Mapping catheter

Abstract

The invention relates to a mapping catheter. Comprising a first tube section, a plurality of electrode sets are arranged at the far end of the first tube section and comprise the first electrode set, the second electrode set and the third electrode set, the first electrode set is configured to map electric signals of the right ventricle apex part, the second electrode set is configured to map His beams, and the third electrode set is configured to map His beams; the third electrode group is used for detecting electric signals in the inferior vena cava of the heart; the first pipe section is an elastic pipe section, and one of a reamed hole or a boss is arranged at the near end of the first pipe section in the axial direction of the first pipe section; the far end of the second pipe section is provided with the other one of a reamed hole or a boss in the axial direction of the second pipe section, the boss is inserted into the reamed hole, and the first pipe section and the second pipe section are connected through welding; the second pipe section and the first pipe section are made of the same material, a supporting layer is arranged in the second pipe section, and the rigidity of the supporting layer is larger than that of the first pipe section. The mapping requirements of the mapping catheter on the His bundle and the right ventricle can be met, and the application range of the mapping catheter can be widened.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a mapping catheter. Background Technology

[0002] With the development of medical technology, mapping catheters are commonly used to perform electrophysiological examinations and treatments on the heart in the treatment of arrhythmias (such as atrial fibrillation). By recording the electrical signals inside the heart and locating the origin of the abnormal heart rate, doctors can help determine the ablation plan.

[0003] Typically, mapping catheters have multiple microelectrodes distributed on their surface. They are inserted into specific areas of the heart through blood vessels to capture the electrocardiographic activity of different regions in real time and create three-dimensional maps to determine the location of abnormal lesions.

[0004] There is currently a clinical need for mapping of the His bundle and right ventricle. Current mapping catheters are insufficient to meet this need. Summary of the Invention

[0005] Based on this, the present application provides a mapping catheter that can ensure the mapping requirements of the His bundle and right ventricle, and can reduce the manufacturing and processing costs of the mapping catheter, which is beneficial to improving the applicability of the mapping catheter.

[0006] On one hand, embodiments of this application provide a mapping catheter, including:

[0007] The first tube segment has multiple electrode groups at its distal end, including a first electrode group, a second electrode group, and a third electrode group. The first electrode group is configured to map the electrical signal at the apex of the right ventricle, the second electrode group is configured to map the His bundle, and the third electrode group is used to detect the electrical signal in the inferior vena cava of the heart to provide an empty electrical signal.

[0008] The first pipe section is an elastic pipe section, and the proximal end of the first pipe section is provided with one of an enlarged hole or a boss along the circumference of the first pipe section.

[0009] The second pipe section has a convex hole or a boss at its distal end along the axial direction of the second pipe section. The boss is inserted into the convex hole and is connected to the first pipe section and the second pipe section by welding. The second pipe section is made of the same material as the first pipe section. A support layer is provided in the second pipe section. The stiffness of the support layer is greater than that of the first pipe section.

[0010] In one implementation, either the first pipe segment or the second pipe segment comprises a block copolymer structure with alternating rigid and flexible segments.

[0011] In one implementation, either the first pipe segment or the second pipe segment comprises a polyether block amide element.

[0012] In one implementation, the support layer includes a woven mesh interlayer.

[0013] In one implementation, the braided mesh interlayer comprises a double-layer alloy wire braided mesh.

[0014] In one implementation, the proximal end of the first pipe segment is fused to the distal end of the second pipe segment.

[0015] In one implementation, the first electrode group is located at the far end of the first tube segment.

[0016] In one implementation, the first electrode group includes a head electrode and a ring electrode. The head electrode is located at the distal end of the first pipe segment. The first ring electrode is sleeved on the outer periphery of the first pipe segment and is located at the proximal end of the head electrode. The first distance between the first ring electrode and the head electrode is 4mm-10mm.

[0017] In one implementation, the second electrode group is located near the first electrode group, and the second distance between the far end of the second electrode group and the near end of the first electrode group is 10mm-25mm; the second electrode group is used to map the His bundle.

