An axisymmetric diagnosis and treatment device, a control method thereof, and a computer program

Abstract

The application discloses an axisymmetric diagnosis and treatment device and a control method and a computer program thereof, and applies to the technical field of medical instruments.The axisymmetric diagnosis and treatment device comprises a catheter main body, an axisymmetric component arranged at the distal end of the catheter main body, the axisymmetric component being configured to assume a contracted state or an expanded state, a plurality of energy transmission components arranged on the surface of the axisymmetric component, each energy transmission component being arranged in a circumferential uniform interval from each other when the axisymmetric component is in the expanded state, so as to transmit energy to a target site for diagnosis and treatment, a plurality of developing marks arranged on the surface of the axisymmetric component, the form of each developing mark regularly changing with the change of longitude, and any energy transmission component having a unique developing mark matched therewith. The scheme of the application can effectively assist an operator in identifying and positioning different energy transmission components and reflecting the actual pose of the axisymmetric component, so as to assist the operator in performing targeted adjustment and supplementary diagnosis and treatment, and improve safety and effectiveness.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to an axisymmetric diagnosis and treatment device, a control method thereof and a computer program. BACKGROUND

[0002] X-ray fluoroscopy is a common method for displaying the position and direction of an operating instrument in the human body. Due to the imaging principle of X-rays, a 3-dimensional structure is projected as a 2-dimensional planar image, so that the corresponding 3-dimensional structure needs to be imagined and reconstructed by means of the difference between planar images at different angles, and then the next operation is performed to achieve the intended surgical purpose. The prior art has great limitations when this method is applied to axisymmetric instruments, especially for spherical instruments (such as balloons, baskets) and energy transmission components (such as electrodes) uniformly distributed on the spherical instruments, because the 2-dimensional planar images at different angles obtained by X-ray fluoroscopy imaging at different angles are roughly the same, and the operator has difficulty in distinguishing and reconstructing the spatial position and relative position relationship of the energy transmission components on the spherical instrument, especially in confusing the front hemisphere (the side facing the operator) and the back hemisphere (the side facing away from the operator), and it is even more impossible to accurately display the relative position relationship between the spherical instrument and the surrounding structure.

[0003] When the operator needs to adjust the spherical instrument by rotation or perform further diagnosis and treatment on the external structure at a specific orientation, the prior art can only ensure the diagnosis and treatment effect by increasing the diagnosis and treatment time and the number of diagnosis and treatment due to the difficulty in distinguishing and identifying the orientation of each energy transmission component, which is easy to cause undesirable effects on non-target tissues and cannot balance safety and effectiveness.

[0004] In summary, how to effectively assist the operator in positioning the position of the energy transmission component and distinguishing the orientation when using the axisymmetric instrument, assist the operator in targeted adjustment and supplementary diagnosis and treatment, and improve safety and effectiveness are technical problems that need to be solved by the technical personnel in the field at present. SUMMARY

[0005] The purpose of the present application is to provide a control method of an axisymmetric diagnosis and treatment device, a computer program product and an axisymmetric diagnosis and treatment device, so as to effectively assist the operator in recognizing and positioning the axisymmetric diagnosis and treatment device, and to ensure accuracy.

[0006] To solve the above technical problems, the present application provides the following technical solutions:

[0007] In a first aspect, the present application provides an axisymmetric diagnosis and treatment device, comprising: a catheter body; an axisymmetric component arranged at a distal end of the catheter body, the axisymmetric component being configured to assume a contracted state or an expanded state; a plurality of energy transmission components arranged on a surface of the axisymmetric component, each of the energy transmission components being arranged in a circumferential uniform interval with each other when the axisymmetric component is in the expanded state, so as to transmit energy to a target site for diagnosis and treatment; a plurality of visualization markers arranged on the surface of the axisymmetric component, a form of each of the visualization markers regularly changing with a change in longitude, and any of the energy transmission components having a unique visualization marker matched therewith.

[0008] In an embodiment, the form of each of the visualization markers regularly changes with a change in longitude, and the form of each of the visualization markers regularly changes with a change in longitude.

[0009] The number of the visualization markers is N, N is not less than 4, and a length, an end position, a scaling factor or an area of the first visualization marker to the Nth visualization marker gradually increases or decreases.

[0010] In an embodiment, each of the visualization markers is a continuous pattern or a discontinuous pattern, and each of the visualization markers is arranged in an interval or in a joint.

[0011] In an embodiment, each of the visualization markers is a strip-shaped visualization marker, and lengths of different visualization markers are different from each other, and the visualization marker with the maximum length extends to an equator line of the axisymmetric component.

[0012] In an embodiment, each of the visualization markers has a same common end, and the common end is a north pole end of the axisymmetric component or a south pole end of the axisymmetric component.

[0013] In an embodiment, the axisymmetric component is a balloon, the visualization markers include first visualization markers formed by a visualization material arranged in the balloon, the visualization markers include second visualization markers connected to the energy transmission components, any of the energy transmission components has a unique first visualization marker and a unique second visualization marker matched therewith, and the second visualization marker has a higher visualization intensity than the first visualization marker.

[0014] In an embodiment, further comprising an insulating base layer for connecting the axisymmetric component and the energy transmission components, and the plurality of visualization markers are embedded in the insulating base layer, or the visualization markers are visualization materials mixed in the insulating base layer.

[0015] In an embodiment, the axisymmetric component is a balloon, the energy transmission components are arranged on a side surface of the balloon and are in a strip shape, and a proximal end of at least one of the visualization markers overlaps a proximal end of the energy transmission component.

[0016] In a second aspect, the present application provides a control method of an axisymmetric diagnosis and treatment device, the axisymmetric diagnosis and treatment device being the axisymmetric diagnosis and treatment device of any one of the first aspect; comprising: placing the axisymmetric component at the target site through the catheter main body; obtaining a radiographic image of the axisymmetric component and displaying the radiographic image; rotating the axisymmetric component, and synchronously rotating a plurality of developing markers whose shapes change regularly with the change of longitude; reflecting the actual pose of the rotated axisymmetric component according to the plurality of developing markers of the radiographic image displayed after rotation; and controlling the matched energy transmission component to work based on all or part of the developing markers.

[0017] In an embodiment, reflecting the actual pose of the rotated axisymmetric component according to the plurality of developing markers of the radiographic image displayed after rotation specifically comprises: identifying the position of an extreme developing marker in the plurality of developing markers; dividing the plurality of developing markers into front developing markers and back developing markers according to the change trend between the developing markers adjacent to the extreme developing marker and the extreme developing marker; and prompting the number of the energy transmission component matched with each developing marker based on the front developing markers and the back developing markers.

[0018] In an embodiment, according to the plurality of developing markers of the radiographic image displayed after rotation, each developing marker or the generated axisymmetric component model is subjected to coloring processing on the radiographic image according to a preset color display rule, and / or the position of the equator is calculated and displayed on the radiographic image according to the radiographic image.

[0019] In an embodiment, the matched energy transmission component is controlled to work based on all or part of the developing markers to perform diagnosis and treatment of the target site, specifically comprising: when no directional discharge instruction is received, controlling each energy transmission component in the axisymmetric diagnosis and treatment device to be in a working state; and when a directional discharge instruction is received, controlling the energy transmission component specified by the directional discharge instruction to be in a working state.

[0020] In a third aspect, the present application provides a computer program product comprising computer programs / instructions, which, when executed by a processor, implement the steps of the control method of the axisymmetric diagnosis and treatment device of any one of the second aspect.

[0021] By means of the technical scheme provided by the embodiment of the application, the axisymmetric diagnosis and treatment device comprises a catheter main body, an axisymmetric component arranged at the distal end of the catheter main body, and a plurality of energy transmission components arranged on the surface of the axisymmetric component, each energy transmission component is arranged in a circumferential uniform interval when the axisymmetric component is in an expanded state, so that energy can be transmitted to a target site for diagnosis and treatment, the repair of the body can be effectively realized, for example, when ablation is performed, the tissue near the ablation area can be not damaged, and the heat sinking effect of the ablation area can be avoided. Moreover, the positions of each visualization marker correspond one-to-one to the positions of each energy transmission component, therefore, the operator only needs to identify each visualization marker from the radiographic image, and the positions of each energy transmission component can be determined. Furthermore, in order to help the operator effectively identify the positions of each visualization marker, in the scheme of the application, the shapes of each visualization marker change regularly with the change of longitude, therefore, the operator can not only conveniently identify each visualization marker by watching the radiographic image, but also can distinguish the orientations of different energy transmission components based on the relative position relationship of different visualization markers in the radiographic image, effectively determine whether each visualization marker is in a front surface or a back surface, and is not prone to errors. Since each visualization marker can be conveniently identified, even if rotation is performed during the operation, the operator can still accurately know the actual pose of the axisymmetric component and the spatial positions of each energy transmission component on the axisymmetric component after rotation. In summary, the scheme of the application can effectively assist the operator in identifying and positioning different energy transmission components and reflecting the actual pose of the axisymmetric component, assist the operator in targeted adjustment and supplementary diagnosis and treatment, and improve safety and effectiveness. BRIEF DESCRIPTION OF DRAWINGS

[0022] In order to more clearly illustrate the technical scheme in the embodiments of the application or the prior art, the drawings needed to be used in the embodiments or the prior art description will be briefly introduced below. Obviously, the drawings in the following description are only some embodiments of the application, and other drawings can be obtained by those skilled in the art without creative labor.

