Catheter

Abstract

The invention relates to the technical field of medical instruments, in particular to a catheter. Comprising a first catheter and a second catheter, the first catheter can be used for mapping electrical signals of tissues, and the second catheter can be used for ablating the tissues; the extension direction of the first conduit is the same as that of the second conduit; the first catheter is also capable of releasing an electrical signal to ablate tissue. The large and small ring structures can be quickly positioned, the adaptability is high, the operation of an operator is effectively reduced, and the operation efficiency is improved.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and particularly to a catheter. Background Art

[0002] Electrophysiological ablation surgery aimed at isolating abnormal electrical signals around the pulmonary veins is a common method for treating current atrial fibrillation cases. Usually, it is necessary to first use a mapping catheter to mark abnormal signal points and reentry areas, and then use an ablation catheter to perform ablation operations on the marked points or areas to achieve the surgical effect. For ablation in the circum-pulmonary region and within the pulmonary veins, a point-to-point mode is usually adopted, which requires the operator to repeatedly operate multiple catheters during the operation for mapping and ablation operations. The process is complex, the learning curve is long, and the number of trial-and-error attempts is large, affecting the overall surgical safety and surgical efficiency. Summary of the Invention

[0003] To solve the problems existing in the prior art, this application provides a catheter.

[0004] The specific technical solution of this application is as follows:

[0005] 1. A catheter, which includes a first catheter and a second catheter. The first catheter and the second catheter have the same extension direction, and the first catheter and the second catheter can respectively perform mapping and / or ablation;

[0006] A first head end is provided at the distal end of the first catheter, and a second head end is provided at the distal end of the second catheter. The first head end is located distal to the second head end;

[0007] The radial dimension of the first head end is smaller than the radial dimension of the second head end.

[0008] 2. The catheter according to item 1, wherein the first catheter can be used for mapping tissue electrical signals, and the second catheter can ablate tissue.

[0009] 3. The catheter according to item 1, wherein the first catheter can also release electrical signals to ablate tissue.

[0010] 4. The catheter according to item 3, wherein the first head end is annular, the second head end is annular, and the diameter of the first head end is smaller than the diameter of the second head end.

[0011] 5. The catheter according to item 3, wherein the plane where the first head end is located is perpendicular to the extension direction of the first catheter, the plane where the second head end is located is perpendicular to the extension direction of the second catheter, and the first head end and the second head end are arranged in parallel.

[0012] 6. The catheter according to item 3, wherein the first catheter and the second catheter are slidably connected, the first catheter is disposed in the annular structure of the second head end, and the first catheter can slide axially relative to the second catheter.

[0013] 7. The catheter according to item 3, wherein the diameter of the first head end is 7 to 22 mm.

[0014] 8. The catheter according to item 7, wherein the diameter of the first head end is 12 to 17 mm.

[0015] 9. The catheter according to item 3, wherein a pull wire capable of adjusting the diameter size of the first head end is connected to the first head end.

[0016] 10. The catheter according to item 9, wherein the distal end of the pull wire is disposed inside the first head end, the proximal end of the pull wire is disposed inside the first catheter, and a control assembly capable of pulling the pull wire is disposed on the proximal end of the first catheter.

[0017] 11. The catheter according to item 3, wherein the diameter of the second head end is variable.

[0018] 12. The catheter according to item 3, wherein the diameter range of the second head end is 10 to 50 mm.

[0019] 13. The catheter according to item 12, wherein the diameter range of the second head end is 15 to 30 mm.

[0020] 14. The catheter according to item 3, wherein the diameter of the second head end is a fixed diameter.

[0021] 15. The catheter according to item 14, wherein the diameter of the second head end is any value in the range of 10 to 50 mm.

[0022] 16. The catheter according to item 14, wherein the diameter of the second head end is any value in the range of 15 to 30 mm.

[0023] 17. The catheter according to item 14, wherein the diameter of the second head end is any integer value in the range of 15 to 30 mm.

[0024] 18. The catheter according to item 3, wherein a first electrode is disposed on the first head end.

[0025] 19. The catheter according to item 18, wherein the first electrode includes an ablation electrode.

[0026] 20. The catheter according to item 19, wherein the first electrode includes a mapping electrode.

[0027] 21. The catheter according to item 20, wherein the first electrode is a comprehensive electrode having mapping and ablation functions.

[0028] 22. The catheter according to item 3, wherein a plurality of second electrodes are arranged on the second head end in a uniformly distributed manner.

[0029] 23. The catheter according to item 22, wherein the second electrode includes a mapping electrode.

[0030] 24. The catheter according to item 23, wherein the second electrode includes an ablation electrode.

[0031] 25. The catheter according to item 24, wherein the second electrode is a comprehensive electrode with mapping and ablation functions.

[0032] 26. The catheter according to item 2, wherein a first transition part for connection is arranged between the first catheter and the first head end, and a second transition part for connection is arranged between the second catheter and the second head end.

