Ultrasound-guided steam ablation surgical device and system

Abstract

The present application relates to the technical field of medical instruments and provides an ultrasound-guided steam ablation surgical device and system. A device body comprises a handle and a catheter; an ultrasound-guided steam ablation assembly comprises an ultrasonic probe and a steam delivery needle, and the ultrasonic probe and the steam delivery needle are both movably provided in the catheter. The ultrasonic probe and the steam delivery needle are each provided with a position determination assembly, and the position determination assemblies are configured to determine position information of the ultrasonic probe and the steam delivery needle. A control assembly is connected to the ultrasonic probe, the steam delivery needle, and the position detection assemblies. The control assembly is configured to determine, on the basis of the position information of the ultrasonic probe and the steam delivery needle, an included angle between the ultrasonic probe and the steam delivery needle, and plan a puncture direction on the basis of the included angle and real-time ultrasonic imaging of a lesion region. When the steam delivery needle of the present application performs a puncture action, the error of the planned puncture direction is adjusted in real time according to position signals fed back by the position detection assemblies, and then ablation treatment is performed, such that the treatment deviation is small.

Description

Ultrasound-guided steam ablation surgical device and system

[0001] Cross-references to related applications

[0002] This application claims priority to Chinese Patent Application No. 2024111912866, filed on August 28, 2024, entitled “Ultrasound-guided Steam Ablation Surgical Device and System”, which is incorporated herein by reference in its entirety. Technical Field

[0003] This application relates to the field of medical device technology, and in particular to an ultrasound-guided steam ablation surgical device and system. Background Technology

[0004] Common surgical procedures for uterine fibroids include abdominal myomectomy, (traditional / robot-assisted) laparoscopic myomectomy, hysteroscopic myomectomy, and uterine fibroid ablation therapy.

[0005] Open myomectomy (abdominal uterine fibroid removal) involves opening the abdomen and is considered a more invasive procedure. Laparoscopic myomectomy (traditional / robot-assisted) is an open surgery requiring laparotomy and general anesthesia to remove the fibroids, using a camera and surgical instruments inserted into the body. While laparoscopic surgery is generally minimally invasive, causing less damage to the abdominal wall and organs, it remains technically challenging. For example, it requires laparoscopic suturing, demanding a high level of skill from the operator. Furthermore, prolonged anesthesia leads to increased blood loss and a higher risk of uterine rupture during pregnancy, making laparoscopic myomectomy a challenging procedure. Hysteroscopic myomectomy uses instruments such as rings and rollers to remove uterine tissue. During the procedure, the uterus needs to be filled with fluid for better observation, which can cause fluid overload.

[0006] Uterine fibroid ablation therapy uses radiofrequency, microwave, ultrasound, steam, or other thermal energy to rapidly raise tissue temperature to a level that causes coagulative necrosis of tissue cell proteins, resulting in irreversible coagulative necrosis of tissue cells. It can also cause transmural damage to blood vessel walls within the tissue, achieving the therapeutic goal of in-situ inactivation of uterine fibroid tissue and cells while preserving the uterus, leading to fibroid shrinkage or complete disappearance through natural cavities. Patients do not require surgery, and the trauma is even less than that of traditional minimally invasive surgery, with the incision only the size of a steam delivery needle (approximately 2mm). Patients can quickly return to normal life after the procedure.

[0007] Although uterine fibroid ablation is a minimally invasive treatment with a quick recovery, the surgical apparatus currently used requires calibration of the steam delivery needle before use to ensure it is straight with the catheter, thus allowing for ultrasound-guided puncture. However, in actual use, the steam delivery needle is easily affected by the forces of the lesion tissue, causing it to shift position and making it impossible to maintain a perfectly straight alignment with the catheter in real time. This results in some error when deploying the puncture direction of the steam delivery needle under ultrasound guidance. Summary of the Invention

[0008] This application provides an ultrasound-guided steam ablation surgical device to address the shortcomings of existing technologies where the steam delivery needle is easily affected by the force of diseased tissue, causing its position to deviate and resulting in errors in the puncture direction. In this application, the steam delivery needle adjusts the planned puncture direction error in real time based on the position signals fed back by each position detection component before performing ablation treatment, resulting in a smaller treatment error.

[0009] This application also provides an ultrasound-guided steam ablation system.

[0010] This application provides an ultrasound-guided steam ablation surgical device, including a device body, an ultrasound-guided steam ablation component, and a control component.

[0011] The main body of the device includes a handle and a catheter, the catheter having a proximal end and a distal end, with a tube of a predetermined length extending between the proximal end and the distal end, and the proximal end of the catheter being connected to the handle.

[0012] The ultrasound-guided steam ablation assembly includes an ultrasound probe and a steam delivery needle. The ultrasound probe is movably disposed at the distal end of the catheter, and the steam delivery needle is movably disposed in the body of the catheter. Both the ultrasound probe and the steam delivery needle are equipped with position detection components, each of which is used to detect the position information of the ultrasound probe and the steam delivery needle.

[0013] The control component is connected to the ultrasound probe, the steam delivery needle and each of the position detection components respectively. The control component is used to determine the angle between the ultrasound probe and the steam delivery needle according to the position information of the ultrasound probe and the steam delivery needle, and to plan the puncture direction based on the angle and real-time ultrasound imaging of the lesion area.

[0014] The ultrasound-guided steam ablation surgical device provided in this application comprises an ultrasound-guided steam ablation component and an adjustment component on the main body of the device. The ultrasound-guided steam ablation component includes an ultrasound probe and a steam delivery needle. The ultrasound probe is movably disposed at the distal end of the catheter, and the steam delivery needle is movably disposed within the catheter body. Both the ultrasound probe and the steam delivery needle are equipped with position detection components, each used to detect the position information of the ultrasound probe and the steam delivery needle. The control component determines the angle between the ultrasound probe and the steam delivery needle based on the position information and plans the puncture direction based on the angle and real-time ultrasound imaging of the lesion area. With this configuration, when the steam delivery needle performs the puncture, it adjusts the error of the planned puncture direction in real time according to the position signals fed back by each position detection component before performing ablation treatment, resulting in a smaller treatment error.

[0015] Meanwhile, the integration of the ultrasound probe and steam delivery needle into a handheld device results in a more compact structure and convenient operation. The angle of the ultrasound probe relative to the catheter can be adjusted according to the location or shape of the lesion in the patient's body, allowing the ultrasound probe to better fit the lesion and clearly detect its condition. Under ultrasound imaging guidance, the puncture direction of the steam delivery needle can be adjusted, ensuring accurate deployment to the lesion with high reliability. The size of the ablation area can also be adjusted using a control. In essence, the device provided in this application can complete the puncture and deployment of the steam delivery needle under ultrasound imaging monitoring, resulting in high surgical safety and reliability. Attached Figure Description

[0016] To more clearly illustrate the technical solutions in this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0017] Figure 1 is a schematic diagram of the ultrasonic-guided steam ablation surgical device provided in an embodiment of this application.

[0018] Figure 2 is an exploded view of the structure of the ultrasound-guided steam ablation surgical device provided in the embodiment of this application.

[0019] Figure 3 is a partial structural schematic diagram of the ultrasound-guided steam ablation surgical device provided in an embodiment of this application.

[0020] Figure 4 is a schematic diagram of the initial ablation region translated along the X-axis according to an embodiment of this application.

[0021] Figure 5 is a schematic diagram of the initial ablation region translated along the Y-axis according to an embodiment of this application.

[0022] Figure 6 is a schematic diagram showing an enlarged view of the initial ablation region provided in an embodiment of this application.

[0023] Figure 7 is a schematic diagram of reducing the initial ablation area according to an embodiment of this application.

[0024] Figure 8 is a schematic diagram of real-time ultrasound imaging with a preset puncture depth overlaid, provided in an embodiment of this application.

[0025] Figure 9 is a schematic diagram of the needle tip structure of the steam delivery needle according to an embodiment of this application.

[0026] Figure 10 is a circuit diagram for measuring unknown impedance provided in an embodiment of this application.

[0027] Figure 11 shows the imaging surface shape of the ultrasonic probe provided in the embodiment of this application.

[0028] Figure 12 is a schematic diagram of another embodiment of the ultrasound-guided steam ablation surgical device provided in this application.

[0029] Figure 13 is a schematic diagram of the usage status of the ultrasound-guided steam ablation surgical device provided in the embodiments of this application.

[0030] Figure 14 is a schematic diagram of an ultrasound-guided steam ablation system provided in an embodiment of this application.

[0031] Figure 15 is a schematic diagram of the installation of the first magnetic element provided in an embodiment of this application.

[0032] Figure 16 is a coordinate diagram showing the error of adjusting and ablation planning based on the position signal fed back by the position detection component according to the embodiment of this application.

[0033] Figure 17 is a schematic diagram of the structure of the fitting graph provided in the embodiment of this application.

[0034] Figure 18 is a coordinate diagram of the ablation area adjustment provided in the embodiments of this application. Detailed Implementation

[0035] To make the objectives, technical solutions, and advantages of this application clearer, the technical solutions of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0036] Table 1 provides an overview of the various treatment protocols for uterine fibroid ablation therapy.

[0037] As shown in the table, during hysteroscopic radiofrequency ablation, the endoscope can only see surface lesions, such as tumors and polyps. It cannot determine the structure, layers, and histological characteristics of smooth, raised lesions. Therefore, it is suitable for submucosal and / or fibroids protruding into the uterine cavity, but cannot effectively treat other lesions.

[0038] Ultrasound has a "see-through" function, allowing observation of the layered structure and lesions of submucosal fibroids. Therefore, ultrasound navigation can be used to locate uterine fibroids and provide real-time imaging of the tumor, facilitating precise treatment. However, ultrasound-guided microwave (radiofrequency) ablation therapy (such as cryo-energy, microwave energy, and impedance-controlled radiofrequency) can damage endometrial tissue and has limited effectiveness in treating uterine fibroids, easily leading to uterine bleeding due to treatment dysfunction. Magnetic resonance-guided focused ultrasound (MRgFUS) is expensive and has a long procedure time.

[0039] Intrauterine ultrasound-guided radiofrequency ablation for uterine fibroids is a relatively new technique. It involves using an intrauterine ultrasound probe to image the fibroid in real time. Guided by the system's imaging software, multiple needles are introduced into the fibroid. A monopolar current is then delivered between the needles and distributed electrodes fixed in the thigh, causing irreversible coagulation of the tumor tissue and resulting in significant shrinkage. Compared to transabdominal and transvaginal ultrasound, intrauterine ultrasound probes can achieve higher quality imaging.

[0040] Laser and radiofrequency ablation induce thermal effects in tissues based on different principles. However, the nonlinear or non-uniform properties of tissues affect the distribution of laser and radiofrequency energy within the tissue. At the onset of radiofrequency ablation, a current loop is formed between the electrode needle and electrode plate, with current flowing at a constant flux through random paths of minimum resistance between the electrodes.