[0023] Figure 1 A structure schematic diagram of the axisymmetric diagnosis and treatment device provided by one specific embodiment of the application;

[0024] Figure 2 A partial schematic diagram of the balloon-shaped end portion of the axisymmetric diagnosis and treatment device provided by one specific embodiment of the application;

[0025] Figure 3 A partial schematic diagram of the mesh basket-shaped end portion of the axisymmetric diagnosis and treatment device provided by another specific embodiment of the application;

[0026] Figure 4 A top view of the north pole side of the balloon-shaped axisymmetric component in one specific embodiment of the application;

[0027] Figure 5 Fig. 6 is a plan view of the north side of the basket-shaped axisymmetric component of one embodiment of the present application;

[0028] Figure 6a Fig. 7 is a plan view of the axisymmetric component of one embodiment of the present application;

[0029] Figure 6b Fig. 8 is a front view of the axisymmetric component of one embodiment of the present application;

[0030] Figure 7a Fig. 9 is a plan view of the axisymmetric component of another embodiment of the present application;

[0031] Figure 7b Fig. 10 is a front view of the axisymmetric component of another embodiment of the present application;

[0032] Figure 8a Fig. 11 is a projection diagram of the axisymmetric component of one embodiment of the present application, in which the X-axis and Y-axis are each rotated by 0°, and the Z-axis is rotated by 0°;

[0033] Figure 8b Fig. 12 is a projection diagram of the axisymmetric component of one embodiment of the present application, in which the X-axis and Y-axis are each rotated by 0°, and the Z-axis is rotated by 30°;

[0034] Figure 8c Fig. 13 is a projection diagram of the axisymmetric component of one embodiment of the present application, in which the X-axis and Y-axis are each rotated by 0°, and the Z-axis is rotated by 60°;

[0035] Figure 8d Fig. 14 is a projection diagram of the axisymmetric component of one embodiment of the present application, in which the X-axis and Y-axis are each rotated by 0°, and the Z-axis is rotated by 90°;

[0036] Figure 9a Fig. 15 is a projection diagram of the axisymmetric component of one embodiment of the present application, in which the X-axis is rotated by 0°, the Y-axis is rotated by 30°, and the Z-axis is rotated by 0°;

[0037] Figure 9b Fig. 16 is a projection diagram of the axisymmetric component of one embodiment of the present application, in which the X-axis is rotated by 0°, the Y-axis is rotated by 30°, and the Z-axis is rotated by 30°;

[0038] Figure 9c Fig. 17 is a projection diagram of the axisymmetric component of one embodiment of the present application, in which the X-axis is rotated by 0°, the Y-axis is rotated by 30°, and the Z-axis is rotated by 60°;

[0039] Figure 9d Fig. 18 is a projection diagram of the axisymmetric component of one embodiment of the present application, in which the X-axis is rotated by 0°, the Y-axis is rotated by 30°, and the Z-axis is rotated by 90°;

[0040] Figure 10 The flow chart of the control method of the axis-symmetry diagnosis and treatment device in one embodiment of the present application;

[0041] Figure 11 The principle diagram of the diagnosis and treatment in one embodiment of the present application;

[0042] Figure 12 The diagram of numbering each developing mark in one embodiment of the present application;

[0043] Figure 13a The projection when the X-axis and the Z-axis of the axis-symmetry component are both rotated by 0° and the Y-axis is rotated by 30° in one embodiment of the present application;

[0044] Figure 13b The projection when the X-axis and the Z-axis of the axis-symmetry component are both rotated by 0° and the Y-axis is rotated by 60° in one embodiment of the present application;

[0045] Figure 13c The projection when the X-axis and the Z-axis of the axis-symmetry component are both rotated by 0° and the Y-axis is rotated by 90° in one embodiment of the present application;

[0046] Figure 14 The diagram of each developing mark being irregular shape in one embodiment of the present application;

[0047] Figure 15 The diagram of each developing mark being non-continuous pattern in one embodiment of the present application. EMBODIMENT

[0048] The core of the present application is to provide an axis-symmetry diagnosis and treatment device and its control method, computer program, which can effectively assist the operator to identify and position different energy transmission components and reflect the actual pose of the axis-symmetry component, assist the operator to make targeted adjustment and supplementary diagnosis and treatment, and improve the safety and effectiveness.

[0049] For those skilled in the art, the present application will be further described in detail below with reference to the accompanying drawings and specific embodiments. In the specific embodiments, the distal end refers to the part of the corresponding component that is far away from the operator, usually the end of the component that enters the patient's body or the surgical area, and the proximal end refers to the part of the corresponding component that is close to the operator, usually the end that the operator holds or operates. For a single component, the end closer to the operator is the proximal end, and the end farther away from the operator is the distal end. In addition, in the present application, unless otherwise specified and limited, the terms "mounting", "connecting", "connecting", "fixing" and the like should be understood broadly, for example, they can be fixedly connected, or detachably connected, or integrally connected; they can be mechanically connected, or electrically connected; they can be directly connected, or indirectly connected through an intermediate medium, or they can be connected inside two elements. For those skilled in the art, the specific meanings of the above terms in the present application can be understood according to the specific circumstances. Obviously, the described embodiments are only a part of the embodiments of the present application, not all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the present application.

[0050] Please refer to Figure 1 and Figure 2 , Figure 1 The structure diagram of the axisymmetric diagnosis and treatment device provided by a specific embodiment of the present application is shown in Figure 2 The partial diagram of the end of the axisymmetric diagnosis and treatment device is shown in. The axisymmetric diagnosis and treatment device can include:

[0051] The catheter body 10;

[0052] The axisymmetric component 20 arranged at the distal end of the catheter body 10, which is configured to assume a contracted state or an expanded state;

[0053] The plurality of energy transmission components 30 arranged on the surface of the axisymmetric component 20, each energy transmission component 30 being arranged in a circumferential uniform interval with each other when the axisymmetric component 20 is in the expanded state, so as to transmit energy to the target site for diagnosis and treatment;

[0054] The plurality of imaging markers 40 arranged on the surface of the axisymmetric component 20, the form of each imaging marker 40 regularly changes with the change of longitude, and any energy transmission component 30 has a unique imaging marker matched therewith.

[0055] The above diagnosis and treatment device includes a diagnosis device and a treatment device. When an axisymmetric device needs to be applied (such as a balloon or a basket catheter), such as obtaining a diagnostic image, identifying a biological potential, generating an electric stimulus, generating radio frequency energy, and generating an ablation electric field, when the energy transmission component as a whole works, and rotation or rework of part of the component is needed, accurate position positioning and pose recognition can be performed through the device and method. The following is a specific description of the application of pulsed electric field ablation, but it does not mean that the protection of this patent is limited to the scope of pulsed electric field ablation, but is not limited to this. Any axisymmetric device for energy transmission component position positioning and orientation recognition can apply to this case. Any adaptive application by those skilled in the art under the guidance of this application is within the protection scope of this case.

[0056] For example, in a cardiac intervention surgery, an axisymmetric diagnosis and treatment device that achieves ablation through pulses uses the principle of pulsed ablation electric field. By applying a pulsed voltage between two electrodes, the original membrane potential of the cells can be changed to produce irreversible nanoscale holes, thereby destroying the steady state of the cells and causing cell death. Because this ablation method only causes cell death in a specific area, while preserving the integrity of the cell tissue scaffold, fiber structure, etc., and the tissue near the ablation area is not damaged, avoiding the heat sink effect of the ablation area, it is beneficial to the repair of the body and has been widely used. In pulmonary vein ablation, the application of pulsed ablation requires a circumferential closed-loop ablation band to isolate the abnormal potential caused by the lesion of the pulmonary vein myocardial tissue. In actual application, some patients may not form a circumferential ablation band after the overall ablation of the axisymmetric diagnosis and treatment device due to the irregularity and unevenness of the patient's own tissue, the different degree of adhesion to the axisymmetric diagnosis and treatment device, the different feedback or sensitivity to the axisymmetric diagnosis and treatment device, etc. In order to strengthen the ablation of the insufficient part, the axisymmetric instrument can be rotated to change the electric field strength of the part that needs to be strengthened, or only the energy transmission component near the part that needs to be strengthened can be started to perform targeted ablation, so as to avoid multiple overall ablations to make up for the insufficient ablation of the part, and balance safety and effectiveness.

