Steam ablation system

Abstract

The invention provides a steam ablation system which comprises a steam executing mechanism, an image planning module and a motion control module. The steam needle assembly can conduct linear motion in the axial direction, rotary motion in a cross section perpendicular to the axial direction, stretching motion of a needle head from an outlet of the steam needle to a treatment site in the direction approximately transverse to the axial direction, and ejection motion of steam from a steam outlet needle hole of the steam needle. The image planning module is used for determining planning parameters, the planning parameters comprise a preset number of needle withdrawing point positions and preset parameters of each needle withdrawing point position, and the preset parameters of each needle withdrawing point position comprise a preset needle withdrawing position, a preset needle withdrawing angle, a preset needle withdrawing length and a preset steam action range; and the motion control module is used for converting the planning parameters of the image planning module into execution parameters and driving and controlling the steam needle assembly to act according to the execution parameters, so that the operation precision and efficiency are improved.

Description

[0001] This application is a divisional application of the patent filed on June 7, 2024, with application number 202410732430.6 and named "Method, device and steam ablation system for determining execution parameters of steam needle". Technical Field

[0002] The present application relates to a method and device for determining execution parameters of a steam needle and a steam ablation system, which can be applicable to an automatic steam ablation system or a semi-automatic steam ablation system, and can quickly determine the execution parameters of the steam needle and improve the operational accuracy and efficiency of the steam ablation surgery. Background Art

[0003] The prior art has steam needles for tissue ablation. During the use of such products, after the doctor inserts the execution device into the urethra, he needs to judge the treatment point for tissue ablation based on experience, select the position that the doctor thinks is appropriate, control the steam needle to be removed, and operate the handle or button to release the steam. When there are multiple treatment points, it is necessary to complete the steam release at the first needle removal position, then withdraw the steam needle and move the steam needle to the second needle removal position to remove the needle and release the steam, and repeat this process until the needle removal and steam ablation at multiple treatment points are completed.

[0004] This process requires the doctor to perform manual and repetitive operations, which is inefficient and relies on the doctor's experience to complete the positioning of the steam needle. Due to the individual differences in the characteristics of each patient's tissue area, the ablation effect of the steam released after the steam needle is inserted has a blind box effect, and the range of action and treatment effect cannot be accurately predicted, which brings greater uncertainty to the effect of the steam ablation surgery and may cause unexpected damage. In addition, in the current technology, the length of the steam needle extending from the sheath and the spray range of the steam are fixed, and cannot be dynamically adjusted according to the needs of the operation. It is not suitable for patients with large individual differences, such as patients with small or large tissue volumes, and may cause the surgical effect to be not good enough, such as excessive or insufficient resection range. Summary of the invention

[0005] The present application is proposed based on the above problems in the background technology, and aims to provide a steam ablation system that can improve operation accuracy and efficiency. In order to achieve the above-mentioned purpose, the present application proposes a steam ablation system, comprising: a steam actuator, an image planning module and a motion control module, characterized in that the steam actuator comprises a steam needle assembly, and under the drive control of the motion control module, the steam needle assembly can perform one or more of the following actions: the steam needle performs linear motion along the axial direction, the steam needle performs rotational motion in a cross-section perpendicular to the axial direction, the needle head of the steam needle extends from the steam needle outlet to the treatment site along a direction roughly transverse to the axial direction, and the steam is ejected from the steam outlet needle hole of the steam needle; the image planning module is used to determine planning parameters based on the preoperative initial image of the target area, the planning parameters include a preset number of needle exit points and preset parameters for each needle exit point, and the preset parameters for each needle exit point include one or more of the following parameters: a preset needle exit position of the steam needle, a preset needle exit angle of the steam needle, a preset needle exit length of the steam needle, and a preset steam action range; the motion control module is used to convert the planning parameters of the image planning module into execution parameters, and drive and control the steam needle assembly to act according to the execution parameters.

[0006] Furthermore, the steam needle assembly further comprises a sheath tube, a steam needle outlet is provided at the front end of the sheath tube, and the steam needle moves linearly along the axially extending channel defined by the sheath tube under the driving control of the motion control module.

[0007] Furthermore, the image planning module selects a suitable treatment plan template from a treatment plan template library to match the contour information of the target area in the initial image, and determines the planning parameters based on the selected treatment plan template.

[0008] Furthermore, the image planning module generates a treatment plan and a schematic diagram according to the level of target tissue proliferation.

[0009] Furthermore, the system also acquires a virtual needle image of the steam needle, and displays the virtual needle image superimposed on the initial image.

[0010] Furthermore, the system also obtains a real-time image of the steam needle inserted into the target area, and substantially aligns the real-time image with the target tissue contour in the initial image, and the steam needle in the real-time image overlaps with the virtual needle image in the initial image.

[0011] Furthermore, the system also establishes a mapping relationship between the moving distance of the steam needle image in the real-time image and the moving distance of the virtual needle image in the initial image.

[0012] Furthermore, the steam actuator also includes a handle assembly, and the handle assembly is attached to the steam needle. The movement of the steam needle and the release of steam can be controlled by manipulating the handle assembly.

[0013] Furthermore, the motion control module includes a linear motion control submodule, a rotational motion control submodule, a depth control submodule, and an action range control submodule. The linear motion control submodule includes a linear motion drive motor and a linear motion transmission assembly, which are used to control the linear motion of the steam needle along the axial direction; the rotational motion control submodule, for example, includes a rotational motion drive motor and a rotational motion transmission assembly, which are used to control the rotational motion of the steam needle in a cross-section; the depth control submodule includes a drive motor and an actuator mechanism, which are used to control the movement of the needle tip of the steam needle from the steam needle outlet along a direction roughly transverse to the axial direction to the treatment site; the action range control submodule includes a steam control mechanism and an actuator mechanism, which are used to control the steam action range by adjusting parameters such as steam temperature, pressure, action time, and speed.

[0014] Furthermore, the system further comprises an ultrasonic stepper module, wherein the ultrasonic stepper module comprises an ultrasonic probe and a stepper device for driving the ultrasonic probe to perform linear and / or rotational motion.

