Catheter capable of performing local ablation

By designing a spherical head end catheter with flexible planar outer electrode and inner electrode, the problems of low ablation efficiency and difficulty in achieving precision mapping and high-efficiency ablation of the prior art mid-point ablation catheter are solved, and multi-pole precision mapping, multi-pole high-efficiency ablation and single-point local fine ablation are achieved, reducing surgical cost and operation difficulty.

CN119564327AActive Publication Date: 2025-03-07SICHUAN JINJIANG ELECTRONICS SCI & TECH CO LTD

Patent Information

Application Number
CN202510143676.4
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-02-10
Publication Date
2025-03-07
Estimated Expiration
2045-02-10

AI Technical Summary

Technical Problem

In the prior art, point ablation efficiency of point ablation catheter is low, and cannot be compatible with the advantages of multipole ablation catheter and local fine point ablation. Moreover, the ablation electrode is separated from the mapping electrode, making it difficult to achieve precision mapping and high-efficiency ablation at the same time, which increases the difficulty and cost of surgical operations.

Method used

A conduit including a spherical head end and a tube body is designed. Several supporting arms, outer electrodes and inner electrodes are provided on the spherical head end. The outer electrode is a flexible planar electrode, the inner electrode corresponds one by one to the outer electrode, with an equal surface area, and confirms the degree of the electrode abutment through impedance detection.

Benefits of technology

Multipole precision mapping, multipole high-efficiency ablation and single-point local fine ablation are achieved, which reduces the surgical time and cost, simplifies the catheter design, and overcomes the defects in the prior art that multipole ablation catheters are difficult to achieve single electrode attachment detection.

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Abstract

The invention relates to the field of electrophysiological ablation, in particular to a catheter capable of performing local ablation, which comprises a spherical head end and a catheter body, the spherical head end is connected to the far end of the catheter body, and the spherical head end comprises a plurality of supporting arms, a plurality of outer side electrodes and a plurality of inner side electrodes; a hollow part is arranged between the supporting arms, and the supporting arms are elastic; the outer side electrode is arranged on the supporting arm, the outer side electrode is a flexible planar electrode, and the shape of the flexible planar electrode is one or more of a circle, an oval and a polygon; the inner side electrodes are arranged on the supporting arms, correspond to the outer side electrodes one by one and are located on the back faces of the outer side electrodes, and the surface area of the inner side electrodes is equal to that of the outer side electrodes. Multi-pole precise mapping, multi-pole high-efficiency ablation and single-point local fine ablation are achieved on the same catheter at the same time, and meanwhile attachment detection of any single outer side electrode can be achieved under the condition of a plurality of ablation electrodes.
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Description

Technical Field

[0001] The present invention relates to the field of electrophysiological ablation, and in particular to a catheter capable of performing local ablation. Background Art

[0002] Currently, point ablation catheters have low ablation efficiency and cannot effectively perform electrophysiological surgeries such as pulmonary vein isolation. Annular, basket, and petal electrodes have a large coverage area, but cannot perform surgery on areas that require point ablation. In practice, a new point ablation catheter needs to be added, which increases the ablation surgery time and patient costs.

[0003] Currently, the ablation electrode and the mapping electrode are usually two separate catheters, which need to be frequently switched during surgery, increasing the difficulty of the surgical operation and patient costs.

[0004] In order to ensure the safety and effectiveness of point ablation, it is usually necessary to add a pressure monitoring function to ensure good contact between the electrode and the tissue, but adding this function will directly increase the manufacturing difficulty and manufacturing cost of the catheter, and will also increase the surgical expenses for patients. At the same time, there is no multi-polar ablation catheter in the prior art that can achieve the pressure monitoring function of a single electrode. Summary of the invention

[0005] The purpose of the present invention is to address the problem that conventional single-point ablation catheters in the prior art are designed independently for ablation and mapping, which makes it difficult to achieve both precise mapping and high-efficiency ablation at the same time; single-point ablation catheters with pressure monitoring are difficult to manufacture and costly, and there is no multi-polar ablation catheter in the prior art that can monitor the pressure of a single electrode to determine the degree of electrode contact; and existing ablation catheters are incompatible with the efficiency of multi-polar ablation catheters and the advantages of local fine-point ablation, and provide a catheter that can perform local ablation.