[0041] Therefore, Rf energy can be delivered to collateral tissues that cause stray Rf flow, thus damaging patient tissues. Furthermore, due to the working principle of radiofrequency ablation, there cannot be any metal implants or metal fittings in or around the current loop path, limiting its application. Additionally, the electrode needles contain nickel, so caution should be exercised in patients with known nickel allergies. The puncture needles and electrode needles used in radiofrequency ablation are made of metal and have relatively sharp tips. Therefore, there is a significant risk of puncturing uterine fibroids and / or the uterine serosa, damaging other tissues and organs. In contrast, steam ablation for uterine fibroids only ablates the fibroid tissue within its diffusion range, and does not produce stray Rf current flow similar to that in radiofrequency ablation.

[0042] Figure 1 is a schematic diagram of the ultrasound-guided steam ablation surgical device provided in an embodiment of this application. Figure 2 is an exploded view of the ultrasound-guided steam ablation surgical device provided in an embodiment of this application. Figure 3 is a partial schematic diagram of the ultrasound-guided steam ablation surgical device provided in an embodiment of this application.

[0043] Referring to Figures 1 to 3, embodiments of this application provide an ultrasound-guided steam ablation surgical device. This ultrasound-guided steam ablation surgical device (hereinafter referred to as the device or surgical device) includes, but is not limited to, the treatment of urogenital structures such as the prostate, uterus, and bladder, as well as any related conditions, including but not limited to benign uterine fibroids, benign prostatic hyperplasia, prostate cancer, abnormal uterine bleeding, overactive bladder, strictures, and tumors.

[0044] It should be noted that, in the embodiments of this application, the term "treatment" and its variations thereof, as described above or below, refers to any reduction in the degree, frequency, or severity of one or more symptoms or signs related to the condition. The term "and / or" means one or all of the listed elements or a combination of any two or more of the listed elements. In the specification of this application, each of "comprising," "including," and "having," and its forms, is not necessarily limited to members of the list that can be associated with the words. The term "comprising" and its variations are not intended to be restrictive when they appear in the specification.

[0045] The apparatus provided in this application is illustrated using the treatment of uterine fibroids as an example, where the uterine fibroid is the diseased tissue. Uterine fibroids are benign growths originating from the smooth muscle tissue of the uterus. Potential patients may not have obvious symptoms and the disease is discovered during a physical examination. Uterine fibroids are mainly classified according to their relationship with the uterine wall, such as intramural fibroids, subserosal fibroids, and submucosal fibroids, among which intramural fibroids are the most common.

[0046] The ultrasound-guided steam ablation surgical device includes a main body 10, an ultrasound-guided steam ablation component 20, a control component 80, and an adjustment component 30.

[0047] The main body 10 of the device includes a handle 11 and a conduit 12. The conduit 12 has a proximal end and a distal end facing each other, and a tube of a predetermined length extends between the proximal end and the distal end. The proximal end of the conduit 12 is connected to the handle 11. The predetermined length of the tube can be understood as being adaptively set according to the required length, for example, the length of the tube may vary depending on the specifications of the device.

[0048] The main body 10 of the device can be integrally molded, meaning it is a hollow shell structure with an ergonomically designed profile. Since the device needs to enter the uterine cavity through natural body cavities, the catheter 12 is configured for vaginal insertion, and the handle 11 is designed for easy handholding. During the procedure, the operator uses a perforated vaginal speculum or other speculum to assist in insertion. The operator uses forceps to stabilize the uterus, manually or pharmacologically dilates the cervix to 9 mm, and then, keeping the ultrasound probe 21 and catheter 12 aligned, gradually inserts the device into the uterine cavity.

[0049] Of course, the main body 10 can also be configured as separate parts, that is, the main body 10 can be composed of two opposing parts, each part of the main body 10 including a gripping part and an extended conduit 12 part. The main body 10 can also be configured as separate handle 11 and conduit 12, with the conduit 12 being detachably connected to the end of the handle 11. The specific configuration of the main body 10 is determined according to actual usage requirements.

[0050] The ultrasound-guided steam ablation assembly 20 includes an ultrasound probe 21 and a steam delivery needle AN. The ultrasound probe 21 is movably located at the distal end of the catheter 12, and the steam delivery needle AN is movably located in the tube body of the catheter 12. Both the ultrasound probe 21 and the steam delivery needle AN are equipped with position detection components, and each position detection component is used to detect the position information of the ultrasound probe (21) and the steam delivery needle (AN).

[0051] The ultrasonic probe 21 is a device that transmits and receives ultrasonic waves during ultrasonic monitoring. The performance of the ultrasonic probe 21 directly affects the characteristics of the ultrasonic waves and thus the monitoring performance. The ultrasonic probe 21 used in ultrasonic monitoring is a transducer that utilizes the piezoelectric effect of materials to convert electrical energy into acoustic energy. The key component of the ultrasonic probe 21 is the crystal wafer, which is a single-crystal or polycrystalline thin film with a piezoelectric effect, used to convert electrical energy and acoustic energy into each other.

[0052] The core component of the ultrasound probe 21 is the ultrasound transducer 211. The ultrasound transducer 211 generates ultrasound waves under high voltage signal excitation and receives the ultrasound waves emitted by human tissue and converts them into echo electrical signals; it is used for ultrasound imaging in the uterine cavity of the patient.

[0053] The control component 80 is connected to the ultrasound probe 21, the steam delivery needle AN and each position detection component. The control component 80 is used to determine the angle between the ultrasound probe 21 and the steam delivery needle AN based on the position information of the ultrasound probe 21 and the steam delivery needle AN, and to plan the puncture direction based on the angle and the real-time ultrasound imaging of the lesion area.

[0054] The adjustment assembly 30 includes a first adjustment component 31, a second adjustment component 32, and an ablation area adjustment control AZC disposed on the handle 11. The first adjustment component 31 is connected to the ultrasound probe 21 and is used to adjust the angle of the ultrasound probe 21 relative to the catheter 12. The second adjustment component 32 is connected to the steam delivery needle AN and is used to adjust the position of the steam delivery needle AN. The ablation area adjustment control AZC is used to control the size of the ablation area.

[0055] It is understood that the ultrasound-guided steam ablation surgical device provided in this application comprises an ultrasound-guided steam ablation component 20 and an adjustment component 30 on the main body 10 of the device. The ultrasound-guided steam ablation component 20 includes an ultrasound probe 21 and a steam delivery needle AN. The ultrasound probe 21 is movably disposed at the distal end of the catheter 12, and the steam delivery needle AN is movably disposed in the tube body of the catheter 12. Both the ultrasound probe 21 and the steam delivery needle AN are connected to the control component 80. The adjustment component 30 includes a first adjustment component 31, a second adjustment component 32, and an ablation area adjustment control AZC disposed on the handle 11. The first adjustment component 31 is connected to the ultrasound probe 21 and is used to adjust the angle of the ultrasound probe 21 relative to the catheter 12; the second adjustment component 32 is connected to the steam delivery needle AN and is used to adjust the position of the steam delivery needle AN; the ablation area adjustment control AZC is used to adjust the size of the ablation area.

[0056] Furthermore, the control component 80 can determine the angle between the ultrasound probe 21 and the steam delivery needle AN based on the position information of the ultrasound probe 21 and the steam delivery needle AN, and plan the puncture direction based on the angle and real-time ultrasound imaging of the lesion area. With this setting, when the steam delivery needle AN performs the puncture action, it adjusts the error of the planned puncture direction in real time according to the position signals fed back by each position detection component before performing ablation treatment, resulting in a smaller treatment error.

[0057] Meanwhile, the ultrasound probe 21 and the steam delivery needle AN are integrated into a handheld device, resulting in a more compact structure and convenient operation. The angle of the ultrasound probe 21 relative to the catheter 12 can be adjusted via the first adjustment component 31 according to the location or shape of the lesion tissue in the patient's body, allowing the ultrasound probe 21 to better fit the lesion tissue for clear detection. Under ultrasound imaging guidance, the puncture direction of the steam delivery needle AN can be adjusted via the second adjustment component 32, ensuring accurate deployment of the steam delivery needle AN to the lesion tissue with high reliability. The size of the ablation area can also be controlled via the ablation area adjustment control AZC. In essence, the device provided in this application can complete the puncture and deployment of the steam delivery needle AN under ultrasound imaging monitoring, resulting in high surgical safety and reliability.

[0058] In some embodiments of this application, the steam delivery needle AN is connected to a steam generator, which provides steam to the steam delivery needle AN. The steam generator can be located outside the surgical device. Alternatively, the steam generator can be located inside the surgical device, i.e., integrated inside the handle 11, for providing steam to the steam delivery needle AN. This is equivalent to both the steam delivery needle AN and the steam generator being located inside the ultrasound-guided steam ablation surgical device. When the steam generator is integrated inside the handle 11, the steam delivery needle AN and the steam generator can be combined to form the steam ablation component 22.

[0059] The steam generator is connected to a water source such as sterile water or saline solution. The steam generator may include a coiled metal tube. When a DC current or an AC current passes through the wall of the metal tube, the sterile water or saline solution flows through the coiled metal tube and is converted into high-quality steam.

[0060] The steam delivery needle AN has a hollow structure with an internal cavity for steam flow. The tip of the steam delivery needle AN may include one or more steam delivery ports or orifices. These ports or orifices are configured to deliver the steam medium from the needle tip to the lesion tissue (uterine fibroid). The steam delivery ports can be arranged in a pattern optimized for steam delivery to a specific tissue, and each port can have a unique diameter (or the same diameter). For example, the steam delivery ports can be arranged in a circumferential array along the steam delivery needle AN, so that when the steam delivery needle AN ejects steam, it will be sprayed in an umbrella-like pattern.

[0061] Referring again to Figure 2, in some embodiments of this application, in order to avoid damage to healthy tissues and organs by puncturing the pseudocapsule and / or uterine serosa of uterine fibroids when the steam delivery needle AN punctures diseased tissue, the steam delivery needle AN is designed as follows.

[0062] A connecting wire for connecting a position sensor is embedded in the needle tube wall of the steam delivery needle AN. A first position sensor ANS is set at the needle tip of the steam delivery needle AN. The first position sensor ANS is electrically connected to the control component 80. The first position sensor ANS is used to monitor the position information or stroke information of the steam delivery needle AN and transmit the monitored position information or stroke information to the control component 80 to realize the positioning of the steam delivery needle AN and the tracking of its running trajectory.

[0063] When the first position sensor ANS feeds back the position information of the steam delivery needle AN monitored in real time to the control component 80, the control component 80 draws the running trajectory of the steam delivery needle AN, realizes the tracking of the running trajectory of the steam delivery needle AN and the positioning of the steam delivery needle AN, and predicts the next puncture direction of the steam delivery needle AN based on the running speed and current position of the steam delivery needle AN.

[0064] If the operator performs manual puncture, the ultrasound imaging device will issue a notification when the puncture is nearing its endpoint. This can be achieved by setting up a text or voice notification module within the ultrasound imaging device. The text notification module can display text on the ultrasound imaging device to remind the operator to pay attention, or the voice mode can emit a simple sound such as "beep" or a complete notification to remind the operator to pay attention. The operator can continue the puncture after noticing these notifications, thus increasing the safety of the procedure.

[0065] When the needle tip exceeds the puncture endpoint or approaches the pseudocapsule of the uterine fibroid, the ultrasound imaging device sends a command to the device's processor. The processor controls the steam delivery needle AN to stop puncture. In other words, the steam delivery needle AN can be restricted from continuing to run by limiting components or other components, thus stopping the puncture action by locking the steam delivery needle AN.