[0015] The aforementioned scheme provided in the present application sets the execution parameters of the controllable and adjustable steam needle actuator for the special scenario of steam needle tissue ablation, and establishes the correlation between the planning parameters and the execution parameters by aligning the steam needle image with the virtual needle image, thereby realizing visual assisted operation, facilitating the rapid determination of the treatment plan, and facilitating the rapid and accurate positioning of the steam needle during the operation, which can greatly improve the efficiency and accuracy of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the present application, the drawings of the specification of the present application will be described and illustrated below. Obviously, the drawings in the following description only illustrate certain aspects of some exemplary embodiments of the present application, and it is possible for a person of ordinary skill in the art to obtain other drawings based on these drawings without creative work.

[0017] Figure 1 It is a flowchart of a method for determining execution parameters of a steam needle provided according to an embodiment of the present application.

[0018] Figure 2 is a schematic diagram of a target area and various plane images provided according to an embodiment of the present application.

[0019] Figure 3It is a schematic diagram of needle exit points in a horizontal plane image provided according to an embodiment of the present application.

[0020] Figure 4 It is a schematic diagram of needle insertion points in a sagittal image provided according to an embodiment of the present application.

[0021] Figure 5 It is a schematic diagram of needle exit points in a cross-sectional image provided according to an embodiment of the present application.

[0022] Figure 6 It is a schematic diagram of a virtual needle image and a steam needle in a sagittal image provided according to an embodiment of the present application.

[0023] Figure 7 It is a schematic diagram of a rotation angle in a cross-sectional image provided according to an embodiment of the present application.

[0024] Figure 8 Schematic diagram of the needle structure of a steam needle provided according to an embodiment of the present application.

[0025] Fig. 9 It is a schematic diagram of the temperature field principle of the action area of ​​the steam needle provided according to an embodiment of the present application.

[0026] Fig.10 It is a structural schematic diagram of a steam ablation system provided according to an embodiment of the present application.

[0027] Fig.11 It is a structural schematic diagram of a steam actuator in a steam ablation system provided according to an embodiment of the present application.

[0028] Caption of the attached figure:

[0029] 11 First point

[0030] 110 First sheath outlet

[0031] 12 Second point

[0032] 120 Second sheath outlet

[0033] 13 Third point

[0034] 14 Fourth point

[0035] 21 Virtual Needle

[0036] 22 Steam Needle

[0037] 220 Steam needle outlet

[0038] 220' Steam needle exit image

[0039] 3 Sheath

[0040] 4 Target area

[0041] 5. Handle DETAILED DESCRIPTION

[0042] Various exemplary embodiments of the present application are described in detail below with reference to the accompanying drawings. The description of the exemplary embodiments is merely illustrative and is by no means intended to limit the present application and its application or use. The present application can be implemented in many different forms and is not limited to the embodiments described herein. These embodiments are provided to make the present application thorough and complete and to fully express the scope of the present application to those skilled in the art. It should be noted that unless otherwise stated, the relative arrangement of the components and steps, numerical expressions, and numerical values, etc., described in these embodiments should be interpreted as being merely exemplary, rather than as limitations.

[0043] The words “include” or “comprising” and the like used in this application mean that the elements preceding the words include the elements listed after the words, and do not exclude the possibility of also including other elements.

[0044] All terms (including technical terms or scientific terms) used in this application have the same meaning as those understood by ordinary technicians in the field to which this application belongs, unless otherwise specifically defined. It should also be understood that terms defined in general dictionaries should be understood to have meanings consistent with their meanings in the context of the relevant technology, and should not be interpreted in an idealized or extremely formal sense, unless explicitly defined in this article.

[0045] Components not described in detail in this section, parameters such as specific models of components, relationships between components, and control circuits may be considered as technologies, methods, and equipment known to ordinary technicians in the relevant fields, but in appropriate circumstances, such technologies, methods, and equipment should be considered as part of the specification.

[0046] It should be noted that although the operations of the present method are described in a particular order, this does not require or imply that the operations must be performed in the particular order, or that all the operations shown must be performed to achieve the desired results. On the contrary, the steps depicted in the flow chart can be performed in a different order. Additionally or alternatively, some steps can be omitted, multiple steps can be combined into one step, and / or one step can be decomposed into multiple steps.

[0047] First refer to Figure 1-2 , Figure 8-11 A method for determining the execution parameters of the vapor needle 22 will be generally described.

[0048] In the present application, the heated steam is introduced into the target area 4 to be ablated or removed by the steam needle 22, and the target area 4 is ablated by releasing the steam. It should be noted that the steam described in the present application includes but is not limited to water vapor, and may also be other ablation media in gaseous / gas-liquid two-phase state.

[0049] The steam needle 22 includes an elongated main body, which can be slidably arranged in the sheath 3. For example, the target area 4 here is the prostate. The steam needle 22 can be inserted into a predetermined position along the channel defined by the sheath 3 or through a predetermined cavity such as the urethra in a similar manner. Then, the needle tip of the steam needle 22 extends from the distal end of the sheath 3 and is inserted into the target area 4. Steam is sprayed from the pinhole near the front needle tip of the steam needle 22. After being sprayed from the pinhole, the high-temperature steam quickly diffuses through the cell gap in a convection manner, and then condenses and liquefies, releasing a large amount of heat, which immediately promotes the necrosis of the proliferating tissue cells. After the cells are necrotic, they will gradually shrink naturally and reduce in size, and finally be absorbed by the human body, thereby achieving the purpose of ablating the surrounding tissues.

[0050] It should be understood that the steam needle 22 of the present application is not only applicable to the ablation of the prostate, but also applicable to the ablation of other tissues in similar situations, without specific limitation.

