A mapping and ablation catheter capable of detecting lesion depth

Abstract

The present invention relates to the field of electrophysiological catheters and is a mapping and ablation catheter capable of detecting the depth of damage. The catheter comprises a head end, on which is provided at least one electrode for mapping and ablation; a positioning sensor assembly comprising at least two positioning sensors, each comprising a coil structure, wherein the at least two 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 assembly comprising a strain gauge and an elastomer, wherein a plurality of strain gauges are arranged on the periphery of the elastomer, and the pressure sensing assembly is used to detect the magnitude and direction of pressure at the head end; and at least one optical probe is used to optically scan the tissue in contact, wherein the optical probe, the positioning sensor assembly, and the electrode have a fixed positional relationship. The present invention achieves more accurate detection results, a deeper detection depth, a larger detection range, and greater ease of use through the mutual cooperation of the optical probe, the positioning sensor assembly, and the pressure sensing assembly.

Description

Technical Field

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

[0002] During electrophysiological ablation procedures, the depth of tissue damage is a key concern for surgeons, but it's often difficult to visually observe. Surgeons often use ablation parameters to roughly estimate the potential damage range and observe changes in electrical signals to determine the effectiveness of ablation. Determining the extent of tissue damage relies on surgeon experience and requires considerable effort to observe complex information.

[0003] Optical coherence imaging technology allows for more intuitive detection of fine structures within tissues, directly revealing the extent of tissue damage. However, optical scanning uses weakly coherent light, resulting in limited detection depth and being easily affected by the blood environment. To maximize detection of internal tissue structures, the detection position and direction must be controlled. 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 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 weak coherent light is easily interfered by blood flow, requiring 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:

[0006] A mapping and ablation catheter capable of detecting lesion depth comprises a tip end, the tip end being provided with:

[0007] at least one electrode for mapping and ablation;

[0008] A positioning sensor assembly, comprising at least two positioning sensors, each comprising 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;

[0009] A pressure sensing component, comprising a strain gauge and an elastic body, wherein a plurality of strain gauges are provided on the periphery of the elastic body, and the pressure sensing component is used to detect the magnitude and direction of the pressure at the head end;

[0010] 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 positional relationship.

[0011] The coil structure of the positioning sensor assembly generates an induced current when it moves within the three-dimensional magnetic field provided by the supporting equipment. The equipment can calculate the position of the coil structure within the magnetic field based on the changes in the induced current. The positioning sensor's functionality allows the position and shape of the head end to be displayed in real time, constructing the contours of various heart components. Combined with the equipment's mapping function, this technology can produce voltage distribution and electrical conduction relationship diagrams for the operator to observe.

[0012] 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 determine 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.

[0013] Good contact remains essential for optical coherence imaging, as light has a limited penetration depth into tissue and is easily affected by blood. Theoretically, maximum detection depth can be achieved when the optical probe is perpendicular to the tissue interface and well adheres to the tissue. However, tissue information may not be detected when the optical probe is parallel to the tissue interface or when blood is present between the probe and the tissue.

[0014] By using the mapping and ablation catheter capable of detecting the depth of damage described in the present invention, the position of the optical probe can be determined through the positioning sensor assembly, and the image detected by the optical probe can be combined and displayed with the three-dimensional model diagram constructed by the positioning sensor assembly. Through the cooperation of the pressure sensing assembly, it can be determined whether the optical probe contacts the tissue and the relationship between the detection direction and the tissue. The positioning sensor assembly and the pressure sensing assembly can 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 has an intuitive grasp of the internal structure and damage condition of the tissue before and after ablation. The optical probe, the positioning sensor assembly, and the pressure sensing assembly 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, making the ablation process safer and the ablation effect easier to grasp.

[0015] 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 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 of tissue within a certain range of the contacted part.

[0016] First, light is emitted from a light source and split into a reference beam and a detection beam by the Michelson interferometer's beam splitter. The detection beam is then transmitted along an optical path to the optical probe and enters the tissue in contact with it. The optical reflection (scattering) of human tissue structures exhibits spatially varying characteristics. The reflected light returns through the optical fiber and interferes with the reference light, forming a specific interference pattern. By analyzing and imaging this pattern, a three-dimensional image of the tissue within a specific depth range can be reconstructed. Therefore, optical coherence scanning of tissue can identify internal tissue structures (such as myocardium, fat, blood vessels, and nerves) within the ablation site and detect post-ablation damage (ablated tissue has different optical properties than normal tissue).

[0017] 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 distance between adjacent electrodes.

[0018] 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.