[0066] If the operator uses the automatic puncture function, when the tip of the steam delivery needle AN reaches the target puncture depth, the device will automatically stop driving the steam delivery needle AN and issue a prompt indicating that the puncture is complete. This prompt is the same as the one mentioned above, that is, it can be displayed on the ultrasound imaging device through the text prompt module to remind the operator to pay attention, or it can issue a simple sound such as "beep" or a complete prompt to remind the operator to pay attention. The operator can continue the puncture after noticing these prompts.

[0067] The first position sensor ANS can be a contact position sensor or a proximity position sensor, such as a photoelectric sensor or a gyroscope. Alternatively, the first position sensor ANS can also be set inside the conduit 12 and located on the movement path of the steam delivery needle AN. For example, a sliding rheostat or a photoelectric encoder can be set inside the conduit 12 to calculate the movement stroke of the steam delivery needle AN and feed it back to the ultrasonic imaging device to achieve tracking and positioning of the operation of the steam delivery needle AN.

[0068] For example, the steam delivery needle AN uses a solenoid needle actuator, which includes two solenoid coils, a Hall effect magnetic sensor, and magnetic elements arranged on the steam delivery needle AN. Magnetic fields are generated in the two windings to advance and retract the steam delivery needle AN.

[0069] The position sensor can be a Hall effect magnetic sensor, which measures the magnetic field of a solenoid coil. The solenoid coil drives the deployment and retraction of the needle by moving a magnetic element attached to the steam delivery needle AN. The magnetic field of the solenoid coil is proportional to the current flowing through it. Since the speed is maintained by a control loop, the solenoid current will automatically increase when the needle tip encounters an obstacle (such as the pseudocapsule of a fibroid). The solenoid current can be monitored in real time, and a critical current corresponds to a critical force on the needle (indicating that the needle has encountered the pseudocapsule of a fibroid). At this point, the drive of the solenoid coil stops, and the operator is alerted to the encounter of a potentially serious obstacle such as the pseudocapsule of a fibroid.

[0070] Referring again to Figure 2, in some embodiments of this application, the ultrasonic probe 21 is provided with a second position sensor SS, which is electrically connected to the control component 80. The second position sensor SS is used to monitor the position information of the ultrasonic probe 21 and feed the position information back to the control component 80.

[0071] A third position sensor ERS is provided on the catheter 12. The third position sensor ERS is electrically connected to the control component 80. The third position sensor ERS is used to monitor the position information of the catheter 12 and feed the position information back to the control component 80.

[0072] The following details how the angle between the ultrasonic probe 21 and the catheter 12 is determined using the position information detected by the second position sensor SS and the third position sensor ERS.

[0073] The ultrasound probe 21 is equipped with a second position sensor SS, which is used to monitor the position of the ultrasound probe 21 in real time and record the position as the first position. The catheter 12 is equipped with a third position sensor ERS, which is used to monitor the position of the catheter 12 in real time and record the position as the second position.

[0074] When the ultrasound probe moves under the drive of the first adjustment component, the ultrasound probe 21 forms a certain angle with the straight line of the conduit 12. For example, the coordinates corresponding to the first position are (x... S y S The coordinates corresponding to the second position are (x N y N The angle θ between the ultrasound probe and the catheter can be calculated using the following formula:

[0075] The angle between the ultrasonic probe 21 and the catheter 12 can be calculated in real time using the above formula. Here, by using a second position sensor SS on the ultrasonic probe 21 and a third position sensor ERS on the catheter 12 to monitor the position and calculate the angle in real time, the structural design of the probe angle adjuster AL can be simplified. In addition, this method does not require the absolute starting point of the steam delivery needle AN, that is, the starting point position of the steam delivery needle AN can be calculated based on the current system state, thereby eliminating the error introduced by the probe angle adjuster AL, and the final angle obtained is the actual angle adjusted by the ultrasonic probe 21.

[0076] In some embodiments of this application, the ultrasound probe 21 can be rotatably connected to the distal end of the catheter 12 via a structure such as a rotating shaft, a pin, or a guide joint, so that the ultrasound probe 21 can rotate relative to the catheter 12, thereby changing the angle between the ultrasound probe 21 and the catheter 12.

[0077] The first adjustment component 31 may include a probe angle adjuster AL and a traction member (not shown in the figure). The probe angle adjuster AL is disposed on the handle 11. One end of the traction member is connected to the ultrasonic probe 21, and the other end of the traction member extends from the end portion of the catheter 12 along the length of the tube body to be connected to the probe angle adjuster AL.

[0078] When the probe angle adjuster AL is triggered, the probe angle adjuster AL drives the traction component to pull the ultrasonic probe 21, so that the ultrasonic probe 21 rotates around the rotation connection point with the catheter 12, thereby realizing the rotation of the ultrasonic probe 21 relative to the catheter 12, so as to adjust the angle between the ultrasonic probe 21 and the catheter 12.

[0079] The probe angle adjuster AL can be a knob, a slider, or a joystick, and the traction component can be a steel wire or a traction rope. For example, the operator controls the pushing and pulling of the steel wire by using the knob or joystick, so that the ultrasonic probe 21 rotates around the rotation connection point with the conduit 12, thereby realizing the rotation of the ultrasonic probe 21 relative to the conduit 12.

[0080] Furthermore, the knob can be configured as a single knob or a dual knob. In the dual knob configuration, one knob controls the left-right direction, and the other controls the up-down direction. Regardless of the type of probe angle adjuster AL, a mechanical locking mechanism is used to lock the knob, slider, or lever.

[0081] When the device enters the uterine cavity, the ultrasound probe 21 is parallel to the catheter 12, that is, the axis of the ultrasound probe 21 is collinear with the axis of the catheter 12, and the ultrasound probe 21 and the catheter 12 are on the same straight line. At this time, the ultrasound probe 21 can be considered to be at zero position, and the ultrasound probe 21 is at 0° relative to the catheter 12.

[0082] When the device is inserted into the uterine cavity, the operator can use the probe angle adjuster AL on the handle 11 to adjust the angle of the ultrasound probe 21 inside the uterine cavity, so as to adaptively adjust the angle of the ultrasound probe 21 according to the location or shape of the lesion tissue.

[0083] In some embodiments of this application, the second adjustment component 32 may include a puncture control component NC and a transmission component (not shown in the figure). The puncture control component NC is disposed on the handle 11, and the transmission component is connected between the puncture control component NC and the steam delivery needle AN. By driving the puncture control component NC, the transmission component controls the steam delivery needle AN to perform linear reciprocating motion within the tube of the catheter 12, thereby extending and retracting the steam delivery needle AN to achieve puncture.

[0084] The transmission components can be connecting rods, drive shafts, lead screws, etc. The connecting rods and drive shafts are slidably fitted with the inner wall of the catheter 12, and the lead screw can be positioned inside the catheter 12 via a guide. The puncture control component NC can be a knob, a slider, or a lever, etc.

[0085] In some embodiments of this application, the adjustment component 30 includes a first driving component connected to the probe angle adjuster AL, which drives the probe angle adjuster AL to move the traction component, so that the ultrasound probe 21 rotates relative to the catheter 12.

[0086] And / or, the adjusting assembly 30 includes a second driving component, which is connected to the puncture control component NC and is used to drive the puncture control component NC to move the traction component, so that the steam delivery needle AN moves linearly back and forth along the tube body of the conduit 12. Both the first and second driving components can be motors, etc.

[0087] In other words, the device provided in this application embodiment can use two methods when planning the puncture direction: manual planning and automatic planning by the control component 80.

[0088] For manually planning the puncture direction, the operator first presses the probe angle adjuster AL on the ultrasound probe 21. Then, the real-time ultrasound imaging interface will display the steam delivery needle AN puncture angle adjustment indicator icon IG, and the interface will also provide the angle between the major and minor axes of the fitted ellipse FC as auxiliary information. The operator can refer to the information displayed on the real-time ultrasound imaging and adjust the probe angle adjuster AL of the ultrasound probe 21 so that the puncture angle adjustment indicator icon IG passes through the major axis of the fitted ellipse (i.e., the lesion area) to complete the manual planning of the puncture direction.

[0089] For the automatic planning method of the control component 80, the control component 80 can automatically collect sensor signals to obtain position information and automatically calculate the angle between the ultrasound probe 21 and the catheter 12. Then, by controlling the relevant driving components, it can control the puncture angle adjustment indicator icon IG to pass through the major axis of the fitted ellipse according to this angle, thus completing the automatic planning of the puncture direction. For example, the control component 80 controls the motor inside the ultrasound probe 21 to drive the movement of relevant structural components, thereby dragging the ultrasound probe 21 to change its angle. The control component 80 reads the sensor information inside the ultrasound probe 21 in real time, calculates the current angle, and displays it.

[0090] In this embodiment, the position is detected in real time by the ultrasonic probe 21 and the magnetic sensor on the catheter 12 to calculate the included angle in real time, and the corresponding puncture angle adjustment icon is superimposed on the real-time ultrasound image to plan the puncture direction. This can achieve the planning of the puncture direction more accurately and quickly.

[0091] Figure 4 is a schematic diagram of the initial ablation region translated along the X-axis according to an embodiment of this application. Figure 5 is a schematic diagram of the initial ablation region translated along the Y-axis according to an embodiment of this application. Figure 6 is a schematic diagram of the initial ablation region enlarged according to an embodiment of this application. Figure 7 is a schematic diagram of the initial ablation region reduced according to an embodiment of this application.

[0092] Referring to Figure 2, and simultaneously to Figures 4 through 7, the following embodiments will explain how the control component 80 specifically plans the ablation area.

[0093] In one embodiment, after planning the puncture direction, the ablation area can be planned, that is, the position or size of the initial ablation area can be adjusted. This can be done by manual adjustment or automatic adjustment by the control component 80.

[0094] For manual adjustment, referring to Figure 2 and Figures 4 through 7, the operator can adjust the position and size of the ablation area using the ablation area adjustment control AZC on the handle 11. This ablation area adjustment control AZC can include various structures, such as movable structures and pressable structures. The movable structure can move along the X and Y axes. Movement along the X-axis allows the indicator graphics of the ablation area AZ and its safety area SZ to translate back and forth along the catheter 12 line; movement along the Y-axis allows the indicator graphics of the ablation area and its safety area to translate vertically along the catheter 12 line or to enlarge or reduce the size of the graphics. After the movable structure completes its operation, pressing the pressable structure indicates confirmation of completion.

[0095] The following describes the process of adjusting the location and size of the initial ablation zone.

[0096] 1. Translate the indicator graphic corresponding to the initial ablation area.

[0097] After the puncture direction is planned, as shown in Figure 4, the operator can adjust the ablation area adjustment control AZC on the handle 11 to move the indicator graphic corresponding to the initial ablation area forward by F or backward by B on the X-axis, so that the indicator graphics of the initial ablation area AZ and its safety area SZ (i.e. the two dashed rectangles in the figure) can be translated back and forth along the catheter 12 line.

