Mapping and ablation system capable of detecting injury depth

Abstract

The invention relates to the field of electrophysiological catheters, in particular to a mapping and ablation system capable of detecting injury depth, which is characterized in that a tail end functional area is arranged at the far end of a catheter, and an electrode, a positioning sensor and an optical probe are arranged in the tail end functional area; the electrode is used for mapping and ablation; the positioning sensor comprises a coil structure; the optical probe is used for performing optical scanning on the contacted tissue. The ablation unit is communicated with the electrode and provides ablation energy for the electrode; the positioning unit is communicated with the catheter and is used for displaying the position and form of the tail end functional area and recognizing the deviation and rotation direction of the tail end functional area; the electrophysiology mapping unit is communicated with the electrode and acquires an electrophysiology signal through the electrode; the optical detection unit is connected with the optical probe through an optical fiber and used for optical coherence tomography; the impedance detection unit is communicated with the electrodes, impedance information of surrounding tissue under different frequencies is collected through the electrodes, and then the frequency response coefficient of the position where each electrode is located is solved and used for recognizing whether the electrodes make contact with the tissue or not.

Description

Technical Field

[0001] The present invention relates to the technical field of electrophysiological catheters, in particular to a mapping and ablation system capable of detecting the depth of injury. Background Art

[0002] In electrophysiological ablation surgery, the depth of tissue damage is a data that the surgeon is more concerned about, but it is often not intuitively observable. The surgeon often roughly estimates the possible damage range by ablation parameters, and judges whether the ablation is effective by observing the changes in electrical signals. The degree of tissue damage depends on the surgeon's experience, and it takes a lot of effort to observe complex information.

[0003] Optical coherence imaging technology can detect the fine structure inside the tissue and directly detect the degree of tissue damage. However, optical tomography is weak coherent light imaging, the detection depth is limited and it is easily affected by the blood environment. In order to detect the internal structure of the tissue to the greatest extent, the detection position and direction need to be regulated. Summary of the invention

[0004] The purpose of the present invention is to provide a mapping and ablation system that can detect the depth of damage to address the problems that the existing electrophysiological ablation equipment in the prior art cannot provide the operator with an intuitive and accurate reference to the range of tissue damage, and that the use of optical coherence imaging combined with a catheter is easily disturbed by blood flow and requires precise control of the detection position and direction.

[0005] In order to achieve the above object, the technical solution adopted by the present invention is: A mapping and ablation system capable of detecting lesion depth, comprising: A catheter, the distal end of which is provided with a terminal functional area, the terminal functional area is provided with a plurality of electrodes, at least two positioning sensors, and at least one optical probe; the electrodes are used for mapping and ablation; the positioning sensor comprises a coil structure, at least two of the coil structures are arranged at a certain angle; the optical probe is used for optically scanning the contacted tissue; the optical probe, the positioning sensor, and the electrode have a fixed position relationship; an ablation unit, connected to the electrode, and providing ablation energy to the electrode; A positioning unit connected to the catheter, wherein the coil structure of the positioning sensor generates an induced current when moving in a three-dimensional magnetic field, and the positioning unit is used to receive the induced current and perform calculation processing to display the position and shape of the terminal functional area, and to identify the offset and rotation direction of the terminal functional area; An electrophysiological mapping unit, connected to the electrodes, and the electrophysiological mapping unit acquires electrophysiological signals through the electrodes; An optical detection unit, connected to the optical probe via an optical fiber, and the optical detection unit is used for optical coherence tomography; An impedance detection unit is connected to the electrodes. The impedance detection unit collects impedance information of the surrounding tissue at different frequencies through each of the electrodes, and then solves the frequency response coefficient of the position of each of the electrodes. The impedance detection unit is used to identify whether the electrodes are in contact with the tissue.

[0006] The positioning unit can calculate the position of the coil structure in the magnetic field through the change of the induced current. Utilizing the function of the positioning sensor, the position and shape of the terminal functional area can be displayed, and combined with the electrophysiological mapping unit, a position, shape, voltage distribution and electrical conduction relationship diagram of each part of the heart can be constructed for the operator to observe.

[0007] Good contact is still essential for optical coherence imaging because light has limited penetration depth into tissue and is easily affected by blood. When the optical probe is perpendicular to the tissue interface and well attached to the tissue, the maximum detection depth can be achieved in theory. When the optical probe is parallel to the tissue interface or there is blood between the optical probe and the tissue, tissue information may not be detected.

