. When the axial centerline of the indicator needle matches the direction of the ray beam, all the visible positioning marks on the indicator needle are illuminated by the ray beam, making the visible positioning marks fully lit. When the axial centerline of the indicator needle deviates from the direction of the X-ray beam, at least a portion of the visible positioning mark on the indicator needle cannot be illuminated by the X-ray beam, and the visible positioning mark cannot be fully lit.

[0013] Furthermore, the visual positioning mark includes a positioning circle located at the front end of the indicator needle body and positioning rings located at different heights of the indicator needle body. When viewed along the direction of the light beam, multiple positioning rings are located on the outer periphery of the positioning circle and form a concentric ring array spaced apart. When the axial centerline of the indicator needle matches the direction of the ray beam, the concentric ring array is fully illuminated; When the axial centerline of the indicator needle deviates from the direction of the ray beam, some of the positioning rings in the concentric ring array cannot be fully lit. The greater the deviation angle, the more positioning rings cannot be fully lit.

[0014] Furthermore, the indicator needle includes a core rod and a plurality of spaced protrusions disposed on the outer periphery of the core rod, the plurality of protrusions forming an array to serve as a visual positioning marker; wherein, the plurality of protrusions are arranged at different heights along the core rod in the axial direction and are located at different orientations on the cross-section of the core rod; the ray beam emitted by the indicator light source illuminates from the front end to the rear end of the core rod, and the irradiated surface can completely cover the core rod and all protrusions of the indicator needle; When the axial centerline of the indicator needle core rod matches the irradiation direction of the X-ray beam, the front surface of all the protrusions on the indicator needle is irradiated by the X-ray beam, making all the protrusions fully lit. When the axial centerline of the indicator needle core deviates from the direction of the X-ray beam, at least a portion of the front surface of the protrusions on the indicator needle cannot be illuminated by the X-ray beam, and at least a portion of the protrusions cannot be fully illuminated. The greater the deviation angle, the more protrusions cannot be fully illuminated.

[0015] Furthermore, the width of the irradiation surface of the ray beam emitted by the indicator light source is greater than or equal to the maximum cross-sectional width of the indicator needle, wherein the ratio of the width of the irradiation surface of the ray beam to the maximum cross-sectional width of the indicator needle is 1.0-1.2.

[0016] Furthermore, the puncture guide also includes a puncture depth measuring component, which includes a scale mounting bracket and a scale. The mounting angle of the scale is adjusted by the scale mounting bracket to make it parallel to the beam of light emitted by the indicator light source. The scale corresponds to the puncture needle of the ablation needle. During puncture, the depth of ablation needle insertion is measured by comparing the relative positions of the aforementioned scale and the puncture needle of the ablation needle. And / or, the puncture guide also includes a guiding cooperation structure corresponding to the ablation needle, which is used to limit the direction of the puncture operation of the ablation needle; the guiding cooperation structure is a V-shaped positioning groove, a Y-shaped positioning groove, or a positioning sleeve, and the setting angle of the V-shaped positioning groove, Y-shaped positioning groove, or positioning sleeve matches the correct puncture direction.

[0017] The present invention also provides a puncture assist device for an ablation needle, the puncture assist device comprising: An indicator needle is provided on the ablation needle, wherein the indicator needle is arranged parallel to the puncture needle of the ablation needle or the indicator needle is arranged on the reverse extension line of the puncture needle; A puncture guide includes a light guiding assembly, the light guiding assembly including a light source mounting bracket and a light source emitter, the light source emitter including an indicator light source for indicating the correct puncture direction of the ablation needle, the indicator light source being used to emit a beam of light to illuminate the indicator needle; The indicator needle is equipped with a visual positioning mark, which enhances visibility when illuminated by the beam of light emitted by the indicator light source. The visual positioning mark on the indicator needle indicates whether the actual puncture direction of the ablation needle matches the aforementioned correct puncture direction.

