Mapping and ablation catheter capable of detecting injury depth

Abstract

The invention relates to the field of electrophysiology catheters, in particular to a mapping and ablation catheter capable of detecting injury depth, which comprises a head end, and at least one electrode for mapping and ablation is arranged on the head end; the positioning sensor assembly comprises at least two positioning sensors, each positioning sensor comprises a coil structure, the at least two coil structures are arranged at a certain included angle, and the positioning sensor assembly is used for displaying the position and form of the head end and recognizing the deviation and rotation direction of the head end; the pressure sensing assembly comprises strain gauges and an elastic body, the strain gauges are arranged on the periphery of the elastic body, and the pressure sensing assembly is used for detecting the pressure magnitude and direction of the head end; the at least one optical probe is used for performing optical scanning on the contacted tissue, and the optical probe, the positioning sensor assembly and the electrode have a fixed position relationship. Through the mutual cooperation of the optical probe, the positioning sensor assembly and the pressure sensing assembly, the detection result is more accurate, the detection depth is deeper, the range is larger, and the use is more convenient.

Description

Technical Field

[0001] The invention relates to the technical field of electrophysiological catheters, in particular to a mapping and ablation catheter 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 more intuitively detect the fine structure inside the tissue and directly show the degree of tissue damage. However, optical scanning is weak coherent light imaging, the detection depth is limited and 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 catheter 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 weak coherent light 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 catheter capable of detecting lesion depth comprises a head end, wherein the head end is provided with: at least one electrode for mapping and ablation; A positioning sensor assembly, comprising at least two positioning sensors, wherein the positioning sensor comprises a coil structure, wherein at least two of the coil structures are arranged at a certain angle, and the positioning sensor assembly is used to display the position and shape of the head end, and to identify the offset and rotation direction of the head end; A pressure sensing component, comprising a strain gauge and an elastic body, wherein a plurality of strain gauges are arranged on the periphery of the elastic body, and the pressure sensing component is used for detecting the magnitude and direction of the pressure at the head end; At least one optical probe is used to optically scan the contacted tissue, and the optical probe, the positioning sensor assembly and the electrode have a fixed position relationship.

[0006] When the coil structure of the positioning sensor assembly moves within the three-dimensional magnetic field provided by the supporting device, an induced current can be generated. The device 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 head end can be displayed in real time, the contours of various parts of the heart can be constructed, and the voltage distribution and electrical conduction relationship diagram can be completed in combination with the mapping function of the device for the operator to observe.

[0007] The pressure sensing component is arranged at the head end. Good contact is conducive to collecting more accurate electrophysiological signals and achieving more effective ablation effects on tissues. The operator can adjust the position of the catheter according to the pressure magnitude and direction measured by the system and select the appropriate contact force and direction. When the head end is in contact with the tissue, the elastomer is deformed, the strain gauge is stretched or squeezed and generates an induced current. The device can obtain the magnitude and direction of the pressure on the head end by analyzing and calculating the induced currents of multiple strain gauges at different positions, and display it.

[0008] 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.

[0009] By using a mapping and ablation catheter capable of detecting the depth of injury as described in the present invention, the position of the optical probe can be clearly determined through the positioning sensor component, and the image detected by the optical probe can be combined and displayed with the three-dimensional model diagram constructed by the positioning sensor component. Through the cooperation of the pressure sensing component, it can be clearly determined whether the optical probe contacts the tissue and the relationship between the detection direction and the tissue. The positioning sensor component and the pressure sensing component can be used to facilitate the operator to adjust the position of the optical probe, align it with the area of ​​interest, and use the optical probe 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. The optical probe, the positioning sensor component, and the pressure sensing component 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 tissue structure and ablation damage condition of the contact site in real time, the ablation process is safer, and the ablation effect is easier to grasp.

[0010] As a preferred technical solution of the present invention, the head end includes a shell, the top end of the shell is closed, and at least one detection hole is provided on the top end and / or the side wall of the shell. The optical probe is installed in the detection hole. The optical probe sends or receives weak coherent light and can perform optical scanning on tissue within a certain range of the contacted part.