[0008] Optical coherence imaging belongs to the optical detection unit. First, light is emitted from the light source and is divided into a reference beam and a detection beam through the beam splitter of the Michelson interferometer. The detection beam continues to be transmitted along the optical path to the optical probe and enters the tissue attached to the optical probe. The optical reflection (scattering) of the human tissue structure has a spatial variation characteristic. The reflected light returns through the optical fiber and interferes with the reference light to present a specific interference pattern. The optical signal processing unit of the signal processing center analyzes and images the pattern to reconstruct a three-dimensional image within a certain depth range inside the tissue. Therefore, optical coherence tomography of the tissue can identify the internal tissue structure of the ablation site (such as myocardium, fat, blood vessels, nerves, etc.), and can also detect the damage after ablation (the tissue after ablation has different optical properties from normal tissue). As mentioned above, optical tomography is weak coherent light imaging, with limited detection depth and easily affected by the blood environment.

[0009] The mapping and ablation system capable of detecting the depth of injury described in the present invention can realize electrophysiological mapping through the electrophysiological mapping unit and the electrode, and can realize ablation through the ablation unit and the electrode. The position of the optical probe can be clearly determined through the positioning unit and the positioning sensor, and the image detected by the optical probe can be combined and displayed with the three-dimensional model diagram constructed by the positioning sensor. The impedance detection unit and the electrode can determine whether the optical probe contacts the tissue, thereby realizing scanning of the target tissue within the maximum depth range. The optical probe is used to detect the tissue condition of the ablation site, so that the operator can have an intuitive grasp of the internal structure and damage of the tissue before and after ablation. Optical coherence imaging, magnetic positioning, and impedance detection cooperate with each other, and the detection results are more accurate, the detection depth is deeper, the range is larger, and the use is more convenient. The tissue structure and ablation damage condition of the contact site can be provided to the operator in real time without changing the original surgical procedure. The ablation process is safer and the ablation effect is easier to grasp.

[0010] As a preferred technical solution of the present invention, the terminal functional area is a linear structure, including a head end and a proximal end, and a plurality of the electrodes are arranged at intervals along the length direction of the terminal functional area.

[0011] As a further preferred technical solution of the present invention, the electrodes include a first electrode, a second electrode, a third electrode, and a fourth electrode. The first electrode is a head electrode and is arranged at the head end. The first electrode, the second electrode, the third electrode, and the fourth electrode are arranged in sequence from the head end to the proximal end.

[0012] As a further preferred technical solution of the present invention, at least one optical probe is provided between adjacent electrodes.

[0013] As a further preferred technical solution of the present invention, the optical probe includes a first optical probe and a second optical probe, the first optical probe is arranged on the catheter between the first electrode and the second electrode, and the second optical probe is arranged on the catheter between the third electrode and the fourth electrode.

[0014] As a further preferred technical solution of the present invention, the positioning sensor includes a first positioning sensor, a second positioning sensor, and a third positioning sensor. The first positioning sensor and the second positioning sensor are arranged at the head end, the coil structures of the first positioning sensor and the second positioning sensor are arranged at a certain angle, and the third positioning sensor is arranged at the proximal end.

[0015] As a further preferred technical solution of the present invention, the terminal functional area is divided into four quadrants along the axis, quadrant I is defined as the direction of bending and deflection of the catheter, quadrant II and quadrant IV are defined as two adjacent directions of the catheter deflection direction, and quadrant III is defined as the direction away from the catheter deflection direction.

[0016] With this structural arrangement, the position and detection direction of the optical probe mounted on the catheter or the electrode can be quickly identified.

[0017] As a preferred technical solution of the present invention, the terminal functional area includes a plurality of electrode arms, which are arranged in parallel and located in the same plane, each of the electrode arms is provided with a plurality of electrodes, one end of all the electrode arms is connected to the catheter, and the other ends are combined and connected to each other, the positioning sensor is arranged in the electrode arm, and the optical probe is arranged on the electrode arm or on the coating between the electrode arms.

[0018] As a further preferred technical solution of the present invention, the length direction of the electrode arm is arranged along the axial direction of the catheter, and all the electrode arms are symmetrically arranged along the axis of the catheter, the positioning sensor includes a first positioning sensor, a second positioning sensor, and a third positioning sensor, the first positioning sensor and the second positioning sensor are symmetrically arranged on the two outermost electrode arms, and the coil structures of the first positioning sensor and the second positioning sensor are respectively arranged at a certain angle, and the third positioning sensor is arranged at the end of the catheter to which the electrode arm is connected.

[0019] As a further preferred technical solution of the present invention, the optical probe is arranged on the axis of the catheter, and the distance between the optical probe and the electrodes on the periphery is equal.

[0020] As a preferred technical solution of the present invention, the terminal functional area includes an elastic spiral coil, one end of which is connected to the catheter, the angle between the spiral coil plane and the axial direction of the catheter is 80°~90°, and a plurality of electrodes are arranged at intervals along the length direction of the spiral coil.