[0019] 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.

[0020] As a further preferred technical solution of the present invention, the head electrode is evenly divided into four areas along the circumference, 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.

[0021] As a preferred technical solution of the present invention, the head end is cylindrical, sheet-shaped or ring-shaped.

[0022] As a preferred technical solution of the present invention, the mapping and ablation catheter capable of detecting lesion depth further includes a manipulation handle, and the manipulation handle is connected to the head end through a tube body.

[0023] 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;

[0024] The three-dimensional magnetic field module is electrically connected to the positioning sensor assembly, and is used to generate a three-dimensional magnetic field and capture the induced current generated by the movement of the positioning sensor assembly in the magnetic field, and calculate the position of the positioning sensor assembly in the three-dimensional magnetic field;

[0025] 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;

[0026] 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 applied to the head end;

[0027] The display module is connected to the three-dimensional magnetic field module, the optical imaging module, and the pressure detection module. The display module is used to display the position of the head end, pressure magnitude, direction, constructed heart cavity model, and tissue condition of the ablation site.

[0028] As a further preferred technical solution of the present invention, a pressure window is provided on the display module, which 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.

[0029] In summary, due to the adoption of the above technical solution, the beneficial effects of the present invention are:

[0030] The present invention describes a mapping and ablation catheter capable of detecting the depth of damage. The positioning sensor assembly can determine the position of the optical probe, and can combine and display the image detected by the optical probe with the three-dimensional model diagram constructed by the positioning sensor assembly. The cooperation of the pressure sensing assembly can determine whether the optical probe contacts the tissue and the relationship between the detection direction and the tissue. The positioning sensor assembly and the pressure sensing assembly can 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 has an intuitive grasp of the internal structure and damage condition of the tissue before and after ablation. The optical probe, the positioning sensor assembly, and the pressure sensing assembly 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, making the ablation process safer and the ablation effect easier to grasp. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 A schematic diagram of possible detection directions of the catheter tip without pressure indication;

[0032] Figure 2 This is a schematic diagram of the structure of the catheter tip (the shell is hidden in some sections);

[0033] Figure 3 Schematic diagram of the division of the head electrode;

[0034] Figure 4 A schematic diagram of the device display interface during catheter use (information not related to the content of this application is not shown);

[0035] Figure 5 The use status of the catheter is suitable for detection Figure 1 ;

[0036] Figure 6 The use status of the catheter is suitable for detection Figure 2 .

[0037] Markings in the figure:

[0038] 10-head end, 11-head electrode, 12-ring electrode, 13-housing, 14-optical probe, 15-positioning sensor assembly, 16-pressure sensing assembly, 161-strain gauge, 162-elastic body;

[0039] 20-tissue, 21-ablation lesion;

[0040] 30-heart chamber model;

[0041] 40-Pressure window. DETAILED DESCRIPTION

[0042] The present invention will be further described in detail below in conjunction with test examples and specific embodiments. However, this should not be understood as limiting the scope of the present invention to the following embodiments, and all technologies implemented based on the present invention fall within the scope of the present invention.

[0043] Unless otherwise specified, in the description of the specific embodiments of the present invention, the terms indicating the orientation or positional relationship, such as "upper", "lower", "left", "right", "center", "inside", and "outside", are based on the expressions of the orientation or positional relationship shown in the accompanying drawings, or are the orientation or positional relationship in which the invented product / device / apparatus is placed when it is conventionally used. These terms of orientation or positional relationship are merely for the purpose of facilitating the description of the scheme of the present invention or simplifying the description of the specific embodiments to facilitate the rapid understanding of the scheme by technicians, 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 positional relationship, and therefore should not be understood as limiting the present invention.

[0044] 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 relative to "vertical", and does not mean that the structure must be completely horizontal, but may be slightly tilted. Alternatively, it can be simply understood that the corresponding devices / components / elements are set in directions such as "horizontal", "vertical", "overhanging", and "parallel", 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 solution of the present invention.

[0045] In addition, the expressions “first”, “second”, “third”, etc. 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.

[0046] In addition, in the description of the embodiments of the present invention, "several," "plurality," and "a number" represent at least two. It can also be any number such as two, three, four, five, six, seven, eight, nine, or even more than nine.

[0047] Furthermore, in the description of the technical solution of the present invention, unless otherwise expressly specified, defined, or limited, the terms "disposed," "installed," "connected," "connected," "provided with," "laid," and "arranged" should be understood broadly. For example, they may refer to fixed connections, detachable connections, or integral connections. They may be welded, riveted, bolted, threaded, or other commonly used connection methods in the art. Such connections may be mechanical, electrical, or communicative; they may be direct, indirect via an intermediate medium, or internally connected between two components.