[0011] First, light is emitted from the light source and is divided into a reference beam and a detection beam by the beam splitter of the Michelson interferometer. The detection beam is transmitted along the optical path to the optical probe and enters the tissue that is attached to the optical probe. The optical reflection (scattering) of the human tissue structure has spatial variation characteristics. The reflected light returns through the optical fiber and interferes with the reference light to present a specific interference pattern. By analyzing and imaging the pattern, a three-dimensional image within a certain depth range inside the tissue can be reconstructed. Therefore, by optical coherence scanning of the tissue, the internal tissue structure of the ablation site (such as myocardium, fat, blood vessels, nerves, etc.) can be identified, and the damage after ablation can also be detected (the tissue after ablation has different optical properties from normal tissue).

[0012] As a preferred technical solution of the present invention, the head end includes a shell, the top end of the shell is closed, the electrode includes a head electrode and at least one ring electrode, the head electrode is arranged at the top end of the shell, the ring electrode is sleeved on the shell, and there is a spacing between adjacent electrodes.

[0013] As a further preferred technical solution of the present invention, the optical probe is installed on the end face and / or side face of the head electrode, the positioning sensor assembly is installed in the shell, and the pressure sensing assembly is installed in the shell behind the head electrode.

[0014] As a further preferred technical solution of the present invention, the head electrode is divided into at least two areas along the circumferential direction and indicated by different colors, wherein the area corresponding to one color is defined as the direction of bending deflection of the shell.

[0015] As a further preferred technical solution of the present invention, the head electrode is evenly divided into four areas along the circumferential direction, which are indicated by red, yellow, green and blue respectively. The red area is defined as the direction of bending deflection of the shell, the yellow area and the green area are defined as two adjacent directions of the shell deflection direction, and the blue area is defined as the direction away from the shell deflection direction.

[0016] As a preferred technical solution of the present invention, the head end is columnar, sheet-shaped or ring-shaped.

[0017] As a preferred technical solution of the present invention, the mapping and ablation catheter capable of detecting the lesion depth further comprises a control handle, and the control handle is connected to the head end through a tube body.

[0018] As a preferred technical solution of the present invention, the mapping and ablation catheter capable of detecting the depth of injury is connected to a three-dimensional magnetic field module, an optical imaging module, a pressure detection module, and a display module; The three-dimensional magnetic field module is electrically connected to the positioning sensor component, and is used to generate a three-dimensional magnetic field and capture the induced current generated by the movement of the positioning sensor component in the magnetic field, and calculate the position of the positioning sensor component in the three-dimensional magnetic field; The optical imaging module is connected to the optical probe via an optical fiber, and the optical imaging module is used for optical coherence imaging; The pressure detection module is electrically connected to the pressure sensing component, and is used to capture the induced current of the strain gauge and calculate the magnitude and direction of the pressure on the head end; The display module is connected to the three-dimensional magnetic field module, the optical imaging module, and the pressure detection module, and is used to display the position of the head end, the pressure magnitude, direction, the constructed heart cavity model, and the tissue condition of the ablation site.

[0019] As a further preferred technical solution of the present invention, a pressure window is provided on the display module, and the pressure window displays in real time the pressure applied to the head end when it contacts the tissue, and the angle between the force direction of the head end and the light emitting direction of the optical probe.

[0020] In summary, due to the adoption of the above technical solution, the beneficial effects of the present invention are: The mapping and ablation catheter capable of detecting the depth of injury described in the present invention can clearly determine the position of the optical probe through the positioning sensor component, and can combine and display the image detected by the optical probe with the three-dimensional model diagram constructed by the positioning sensor component. Through the cooperation of the pressure sensing component, it can be clearly determined whether the optical probe contacts the tissue and the relationship between the detection direction and the tissue. The positioning sensor component and the pressure sensing component can be used to facilitate the operator to adjust the position of the optical probe, align it with the area of ​​interest, and use the optical probe 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. The optical probe, the positioning sensor component, and the pressure sensing component 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 tissue structure and ablation damage condition of the contact site in real time, the ablation process is safer, and the ablation effect is easier to grasp. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 A schematic diagram of possible detection directions of the catheter tip without pressure indication; Figure 2It is a schematic diagram of the structure of the catheter tip (the shell is hidden in some sections); Figure 3 Schematic diagram of the division of the head electrode; Figure 4 A schematic diagram of the device display interface during the use of the catheter (information not related to the content of this application is not shown); Figure 5 The use status of the catheter is suitable for detection Figure 1 ; Figure 6 The use status of the catheter is suitable for detection Figure 2 .