[0051] Figure 8 As shown in FIG. 1 , it is a schematic diagram of the structure of the steam needle 22. It can be seen that a plurality of gas outlet needle holes are arranged near the needle head of the steam needle 22. The needle holes can be arranged in multiple rows. The needle body is hollow. The steam flows from the steam generating device through the hollow needle body to the needle holes. The temperature field formed is as shown in FIG. Fig. 9 As shown, Fig. 9 Schematic diagram of the temperature field principle of the area where the steam is ejected from the pinhole of the steam needle 22. It can be seen that a roughly spherical temperature field distribution is formed around the pinhole. It should be noted that Fig. 9 The temperature field distribution shape shown is only roughly spherical, not strictly spherical. Depending on the difference in the length of the pinhole arrangement, the temperature field distribution shape will be slightly different. More often, its temperature field distribution shape may be ellipsoidal or peach-shaped. It should be understood that no matter what shape, a spherical fitting can be used to obtain the radius R of the roughly spherical area. According to experiments, temperature is one of the decisive parameters affecting cell survival. High temperature can change the permeability and fluidity of the cell membrane, leading to primary cytoplasm damage. When the tissue temperature reaches 60-100°C or above, thermal coagulation necrosis of cells can occur within 10s. Therefore, according to the temperature field distribution law, the ablation area is defined by the parameter R, and R is the radius of the approximately spherical steam action range, which is related to the temperature field distribution of the steam needle 22, such as the area with a temperature of more than 60°C near the pinhole.

[0052] Fig.10, which is a schematic diagram of the structure of a steam ablation system provided according to an embodiment of the present application. The steam ablation system includes a steam actuator, a motion control module, an image planning module and an ultrasonic stepper module.

[0053] The steam actuator includes a steam needle assembly and a handle assembly. The steam needle assembly may include a sheath tube 3, and a steam needle outlet 220 is provided at the front end of the sheath tube 3, through which the steam needle 22 may extend. The handle assembly is attached to the sheath tube 3 and the steam needle 22, and the movement of the steam needle 22 and the release of steam may be controlled by manipulating the handle assembly.

[0054] The motion control module is attached to the steam needle 22 of the steam actuator, and can control the movement of the steam needle 22 and the release of steam. In this embodiment, the sheath 3 is slender as a whole, and the direction in which the slender sheath 3 extends as a whole is the axial direction, that is, the axis-limited direction. The motion controlled by the motion control module includes: linear motion of the steam needle 22 along the axial direction, rotational motion of the steam needle 22 in a cross-section perpendicular to the axial direction, and extension motion of the needle tip of the steam needle 22 from the steam needle outlet 220 to the treatment point in a direction roughly transverse to the axial direction; the motion control module can also control the steam action range of the steam needle 22.

[0055] The image planning module includes an MR or ultrasound or endoscope or fusion image generation module, and a planning module, which can plan based on the image and obtain planning parameters.

[0056] The ultrasonic stepper module includes an ultrasonic probe (eg, a rectal ultrasound probe TRUS) and a stepper device for driving the ultrasonic probe to perform linear and / or rotational motion.

[0057] The motion control module includes four submodules, namely, a linear motion control submodule, a rotational motion control submodule, a depth control submodule, and an action range control submodule. Among them, the linear motion control submodule includes, for example, a linear motion drive motor and a linear motion transmission assembly, which are used to control the linear motion of the steam needle 22 along the axial direction; the rotational motion control submodule includes, for example, a rotational motion drive motor and a rotational motion transmission assembly, which are used to control the rotational motion of the steam needle 22 in the cross section; the depth control submodule includes a drive motor and an actuator, which are used to control the movement of the needle of the steam needle 22 from the steam needle outlet 220 to the treatment site in a direction roughly transverse to the axial direction; the action range control submodule includes a steam control mechanism and an actuator, which are used to control the steam action range by adjusting parameters such as steam temperature, pressure, action time, and speed. The motion control module can convert the planning parameters of the image planning module into execution parameters, and enable each submodule to control the action according to the execution parameters.

[0058] See also Figure 1The present application provides a method for determining execution parameters of a steam needle 22, which mainly comprises the following steps:

[0059] Step S1: a needle exit point preset step, obtaining an initial image of the target area 4, determining the number of needle exit points based on the initial image, and determining preset parameters for each needle exit point, wherein the preset parameters for each needle exit point include an action center position and an ablation radius;

[0060] Step S2: a steam needle image registration step, obtaining a virtual needle image of the steam needle, and superimposing the virtual needle image on the initial image for display; obtaining a real-time image of the target area 4, the real-time image including the steam needle image corresponding to the steam needle in the target area 4; registering the real-time image with the initial image;

[0061] Step S3: a parameter determination step, establishing a mapping relationship between the moving distance of the steam needle image in the real-time image and the moving distance of the virtual needle image in the initial image, and converting the preset parameters of the needle exit point into the execution parameters of the steam needle at least based on the mapping relationship.

[0062] The following is a detailed description of the above method steps:

[0063] In the needle-exit point preset step S1, an initial image of the target area 4 is first acquired.

[0064] The image planning module is used to obtain an image of the area where the target area 4 is located. The ultrasonic stepper can be used to drive the ultrasonic probe to obtain a three-dimensional or key two-dimensional plane ultrasonic image containing the target area 4. The ultrasonic probe is already calibrated. The calibrated ultrasonic probe is used to obtain a cross-sectional image of the target area 4, that is, the size conversion relationship between the pixels in the ultrasound and the real world has been calibrated. The conversion matrix T_us_image2world is defined, and the cross-sectional image of the target area 4 is obtained by scanning with a fixed step length. The three-dimensional image can be obtained by performing three-dimensional reconstruction on the obtained series of cross-sectional images, and the image coordinate system Image_coordinates of each operation surface is formed, as shown in detail. Figure 2 As shown, the obtained three-dimensional image is the initial image of the target area 4. In an alternative embodiment, the initial image may also be a two-dimensional image set, and the two-dimensional images in the two-dimensional image set may be directly obtained by an ultrasound probe or obtained by slicing the three-dimensional image.