[0018] In one implementation, the second electrode group includes multiple electrode pairs, each electrode pair including two second ring electrodes. The second ring electrodes are sleeved on the outer periphery of the first pipe segment, and the spacing between adjacent second ring electrodes is 2mm-5mm.

[0019] The spacing between adjacent electrode pairs is 4mm-10mm.

[0020] In one implementation, the third electrode group is located near the end of the second electrode group, and the third distance between the far end of the third electrode group and the near end of the first electrode group is 150mm-300mm.

[0021] The third electrode group consists of two third ring electrodes, with a spacing of 2mm-10mm between the two third ring electrodes.

[0022] The mapping catheter provided in this application embodiment features multiple electrode sets at the distal end of a first segment, which is designed as an elastic segment. Thus, when the mapping catheter is inserted into the human heart through a sheath, the elastic first segment can regain its shape after extending out of the sheath. Furthermore, this elastic first segment maintains high flexibility while retaining its shape, allowing it to conform to the structure of the right ventricle and His bundle across the tricuspid valve. This facilitates the multiple electrode sets on the first segment to adhere to the right ventricle and His bundle, ensuring mapping accuracy.

[0023] Furthermore, a second segment of the same material as the first segment is connected to its proximal end, and a support layer is provided within the second segment. The stiffness of the support layer is greater than that of the first segment. Thus, by using a second segment of the same material as the first segment, both segments can be manufactured using the same process (e.g., extrusion) during the production of the mapping catheter. This reduces the difficulty and cost of manufacturing the mapping catheter and expands its applicability.

[0024] In addition, by incorporating a support layer within the second tube segment and setting its stiffness to be greater than that of either the first or second tube segment, the stiffness of the second tube segment can be increased, thus allowing it to be more rigid than the first segment. During the insertion of the mapping catheter into the heart via the sheath, the stiffer second tube segment can exert force on the first tube segment, facilitating its insertion through the sheath into the right ventricle and His bundle across the tricuspid valve. Attached Figure Description

[0025] Figure 1 This is a schematic diagram of the overall structure of the mapping catheter according to some embodiments of this application.

[0026] Figure 2 yes Figure 1 A magnified structural diagram of point A in the middle.

[0027] Figure 3 yes Figure 2 A cross-sectional view along line BB.

[0028] Figure 4 This is an exploded structural diagram of the first and second segments of the mapping catheter provided in some embodiments of this application.

[0029] Explanation of reference numerals in the attached figures:

[0030] 11-First tube section; 12-Electrode group; 13-Second tube section; 14-Handle;

[0031] 111 - Hole enlargement; 121 - First electrode group; 122 - Second electrode group; 123 - Third electrode group; 131 - Support layer; 132 - Boss;

[0032] 1211 - Head electrode; 1212 - First ring electrode; 1221 - Electrode pair; 1221a - Second ring electrode; 1231 - Third ring electrode. Detailed Implementation

[0033] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0034] In the description of this application, it should be understood that if terms such as "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" appear, these terms indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application.

[0035] Furthermore, where the terms "first" and "second" appear, these terms are for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined with "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, where the term "multiple" appears, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0036] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "joining," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise expressly limited. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0037] In this application, unless otherwise expressly specified and limited, the use of descriptions such as "above" or "below" the second feature indicates that the first and second features are in direct contact or indirect contact via an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. Similarly, "below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0038] It should be noted that if an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. If an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. If so, the terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used in this application are for illustrative purposes only and do not represent the only possible implementation.

[0039] Figure 1 This is a schematic diagram of the overall structure of the mapping catheter according to some embodiments of this application.

[0040] In some examples, refer to Figure 1 As shown, in view of the technical problems existing in the related art, this application provides a mapping catheter. The mapping catheter may include a first tube segment 11.