[0006] In order to achieve the above object, the technical solution adopted by the present invention is: A catheter capable of performing local ablation comprises a spherical head end and a tube body, wherein the spherical head end is connected to the distal end of the tube body, and the spherical head end comprises a plurality of support arms, a plurality of outer electrodes and a plurality of inner electrodes; a hollow portion is provided between the support arms, and the support arms are elastic; the outer electrodes are provided on the support arms, and the outer electrodes are flexible planar electrodes, and the shapes of the flexible planar electrodes are one or more of circular, elliptical and polygonal; the inner electrodes are provided on the support arms and correspond one to one with the outer electrodes, and the inner electrodes are located on the back of the outer electrodes, and the surface area of ​​the inner electrodes is equal to the surface area of ​​the outer electrodes.

[0007] In this field, the distal end refers to the front end of the EP mapping catheter, that is, the part that first enters the human body, the proximal end refers to the end of the EP mapping catheter closer to the operator, and the head end is located at the distal end of the EP mapping catheter, that is, the end that enters the human body.

[0008] By adopting the catheter capable of local ablation described in the present invention, multipolar ablation and mapping can be realized by setting the spherical head end and the plurality of outer electrodes thereon. By setting the outer electrodes as flexible plane electrodes, local tissue ablation within the plane range can be realized, that is, the same catheter can simultaneously realize multipolar precision mapping, multipolar high-efficiency ablation, and single-point local fine ablation. The catheter does not need to be replaced during use, which improves efficiency and reduces overall costs. By setting the hollow portion and the elastic support arm, the spherical head end can be deformed and restored, which is convenient for entering and exiting the sheath. By setting the hollow portion, the spherical head end is hollowed out, so that blood The spherical head end can enter the interior of the inner electrode and can contact the blood. The surface area of ​​the inner electrode is equal to the surface area of ​​the outer electrode and can have the same reference standard. The impedance detection and comparison of each pair of the outer electrode and the inner electrode can confirm the degree of contact of the outer electrode. Even in the case of multiple ablation electrodes, the contact detection of any single outer electrode can be achieved, which overcomes the problem that it is difficult for multi-polar ablation catheters in the prior art to determine the degree of contact of a single electrode through pressure monitoring. The device has good practicality, does not need to integrate a pressure sensor on the electrode, and greatly simplifies the design difficulty of the spherical head end.

[0009] As a preferred technical solution of the present invention, the inner electrode is consistent in shape and size with the outer electrode, which facilitates the design and manufacture of the spherical head end.

[0010] As a preferred technical solution of the present invention, the outer electrodes are arranged in layers from the pole of the spherical head end to the equator; the outer electrodes in each layer are arranged evenly; and the outer electrodes in adjacent layers are arranged alternately.

[0011] With this structural setting, the outer electrode can almost completely cover the surface of the spherical head end, so that the working surface that is suitable for the spherical head end is evenly distributed with electrodes, and can work in all directions. There is no need to adjust the position of the tube body too much to adjust the position of the spherical head end, especially there is no need to rotate the tube body too much to adjust the position of the spherical head end.

[0012] As a further preferred technical solution of the present invention, the number of layers of the outer electrodes is 3 to 5; one outer electrode is arranged in the first layer; 6 to 10 outer electrodes are arranged in the remaining layers; and at least one layer is close to the equator or located on the equator.

[0013] As a further preferred technical solution of the present invention, the number of layers of the outer electrodes is 4; the first layer is provided with a top outer electrode, and the top outer electrode is arranged opposite to the distal end of the tube body; the second layer is provided with 6 second-layer outer electrodes; the third layer is provided with 6 third-layer outer electrodes, and the third layer is close to the equator or located on the equator; the fourth layer is provided with 6 fourth-layer outer electrodes.

[0014] As a further preferred technical solution of the present invention, the outer electrodes of adjacent layers have opposite polarities, which are used for bipolar ablation; Alternatively, each of the outer electrodes discharges relative to a neutral electrode for monopolar ablation, and the neutral electrode is arranged on the human body.

[0015] As a preferred technical solution of the present invention, a perfusion tube is provided at the distal end of the tube body, and the perfusion tube extends into the spherical head end.