[0057] Specifically, the catheter body 10 can be moved under the operation of the operator, and the specific shape and structure can be set and adjusted according to actual needs, as long as the required corresponding functions can be realized under the operation of the operator.

[0058] It can be understood that the axisymmetric component 20 can be a basket or a balloon, and the shape thereof has the attribute of axisymmetry. If a plurality of energy transmission components are uniformly spaced in the circumferential direction at an interval of 36°, then rotating in situ by 36° will result in a specific position of an energy transmission component (for example, numbered a) being replaced by another energy transmission component (for example, numbered b) adjacent to the energy transmission component. To describe each position on the axisymmetric component 20, the axisymmetric component can be represented by longitude and latitude, wherein a meridian represents a line connecting a point on the surface of the axisymmetric component 20 to the distal end and the proximal end of the axis of symmetry, and the longitude represents the angle between the meridian and the plane of the 0-degree meridian, similar to the division logic of the longitude and latitude of the Earth. At the same time, the axisymmetric component is defined to have an equator, which is generally a cross section perpendicular to the axis of symmetry and passing through the center of the rotating body. The line is a collection of points on the rotating body farthest from the axis of symmetry, similar to the position of the Earth's equator relative to the Earth's axis. Accordingly, the parallel is a closed curve perpendicular to the axis of symmetry and parallel to the equator, and the latitude represents the angle between the line connecting a point on the surface of the axisymmetric component 20 to the center of the axis of symmetry and the equator plane. In this application, in order to facilitate the regular change of longitude, the longitude and latitude can be represented by one-dimensional linear elements, respectively.

[0059] In addition, it can be understood that "the shape changes regularly with the longitude" indicates that the core of the change between different visualization markers is that the shape (rather than only the position) of the visualization marker changes as a function of the longitude, and the geometric profile (such as the shape type or boundary) of the visualization marker changes continuously with the longitude, and the change follows a mathematical rule. The shape change is reflected in the deformation of the shape itself (for example, from a circle to an ellipse), for example, the basic shape (such as a circle or a square) of the visualization marker does not change, but its shape attribute changes regularly with the longitude (such as diameter, length, end position, area). The shape change mainly reflects in "size", rather than shape type.

[0060] The axisymmetric component 20 is arranged at the distal end of the catheter body 10 and can be controlled to present a contracted state or an expanded state. Since it is applied to sites such as the ostium of the pulmonary vein, the axisymmetric component 20 is generally spherical, for example, the shape of the axisymmetric component 20 can be specifically balloon-shaped or basket-shaped, so that energy can be conveniently transmitted to the surrounding for diagnosis and treatment. Of course, in specific occasions, the specific shape and size of the axisymmetric component 20 can be adjusted according to actual needs. The balloon-shaped axisymmetric component 20 is shown in Figure 2 , and the basket-shaped axisymmetric component 20 is shown in Figure 3 . In addition, the axisymmetric components 20 shown in Figure 2 and Figure 3 are in the expanded state. In actual application, the axisymmetric diagnosis and treatment device is usually configured to present a contracted state before reaching the target site, and is configured to present an expanded state after reaching the target site so as to diagnose and treat the target site.

[0061] A plurality of energy transmission components 30 are arranged on the surface of the axisymmetric component 20, and the specific number can be set as required. Generally, two adjacent energy transmission components 30 constitute a pair of positive and negative energy transmission components. The energy transmission components 30 are uniformly spaced from each other when the axisymmetric component 20 is in an expanded state, so that energy can be transmitted to the surrounding area to achieve diagnosis and treatment of the target site. During diagnosis and treatment, the energy transmission components 30 usually transmit pulse energy, and the pulse period, amplitude, and other circuit parameters of the pulse signal used can be set and adjusted as required on the basis of safety to achieve the desired diagnosis and treatment effect.

[0062] In the present application, the energy transmission components 30 are circumferentially and uniformly spaced from each other when the axisymmetric component 20 is in an expanded state. Circumferentially and uniformly spaced means that the energy transmission components 30 have a stable spacing on the surface of the axisymmetric component 20, without limiting the shape of the energy transmission components 30. For example, the energy transmission components 30 can be Figure 2 In this way, each energy transmission component 30 is arranged along the corresponding meridian, that is, perpendicular to the latitude line, but in other embodiments, it can not be completely perpendicular to the latitude line, that is, it can have other angles with the latitude line.

[0063] In the present application, in order to facilitate the operator to identify and position the axisymmetric diagnosis and treatment device, that is, to effectively position the energy transmission components 30 and distinguish their orientations, a plurality of developing marks 40 are arranged on the surface of the axisymmetric component 20. The shape of each developing mark 40 changes regularly with the change in longitude, and each energy transmission component 30 has a unique developing mark matched therewith. In this way, in the radiographic image, the operator can intuitively and accurately determine the spatial position of each developing mark 40 by observing the regular change in the pattern of each developing mark 40 shown in the radiographic image, and is less likely to make mistakes and confuse the front and back hemispheres. Since each energy transmission component 30 has a unique developing mark matched therewith, the position of each developing mark 40 is obtained, which means that the position of each energy transmission component 30 can be determined, thereby providing assistance for the operator to control the axisymmetric diagnosis and treatment device.

[0064] In some embodiments, when the pattern of each developing mark 40 changes regularly with the change in longitude, the specific implementation can have various forms, such as regular change in length (e.g., the length of each developing mark increases or decreases with the increase in longitude, which can be referred to in Figures 2-5 ), regular change in end position (e.g., the latitude of the proximal end or distal end of each developing mark gradually increases or decreases, which can be referred to in Figures 2-5), regular change in scaling coefficient (e.g. multiple imaging marks are constituted by a series of similar patterns with different scaling coefficients, the scaling coefficient increases or decreases with the increase of longitude), regular change in area (e.g. multiple imaging marks are constituted by a series of different patterns, the area of each pattern increases or decreases with the increase of longitude, which can be referred to Figure 14

[0065] In actual application, the specific position of each imaging mark 40 can be set according to the need, which can be matched with the position of the corresponding energy conducting component 30. For example, any imaging mark 40 can be arranged around the corresponding energy conducting component 30, or the imaging mark 40 can be overlapped with the corresponding energy conducting component 30 in the direction perpendicular to the surface of the axisymmetric component 20, as long as the position of the corresponding energy conducting component 30 can be accurately determined when the position of each imaging mark 40 in space is known. For example, in an embodiment, the position of any imaging mark 40 is on the same meridian as the corresponding energy conducting component 30, which is the embodiment usually used in the actual application of the present application.

[0066] In addition, since the imaging mark 40 needs to be developed in the radiographic image, the imaging mark 40 can be realized by using a developable material, and the specific material can be set according to the actual need.

[0067] In a specific embodiment of the present application, the regular change of the pattern of each imaging mark 40 with the change of longitude includes that the number of imaging marks 40 is N, N is not less than 4, and the length, end position, scaling coefficient or area of the first imaging mark 40 to the Nth imaging mark 40 gradually increases or decreases.

[0068] This embodiment takes into account that the longitude has a change range of 360°, and in order to enable the operator to accurately position the position of each energy conducting component 30 based on the position of each imaging mark 40, especially to realize circumferential ablation, the number of energy conducting components 30 and imaging marks 40 cannot be too low, and is usually at least 4, so that the operator cannot easily confuse the position of each energy conducting component 30 on the front and rear hemispheres.

[0069] In this embodiment, the length, end position, scaling coefficient or area can be used to realize the regular change of the pattern of each imaging mark 40 with the change of longitude, which ensures high flexibility.

[0070] ​If the length of the 1st developing mark 40 to the Nth developing mark 40 gradually increases or decreases, in order to facilitate the surgeon to identify, the starting point of each developing mark 40 is usually consistent, for example, can be the north pole end of the axisymmetric component 20 or the south pole end of the axisymmetric component 20, and due to the different lengths of different developing marks 40, the end position of each developing mark 40 can change regularly with the change of longitude.

[0071] If the end position of the 1st developing mark 40 to the Nth developing mark 40 gradually increases or decreases, in order to facilitate the surgeon to identify, the length and shape of each developing mark 40 is usually consistent, and through the regular change of the end position with the change of longitude, the surgeon can effectively determine the spatial position of each developing mark 40.

[0072] If the scaling factor of the 1st developing mark 40 to the Nth developing mark 40 gradually increases or decreases, or the area of the 1st developing mark 40 to the Nth developing mark 40 gradually increases or decreases, the shape and / or length of each developing mark 40 will change regularly with the change of longitude, and the surgeon can also conveniently determine the spatial position of the developing mark 40.