[0041] In some examples, the first segment 11 may be the distal segment of the mapping catheter. It is understood that in some examples of embodiments of this application, "distal" may refer to the portion of the mapping catheter that is furthest from the operator (e.g., a physician); for example, "distal" may refer to the portion of the mapping catheter inserted into the body that contacts the right ventricle and His bundle. "Proximal" may refer to the portion of the mapping catheter that is closer to the operator.

[0042] In some examples, a plurality of electrode groups 12 may be provided at the distal end of the first pipe segment 11. The electrode groups 12 may be sleeved on the outer periphery of the first pipe segment 11. The electrode groups 12 may contact the peripheral wall of the first pipe segment 11.

[0043] In some examples, the peripheral wall of the first tube segment 11 may be provided with through holes, through which the wiring of the electrode group 12 can enter into the first tube segment 11 and run within the first tube segment 11.

[0044] In some examples, electrode assembly 12 can be used to contact the target location to be mapped, thereby mapping the electrical signal at the target location. For example, electrode assembly 12 can contact the apex of the right ventricle and the His bundle to map the electrical signals at the apex of the right ventricle and the His bundle.

[0045] In some examples, the first tube segment 11 can be an elastic tube segment. It is understood that after the mapping catheter is inserted into the human body through the sheath along the blood vessels, the first tube segment 11, being an elastic tube segment, can recover its deformation under its own elastic force after it extends out of the sheath. This ensures that the electrode group 12 on the first tube segment 11 can effectively contact the target location to be mapped, thereby improving the accuracy of electrical signal mapping at the target location.

[0046] In addition, the elastic first tube segment 11 is flexible. After contacting the target location to be calibrated, the force exerted by the first tube segment 11 on the target location is small, which can effectively protect human tissue and reduce the damage to human tissue.

[0047] In some examples, refer to Figure 1 As shown, the mapping catheter may include a second segment 13. The distal end of the second segment 13 may be connected to the proximal end of the first segment 11.

[0048] In some examples, the second tube segment 13 may be made of the same material as the first tube segment 11. That is, in some examples of embodiments of this application, the second tube segment 13 may be manufactured using the same manufacturing process as the first tube segment 11. This simplifies the manufacturing process of the mapping catheter and reduces the manufacturing cost of the mapping catheter.

[0049] Figure 2 yes Figure 1 A magnified structural diagram of point A in the middle. Figure 3 yes Figure 2 A cross-sectional view along line BB.

[0050] In some examples, during the insertion of the mapping catheter to the target location through the sheath, the second segment 13 needs to apply a certain force to the first segment 11. (Refer to...) Figure 2 and Figure 3 As shown in some examples of embodiments of this application, a support layer 131 may be provided inside the second pipe segment 13. The stiffness of the support layer 131 may be greater than the stiffness of the first pipe segment 11.

[0051] In other words, in some examples of the embodiments of this application, by setting a support layer 131 with a stiffness greater than that of the first pipe section 11 in the second pipe section 13, the second pipe section 13 is supported by the support layer 131, thereby improving the stiffness of the second pipe section 13, making the stiffness of the second pipe section 13 greater than that of the first pipe section 11.

[0052] The mapping catheter provided in this embodiment features multiple electrode groups 12 disposed at the distal end of a first tube segment 11, and the first tube segment 11 is designed as an elastic segment. Thus, when the mapping catheter is inserted into the human heart through a sheath, the elastic first tube segment 11 can recover its shape after extending out of the sheath. Furthermore, the elastic first tube segment 11 maintains high flexibility while recovering its shape, allowing it to conform to the structure of the right ventricle spanning the tricuspid valve and the His bundle. This facilitates the multiple electrode groups 12 on the first tube segment 11 to adhere to the right ventricle and the His bundle, ensuring the accuracy of the mapping.

[0053] Furthermore, a second tube segment 13, made of the same material as the first tube segment 11, is connected to the proximal end of the first tube segment 11, and a support layer 131 is provided within the second tube segment 13. The stiffness of the support layer 131 is greater than that of the first tube segment 11. Thus, by using a second tube segment 13 made of the same material as the first tube segment 11, the first tube segment 11 and the second tube segment 13 can be produced using the same process (e.g., extrusion) during the manufacturing of the mapping catheter. This reduces the difficulty and cost of manufacturing the mapping catheter and expands its applicability.