[0098] The purpose of the back-and-forth movement is to align the center of the initial ablation zone (and the safe zone) with the center of the fitted ellipse FC (during the alignment process, an indicator icon will be superimposed on the real-time ultrasound image on the imaging display to assist in alignment). Since the ablation zone adjustment control AZC is composed of related sensors (such as linear resistors, magnetic sensors, encoders, etc.), the sensor signals are processed by an operational amplifier (OPA) and / or an analog-to-digital converter (ADC) before being analyzed by a microprocessor (MCU) or a field-programmable gate array (FPGA). The angle information obtained by the MCU or FPGA is fed back to the control component 80, which will display the back-and-forth movement of the initial ablation zone AZ and its safe zone SZ on the imaging display as it moves along the catheter 12 (generally superimposed on the real-time ultrasound image).

[0099] The size of the safe region SZ is determined based on the size of the ablation region (including the initial ablation region and the target ablation region) AZ. It is generally larger than the ablation region, and the size of the safe region compared to its corresponding ablation region can be preset.

[0100] Similarly, referring to Figure 5, the operator can adjust the ablation area adjustment control AZC and combination keys on the handle 11 (or operate the imaging software on the imaging display) to translate the indicator graphic corresponding to the initial ablation area along the vertical direction of the catheter 12 line, that is, move it upward U or downward D on the Y-axis, so that the indicator graphics of the initial ablation area AZ and its safety area SZ are translated vertically up and down along the vertical direction of the catheter 12 line. The purpose of this up and down movement is to make the initial ablation area AZ inscribed in the fitted ellipse FC (or other state adjusted by the operator), that is, to set the ablation area within the lesion area.

[0101] 2. Enlarge and reduce the size of the indicator graphic corresponding to the initial ablation area.

[0102] Referring to Figures 6 and 7, the operator can adjust the ablation area adjustment control AZC and combination keys on the handle 11 (or operate the imaging software on the imaging display) to enter the zoom-in or zoom-out state for adjusting the size of the indicator graphic corresponding to the ablation area. Here, + indicates zoom-in, and - indicates zoom-out.

[0103] Regarding the automatic adjustment method of control component 80, the super-imaging system can, after receiving the operator's translation operation command in the imaging software, translate the indicator graphic corresponding to the initial ablation area along the X-axis or along the Y-axis according to the translation operation command. Similarly, the super-imaging system can, after receiving the operator's zoom operation command in the imaging software, zoom in and out of the indicator graphic corresponding to the initial ablation area according to the zoom operation command.

[0104] After adjusting the size and position of the initial ablation area as described above, press the confirmation button to finally determine an ablation area of ​​a fixed size or dimension, which will be recorded as the target ablation area.

[0105] In addition, the operator can also obtain historical medical images by operating the relevant software controls on the imaging display, and the previous ablation planning data will also be displayed on the imaging display. Since the patient's position is different during the procedure compared to the previous examination, and the operator needs to use vaginal dilators, forceps, and other instruments to stabilize the uterus before inserting the ultrasound probe 21 and handle 11 into the uterine cavity, the position of the uterus will change. Therefore, the operator needs to shift and rotate the lesion area in the previous historical medical images to align it with the lesion area image in the real-time ultrasound imaging, thus completing the planning and setting of the target ablation area's position and size.

[0106] In this embodiment, by adjusting the position and size of the initial ablation area, the final target ablation area can be made to be closer to the actual lesion area in terms of position and size. This can guide the subsequent accurate deployment of the steam delivery needle AN, thereby improving the accuracy of the treatment of the lesion area.

[0107] Figure 8 is a schematic diagram of real-time ultrasound imaging with a preset puncture depth overlaid, provided in an embodiment of this application.

[0108] The following embodiments illustrate how the control component 80 calculates the preset puncture depth.

[0109] Referring to Figure 8, the control component 80 is also used to determine the preset puncture depth corresponding to the steam delivery needle AN based on the amount of movement of the indicator pattern in the first axis, the center point position of the fitted pattern of the lesion area displayed on the real-time ultrasound imaging, and the distance between the tip of the steam delivery needle AN and the nearest air outlet; the first axis is the long axis of the fitted pattern corresponding to the lesion area.

[0110] The target ablation region is typically a three-dimensional cylinder. In two-dimensional real-time ultrasound imaging, the cross-section of this cylinder is usually displayed, meaning the displayed target ablation region is rectangular. After obtaining the target ablation region, information such as its location and dimensions can also be obtained. For example, the lengths of the two sides of the rectangular cross-section corresponding to the target ablation region (denoted as the longer side Ra and the shorter side Rb) can be obtained. Then, the volume of the target ablation region, i.e., the ablation volume V, can be calculated using the following formula:

[0111] Meanwhile, the long side of the cross-sectional rectangle corresponding to the target ablation area can also be used as the amount of movement of the initial ablation area in the long axis direction. At the same time, the needle tip of the steam delivery needle AN and the nearest air outlet on the steam delivery needle AN can be obtained. Then, the distance between the needle tip and the nearest air outlet can be calculated, and the position of the center point of the fitted graph corresponding to the lesion area can be obtained. By calculating these three data, the puncture depth corresponding to the steam delivery needle AN under the target ablation area can be obtained, which is denoted as the preset puncture depth NEP. At the same time, the preset puncture depth can be superimposed and displayed on the real-time ultrasound image.

[0112] Furthermore, different preset puncture depths can be calculated for different target ablation area sizes. By calculating the preset puncture depth corresponding to the target ablation area, a data basis can be provided for the subsequent deployment of the vapor delivery needle anastomosis (AN), improving the efficiency and accuracy of the subsequent AN deployment and avoiding the problem of the AN deployment exceeding the lesion area and damaging other tissues, thus facilitating the effective deployment of the AN.

[0113] After planning the target ablation area, puncture direction, and preset puncture depth as described above, the steam delivery needle AN on the handle 11 can be deployed according to these parameters. There are two deployment methods for the steam delivery needle AN: manual deployment and automatic deployment. That is, manual puncture deployment or automatic (intelligent) puncture deployment can be performed to insert the steam delivery needle AN into the designated depth of the uterine fibroid (i.e., the preset puncture depth).

[0114] For the manual deployment method, the operator can manipulate the puncture control component NC on the handle 11 to advance or pull back along the structural groove, thereby achieving forward puncture and backward retraction of the steam delivery needle AN. When the steam delivery needle AN moves forward or backward on the conduit 12, the control component 80 collects the position information of the first position sensor ANS on the needle tip, converts it into the displacement of the steam delivery needle AN on the conduit 12, and then displays the current position of the steam delivery needle AN using an icon (for example, using an arrow to represent the steam delivery needle AN, the direction of the arrow indicating the running direction of the steam delivery needle AN, and the position of the arrow being the current position of the needle tip).

[0115] Optionally, the control component 80 can determine the current puncture speed of the steam delivery needle AN based on the displacement and displacement time difference during deployment. The displacement is determined by the position sensor at the tip of the steam delivery needle AN. If the current puncture speed of the steam delivery needle AN does not meet the preset puncture speed requirement, a first prompt message is output. The first prompt message is used to indicate that the puncture speed should be adjusted. Here, the displacement refers to the distance the steam delivery needle AN moves during deployment, and the displacement time difference refers to the duration of movement during deployment. The current puncture speed can be obtained by dividing the current displacement of the steam delivery needle AN by the current displacement time difference.

[0116] The preset puncture speed requirement can include a preset puncture speed or a preset puncture speed threshold range. The current puncture speed of the steam delivery needle AN can be compared with the preset puncture speed or the preset puncture speed threshold range. If it exceeds the preset puncture speed or the preset puncture speed threshold range, it can be considered that the current puncture speed is too fast or too slow (for example, if the current puncture speed is less than the preset puncture speed, then the puncture is too slow) and does not meet the preset puncture speed requirement. In this case, a first prompt message for adjusting the puncture speed can be output to the operator. This first prompt message can be output through text, voice, light, or other display methods.

[0117] Alternatively, when the steam delivery needle AN is deployed to a preset puncture depth in the lesion area, the puncture depth indicator icon displayed on the real-time ultrasound imaging can be changed from a first color to a second color, and a second prompt message can be output. This second prompt message indicates that the steam delivery needle AN has been deployed to the preset puncture depth in the lesion area. In other words, the puncture depth indicator icon can be overlaid on the real-time ultrasound imaging. When the steam delivery needle AN is inserted into the designated position in the lesion area, the puncture depth indicator icon can be changed from its original first color to the second color, and a second prompt message indicating that the steam delivery needle AN has been deployed to the preset puncture depth in the lesion area can be output to the operator. This second prompt message can be output through text, voice, light, or other display methods.

[0118] Figure 9 is a schematic diagram of the needle tip structure of the steam delivery needle AN according to an embodiment of this application.

[0119] Referring to Figure 9, in some embodiments of this application, in order to further reduce the risk of penetration by the steam delivery needle AN, the tip of the steam delivery needle AN is blunted, that is, the tip of the steam delivery needle AN is provided with an arc-shaped blunting part 221. The blunting part 221 is configured such that when the steam delivery needle AN accidentally touches the false membrane, the tip of the steam delivery needle AN will not pierce the false membrane.

[0120] This is equivalent to blunting the tip of the steam delivery needle AN to the point that the pseudocapsule of the uterine fibroid will not be penetrated under the force applied by the drive component (<critical force) and under the normal thrust applied by the operator. In other words, the rounded tip of the steam delivery needle AN is less likely to unintentionally puncture the pseudocapsule of the uterine fibroid under a small force.

[0121] In this configuration, the steam delivery needle AN's tip, during use (i.e., after blunting, the needle tip needs to penetrate the uterine mucosa (endometrium) and fibroid pseudocapsule), allows initial needle deployment to occur within 10 to 15 milliseconds, and the needle may reach speeds exceeding 1 m / s to allow the blunted tip to penetrate the uterine mucosa (endometrium) and fibroid pseudocapsule. Due to friction, the needle does not reach its terminal velocity within the short pulse duration, and the needle reaches speeds less than 1 m / sec or less than 0.5 m / sec.

[0122] Puncture speed within uterine fibroids: The needle tip of the steam delivery needle AN can be instructed to move at a slower speed, for example, in the range of 0.1 mm / s to 10 mm / s. When the needle tip encounters an obstacle (such as the pseudocapsule of the fibroid), the current in the drive component (such as a motor) will automatically increase. The solenoid current can be monitored in real time, and the critical current corresponds to the critical force on the needle (indicating that the needle has encountered the pseudocapsule of the fibroid). At this point, the drive stops, and the operator is alerted that a serious obstacle, such as the pseudocapsule of a fibroid, has been encountered.

[0123] In some embodiments of this application, a pair of electrode plates are spaced apart at the tip of the steam delivery needle AN. By measuring the tissue impedance between the electrode plates, it is determined whether the puncture depth of the steam delivery needle AN exceeds the preset puncture depth.

[0124] Essentially, measuring the impedance of the tissue preceding the electrode pads can provide another indication of proximity to the pseudocapsule, used to calculate the impedance of biological tissue. When the needle tip approaches the pseudocapsule of the uterine fibroid, the impedance amplitude changes abruptly, serving as an alarm feedback.