[0021] As a further preferred technical solution of the present invention, the positioning sensor includes a first positioning sensor, a second positioning sensor, and a third positioning sensor. The first positioning sensor is arranged at the top of the spiral coil, the second positioning sensor is arranged on the spiral coil opposite to the first positioning sensor, the third positioning sensor is arranged at the end of the catheter connected to the spiral coil, and the optical probe is arranged between adjacent electrodes.

[0022] In summary, due to the adoption of the above technical solution, the beneficial effects of the present invention are: The present invention discloses a mapping and ablation system capable of detecting the depth of injury. Electrophysiological mapping can be achieved through the electrophysiological mapping unit and the electrode, ablation can be achieved through the ablation unit and the electrode, the position of the optical probe can be clearly determined through the positioning unit and the positioning sensor, and the image detected by the optical probe can be combined and displayed with the three-dimensional model diagram constructed by the positioning sensor. The impedance detection unit and the electrode can determine whether the optical probe is in contact with the tissue, thereby realizing scanning of the target tissue within the maximum depth range. The optical probe is used to detect the tissue condition of the ablation site, so that the operator can have an intuitive grasp of the internal structure and injury condition of the tissue before and after ablation. Optical coherence imaging, magnetic positioning, and impedance detection cooperate with each other, and the detection results are more accurate, the detection depth is deeper, the range is larger, and the use is more convenient. The operator can be provided with the tissue structure and ablation injury condition of the contact site in real time without changing the original surgical procedure, and the ablation process is safer and the ablation effect is easier to grasp. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 is a schematic diagram of the structure of the mapping and ablation system capable of detecting the lesion depth in Example 1; Figure 2 is a schematic diagram of the terminal functional area in Example 1; Figure 3 This is a reference diagram of the use status of the terminal functional area in Example 1; Figure 4 is a schematic diagram of the structure of a mapping and ablation system capable of detecting lesion depth in Example 2; Figure 5 This is a reference diagram of the use status of the terminal functional area in Example 2; Figure 6 is a schematic diagram of the structure of a mapping and ablation system capable of detecting lesion depth in Example 3; Figure 7 Schematic diagram of the terminal functional area in Example 3 Figure 1 ; Figure 8 Schematic diagram of the terminal functional area in Example 3 Figure 2 .

[0024] Markings in the figure: 100-terminal functional area, 101-head end, 102-proximal end, 103-electrode arm, 104-helical coil; 200 - electrode, 201 - first electrode, 202 - second electrode, 203 - third electrode, 204 - fourth electrode; 301 - first positioning sensor, 302 - second positioning sensor, 303 - third positioning sensor; 400-optical probe, 401-first optical probe, 402-second optical probe; 500-Organization. DETAILED DESCRIPTION

[0025] The present invention is further described in detail below in conjunction with test examples and specific implementation methods. However, this should not be understood as the scope of the above subject matter of the present invention being limited to the following embodiments, and all technologies realized based on the content of the present invention belong to the scope of the present invention.

[0026] Unless otherwise specified, in the description of the specific embodiments of the present invention, the terms indicating the orientation or position relationship such as "up", "down", "left", "right", "center", "inside", "outside", etc. are all expressions based on the orientation or position relationship shown in the drawings, or are the orientation or position relationship when the invented product / equipment / device is usually used. These terms of orientation or position relationship are only for the convenience of describing the scheme of the present invention or simplifying the description in the specific embodiments, so as to facilitate the technicians to quickly understand the scheme, and do not indicate or imply that a specific device / component / element must have a specific orientation, or be constructed and operated in a specific position relationship, and therefore cannot be understood as a limitation on the present invention.

[0027] In addition, if the terms "horizontal", "vertical", "overhanging", "parallel" and the like appear, it does not mean that the corresponding devices / components / elements are required to be absolutely horizontal or vertical or overhanging or parallel, but may be slightly tilted or have deviations. For example, "horizontal" only means that its direction is more horizontal than "vertical", and does not mean that the structure must be completely horizontal, but may be slightly tilted. Alternatively, it can be simplified to mean that the corresponding devices / components / elements are set in directions such as "horizontal", "vertical", "overhanging", "parallel", etc., and can have an error / deviation of ±10% relative to the corresponding direction setting, more preferably an error / deviation within ±8%, more preferably an error / deviation within ±6%, more preferably an error / deviation within ±5%, and more preferably an error / deviation within ±4%. As long as the corresponding device / component / element is within the error / deviation range, it can still achieve its role in the scheme of the present invention.