[0016] With this structural setting, during the operation, heparin saline can be continuously infused into the spherical head end through the infusion tube to perform anticoagulation treatment and avoid the formation of thrombus.

[0017] As a further preferred technical solution of the present invention, a plurality of proximal perfusion channels are provided on the perfusion tube at the intersection of the distal end of the tube body and the spherical head end; a plurality of apical perfusion channels are provided on the top of the perfusion tube; and a plurality of distal perfusion channels are provided on the perfusion tube between the proximal perfusion channel and the apical perfusion channel.

[0018] As a preferred technical solution of the present invention, adjacent support arms are staggered and connected, and intersect and connect on an extension line of the axis of the tube body.

[0019] As a preferred technical solution of the present invention, the proximal end of the tube body is connected to a control handle, and the control handle is provided with a Luer connector.

[0020] In summary, due to the adoption of the above technical solution, the beneficial effects of the present invention are: 1. The catheter capable of local ablation described in the present invention can realize multipolar ablation and mapping by setting the spherical head end and the plurality of outer electrodes thereon. By setting the outer electrodes as flexible plane electrodes, local tissue ablation within the plane range can be realized, that is, the same catheter can realize multipolar precision mapping, multipolar high-efficiency ablation, and single-point local fine ablation at the same time. The catheter does not need to be replaced during use, thereby improving efficiency and reducing overall costs. 2. The catheter capable of local ablation described in the present invention, by providing the hollow portion and the elastic support arm, enables the spherical head end to deform and recover, making it convenient to enter and exit the sheath; 3. The catheter capable of performing local ablation described in the present invention makes the spherical head end hollow by setting the hollow part, so that blood can enter the inside of the spherical head end, and the inner electrode can contact the blood. The surface area of ​​the inner electrode is equal to the surface area of ​​the outer electrode, and can have the same reference standard. The impedance detection and comparison of each pair of the outer electrode and the inner electrode can confirm the degree of contact of the outer electrodes. Even in the case of multiple ablation electrodes, the contact detection of any single outer electrode can be achieved, which overcomes the problem that it is difficult for multi-polar ablation catheters in the prior art to determine the degree of contact of a single electrode through pressure monitoring. The catheter has good practicality, does not need to integrate a pressure sensor on the electrode, and greatly simplifies the design difficulty of the spherical head end. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 Schematic diagram of the three-dimensional structure of the spherical head Figure 1 ; Figure 2 It is a schematic diagram of the planar structure of the spherical head end (front view); Figure 3 It is a schematic diagram of the planar structure of the spherical head end (top view); Figure 4 A schematic diagram of an electrode configuration for a spherical head; Figure 5 Schematic diagram of the three-dimensional structure of the spherical head Figure 2 ; Figure 6 Schematic diagram of the three-dimensional structure of the spherical head Figure 3 ; Figure 7 A schematic diagram of the structure of a catheter capable of performing local ablation; Figure 8 It is a schematic diagram of the catheter bending; Fig. 9 Schematic diagram of the reference electrode and neutral electrode setup; Fig.10 Schematic diagram of impedance detection in different parts of the heart.