[0033] 27. The catheter according to item 2, wherein the distance between the first head end and the second head end in the extending direction of the first catheter or the second catheter is 2 - 15 mm.

[0034] 28. The catheter according to item 27, wherein the distance between the first head end and the second head end in the extending direction of the first catheter or the second catheter is 5 - 10 mm.

[0035] 29. The catheter according to item 1, wherein the catheter further includes a tube body, the first catheter and the second catheter both pass through the tube body, and a magnetic inductor is arranged at the distal end of the tube body.

[0036] 30. The catheter according to item 26, wherein the first catheter and the second catheter are both slidably connected to the tube body.

[0037] Beneficial effects

[0038] For the catheter of the present application, during use, the first head end can be used to perform mapping in the circumferential pulmonary region and pulmonary veins first, and then ablation operations can be directly performed using the electrodes on the first head end and the second head end; the first head end can perform a variable diameter operation, and its outer diameter can be variable in the range of 12 - 17 mm to adapt to different pulmonary vein tube sizes under different physiological anatomical structures. Mapping can be performed on more sizes of pulmonary vein tubes.

[0039] The boundary connection line between the first head end and the second head end is conical, which can make it easier for the first head end to enter the circumferential pulmonary vein, and the second head end can be synchronously abutted against the circumferential pulmonary vein orifice.

[0040] Furthermore, the catheter in the present application can directly perform ablation operations on the pulmonary veins and the circumferential pulmonary vein orifice region, achieving one-step isolation.

[0041] In this application, the catheter can achieve two functions of mapping and ablation. The first distal end and the second distal end form large and small loop structures, which can quickly locate, have strong adaptability, effectively reduce the operation of the operator, and improve the surgical efficiency. Brief Description of the Drawings

[0042] Figure 1 is a schematic structural diagram of the catheter of this application;

[0043] Figure 2 is a structural diagram of the catheter of this application during ablation of tissue;

[0044] Figure 3 is a cross-sectional view of the catheter of this application during ablation of tissue;

[0045] Figure 4 is a schematic diagram of the moving position of the catheter of this application.

[0046] In the figure, 1 is the first catheter; 11 is the first distal end; 2 is the second catheter; 22 is the second distal end; 3 is the tube body; 4 is the magnetic sensor; 5 is the tissue; 6 is the ring electrode. Detailed Description of the Invention

[0047] The following is a detailed description of this application. Although specific embodiments of this application are shown, it should be understood that this application can be implemented in various forms and should not be limited by the embodiments set forth herein. On the contrary, these embodiments are provided so that this application can be more thoroughly understood and the scope of this application can be completely conveyed to those skilled in the art.

[0048] It should be noted that certain terms are used in the specification and claims to refer to specific components. Those skilled in the art should understand that technicians may use different terms to refer to the same component. The specification and claims do not use the difference in terms as a way to distinguish components, but use the difference in the functions of components as the criterion for distinction. As used throughout the specification and claims, the terms "comprising" or "including" are open-ended terms and should be interpreted as "including but not limited to". The subsequent description of the specification is a preferred embodiment for implementing this application, but the description is for the purpose of the general principles of the specification and is not intended to limit the scope of this application. The scope of protection of this application shall be determined by the appended claims.

[0049] Referring to Figure 1 , this application provides a catheter. It includes a first catheter 1 and a second catheter 2. The first catheter 1 and the second catheter 2 have the same extending direction. The first catheter 1 and the second catheter 2 can respectively perform mapping and / or ablation.

[0050] In the field of interventional medicine, the end closer to the operator is defined as the "proximal end", and the end farther from the operator is defined as the "distal end"; for an elongated object, the direction parallel to its length extension direction is defined as the "axial direction", and the direction perpendicular to its extension is defined as the "radial direction"; for an object with a circular cross-section, the direction surrounding its axial direction is defined as the "circumferential direction".

[0051] Reference Figure 1 and Figure 2 , the first catheter 1 and the second catheter 2 are arranged side by side and both extend towards the distal end. Ring electrodes 6 are provided on both the first catheter 1 and the second catheter 2. The ring electrodes 6 can be used for mapping and / or ablation.

[0052] After the first catheter 1 and the second catheter 2 enter the human body, the first catheter 1 and the second catheter 2 can respectively perform mapping or ablation on human tissue 5. Through the combined action of the first catheter 1 and the second catheter 2, compared with using a conventional single catheter, the working efficiency is greatly improved.

[0053] Reference Figure 2 and Figure 3 , when the first catheter 1 and the second catheter 2 are in use, according to the actual situation or by selecting appropriate structural dimensions, the first catheter 1 and the second catheter 2 can achieve the mapping and / or ablation functions as expected. For example, when performing mapping and ablation at the pulmonary vein ostium, the diameter of the ostium part of the vein is larger and the internal diameter of the vein is smaller. Therefore, the one with a larger radial dimension among the first catheter 1 and the second catheter 2 is used for mapping, and the one with a smaller radial dimension enters the vein interior for ablation. Similarly, according to different situations, the first catheter 1 and the second catheter 2 can respectively perform mapping or ablation, thereby achieving precise treatment of human tissue 5; at the same time, the simultaneous use of the first catheter 1 and the second catheter 2 greatly improves the working efficiency. Even further, it can effectively reduce the operations of the operator, reduce the possibility of surgical operation errors, and improve the safety and success rate of the surgery.