[0028] In addition, the expressions “first”, “second”, “third”, etc., which appear in the terms, are merely used to distinguish the description of the same or similar components and should not be understood as emphasizing or implying the relative importance of specific components.

[0029] In addition, in the description of the embodiments of the present invention, "several", "plurality" and "a number" represent at least 2. It can be any number such as 2, 3, 4, 5, 6, 7, 8, 9, and even more than 9.

[0030] In addition, in the description of the technical solution of the present invention, unless otherwise clearly specified / defined / restricted, the terms "set", "install", "connect", "connected", "provided with", "laid", and "arranged" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection, and can be welding, riveting, bolting, threading, and other commonly used connection means in the field. This connection can be a mechanical connection, an electrical connection, or a communication connection; it can be a direct connection, or an indirect connection through an intermediate medium, and it can be the internal connection of two elements.

[0031] In the related technology, the existing electrophysiological ablation equipment cannot provide the operator with an intuitive and accurate reference of the tissue damage range. At the same time, the use of optical coherence imaging combined with the catheter is easily disturbed by blood flow, and the detection position and direction need to be precisely controlled. Figures 1 to 8 To elaborate.

[0032] Example 1 like Figures 1 to 3 As shown, a mapping and ablation system capable of detecting the depth of injury described in the present invention includes a catheter, an ablation unit, a positioning unit, an electrophysiological mapping unit, an optical detection unit and an impedance detection unit.

[0033] The distal end of the catheter is provided with a terminal functional area 100, and the proximal end of the catheter is provided with a control handle. The terminal functional area 100 is connected to the control handle through a tube body, and the control handle can control the terminal functional area 100 to be placed at different positions of the patient's heart.

[0034] The terminal functional area 100 is provided with a plurality of electrodes 200, at least two positioning sensors, and at least one optical probe 400; the electrode 200 is used for mapping and ablation; the positioning sensor includes a coil structure, and at least two of the coil structures are arranged at a certain angle; the optical probe 400 is used for optical scanning of the contacted tissue 500; the optical probe 400, the positioning sensor, and the electrode 200 have a fixed position relationship; the electrode 200 limits the ablation range, and the optical probe 400 is installed within the ablation range.

[0035] The ablation unit is connected to the electrode 200 , and provides ablation energy to the electrode 200 .

[0036] The positioning unit is connected to the catheter, and the coil structure of the positioning sensor generates an induced current when moving in a three-dimensional magnetic field. The positioning unit is used to receive the induced current and calculate and process it to display the position and shape of the terminal functional area 100, as well as to identify the offset and rotation direction of the terminal functional area 100.

[0037] The electrophysiological mapping unit is connected to the electrode 200 , and the electrophysiological mapping unit acquires electrophysiological signals through the electrode 200 .

[0038] The optical detection unit is connected to the optical probe 400 via an optical fiber, and the optical detection unit is used for optical coherence tomography.

[0039] The impedance detection unit is connected to the electrode 200. The impedance detection unit collects impedance information of the surrounding tissue 500 at different frequencies through each of the electrodes 200, and then solves the frequency response coefficient of each position of the electrode 200. Since the impedance of the heart tissue and blood respond differently to the frequency, the impedance detection unit can be used to identify whether the electrode 200 is in contact with the tissue 500.

[0040] The positioning unit can calculate the position of the coil structure in the magnetic field through the change of the induced current. By using the function of the positioning sensor, the position and shape of the terminal functional area 100 can be displayed, and the position, shape, voltage distribution and electrical conduction relationship diagram of each part of the heart can be constructed for the operator to observe. The positioning sensor has a relatively fixed positional relationship with other components of the terminal functional area 100. The positioning unit can realize the display of the position and shape of the positioning sensor and other components that have an inherent positional relationship with the positioning sensor by receiving, calculating and processing the induced current.

[0041] Good contact is still essential for optical coherence imaging because the penetration depth of light into the tissue 500 is limited and is easily affected by blood. When the optical probe 400 is perpendicular to the interface of the tissue 500 and is well attached to the tissue 500, the maximum detection depth can be achieved in theory. When the optical probe 400 is parallel to the interface of the tissue 500, or when blood is present between the optical probe 400 and the tissue 500, information about the tissue 500 may not be detected.