[0054] In addition, by providing a support layer 131 within the second tube segment 13 and setting the stiffness of the support layer 131 to be greater than that of either the first tube segment 11 or the second tube segment 13, the stiffness of the second tube segment 13 can be increased through the support layer 131, thereby making the stiffness of the second tube segment 13 greater than that of the first tube segment 11. During the insertion of the mapping catheter into the human heart through the sheath, the first tube segment 11 can be subjected to force through the stiffer second tube segment 13, facilitating the insertion of the first tube segment 11 through the sheath into the right ventricle and His bundle across the tricuspid valve.

[0055] In some examples, either the first segment 11 or the second segment 13 may include a block copolymer structure with alternating rigid and flexible segments.

[0056] In some examples, the block copolymer structure with alternating rigid and flexible segments may include thermoplastic polyurethane elastomers, thermoplastic vulcanizates, or styrene block copolymers, etc. It is understood that the specific types of block copolymer structures with alternating rigid and flexible segments in some examples of the embodiments of this application are only shown as specific examples and are not intended to limit the specific types of block copolymer structures with alternating rigid and flexible segments. In other examples, the block copolymer structure with alternating rigid and flexible segments may include other types.

[0057] In some examples, block copolymer structures with alternating rigid and flexible segments can connect different rigid and flexible segments through covalent bonds, resulting in nanoscale microphase separation driven by thermodynamics, thus forming a microstructure with alternating rigid and flexible phases.

[0058] In some examples of embodiments of this application, either the first tube segment 11 or the second tube segment 13 is configured as a block copolymer structure comprising alternating rigid and flexible segments. Thus, the rigid segment microregions can serve as physical crosslinking points and reinforcing phases, providing strength and rigidity, while the flexible segments can serve as continuous phases, providing elasticity and toughness. This allows the first tube segment 11 and the second tube segment 13 to recover their deformation through their own elasticity after bending. Consequently, after the first tube segment 11 extends out of the sheath, it can recover its deformation under its own elasticity, facilitating the contact of the electrode assembly 12 on the first tube segment 11 with the target location and improving the accuracy of electrical signal measurement at the target location.

[0059] In some examples, either the first segment 11 or the second segment 13 may include a polyether block amide component. That is, the block copolymer structure with alternating rigid and flexible segments described in detail in the foregoing embodiments of this application may include a polyether block amide component.

[0060] In some examples, polyether block amide components exhibit shape memory properties. The springback rate is typically greater than 95% when bent at 180°. Using polyether block amide components to fabricate the first tube segment 11 and the second tube segment 13 facilitates the springback of the first tube segment 11 after it extends out of the sheath, and facilitates the contact of the electrode assembly 12 on the first tube segment 11 with the target position.

[0061] In some examples of embodiments of this application, either the first tube segment 11 or the second tube segment 13 is made using a polyether block amide element. Thus, the polyether block amide element, as a medical polymer material, improves the safety of the mapping catheter entering the human body.

[0062] In some examples, refer to Figure 2 and Figure 3 As shown, the support layer 131 may include a woven mesh interlayer.

[0063] In some examples, the support layer 131 may be located on the inner wall of the second pipe section 13.

[0064] In some examples, the support layer 131 may be installed inside the second pipe segment 13. That is, the support layer 131 may be located between the inner wall and the outer wall of the second pipe segment 13.

[0065] In some examples, the material used to weave the mesh layer can be biocompatible and possess a degree of elasticity. Examples include medical-grade stainless steel wire or nickel-titanium alloy wire.

[0066] In some examples, a woven mesh structure is used, which makes the support layer 131 flexible and elastic. It can deform as it enters the sheath, making it easier to enter. After entering the heart and exiting the sheath, it returns to the corresponding curvature, which makes it easier for the second tube segment 13 to control the first tube segment 11. This allows the electrode group 12 on the first tube segment 11 to fit the target position to be measured, thereby improving the accuracy of the mapping.