[0054] A first head end 11 is provided at the distal end of the first catheter 1, and a second head end 22 is provided at the distal end of the second catheter 2. The first head end 11 is located at the distal end of the second head end 22;

[0055] Reference Figure 1 , the radial dimension of the first head end 11 is smaller than the radial dimension of the second head end 22.

[0056] The first head end 11 with a smaller radial dimension is arranged at the distal position of the second head end 22. Therefore, a cone with a gradually decreasing radial dimension from the proximal end to the distal end is formed between the first head end 11 and the second head end 22.

[0057] Reference Figure 1 and Figure 3, It is worth mentioning that the conical structure formed between the first head end 11 and the second head end 22 is similar to the pulmonary vein ostium structure of human tissue 5. For example Figure 3 In Figure 3 , the first head end 11 and the second head end 22 are respectively attached to the tissues on the inner and outer sides of the pulmonary vein ostium; therefore, when the first head end 11 and the second head end 22 penetrate into the human pulmonary vein ostium, the first head end 11 with a smaller size can easily enter the pulmonary vein from the larger-sized pulmonary vein ostium, and then the first head end 11 can also play a guiding role for the second head end 22 so that the second head end 22 can be accurately positioned at the position of the pulmonary vein ostium.

[0058] Reference Figure 3 , Further, when the second head end 22 reaches the position of the pulmonary vein ostium under the guidance of the first head end 11, the second head end 22 contacts and abuts against the human tissue 5 around the pulmonary vein ostium, that is, the end face at the distal end of the second head end 22 abuts against the human tissue; at this time, the human tissue 5 can also provide a supporting force for the second head end 22, making it more convenient for the operator to control the first head end 11 and the second head end 22. Further, after the second head end 22 abuts against the human tissue 5, the operator can more easily control the first head end 11 to reach the target position by relying on the support of the second head end 22 and the human tissue 5. The control accuracy of the first head end 11 is greatly improved. At the same time, the control simplicity of the first head end 11 is also increased.

[0059] Reference Figure 1 , The first catheter 1 can be used to map the electrical signals of the tissue 5, and the second catheter 2 can ablate the tissue 5.

[0060] During the conventional use process, when ablating the tissue 5, the tissue 5 will be mapped according to the electrophysiological characteristics of the human tissue 5, and then the lesion point will be found, and then the catheter used for mapping will be replaced with an ablation catheter to perform ablation treatment on the lesion point. Replacing the catheter after mapping and then performing ablation treatment, compared with the first catheter 1 and the second catheter 2 in this application jointly penetrating into the human body, the first catheter 1 and the second catheter 2 in this application can save a large amount of surgical time during use, and at the same time reduce the steps of the catheter penetrating into and being withdrawn from the human body, further reducing the possibility of accidents during the operation, which helps to improve the success rate of the operation.

[0061] Reference Figure 3 , On the other hand, since the internal size of the pulmonary vein is small, in order to accurately find the lesion point, it is necessary to perform electrophysiological mapping on the part of the pulmonary vein close to the heart, and the second head end 22 with a larger size is difficult to enter the pulmonary vein. Therefore, in this application, the first head end 11 with a smaller radial size is used for mapping, so as to be able to perform a more comprehensive electrophysiological mapping on the human heart and pulmonary vein to find the accurate site of the lesion.

[0062] The first catheter 1 is also capable of releasing ablation energy to ablate the tissue 5.

[0063] Furthermore, in some specific cases, the lesion site is inside the pulmonary vein, and it is difficult for the second catheter 2 with a larger radial dimension to enter the pulmonary vein. Therefore, in this application, the first catheter 1 is configured to be capable of ablation, so that the tissue 5 inside the pulmonary vein can be ablated.

[0064] Reference Figure 1 , the first distal end 11 is circular, the second distal end 22 is circular, and the diameter of the first distal end 11 is smaller than the diameter of the second distal end 22.

[0065] Both the first distal end 11 and the second distal end 22 are configured as circular structures, hiding the ends of the first distal end 11 and the second distal end 22 in the circular structures, thereby reducing the sharpness between the first distal end 11 and the second distal end 22, and thus reducing the possibility of the first distal end 11 and the second distal end 22 causing stab wounds to the tissue 5.

[0066] The circular diameter of the first distal end 11 is smaller than the diameter of the second distal end 22. Therefore, when the first catheter 1 and the second catheter 2 penetrate deep inside the human body, the first distal end 11 can penetrate into the smaller-diameter human tissue 5. And due to the larger radial dimension, the second distal end 22 abuts against the outside of the structure of the human tissue 5 with a smaller diameter.