[0065] See also Figure 2, the elliptical area in the figure is the outline of the tissue to be removed in the target area 4, the steam needle 22 is inserted along the y-axis direction, the insertion process can be guided by the sheath tube 3 or similar components, and can rotate and swing around the y-axis in a cross section perpendicular to it. After the steam needle 22 is inserted into the front end of the sheath tube 3 or similar components, the steam needle 22 can be bent, and the needle part extends from the steam needle outlet 220. The plane defined by the yz axis is defined as the sagittal plane, the plane defined by the xz axis is defined as the cross section perpendicular to the sagittal plane, and the plane defined by the xy axis is defined as the horizontal plane. It should be understood that the outline of the target area 4 is usually irregular. Here, for the sake of convenience, the outline of the target area 4 is simplified to an ellipse, with the xy plane as the horizontal plane, the z-axis direction as the up-down direction, and the insertion direction of the steam needle 22, that is, the direction along the y-axis toward the target area 4, as the front, and the reverse direction as the back. Unless otherwise specified in the following text, the expression of direction is the same as this.

[0066] After obtaining an initial image of the target area 4, the number of needle points is determined based on the initial image. The size of the target area 4 can be estimated based on the image information, and the number of needle points can be determined based on the size of the target area 4. As a preferred method, a general treatment plan for the target area 4 is obtained in advance based on a large number of experiments, such as setting a treatment plan template of 4-10 points according to the size of the target area 4 to meet the treatment needs of target areas 4 of different sizes.

[0067] Further, the preset parameters of each needle-exit point are determined. After the number of needle-exit points is determined, the corresponding preset parameters are determined for each needle-exit point.

[0068] A prefabricated treatment plan template library is generated based on a large number of experiments to obtain general treatment plans for target area 4. For example, a 4-, 6-, or 8-needle treatment plan template is set according to the size of prostate hyperplasia to basically meet the treatment needs of prostates of various sizes; taking the 4-needle plan as an example, refer to Figure 3-Figure 5 , Figure 3 It is a schematic diagram of the needle point position in the horizontal plane image. Figure 4 It is a schematic diagram of the needle insertion point in the sagittal image.

[0069] Figure 5 It is a schematic diagram of the needle exit point in the cross-sectional image. The treatment plan template includes the number of needle exit points and the preset parameters of each needle exit point. The preset parameters of each needle exit point include the action center position and the ablation radius. The action center position is defined by the needle exit position parameter (Z), the needle exit angle parameter (θ), and the needle exit depth parameter (D). The ablation radius is defined by the action range parameter (R). For the meaning of the needle exit position parameter Z, the needle exit depth parameter D, and the action range parameter R, please refer to Fig.11 For the meaning of the needle angle parameter θ, see Figures 3 to 5Description; wherein, the needle position parameter Z represents the distance of the linear movement of the steam needle 22 along the axial direction limited by the sheath tube 3, the needle angle parameter θ represents the angle of rotational movement of the steam needle 22 in the cross-sectional direction, the needle depth parameter D represents the distance that the needle tip of the steam needle 22 extends from the steam needle outlet 220 in a direction roughly transverse to the axial direction, and the action range parameter R represents the steam action range.

[0070] The combination of needle position parameters (Z), needle angle parameters (θ), needle depth parameters (D) and action range parameters (R) of multiple needle points forms a set of treatment plan templates. The prefabricated treatment plan template library is a collection of multiple sets of treatment plan templates determined based on a large number of experiments.

[0071] In a preferred embodiment for ablation of prostate hyperplasia tissue, the needle exit points are set in a symmetrical distribution along both sides of the urethra axis to achieve a better resection effect. Taking the four-needle scheme as an example, the interval △Z of the needle exit position parameter Z of two adjacent needles is 1.5cm, the needle exit depth parameter D is set to 1.5cm, and the needle exit angle parameter θ is set to a symmetrical angle, such as the 4 and 8 o'clock directions, and the range parameter is 1cm. At the same time, doctors can manually adjust and modify the above four parameters and add or delete needle exit points.

[0072] Specifically, see Figure 3 In the horizontal plane image shown, the four needle exit points are the first point 11, the second point 12, the third point 13, and the fourth point 14. Each needle exit point has a corresponding action center position and ablation radius. During the treatment, the steam needle 22 is inserted into each point and the ablation operation is performed according to the corresponding parameters. Preferably, the four needle exit points are relative to Figure 2 The positions of the points can be adjusted according to the treatment needs. The circles around each point in the figure represent the ablation range of the steam needle 22 at the needle exit point. Specifically, the steam needle 22 has steam spray holes in the circumferential direction. During ablation, steam is sprayed from each spray hole to form a roughly spherical ablation area around the center of action of the steam needle 22. Figure 3 The radius of the middle circle is the ablation radius R corresponding to the needle exit point. The ablation radius R is actually the radius of the area of ​​action formed by the steam spraying outward from the needle hole of the steam needle 22 .

[0073] exist Figure 4In the sagittal image shown, the first point 11 and the second point 12 are distributed front and back, and the triangles in the figure represent the first sheath tube outlet 110 and the second sheath tube outlet 120 as the steam needle outlet 220, respectively. Taking the first sheath tube outlet 110 as an example, when it is necessary to insert into the first point 11, the steam needle 22 moves along the axial linear motion limited by the sheath tube 3 to the position of the first sheath tube outlet 110. If necessary, its rotation angle is determined and the steam needle 22 and the steam needle outlet 220 are adjusted, which will be described in detail below. Then the needle head of the steam needle 22 is controlled to extend from the steam needle outlet 220 and inserted into the first point 11. Similarly, when it is necessary to insert into the second point 12, the steam needle 22 moves along the axial linear motion limited by the sheath tube 3 to the position of the second sheath tube outlet 120, and then the needle head of the steam needle 22 is controlled to extend from the steam needle outlet 220 and inserted into the second point 12. The third point 13 and the fourth point 14 are also distributed front and back in the sagittal direction, and the meanings of their needle point parameters are similar to this, and will not be repeated.