[0022] Markings in the figure: 1- Spherical head; 2- Support arm; 3- hollow part; 4-tube body; 5-lateral electrode, 51-top lateral electrode, 52-second layer lateral electrode, 53-third layer lateral electrode, 54-fourth layer lateral electrode; 6-perfusion tube, 61-proximal perfusion channel, 62-distal perfusion channel, 63-apical perfusion channel; 7-medial electrode, 71-top medial electrode, 72-second layer medial electrode, 73-third layer medial electrode, 74-fourth layer medial electrode; 8-Control handle; 9- Luer connector; 10-Human body; 11-reference electrode; 12-neutral electrode; 13- Impedance collected by the outer electrodes; 14- Impedance collected by the medial electrode. 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, on the one hand, the current point ablation catheter has low ablation efficiency and cannot efficiently perform electrophysiological surgeries such as pulmonary vein isolation. Then, similar to the ring, basket, and petal electrodes, the coverage range is large, but the point ablation site required during the operation cannot be operated. In practice, a point ablation catheter needs to be added again, which is incompatible with the efficiency of the multipolar ablation catheter and the advantages of local fine point ablation, increasing the ablation operation time and patient costs; on the other hand, the ablation electrode and the mapping electrode are usually two separate catheters, which need to be frequently switched during the operation, making it difficult to achieve precise mapping and high-efficiency ablation at the same time, which also increases the difficulty of surgical operation and patient costs; on the other hand, in order to ensure the safety and effectiveness of point ablation, it is usually necessary to add a pressure monitoring function to ensure that the electrode and the tissue are well attached, but adding this function will directly increase the manufacturing difficulty and manufacturing cost of the catheter, and will also increase the patient's surgical costs. At the same time, there is no multipolar ablation catheter in the prior art to realize the single electrode pressure monitoring function. The pulsed electric field technology is to apply a short high voltage to the tissue to generate a local high electric field of hundreds of volts per centimeter. The local high electric field destroys the cell membrane by creating pores in the cell membrane. The electric field applied at the membrane is greater than the cell threshold so that the pores are not closed. This type of electroporation is irreversible, thereby allowing biomolecular materials to be exchanged across the membrane, leading to cell necrosis or apoptosis. Pulse irreversible electroporation ablation is different from physical therapies based on the principle of thermal ablation such as radio frequency, cryotherapy, microwave, and ultrasound. The irreversible electroporation destruction of the myocardial cell membrane by microsecond pulses is a non-thermal biological effect that can effectively avoid damage to blood vessels, nerves, and esophagus. The high-frequency pulsed electric field maintains the non-thermal advantage of irreversible electroporation. The electric field pulse is expected to break through the problem of uneven internal electric field distribution caused by the cell membrane capacitance effect and the anisotropy of biological tissues. When a biphasic pulse is used, after the previous positive pulse train ends, a negative pulse train with the same pulse width and equal field strength is applied. This may cause the action potential induced by the positive pulse to not have time to be fully generated. The negative pulse causes the action potential to develop in the opposite direction, which will greatly reduce the stimulation of the electric field to the nerves. For this reason, the technical solution of the present application was produced. The following is combined with Figures 1 to 10 To elaborate.

[0030] Example 1 like Figures 1 to 10 As shown, a catheter capable of performing local ablation described in the present invention includes a spherical head end 1, a tube body 4, and a control handle 8 which are connected in sequence.

[0031] like Figure 7 As shown, the spherical head end 1 is connected to the distal end of the tube body 4, the control handle 8 is connected to the proximal end of the tube body 4, and the control handle 8 is provided with a Luer connector 9.

[0032] like Figure 8As shown, the control handle 8 can adjust the bending of the distal end of the tube body 4 so that the spherical head end 1 reaches different positions. This is a conventional technical means in the field and will not be repeated in this embodiment.

[0033] The spherical head end 1 includes a plurality of support arms 2 , a plurality of outer electrodes 5 and a plurality of inner electrodes 7 .

[0034] like Figures 1 to 8 As shown, one end of all the support arms 2 is connected to the distal end of the tube body 4, and the other end is intersected and connected to the extension line of the axis of the tube body 4. The support arms 2 are evenly arranged along the circumference of the tube body 4, and adjacent support arms 2 are staggered and connected, so that a single support arm 2 forms a serpentine structure; the support arms 2 are made of an elastic alloy material, for example, the support arms 2 can be made of a nickel-titanium alloy material.

[0035] like Figure 1 and Figure 2 As shown, a hollow portion 3 is provided between the support arms 2, so that the spherical head end 1 forms a hollow spherical structure, thereby increasing the elasticity of the spherical head end 1, facilitating its contraction into the vascular sheath and then reaching the heart, and after reaching the heart position and extending the sheath tube, it returns to a spherical structure for ablation and mapping; the shape of the hollow portion 3 is roughly diamond-shaped or chestnut-shaped.

[0036] like Figure 1 , Figure 3 and Figure 6 As shown, the outer electrode 5 is arranged on the support arm 2. The outer electrode 5 is a flexible planar electrode, and the shape of the flexible planar electrode is one or more of a circle, an ellipse, and a polygon. Among them, as for the shape of the flexible planar electrode, those skilled in the art can understand that it is not required to be an absolute circle, an ellipse, or a polygon. As long as the general shape is similar to a circle, an ellipse, or a polygon, it should be considered to meet the requirements of the present application. For example, there is a small notch on a circle, or there are straight or curved cut edges, such as a spindle or a waisted circle, such as a triangle or rectangle with rounded corners, a triangle or rectangle with arc-shaped sides, etc.