[0067] Reference Figure 2 , the circular structures of the first distal end 11 and the second distal end 22, on the one hand, hide the sharp ends, reducing the sharpness of the first catheter 1 and the second catheter 2 at the distal position; reducing the possibility of the first distal end 11 and the second distal end 22 causing stab wounds to the human tissue 5. On the other hand, the small-sized first distal end 11 is located at the distal position of the second distal end 22, enabling the first distal end 11 to enter into the smaller-sized human tissue 5. The first distal end 11 can play a guiding role for the second distal end 22. After entering the human tissue 5, when the second distal end 22 abuts against the tissue 5, it can provide support for the first distal end 11, improving the positioning accuracy of the first distal end 11.

[0068] Reference Figure 3 , the plane where the first distal end 11 is located is perpendicular to the extending direction of the first catheter 1, the plane where the second distal end 22 is located is perpendicular to the extending direction of the second catheter 2, and the first distal end 11 and the second distal end 22 are arranged in parallel.

[0069] The plane where the circular structures of the first distal end 11 and the second distal end 22 are located is the perpendicular position of their respective catheters, that is, the first distal end 11 and the second distal end 22 are surrounded on the radial planes of the first catheter 1 and the second catheter 2.

[0070] Reference Figure 3, so that when the first distal end 11 enters the human pulmonary vein, the outer peripheral surface of the first distal end 11 contacts the inner wall of the pulmonary vein, and the distal end surface of the second distal end 22 fits around the circumference of the pulmonary vein orifice.

[0071] The first distal end 11 and the second distal end 22 which are perpendicular to the first catheter 1 and the second catheter 2 form a frustum-shaped three-dimensional structure at the distal positions of the first catheter 1 and the second catheter 2. The shapes of the first distal end 11 and the second distal end 22 are made similar to the shape of the pulmonary vein orifice of the heart, making it easier for the first distal end 11 and the second distal end 22 to fit the pulmonary vein orifice of the heart. When ablating the human tissue 5, it reduces the possibility of the ablation operation on the tissue 5 failing due to the fitting gap and further the risk of complications.

[0072] On the other hand, after the radially arranged first distal end 11 enters the pulmonary vein, the first distal end 11 can achieve complete contact with the entire circumference of the inner wall of the pulmonary vein, greatly increasing the contact area between the first distal end 11 and the pulmonary vein. Further, when mapping or ablating the human tissue 5, increasing the contact area can bring higher efficiency, effectively reduce the operation time, reduce the complexity of the operation, improve the convenience of the operation, and thus achieve the purpose of improving the success rate of the operation.

[0073] Reference Figure 4 , the first catheter 1 and the second catheter 2 are slidably connected, the first catheter 1 is arranged in the annular structure of the second distal end 22, and the first catheter 1 can slide axially relative to the second catheter 2.

[0074] Under the guidance of the first catheter 1, after the second catheter 2 contacts the human tissue 5, the second catheter 2 will be fixedly abutted against the human tissue 5. Here, although the second catheter 2 can provide support for the first catheter 1, due to the fixed structure of the human tissue 5, it also makes it difficult for the second catheter 2 to move deeper. At this time, if the tissue 5 that the first catheter 1 needs to ablate or map is located deeper, it will be difficult to reach the target position due to the limitation of the second catheter 2. Therefore, in the present application, the first catheter 1 is arranged to be able to slide relative to the second catheter 2. After the second catheter 2 abuts against the human tissue 5, the first catheter 1 can still penetrate or retract, so that the first catheter 1 can accurately reach the target position under the support of the second catheter 2; improve the ablation accuracy of the operation, and thus reduce the possibility of the patient having complications after the operation and improve the success rate of the operation.

[0075] The diameter of the first distal end 11 is 7 - 22 mm; preferably 12 - 17 mm.

[0076] Specifically, the diameters of the first head end 11 are: 7 mm, 7.5 mm, 8 mm, 8.5 mm, 9 mm, 9.5 mm, 10 mm, 10.5 mm, 11 mm, 11.5 mm, 12 mm, 12.5 mm, 13 mm, 13.5 mm, 14 mm, 14.5 mm, 15 mm, 15.5 mm, 16 mm, 16.5 mm, 17 mm, 17.5 mm, 18 mm, 18.5 mm, 19 mm, 19.5 mm, 20 mm, 20.5 mm, 21 mm, 21.5 mm, 22 mm.

[0077] More specifically, in a specific embodiment, the diameter variation range of the first head end is: 7 - 17 mm, 8 - 18 mm, 9 - 19 mm, 10 - 20 mm, 11 - 21 mm, 12 - 22 mm.

[0078] In another specific embodiment, the diameter variation range of the first head end is: 7 - 12 mm, 8 - 13 mm, 9 - 14 mm, 10 - 15 mm, 11 - 16 mm, 12 - 17 mm, 13 - 18 mm, 14 - 19 mm, 15 - 20 mm, 16 - 21 mm, 17 - 22 mm.

[0079] Reference Figure 1 , a pulling wire (not shown in the figure) capable of adjusting the diameter size of the first head end 11 is connected to the first head end 11.