[0042] Optical coherence imaging belongs to the optical detection unit. First, light is emitted from the light source and is divided into a reference beam and a detection beam through the beam splitter of the Michelson interferometer. The detection beam continues to be transmitted along the optical path to the optical probe 400 and enters the tissue 500 that is attached to the optical probe 400. The optical reflection (scattering) of the structure of the human tissue 500 has a spatial variation characteristic. The reflected light returns through the optical fiber and interferes with the reference light to present a specific interference pattern. The optical signal processing unit of the signal processing center analyzes and images the pattern to reconstruct a three-dimensional image within a certain depth range of the tissue 500. Therefore, through optical coherence tomography of the tissue 500, the internal tissue 500 structure (such as myocardium, fat, blood vessels, nerves, etc.) of the ablation site can be identified, and the damage after ablation can also be detected (the tissue 500 after ablation has different optical properties from normal tissue). As mentioned above, optical tomography is weak coherent light imaging, with limited detection depth and easily affected by the blood environment.

[0043] For example, Figure 1 As shown, the terminal functional area 100 is a linear structure, including a head end 101 and a proximal end 102, and a plurality of the electrodes 200 are arranged at intervals along the length direction of the terminal functional area 100. The linear structure is soft and can be actively bent by adjustment, or passively deformed to conform to the tissue 500; each electrode 200 and other nearby electrodes 200 form an electrode pair to collect electrophysiological signals, and the signals are transmitted to the electrophysiological mapping unit via the internal wire of the catheter to complete the electrophysiological mapping of the heart; the electrodes 200 can also discharge each other to achieve tissue 500 ablation, and the ablation unit transmits energy to the electrode 200 and forms an electric field around the electrode 200, and the tissue 500 within a specific electric field strength range is destroyed and loses its activity, thereby blocking signal transmission, and the operator can select any one or more pairs of electrodes 200 to discharge as needed.

[0044] In an optional embodiment, at least one optical probe 400 is provided between adjacent electrodes 200; generally speaking, since the spacing between adjacent electrodes 200 is ten millimeters to several tens of millimeters, usually only one optical probe 400 is required to be provided between adjacent electrodes 200 in one direction, and one optical probe 400 may be provided in four directions, namely, four optical probes 400 are provided between adjacent electrodes 200, and the four optical probes 400 may be provided on the same cross section, or may be provided in a staggered manner along the length direction of the terminal functional area 100. Of course, if there is a very high demand for detection accuracy, a plurality of optical probes 400 can be arranged in one direction between adjacent electrodes 200, and these plurality of optical probes 400 are also arranged at intervals along the length direction of the terminal functional area 100; or, 4, 6, 8, 10 or 12 optical probes 400 are evenly or unevenly distributed circumferentially of the catheter between adjacent electrodes 200. For example, the optical probes 400 can be densely arranged in the catheter area that often needs to be in contact, and the optical probes 400 can be sparsely arranged in the catheter area that is relatively seldom in contact.

[0045] For example, Figure 3 As shown, the electrode 200 includes a first electrode 201, a second electrode 202, a third electrode 203, and a fourth electrode 204. The first electrode 201 is a head electrode and is disposed at the head end 101. The first electrode 201, the second electrode 202, the third electrode 203, and the fourth electrode 204 are sequentially arranged from the head end 101 to the proximal end 102. The optical probe 400 includes a first optical probe 401 and a second optical probe 402. The first optical probe 401 is disposed on the catheter between the first electrode 201 and the second electrode 202, and the second optical probe 402 is disposed on the catheter between the third electrode 203 and the fourth electrode 204.

[0046] For example, Figure 1 As shown, the positioning sensor includes a first positioning sensor 301, a second positioning sensor 302, and a third positioning sensor 303. The first positioning sensor 301 and the second positioning sensor 302 are arranged at the head end 101, and the coil structures of the first positioning sensor 301 and the second positioning sensor 302 are arranged at a certain angle, and the third positioning sensor 303 is arranged at the proximal end 102; the position and shape of the entire terminal functional area 100 can be displayed by the three positioning sensors, and the first positioning sensor 301 and the second positioning sensor 302 distributed at a certain angle can also identify the direction of rotation and bending of the catheter.

[0047] For example, Figure 2 As shown, the terminal functional area 100 is divided into four quadrants along the axis, the first quadrant is defined as the direction of the catheter bending deflection, the second quadrant and the fourth quadrant are defined as two adjacent directions of the catheter deflection direction, and the third quadrant is defined as the direction away from the catheter deflection direction. With this structural setting, the position and detection direction of the optical probe 400 installed on the catheter or the electrode can be quickly identified.

[0048] In an optional embodiment, if Figure 3 As shown, the first optical probe 401 is located between the first electrode 201 and the second electrode 202 along the axial direction of the catheter, and is located in the third quadrant along the circumferential direction of the catheter. The detection direction of the first optical probe 401 is perpendicular to the axial direction of the catheter. Figure 3 As shown by the arrow L1; the second optical probe 402 is located in the middle of the third electrode 203 and the fourth electrode 204 along the axial direction of the catheter, and is located in the third quadrant along the circumference of the catheter. The detection direction of the second optical probe 402 is perpendicular to the axial direction of the catheter, as shown in FIG. Figure 3 As shown by the arrow L2 in the middle. The tube bodies in different quadrants can be set to different colors for easy distinction. With the above positioning function, the operator can visually rotate the catheter and make the optical probe 400 face the target tissue 500.