[0074] In this embodiment, the portion of the steam needle 22 extending from the steam needle outlet 220 at the front end of the sheath 3 is bendable, that is, the steam needle is inserted into the first point 11 in a manner roughly transverse to the axial direction, and the size of the portion of the steam needle 22 extending from the sheath 3 is the needle length L, which is related to the needle depth parameter D. Generally speaking, the needle length L represents the lateral distance from the needle to the steam needle outlet 220, and the needle depth parameter D represents the lateral distance from the needle hole action center position near the needle to the steam needle outlet 220. For the same steam ablation needle, the relationship between D and L is determined, so D or L can be used as a parameter to characterize the lateral extension movement of the steam needle needle. The rectangular frame surrounding each point in the figure corresponds to the projection diagram of the ablation range on the sagittal plane.

[0075] exist Figure 5 In the cross-sectional image shown, the dotted vertical line OC is parallel to the Z axis, and the triangle at point O corresponds to the first sheath tube outlet 110. The first point 11 and the third point 13 are located on both sides of the vertical line OC, respectively, and are set at a specified angle with the vertical line OC, which is the rotation angle θ of the rotating steam needle 22 with the axis of the sheath tube 3 as the central axis. The steam needle 22 is inserted to the position of the first sheath tube outlet 110 together with the sheath tube 3, and rotates toward the side of the first point 11, and the needle extends from the steam needle outlet 220, and can be inserted into the first point 11; further, the steam needle is rotated toward the side of the third point 13, and the needle extends from the steam needle outlet 220, and can be inserted into the third point 13.

[0076] From the cross-sectional image, it can be seen that the principle of rotating the steam needle 22 to insert into the second point 12 and the fourth point 14 is similar to this. The steam needle 22 moves along the axial direction limited by the sheath tube 3 to the position of the second sheath tube outlet 120, and is rotated toward the side of the second point 12. The needle tip extends from the steam needle outlet 220 and can be inserted into the second point 12. Further, after the steam needle is rotated toward the side of the fourth point 14, the needle tip extends from the steam needle outlet 220 and can be inserted into the fourth point 14. The details will not be repeated here.

[0077] As can be seen from the foregoing, each needle exit point of the steam needle 22 has at least four key parameters, namely, needle exit position Z, needle exit depth D or needle exit length L, effective range R, and needle exit angle θ, which are used to implement ablation operations on different parts. These parameters can be preset in the treatment plan template. In the treatment plan template library, the included treatment plan templates all include the number of needle exit points and the corresponding preset parameters. Based on the number of needle exit points and the corresponding preset parameters, the total ablation volume of each treatment plan template can be estimated, and each treatment plan template can be classified for easy storage and call.

[0078] As mentioned above, and with reference to Figures 3 to 5 ,For two-dimensional images in different directions, based on the contour information of the target area 4 in the initial image, a suitable treatment plan template can be selected from the treatment plan template library to match it.

[0079] Furthermore, combined with Figure 3 , the contour of the target area 4 in the horizontal plane image can be segmented manually or by image algorithm, and the doctor can adjust the needle position Z and ablation radius R of the given template based on the contour of the target area 4. Figure 4 , the contour of the target area 4 in the sagittal image can be segmented manually or by image algorithm, and the doctor can adjust the needle position Z, needle depth D or needle length L, and range of action R of a given template based on the contour of the target area 4. Figure 5 The outline of the target area 4 in the cross-sectional image is segmented manually or by an image algorithm. The doctor can adjust the needle extraction depth D or needle extraction length L, the effective range R, and the needle extraction angle θ of a given template based on the outline of the target area 4.

[0080] Preferably, planning selection or scheme adjustment can be performed through a combination of sagittal images and cross-sectional images, or a combination of horizontal images and cross-sectional images, or a combination of sagittal images, cross-sectional images, and horizontal images to enhance the scientific nature of the planning. Template selection can also be performed in the three-dimensional image after three-dimensional reconstruction, and the number of treatment points of a given template, i.e., the number of needle points, needle position Z, needle angle θ, needle length L or needle depth D, range of action R and other parameters can be manually adjusted and confirmed. After the adjustment is completed, it is used as the preset parameters corresponding to each needle point, and the image planning trajectory of the treatment plan can be generated.

[0081] Furthermore, not only based on preoperative images, in a preferred embodiment, the level of target prostate tissue hyperplasia can be comprehensively obtained based on the patient's age, prostate volume, IPSS score table, etc., such as mild, moderate, and severe. A treatment plan and a schematic diagram are generated according to the level, and the schematic diagram contains information such as the outline of the target area 4 and treatment points. As an example, if the hyperplasia level is judged to be mild, 4 treatment points are generated, 6 treatment points are generated when it is moderate, and 8 treatment points are generated when it is severe. The default needle exit angle θ is the angle corresponding to the 4 o'clock and 8 o'clock directions symmetrically distributed relative to the vertical line OC on the cross section. The default needle exit length L is 8 mm for mild cases, and the ablation radius is 1.5 cm. The needle exit length L is 10 mm for moderate cases, and the ablation radius is 1.8 cm. The needle exit length L is 15 mm for severe cases, and the ablation radius (or range of action) is 2 cm. The generated schematic diagram may be only a sagittal image or other cross-sectional images. Taking the sagittal plane as an example, the target contour generated on this cross-sectional image may be an ellipse with a long axis of 3 cm and a short axis of 1 cm for mild cases, an ellipse with a long axis of 3.6 cm and a short axis of 2 cm for moderate cases, and an ellipse with a long axis of 4 cm and a short axis of 3 cm for severe cases. The above parameters are only examples and may be adjusted according to needs without specific limitation.

[0082] Next, combine Figure 6 The step S2 of steam needle image registration is described in detail. Figure 6 Schematic diagram of the virtual needle 21 and the vapor needle 22 in the sagittal image.