[0067] In some examples, the braided mesh interlayer may include a double-layer alloy wire braided mesh.

[0068] By using a double-layer alloy wire braided mesh as the braided mesh interlayer, the rigidity of the second pipe section 13 is ensured, which facilitates the second pipe section 13 to apply force to the first pipe section 11 and to send the first pipe section 11 to the target position.

[0069] Figure 4 This is an exploded structural diagram of the first and second segments of the mapping catheter provided in some embodiments of this application.

[0070] In some examples, refer to Figure 4 As shown, the proximal end of the first pipe section 11 may be provided with either an enlarged hole 111 or a boss 132 along the axial direction of the first pipe section.

[0071] In some examples, the proximal end of the first pipe segment 11 may be provided with a reamed hole 111 along the axial direction of the first pipe segment 11. The reamed hole 111 may include a tapered reamed hole 111.

[0072] In some examples, the inner proximal end of the first pipe segment 11 can be ground to remove the pipe material inside the first pipe segment 11, thereby forming an enlarged hole 111.

[0073] In some examples, refer to Figure 4 As shown, the distal end of the second pipe section 13 may be provided with either an enlarged hole 111 or a boss 132 along the axial direction of the second pipe section 13.

[0074] In some examples, a boss 132 may be provided at the distal end of the second pipe segment 13 along the circumference of the second pipe segment 13. The boss 132 may include a tapered boss 132.

[0075] In some examples, the outer distal end of the second pipe segment 13 may be ground to remove the outer pipe material of the second pipe segment 13, thereby forming the boss 132.

[0076] In some examples, the boss 132 can be inserted into the enlarged hole 111 to connect the first pipe segment 11 and the second pipe segment 13.

[0077] In some examples, the boss 132 can be interference-fitted with the enlarged hole 111.

[0078] In some examples, the boss 132 may be bonded to the inner wall of the enlarged hole 111.

[0079] In some examples of embodiments of this application, one of a reamer 111 or a boss 132 is provided along the axial direction of the first pipe segment 11 at the proximal end of the first pipe segment 11, and the other of a reamer 111 or a boss 132 is provided along the axial direction of the second pipe segment 13 at the distal end of the second pipe segment 13; and the first pipe segment 11 and the second pipe segment 13 are connected by inserting the boss 132 into the reamer 111; thus, the axial connection of the first pipe segment 11 and the second pipe segment 13 is facilitated, the manufacturing and processing difficulty of the mapping catheter can be reduced, and the manufacturing and processing cost of the mapping catheter can be reduced.

[0080] In some examples, the proximal end of the first pipe segment 11 and the distal end of the second pipe segment 13 can be fused together. That is, in some examples of embodiments of this application, the boss 132 can be inserted into the enlarged hole 111, and then the boss 132 can be connected to the inner wall of the enlarged hole 111 by fusion.

[0081] In some examples, after the boss 132 is inserted into the enlarged hole 111, the connection between the first pipe segment 11 and the second pipe segment 13 can be heated by a heat equalization device. The heat equalization device can distribute heat evenly, thereby heating the proximal end of the first pipe segment 11 and the distal end of the second pipe segment 13 that pass through the heat equalization device. The circumferential temperature of the first pipe segment 11 and the second pipe segment 13 rises synchronously, and the boss 132 can be fused to the inner wall of the enlarged hole 111, thereby connecting the first pipe segment 11 and the second pipe segment 13.

[0082] In some examples, when heating the proximal end of the first pipe segment 11 and the distal end of the second pipe segment 13 using a heat exchanger, a liner can be inserted inside the first pipe segment 11 and the second pipe segment 13, with the peripheral wall of the liner abutting against the inner wall of the first pipe segment 11 and the second pipe segment 13. During the welding process, the liner can support the first pipe segment 11 and the second pipe segment 13, thereby ensuring that the outer and inner diameters of the first pipe segment 11 and the second pipe segment 13 remain unchanged, ensuring the consistency of the radial dimensions of the measuring conduit.