[0037] In some optional embodiments, the outer electrodes 5 are arranged at the staggered positions of the adjacent support arms 2 and at the intersection of all the support arms 2. Figure 1 , Figure 3 and Figure 6 As shown, the circular flexible planar electrode is exemplarily provided at the intersection position of the support arms 2 , and the elliptical flexible planar electrode is provided at the staggered position of the support arms 2 .

[0038] In some optional embodiments, the flexible planar electrode is made of gold or platinum material, and platinum material with a higher melting point may be preferred.

[0039] like Figure 5 As shown, the inner electrode 7 is disposed on the support arm 2 and corresponds one-to-one with the outer electrode 5 . The inner electrode 7 is located on the back side of the outer electrode 5 , and the surface area of ​​the inner electrode 7 is equal to the surface area of ​​the outer electrode 5 .

[0040] In some optional embodiments, the width of the flexible planar electrode is greater than the width of the support arm 2 .

[0041] In some optional embodiments, the inner electrode 7 is consistent in shape and size with the outer electrode 5 , so as to facilitate the design and manufacture of the spherical head 1 .

[0042] like Figure 1 As shown, the outer electrodes 5 are arranged in layers from the poles to the equator of the spherical head end 1; each layer of the outer electrodes 5 is evenly arranged; and the outer electrodes 5 of adjacent layers are staggered. With this structural arrangement, the outer electrodes 5 can almost completely cover the surface of the spherical head end 1, so that the working surface suitable for the spherical head end 1 is evenly distributed with electrodes, and can work in all directions, without the need to adjust the position of the tube body 4 too much to adjust the position of the spherical head end 1, especially without the need to rotate the tube body 4 too much to adjust the position of the spherical head end 1. Among them, the axis of the tube body 4 is used as the axis of the spherical head end 1, and the equator of the spherical head end 1 is perpendicular to the axis of the spherical head end 1.

[0043] In some optional embodiments, the number of layers of the outer electrodes 5 is 3 to 5; one outer electrode 5 is set in the first layer; 6 to 10 outer electrodes 5 are set in the remaining layers; and at least one layer is close to the equator or located on the equator.

[0044] As an example, Figure 1 As shown, the number of layers of the outer electrodes 5 is 4, the first layer is provided with a circular top outer electrode 51, and the top outer electrode 51 is arranged opposite to the distal end of the tube body 4, the second layer is evenly provided with 6 elliptical second-layer outer electrodes 52, the third layer is evenly provided with 6 elliptical third-layer outer electrodes 53, and the third layer is close to the equator or located on the equator, and the fourth layer is evenly provided with 6 elliptical fourth-layer outer electrodes 54. Figure 5As shown, the corresponding inner electrode 7 is also provided with 4 layers, including a top inner electrode 71, a second inner electrode 72, a third inner electrode 73, and a fourth inner electrode 74, wherein the top inner electrode 71 is arranged on the back of the top outer electrode 51, the second inner electrode 72 is arranged on the back of the second outer electrode 52, the third inner electrode 73 is arranged on the back of the third outer electrode 53, and the fourth inner electrode 74 is arranged on the back of the fourth outer electrode 54. Figure 1 As shown, the third layer of outer electrodes 53 is arranged on the equator of the spherical head end 1, the top outer electrode 51 and the second layer of outer electrodes 52 are arranged on the upper hemisphere, and the fourth layer of outer electrodes 54 is arranged on the lower hemisphere across the equator.

[0045] In some optional embodiments, such as Figure 4 As shown, the polarities of the outer electrodes 5 of adjacent layers are opposite. This electrode configuration is suitable for bipolar ablation. Figure 4 The example in which the first and third layers of the outer electrodes 5 are negative electrodes and the second and fourth layers of the outer electrodes 5 are positive electrodes is shown.

[0046] In some optional embodiments, such as Fig. 9 As shown, each of the outer electrodes 5 discharges relative to the neutral electrode 12 . This electrode configuration is suitable for monopolar ablation. The neutral electrode 12 is arranged on the human body 10 .