[0083] See also Figure 6 , a virtual needle 21 is generated, and a corresponding virtual needle image is obtained, and the virtual needle image is superimposed and displayed in the initial image. After the steam needle 22 is inserted into the target area 4, a real-time image of the target area 4 and a steam needle image corresponding to the steam needle 22 are obtained. In this embodiment, the real-time image is an ultrasonic image. After the steam needle is inserted into the target area 4, the real-time image of the target area 4 includes both the real-time image information of the target area 4 and the real-time image information of the steam needle 22.

[0084] Taking the sagittal ultrasound image as an example, the most distal end point of the steam needle 22 insertion direction, i.e., the most anterior point in the sagittal image, is set as the execution origin of the steam needle 22. The spatial position coordinates of the starting point and the ending point of the virtual needle 21 on the image can be fitted according to the coordinates of the treatment point. The position of the virtual needle 21 in the image can be obtained by solving an optimization algorithm such as a genetic algorithm.

[0085] Preferably, the virtual needle 21 is horizontally inserted into the target area 4 along the Y-axis direction from the rear side of the direction shown in the image, and the intersection range of the ablation range of the treatment point that can be generated by the virtual needle 21 and the planned ablation range of the treatment point adjusted by the doctor is maximized. In the actual operation process, a range threshold can be preset. When the intersection range of the two exceeds the range threshold, the virtual needle 21 can be considered to meet the requirements. For example, the ablation range of each treatment point mentioned above is an approximate sphere. When fitting the virtual needle 21, the intersection range of the sphere of the ablation range of the 4 treatment points that can be generated by the virtual needle 21 and the sphere of the planned ablation range of the 4 treatment points adjusted by the doctor is greater than the range threshold. In other words, the virtual needle when the ablation range of the treatment point that can be generated by the virtual needle and the planned ablation range of the treatment point adjusted by the doctor have the largest intersection range is used as the virtual needle 21 used in this application. In the scheme of setting the range threshold as a reference for fitting the virtual needle, the intersection area of ​​the virtual ablation range of the virtual needle and the planned ablation range is as large as possible.

[0086] Taking the target area 4 as the prostate as an example, when acquiring its real-time image, the sheath tube 3 containing the steam needle 22 can be observed through the endoscope to be inserted into the bladder neck position, and the sheath tube axis and the ultrasound axis position are adjusted to be in the same plane and parallel to each other as much as possible, so that the steam needle outlet 220 is vertically downward as the initial position, and the Z axis of the spatial physical coordinate system where the sheath tube 3 is located is aligned with the perpendicular line OC of the cross section, so as to be able to acquire a real-time ultrasound sagittal image containing the steam needle 22. By first adjusting the steam needle to a position roughly parallel to the sagittal plane, the control accuracy can be further improved.

[0087] When inserting the steam needle 22, the angle between it and the Y axis of the sagittal plane should be as small as possible, that is, less than the preset angle threshold. When the angle is zero, the steam needle 22 completely overlaps with the sagittal plane, but in actual operation, there is inevitably an angle between the two. Observing on the real-time image, the area near the intersection of the steam needle 22 and the sagittal plane is relatively bright because the two overlap more; the brightness is weaker towards the two ends of the steam needle 22 because the overlap is less. Therefore, the angle between the steam needle 22 and the sagittal plane can be observed and adjusted according to the gradient setting in the real-time image with the highlighted area of ​​the steam needle image as the center and gradually darkening towards the two ends of the steam needle image. If the highlighted area in the Y-axis direction is longer, it means that the steam needle 22 overlaps with the sagittal plane more, and its angle with the Y axis is relatively small; conversely, it means that the steam needle 22 overlaps with the sagittal plane less, or even only has one highlighted point, which means that its angle with the Y axis is relatively large. In the above manner, the steam needle can be easily adjusted to a position roughly parallel to the sagittal plane.

[0088] When the angle between the steam needle 22 and the Y-axis of the sagittal plane is smaller than a preset angle threshold, the image registration step is performed.

[0089] In one embodiment, after acquiring the real-time image of the prostate, the target area 4 is segmented manually or by an image algorithm and registered with the aforementioned initial image. Exemplarily, the real-time image is registered with the initial image, and the angle and scale of mutual registration between the two can be adjusted so that the contours of the prostate in the two images are basically aligned, and the first conversion matrix T1 of the pixel distance between the initial image coordinate system and the real-time image coordinate system is obtained, that is, after the registration is completed, the pixel distance in the initial image can be converted to the pixel distance of the intraoperative real-time image, and then the distance in the physical world corresponding to the pixel distance in the initial image can be obtained through the pre-obtained second conversion matrix T2 between the real-time image coordinate system and the physical space coordinate system.

[0090] After the contours of the prostate in the two images are aligned, there will inevitably be a deviation between the steam needle 22 and the virtual needle 21. It is necessary to adjust the position and / or posture of the real steam needle 22 in the urethra so that the steam needle image in the real-time image coincides with the virtual needle image in the initial image, that is, to achieve registration of the steam needle 22 and the virtual needle 21.

[0091] After the registration is completed, step S3, i.e., the parameter determination step, is further performed to establish a mapping relationship between the moving distance of the steam needle image in the real-time image and the moving distance of the virtual needle image in the initial image; at least based on the mapping relationship, the preset parameters of the needle exit point are converted into the execution parameters of the steam needle.

[0092] First, a mapping relationship between the moving distance of the steam needle image in the real-time image and the moving distance of the virtual needle image in the initial image is established. As an implementation method, the two are moved in the same direction by the same pixel distance in the real-time image and the initial image, and the scaling factor g is obtained according to the position deviation of the two.