[0018] Compared with existing technologies, this invention, by adopting the above technical solution, has the following advantages and positive effects: The interventional ablation puncture system provided by this invention is suitable for scenarios where ablation needles are manually inserted. It includes an ablation needle and a puncture guide. The ablation needle is held manually, and the puncture guide includes a light guiding component with a light source emitter. The light source emitter includes an indicator light source for indicating the correct puncture direction of the ablation needle. The indicator light source emits a beam of light to illuminate the indicator needle. Simultaneously, the indicator needle is provided with a visual positioning mark, which becomes visible when illuminated by the beam of light emitted by the indicator light source. The visual positioning mark on the indicator needle indicates whether the actual puncture direction of the ablation needle matches the aforementioned correct puncture direction. Thus, this invention can directly and quickly guide the puncture direction of the ablation needle, assisting physicians in quickly determining the puncture direction. It has the advantages of simple structure, convenient operation, and flexibility, and can effectively reduce the number of repeated punctures compared with existing technologies.

[0019] Furthermore, the puncture guide also includes a base, on which a guiding cooperation structure can be set to limit the direction of the puncture operation of the ablation needle. Specifically, the guiding cooperation structure can be a V-shaped positioning groove, a Y-shaped positioning groove, or a positioning sleeve, etc., so as to avoid or reduce the slight deviation of the puncture direction of the ablation needle caused by hand tremors, emotional influence, etc. during puncture. Attached Figure Description

[0020] Figure 1 This is a schematic diagram of the procedure for treating thyroid tumors using microwave ablation.

[0021] Figure 2 This is a schematic diagram of the interventional ablation puncture system provided in an embodiment of the present invention. Figure 1 .

[0022] Figure 3 This is a schematic diagram of the interventional ablation puncture system provided in an embodiment of the present invention. Figure 2 .

[0023] Figure 4 This is an illumination diagram of a positioning mark using a visual positioning ring as an indicator needle, provided as an embodiment of the present invention.

[0024] Figure 5 for Figure 4 A schematic diagram of the concentric ring array when all rings are lit (the actual puncture direction matches the planned puncture direction).

[0025] Figure 6 for Figure 4 A schematic diagram of a concentric ring array that is not fully lit (the actual puncture direction deviates from the planned puncture direction).

[0026] Figure 7 This is an illumination diagram illustrating the positioning mark using a visual positioning bump as an indicator needle, provided in an embodiment of the present invention.

[0027] Figure 8 for Figure 7 A schematic diagram showing the positioning bumps in different positions illuminated (the actual puncture direction matches the planned puncture direction).

[0028] Figure 9 for Figure 7 A schematic diagram showing when the positioning bumps in different positions are not fully lit (the actual puncture direction deviates from the planned puncture direction).

[0029] Figure 10 This is a schematic diagram of an interventional ablation and puncture system including a cooling structure, provided as an embodiment of the present invention.

[0030] Explanation of reference numerals in the attached figures: Interventional ablation puncture system 10; Ablation needle 100, puncture needle 110, handle 120, indicator needle 130, needle body 131, visual positioning ring 132, positioning circle 1321, concentric ring array 1322, protrusion 133; external connector 140. Ablation device 200; Puncture guide 300, indicator light source 310, beam 311. Detailed Implementation

[0031] The following detailed description, in conjunction with the accompanying drawings and specific embodiments, provides a further detailed account of the interventional ablation puncture system and the puncture auxiliary device for the ablation needle disclosed in this invention. 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 to achieve better technical effects. In the accompanying drawings of the following embodiments, the same reference numerals 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.

[0032] 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.

[0033] 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.

[0034] 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

[0035] See Figure 2 As shown, this invention provides an interventional ablation puncture system 10, which includes an ablation needle 100, an ablation device 200, and a puncture guide 300.

[0036] The ablation needle 100 may specifically include a puncture needle 110, a handle 120, and an indicator needle 130. The puncture needle 110 may consist of a needle tip (or puncture head) and a syringe tube. The needle tip may be installed at one end of the syringe tube (distal end), and the other end (proximal end) of the syringe tube is connected to the head of the handle 120. The other end of the handle 120 can be connected to the ablation device 120. Preferably, the puncture needle 110 and the handle 120 are detachably connected. When the puncture needle 110 is installed on the handle 120, the puncture needle 110 is fixed to the handle 120. When the puncture needle 110 is removed from the handle 120, the puncture needle 110 is separated from the handle 120, allowing the user to remove the puncture needle 110 for disinfection or replacement.