[0125] Because uterine fibroids are generally solid, spherical / ellipsoidal masses with smooth surfaces and a firmer texture than the uterine myometrium, a pseudocapsule forms when they compress the surrounding myometrial fibers. A loose, reticular space exists between the fibroid and the pseudocapsule, making it easy to detach. When uterine fibroids grow large or multiple fibroids fuse, they can present irregular shapes. Therefore, by installing a pair of electrode pads at the tip or end of the steam delivery needle (AN needle), measuring the tissue impedance between the electrode pads can provide an indication of proximity to the pseudocapsule, which is then used to determine whether the current puncture depth exceeds the preset puncture depth.

[0126] Figure 10 is a circuit diagram for measuring unknown impedance provided in an embodiment of this application.

[0127] Referring to Figure 10, the principle of tissue electrical impedance measurement is as follows:

[0128] To measure the unknown impedance (Z) UNKNOWN To obtain the voltage across an unknown impedance, an AC excitation signal is applied, the voltage across the excitation signal is measured, and then the current flowing through the unknown impedance is measured. The current is converted to a voltage by an analog-to-digital converter (ADC) using a transimpedance amplifier (TIA), and a Discrete Fourier Transform (DFT) is performed on the ADC data to obtain the current and voltage values. The amplitude can then be calculated using the real and imaginary parts to obtain the voltage across the unknown impedance (V). ZUNKNOWN ) and unknown impedance current (I ZUNKNOWN The unknown impedance of the sensor can be calculated using the following formula:

[0129] Where: Z UNKNOWN Indicates the magnitude of the unknown impedance; Indicates the magnitude of the voltage across the unknown impedance; R represents the magnitude of the current through an unknown impedance; TIA This is the value of the high-speed TIA gain resistor, in Ω.

[0130] The meanings of each module or component in the circuit diagram are as follows: C ISO1 Indicates capacitor 1, C ISO，2 Represents capacitor 2, R LIMIT The excitation voltage (VOLTAGE) represents the limiting resistance, the excitation voltage (VOLTAGE METER) represents the excitation voltage or the voltage of the excitation signal, the excitation signal (SIGNAL) represents the excitation signal, and the current meter (CURRENT METER) represents the current meter.

[0131] Before and during steam ablation, condensed sterile water can be continuously sprayed from the steam delivery needle AN, potentially creating a layer of sterile water covering the bioimpedance electrode. Sterile water has a very high resistance compared to saline and tissue, but its capacitance is comparable. Therefore, in the presence of sterile water, the impedance value |Z| may become high enough to saturate the voltage amplifier, making bioimpedance calculations less meaningful. Given the electrical model of cellular structures, extracellular fluid measurements can be performed using alternating currents up to 50 kHz. This problem can be circumvented by using currents at higher frequencies that penetrate the cell, allowing measurement of intercellular fluid.

[0132] In addition, the metal electrode pads are strongly reflective under ultrasound, appearing as obvious bright spots on the ultrasound image, which also facilitates ultrasound identification of the needle tip. Since uterine fibroids are mainly composed of spindle-shaped smooth muscle cells and varying amounts of fibrous connective tissue, and the muscle cells are of uniform size, their impedance values ​​are relatively stable. When the tip of the steam delivery needle (AN) approaches the loose reticular space or the pseudocapsule of the uterine fibroid, the conductivity of their fibrous tissue changes, leading to a sudden change in impedance amplitude. This sudden change in impedance amplitude confirms that the current puncture depth exceeds the serosa, i.e., it exceeds the preset puncture depth.

[0133] Alternatively, the ratio of the currently measured impedance to the impedance at the initial deployment can be used as a basis for determining whether the current puncture depth exceeds the preset puncture depth. When it is determined that the current puncture depth exceeds the preset puncture depth, a third prompt message indicating that the current puncture depth of the steam delivery needle AN has exceeded the preset puncture depth can be output on the imaging display. This third prompt message can be output through text, voice, light, or other display methods.

[0134] In this embodiment, by outputting corresponding prompts when the puncture speed during the deployment of the steam delivery needle AN is not up to standard, the puncture depth reaches the preset puncture depth, or the current puncture depth exceeds the preset puncture depth, the operator can quickly know the current puncture deployment status and react in a timely manner, while avoiding tissue damage caused by excessive puncture.

[0135] The following embodiments illustrate how the control component 80 automatically deploys the steam delivery needle AN during the automatic deployment process.

[0136] In one embodiment, the control component 80 is used to determine the puncture speed of the steam delivery needle AN based on the displacement and displacement time difference of the steam delivery needle AN during deployment; and to control the steam delivery needle AN to puncture into the lesion tissue at the puncture speed.

[0137] The current puncture speed is obtained by dividing the current displacement of the steam delivery needle AN by the current displacement time difference. Then, the control component 80 can control the motor to insert the steam delivery needle AN into the lesion tissue according to the current puncture speed.

[0138] In the process of controlling the motor to insert the steam delivery needle AN into the lesion tissue, the puncture speed can be converted into the motor's running speed according to a preset conversion method, and the motor can be controlled to puncture the steam delivery needle AN into the lesion tissue according to the running speed; the motor is the motor in the handle 11, which is used to control the operation of the steam delivery needle AN.

[0139] There is a certain relationship between the puncture speed VN of the steam delivery needle AN and the operating speed VM of the motor in the handle 11. This relationship can be expressed as VN = kVM, where k represents the proportionality coefficient between the two speeds and is a known quantity. The control component 80 can calculate the current operating speed of the motor by acquiring signals from the encoder or other sensors. For example, within a certain time period Tc, if the number of pulses output by the encoder M1 is acquired, and the motor generates Z pulses per revolution, then the operating speed of the motor can be expressed as: VM = (M1 / ZTc)(r / s), where r represents the number of revolutions of the motor (revolutions per second), and s represents the time unit (seconds). After calculating the operating speed of the motor, the motor can be controlled to drive the steam delivery needle AN to be inserted into the lesion tissue at that operating speed.

[0140] Furthermore, it is possible to monitor in real time whether the current puncture speed of the steam delivery needle AN during deployment meets the preset puncture requirements. Optionally, if the current puncture speed of the steam delivery needle AN does not meet the preset puncture speed requirements, the control component 80 can convert the current puncture speed of the steam delivery needle AN into the first operating speed of the motor, and convert the preset puncture speed corresponding to the preset puncture speed requirements into the second operating speed of the motor; and adjust the operating speed of the motor according to the difference between the first operating speed and the second operating speed.

[0141] The preset puncture speed requirement can include a preset puncture speed. Specifically, the current puncture speed of the steam delivery needle AN can be compared with the preset puncture speed. If the current puncture speed does not reach the preset puncture speed (this can include the current puncture speed being less than or greater than the preset puncture speed), then the preset puncture speed requirement is not met. In this case, the current puncture speed of the steam delivery needle AN can be converted into the current operating speed of the motor according to the preset conversion method described above, and recorded as the first operating speed. At the same time, the preset puncture speed can be converted into the second operating speed according to the preset conversion method. Then, the first running speed VM and the second running speed VM' of the motor can be compared to see if they are within the preset acceptable error range. If they are not within the error range, the difference or absolute value of the difference between the first and second running speeds can be calculated. Then, the calculated difference or absolute value of the difference can be used as feedback to adjust the current running speed of the motor. Alternatively, other control methods, such as PID control, can be used to adjust the current running speed of the motor so that the running speed of the motor reaches the expected value, that is, the current puncture speed of the steam delivery needle AN can meet the preset puncture speed requirement. In other words, the current puncture speed of the steam delivery needle AN can be equal to or close to the preset puncture speed.

[0142] Furthermore, similar to the insurance mechanism in the manual deployment process, during the automatic deployment process, the control component 80 can also output corresponding prompt information in cases such as the puncture speed not meeting the requirements, the puncture depth reaching the preset puncture depth, and the current puncture depth exceeding the preset puncture depth (which can be achieved through sensor monitoring, ultrasonic imaging monitoring, and electrical impedance monitoring, etc.), so that the operator can quickly know the current puncture deployment status and react in a timely manner.

[0143] In this embodiment, the steam delivery needle AN is automatically inserted into the lesion tissue at a calculated puncture speed, effectively achieving automated deployment. Furthermore, by using a preset conversion method to convert the puncture speed into the motor's operating speed and then controlling the motor's operation to deploy the steam delivery needle AN, the automated deployment process is refined, allowing for accurate control of the AN's operation during automated deployment. Moreover, if the current puncture speed does not meet the preset puncture speed requirement, the motor's operating speed can be adjusted, ensuring that the entire automated deployment process meets the expected puncture speed requirements, thereby achieving smooth deployment of the steam delivery needle AN.

[0144] During the deployment of the steam delivery needle AN described above, if the steam delivery needle AN is inserted to the designated location (i.e., the preset puncture depth) in the lesion tissue, a safety rotation confirmation is performed to ensure that the safe area corresponding to the target ablation area does not exceed / cross the edge of the serous membrane S, thus guaranteeing the safety of the puncture. The following examples illustrate the safety rotation confirmation process after deployment is completed.

[0145] In one embodiment, the control component 80 is further configured to perform a safe rotation confirmation of the steam ablation ultrasound navigation system when the steam delivery needle AN is deployed to a preset puncture depth within the lesion tissue; during the safe rotation confirmation process, it monitors whether the safe area SZ corresponding to the target ablation area exceeds the edge of the peripheral tissue; the peripheral tissue is the tissue adjacent to the lesion tissue; if the safe area exceeds the edge of the peripheral tissue, a fourth prompt message is output; the fourth prompt message is used to indicate the adjustment of the position and / or size of the target ablation area.

[0146] Taking a uterine fibroid as an example, the aforementioned peripheral tissue can be the serosa S near or adjacent to the uterine fibroid. Regarding safe rotation confirmation, there are different safe rotation confirmation methods for manual and automatic deployment modes. In the manual safe rotation confirmation mode, the operator can manually rotate the ultrasound probe 21 and handle 11. Alternatively, in the automatic safe rotation confirmation mode, the steam ablation ultrasound navigation system / control component 80 can perform three-dimensional (3D) ultrasound imaging of the lesion tissue again. Both methods can complete the safe rotation confirmation.

[0147] Specifically, regarding the manual safety rotation confirmation method, the operator can observe all two-dimensional real-time ultrasound images on the imaging display during manual safety rotation to ensure that the boundary of the safety zone SZ does not cross the edge of the serous membrane S in any of the two-dimensional real-time ultrasound images. When the boundary of the safety zone SZ crosses the edge of the serous membrane S, the control component 80 can issue a fourth prompt message to alert the operator. This fourth prompt message can be in the form of voice, text, or light. Upon this situation or after receiving the fourth prompt message, the operator can confirm the need to adjust the position and / or size of the target ablation area based on the fourth prompt message. The operator can then adjust the position and size of the target ablation area using the ablation area adjustment control AZC on the handle 11 to ensure that the boundary of the safety zone SZ corresponding to the target ablation area does not cross the edge of the serous membrane S. This process can be repeated until the safety rotation confirmation is completed without any instances of the boundary of the safety zone SZ crossing the edge of the serous membrane S.