[0093] Still taking the target area 4 as the prostate as an example, after the steam needle 22 and the virtual needle 21 are aligned, the steam needle outlets of the insertion ends of the steam needle 22 and the virtual needle 21 are both located at the position corresponding to the first point 11, and the Y-axis coordinate here is set as W1. The steam needle 22 is moved forward to the vicinity of the bladder neck or in the bladder, and the steam needle outlet image 220' of the insertion end of the steam needle 22 is marked on the real-time image. The Y-axis coordinate here is set as W0. At this time, the pixel distance moved by the steam needle 22 on the real-time image is d1 = W1-W0. Afterwards, the virtual needle 21 is controlled by software to move forward the same distance d1 in the initial image, and observe whether the steam needle 22 and the virtual needle 21 overlap at this time. If they overlap, it is considered that the alignment is completed. If the deviation is large, for example, greater than a certain threshold, it is necessary to mark the steam outlet position W0' of the insertion end of the virtual needle 21 in the initial image again, and obtain the distance scaling factor g = (W1-W0) / (W1-W0'). When the physical position of the steam needle 22 is moved later, the scaling factor g needs to be considered. After this step, the steam needle outlet image 220' of the steam needle 22 stays at the bladder neck position.

[0094] Afterwards, based at least on the aforementioned mapping relationship, i.e., the scaling factor g, the aforementioned preset parameters including the needle removal position Z, the needle removal angle θ, the needle removal length L or the needle removal depth D, and the effective range R are converted into execution parameters of the physical space of the steam needle 22 to control the steam needle 22 to perform the ablation operation.

[0095] The spatial physical coordinate system where the actuator containing the steam needle 22 is located is set as the X'Y'Z' coordinate system, where the X' axis, Y' axis, and Z' axis are parallel to the aforementioned X axis, Y axis, and Z axis, respectively. The execution needle position W_base is the linear physical position of the steam needle 22 in the sheath 3, the execution angle θ_base is the rotation angle of the steam needle 22 in the sheath 3, the execution needle length L_base is the physical distance that the steam needle 22 extends from the opening of the sheath 3, and the execution ablation radius R_base is the effective range after the steam is ejected. The actuator controls various movements of the steam needle according to the execution parameters in its spatial physical coordinate system X'Y'Z' coordinate system.

[0096] See also Figure 6, with the Y-axis coordinate corresponding to the first point 11 as W1. On the initial sagittal image, the end position W3 of the virtual needle 21 at the urethral orifice and bladder neck is taken as the origin. At this time, the pixel distance W1-W3 is the distance that the virtual needle 21 moves to the W1 position, that is, the linear physical position W_base of the virtual needle 21 corresponding to the first treatment point 11 in the sheath 3 = T2*|W1-W3|*g, where g is the scaling factor.

[0097] Figure 7 is a diagram showing the rotation angles that can be seen in cross-sectional images. Figure 7 , the ultrasonic stepper moves to the W1 and W2 positions, and alignment is achieved in each cross-section. Through the known calibration relationship, the steam outlet is automatically / manually marked on the cross-sectional image. At this time, θ1 is the preset rotation angle of the steam needle 22 corresponding to the first needle exit point 11, and the actual execution angle is θ_base=θ1. The execution needle exit length L_base=T2*L*gL of the needle exit point, and the execution ablation radius R_base=T2*R*gR, where L and R are the preset needle exit length and the preset range of action, respectively, and gL is the execution needle exit length coefficient, the numerator of which is the pixel distance after the needle exit length is executed in the planning image, and the denominator is the pixel distance after the needle exit length is adjusted in the planning image. gR is the ablation radius coefficient, the numerator of which is the pixel distance of the ablation radius in the planning image, and the denominator is the pixel distance after the ablation radius is adjusted in the planning image.

[0098] The present application also proposes a computer-readable storage medium on which a computer program is stored. When the program is executed by a processor, the method described in any embodiment of the present application is implemented.

[0099] In order to implement the method described in the aforementioned embodiment of the present application, the present application also proposes a device for determining execution parameters of a steam needle, characterized in that it includes the following modules: a needle exit point preset module, used to obtain an initial image of the target area 4, determine the number of needle exit points based on the initial image, and determine the preset parameters of each needle exit point, wherein the preset parameters of each needle exit point include the action center position and the ablation radius; a steam needle image registration module, used to obtain a virtual needle image of the steam needle, and superimpose the virtual needle image in the initial image for display; obtain a real-time image of the target area 4, wherein the real-time image contains the image information of the steam needle located in the target area 4; register the real-time image with the initial image; a parameter determination module, used to establish a mapping relationship between the moving distance of the steam needle image in the real-time image and the moving distance of the virtual needle image in the initial image; at least based on the mapping relationship, convert the preset parameters of the needle exit point into the execution parameters of the steam needle. The above modules are functional architecture modules and can be implemented by computer software.

[0100] The present application is described with reference to the flowcharts and / or block diagrams of the methods, devices (systems), and computer program products according to the embodiments of the present application. It should be understood that each process and / or box in the flowchart and / or block diagram, as well as the combination of the processes and / or boxes in the flowchart and / or block diagram, can be implemented by computer program instructions. These computer program instructions can be provided to a processor of a general-purpose computer, a special-purpose computer, an embedded processor, or other programmable data processing device to generate a machine, so that the instructions executed by the processor of the computer or other programmable data processing device generate instructions for implementing the processes in the flowchart and / or block diagram. Figure 1 A process or multiple processes and / or boxes Figure 1 A device that provides the functions specified in a block or multiple blocks.

[0101] These computer program instructions may also be stored in a computer-readable memory capable of directing a computer or other programmable data processing device to operate in a specific manner, so that the instructions stored in the computer-readable memory produce an article of manufacture comprising an instruction device, which implements the process Figure 1 A process or multiple processes and / or boxes Figure 1 A function specified in one or more boxes.

[0102] These computer program instructions can also be loaded onto a computer or other programmable data processing device so that a series of operating steps are executed on the computer or other programmable device to produce a computer-implemented process, thereby providing instructions for implementing the process. Figure 1 A process or multiple processes and / or boxes Figure 1 A step that specifies a function in one or more boxes.

[0103] Furthermore, the present application also proposes an electronic device, including a memory, a processor, and a computer program stored in the memory and executable on the processor, wherein the processor implements the method described in any embodiment of the present application when executing the computer program. In a typical configuration, the electronic device includes one or more processors (CPU), an input / output interface, a network interface, and a memory. The memory may include non-permanent memory in a computer-readable medium, a random access memory (RAM), and / or a non-volatile memory in the form of a read-only memory (ROM) or a flash memory (flash RAM). The memory is an example of a computer-readable medium.