[0037] In this embodiment, the ablation needle 110 can be a radiofrequency ablation needle, microwave ablation needle, cryoablation needle, laser ablation needle, pulsed electric field ablation needle, or chemical ablation needle, and the corresponding ablation device 120 needs to be selected accordingly. Taking microwave ablation as an example, the ablation device 120 can specifically be a microwave ablation device (or microwave therapy device).

[0038] The improvement in this embodiment is that an indicator needle 130 is provided on the ablation needle 110, and a puncture guide 300 corresponding to the indicator needle is provided.

[0039] The indicator needle 130 can be arranged parallel to the puncture needle 110, or it can be arranged on the reverse extension line of the puncture needle 110, so that the orientation angle of the indicator needle 130 relative to the handle 120 is the same as the orientation angle of the puncture needle 110 relative to the handle 120. When the tilt direction of the puncture needle 110 changes, the tilt direction of the indicator needle 130 also changes. In this way, the current puncture angle of the puncture needle 110 can be indicated by the indicator needle 130.

[0040] As a typical installation method, the indicator needle 130 can be fixed by mounting it to the rear end of the handle 120 via a mounting base. After fixing, the indicator needle 130 and the puncture needle 110 are parallel to each other or coincide based on their extension lines. See [reference needed]. Figure 2 As shown. Alternatively, the indicator needle 130 is fixed after being mounted on the upper end of the handle 120 via a mounting base. After fixing, the indicator needle 130 and the puncture needle 110 are parallel to each other. See [reference needed]. Figure 3 As shown.

[0041] The puncture guide 300 includes at least a light guiding component for indicating the puncture direction.

[0042] Specifically, the light guiding assembly may include a light source mounting bracket and a light source emitter. The light source emitter is mounted on the light source mounting bracket, and the mounting angle of the light source emitter can be adjusted via the light source mounting bracket. The light source emitter includes an indicator light source for indicating the correct puncture direction of the ablation needle, and the indicator light source is used to emit a beam of light to illuminate the indicator needle. Preferably, the mounting seat of the indicator needle 130 is located at the rear end of the indicator needle 130, and the width of the mounting seat is greater than the width of the indicator beam, and the mounting seat can block the indicator beam from continuing to transmit downwards.

[0043] The indicator needle is equipped with a visual positioning mark, which can be enhanced in visibility when illuminated by the beam of light emitted by the indicator light source, that is, the visibility of the visual positioning mark is enhanced. The visual positioning mark on the indicator needle is used to indicate whether the actual puncture direction of the ablation needle matches the aforementioned correct puncture direction.

[0044] The correct puncture direction is determined based on pre-planned puncture path information. Specifically, the planned puncture path information includes the needle insertion position, puncture angle, and puncture depth. The correct puncture direction is determined based on the puncture angle (the planned puncture angle determines the puncture direction of the puncture needle).

[0045] In this embodiment, the puncture path can be planned automatically by external devices (such as remote hosts, host computers, etc.) based on the collected three-dimensional static image data of the patient (such as CT imaging data), or manually by medical staff based on the collected three-dimensional static image data of the patient, or a semi-automatic plan combining devices and manual planning.

[0046] The installation angle of the light source emitter can be adjusted manually or automatically. When using manual adjustment, after the physician has planned the puncture path information or obtained the puncture path information automatically planned by the external device, the puncture guide 300 can be placed on the operating table next to the patient and the light source mounting bracket of the puncture guide 300 can be fixed. Then, according to the planned needle insertion position (on the patient) and puncture angle, the position and angle of the light source emitter on the puncture guide 300 can be adjusted so that the irradiation direction of the ray beam (indicator beam) emitted by the indicator light source on the light source emitter conforms to the aforementioned puncture angle (for example, at a 30-degree tilt angle with the vertical direction). At this time, the indicator beam indicates the correct puncture direction, which corresponds to the previously planned puncture angle.