[0073] For easy understanding, please refer to Figure 2 the balloon-shaped axisymmetric component 20 shown in Figure 3 the basket-shaped axisymmetric component 20 shown in. In Figure 2 and Figure 3 , each energy conducting component 30 is uniformly spaced from each other when the axisymmetric component 20 is in the expanded state, which can effectively achieve circumferential treatment. And each developing mark 40 is a strip-shaped developing mark, according to the different positions of each energy conducting component 30, each developing mark 40 is arranged at the meridian position where the corresponding energy conducting component 30 is located, thereby realizing the matching of each energy conducting component 30 and the corresponding developing mark 40.

[0074] For easy understanding, please refer to Figure 4 and Figure 5 , Figure 4 the top view of the north pole side of the balloon-shaped axisymmetric component 20 of Figure 2 , Figure 5 the top view of the north pole side of the basket-shaped axisymmetric component 20 of Figure 3 . It should be noted that the north pole side described here refers to the side of the axisymmetric component 20 away from the catheter body 10 (i.e. the distal end), Figure 4 and Figure 5 , the north pole end is the common end of each developing mark 40, and accordingly, the south pole side refers to the side of the axisymmetric component 20 close to the catheter body 10 (i.e. the proximal end).

[0075] In Figure 4In the example, when the axisymmetric component 20 is in the expanded state, the energy conducting components 30 are evenly spaced from each other, that is, evenly arranged at different meridian positions of the axisymmetric component 20. In order to ensure a better diagnosis and treatment effect, each energy conducting component 30 can be specifically in the shape of a fishbone or a strip. Figure 4 In the example shown, there are a total of 10 energy conducting components 30. Of course, in other specific occasions, each energy conducting component 30 can be set to other shapes as needed. Figure 4 In the example, each energy conducting component 30 is attached to the outer surface of the axisymmetric component 20 , for example, can be attached to the substrate on the outer surface of the axisymmetric component 20 .

[0076] from Figures 2 to 5 It can be seen that the lengths of the first development mark 40 to the Nth development mark 40 gradually increase or decrease, and such regular changes can be easily recognized by the operator, thereby realizing the spatial positioning of each development mark 40, and each development mark 40 is matched with the corresponding energy conduction component 30, which means that the operator can easily determine the current spatial position of each energy conduction component 30.

[0077] See Figure 14 In this example, the scaling factors of the first to the Nth development marks 40 gradually increase or decrease, so that as the longitude changes, the shape and length of each development mark 40 change regularly, and the operator can easily determine the spatial position of the development mark 40. In addition, it can be seen that Figure 14 Each of the development marks 40 in this example has an irregular shape.

[0078] Furthermore, in a specific embodiment of the present invention, each development mark 40 can be a continuous pattern or a discontinuous pattern (see Figure 15 ), the developed marks 40 can be spaced or joined. This approach can be combined with the aforementioned changing trends of gradually increasing or decreasing length, endpoint position, scaling factor, or area. That is, the length is discontinuous and the shape is divided into multiple pieces, with the characteristic of regular changes with longitude, thus providing a richer and more flexible setting.

[0079] This embodiment takes into account that the present application scheme regularly changes the shape of the development mark 40 with the longitude, so that the operator can locate the spatial position of each development mark 40 accordingly. However, the present application scheme does not limit the specific shape of the development mark 40. In this embodiment, each development mark 40 can be a continuous graphic or a non-continuous graphic, and the development marks 40 can be set at intervals or in a connected manner, which fully guarantees the implementation flexibility of the present application scheme.

[0080] For example, the aboveFigure 2 , Figure 3 as well as Figure 12 In the example, each developing mark 40 is a continuous pattern, which can be seen in Figure 15 ,exist Figure 15 In the example, each development mark 40 is a discontinuous graphic. Since the length of each development mark 40 (since it is a discontinuous graphic, its length can be regarded as the total length of each segment of the continuous graphic, or its length can be regarded as the distance between the two farthest endpoints in the graphic of the development mark 40) changes regularly with the longitude, the operator can easily determine the spatial position of each development mark 40.

[0081] In addition, in the above examples, the development marks 40 are spaced apart from each other. In some embodiments, the development marks 40 may be joined together as long as they can show regular changes with the longitude.

[0082] In a specific embodiment of the present invention, each development mark 40 is a strip-shaped development mark 40 , and the lengths of different development marks 40 are different. The development mark with the longest length extends to the equator of the axisymmetric component.

[0083] This embodiment further takes into account that the axisymmetric diagnosis and treatment device is relatively small in size and needs to be provided with structures such as the energy conduction component 30, so that there is not much space for arranging the development mark 40. In addition, considering that the axisymmetric component 20 needs to shrink / expand, the development mark 40 should not be too large or too complicated. In this regard, this embodiment takes into account that each development mark 40 can be a strip-shaped development mark 40, which has a simple structure, does not take up too much space, and is not easy to affect the contraction / expansion function of the axisymmetric component 20. Since the position of each development mark 40 needs to correspond to the position of the corresponding energy conduction component 30, so as to achieve a unique match between the energy conduction component 30 and the corresponding development mark 40, in this embodiment, for each strip-shaped development mark 40, the lengths of different development marks 40 are different, so that the operator can realize the spatial positioning of each development mark 40 based on the lengths of different development marks 40 in the ray projection diagram. In the above Figures 2 to 5 In all of them, this implementation method is adopted. For example, in the above Figure 4 and Figure 5 In the figure, each development mark 40 is a strip-shaped development mark 40. When viewed from above the axisymmetric component 20, starting from the development mark 40 with the shortest length, the lengths of the development marks 40 increase in a clockwise direction.

[0084] The longest of the radiographic markers extends to the equator of the axisymmetric component, otherwise if the longest radiographic marker extends beyond the equator and the relatively shorter radiographic markers extend to near the equator, even if there is a certain difference in length between the two, when the ray projection is just from the north pole side to the south pole side, the length of the longest radiographic marker extending beyond the equator in the ray projection is still only to the equator (because the part extending beyond the equator overlaps with the part extending to the equator), which will result in a small difference in the length of the longest radiographic marker and the relatively shorter radiographic marker displayed on the ray projection, and to a certain extent, it will mislead the operator or interfere with the operator's judgment of the position. In the embodiment, the longest radiographic marker only extends to the equator of the axisymmetric component, ensuring that all radiographic markers are distributed on the south hemisphere or the north hemisphere of the equator, avoiding the misrecognition and unclear influence caused by improper setting of the radiographic markers.

[0085] Furthermore, each radiographic marker 40 can have a same common end, and the common end is the north pole end of the axisymmetric component 20 or the south pole end of the axisymmetric component 20. Figure 4 In the embodiment, the common end of each radiographic marker 40 is the north pole end of the axisymmetric component 20, and the north pole end is the end of the axisymmetric component 20 far away from the catheter body 10. Correspondingly, the south pole end is the end of the axisymmetric component 20 close to the catheter body 10. Figure 5 In the embodiment, the common end of each radiographic marker 40 is the north pole end of the axisymmetric component 20, and the north pole end is the end of the axisymmetric component 20 far away from the catheter body 10. Correspondingly, the south pole end is the end of the axisymmetric component 20 close to the catheter body 10.

[0086] It should be noted that the same common end and the regular change in longitude make the plurality of developing marks aggregated into a fireworks-like or radial pattern outward from the common end, so that the pattern can present a way of describing an axisymmetric pattern surface and semi-enclosing the symmetric center, thereby helping the operator to determine the position and angle of the symmetric axis, and combining the position, angle of the symmetric axis and the common end, to help determine whether each developing mark is a front developing mark or a back developing mark. Meanwhile, it also has the characteristic that the common end can be taken as the center to draw different circles along the endpoints of each different developing mark to form concentric circles (similar to contour lines), so that no matter in which direction and deflection angle the axisymmetric part is in contact with the human tissue such as the pulmonary vein, the current pose of the axisymmetric part can be intuitively obtained, even for the extreme case of the frontal projection (part of the developing marks overlap), the front developing mark and the back developing mark can be distinguished according to the relative position of each developing mark calculated according to the regular change in longitude, or by slightly rotating the axisymmetric part, the positional relationship of all lines can be directly observed and the overall distribution of the energy transmission part on the axisymmetric part can be further constructed.

[0087] Reference can be made to Figure 6a , Figure 6b , Figure 7a and Figure 7b , Figure 6a is a top view of the axisymmetric part 20 in a specific case, Figure 6b is a front view of the axisymmetric part 20 in a specific case, Figure 7a is a top view of the axisymmetric part 20 in another specific case; Figure 7b is a front view of the top view of the axisymmetric part 20 in another specific case. In the embodiments of Figure 6a and Figure 6b , the same common end of each line-shaped developing mark 40 is the north pole end of the axisymmetric part 20, and in the top view of the axisymmetric part 20, the length of each developing mark 40 increases in turn along the clockwise direction from the shortest developing mark 40. Figure 7a and Figure 7b , the same common end of each line-shaped developing mark 40 is the south pole end of the axisymmetric part 20, and in the top view of the axisymmetric part 20, the length of each developing mark 40 increases in turn along the clockwise direction from the shortest developing mark 40.