[0148] For the automatic safety rotation confirmation method, the control component 80 can perform ultrasound three-dimensional (3D) imaging on the lesion tissue (e.g., uterine fibroids). If the boundary of the safe area SZ corresponding to the target ablation area crosses the edge of the serosal membrane S, the steam ablation ultrasound navigation system / control component 80 can automatically adjust the position and size of the target ablation area so that the boundary of the safe area SZ corresponding to the target ablation area is inside the edge of the serosal membrane S.

[0149] In this embodiment, the steam ablation ultrasound navigation system is safely rotated and confirmed when the steam delivery needle AN is deployed to the preset puncture depth within the lesion tissue. This ensures that other tissues surrounding the lesion tissue are not punctured, thus avoiding damage to other tissues. Simultaneously, if the safe zone crosses the edge of other tissues during the safety confirmation process, a prompt message is output to instruct adjustments to the ablation area. This facilitates quick and timely adjustments to the ablation area, accurately achieving the deployment of the steam delivery needle AN and subsequent ablation treatment of the lesion tissue.

[0150] In one embodiment, after the above-mentioned safe rotation confirmation is completed, the lesion tissue corresponding to the target ablation area can be ablated according to the deployed steam delivery needle AN. After all the lesion tissue is ablated, Doppler imaging can be performed on the lesion tissue. At the same time, Doppler imaging of the lesion tissue can also be performed and saved before ablation. Then, the ablation effect can be evaluated by comparing the Doppler imaging of the lesion tissue before and after ablation.

[0151] Taking uterine fibroids as an example, Doppler imaging (such as Doppler flow imaging) can characterize vascular flow within the lesion using blood flow impedance parameters. Submucosal uterine fibroids, due to their rich peripheral blood flow, exhibit higher blood flow velocities at their edges than at the center. This allows them to be distinguished from other lesions with dispersed vascular systems and low central flow velocities, such as adenomyosis or polyps that may have only one feeding vessel. Furthermore, the vapor condensation process causes rapid collapse of vessels in the ablation treatment area; therefore, comparing Doppler images before and after lesion ablation can also help determine / evaluate the ablation effect.

[0152] Of course, other methods can also be used to evaluate the ablation effect, such as by using digital subtraction angiography images before and after ablation, or by evaluating the ratio of the diffusion range of the introduced air after ablation / the vapor diffusion range of the vapor recorded during ablation to the lesion tissue before ablation. Here, the diffusion range of the introduced air after ablation refers to the air remaining in the ablated lesion tissue / ablated tissue, which can characterize the size of the actual ablation area.

[0153] In some embodiments of this application, the steam ablation component 22 further includes an electronic controller / processor (MCU / FPGA) and a switching valve. The processor is configured to control the generation and delivery of steam, and the switching valve is located on the medium pipeline to control the delivery of the medium pipeline into the lesion tissue through the steam delivery needle AN. The electronic controller / processor can be integrated inside the steam generator or located separately outside the steam generator and electrically connected to both the steam generator and the switching valve, respectively, to control the switching valve to open or close based on feedback from the steam volume.

[0154] Figure 11 shows the imaging surface shape of the ultrasonic probe provided in the embodiment of this application.

[0155] Referring again to Figures 1 to 3, and simultaneously to Figure 11, in some embodiments of this application, the imaging surface of the ultrasound probe 21 is curved, that is, the shape of the front end surface of the ultrasound probe 21 is designed to be slightly convex or other arc-shaped, with a small contact area and a fan-shaped imaging field of view. This allows the ultrasound probe 21 to adhere to the endometrium (mucosal layer) of the uterine cavity to image submucosal fibroids, resulting in better imaging effects.

[0156] In addition, the imaging surface of the ultrasound probe 21 is composed of multiple planes, with adjacent planes arranged at an angle to each other, similar to a prism structure.

[0157] Referring again to Figures 1 to 3, in some embodiments of this application, the main body 10 of the device includes a first part and a second part disposed opposite to each other. The first part and the second part are detachably connected by a structure such as a buckle, a clamp or a screw. After the first part and the second part are connected, an installation cavity is formed, and a component is disposed in the installation cavity.

[0158] The first part has a first handle 111 and a first tube 121 connected to each other. The second part has a second handle 112 that cooperates with the first handle 111 and a second tube 122 that cooperates with the first tube 121. The second handle 112 and the second tube 122 are connected to each other.

[0159] A fluid channel is provided on either the first handle 111 or the second handle 112, extending to the corresponding pipe body. The fluid channel can be a groove structure formed by the first handle 111 or the second handle 112, or it can be formed by a liquid supply pipe 50 arranged in the mounting cavity. The steam generator is disposed on the first handle 111 or the second handle 112 along with the fluid channel.

[0160] A wiring channel is provided on the other of the first handle 111 and the second handle 112, and the wiring channel extends to the corresponding tube. The wiring channel can be a groove structure limited by the first handle 111 or the second handle 112, or the wiring channel can be a virtual channel formed by the cable 40 being laid in the first handle 111 or the second handle 112, occupying the internal space of the first handle 111 or the second handle 112.

[0161] For example, a fluid channel can be located within the first handle 111 and extend to the first tube 121. One end of the fluid channel is connected to a water source, and the other end is connected to a steam delivery needle AN. A steam generator is located within the first handle 111, which has the fluid channel. A cable 40 is located within the second handle 112 and extends to the second tube 122, where it is connected to the ultrasonic probe 21.

[0162] Of course, the cable 40 can also be located inside the first handle 111 and extend to the first tube 121 and connect to the ultrasonic probe 21. The fluid channel is located inside the second handle 112 and extends to the second tube 122. One end of the fluid channel is connected to a water source, and the other end of the fluid channel is connected to the steam delivery needle AN. The steam generator is located in the second handle 112 with the fluid channel.

[0163] With this configuration, after installing corresponding structural components such as the cable 40, liquid supply pipe 50, or steam generator on the first handle 111 and the first pipe 121, and the second handle 112 and the second pipe 122, the first assembly composed of the first handle 111 and the first pipe 121, and the second assembly composed of the second handle 112 and the second pipe 122 are connected together using structures such as buckles, clamps, or screws. This simplifies installation and facilitates the installation and maintenance of the device.

[0164] Referring again to Figures 2 and 3, and simultaneously to Figure 5, in some embodiments of this application, an auxiliary channel is provided on the first handle 111 or the second handle 112. This auxiliary channel communicates with the steam delivery needle AN, allowing steam or air to be introduced into the steam delivery needle AN, or allowing steam to exit from the auxiliary channel. Specifically, an injection port IP is provided on the auxiliary channel, into which physiological saline or sterile water (similar to ultrasound coupling agent) is injected using an injection device.

[0165] Because real-time ultrasound imaging may result in poor image quality (e.g., dark areas or unclear images), apply sufficient force carefully to the intrauterine ultrasound probe 21 to ensure adequate contact between the imaging surface and the tissue. If the image does not improve, there may be air bubbles between the imaging surface of the intrauterine ultrasound probe 21 and the endometrium. A syringe connected to the injection port IP can be used to inject saline or other sterile fluid through the fluid path within the ablation handle catheter 12 into the target area of ​​the tissue being treated to remove air bubbles, acting similarly to a coupling agent.

[0166] In abnormal situations, the generated vapor is discharged through the injection port IP to prevent it from spreading in the patient's body, making the surgery safer.

[0167] Essentially, air is introduced into the steam flow within the steam channel. In this implementation, the electronic valve for steam inflow is closed before the steam delivery ends, while the electronic valve for air inflow is opened to introduce the steam flow (steam delivery needle AN). Air is drawn into the steam flow via the Venturi effect, or injected or delivered using a pump or fan. In use, after steam delivery, the air remains in the ablated tissue. It will be slowly absorbed over a period of time (e.g., within minutes). The ultrasonic images observed after steam delivery will appear bright in the ablation area because the air reflects the image, thus providing a map of the ablated tissue. Such images can be saved and retrieved for future evaluation of the ablation effect.

[0168] In addition, the auxiliary channel and injection port IP can also be directly applied in the above embodiments. For example, the auxiliary channel is set inside the device body 10 and is connected to the steam delivery needle AN of the steam ablation component 22, and the injection port IP is set on the handle 11 of the device body 10.

[0169] Figure 12 is a schematic diagram of another embodiment of the ultrasound-guided steam ablation surgical device provided in this application.

[0170] In some embodiments of this application, after the fibroid localization and ultrasound imaging are optimized, the operator needs to use one hand or with the assistance of an assistant to strictly hold the device in the current position before adjusting the location and size of the ablation area. Similarly, when deploying the steam delivery needle via AN puncture, the device also needs to be strictly held in the current position; and during steam ablation, the operator also needs to strictly hold the device in one position. Even slight movement of the device may result in ablation energy being delivered to a location deviated from the lesion tissue.

[0171] Therefore, in some embodiments of this application, referring to FIG12, the ultrasound-guided steam ablation surgical device further includes a support component 60, which is disposed on the handle 11 and is used to support the handle 11 and the catheter 12 so as to keep the catheter 12 stable.

[0172] Specifically, the support assembly 60 includes a sleeve and a support 62. The sleeve is disposed on the support 62 and is fitted over the outside of the handle 11, facilitating surgical manipulation by the operator and enabling automatic ablation deployment. The support 62 includes multiple segmented support arms spaced apart.

[0173] During use, the support arm can be rigidly attached to the patient's examination bed or the horizontal adjustment track in front of the bed. The intrauterine ultrasound probe 21 and catheter 12 are conveniently inserted into the patient's uterine cavity.

[0174] The support arm has an unlocked state and a locked state. In the unlocked state, the segmented support arm can move freely and can be adjusted to any desired bend or position. In the locked state, the bend or position of the support arm is locked in the appropriate position.

[0175] After the operator positions and images the uterine fibroid with ultrasound, the motor activates the support arm to rigidly lock its segment in place and hold the device cylinder in the desired position. The support arm can be unlocked to move the device to a new location within the fibroid or to another fibroid, and then relocked to deliver steam to the new site or to another fibroid.

[0176] When the sleeve is held in a stable position by the support 62, ablation zone adjustment, steam delivery needle AN deployment, safe rotation, and steam delivery can be performed with little or no interruption. A single operator can then focus on the ultrasound image to reliably deliver steam to the target location. A single surgeon can then manually move the ultrasound probe 21 and catheter 12 to a new location on the fibroid or to the next fibroid and repeat the process. This setup improves surgical efficiency while making the procedure easier for the operator, reducing the learning curve, and shortening the learning path.

[0177] Figure 13 is a schematic diagram of the usage status of the ultrasound-guided steam ablation surgical device provided in the embodiments of this application.

[0178] Referring to Figure 13, during use, the handle 11 can be fixed to the support 62 first, and the catheter 1212 can be inserted into the uterine cavity through the natural cavity (vagina); then, the start button can be pressed. Three-dimensional ultrasound imaging can then be performed on the positioned lesion tissue. The motion module on the support 62 can drive the surgical control handle to swing at a certain angle, thereby enabling the catheter 1212 to perform 3D imaging scanning of the lesion tissue (taking uterine fibroids as an example). 3D imaging can be obtained by scanning the sound beam in a two-dimensional manner and superimposing multiple cross-sectional B-mode images. The control component 80 can receive the three-dimensional ultrasound imaging image dataset, process it through its related processor, and output relevant data, including but not limited to the 3D volume of the uterine fibroid, the location information of the fibroid and the uterine cavity, and 3D imaging of the uterine fibroid and the uterine cavity, to achieve accurate planning, deployment, and ablation treatment.