[0047] When using the automatic adjustment method, the light source mounting bracket of the puncture guide 300 also includes a mounting position adjustment mechanism to automatically adjust the position and angle of the light source emitter. In this case, the controller of the puncture guide 300 can communicate with an external device and receive puncture path information automatically planned by that external device. It is then configured to: based on the puncture angle (e.g., a 30-degree tilt angle with the vertical) in the externally set puncture path information, control the position adjustment mechanism to adjust the position and angle of the light source emitter, so that the light emission angle of the indicator light source matches the aforementioned puncture angle. At this point, the ray beam (indicator beam) emitted by the indicator light source indicates the correct puncture direction.

[0048] At this point, a tilt detection module (such as a tilt sensor) can be added to detect the actual tilt angle of the indicator light source and feed the detected tilt angle information back to the controller of the puncture guide 300 in real time. The controller can compare the received tilt angle information with the puncture angle in the puncture path information. If the two do not match (i.e., a tilt angle deviation occurs), the position adjustment mechanism can be re-controlled to adjust the angle of the light source emitter, so that the light emission angle of the indicator light source is rematched with the aforementioned puncture angle. In this way, real-time dynamic calibration of the indicator beam can be achieved.

[0049] Preferably, the light source emitter may further include a puncture position indicator light source for indicating the needle insertion point (i.e., marking the needle insertion position) on the patient's body. The puncture indicator light source can be mounted on the puncture guide 300 via an independent support arm to independently adjust its position and angle. The puncture indicator light source is preferably a point source laser emitter that emits colored laser light to highlight the needle insertion point and guide the puncture needle.

[0050] In one embodiment of this invention, the visible positioning mark on the indicator needle 130 uses a reflective unit. The surface of the reflective unit is provided with a retroreflective material, which can significantly enhance visibility under low light or direct sunlight conditions. In this case, under the illumination of the indicator beam from the indicator light source, the light is reflected after passing through the retroreflective material, thus enhancing the visibility of the positioning mark. Specifically, the retroreflective material can be a transparent prism material with densely packed tiny reflective particles on its surface or a glass microsphere reflective material.

[0051] Preferably, in order to further enhance visibility, when installing the reflective unit, the installation angle of the reflective unit is adjusted so that the indicator beam can directly hit the retroreflective material to increase the retroreflectivity, thereby further enhancing visibility.

[0052] In another embodiment of this invention, the visual positioning mark on the indicator needle 130 is a photoluminescent unit. The surface of the photoluminescent unit is provided with a photoluminescent material, and the indicator beam emitted by the indicator light source contains light components that can be absorbed and emitted by the photoluminescent material, thus distinguishing the indicator beam from ambient light. Preferably, for example, the photoluminescent material is a material containing phosphor, and the indicator beam emitted by the indicator light source may contain low-intensity ultraviolet light of a preset wavelength. The lighting environment created by operating room lighting typically does not contain ultraviolet light (the spectral range of the operating room's shadowless lamps is concentrated in the visible light band, with wavelengths in the range of 400-700 nm, filtering out ultraviolet and infrared components), thus distinguishing the indicator beam from ambient light.

[0053] Under the illumination of the indicator beam of the indicator light source, the photoluminescent unit material absorbs light components of a specific wavelength and then radiates light of different wavelengths to display light (manifest as luminescence), thereby enhancing the visibility of the positioning mark. It should be noted that the indicator light source is only used to illuminate the visible positioning mark on the indicator needle 130 for display purposes and is not used for lighting or treatment. The light components and illumination time in the beam emitted by the indicator light source should comply with existing relevant safety standards.

[0054] In a preferred embodiment, the indicator needle 130 has multiple visual positioning marks. The beam emitted by the indicator light source is configured to have a certain width to satisfy the following conditions: when the actual puncture direction of the ablation needle matches the aforementioned correct puncture direction (i.e., the puncture direction is correct), the beam can completely cover all the visual positioning marks on the indicator needle, allowing the visual positioning marks to be fully displayed; when the actual puncture direction of the ablation needle deviates from the aforementioned correct puncture direction (i.e., the puncture direction deviates), the beam cannot cover all the visual positioning marks on the indicator needle, preventing the visual positioning marks from being fully displayed. Thus, the completeness of the visual positioning marks on the indicator needle indicates whether the actual puncture direction of the ablation needle matches the aforementioned correct puncture direction. By observing the completeness of the visual positioning marks on the indicator needle 130, the physician can obtain a more accurate judgment on whether the puncture angle is correct.