[0049] The detection direction can be used to determine whether the optical probe 400 is facing the tissue. However, the optical probe 400 cannot be ensured to be in the best position simply by the shape. Figure 3 As shown, the detection direction of the first optical probe 401 is facing the tissue 500, and the catheter is bent in the corresponding direction. However, at this time, the first optical probe 401 is not in contact with the tissue 500, and the ablation depth cannot be detected. The impedance detection function can be combined to determine whether the optical probe 400 is close to the tissue 500. Figure 3 When the impedance of the third electrode 203 and the fourth electrode 204 changes and is identified as being in contact with the tissue 500, the second optical probe 402 installed between the third electrode 203 and the fourth electrode 204 is likely to be in good contact with the tissue 500.

[0050] The present embodiment describes a mapping and ablation system capable of detecting the depth of injury. Electrophysiological mapping can be performed through the electrophysiological mapping unit and the electrode 200. Ablation can be performed through the ablation unit and the electrode 200. The position of the optical probe 400 can be determined through the positioning unit and the positioning sensor. The image detected by the optical probe 400 can be combined and displayed with the three-dimensional model constructed by the positioning sensor. Whether the optical probe 400 contacts the tissue can be determined through the impedance detection unit and the electrode 200. The detection unit can cooperate with the optical detection unit to realize optical scanning of the target tissue 500 within the maximum depth range; the optical probe 400 is used to detect the condition of the tissue 500 at the ablation site, so that the operator can have an intuitive grasp of the internal structure and damage of the tissue 500 before and after ablation. The three elements of optical coherence imaging, magnetic positioning, and impedance detection cooperate with each other, and the detection results are more accurate, the detection depth is deeper, the range is larger, and the use is more convenient. Without changing the original surgical procedure, the operator can be provided with the structure of the tissue 500 and the ablation damage condition of the contact site in real time, the ablation process is safer, and the ablation effect is easier to grasp.

[0051] Example 2 like Figures 4 to 5 As shown, the mapping and ablation system capable of detecting the damage depth described in the present invention is different from that in Example 1 in that, in this embodiment, the terminal functional area 100 includes a plurality of electrode arms 103 .

[0052] The overall configuration of the terminal functional area 100 is supported by an internal elastic support member and can be transformed between an expanded state and a contracted state; in the expanded state, each of the electrode arms 103 is located almost in the same plane.

[0053] The electrode arms 103 are arranged in parallel, and each electrode arm 103 is provided with a plurality of electrodes 200 . One end of all the electrode arms 103 is connected to the catheter, and the other ends are connected to each other. The positioning sensor is arranged in the electrode arm 103 , and the optical probe 400 is arranged on the electrode arm 103 or on the film between the electrode arms 103 .

[0054] For example, Figure 4As shown, the length direction of the electrode arm 103 is arranged along the axis direction of the catheter, and all the electrode arms 103 are symmetrically arranged along the axis of the catheter. The first electrode 201 can form an electrode pair with the second electrode 202 adjacent to it in the longitudinal direction, and the first electrode 201 can also form an electrode pair with the third electrode 203 adjacent to it in the transverse direction to collect electrophysiological signals or ablate tissue. When all the electrodes 200 form an electrode pair with the electrodes 200 adjacent to them in the transverse and longitudinal directions and discharge, an approximately planar electric field area is formed around the electrodes 200.

[0055] For example, Figure 4 As shown, the positioning sensor includes a first positioning sensor 301, a second positioning sensor 302, and a third positioning sensor 303. The first positioning sensor 301 and the second positioning sensor 302 are symmetrically arranged on the two outermost electrode arms 103, and the coil structures of the first positioning sensor 301 and the second positioning sensor 302 are arranged at a certain angle, and the third positioning sensor 303 is arranged at the end of the catheter connected to the electrode arm 103. The calculation and processing of the position information between the three positioning sensors can define the changes in the position and morphology of the mapping / ablation plane, so that the operator can more intuitively observe the movement, rotation, and abutment of the terminal functional area 100.

[0056] like Figure 4 and Figure 5 As shown, the planar end functional area 100 can map and ablate the tissue 500 in the covered area, and the optical probe 400 can be distributed at any position on the plane, and the light emission direction is perpendicular to the plane, such as Figure 5 As shown by the middle arrow L3, the elastic support member enables the terminal functional area 100 to deform when subjected to force; different degrees of deformation of the terminal functional area 100 represent different forces, and the system can simulate and calculate the magnitude and direction of the force according to the changes in the shape of the elastic support member. Combined with the impedance detection function, the adhesion effect between the optical probe 400 and the tissue 500 can be more accurately determined.