[0179] Figure 14 is a schematic diagram of an ultrasound-guided steam ablation system provided in an embodiment of this application.

[0180] Referring to Figure 14, this application also provides an ultrasound-guided steam ablation system, including a control component 80 and the aforementioned ultrasound-guided steam ablation surgical device; the control component 80 is connected to an ultrasound probe 21 and a steam delivery needle AN, respectively, for driving the ultrasound probe 21 to obtain real-time ultrasound imaging of the lesion area; based on historical medical images of the lesion area of ​​the subject, the initial ablation area and ablation parameters for ablation of the lesion area of ​​the subject are determined; the puncture direction is planned based on the angle between the ultrasound probe 21 and the catheter 12 and the real-time ultrasound imaging of the lesion area, and the position and / or size of the initial ablation area are adjusted based on the real-time ultrasound imaging of the lesion area to determine the target ablation area; guided by the target ablation area, ablation parameters, and puncture direction, the steam delivery needle of the steam ablation component 22 is deployed to the lesion area.

[0181] The control component 80 includes a main unit of an ultrasound imaging system and a steam control unit that are interconnected. The main unit of the ultrasound imaging system is used to acquire real-time ultrasound images of the lesion tissue based on the ultrasound probe 21 and to guide the steam delivery needle AN to be deployed to the lesion tissue based on the ultrasound images. The steam control unit is used to deliver fluid to the device under the control of the main unit of the ultrasound imaging system.

[0182] The ultrasound probe 21 and the ultrasound imaging system communicate with each other via cable 40. The steam control console can supply power to the handle 11 and communicate with it via cable 40. The steam control console can supply sterile water to the steam generator via a fluid channel.

[0183] In addition, the processes executed by the aforementioned control component 80 are all included, as detailed in the descriptions of the above embodiments, and will not be repeated here. For example, the main unit of the ultrasound imaging system is used to acquire real-time ultrasound images of the lesion tissue based on the ultrasound probe 21; determine the initial ablation area and ablation parameters for ablation of the lesion area based on historical medical images of the lesion area of ​​the lesion tissue; plan the puncture direction based on the angle between the ultrasound probe 21 and the catheter 12 and the real-time ultrasound images of the lesion area; and adjust the position and / or size of the initial ablation area based on the real-time ultrasound images of the lesion area to determine the target ablation area; deploy the steam delivery needle AN into the lesion area according to the guidance of the target ablation area, ablation parameters, and puncture direction; and connect the steam control console to the device for delivering fluid to the device under the control of the main unit of the ultrasound imaging system.

[0184] The main unit of the aforementioned ultrasound imaging system can be a computer device, such as a tablet or laptop. The main unit of the ultrasound imaging system may include the following functional modules:

[0185] 1) Electronic circuits: mainly used for analog front-end, digital back-end (including user interface), user interaction processing, etc.; the user interface here is mainly the interface through which the operator inputs information to the processor, such as keyboard, touch screen, control panel, mouse, joystick, function keys, etc.

[0186] 2) An imaging display, including ultrasound imaging software (with intelligent guided ablation function), which has the following functions:

[0187] ① Two-dimensional / three-dimensional / Doppler ultrasound imaging and related parameter settings;

[0188] ② Communicate with the steam control console (RS232 / USB and synchronous triggering);

[0189] ③ Intelligent guided ablation function module: The relevant sensor signals of the control handle 11 or ultrasound probe 21 are processed by the system and fed back to the ultrasound imaging software. The ultrasound imaging software overlays and displays some graphics or icons on the ultrasound imaging to assist the ablation deployment operation; or accesses information sources (including but not limited to examination data analysis and surgical guide data, clinical databases and / or artificial intelligence databases) to realize algorithms that can automatically or semi-automatically analyze the information on the imaging display to assist the ablation deployment.

[0190] The aforementioned steam control console is connected to the main unit and devices of the ultrasound imaging system via cable 40. The steam control console can also supply power to the devices and communicate with them via the processing cable 40. This steam control console can supply fluid to the devices and control the amount and rate of fluid delivery. The steam ablation handle can determine the appropriate amount of steam based on the size of the target ablation area determined by the ultrasound navigation system, and control the steam flow rate and ablation time according to parameter settings. The fluid supplied by the steam control console to the steam ablation handle can include, but is not limited to, sterile water, water, steam, medication, alcohol, or other fluids.

[0191] In one embodiment, the control component 80 is further configured to monitor the ablation process of the lesion tissue in real time based on real-time ultrasound imaging of the lesion tissue during the ablation process.

[0192] In ablation of lesions, the ablation energy / required energy can be calculated first. The ablation energy determines the pressure of the fluid supplied by the steam control console, and the output fluid velocity is calculated from this pressure to deliver steam to the lesion. The process of calculating the ablation energy and the output fluid velocity is explained below. First, the volume of the target ablation region is calculated. The target ablation region is a cylinder with a rectangular cross-section. Let the longer side of the rectangle be R. a The shorter side is R. b Then, the volume corresponding to the target ablation area, i.e., the ablation volume V, can be calculated using the following formula:

[0193] The safe and effective energy dose applied to the tissue is generally determined based on the required degree of tissue damage. Typically, the degree of tissue damage increases with increasing dose. The energy per unit volume in the steam ablation ultrasound-guided system can be preset to m±n% (cal / cc), where m and n can be integers or decimals, and the specific values ​​can be set according to the actual situation.

[0194] In this embodiment, taking uterine fibroids as an example, it is assumed that the energy per unit volume in the steam ablation ultrasound navigation system is set to C (cal / cc) in advance, and the energy required for the ablation volume V is CV (cal). Alternatively, an appropriate energy delivery time, i.e., the ablation time T, can be pre-set in the steam ablation ultrasound navigation system based on historical clinical ablation results.

[0195] After calculating the ablation energy and setting the ablation time, the required energy delivery rate CV / T can be determined. The steam ablation ultrasonic navigation system then establishes a pressure level in the steam control console that matches the energy delivery rate, delivering fluid to the handle 11 at the desired rate. Typically, changing the ablation time will change the energy delivery rate, allowing the steam control console to adaptively adjust the matching pressure.

[0196] During the process of delivering fluid to the handle 11 at the required energy delivery rate to ablate the diseased tissue, the diffusion rate and range of steam in the diseased tissue can be monitored in real time by real-time ultrasound imaging of the diseased tissue. At the same time, the diffusion rate of steam in the diseased tissue can be adjusted or modified based on the results of real-time monitoring.

[0197] Referring again to Figure 14, the ultrasound-guided steam ablation surgical device provided in this embodiment of the application further includes a magnetic navigation component 70, which includes a magnetic positioning module 71, a first magnetic element 72, a second magnetic element 73, and a third magnetic element 74. The first magnetic element 72 is disposed on the ultrasound probe 21, the second magnetic element 73 is disposed on the steam ablation component 22, and the third magnetic element 74 is disposed on the catheter 12. The magnetic positioning module 71 is electrically connected to the control component 80 and is disposed on the outside of the device body 10, and is used to detect the magnetic fields of the first magnetic element 72, the second magnetic element 73, and the third magnetic element 74, respectively.

[0198] When an ultrasound-guided steam ablation device is used to treat uterine fibroids, the ultrasound probe 21 and catheter 12 need to enter the uterine cavity through the natural cavity (vagina), and the cervix needs to be dilated to 9 mm. Therefore, the structural dimensions of the ultrasound probe 21 and catheter 12 must be less than 9 mm. Maintaining the ultrasound probe 21 and catheter 12 in such a small structure, i.e., the ultrasound probe 21 needs to be positioned at 0° (otherwise it cannot be used), and simultaneously ensuring that the steam delivery needle AN and catheter 12 remain straight, makes the structure and assembly process extremely complex.

[0199] Therefore, this embodiment of the application uses a magnetic navigation component 70 for navigation guidance, so that the ultrasonic probe 21 and the conduit 12 do not need to be kept straight, and the steam delivery needle AN does not need to be kept straight with the conduit 12; the transducer assembly angle inside the ultrasonic probe 21 does not need to be set to a certain value. The error between the tip of the steam delivery needle AN and the initial starting point set by the system does not affect the positioning of the current position of the tip. Therefore, the structural design and assembly calibration process can be simplified.

[0200] The magnetic positioning module 71 includes a coil array for tracking and positioning the model during surgery (angle adjustment of the ultrasound imaging transducer and tip travel of the steam delivery needle AN). Specifically, the magnetic positioning module 71 comprises a coil array (two or more triaxial solid-state magnetic sensors), which can be spaced apart on a rigid, non-magnetic base and placed on or near the patient's lower torso. The magnetic positioning module 71 provides measurements of six magnetic field values, addressing five degrees of freedom of the magnetic element (i.e., x, y, z coordinates relative to the sensor coordinate system, as well as polar and azimuth angles).

[0201] The first magnetic element 72, the second magnetic element 73, and the third magnetic element 74 can all be passive magnetic elements or other active magnetic elements. Passive magnetic elements have no leads, such as magnets; active magnetic elements require leads, such as coils. The magnetic positioning module 71 can also use various magnetic sensor technologies, such as fluxgate magnets and saturable core sensors, to detect the alternating magnetic field generated in the moving permanent magnet element or coil, thereby obtaining the five degrees of freedom of the magnetic elements on the ultrasound imaging transducer and the catheter 12. The adjustment angle of the ultrasound imaging transducer can be calculated. The angle obtained here is the angle between the transducer and the catheter 12. Adding the angle between the puncture path and the catheter 12, we get the actual angle between the transducer and the puncture path. During this process, the steam delivery needle AN and the catheter 12 are not perfectly straight.

[0202] The alternating magnetic field generated in the moving second magnetic element 73 is detected by magnetic sensor technology to realize the positioning of the tip of the steam conveying needle AN and convert its motion trajectory into the ultrasonic image coordinate system (since the system locks the magnetic sensor to the ultrasonic imaging transducer, the ultrasonic image and the magnetic sensor tracking coordinate system are registered / aligned).

[0203] Because the steam delivery needle AN is small in size, with a diameter of approximately 2 mm and a hollow interior, its walls are very thin. A second magnetic element 73 is mounted at the tip of the steam delivery needle AN. This second magnetic element 73 can be a magnet or a coil. When the passive magnetic element moves in pulse steps (microscopically appearing as non-uniform movement, macroscopically appearing as uniform movement), it becomes a moving magnetic element. As a magnetic field transmitter, the magnetic positioning module 71 receives and analyzes this information to obtain the puncture path and current position of the steam delivery. This information is then coupled to the ultrasonic coordinate system and displayed on the ultrasonic interface.

[0204] Since the coil requires leads, it is preferable to use embedded passive magnetic components in the design, in which case no electronic components need to be installed at the needle tip. If active magnetic components such as coils with leads are used, the leads are placed inside the tube wall of the steam delivery needle AN without affecting other functions of the needle tip.