[0055] In specific settings, the visual positioning identifier can be a visual positioning ring or a visual positioning block.

[0056] When a visual positioning ring is used, the needle body of the indicator needle preferably adopts a gradient structure. Specifically, the needle body of the indicator needle can be a cone, a frustum, a pyramid, a truncated pyramid structure, etc.

[0057] See Figure 4 As shown, an example of a needle body with a frustum structure is illustrated. In this case, the cross-section of the needle body 131 of the indicator needle 130 gradually thickens from the front end to the rear end of the needle body 131. The ray beam 311 emitted by the indicator light source 310 irradiates from the front end to the rear end of the needle body. The ray beam 311 has a certain width, and the irradiation surface (cross-section of the beam) of the ray beam 311 can completely cover the rear end cross-section of the needle body.

[0058] When the axial centerline of the indicator needle 130 (i.e. the axial centerline of the needle body 131) matches the irradiation direction of the ray beam 311 (coinciding in the figure), all the visible positioning marks on the indicator needle 130 are irradiated by the ray beam 311, making all the visible positioning marks fully lit.

[0059] When the axial centerline of the indicator needle 130 (i.e. the axial centerline of the needle body 131) deviates from the irradiation direction of the ray beam 311, for example, when the axial centerline of the indicator needle has a certain angle with the ray beam 311, at least part of the visible positioning mark on the indicator needle cannot be irradiated by the ray beam, resulting in the visible positioning mark not being fully lit (including two situations: the visible positioning mark is partially lit and the visible positioning mark is not lit).

[0060] Preferably, the visual positioning mark may include a positioning circle 1321 located at the front end of the indicator needle body 131 and positioning rings located at different heights of the indicator needle body 131. When viewed along the direction of the light beam, a plurality of the positioning rings are located on the outer periphery of the positioning circle 1321 and form a concentric ring array 1322 spaced apart.

[0061] When the axial centerline of the indicator needle 131 matches the illumination direction of the ray beam 311, the concentric ring array 1322 is fully illuminated. (See below) Figure 5 As shown. At this point, the physician can clearly observe the complete concentric ring array, indicating that the current puncture direction is correct and the puncture can continue.

[0062] When the axial centerline of the indicator needle 131 deviates from the irradiation direction of the ray beam 311, some of the positioning rings in the concentric ring array 1322 will not be fully illuminated. (See also...) Figure 6 As shown. At this point, the physician can clearly observe the incomplete concentric ring array, indicating that the current puncture direction has deviated and needs adjustment; the greater the angle of deviation, the more positioning rings will not be fully illuminated.

[0063] Specifically, when adjustments are needed, the physician can tilt the ablation needle toward the area where the concentric ring array is not lit. When all 1322 of the concentric ring array are lit, it indicates that the current puncture direction is correct and the puncture can continue.

[0064] See Figure 7 As shown, when a visual positioning block is used, the indicator needle 130 may include a core rod in the middle (i.e., needle body 131 in the figure) and a plurality of spaced protrusions 133 arranged on the outer periphery of the core rod. The plurality of protrusions 133 form an array to serve as a visual positioning mark.

[0065] Specifically, multiple protrusions 133 are evenly spaced along different heights of the core rod in the axial direction. Simultaneously, the multiple protrusions 133 are located at different positions on the cross-section of the core rod. Viewed along the direction of the light beam, the multiple protrusions 133 form a uniformly spaced protrusion ring array around the cross-section of the core rod. The ray beam 311 emitted by the indicator light source 310 illuminates from the front end to the rear end of the core rod, and the irradiated surface can completely cover the core rod of the indicator needle and all the protrusions 133.

[0066] When the axial centerline of the indicator needle 130 core rod is aligned with the irradiation direction of the X-ray beam 311, the front surface of the protrusions 133 on the indicator needle 130 can be fully irradiated by the X-ray beam 311, making all protrusions 133 fully illuminated and the protrusion ring array fully displayed. (See [reference]) Figure 8 As shown, this indicates that the current puncture direction is correct and puncture can continue.