[0080] The distal end of the pulling wire is fixedly connected to the end of the first head end 11, and the pulling wire is slidably connected inside the first head end 11.

[0081] When the end of the first head end 11 is pulled toward the proximal end under the action of the pulling wire, the pulling wire located inside the first head end 11 becomes shorter, and further, the first head end 11 will contract inward, making the first head end 11 become a ring with a smaller diameter.

[0082] The diameter of the ring-shaped first head end 11 can be controlled by the pulling wire. During use, after the first head end 11 enters the pulmonary vein, since the position of the pulmonary vein orifice presents a shape with a gradually decreasing diameter as it goes deeper, therefore, when the first head end 11 needs to enter the deep part of the pulmonary vein, the radial dimension of the first head end 11 needs to be reduced to less than the size of the deep part of the pulmonary vein. And when at the shallow position near the heart in the pulmonary vein, if the first head end 11 needs to fit with the pulmonary vein, the diameter of the first head end 11 needs to be controlled to become larger.

[0083] Reference Figure 1, a wire is used to control the radial dimension of the first distal end 11, so that the first distal end 11 can be in contact with the pulmonary vein or other suitable areas of the human tissue 5 at a shallow position and can also penetrate into a position with a smaller size. The adaptability of the first distal end 11 is improved; the first distal end 11 can cope with more usage scenarios.

[0084] The distal end of the wire is arranged inside the first distal end 11, and the proximal end of the wire is arranged inside the first catheter 1. A control component capable of pulling the wire is arranged on the proximal end of the first catheter 1.

[0085] Reference Figure 1 , a handle (not shown in the figure) is arranged at the proximal end of the catheter. The handle is held by the operator to control the catheter. The control component is arranged on the handle and is located at the distal position of the handle for the convenience of the operator to use the control component.

[0086] Reference Figure 1 , the operator can control the diameter of the first distal end 11 through the control component, so that the first distal end 11 can perform the operation with a suitable size during the operation.

[0087] The diameter of the second distal end 22 is variable.

[0088] The control component includes a first control part capable of controlling the first distal end and a second control part capable of controlling the second distal end.

[0089] The first control part can control the diameter change of the first distal end through the wire.

[0090] Similarly, in a specific embodiment, when the second distal end has a variable diameter. A second wire is also connected to the second distal end, and the second control part can control the second wire to change the diameter of the second distal end.

[0091] The first control part can pull the wire towards the distal end or the proximal end. When the first control part pulls the wire towards the proximal end, the first distal end will contract towards the inside, so that the diameter of the first distal end becomes smaller. When the first control part moves the wire towards the distal end, the first distal end will expand towards the outside, making the diameter of the first distal end larger. Similarly, the second distal end will also expand or contract under the action of the second control part.

[0092] In a specific embodiment; the diameter range of the second distal end 22 is 10 - 50 mm; further preferably, the diameter range of the second distal end 22 is 15 - 30 mm.

[0093] Specifically, the diameter of the second head end can be controlled to be: 10mm, 10.5mm, 11mm, 11.5mm, 12mm, 12.5mm, 13mm, 13.5mm, 14mm, 14.5mm, 15mm, 15.5mm, 16mm, 16.5mm, 17mm, 17.5mm, 18mm, 18.5mm, 19mm, 19.5mm, 20mm, 20.5mm, 21mm, 21.5mm, 22mm, 22.5mm, 23mm, 23.5mm, 24mm, 24.5mm, 25mm, 25.5mm, 26mm, 26.5mm, 27mm, 27.5mm, 28mm, 28.5mm, 29mm, 29.5mm, 30mm, 30.5mm, 31mm, 31.5mm, 32mm, 32.5mm, 33mm, 33.5mm, 34mm, 34.5mm, 35mm, 35.5mm, 36mm, 36.5mm, 37mm, 37.5mm, 38mm, 38.5mm, 39mm, 39.5mm, 40mm, 40.5mm, 41mm, 41.5mm, 42mm, 42.5mm, 43mm, 43.5mm, 44mm, 44.5mm, 45mm, 45.5mm, 46mm, 46.5mm, 47mm, 47.5mm, 48mm, 48.5mm, 49mm, 49.5mm, 50mm.

[0094] More specifically, in a specific embodiment, the range in which the diameter of the second head end can be changed is: 10 - 20mm, 15 - 25mm, 20 - 30mm, 25 - 35mm, 30 - 40mm, 35 - 45mm, 40 - 50mm.

[0095] In another specific embodiment, the range in which the diameter of the second head end can be changed is: 10 - 25mm, 15 - 30mm, 20 - 35mm, 25 - 40mm, 30 - 45mm, 35 - 50mm.

[0096] The diameter of the second head end 22 is a fixed diameter.

[0097] Preferably, the diameter of the second head end 22 is any value within 10 - 50mm; more preferably, the diameter of the second head end 22 is any value within 15 - 30mm; more preferably, the diameter of the second head end 22 is any integer value within 15 - 30mm.