[0022] Markings in the figure: 10-head end, 11-head electrode, 12-ring electrode, 13-shell, 14-optical probe, 15-positioning sensor assembly, 16-pressure sensing assembly, 161-strain gauge, 162-elastic body; 20-tissue, 21-ablation lesion; 30-heart chamber model; 40-Pressure window. DETAILED DESCRIPTION

[0023] 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.

[0024] 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.

[0025] 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.

[0026] 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.

[0027] 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.

[0028] 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.

[0029] 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, optical coherence imaging is easily disturbed by blood flow, and the detection position and direction need to be precisely controlled. Figures 1 to 6 To elaborate.

[0030] Example 1 like Figures 2 to 6 As shown, a mapping and ablation catheter capable of detecting injury depth described in the present invention comprises a head end 10, a tube body and a control handle, wherein the control handle is connected to the head end 10 through the tube body, the head end 10 is located at the distal end of the tube body, and the control handle is located at the proximal end of the tube body.

[0031] In this field, the distal end refers to the front end part of the electrophysiological mapping catheter, that is, the part that first enters the human body, the proximal end refers to the end of the electrophysiological mapping catheter closer to the operator, and the head end is located at the distal end of the electrophysiological mapping catheter, that is, the end that enters the human body. Therefore, those skilled in the art can clearly and unambiguously know the meaning of the head end 10, and can understand that the end of the distal end of the tube body is the head end 10 of the electrophysiological mapping catheter.

[0032] The head end 10 is provided with at least one electrode, a positioning sensor assembly 15, a pressure sensing assembly 16, and at least one optical probe 14. The electrode is used for mapping and ablation, and the electrode limits the ablation range. The electrode can collect electrophysiological signals or transmit ablation energy to the contacted tissue, such as transmitting radio frequency energy, laser or high-voltage pulse electric field, which can inactivate and denature cells and thus block the energy transmitted by electrophysiological signals. The positioning sensor assembly 15 includes at least two positioning sensors, and the positioning sensor includes a coil structure, and at least two of the coil structures are arranged at a certain angle. The positioning sensor assembly 15 is used to display the position and shape of the head end 10, and to identify the offset and rotation direction of the head end 10. The pressure sensing assembly 16 includes a strain gauge 161 and an elastic body 162. Several strain gauges 161 are fixedly provided on the periphery of the elastic body 162. The pressure sensing assembly 16 is used to detect the pressure size and direction of the head end 10. The optical probe 14 is used to optically scan the contacted tissue 20. The optical probe 14, the positioning sensor component 15 and the electrode have a fixed position relationship. The optical probe 14 can be adjusted to be in contact with the tissue 20 under the guidance of the positioning sensor component 15 and the pressure sensing component 16.

[0033] The mapping and ablation catheter capable of detecting lesion depth is used together with matching equipment for electrophysiological signal mapping, tissue ablation and monitoring of ablation effects.

[0034] When the coil structure of the positioning sensor assembly 15 moves within the three-dimensional magnetic field provided by the supporting device, an induced current can be generated. The device can calculate the position of the coil structure in the magnetic field through the change of the induced current. Using the function of the positioning sensor, the position and shape of the head end 10 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.

[0035] The pressure sensing component 16 is arranged at the head end 10. Good contact is conducive to collecting more accurate electrophysiological signals and achieving more effective ablation effect on the tissue 20. The operator can adjust the catheter position according to the pressure magnitude and direction measured by the system and select the appropriate contact force and direction. When the head end 10 is in contact with the tissue 20, the elastomer 162 is deformed, the strain gauge 161 is stretched or squeezed and generates an induced current. The device can obtain the magnitude and direction of the pressure on the head end 10 by analyzing and calculating the induced currents of multiple strain gauges 161 at different positions, and display it.

[0036] Good contact is still essential for optical coherence imaging because the penetration depth of light into tissue is limited and is easily affected by blood. When the optical probe 14 is perpendicular to the interface of tissue 20 and well attached to tissue 20, the maximum detection depth can be achieved in theory. When the optical probe 14 is parallel to the interface of tissue 20, or when there is blood between the optical probe 14 and tissue 20, information about tissue 20 may not be detected.