[0057] For example, Figure 4 and Figure 5 As shown, the optical probe 400 is arranged on the axis of the catheter, and the distance between the optical probe 400 and the peripheral electrode 200 is equal. In this case, as long as the electrodes 200 around the optical probe 400 are well attached to the tissue 500, it can be ensured that the optical probe 400 is facing the tissue 500 and is well attached.

[0058] Example 3 like Figures 6 to 8As shown, the mapping and ablation system capable of detecting the lesion depth described in the present invention is different from Example 1 in that, in this embodiment, the terminal functional area 100 includes an elastic spiral ring 104 .

[0059] One end of the spiral coil 104 is connected to the catheter, and the angle between the plane of the spiral coil 104 and the axial direction of the catheter is 80°~90°. A plurality of electrodes 200 are arranged at intervals along the length direction of the spiral coil 104. Each electrode 200 and other nearby electrodes 200 can form an electrode pair to collect electrophysiological signals. The electrodes 200 can also discharge each other to achieve tissue 500 ablation; when all the electrodes 200 discharge each other, a circular electric field is formed. The operator can also select any two or more adjacent electrodes 200 to discharge as needed to control the ablation area.

[0060] For example, Figure 6 As shown, the positioning sensor includes a first positioning sensor 301, a second positioning sensor 302, and a third positioning sensor 303. The first positioning sensor 301 is arranged at the top of the spiral coil 104, the second positioning sensor 302 is arranged on the spiral coil 104 opposite to the first positioning sensor 301, and the third positioning sensor 303 is arranged at the end of the catheter connected to the spiral coil 104. The optical probe 400 is arranged between adjacent electrodes 200. The three positioning sensors can define the position and shape of the terminal functional area 100. The annular mapping and ablation distal end is mainly used for annular mapping and ablation of lumen or lumen-like areas. The part that contacts the tissue 500 is usually the outer ring of the annular ring. Therefore, the optical probe 400 can be installed on any part outside the spiral coil 104, and the center of the light beam is emitted radially outward along the spiral coil 104, as shown in FIG. Figure 6 As shown by the arrow L4.

[0061] The supporting member inside the spiral coil 104 is elastic and will deform in different directions and degrees under different external forces. The deformation can be identified and displayed through the positioning function, and the direction of force can also be indicated by the change in the shape of the spiral coil 104.

[0062] When the spiral coil 104 is deformed, the possible force direction of the spiral coil 104 is as follows: Figure 7 and Figure 8 As shown by arrow F in FIG. Through the magnetic positioning function and the analysis of deformation and force, the operator can visually rotate the catheter to make the outer ring of the spiral ring 104 face the target tissue, and combined with impedance detection, it can be more accurately determined whether the optical probe 400 is in contact with the tissue 500.

[0063] For example, when Figure 6 When the two electrodes 200 with darker colors are in good contact with the tissue 500, the optical probe 400 installed between the two electrodes 200 must also be in good contact with the tissue 500. That is, when the spiral coil 104 has no axial deformation and the electrodes 200 around the optical probe 400 are in good contact with the tissue 500, it means that the optical probe 400 is facing the tissue 500 and can detect the maximum depth.

[0064] The optical probe 400 may be one or more, and the optical probe 400 may be defined as a special shape or color in the system, and the system may display the electrode 200 after being attached to the tissue 500 as a feature different from other electrodes 200 for easy identification. The above positioning technology, impedance detection technology and optical scanning technology can provide better surgical guidance for the surgeon.

[0065] The above embodiments are only used to better illustrate how the disclosed content is implemented. According to the use requirements, the terminal functional area 100 is not limited to the above configuration. For example, the electrode arm 103 may be straight or curved, single or multiple arranged in a certain structure. The ablation area formed may be point-shaped, line-shaped, ring-shaped or plane-shaped, etc. The number and installation position of the optical probe 400 are also diverse, depending on actual needs.

[0066] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in the protection scope of the present invention.