[0098] Specifically, the diameter range of the second head end is: 10mm, 10.5mm, 11mm, 11.5mm, 12mm, 12.5mm, 13mm, 13.5mm, 14mm, 14.5mm, 15mm, 15.5mm, 16mm, 16.5mm, 17mm, 17.5mm, 18mm, 18.5mm, 19mm, 19.5mm, 20mm, 20.5mm, 21mm, 21.5mm, 22mm, 22.5mm, 23mm, 23.5mm, 24mm, 24.5mm, 25mm, 25.5mm, 26mm, 26.5mm, 27mm, 27.5mm, 28mm, 28.5mm, 29mm, 29.5mm, 30mm, 30.5mm, 31mm, 31.5mm, 32mm, 32.5mm, 33mm, 33.5mm, 34mm, 34.5mm, 35mm, 35.5mm, 36mm, 36.5mm, 37mm, 37.5mm, 38mm, 38.5mm, 39mm, 39.5mm, 40mm, 40.5mm, 41mm, 41.5mm, 42mm, 42.5mm, 43mm, 43.5mm, 44mm, 44.5mm, 45mm, 45.5mm, 46mm, 46.5mm, 47mm, 47.5mm, 48mm, 48.5mm, 49mm, 49.5mm, 50mm.

[0099] Reference Figure 1 , a first electrode is provided on the first head end 11. A plurality of second electrodes are uniformly arranged on the second head end 22.

[0100] That is: the ring electrode 6 includes a first electrode provided on the first head end 11 and a second electrode provided on the second head end 22.

[0101] In the art, the uses of the first electrode and the second electrode are qualitatively determined according to the implementation dimensions. When the size of the first electrode or the second electrode meets the mapping accuracy, mapping can be performed. When the size of the first electrode or the second electrode meets the ablation size during implementation, ablation can be performed. At the same time, if both the mapping and ablation sizes can be met in terms of technology, the mapping and ablation functions of the first electrode and the second electrode can be satisfied simultaneously.

[0102] The first head end 11 uses the first electrode to map and / or ablate the tissue 5. A plurality of first electrodes are provided on the first head end 11, and the plurality of first electrodes are arranged with different intervals or densities according to different usage situations.

[0103] Reference Figure 1, in a specific embodiment, the first electrode is an ablation electrode. At this time, the first tip 11 is used to ablate the tissue 5. After mapping the human tissue 5, the lesion point is diagnosed according to the electrophysiological three-dimensional model, and then the first electrode on the first tip 11 is used to ablate the tissue 5, thus completing the ablation surgery.

[0104] When using the first tip 11 for ablation, the first tip 11 can be first controlled to be in a state with a smaller diameter to facilitate penetration into the human tissue 5, and then the diameter of the first tip 11 is controlled to increase to fit the inside of the tissue 5, thereby realizing ablation of the deep position of the human tissue 5.

[0105] Reference Figure 1 , in a specific embodiment, the first electrode is a mapping electrode;

[0106] In this embodiment, the first electrode on the first tip 11 is used to map the human tissue 5. After the first tip 11 penetrates into the human tissue 5 such as the pulmonary vein, the diameter of the first tip 11 can be expanded, and then the first tip 11 is brought into contact with the human tissue 5 to map the human tissue 5 and obtain an electrophysiological three-dimensional model of the human tissue 5. Since the size of the first tip 11 can be changed according to the usage situation, the first tip 11 can map the deep part of the human tissue 5 such as the pulmonary vein. At the same time, the first tip 11 can also map the human tissue 5 with a smaller size.

[0107] Reference Figure 1 , in a specific embodiment, the first electrode is a comprehensive electrode with mapping and ablation functions.

[0108] When the first electrode can perform mapping and ablation simultaneously, at this time, the first tip 11 can penetrate into the pulmonary vein or other tissues 5 to map the human tissue 5. Then, an accurate electrophysiological three-dimensional model of the human tissue 5 is obtained, and then the lesion point is diagnosed, and then the first electrode on the first tip 11 is used to ablate the lesion point. Thus, ablation treatment of the patient is realized.

[0109] Using the first tip 11 for mapping and ablation simultaneously greatly reduces the mapping and ablation time of the human tissue 5, further reduces the operation steps of the surgery, and can achieve the purpose of reducing the surgical risk.

[0110] Reference Figure 1 , in a specific embodiment, the second electrode is an ablation electrode;

[0111] In this embodiment, the second distal end 22 is used to ablate the tissue 5. Since the size of the second distal end 22 is relatively large, it is difficult to comprehensively observe and control when the second distal end 22 is in contact with the tissue 5. Therefore, it is necessary to use the first distal end 11 to first enter the interior of a similar structure such as the pulmonary vein. Through the guidance of the first distal end 11, the second distal end 22 is then positioned at a position in contact with the tissue 5. The second distal end 22 is a ring with a relatively large diameter, so the second distal end 22 can be in contact with the relatively large-sized ring-shaped tissue 5 and perform ablation, effectively increasing the area of the tissue 5 that can be ablated and improving the ablation efficiency of the tissue 5.