[0037] In an optional embodiment, if Figure 2 As shown, the mapping and ablation catheter capable of detecting the damage depth adopts a commonly used single-point ablation catheter, wherein the head end 10 includes a shell 13, the top end of which is closed, and at least one detection hole is provided on the top end and / or the side wall of the shell 13, wherein the optical probe 14 is installed in the detection hole, and the optical probe 14 sends or receives weak coherent light, and can optically scan the tissue 20 within a certain range of the contacted part.

[0038] First, light is emitted from a light source and is divided into a reference beam and a detection beam by a beam splitter of a Michelson interferometer. The detection beam is transmitted along the optical path to the optical probe 14 and enters the tissue 20 that is attached to the optical probe 14. The optical reflection (scattering) of the structure of human tissue 20 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. A three-dimensional image within a certain depth range of the tissue 20 can be reconstructed by analyzing and imaging the pattern. Therefore, the structure of the internal tissue 20 (such as myocardium, fat, blood vessels, nerves, etc.) of the ablation site can be identified by optical coherence scanning of the tissue 20, and the damage after ablation can also be detected (the tissue after ablation has different optical properties from the normal tissue 20).

[0039] In an optional embodiment, if Figure 2As shown, the mapping and ablation catheter capable of detecting the depth of injury adopts a commonly used single-point ablation catheter, wherein the head end 10 includes a shell 13, the top end of the shell 13 is closed, the electrodes include a head electrode 11 and at least one ring electrode 12, the head electrode 11 is disposed at the top end of the shell 13, the ring electrode 12 is sleeved on the shell 13, and there is a spacing between adjacent electrodes, the optical probe 14 is mounted on the end face and / or side of the head electrode 11, the positioning sensor assembly 15 is mounted in the shell 13, and the pressure sensing assembly 16 is mounted in the shell 13 behind the head electrode 11. The head electrode 11 and the ring electrode 12 can collect electrophysiological signals of the tissue 20 and transmit them to supporting equipment through their respective wires. The head electrode 11 can also transmit energy (such as radio frequency energy or high-voltage pulse electric field energy) to ablate the tissue 20. For the convenience of display, Figure 2 The housing 13 of the pressure sensing component 16 is removed.

[0040] In an optional embodiment, the head electrode 11 is divided into at least two regions along the circumferential direction and indicated by different colors, wherein the region corresponding to one color is defined as the direction in which the shell 13 is bent and deflected. Figure 3 As shown, the head electrode 11 is evenly divided into four areas along the circumferential direction, which are indicated by red (R), yellow (Y), green (G), and blue (B), respectively. The red area is defined as the direction of bending and deflection of the shell 13, the yellow area and the green area are defined as two adjacent directions of the deflection direction of the shell 13, and the blue area is defined as the direction away from the deflection direction of the shell 13.

[0041] In an optional embodiment, the head end 10 is columnar, sheet-shaped or ring-shaped.

[0042] For example, Figure 4The figure shows various models and related function display interfaces observed by the operator. Under the action of the positioning sensor assembly 15, the model of the head end 10 is displayed, and the heart cavity model 30 is established by recording the movement trajectory of the head end 10. The positions of the components in the head end 10 are relatively fixed, so the positions of the head electrode 11, the central axis of the catheter and the optical probe 14 can be defined under the action of the positioning sensor assembly 15. At the same time, because the direction of the light beam is in a fixed angle relationship with the central axis of the catheter, the central direction of the detection beam can be displayed (hollow arrow L in the figure). Under the action of the pressure sensing assembly 16, the pressure applied to the head end 10 when it contacts the tissue 20 is displayed in real time in the pressure window 40, and the direction of the force is indicated at the head end 10 in the form of an arrow (solid arrow F in the figure). The system can calculate the angle θ between the force direction and the central direction of the detection light. When the angle and the contact force meet the set values ​​at the same time, the system will prompt that the contact is good, and the maximum depth of the tissue 20 can be detected at this time. For example, the contact force may be set to 5g~10g, and the angle may be set to 175°~185°; the above setting parameters are examples, and the thresholds may be set in the system according to actual conditions.

[0043] For example, Figure 5 As shown, when the optical probe 14 is located on the side of the head electrode 11, the center direction of the light beam is perpendicular to the catheter axis. The side where the optical probe 14 is located is flat against the tissue 20 so that the pressure direction and the center direction of the light beam are parallel.