[0067] When the axial centerline of the indicator needle 130 core deviates from the irradiation direction of the X-ray beam 311, at least a portion of the front surface of the protrusions 133 on the indicator needle 130 cannot be irradiated by the X-ray beam, resulting in at least a portion of the protrusions 133 not being fully illuminated and the protrusion ring array not being fully displayed. See [link to documentation]. Figure 9 As shown. At this point, the physician can clearly observe the incomplete array of bumps, indicating that the current puncture direction has deviated and needs adjustment; the greater the angle of deviation, the more bumps will not be fully illuminated.

[0068] Specifically, when adjustments are needed, the physician can tilt the ablation needle toward the direction of the non-illuminated or partially illuminated bumps. When the entire bump ring array is illuminated, it indicates that the current puncture direction is correct and the puncture can continue.

[0069] In this embodiment, there are at least four protrusions, corresponding to at least the four cardinal directions (north, south, east, and west) of the core rod. Preferably, there are eight or ten protrusions. Figure 7 The example illustrates the scenario where eight bumps are evenly spaced.

[0070] In this embodiment, the width of the irradiation surface (beam cross-sectional width) of the ray beam 311 emitted by the indicator light source 310 should be greater than or equal to the maximum cross-sectional width of the indicator needle, so that the irradiation surface of the ray beam 311 can completely cover the indicator needle.

[0071] Preferably, the ratio of the width of the illumination surface of the indicator light source 310 to the maximum cross-sectional width of the indicator needle is preferably 1.0-1.2. For example, taking a cylindrical beam emitted by the indicator light source as an example, its illumination surface (i.e., the beam cross-section) is circular, and the width of the illumination surface refers to the diameter of this circle, denoted by D1; the needle body of the indicator needle adopts a frustum structure with a circular cross-section, and its rear end (bottom end) has the largest cross-section, the maximum cross-sectional width of which is the diameter of the bottom end cross-section, denoted by D2; when setting the indicator beam of the indicator light source 310, the ratio of D1 to D2 should be within the range of 1.0-1.2.

[0072] In specific settings, the ratio can be set according to the location of the area to be ablated, the size of the lesion area, etc. For example, for lesions growing in important organs or lesions requiring high operational precision, the ratio can be set to 1.0-1.1 to ensure more precise puncture direction accuracy; for lesions in non-important organs or lesions requiring general operational precision, the ratio can be set to 1.1-1.2.

[0073] In this embodiment, the puncture guide 300 may further include a puncture depth measuring component and a guiding cooperation structure.

[0074] The puncture depth measuring component may specifically include a scale mounting bracket and a scale. The mounting angle of the scale is adjusted by the scale mounting bracket to make it parallel to the X-ray beam emitted by the indicator light source. The scale corresponds to the puncture needle of the ablation needle. During puncture, the depth of ablation needle insertion is measured by comparing the relative positions of the aforementioned scale and the puncture needle of the ablation needle.

[0075] The guiding and cooperating structure is designed to limit the direction of the ablation needle puncture operation, thereby avoiding or reducing the slight deviation of the ablation needle puncture direction caused by hand tremors, emotional influence, etc. during puncture.

[0076] Specifically, the guiding and cooperating structure can be a V-shaped positioning groove, a Y-shaped positioning groove, or a positioning sleeve, and the setting angle of the V-shaped positioning groove, Y-shaped positioning groove, or positioning sleeve matches the correct puncture direction. Specifically, the V-shaped positioning groove or Y-shaped positioning groove forms a V-shaped groove defining the insertion cannula. During puncture, a portion of the ablation needle abuts against the V-shaped groove to approach the puncture site. The positioning sleeve forms an inner cavity defining the insertion cannula, through which the ablation needle passes to approach the puncture site.

[0077] In this embodiment, the surface of the ablation needle body can also be provided with scale markings. For example, multiple scale markings can be evenly spaced on the circumferential side of the needle body, and the distance between adjacent scale markings can be set to 10mm, 20mm, etc., as needed. During ablation needle puncture, the operator can visually obtain approximate puncture depth information through the scale markings on the needle body. Furthermore, numerical markers are provided between adjacent scale markings, using consecutive Arabic numerals. During ablation needle puncture, the puncture depth is obtained based on the combination of scale markings and numerical markers.