[0112] Reference Figure 1 , in a specific embodiment, preferably, the second electrode is a mapping electrode;

[0113] When using the second distal end 22 for mapping, since the diameter of the second distal end 22 is relatively large, the second electrode can map a larger range, so the second distal end 22 can perform rapid mapping when the accuracy requirement is relatively low.

[0114] Reference Figure 1 , in a specific embodiment, further preferably, the second electrode is a comprehensive electrode with mapping and ablation functions.

[0115] In this embodiment, when the second distal end 22 can both map and ablate, generally the first distal end 11 is used to assist in mapping at this time. The second distal end 22 performs a large-range rough mapping, and then the first distal end 11 is used for precise mapping to obtain a precise three-dimensional model of the human tissue 5 for diagnosing lesions.

[0116] Then the large-sized second distal end 22 is used to perform large-range ablation on the lesion points.

[0117] A first transition part for connection is provided between the first catheter 1 and the first distal end 11, and a second transition part for connection is provided between the second catheter 2 and the second distal end 22.

[0118] Since the first catheter 1 extends distally along the central axis, and the plane where the ring-shaped first distal end 11 is located is perpendicular to the central axis of the first catheter 1, the first transition part is curved and extends from the distal end of the first catheter 1 in a direction away from the central axis of the first catheter 1 and is connected to the first distal end 11. The first transition part is used to connect the first distal end 11 with the first catheter 1, enabling the first distal end 11 to form a structure perpendicular to the axis of the first catheter 1 inside the human body for mapping and / or ablation.

[0119] Similarly, the second transition portion is used to connect the second catheter 2 and the second distal end 22. Moreover, the second transition portion can also support the second distal end 22, enabling the second distal end 22 to abut against the human tissue 5.

[0120] The distance between the first distal end 11 and the second distal end 22 in the extending direction of the first catheter 1 or the second catheter 2 is 2 to 15 mm; preferably 5 to 10 mm.

[0121] Specifically, the distance between the first distal end 11 and the second distal end 22 is: 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm.

[0122] Reference Figure 1 The catheter further includes a tube body 3. Both the first catheter 1 and the second catheter 2 pass through the tube body 3, and a magnetic sensor 4 is provided at the distal end of the tube body 3.

[0123] Reference Figure 4 The tube body 3 is used to connect and wrap the first catheter 1 and the second catheter 2, and both the first catheter 1 and the second catheter 2 are disposed inside the tube body 3. Thus, the possibility that the distance between the first distal end 11 and the second distal end 22 changes during mapping or ablation inside the human body is reduced. In addition, the first catheter 1 and the second catheter 2 are connected through the tube body 3, enabling the first distal end 11 to more smoothly guide the second distal end 22, and the second distal end 22 can also support the first distal end 11.

[0124] Reference Figure 4 In addition, in another specific embodiment, the tube body 3 can also be used to replace the sheath tube for accommodating the first distal end 11 and the second distal end 22. That is, when transporting the first distal end 11 and the second distal end 22 into the human body, it is necessary to accommodate both the first distal end 11 and the second distal end 22 inside the tube body 3, so that the first distal end 11 and the second distal end 22 of the ring structure elastically deform into a straight line under the constraint of the tube body 3, and then are transported to the target position inside the human body through the vein.

[0125] Reference Figure 4 The magnetic sensor is used for positioning. The operator can detect the magnetic sensor, thereby enabling the operator to determine the specific position of the distal end of the tube body 3. Since the distal position of the tube body 3 is close to the first distal end 11 and the second distal end 22, by positioning the magnetic sensor, the operator can know the precise positions of the first distal end 11 and the second distal end 22, and thus the operator can accurately transport the first distal end 11 and the second distal end 22 to the target position.

[0126] Reference Figure 4, the tube body 3 is connected to the first catheter 1 and the second catheter 2 respectively at positions near the distal end;

[0127] In one embodiment, both the first catheter 1 and the second catheter 2 are slidably connected to the tube body 3, and both the first catheter 1 and the second catheter 2 can reciprocate inside the tube body 3, thereby realizing the control of the position between the first head end 11 and the second head end 22.

[0128] Reference Figure 4 , in a specific embodiment, both the first catheter 1 and the second catheter 2 are fixedly connected to the tube body 3, and at the same time, the position between the first head end 11 and the second head end 22 is fixed. After penetrating into the human body, the possibility of displacement between the first head end 11 and the second head end 22 can be significantly reduced. This situation is applicable when the fixed sizes of the first head end 11 and the second head end 22 are similar to the size of the patient's tissue 5.

[0129] Reference Figure 4 , in a specific embodiment, the first catheter 1 is fixedly connected to the tube body 3, the second catheter 2 is slidably connected to the tube body 3. After the first head end 11 enters the tissue 5, the second catheter 2 can be controlled to move towards the distal end, thereby reducing the distance between the first head end 11 and the second head end 22, so that the first head end 11 can immediately abut against the position of the pulmonary vein ostium after the first head end 11 enters a position such as the pulmonary vein ostium in similar tissue 5.