[0044] For example, Figure 6 As shown, when the optical probe 14 is located at the end surface of the head electrode 11, the center direction of the light beam is parallel to the catheter axis. The optical probe 14 faces the tissue 20 so that the pressure direction is parallel to the center direction of the light beam.

[0045] The above examples are intended to illustrate how the various components of the head end 10 cooperate with each other to achieve maximum detection of the tissue 20. The shape of the head end 10 and the positional relationship of the various components may be different.

[0046] In an optional embodiment, during or after ablation, the operator can attempt to scan the same location multiple times and select appropriate scanned images to display on the three-dimensional model. The operator can also adjust ablation parameters according to the detected internal tissue 20 conditions.

[0047] Exemplarily, the mapping and ablation catheter capable of detecting the depth of injury is connected to a three-dimensional magnetic field module, an optical imaging module, a pressure detection module, and a display module.

[0048] The three-dimensional magnetic field module is electrically connected to the positioning sensor component 15, and is used to generate a three-dimensional magnetic field and capture the induced current generated by the movement of the positioning sensor component 15 in the magnetic field, and calculate the position of the positioning sensor component 15 in the three-dimensional magnetic field.

[0049] The optical imaging module is connected to the optical probe 14 via an optical fiber, and the optical imaging module is used for optical coherence imaging.

[0050] The pressure detection module is electrically connected to the pressure sensing component 16 , and is used to capture the induced current of the strain gauge 161 and calculate the magnitude and direction of the pressure on the head end 10 .

[0051] like Figure 4 As shown, the display module is connected to the three-dimensional magnetic field module, the optical imaging module, and the pressure detection module, and the display module is used to display the position of the head end 10, the pressure size, direction, the constructed heart cavity model 30, and the condition of the ablation site tissue 20.

[0052] In an optional embodiment, if Figure 4 As shown, the display module is provided with a pressure window 40 , which displays in real time the pressure applied to the head end 10 when it contacts the tissue 20 , and the angle between the force direction of the head end 10 and the light emitting direction of the optical probe 14 .

[0053] In the present embodiment, a mapping and ablation catheter capable of detecting the depth of injury is described. The position of the optical probe 14 can be clearly determined by the positioning sensor assembly 15, and the image detected by the optical probe 14 can be combined and displayed with the three-dimensional model diagram constructed by the positioning sensor assembly 15. The pressure sensing assembly 16 cooperates to determine whether the optical probe 14 contacts the tissue 20 and the relationship between the detection direction and the tissue 20. The positioning sensor assembly 15 and the pressure sensing assembly 16 can be used to facilitate the operator to adjust the position of the optical probe 14, align it with the area of ​​interest, and use the optical probe 14 to detect the situation of the tissue 20 at the ablation site, so that the operator can have an intuitive grasp of the internal structure and injury of the tissue 20 before and after ablation. The optical probe 14, the positioning sensor assembly 15, and the pressure sensing assembly 16 cooperate with each other, so that the detection result is 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 20 at the contact site and the ablation injury situation in real time, so that the ablation process is safer and the ablation effect is easier to grasp.

[0054] Comparative Example 1 like Figure 1As shown, without the coordinated action of the positioning sensor assembly 15 and the pressure sensing assembly 16 , the detection angle of the head end 10 to the tissue 20 may be arbitrary or roughly estimated.

[0055] The head electrode 11 of the head end 10 discharges against the tissue 20 and forms an ablation focus 21. Although the head electrode 11 is in good contact with the tissue 20 and the range of the ablation focus 21 is also large, the detection direction α of the optical probe 14 deviates from the direction β of the maximum damage depth. At this time, the damage range of the detected tissue 20 is limited and cannot achieve the expected purpose. When the optical probe 14 deviates far from the damage point, it may not even be able to detect the internal structure image of the tissue 20 due to poor adhesion to the tissue 20. The morphology of the tissue 20 is irregular. Even if the position of the head end 10 is readjusted after ablation to scan the ablation site, it is difficult for the operator to align the optical probe 14 with the ablation tissue 20 by naked eye observation.

[0056] The above-mentioned problem can be solved by using a mapping and ablation catheter capable of detecting the lesion depth as described in Example 1.