[0104] As a computer-readable storage medium, the storage device can be used to store software programs, computer executable programs and module units, such as program instructions corresponding to the method in the embodiment of the present application. The storage device may mainly include a storage program area and a storage data area, wherein the storage program area may store an operating system, an application required for at least one function; the storage data area may store data created according to the use of the terminal, etc. In addition, the storage device may include a high-speed random access memory, and may also include a non-volatile memory, such as at least one disk storage device, a flash memory device, or other non-volatile solid-state storage device. In some instances, the storage device may further include a memory remotely arranged relative to the processor 620, and these remote memories may be connected via a network. Examples of the above-mentioned network include, but are not limited to, the Internet, an intranet, a local area network, a mobile communication network, and combinations thereof.

[0105] In summary, the steam ablation system provided by the present application directly heats the target area 4 by using high-temperature water vapor as a heat source, which can ensure that the tissue is hydrated during the operation and dehydration and carbonization will not occur. Moreover, the steam temperature can be precisely controlled through the method and / or device for determining the execution parameters of the steam needle provided by the present application. Furthermore, the method and device provided by the present application do not rely on complex navigation mechanisms and calibration processes such as optical magnetic navigation multi-axis robotic arms. Through a rapid calibration method based on a treatment plan template, the cost of using the equipment is reduced, and the preoperative planning and intraoperative treatment execution actions are quickly calibrated. During the operation, the doctor relies on handheld instruments to complete the entire process, and the entire surgical process is faster, more portable, and more flexible. In addition, through rapid preoperative or intraoperative calibration on the image planning module, the present application can also realize visual assisted operation, so that after the doctor inserts the steam needle, the ablation operation at each treatment point in the subsequent surgical process can be automatically performed. At the same time, the needle removal position parameters, needle removal angle parameters, needle removal depth parameters, and action range parameters can be accurately controlled to improve the accuracy of the treatment, while greatly shortening the doctor's operating time for adjusting the position, angle, etc., making the steam ablation operation safe and controllable.

[0106] It should be understood that the specific embodiments described above are only used to explain the present application, and the protection scope of the present application is not limited thereto. Any technical personnel familiar with the technical field can make changes, substitutions, and combinations within the technical scope disclosed in the present application according to the technical solution and application concept of the present application, which should be covered by the protection scope of the present application.

Claims

1. A steam ablation system, comprising: a steam actuator, an image planning module and a motion control module, characterized in that: The steam actuator includes a steam needle assembly. Under the drive control of the motion control module, the steam needle assembly can perform one or more of the following actions: the steam needle performs linear motion along the axial direction, the steam needle performs rotational motion in a cross section perpendicular to the axial direction, the needle tip of the steam needle extends from the steam needle outlet to the treatment site along a direction roughly transverse to the axial direction, and the steam is ejected from the steam outlet needle hole of the steam needle; the image planning module is used to determine planning parameters based on the preoperative initial image of the target area, the planning parameters include a preset number of needle exit points and preset parameters of each needle exit point, and the preset parameters of each needle exit point include one or more of the following parameters: a preset needle exit position of the steam needle, a preset needle exit angle of the steam needle, a preset needle exit length of the steam needle, and a preset steam action range; the motion control module is used to convert the planning parameters of the image planning module into execution parameters, and drive and control the steam needle assembly to act according to the execution parameters.

2. The vapor ablation system according to claim 1, characterized in that: The steam needle assembly further comprises a sheath tube, a steam needle outlet is arranged at the front end of the sheath tube, and the steam needle moves linearly along the axially extending channel defined by the sheath tube under the driving control of the motion control module.

3. The vapor ablation system according to claim 1, characterized in that: The image planning module selects a suitable treatment plan template from a treatment plan template library to match the contour information of the target area in the initial image, and determines the planning parameters based on the selected treatment plan template.

4. The vapor ablation system according to claim 1, characterized in that: The image planning module generates a treatment plan and a schematic diagram according to the level of target tissue proliferation.

5. The vapor ablation system according to claim 1, characterized in that: The system also acquires a virtual needle image of the vapor needle, and displays the virtual needle image superimposed on the initial image.

6. The vapor ablation system according to claim 5, characterized in that: The system also acquires a real-time image of the vapor needle inserted into the target area, and substantially aligns the real-time image with the target tissue contour in the initial image, so that the vapor needle in the real-time image overlaps with the virtual needle image in the initial image.

7. The vapor ablation system according to claim 6, characterized in that: The system also establishes a mapping relationship between the moving distance of the vapor needle image in the real-time image and the moving distance of the virtual needle image in the initial image.

8. The vapor ablation system according to claim 1, characterized in that: The steam actuator further comprises a handle assembly, wherein the handle assembly is attached to the steam needle, and the movement of the steam needle and the release of steam can be controlled by manipulating the handle assembly.

9. The vapor ablation system according to claim 1, characterized in that: The motion control module includes a linear motion control submodule, a rotational motion control submodule, a depth control submodule, and an action range control submodule. The linear motion control submodule includes a linear motion drive motor and a linear motion transmission component, which are used to control the linear motion of the steam needle along the axial direction; the rotational motion control submodule, for example, includes a rotational motion drive motor and a rotational motion transmission component, which are used to control the rotational motion of the steam needle in the cross section; the depth control submodule includes a drive motor and an actuator mechanism, which are used to control the movement of the needle tip of the steam needle from the steam needle outlet along a direction roughly transverse to the axial direction to the treatment site; the action range control submodule includes a steam control mechanism and an actuator mechanism, which are used to control the steam action range by adjusting parameters such as steam temperature, pressure, action time, and speed.

10. The vapor ablation system according to claim 1, characterized in that: The system further comprises an ultrasonic stepper module, which comprises an ultrasonic probe and a stepper device for driving the ultrasonic probe to perform linear and / or rotational motion.

Images