[0078] Preferably, when the ablation needle is a microwave ablation needle, considering that the ablation needle will generate a large amount of heat during use, a cooling structure can also be provided on the ablation needle. Specifically, a water-cooling channel can be provided on the puncture needle of the ablation needle to cool the area in contact with human tissue and prevent the puncture needle from overheating. The water-cooling channel on the ablation needle can be connected to an external circulation pump system (not shown in the figure) through an inlet water pipe, a return water pipe, and an external connector 140. See [reference needed]. Figure 10 As shown.

[0079] Another embodiment of the present invention also provides a puncture assistance device for an ablation needle.

[0080] The puncture assist device includes an indicator needle mounted on the ablation needle and a puncture guide that is independent of the ablation needle.

[0081] The indicator needle is arranged parallel to the puncture needle of the ablation needle, or the indicator needle is arranged on the reverse extension line of the puncture needle.

[0082] The puncture guide includes a light guiding assembly, which includes a light source mounting bracket and a light source emitter. The light source emitter includes an indicator light source for indicating the correct puncture direction of the ablation needle, and the indicator light source is used to emit a beam of light to illuminate the indicator needle.

[0083] The indicator needle is equipped with a visual positioning mark, which enhances visibility when illuminated by the beam of light emitted by the indicator light source. The visual positioning mark on the indicator needle indicates whether the actual puncture direction of the ablation needle matches the aforementioned correct puncture direction.

[0084] Other technical features are described in the preceding embodiments and will not be repeated here.

[0085] 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. An interventional ablation puncture system, characterized in that... include: An ablation needle includes a puncture needle, a handle, and an indicator needle, wherein the indicator needle is arranged parallel to the puncture needle or is arranged on the reverse extension line of the puncture needle; A puncture guide includes a light guiding assembly, the light guiding assembly including a light source mounting bracket and a light source emitter, the light source emitter including an indicator light source for indicating the correct puncture direction of the ablation needle, the indicator light source being used to emit a beam of light to illuminate the indicator needle; The indicator needle is equipped with a visual positioning mark, which enhances visibility when illuminated by the beam of light emitted by the indicator light source. The visual positioning mark on the indicator needle indicates whether the actual puncture direction of the ablation needle matches the aforementioned correct puncture direction.

2. The interventional ablation puncture system according to claim 1, characterized in that, The visual positioning mark uses a reflective unit, and the surface of the reflective unit is provided with retroreflective material; When illuminated by the indicator beam of the indicator light source, the light is reflected by the retroreflective material, which enhances the visibility of the positioning mark.

3. The interventional ablation puncture system according to claim 1, characterized in that, The visual positioning mark uses a photoluminescent unit, and a photoluminescent material is disposed on the surface of the photoluminescent unit. The indicator beam emitted by the indicator light source contains light components that can be absorbed and illuminated by the photoluminescent material, which makes the indicator beam distinguishable from ambient light. Under the illumination of the indicator beam of the indicator light source, the photoluminescent unit material absorbs light components of a specific wavelength and then radiates light of different wavelengths to make the location mark visible, thereby enhancing the visibility of the location mark.

4. The interventional ablation puncture system according to any one of claims 1-3, characterized in that, The indicator needle has multiple visible positioning marks, and the ray beam emitted by the indicator light source is configured to have a certain width such that: When the actual puncture direction of the ablation needle matches the aforementioned correct puncture direction, the X-ray beam can completely cover all the visual positioning marks on the indicator needle so that the visual positioning marks are fully displayed; when the actual puncture direction of the ablation needle deviates from the aforementioned correct puncture direction, the X-ray beam cannot cover all the visual positioning marks on the indicator needle so that the visual positioning marks are not fully displayed; the matching is indicated by whether the visual positioning marks on the indicator needle are fully displayed.