[0057] 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 catheter capable of detecting lesion depth, comprising a tip (10), characterized in that: The head end (10) is provided with: at least one electrode for mapping and ablation; A positioning sensor assembly (15) comprising at least two positioning sensors, wherein the positioning sensor comprises a coil structure, wherein at least two of the coil structures are arranged at a certain angle, and the positioning sensor assembly (15) is used to display the position and shape of the head end (10), and to identify the offset and rotation direction of the head end (10); A pressure sensing component (16), comprising a strain gauge (161) and an elastic body (162), wherein a plurality of strain gauges (161) are arranged on the periphery of the elastic body (162), and the pressure sensing component (16) is used to detect the magnitude and direction of the pressure of the head end (10); At least one optical probe (14) is used to optically scan the contacted tissue (20), and the optical probe (14), the positioning sensor assembly (15) and the electrode have a fixed position relationship.

2. The mapping and ablation catheter capable of detecting lesion depth according to claim 1, characterized in that: The head end (10) comprises a shell (13), the top end of the shell (13) is closed, at least one detection hole is provided on the top end and / or the side wall of the shell (13), the optical probe (14) is installed in the detection hole, and the optical probe (14) sends or receives weak coherent light.

3. The mapping and ablation catheter capable of detecting lesion depth according to claim 1, characterized in that: The head end (10) comprises a shell (13), the top end of the shell (13) is closed, the electrodes comprise a head electrode (11) and at least one ring electrode (12), the head electrode (11) is arranged at the top end of the shell (13), the ring electrode (12) is sleeved on the shell (13), and there is a spacing between adjacent electrodes.

4. The mapping and ablation catheter capable of detecting lesion depth according to claim 3, characterized in that: The optical probe (14) is mounted on the end face and / or side face of the head electrode (11), the positioning sensor assembly (15) is mounted in the housing (13), and the pressure sensing assembly (16) is mounted in the housing (13) behind the head electrode (11).

5. The mapping and ablation catheter capable of detecting lesion depth according to claim 3, characterized in that: The head electrode (11) is divided into at least two areas along the circumferential direction and indicated by different colors, wherein the area corresponding to one color is defined as the direction of bending and deflection of the shell (13).

6. The mapping and ablation catheter capable of detecting lesion depth according to claim 5, characterized in that: The head electrode (11) is evenly divided into four areas along the circumferential direction, which are indicated by red, yellow, green and blue respectively. The red area is defined as the direction of bending and deflection of the shell (13), the yellow area and the green area are defined as two adjacent directions of the deflection direction of the shell (13), and the blue area is defined as the direction away from the deflection direction of the shell (13).

7. The mapping and ablation catheter capable of detecting lesion depth according to claim 1, characterized in that: The head end (10) is columnar, sheet-shaped or ring-shaped.

8. The mapping and ablation catheter capable of detecting lesion depth according to claim 1, characterized in that: It also comprises a control handle, which is connected to the head end (10) via a tube body.

9. The mapping and ablation catheter capable of detecting lesion depth according to any one of claims 1 to 8, characterized in that: The mapping and ablation catheter capable of detecting the depth of injury is connected to a three-dimensional magnetic field module, an optical imaging module, a pressure detection module, and a display module; The three-dimensional magnetic field module is electrically connected to the positioning sensor component (15), and is used to generate a three-dimensional magnetic field and capture the induced current generated by the movement of the positioning sensor component (15) in the magnetic field, and calculate the position of the positioning sensor component (15) in the three-dimensional magnetic field; The optical imaging module is connected to the optical probe (14) via an optical fiber, and the optical imaging module is used for optical coherence imaging; The pressure detection module is electrically connected to the pressure sensing component (16), and is used to capture the induced current of the strain gauge (161) and calculate the magnitude and direction of the pressure applied to the head end (10); The display module is connected to the three-dimensional magnetic field module, the optical imaging module, and the pressure detection module, and is used to display the position of the head end (10), the pressure magnitude, the direction, the constructed heart cavity model (30), and the condition of the ablation site tissue (20).

10. The mapping and ablation catheter capable of detecting lesion depth according to claim 9, characterized in that: The display module is provided with a pressure window (40), and the pressure window (40) displays in real time the magnitude of the pressure applied to the head end (10) when it contacts the tissue (20), and the magnitude of the angle between the force applied to the head end (10) and the light emitting direction of the optical probe (14).

Images