[0047] like Figure 1 , Figure 2 and Figure 6 As shown, the distal end of the tube body 4 is provided with a perfusion tube 6, and the perfusion tube 6 extends into the spherical head end 1. With this structural arrangement, heparin saline can be continuously perfused into the spherical head end 1 through the perfusion tube 6 during the operation to perform anticoagulation treatment and avoid thrombosis.

[0048] As an example, Figure 1 As shown, the perfusion tube 6 at the intersection of the distal end of the tube body 4 and the spherical head end 1 is provided with a plurality of proximal perfusion channels 61, the top of the perfusion tube 6 is provided with a plurality of apical perfusion channels 63, and the perfusion tube 6 between the proximal perfusion channels 61 and the apical perfusion channels 63 is provided with a plurality of distal perfusion channels 62, and the proximal perfusion channels 61, the distal perfusion channels 62, and the apical perfusion channels 63 are uniformly arranged along the circumference of the perfusion tube 6; the intersection of the distal end of the tube body 4 and the spherical head end 1 is a position where thrombus is prone to occur, and heparin saline can be continuously infused therein through the proximal perfusion channel 61 for anticoagulation treatment.

[0049] In some optional embodiments, the opening directions of the proximal perfusion channel 61 and the distal perfusion channel 62 are both arranged along the radial direction of the perfusion tube 6, the distal perfusion channel 62 infuses heparinized saline into the center of the spherical head end 1, and the opening direction of the top perfusion channel 63 is arranged along the axial direction of the perfusion tube 6, and the top perfusion channel 63 can infuse heparinized saline into the end of the spherical head end 1 away from the tube body 4. Such a design can cover the entire spherical head end 1 with anticoagulant heparinized saline to prevent blood coagulation.

[0050] In some optional embodiments, the outer diameter of the perfusion tube 6 is smaller than the inner diameter of the tube body 4 , and the support arm 2 is evenly wrapped around the perfusion tube 6 .

[0051] like Figure 1 , Figure 5 , Fig. 9 and Fig.10 As shown, at least one reference electrode 11 is set on the human body 10, and the outer electrode 5 collects real-time impedance data relative to the reference electrode 11, that is, the impedance 13 collected by the outer electrode, and the inner electrode 7 collects real-time impedance data relative to the reference electrode 11, that is, the impedance 14 collected by the inner electrode. The impedance in the blood of the human body 10 is basically constant, that is, the impedance 14 collected by the inner electrode is basically constant, and the impedance 13 collected by the outer electrode varies with the degree of contact with the human tissue; when the outer electrode 5 is not in contact with the human tissue, the impedance collected by the outer electrode 5 is the blood impedance, that is, at this time, the outer electrode 5 The impedance 13 collected by the electrode is consistent with the impedance 14 collected by the inner electrode; when the outer electrode 5 is close to human tissue, the impedance collected by the outer electrode 5 is the impedance of the myocardial tissue, which is greater than the impedance of the blood, that is, at this time, the impedance 13 collected by the outer electrode is greater than the impedance 14 collected by the inner electrode; therefore, through the real-time comparison of the impedance 13 collected by the outer electrode and the impedance 14 collected by the inner electrode, it can be clearly determined whether the outer electrode 5 is in contact with human tissue or blood. Since effective ablation requires the electrode to be in good contact with human tissue, it can better feedback the contact situation of human tissue and improve the effectiveness of ablation. And since each of the outer electrodes 5 and the inner electrode 7 is paired, located almost in the same spatial position, and independently set up for detection, it is possible to accurately know whether each of the outer electrodes 5 is in contact.

[0052] The catheter capable of performing local ablation described in this embodiment can realize multipolar ablation and mapping by providing the spherical head 1 and the plurality of outer electrodes 5 thereon. By providing the outer electrodes 5 as flexible planar electrodes, local tissue ablation within the plane range can be realized, that is, the same catheter can simultaneously realize multipolar precision mapping, multipolar high-efficiency ablation, and single-point local fine ablation. There is no need to replace the catheter during use, thereby improving efficiency and reducing overall costs.

[0053] The catheter capable of performing local ablation described in this embodiment, by providing the hollow portion 3 and the elastic support arm 2, enables the spherical head end 1 to be deformed and restored, thereby facilitating entry and exit of the sheath.