[0088] In addition, it should be emphasized that each developing mark 40 is arranged at a different meridian position of the axisymmetric part 20, and the specific length of the shortest developing mark 40 and the specific length of the longest developing mark 40 can be set as needed.

[0089] For example, in a specific embodiment of the present invention, the axisymmetric component 20 is a balloon, the energy conducting component 30 is arranged on the side of the balloon and is in the shape of an elongated strip, and the proximal end of at least one development mark 40 overlaps with the proximal end of the energy conducting component. In this embodiment, for example, the proximal end of the longest developing mark 40 overlaps with the proximal end of the energy conducting component, which means that among the developing marks 40, the longer developing mark 40 can have a sufficient length so that after it starts from the distal end, its proximal end can overlap with the proximal end of the energy conducting component, thereby facilitating the operator to observe the developing mark 40. At the same time, in conjunction with other developing operations, it is beneficial to use the prompt that the end point of the longest developing mark corresponds to the end point of the electrode to help the operator judge the contact position between the electrode and the human tissue. For example, the developing liquid is blocked in the gap between the axially symmetrical component 20 and the human tissue, and the latitude line where the end point of the longest developing mark is located can be seen as a position not covered by the area where the developing liquid is located. It can be judged that the middle section of the electrode is in contact with the human tissue, rather than the tail section of the electrode. When the position where the middle section of the electrode is in contact with the human tissue is a more desired contact position, this will be a favorable auxiliary judgment basis.

[0090] For example, in the above Figure 4 In the example, the length of the longest development mark 40 is set to be equal to the length of the meridian from the North Pole to the equator, and the length of the shortest development mark 40 is usually higher than the set threshold, so that even if the length of the shortest development mark 40 does not overlap with other development marks 40 in the ray projection diagram, the operator can easily identify the shortest development mark 40 in the ray projection diagram.

[0091] See Figure 8a , Figure 8b , Figure 8c as well as Figure 8d , which are projections of the axisymmetric component 20 when both the X-axis and the Y-axis are rotated by 0°, and the Z-axis is rotated by 0°, 30°, 60°, and 90°, respectively. It can be seen that, taking the longest developing mark 40 as an example, its position continuously moves along the direction of rotation. The angle of rotation of the longest developing mark 40 can be called the rotation angle of the axisymmetric component 20. Figure 8a , X axis, Y axis, and Z axis are all rotated 0°. Figure 8b , the Z axis rotates 30°, sin30°=1 / 2, so at this time, the longest development mark 40 is located between the center of the circle and Figure 8b The center of the spherical radius on the east side. If the Z axis is rotated 45 degrees, At this time, the longest development mark 40 is located at Similarly, for Figure 8c , Z axis rotates 60°, At this time, the longest development mark 40 is located at ForFigure 8d , the Z axis is rotated exactly 90°, sin90°=1, and at this time, the longest development mark 40 is located exactly on the outermost side of the east sphere.

[0092] In the above Figure 8a , Figure 8b , Figure 8c as well as Figure 8d In this embodiment, the common end is the north pole, and when viewed from above the axisymmetric component 20, the longest development mark 40 is pre-set to the 0° meridian. Starting from the longest development mark 40 and rotating counterclockwise (according to a right-handed coordinate system, when a point in the image rotates from the left side of the projection to the right side, the rotation direction is counterclockwise), the length of each development mark 40 decreases. Therefore, when observing the ray projection, excluding the sudden change from the shortest to the longest development mark 40, and assuming that the remaining development marks follow a gradual change pattern, if the ray projection shows a decreasing trend from left to right starting from the position of the longest development mark 40, then these decreasing development marks 40 are currently located on the front side of the axisymmetric component 20, that is, these decreasing development marks 40 are currently facing the radiation generating device. Correspondingly, if the longest development mark 40 shows a decreasing trend from right to left in the ray projection diagram, it means that these increasing development marks 40 are currently located on the back side of the axisymmetric component 20. Figure 8a , Figure 8b , Figure 8c In FIG, it can be seen that the longest development mark 40 and the development marks 40 with decreasing lengths on its right side are currently located on the front side of the axisymmetric component 20 and face the ray generating device. Figure 8d In the figure, the longest developing mark 40 and the developing marks 40 with decreasing lengths on its left side are located on the back side of the axisymmetric component 20 (the longest developing mark 40 is located on the rightmost side at this time). In this special case, although it is difficult to directly find the longest developing mark 40, the developing marks can be intuitively seen to be decreasing from right to left. Therefore, it can be determined that the displayed marks are on the back side rather than the front side of the axisymmetric component 20. Therefore, the judgment rules followed by not being able to identify the longest developing mark and identifying the longest developing mark are consistent, which is more convenient for the operator to use and quickly judge.

[0093] It should be noted that the above Figure 8a , Figure 8b , Figure 8c as well as Figure 8dIn the example embodiment, the longest visualized marker is taken as the 0° meridian, and each energy conducting component is arranged according to the rule of gradually decreasing in the counterclockwise direction, but those skilled in the art can set other visualized markers as the initial 0° meridian (for example, take the shortest visualized marker as the 0° meridian) and set each energy conducting component according to the rule of gradually decreasing in the clockwise direction, etc., which all belong to the protection scope of the embodiments of the present application and will not be repeated here.

[0094] In addition, in the examples of Figure 8a , Figure 8b , Figure 8c and Figure 8d , if the X-axis or the Y-axis exists rotation, it does not affect the identification of the operator, and even in some cases, it is helpful for the operator to more intuitively identify the positions of each visualized marker 40 in the ray projection image. In the clinical angle, the ray generating device usually does not directly project the axisymmetric component, and the circumferential abutment between the axisymmetric component and the human tissue also needs to be curved to a certain extent. Therefore, the conventional ray projection image has a small probability of presenting the X-axis and the Y-axis both rotating 0° and the longest visualized marker being located at the center position of the image in the initial state, but more presents a certain deflection angle in the X / Y / Z directions. For example, as shown in Figure 8a , Figure 8b , Figure 8c and Figure 8d , the X-axis and the Y-axis are both rotated 0°, and the longest visualized marker is located at the center position of the image in the initial state, but more presents a certain deflection angle in the X / Y / Z directions. For example, as shown in Figure 9a , Figure 9b , Figure 9c and Figure 9d , the X-axis and the Y-axis are both rotated 0°, and the longest visualized marker is located at the center position of the image in the initial state, but more presents a certain deflection angle in the X / Y / Z directions. For example, as shown in Figure 9a , Figure 9b , Figure 9c and Figure 9d , the X-axis of the axisymmetric component 20 is rotated 0°, the Y-axis is rotated 30°, and the Z-axis is rotated 0°, 30°, 60° and 90° respectively. It can be seen that for the cases of Figure 9a , Figure 9b , Figure 9c and Figure 9d , the operator can intuitively and conveniently identify the positions of each visualized marker 40 in the ray projection image, and can intuitively see whether each visualized marker 40 is located on the front surface of the axisymmetric component 20 or on the back surface of the axisymmetric component 20. Even the trend of the visualized change can be omitted to intuitively obtain the actual distribution of each visualized marker, and the distribution of each energy conducting component (such as the electrode) can also be directly judged.

[0095] In one embodiment of the present application, an insulating base layer can be further included, which is arranged between the axisymmetric component 20 and the energy-conducting component 30. The plurality of visualization markers 40 can be embedded in the insulating base layer, or the visualization markers 40 can be visualization materials mixed in the insulating base layer.

[0096] The above detailed description of the regular change of the shape of the visualization markers 40 with the change of the longitude makes it possible for the operator to effectively identify the spatial position of each visualization marker 40. In this embodiment, the visualization markers 40 are usually embedded in the insulating base layer when the visualization markers 40 are made of visualization materials, or the visualization markers 40 are directly made of visualization materials mixed in the insulating base layer, so that the surface flatness of the insulating base layer can be effectively ensured, i.e., the surface flatness of the insulating base layer is not affected by the shape of the visualization markers 40.

[0097] In one embodiment of the present application, the axisymmetric component 20 is a balloon, the visualization markers 40 include first visualization markers formed by mixing visualization materials in the balloon, and the visualization markers 40 include second visualization markers connected to the energy-conducting component. Any energy-conducting component 30 has a unique first visualization marker and a unique second visualization marker matched therewith.

[0098] The second visualization marker has a higher visualization intensity than the first visualization marker.