Claims

1. A mapping and ablation system capable of detecting lesion depth, characterized in that: include: A catheter, the distal end of which is provided with a terminal functional area (100), the terminal functional area (100) being provided with a plurality of electrodes (200), at least two positioning sensors, and at least one optical probe (400); the electrodes (200) being used for mapping and ablation; the positioning sensor comprising a coil structure, at least two of the coil structures being arranged at a certain angle; the optical probe (400) being used for optically scanning the contacted tissue (500); the optical probe (400), the positioning sensor, and the electrode (200) having a fixed position relationship; an ablation unit, connected to the electrode (200), the ablation unit providing ablation energy to the electrode (200); A positioning unit connected to the catheter, wherein the coil structure of the positioning sensor generates an induced current when moving in a three-dimensional magnetic field, and the positioning unit is used to receive the induced current and perform calculation processing to display the position and shape of the terminal functional area (100), and to identify the offset and rotation direction of the terminal functional area (100); An electrophysiological mapping unit, connected to the electrode (200), the electrophysiological mapping unit acquiring an electrophysiological signal through the electrode (200); An optical detection unit, connected to the optical probe (400) via an optical fiber, the optical detection unit being used for optical coherence tomography; An impedance detection unit is connected to the electrodes (200), and the impedance detection unit collects impedance information of the surrounding tissue (500) at different frequencies through each of the electrodes (200), and then solves the frequency response coefficient of the position of each of the electrodes (200). The impedance detection unit is used to identify whether the electrodes (200) are in contact with the tissue (500).

2. The mapping and ablation system capable of detecting lesion depth according to claim 1, characterized in that: The terminal functional area (100) is a linear structure, comprising a head end (101) and a proximal end (102), and a plurality of electrodes (200) are arranged at intervals along the length direction of the terminal functional area (100).

3. The mapping and ablation system capable of detecting lesion depth according to claim 2, characterized in that: The electrode (200) comprises a first electrode (201), a second electrode (202), a third electrode (203), and a fourth electrode (204); the first electrode (201) is a head electrode and is arranged at the head end (101); the first electrode (201), the second electrode (202), the third electrode (203), and the fourth electrode (204) are arranged in sequence from the head end (101) to the proximal end (102).

4. The mapping and ablation system capable of detecting lesion depth according to claim 2, characterized in that: At least one optical probe (400) is disposed between adjacent electrodes (200).

5. The mapping and ablation system capable of detecting lesion depth according to claim 2, characterized in that: The positioning sensor comprises a first positioning sensor (301), a second positioning sensor (302), and a third positioning sensor (303); the first positioning sensor (301) and the second positioning sensor (302) are arranged at the head end (101); the coil structures of the first positioning sensor (301) and the second positioning sensor (302) are arranged at a certain angle; and the third positioning sensor (303) is arranged at the proximal end (102).

6. The mapping and ablation system capable of detecting lesion depth according to claim 1, characterized in that: The terminal functional area (100) comprises a plurality of electrode arms (103), the electrode arms (103) are arranged in parallel and located in the same plane, each electrode arm (103) is provided with a plurality of electrodes (200), one end of all the electrode arms (103) are connected to the catheter, and the other ends are connected to each other, the positioning sensor is arranged in the electrode arm (103), and the optical probe (400) is arranged on the electrode arm (103) or on the coating between the electrode arms (103).

7. The mapping and ablation system capable of detecting lesion depth according to claim 6, characterized in that: The length direction of the electrode arm (103) is arranged along the axial direction of the catheter, and all the electrode arms (103) are symmetrically arranged along the axis of the catheter. The positioning sensor includes a first positioning sensor (301), a second positioning sensor (302), and a third positioning sensor (303). The first positioning sensor (301) and the second positioning sensor (302) are symmetrically arranged on the two outermost electrode arms (103), and the coil structures of the first positioning sensor (301) and the second positioning sensor (302) are respectively arranged at a certain angle. The third positioning sensor (303) is arranged at the end of the catheter connected to the electrode arm (103).

8. The mapping and ablation system capable of detecting lesion depth according to claim 7, characterized in that: The optical probe (400) is arranged on the axis of the catheter, and the distance between the optical probe (400) and the electrodes (200) at the periphery is equal.

9. The mapping and ablation system capable of detecting lesion depth according to claim 1, characterized in that: The terminal functional area (100) comprises an elastic spiral coil (104), one end of which is connected to the catheter, the angle between the plane of the spiral coil (104) and the axial direction of the catheter is 80° to 90°, and a plurality of electrodes (200) are arranged at intervals along the length direction of the spiral coil (104).

10. The mapping and ablation system capable of detecting lesion depth according to claim 9, characterized in that: The positioning sensor comprises a first positioning sensor (301), a second positioning sensor (302), and a third positioning sensor (303); the first positioning sensor (301) is arranged at the top of the spiral coil (104); the second positioning sensor (302) is arranged on the spiral coil (104) opposite to the first positioning sensor (301); the third positioning sensor (303) is arranged at the end of the catheter connected to the spiral coil (104); and the optical probe (400) is arranged between adjacent electrodes (200).

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