[0205] Figure 15 is a schematic diagram of the installation of the first magnetic element provided in an embodiment of this application.

[0206] Referring to Figure 15, in this embodiment of the application, the first magnetic element is preferably locked at the center position of the ultrasound probe 21, that is, the first magnetic element is set on the extension line of the ultrasound imaging transducer 9 of the ultrasound probe 21. This ensures that the ultrasound image is registered with the sensor tracking coordinate system, even when the tip of the ultrasound probe moves relative to the patient's anatomical structure. Furthermore, the system can acquire the angle between the tip of the ultrasound probe and the extension rod in real time. Therefore, when the ultrasound transducer 211 is assembled into the ultrasound probe 21, it is not necessary to fix the angle between it and the tip structure of the probe.

[0207] Essentially, the position detection component includes a first magnetic element 72, a second magnetic element 73, and a magnetic positioning module 71; the first magnetic element 72 is disposed on one of the ultrasonic probe 21 and the steam delivery needle AN, the second magnetic element 73 is disposed on the other of the ultrasonic probe 21 and the steam delivery needle AN, the magnetic positioning module 71 is used to detect the magnetic field information of the first magnetic element 72 and the second magnetic element 73, and the magnetic positioning module 71 is connected to the control component 80.

[0208] This application embodiment employs an ultrasound-guided steam ablation surgical device. During surgery, preoperative planning is first performed: determining the surgical equipment parameters, primarily the appropriate steam delivery needle model. Next, ablation planning is conducted: planning the steam delivery needle's puncture angle and depth. Finally, ablation deployment is performed: as the steam delivery needle (AN) performs the puncture, it adjusts in real-time based on position signals from the position detection component to correct any errors in the ablation plan. Simultaneously, the ablation area is fine-tuned before ablation treatment to reduce cooling errors.

[0209] Figure 16 is a coordinate diagram showing the error of adjusting and ablation planning based on the position signal fed back by the position detection component according to the embodiment of this application.

[0210] Before ablation deployment, during the puncture direction planning, the structural manufacturing and assembly tolerances between the steam delivery needle AN and the catheter 12 will result in a certain angle between them. When the angle between the extensions of the steam delivery needle AN and the catheter 12 is uncertain, it is assumed that the steam delivery needle AN and the catheter 12 remain parallel, i.e., the angle θ2 between the extensions of the steam delivery needle AN and the catheter 12 is 0.

[0211] When adjusting the position of the ultrasonic probe 21, the position information detected by the position detection component installed inside the ultrasonic probe 21 can be used to determine the distance θ1 between the ultrasonic probe 21 and the extension line of the catheter 12 in real time.

[0212] Based on the angle θ2 between the steam delivery needle AN and the extension line of the catheter 12, and the angle θ1 between the ultrasonic probe 21 and the extension line of the catheter 12, the angle between the ultrasonic probe 21 and the steam delivery needle AN (i.e. the puncture direction under ultrasound) θ = θ1 + θ2 = θ1 is planned.

[0213] Referring to Figure 16, during ablation planning, the guide line for the steam delivery needle AN puncture direction is positioned so that it passes through the major axis of the fitted graph. The included angle is calculated from the coordinates of points a and b in the figure and displayed at the relevant position on the monitor: θ = θ1. Therefore:

[0214] Referring again to Figure 16, during ablation deployment, the steam delivery needle AN performs a puncture action. Based on the position information detected by the position detection component installed inside the steam delivery needle AN, the distance θ2 between the steam delivery needle AN and the extension line of the conduit 12 can be determined in real time. Therefore:

[0215] The display information θ = θ1 + θ2 is updated, and the angle of the puncture guidance indicator icon drawn on the ultrasound image is also updated to θ = θ1 + θ2.

[0216] Figure 17 is a schematic diagram of the structure of the fitting graph provided in the embodiment of this application.

[0217] Referring to Figure 17, based on the aforementioned real-time determination of θ2 between the extension lines of the steam delivery needle AN and the catheter 12, and the angle between the puncture guidance indicator icon drawn on the ultrasound image, the planned puncture stroke L is compensated. Since the location of the fibroid is not fixed, when the steam delivery needle is inserted into the fibroid, the position of the fibroid shifts slightly under the action of the needle. As shown in Figure 17, the center point of the fitted graph moves from point m to point n.

[0218] Figure 18 is a coordinate diagram of the ablation area adjustment provided in the embodiments of this application.

[0219] Referring to Figure 18, fit the data obtained from the above formula to a coordinate system for calculation:

[0220] The calculated value is used as supplementary feedback for the puncture depth. After the puncture is completed, based on the relationship between θ3 and θ, the ablation area indicator graphic is rotated accordingly to align it with the steam delivery needle.

[0221] In addition, the position detection component includes multiple position sensors connected to the control component 80. Two position sensors are located on the steam delivery needle AN to monitor the first movement path of the steam delivery needle AN, and the other two position sensors are located on the ultrasound probe 21 to monitor the second movement path of the ultrasound probe 21. The control component 80 determines the angle between the first and second movement paths based on the first and second movement paths, and plans the puncture direction based on the angle and real-time ultrasound imaging of the lesion area.

[0222] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this application, and are not intended to limit them. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this application.

Claims

1. An ultrasound-guided steam ablation surgical device, comprising: The device body includes a handle and a catheter, the catheter having a proximal end and a distal end, a tube of a predetermined length extending between the proximal end and the distal end, and the proximal end of the catheter being connected to the handle; An ultrasound-guided steam ablation assembly includes an ultrasound probe and a steam delivery needle. The ultrasound probe is movably disposed at the distal end of the catheter, and the steam delivery needle is movably disposed in the body of the catheter. Both the ultrasound probe and the steam delivery needle are equipped with position detection components, each of which is used to detect the position information of the ultrasound probe and the steam delivery needle. A control component is connected to the ultrasound probe, the steam delivery needle, and each of the position detection components. The control component is used to determine the angle between the ultrasound probe and the steam delivery needle based on the position information of the ultrasound probe and the steam delivery needle, and to plan the puncture direction based on the angle and real-time ultrasound imaging of the lesion area.

2. The ultrasound-guided steam ablation surgical device according to claim 1, wherein, The position detection component includes a first magnetic element, a second magnetic element, and a magnetic positioning module; The first magnetic element is disposed in one of the ultrasonic probe and the steam delivery needle, and the second magnetic element is disposed in the other of the ultrasonic probe and the steam delivery needle. The magnetic positioning module is used to detect the magnetic field information of the first magnetic element and the second magnetic element, and the magnetic positioning module is connected to the control component.

3. The ultrasound-guided steam ablation surgical device according to claim 1, wherein, The position detection component includes multiple position sensors connected to the control component. Two of the position sensors are located on the steam delivery needle to monitor a first movement path of the steam delivery needle, and the other two position sensors are located on the ultrasound probe to monitor a second movement path of the ultrasound probe. The control component determines the angle between the first movement path and the second movement path, and plans the puncture direction based on the angle and real-time ultrasound imaging of the lesion area.

4. The ultrasound-guided steam ablation surgical device according to claim 1 further includes an adjustment component, the adjustment component including a first adjustment component, a second adjustment component, and an ablation area adjustment control disposed on the handle; The first adjustment component is connected to the ultrasound probe and is used to adjust the angle of the ultrasound probe relative to the catheter; the second adjustment component is connected to the steam delivery needle and is used to adjust the position of the steam delivery needle; the ablation area adjustment control is used to control the size of the ablation area.

5. The ultrasound-guided steam ablation surgical device according to claim 4, wherein, The ultrasound probe is rotatably connected to the distal end of the catheter; The first adjustment component includes a probe angle adjuster and a traction member. The probe angle adjuster is located on the handle. One end of the traction member is connected to the probe angle adjuster, and the other end of the traction member extends along the tube body of the catheter and is connected to the ultrasound probe.

6. The ultrasound-guided steam ablation surgical device according to claim 4, wherein, The second adjustment component includes a puncture control component and a transmission component. The puncture control component is located on the handle, and the transmission component is connected between the puncture control component and the steam delivery needle to transmit the driving action of the puncture control component to the steam delivery needle, thereby causing the steam delivery needle to change position.

7. The ultrasound-guided steam ablation surgical device according to claim 4, wherein, The adjustment assembly further includes a first driving component, which is connected to the first adjustment component and electrically connected to the control component, for driving the ultrasound probe to rotate relative to the catheter according to the control command of the control component; And / or, The adjustment component includes a second driving component, which is connected to the second adjustment component and electrically connected to the control component, for driving the steam delivery needle to move according to the control command of the control component.

8. The ultrasound-guided steam ablation surgical device according to claim 1, wherein, The tip of the steam delivery needle is provided with an arc-shaped blunting section.

9. The ultrasound-guided steam ablation surgical device according to claim 1, wherein, The tip of the steam delivery needle is provided with a pair of electrode plates at intervals. By measuring the tissue impedance between the electrode plates, it is determined whether the puncture depth of the steam delivery needle exceeds the preset puncture depth.

10. The ultrasound-guided steam ablation surgical device according to claim 1, wherein, The imaging surface of the ultrasonic probe is curved. Alternatively, the imaging surface of the ultrasonic probe may be composed of multiple planes, with adjacent planes arranged at an angle to each other.

11. The ultrasound-guided steam ablation surgical device according to claim 1, wherein, The handle is also provided with an auxiliary channel, which is connected to the steam delivery needle.

12. The ultrasound-guided steam ablation surgical device according to any one of claims 1 to 11, wherein, The ultrasound-guided steam ablation assembly also includes a steam generator located on the handle and configured to generate steam, with the steam delivery needle connected to the steam generator.

13. The ultrasound-guided steam ablation surgical device according to any one of claims 1 to 11, wherein, The main body of the device includes a first part and a second part arranged opposite to each other, and the first part and the second part are detachably connected; the first part is provided with a first handle and a first tube connected to each other, and the second part is provided with a second handle and a second tube connected to each other. A fluid channel is provided on either the first handle or the second handle, the fluid channel extending to the corresponding tube, and the steam delivery needle communicating with the fluid channel; The other of the first handle and the second handle is provided with a wiring channel that extends to the corresponding tube. A cable is arranged in the wiring channel and the cable is connected to the ultrasonic probe.

14. The ultrasound-guided steam ablation surgical device according to any one of claims 1 to 11, further comprising a support assembly, the support assembly comprising a sleeve and a bracket, the sleeve being disposed on the bracket and sleeved on the outside of the handle.

15. An ultrasound-guided steam ablation system, comprising the ultrasound-guided steam ablation surgical device as described in any one of claims 1 to 14; The control component is connected to the ultrasound probe and the steam delivery needle, respectively, and is used to drive the ultrasound probe to obtain real-time ultrasound imaging of the lesion area; determine the initial ablation area and ablation parameters for the lesion area of ​​the subject based on historical medical images of the lesion area; plan the puncture direction based on the angle between the ultrasound probe and the steam delivery needle and the real-time ultrasound imaging of the lesion area, and adjust the position and / or size of the initial ablation area based on the real-time ultrasound imaging of the lesion area to determine the target ablation area; and deploy the steam delivery needle into the lesion area according to the guidance of the target ablation area, the ablation parameters, and the puncture direction.

Images