[0099] This embodiment further considers that, for any energy-conducting component 30, two groups of visualization markers can be arranged, one group of visualization markers is composed of each first visualization marker, and it can be understood that the shape of each first visualization marker needs to change regularly with the change of the longitude. The other group of visualization markers is composed of each second visualization marker, and it can be understood that the shape of each second visualization marker also needs to change regularly with the change of the longitude. Since two groups of visualization markers are arranged, for any energy-conducting component 30, a unique first visualization marker and a unique second visualization marker are matched therewith. At the same time, this arrangement is also beneficial for the operator to judge the attachment of the energy-conducting component and the axisymmetric component. Once the abnormal condition of the detachment of the two components is found in the operation, it is beneficial to quickly identify and avoid the occurrence of the detachment condition, and improve the safety.

[0100] In other words, with this embodiment, the surgeon can determine the spatial position of each energy conducting component 30 regardless of which set of imaging markers is used. Simultaneously providing two sets of imaging markers further facilitates identification. Of course, these two sets of imaging markers must not interfere with each other. In this embodiment, each first imaging marker is formed by mixing imaging material into the balloon and has a lower imaging intensity, while each second imaging marker can be directly connected to the corresponding energy conducting component and has a higher imaging intensity.

[0101] Using the technical solution provided in the embodiments of the present invention, an axisymmetric diagnostic and treatment device includes a catheter body 10, an axisymmetric component 20 disposed at the distal end of the catheter body 10, and multiple energy conduction components 30 arranged on the surface of the axisymmetric component 20. When the axisymmetric component 20 is in an expanded state, the energy conduction components 30 are evenly spaced circumferentially from one another to transmit energy to the target area for diagnosis and treatment, effectively achieving repair of the body. For example, during ablation, tissue adjacent to the ablation zone can be spared from damage, thereby avoiding the heat sink effect of the ablation zone. Furthermore, the position of each imaging mark corresponds one-to-one to the position of each energy conduction component 30. Therefore, the operator only needs to identify each imaging mark from the ray projection image to determine the position of each energy conduction component 30. Moreover, in order to help the surgeon effectively identify the position of each development mark, in the present application, the shape of each development mark changes regularly with the longitude. Therefore, by viewing the ray projection diagram, the surgeon can not only easily identify each development mark, but also distinguish the orientation of different energy conduction components 30 based on the relative position relationship of different development marks in the ray projection diagram, and effectively determine whether each development mark is on the front or back, which is not easy to make mistakes. And because each development mark can be easily identified, even if it is rotated during the operation, the surgeon can still accurately know the actual position of the axisymmetric component 20 after rotation and the spatial position of each energy conduction component 30 thereon. In summary, the present application can effectively assist the surgeon in identifying and locating different energy conduction components and reflecting the actual position of the axisymmetric component, assisting the surgeon in making targeted adjustments and supplementary diagnosis and treatment, and improving safety and effectiveness.

[0102] Corresponding to the above embodiment of the axisymmetric diagnosis and treatment device, an embodiment of the present invention further provides a control method for the axisymmetric diagnosis and treatment device, which can be referenced in correspondence with the above.

[0103] See Figure 10 , is a flow chart of an implementation method of a control method for an axisymmetric diagnosis and treatment device, the control method for the axisymmetric diagnosis and treatment device may include the following steps:

[0104] Step S101: placing the axisymmetric component in the target site through the catheter main body. The axisymmetric diagnosis and treatment device described herein can be any of the axisymmetric diagnosis and treatment devices described above.

[0105] In actual applications, the axisymmetric diagnosis and treatment device needs to be adjusted in position before reaching the target site, Figure 11 For a schematic diagram of the principle of diagnosis and treatment (specifically, the principle of ablation) in a specific application, the position of the axisymmetric diagnosis and treatment device needs to be adjusted, and in the process, the ray projection diagram is transmitted to the computer and displayed by the computer, so that the operator can observe whether the position of the axisymmetric component 20 in the axisymmetric diagnosis and treatment device is effectively placed in the target site based on the ray projection diagram displayed by the computer. For example, in actual applications, the axisymmetric component 20 should be effectively close to or even adhere to the target site when placed in the target site. Of course, there are various specific implementation methods for judging whether it is effectively close, for example, in some cases, the leakage of contrast medium can be observed, that is, after adjusting the position of the axisymmetric component 20, if the contrast medium no longer leaks, it can be determined that the axisymmetric component 20 blocks the blood vessel opening, for example, specifically blocks the pulmonary vein opening. A more preferred embodiment includes that the operator can also rotate / move the axisymmetric component 20, and determine whether the energy transmission component 30 on the axisymmetric component 20 effectively approaches the upper wall of the pulmonary vein opening by observing the position of each visible marker 40.

[0106] After determining that the axisymmetric diagnosis and treatment device reaches the target site and whether the energy transmission component 30 effectively adheres to the target site, ablation can be performed.

[0107] Step S102: obtaining the ray projection diagram of the axisymmetric component and displaying the ray projection diagram.

[0108] The ray projection diagram of the axisymmetric component 20 is usually the ray projection diagram under X-ray. Whether in the process of adjusting the position of the axisymmetric component 20 or in the process of performing ablation, the computer can obtain the ray projection diagram of the axisymmetric component 20 and display the ray projection diagram on the display screen, so that the operator can adjust the axisymmetric component 20 based on the ray projection diagram displayed by the computer in the process of adjusting the position of the axisymmetric component 20 and in the process of performing ablation.

[0109] In specific clinical applications, if the current abutting position is not ideal, or if the effect is not complete after several operations, resulting in incomplete signal acquisition or discontinuous ablation, etc., the rotationally symmetrical component can be used to supplement the acquisition or ablation. In particular, in pulmonary vein ablation, when the energy transmission component is used as a pulsed electric field ablation electrode, the area between the electrodes is more likely to form an electroporation for ablation due to being in the ablation electric field. On the contrary, the part directly in contact with each electrode is more difficult to form effective ablation, that is, it is more likely to be a so-called "ablation dead zone". If there is an insufficient ablation in the first ablation, it is necessary to rotate the rotationally symmetrical component to adjust the relatively weak field strength part directly in contact with the electrode to the relatively strong field strength part between the adjacent electrodes, that is, the first abutting position and the second abutting position are staggered, and the energy transmission component is excited again to ablate, combined with the previous ablation position, to accelerate the formation of a complete circumferential closed ablation band and complete the required pulmonary vein isolation effect. However, the prior art is difficult to confirm that the first abutting position and the second abutting position have been staggered, and it is also difficult to further confirm which electrodes need to be excited for re-ablation. The present application overcomes this problem and achieves rotation control and directional ablation conveniently and accurately through the following methods.

[0110] Step S103: Rotate the rotationally symmetrical component, and the plurality of visualization markers regularly changing in shape with the change in longitude are synchronously rotated.

[0111] After the rotationally symmetrical component 20 is placed at the target site by the catheter body and the radiographic projection of the rotationally symmetrical component 20 is displayed, the rotationally symmetrical component 20 can be rotated to adjust its posture. It can be understood that during the rotation of the rotationally symmetrical component 20, the plurality of visualization markers 40 regularly changing in shape with the change in longitude and arranged on the surface of the rotationally symmetrical component 20 are synchronously rotated with the rotation of the rotationally symmetrical component 20. For example, in one occasion, the rotationally symmetrical component 20 is rotated to achieve effective abutting of the rotationally symmetrical component 20 to the target site, and each visualization marker 40 is also rotated to the required position, which means that each energy transmission component 30 reaches the required position.

[0112] Step S104: Reflect the actual pose of the rotated rotationally symmetrical component according to the plurality of visualization markers of the displayed radiographic projection after rotation.

[0113] After the rotation of the axisymmetric component 20 is completed, based on the plurality of developed marks 40 in the displayed ray projection diagram after the rotation, the actual pose of the axisymmetric component 20 can be determined, that is, the positions of the plurality of developed marks 40 on the axisymmetric component 20 can be located.

[0114] In the scheme of the present application, since the shapes of the developed marks 40 at different positions are different from each other, the 2D projection of the 3D axisymmetric diagnosis and treatment device under x-rays has uniqueness, that is, the projection of the axisymmetric diagnosis and treatment device at each angle has and only has one 2D pattern corresponding thereto. Moreover, the positions of the plurality of developed marks 40 correspond to the positions of the plurality of energy conducting components 30 one by one, so based on the plurality of developed marks 40 in the ray projection diagram, the positions of the plurality of developed marks 40 can be effectively determined, that is, based on the plurality of developed marks 40 in the ray projection diagram, the actual pose of the axisymmetric component 20 can be determined.

[0115] In addition, when locating the positions of the plurality of developed marks 40, the computer can automatically determine the positions of the plurality of developed marks 40 in the displayed ray projection diagram based on the relative positional relationship of the plurality of developed marks 40 in the ray projection diagram, and the specific principle has been described in detail above and will not be repeated here.