[0048] 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 interfered by blood flow, and the detection position and direction need to be precisely controlled. Figures 1 to 6 To elaborate.

[0049] Example 1

[0050] like Figures 2 to 6As shown, the mapping and ablation catheter capable of detecting the depth of injury described in the present invention includes 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.

[0051] 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.

[0052] 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 radiofrequency 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. 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 magnitude and direction of the head end 10. The optical probe 14 is used to optically scan the tissue 20 it contacts. The optical probe 14, the positioning sensor assembly 15 and the electrode have a fixed positional relationship. The optical probe 14 can be adjusted to be in contact with the tissue 20 under the guidance of the positioning sensor assembly 15 and the pressure sensing assembly 16.

[0053] The mapping and ablation catheter capable of detecting lesion depth is used together with supporting equipment for electrophysiological signal mapping, tissue ablation and ablation effect monitoring.

[0054] When the coil structure of the positioning sensor assembly 15 moves within the three-dimensional magnetic field provided by the supporting equipment, it generates an induced current. The equipment calculates the position of the coil structure within the magnetic field based on the changes in the induced current. The positioning sensor's function can be used to display the position and shape of the head end 10, and to construct a diagram of the position, shape, voltage distribution, and electrical conductivity of various cardiac components for the operator to observe.

[0055] The pressure sensing component 16 is arranged at the head end 10. Good contact is conducive to collecting more accurate electrophysiological signals and achieving a more effective ablation effect on the tissue 20. 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 10 is in contact with the tissue 20, the elastic body 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 current of multiple strain gauges 161 at different positions, and display it.

[0056] Good contact remains essential for optical coherence imaging, as light has a limited penetration depth into tissue and is easily affected by blood. When the optical probe 14 is perpendicular to the interface of tissue 20 and well attached to the tissue 20, theoretically, the maximum detection depth can be achieved. However, when the optical probe 14 is parallel to the interface of tissue 20, or when blood is present between the optical probe 14 and the tissue 20, information about the tissue 20 may not be detected.

[0057] In an optional embodiment, if Figure 2 As 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, and at least one detection hole is provided on the top end and / or side wall of the shell 13, and the optical probe 14 is installed in the detection hole. The optical probe 14 sends or receives weak coherent light and can perform optical scanning on the tissue 20 within a certain range of the contacted part.

[0058] First, light is emitted from a light source and split into a reference beam and a detection beam by the Michelson interferometer's beam splitter. The detection beam is then transmitted along an optical path to the optical probe 14 and enters the tissue 20 in contact with the optical probe 14. The optical reflection (scattering) of the structure of human tissue 20 exhibits spatially varying characteristics. The reflected light returns through the optical fiber and interferes with the reference light, forming a specific interference pattern. By analyzing and imaging this pattern, a three-dimensional image of the tissue 20 within a certain depth range can be reconstructed. Therefore, optical coherence scanning of tissue 20 can identify the internal tissue 20 structures (such as myocardium, fat, blood vessels, nerves, etc.) within the ablation site and can also detect damage after ablation (ablated tissue has different optical properties from normal tissue 20).

[0059] In an optional embodiment, if Figure 2As shown, the mapping and ablation catheter that can detect the depth of injury adopts a commonly used single-point ablation catheter, the head end 10 includes a shell 13, the top end of the shell 13 is closed, the electrode includes 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, the optical probe 14 is installed on the end face and / or side of the head electrode 11, the positioning sensor assembly 15 is installed in the shell 13, and the pressure sensing assembly 16 is installed 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 the 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 including the pressure sensing component 16 is removed.

[0060] In an optional embodiment, the head electrode 11 is divided into at least two areas along the circumference and indicated by different colors, wherein the area corresponding to one color is defined as the direction of the bending deflection of the shell 13. For example, 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.

[0061] In an optional embodiment, the head end 10 is cylindrical, sheet-shaped or ring-shaped.