[0130] Reference Figure 4 , preferably, in a specific embodiment, the first catheter 1 is slidably connected to the tube body 3, and the second catheter 2 is fixedly connected to the tube body 3.

[0131] The first head end 11 can reciprocate along the tube body 3, greatly increasing the flexibility of the first head end 11. This enables the first head end 11 to more conveniently align with positions such as the pulmonary vein ostium, and during the process of penetrating into the pulmonary vein, the position of the first head end 11 and the second head end 22 can also be adjusted by controlling the reciprocating movement of the first head end 11. The positioning accuracy of the first head end 11 and the second head end 22 is improved. Furthermore, the mapping or ablation accuracy and efficiency during the ablation operation on the human body are improved, and the success rate of the operation is increased.

[0132] Reference Figure 4 , further preferably, in a specific embodiment, both the first catheter 1 and the second catheter 2 are slidably connected to the tube body 3.

[0133] After the first catheter 1 and the second catheter 2 respectively enter the human body through the catheter body 3, the distance between the first head end 11 and the second head end 22 can be changed by the sliding between the first catheter 1 and the second catheter 2 and the catheter body 3. Further, since both the first catheter 1 and the second catheter 2 can move in the catheter body 3, the distances between the first head end 11 and the second head end 22 and the catheter body 3 can also be controlled. Therefore, during use, the first head end 11 and the second head end 22 can be moved in the catheter body 3 until they are in a suitable position, and then the tissue can be ablated. This makes the first head end 11 and the second head end 22 more flexible, and they can better cope with and adapt to different environmental conditions during tissue ablation.

[0134] In summary, the present application provides a catheter. When in use, the catheter needs to be delivered into the human body through a sheath. Then, inside the human body, the first head end 11 and the second head end 22 are first pushed out of the sheath. The first head end 11 and the second head end 22 are annularly located inside the human body. The first head end 11 and the second head end 22 are simultaneously delivered to the target position of the human tissue 5. First, the first head end 11 is delivered into small-sized tissue 5 such as the human pulmonary vein. Then, under the guidance of the first head end 11, the second head end 22 is delivered forward until it abuts against the tissue 5. Since the shapes of the first head end 11 and the second head end 22 are similar to the shape at the pulmonary vein orifice, the first head end 11 and the second head end 22 can be perfectly fitted to the tissue 5. Then, with the support of the force between the second head end 22 and the abutting tissue 5, the operator can control the first head end 11, accurately position the first head end 11 to the target position for mapping, or accurately position it to the lesion point for ablation, thereby completing the mapping and ablation surgery on the patient. At the same time, the second head end 22 can also come into contact with a large area of tissue 5 and perform large-area tissue 5 ablation simultaneously, improving the ablation efficiency. It reduces the operation time and operation steps, reduces the possibility of accidents during the operation, and improves the success rate of the operation.

[0135] This specific embodiment is only an explanation of the present application and does not limit the present application. After reading this specification, those skilled in the art can make modifications to this embodiment without creative contributions as needed, but as long as they are within the scope of the claims of the present application, they are protected by the patent law.

Claims

1. A catheter, wherein, Comprising a first catheter and a second catheter, the first catheter and the second catheter having the same extending direction, the first catheter and the second catheter being respectively capable of performing mapping and / or ablation; A first tip is provided at the distal end of the first catheter, and a second tip is provided at the distal end of the second catheter, the first tip being located distal to the second tip; The radial dimension of the first tip is smaller than the radial dimension of the second tip.

2. The catheter according to claim 1, wherein the first catheter can be used for mapping tissue electrical signals, and the second catheter can ablate tissue.

3. The catheter according to claim 1, wherein the first catheter can also release electrical signals to ablate tissue.

4. The catheter according to claim 3, wherein the first tip is annular, the second tip is annular, and the diameter of the first tip is smaller than the diameter of the second tip.

5. The catheter according to claim 3, wherein the plane where the first tip is located is perpendicular to the extending direction of the first catheter, the plane where the second tip is located is perpendicular to the extending direction of the second catheter, and the first tip and the second tip are arranged in parallel.

6. The catheter according to claim 3, wherein the first catheter and the second catheter are slidably connected, the first catheter is arranged in the annular structure of the second tip, and the first catheter can slide axially relative to the second catheter.

7. The catheter according to claim 3, wherein the diameter of the first tip is 7 - 22 mm.

8. The catheter according to claim 7, wherein the diameter of the first tip is 12 - 17 mm.

9. The catheter according to claim 3, wherein a pull wire capable of adjusting the diameter dimension of the first tip is connected to the first tip.

10. The catheter according to claim 9, wherein the distal end of the pull wire is arranged inside the first tip, the proximal end of the pull wire is arranged inside the first catheter, and a control assembly capable of pulling the pull wire is arranged at the proximal end of the first catheter.

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