[0116] In one specific embodiment of the present application, the step S104 can specifically include:

[0117] identifying the positions of extreme developed marks 40 in the plurality of developed marks 40;

[0118] dividing the plurality of developed marks 40 into front developed marks 40 and back developed marks 40 according to the change trend between the developed marks 40 adjacent to the extreme developed marks 40 and the extreme developed marks 40;

[0119] prompting the number of the energy conducting component matched with each developed mark 40 based on the front developed marks 40 and the back developed marks 40.

[0120] It should be noted that this kind of embodiment can be generally used in the case that the projection direction is located at the side of the axisymmetric component 20, at this time, the front development mark 40 and the back development mark 40 can appear the overlapping situation, therefore, according to the principle of this kind of embodiment, the resolution can be realized through the change trend between the adjacent development marks 40. In some occasions, the projection direction has a certain angle with the side of the axisymmetric component 20, then, the embodiment of judging the change trend can not be used, but the position of each development mark 40 can be directly determined, because in the case of the angle, the radial development marks 40 from the common end of each development mark 40 can be directly observed in the ray projection diagram, which has the effect of indicating the three-dimensional distribution under the two-dimensional image, therefore, the position of each development mark 40 can be more conveniently distinguished and determined, and whether the development mark 40 is the front development mark 40 or the back development mark 40 can also be more conveniently distinguished and determined.

[0121] In the embodiment in which the front development mark 40 and the back development mark 40 can appear more overlapping, the position of the extreme value development mark 40 in the plurality of development marks 40 needs to be identified, the extreme value development mark 40 is a predefined development mark 40, which is usually the maximum value development mark 40, for example, in one occasion, each development mark 40 is a strip-shaped development mark 40, and the extreme value development mark 40 is the longest development mark 40, preferably, the longest development mark 40 extends from the common end to the equator of the axisymmetric component 20.

[0122] Then, according to the change trend between the extreme value development mark 40 and the development mark 40 adjacent to the extreme value development mark 40, the plurality of development marks 40 can be divided into the front development mark 40 and the back development mark 40. The above text Figure 8a , Figure 8b , Figure 8c and Figure 8dFor example, in the circumferential direction, excluding the case where the mutation changes directly from the shortest developing mark 40 to the longest developing mark 40, and other developing marks change cyclically, if the developing marks 40 present a trend of decreasing from left to right from the extreme developing mark in the radiographic image, it indicates that these decreasing developing marks 40 are currently located in the front, i.e. the front is facing the ray generating device. Correspondingly, if the developing marks 40 present a trend of decreasing from right to left from the extreme developing mark in the radiographic image, it indicates that these increasing developing marks 40 are currently located in the back, i.e. the back is facing the ray generating device. Based on this rule, the extreme developing mark 40 can be determined, and the developing marks 40 adjacent to the extreme developing mark 40 can be determined, and the trend of change between the extreme developing mark 40 and the developing marks 40 adjacent to the extreme developing mark 40 is a trend of decreasing from left to right or a trend of increasing from left to right, so that it can be determined that each developing mark 40 is a front developing mark 40 or a back developing mark 40. Here, how to distinguish the front developing mark 40 and the back developing mark 40 has been described in detail in the previous part, and is directly introduced in the control method part and will not be repeated.

[0123] In this embodiment, after the plurality of developing marks 40 are divided into front developing marks 40 and back developing marks 40, the number of the energy conducting component 30 matched by each developing mark 40 is prompted based on the front developing marks 40 and the back developing marks 40.

[0124] This embodiment also takes into account that although the operator can effectively position each energy conducting component 30 based on the positions of each developing mark 40 in the radiographic image combined with thinking or imagination, in order to reduce the probability of error, the number of the energy conducting component 30 matched by each developing mark 40 can be prompted in the radiographic image displayed by the computer, which has an auxiliary effect, can improve the efficiency of the operator in positioning each energy conducting component 30, and reduce the probability of error.

[0125] It should be noted that different developing marks 40 can have different numbers, which can be preset, and different developing marks 40 correspond to different energy conducting components 30 one by one, so for any developing mark 40, the energy conducting component 30 matched by the developing mark 40 can have the same / associated number, so that after each developing mark 40 is identified, the number of the energy conducting component 30 can be directly displayed.

[0126] When numbering, a numerical sequence, an English letter sequence, etc. can be used to realize numbering, for example, the longest developing mark 40 and the corresponding energy conducting component 30 are numbered as 1, the second longest developing mark 40 and the corresponding energy conducting component 30 are numbered as 2, and so on.

[0127] For example, in the case of Figure 12For example, in the example shown in FIG. 1, the longest developing mark 40 and its corresponding energy conducting component 30 are numbered as A, the second longest developing mark 40 and its corresponding energy conducting component 30 are numbered as B, and so on, and the shortest developing mark 40 and its corresponding energy conducting component 30 are numbered as J. In addition, the number is usually placed near the developing mark 40, so as to facilitate the observation of the operator. For example, in one case, the computer can determine the center of the axisymmetric component 20 and the endpoint position of each developing mark 40 based on OpenCV. The endpoint position described herein refers to the non-common end of each developing mark 40. Then, the computer can find the longest developing mark 40 and display "A" near the endpoint position of the longest developing mark 40, for example, the A marked in FIG. 1. Similarly, the display of the numbers near other developing marks 40 can be performed. Subsequently, when the radiographic image changes, the offset of the endpoint position of the longest developing mark 40 relative to the center of the axisymmetric component 20 can be determined, so as to update the display position of the number A, and the display positions of other numbers can also be updated based on the offset. Figure 12

[0128] Step S105: based on all or part of the developing marks, control the matched energy conducting components to work.

[0129] Based on the operation of the operator, the energy conducting components 30 in the axisymmetric diagnosis and treatment device can be controlled, so that all or part of the energy conducting components 30 can be controlled to work based on all or part of the developing marks 40, that is, all or part of the energy conducting components 30 can be controlled to release energy, so as to diagnose and treat the target site.

[0130] In one specific embodiment of the present application, the following can also be included:

[0131] According to the developing marks 40 of the displayed radiographic image after rotation, each developing mark 40 or the generated axisymmetric component model is colored according to a preset color display rule.

[0132] ​The embodiment considers that different colors are used to display different developing marks 40, which can help the operator to conveniently and quickly locate the positions of different developing marks 40. Therefore, according to the plurality of developing marks of the displayed ray projection image after rotation, the color display rule is preset, and each developing mark or the generated axisymmetric component model is subjected to color processing on the display image, and / or the position of the equator line is calculated and displayed on the ray projection image. Specifically, according to the plurality of developing marks 40 of the displayed ray projection image after rotation, each developing mark 40 is subjected to color processing according to the preset color display rule. It is also considered that the axisymmetric component model in the ray projection image is colored, so the generated axisymmetric component model can also be colored according to the plurality of developing marks 40 of the displayed ray projection image after rotation, according to the preset color display rule. In addition, it can be understood that the X-ray projection cannot display colors, and the present application is directed to the different color display of each developing mark 40 in the ray projection image displayed by the display after computer processing, or the different color display of different positions of the axisymmetric component model. Similarly, the operation of changing the display of the ray projection image and adding auxiliary information is also an operation on the ray projection image displayed by the display, rather than directly operating the X-ray projection.

[0133] In some embodiments, in order to facilitate the identification of the position of the extreme value developing mark, for example, the identification of the position of the longest developing mark, the position of the equator line of the axisymmetric component can be identified by an algorithm, and the equator line is displayed on the display, thereby more objectively helping the operator to identify the position of the longest developing mark and avoiding subjective judgment to confuse the extreme value developing mark and the near extreme value developing mark.

[0134] In addition, in actual application, other forms of annotations can also be added according to actual needs, for example, some auxiliary lines can be annotated, and Figure 12 In the example, the equator line of the axisymmetric component 20 is annotated as an auxiliary line. For example, a text description of “the extreme value developing mark is on the front surface” or a text description of “the extreme value developing mark is on the back surface” can be added as auxiliary information.

[0135] In a specific embodiment of the present application, based on all or part of the developing marks, the matched energy transmission component is controlled to work to diagnose and treat the target site, which can specifically include:

[0136] When no directional discharge instruction is received, each energy transmission component 30 in the axisymmetric diagnosis and treatment device is in a working state to perform circumferential diagnosis and treatment of the target site;

[0137] When receiving the directional discharge instruction, the energy conducting components 30 specified by the directional discharge instruction are controlled to be in working state to perform directional diagnosis and treatment of the target site.