5. The interventional ablation puncture system according to claim 4, characterized in that, The needle body of the indicator needle adopts a gradient structure, and the cross-section of the needle body gradually becomes thicker from the front end to the rear end. The beam of light emitted by the indicator light source shines from the front end to the rear end of the needle body, and the irradiation surface can completely cover the rear end cross-section of the needle body. When the axial centerline of the indicator needle matches the direction of the ray beam, all the visible positioning marks on the indicator needle are illuminated by the ray beam, making the visible positioning marks fully lit. When the axial centerline of the indicator needle deviates from the direction of the X-ray beam, at least a portion of the visible positioning mark on the indicator needle cannot be illuminated by the X-ray beam, and the visible positioning mark cannot be fully lit.

6. The interventional ablation puncture system according to claim 5, characterized in that, The visual positioning mark includes a positioning circle located at the front end of the indicator needle body and positioning rings located at different heights of the indicator needle body. When viewed along the direction of the light beam, multiple positioning rings are located on the outer periphery of the positioning circle and form a concentric ring array spaced apart. When the axial centerline of the indicator needle matches the direction of the ray beam, the concentric ring array is fully illuminated; When the axial centerline of the indicator needle deviates from the direction of the ray beam, some of the positioning rings in the concentric ring array cannot be fully lit. The greater the deviation angle, the more positioning rings cannot be fully lit.

7. The interventional ablation puncture system according to claim 4, characterized in that, The indicator needle includes a core rod and a plurality of spaced protrusions disposed on the outer periphery of the core rod. The plurality of protrusions form an array to serve as a visual positioning marker. The plurality of protrusions are evenly spaced along different heights of the core rod in the axial direction and are located at different orientations on the cross-section of the core rod. The ray beam emitted by the indicator light source illuminates from the front end to the rear end of the core rod, and the irradiated surface can completely cover the core rod and all protrusions of the indicator needle. When the axial centerline of the indicator needle core rod matches the irradiation direction of the X-ray beam, the front surface of all the protrusions on the indicator needle is irradiated by the X-ray beam, making all the protrusions fully lit. When the axial centerline of the indicator needle core deviates from the direction of the X-ray beam, at least a portion of the front surface of the protrusions on the indicator needle cannot be illuminated by the X-ray beam, and at least a portion of the protrusions cannot be fully illuminated. The greater the deviation angle, the more protrusions cannot be fully illuminated.

8. The interventional ablation puncture system according to claim 4, characterized in that, The width of the irradiation surface of the ray beam emitted by the indicator light source is greater than or equal to the maximum cross-sectional width of the indicator needle, wherein the ratio of the irradiation surface width of the ray beam to the maximum cross-sectional width of the indicator needle is 1.0-1.

2.

9. The interventional ablation puncture system according to any one of claims 1-3, characterized in that, The puncture guide also includes a puncture depth measuring component, which includes a scale mounting bracket and a scale. The mounting angle of the scale is adjusted by the scale mounting bracket to make it parallel to the beam of light emitted by the indicator light source. The scale corresponds to the puncture needle of the ablation needle. During puncture, the depth of ablation needle insertion is measured by comparing the relative positions of the aforementioned scale and the puncture needle of the ablation needle. And / or, the puncture guide also includes a guiding cooperation structure corresponding to the ablation needle, which is used to limit the direction of the puncture operation of the ablation needle; the guiding cooperation structure is a V-shaped positioning groove, a Y-shaped positioning groove, or a positioning sleeve, and the setting angle of the V-shaped positioning groove, Y-shaped positioning groove, or positioning sleeve matches the correct puncture direction.

10. A puncture assist device for an ablation needle, characterized in that... include: An indicator needle is provided on the ablation needle, wherein the indicator needle is arranged parallel to the puncture needle of the ablation needle or the indicator needle is arranged on the reverse extension line of the puncture needle; A puncture guide includes a light guiding assembly, the light guiding assembly including a light source mounting bracket and a light source emitter, the light source emitter including an indicator light source for indicating the correct puncture direction of the ablation needle, the indicator light source being used to emit a beam of light to illuminate the indicator needle; The indicator needle is equipped with a visual positioning mark, which enhances visibility when illuminated by the beam of light emitted by the indicator light source. The visual positioning mark on the indicator needle indicates whether the actual puncture direction of the ablation needle matches the aforementioned correct puncture direction.

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