[0054] The catheter capable of performing local ablation described in this embodiment has the hollow portion 3 arranged so that the spherical head end 1 is hollowed out, thereby allowing blood to enter the interior of the spherical head end 1, and the inner electrode 7 can be in contact with the blood. The surface area of ​​the inner electrode 7 is equal to the surface area of ​​the outer electrode 5, and can have the same reference standard. By comparing the impedance detection of each pair of the outer electrode 5 and the inner electrode 7, the degree of contact of the outer electrode 5 can be confirmed. Even in the case of multiple ablation electrodes, the contact detection of any single outer electrode 5 can be achieved, thereby overcoming the problem that it is difficult for multi-polar ablation catheters in the prior art to determine the contact degree of a single electrode through pressure monitoring. The catheter has good practicality, does not require the integration of a pressure sensor on the electrode, and greatly simplifies the design difficulty of the spherical head end 1.

[0055] 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 catheter capable of performing local ablation, comprising a spherical head end (1) and a tube body (4), wherein the spherical head end (1) is connected to the distal end of the tube body (4), characterized in that: The spherical head end (1) comprises a plurality of support arms (2), a plurality of outer electrodes (5) and a plurality of inner electrodes (7); A hollow portion (3) is provided between the support arms (2), and the support arms (2) are elastic; The outer electrode (5) is arranged on the support arm (2), and the outer electrode (5) is a flexible planar electrode, and the shape of the flexible planar electrode is one or more of a circular shape, an elliptical shape, and a polygonal shape; The inner electrode (7) is arranged on the support arm (2) and corresponds to the outer electrode (5) one by one. The inner electrode (7) is located on the back side of the outer electrode (5), and the surface area of ​​the inner electrode (7) is equal to the surface area of ​​the outer electrode (5).

2. The catheter capable of local ablation according to claim 1, characterized in that: The inner electrode (7) is consistent in shape and size with the outer electrode (5).

3. The catheter capable of local ablation according to claim 1, characterized in that: The outer electrodes (5) are arranged in layers from the poles of the spherical head end (1) toward the equator; Each layer of the outer electrodes (5) is evenly arranged; The outer electrodes (5) of adjacent layers are arranged in a staggered manner.

4. The catheter capable of local ablation according to claim 3, characterized in that: The number of layers of the outer electrodes (5) is 3 to 5; The first layer is provided with an outer electrode (5); The remaining layers are provided with 6 to 10 outer electrodes (5); At least one layer is near or on the equator.

5. The catheter capable of local ablation according to claim 4, characterized in that: The number of layers of the outer electrodes (5) is 4; The first layer is provided with a top outer electrode (51), and the top outer electrode (51) is arranged opposite to the distal end of the tube body (4); The second layer is provided with 6 second layer outer electrodes (52); The third layer is provided with six third layer outer electrodes (53), and the third layer is close to the equator or located on the equator; The fourth layer is provided with six fourth-layer outer electrodes (54).

6. The catheter capable of local ablation according to claim 3, characterized in that: The outer electrodes (5) of adjacent layers have opposite polarities for bipolar ablation; Alternatively, each of the outer electrodes (5) discharges relative to the neutral electrode (12) for monopolar ablation, and the neutral electrode (12) is arranged on the human body (10).

7. The catheter capable of local ablation according to claim 1, characterized in that: The distal end of the tube body (4) is provided with an irrigation tube (6), and the irrigation tube (6) extends into the spherical head end (1).

8. The catheter capable of local ablation according to claim 7, characterized in that: The perfusion tube (6) is provided with a plurality of proximal perfusion channels (61) at the intersection of the distal end of the tube body (4) and the spherical head end (1); The top of the perfusion tube (6) is provided with a plurality of top perfusion channels (63); A plurality of distal perfusion channels (62) are provided on the perfusion tube (6) between the proximal perfusion channel (61) and the top perfusion channel (63).

9. The catheter capable of local ablation according to claim 1, characterized in that: Adjacent support arms (2) are staggeredly connected and converge on an extension line of the axis of the tube body (4).

10. The catheter capable of local ablation according to any one of claims 1 to 9, characterized in that: The proximal end of the tube body (4) is connected to a control handle (8), and the control handle (8) is provided with a Luer connector (9).

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