[0138] The embodiment considers that the shaft-symmetrical diagnosis and treatment device has multiple energy conducting components 30, in some cases, each energy conducting component 30 needs to be in working state, but in some cases, if each energy conducting component 30 is in working state, it may cause insufficient ablation in some directions and excessive ablation in some directions, and if one or more energy conducting components 30 can be controlled to discharge, the treatment efficiency and safety can be improved. Therefore, in the embodiment, if no directional discharge instruction is received, it is defaulted that each energy conducting component 30 in the shaft-symmetrical diagnosis and treatment device is in working state to perform circumferential diagnosis and treatment of the target site, i.e. circumferential ablation. If the directional discharge instruction is received, it means that the operator wants some energy conducting components 30 to work, therefore, based on the directional discharge instruction, each energy conducting component 30 in the shaft-symmetrical diagnosis and treatment device specified by the directional discharge instruction is controlled to be in working state, and the rest of the energy conducting components 30 are in non-working state, so as to realize directional diagnosis and treatment of the target site, i.e. realize directional supplemental ablation, which is beneficial to improve the treatment efficiency and safety.

[0139] In Figure 11 , the operation of adjusting the position and performing directional discharge is shown, i.e. the operator can know the position of each energy conducting component 30 based on the position of each developing mark 40, so as to adjust the position of each energy conducting component 30, and after reaching the required position, the purpose that each energy conducting component 30 specified by the directional discharge instruction is in working state and the rest of the energy conducting components 30 are not in working state can be realized through the directional discharge instruction.

[0140] For reference Figure 13a , Figure 13b and Figure 13c , the projections of the shaft-symmetrical component 20 under the conditions that the X-axis and the Z-axis are both rotated by 0° and the Y-axis is rotated by 30°, 60° and 90° are shown in sequence, it can be seen that in actual application, no matter how the shaft-symmetrical component 20 is projected, the area of the feature region can usually exceed 40% of the circular area in the case of the most shielding area, which can provide sufficient recognition for the computer and the operator.

[0141] The application can effectively identify whether the positions close to the energy transmission components before and after rotation are staggered, and can further provide the operator with a selectable directional excitation supplementary treatment mode, instead of uniformly using undifferentiated circumferential excitation of all energy transmission components. In particular, in ablation treatment, multiple excitations can easily cause excessive ablation and thrombosis and other adverse phenomena, which need to be avoided by precise treatment. In the actual process, due to the irregularity of the patient's physiological anatomy, it is difficult to ensure that all energy transmission components of the axisymmetric component are in place at one time. However, the axisymmetric component has a unique traceable and identifiable relative relationship and corresponding number for each energy transmission component, so that the existing verification methods such as intraoperative block verification and directional verification can verify the corresponding insufficient ablation position, or the more likely insufficient ablation position such as impedance detection or leakage of developing liquid before the operator starts ablation, so as to target control the rotation of the axisymmetric component, and selectively choose the part of the energy transmission component that needs to be excited for directional diagnosis and treatment, so as to ensure the precise realization of circumferential diagnosis and treatment, and take into account safety and effectiveness.

[0142] Corresponding to the above embodiments of the control method of the axisymmetric diagnosis and treatment device, the embodiments of the application further provide a computer readable storage medium and a computer program product, which can be mutually corresponding and referred to above. The computer program product includes computer programs / instructions, which are executed by the processor to realize the steps of the control method of the axisymmetric diagnosis and treatment device in any of the above embodiments.

[0143] The computer readable storage medium stores the computer program, which is executed by the processor to realize the steps of the control method of the axisymmetric diagnosis and treatment device in any of the above embodiments. The computer readable storage medium mentioned herein includes RAM (Random Access Memory, Random Access Memory), memory, ROM (Read-Only Memory, Read-Only Memory), EEPROM (Electrically Erasable Programmable Read Only Memory, Electrically Erasable Programmable Read Only Memory), register, hard disk, removable disk, or any other form of storage medium known in the technical field.

[0144] Those skilled in the art can further understand that the units and algorithm steps of each example described in combination with the embodiments disclosed in the present application can be realized in electronic hardware, computer software or a combination of both. In order to clearly illustrate the interchangeability of hardware and software, the components and steps of each example have been described in the above description in general terms. Whether the functions are performed in hardware or software depends on the specific application and design constraints of the technical solution. A person skilled in the art can use different methods to implement the described functions for each specific application, but such implementation should not be considered beyond the scope of the present application.

[0145] The principles and implementation manners of the present application are described in the present application by using specific examples. The above description of the examples is only used to help understand the technical solutions and core ideas of the present application. It should be pointed out that, for those skilled in the art, without departing from the principles of the present application, some improvements and modifications can be made to the present application, and these improvements and modifications also fall within the protection scope of the present application.

Claims

1. An axisymmetric diagnosis and treatment device, characterized in that: include: a catheter body; an axisymmetric component disposed at a distal end of the catheter body, the axisymmetric component being configured to assume a contracted state or an expanded state; a plurality of energy conducting components disposed on the surface of the axisymmetric component, wherein the energy conducting components are evenly spaced apart from each other circumferentially when the axisymmetric component is in an expanded state, so as to transmit energy to a target site; A plurality of developing marks are provided on the surface of the axisymmetric component, wherein the shape of each developing mark changes regularly with the longitude, and any energy conducting component has a unique developing mark matching it; Each of the development marks has the same common end, and the common end is the north end or the south end of the axisymmetric component. The projection of the axisymmetric diagnosis and treatment device at each angle has a unique two-dimensional pattern corresponding to it.

2. The axisymmetric diagnosis and treatment device according to claim 1, characterized in that: The regular changes in the morphology of each of the development marks as the longitude changes include: The number of the development marks is N, N is not less than 4, and the lengths, endpoint positions, scaling factors or areas of the development marks from the first to the Nth gradually increase or decrease.

3. The axisymmetric diagnosis and treatment device according to claim 2, characterized in that: Each of the development marks is a continuous pattern or a discontinuous pattern, and each of the development marks is arranged at intervals or in a joint arrangement.

4. The axisymmetric diagnosis and treatment device according to claim 2, characterized in that: Each of the development marks is a strip-shaped development mark, and the lengths of different development marks are different from each other, wherein the development mark with the longest length extends to the equator of the axisymmetric component.

5. The axisymmetric diagnosis and treatment device according to claim 1, characterized in that: The axisymmetric component is a balloon, the imaging marker includes a first imaging marker formed by an imaging substance disposed in the balloon, and the imaging marker includes a second imaging marker connected to the energy conducting component, and any energy conducting component has a unique first imaging marker and a unique second imaging marker matched therewith; The second development mark has a higher development intensity than the first development mark.

6. The axisymmetric diagnosis and treatment device according to claim 1, characterized in that: It also includes an insulating base layer, wherein the insulating base layer is used to connect the axisymmetric component and the energy conduction component; The plurality of development marks are embedded in the insulating base layer, or the development marks are development materials mixed into the insulating base layer.

7. The axisymmetric diagnosis and treatment device according to claim 1, characterized in that: The axisymmetric component is a balloon, the energy conducting component is arranged on the side of the balloon and is in the shape of an elongated strip, and the proximal end of at least one of the development marks overlaps with the proximal end of the energy conducting component.

8. A computer program product comprising a computer program / instructions, characterized in that When the computer program / instructions are executed by a processor, the computer program / instructions realize control of an axisymmetric diagnosis and treatment device, wherein the axisymmetric diagnosis and treatment device is the axisymmetric diagnosis and treatment device according to any one of claims 1 to 7, and the control method of the axisymmetric diagnosis and treatment device comprises: After the axisymmetric component is placed at the target location, obtaining a ray projection diagram of the axisymmetric component and displaying the ray projection diagram; The axisymmetric component is rotated, and multiple development marks whose shapes change regularly with longitude rotate synchronously; reflecting the actual position and posture of the rotated axisymmetric component according to the plurality of development marks of the ray projection diagram displayed after rotation; Based on all or part of the developed marks, the operation of the matched energy conducting component is controlled.

9. The computer program product according to claim 8, wherein Reflecting the actual position and posture of the rotated axisymmetric component according to the multiple development marks of the ray projection diagram displayed after rotation specifically includes: Identifying the location of an extreme value development mark among the plurality of development marks; dividing the plurality of development marks into front development marks and back development marks according to a change trend between a development mark adjacent to the extreme development mark and the extreme development mark; Based on the front development mark and the back development mark, the number of the energy conduction component matching each of the development marks is prompted.

10. The computer program product according to claim 8, wherein Also includes: According to the multiple development marks of the ray projection diagram displayed after rotation, each development mark or the generated axisymmetric component model is colored on the displayed image according to a preset color display rule, and / or, the position of the equator line is calculated based on the ray projection diagram and displayed on the ray projection diagram.

11. The computer program product according to claim 8, wherein Based on all or part of the developed marks, the operation of the matched energy conduction components is controlled, including: When no directional discharge instruction is received, all energy conduction components in the axisymmetric diagnosis and treatment device are controlled to be in a working state; When a directed discharge instruction is received, the energy conduction component specified by the directed discharge instruction is controlled to be in an operating state.

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