[0062] For example, Figure 4The figure shows the various models and related functional display interfaces viewed by the operator. Under the action of the positioning sensor assembly 15, a model of the tip 10 is displayed, and by recording the movement trajectory of the tip 10, a cardiac cavity model 30 is constructed. The positions of the various components in the tip 10 are relatively fixed. Therefore, the positioning sensor assembly 15 can be used to define the positions of the tip electrode 11, the catheter center axis, and the optical probe 14. Furthermore, because the beam direction forms a fixed angle with the catheter center axis, the center direction of the probe beam can be displayed (hollow arrow L in the figure). Under the action of the pressure sensing assembly 16, the pressure applied to the tip 10 when it contacts the tissue 20 is displayed in real time in the pressure window 40, with the direction of the force indicated by an arrow on the tip 10 (solid arrow F in the figure). The system calculates the angle θ between the force direction and the center direction of the probe beam. When both the angle and the contact force meet the set values, the system indicates that the contact is good and the maximum depth of the tissue 20 can be detected. For example, the contact force can be set to 5g~10g and the angle can be set to 175°~185°; the above setting parameters are examples, and the threshold value can be set in the system according to actual conditions.

[0063] 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 of the optical probe 14 is flat against the tissue 20 so that the pressure direction and the center direction of the light beam are parallel.

[0064] 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 and the center direction of the light beam are parallel.

[0065] The above examples are intended to illustrate how the various components of the head end 10 cooperate with each other to achieve maximum tissue 20 detection. The shape of the head end 10 and the positional relationship of the various components may vary.

[0066] In an optional embodiment, during or after ablation, the operator can scan the same location multiple times and select the appropriate scan image to display on the 3D model. The operator can also adjust the ablation parameters based on the detected internal tissue 20.

[0067] Exemplarily, the mapping and ablation catheter capable of detecting lesion depth is connected to a three-dimensional magnetic field module, an optical imaging module, a pressure detection module, and a display module.

[0068] The three-dimensional magnetic field module is electrically connected to the positioning sensor assembly 15. The three-dimensional magnetic field module is used to generate a three-dimensional magnetic field and capture the induced current generated by the movement of the positioning sensor assembly 15 in the magnetic field, and calculate the position of the positioning sensor assembly 15 in the three-dimensional magnetic field.

[0069] 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.

[0070] 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 .

[0071] 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. 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.

[0072] In an optional embodiment, if Figure 4 As shown, a pressure window 40 is provided on the display module, and the pressure window 40 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 .

[0073] In this embodiment, a mapping and ablation catheter capable of detecting lesion depth is described. The positioning sensor assembly 15 can determine the position of the optical probe 14 and combine and display the image detected by the optical probe 14 with the three-dimensional model constructed by the positioning sensor assembly 15. The pressure sensing assembly 16 cooperates to determine whether the optical probe 14 is in contact with tissue 20 and the relationship between the detection direction and the tissue 20. The positioning sensor assembly 15 and the pressure sensing assembly 16 facilitate the operator's adjustment of the position of the optical probe 14 to align it with the area of ​​interest. The optical probe 14 is then used to detect the condition of the tissue 20 at the ablation site, allowing the operator to intuitively understand the internal structure and damage of the tissue 20 before and after ablation. The optical probe 14, the positioning sensor assembly 15, and the pressure sensing assembly 16 cooperate to provide more accurate detection results, a deeper detection depth, a wider detection range, and greater ease of use. Without changing the original surgical procedure, the operator can be provided with real-time information on the structure of the tissue 20 at the contact site and the ablation damage, making the ablation process safer and easier to assess the ablation effect.

[0074] Comparative Example 1

[0075] 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.

[0076] 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 has 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 detected damage range of the tissue 20 is limited and cannot achieve the intended purpose. When the optical probe 14 deviates far from the damage point, it may even be unable 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 ablated tissue 20 by naked eye observation.

[0077] The above problem can be solved by using a mapping and ablation catheter capable of detecting the lesion depth as described in Example 1.

[0078] 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 scope of protection 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) includes at least two positioning sensors, each of which includes 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) comprises a strain gauge (161) and an elastic body (162), wherein a plurality of strain gauges (161) are provided 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), wherein the optical probe (14), the positioning sensor assembly (15) and the electrode have a fixed positional relationship, and the direction of the detection light beam of the optical probe (14) is in a fixed angle relationship with the central axis of the catheter; The angle θ between the pressure direction of the head end (10) and the center direction of the detection beam, the pressure magnitude of the head end (10) and the angle θ have a set threshold value, and when the angle θ and the pressure magnitude simultaneously meet the set threshold value, the contact is good and the maximum depth of the tissue (20) is detected.

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, and at least one detection hole is provided on the top end and / or the side wall of the shell (13), and 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) 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 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 circumference, which are indicated by red, yellow, green and blue respectively. The red area is defined as the direction of bending deflection of the shell (13), the yellow area and the green area are defined as two directions adjacent to 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 cylindrical, 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 includes a manipulation handle, which is connected to the head end (10) through 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