[0083] In some examples of embodiments of this application, the proximal end of the first tube segment 11 and the distal end of the second tube segment 13 are connected by fusion welding. This eliminates the need for additional connection structures at the junction of the first tube segment 11 and the second tube segment 13, ensuring that all materials used in the mapping catheter are medical-grade, thus improving the safety of the mapping catheter.

[0084] In some examples, refer to Figure 1 As shown, the plurality of electrode groups 12 may include a first electrode group 121. The first electrode group 121 may be located at the distal end of the first tube segment 11. The first electrode group 121 may be used to map the electrical signal of the right ventricle.

[0085] In some examples, the first electrode group 121 may be located at the farthest end of the first tube segment 11.

[0086] In some examples, the first electrode group 121 can extend into the apex of the right ventricle to map the electrical signal at the apex.

[0087] In some examples of embodiments of this application, by setting a first electrode group 121 at the distal end of the first tube segment 11, when the first tube segment 11 extends into the right ventricle, the first electrode can extend into the apex of the right ventricle under the drive of the first tube segment 11, which facilitates the mapping of electrical signals at the apex of the heart.

[0088] In some examples, the first electrode assembly 121 may include a head electrode 1211. The head electrode 1211 may be located at the distal end of the first tube segment 11. The head electrode 1211 may extend to the apex of the heart where a display is located.

[0089] In some examples, the head electrode 1211 may be inserted at the distal end of the first tube segment 11.

[0090] In some examples of embodiments of this application, a head electrode 1211 is provided at the distal end of the first tube segment 11, which facilitates the insertion of the head electrode 1211 into the apex of the right ventricle under the action of the first tube segment 11. This facilitates the mapping of electrical signals at the apex of the right ventricle.

[0091] In some examples, the first electrode group 121 may include a first ring electrode 1212. The first ring electrode 1212 may be sleeved on the outer periphery of the first pipe segment 11.

[0092] In some examples, the inner wall of the first ring electrode 1212 can be in close contact with the peripheral wall of the first tube segment 11.

[0093] In some examples, the first ring electrode 1212 may be located near the head electrode 1211. The first distance between the first ring electrode 1212 and the head electrode 1211 may be 4 mm to 10 mm.

[0094] In some examples, the first distance between the first ring electrode 1212 and the head electrode 1211 can be any one of 4mm, 6mm, 8mm, or 10mm. It is understood that the specific values ​​of the first distance in some examples of the embodiments of this application are only shown as specific examples and are not intended to limit the specific value of the first distance.

[0095] It should be noted that the numerical values ​​and ranges involved in the embodiments of this application are approximate values. Due to the influence of the manufacturing process, there may be a certain range of errors, which can be considered negligible by those skilled in the art.

[0096] In some examples, the first spacing can be set based on the apical structure of the right ventricle of the human heart.

[0097] In some examples of embodiments of this application, a first ring electrode 1212 is sleeved around the outer periphery of the first tube segment 11, and the first ring electrode 1212 is located near the proximal end of the head electrode 1211; the distance between the first ring electrode 1212 and the head electrode 1211 is set to 4mm-10mm. This facilitates the cooperation between the first ring electrode 1212 and the head electrode 1211, thereby enabling the mapping of the apex of the right ventricle.

[0098] In some examples, refer to Figure 1 As shown, the plurality of electrode groups 12 may include a second electrode group 122. The second electrode group 122 may be located near the proximal end of the first electrode group 121. The second electrode group 122 may be used for mapping the His beam.

[0099] In some examples, the second distance between the distal end of the second electrode group 122 and the proximal end of the first electrode group 121 can be 10mm-25mm. That is, the second distance between the distal electrode of the second electrode group 122 and the first ring electrode 1212 can be 10mm-25mm.

[0100] In some examples, the second distance between the distal end of the second electrode group 122 and the proximal end of the first electrode group 121 can be 10 mm, 15 mm, 20 mm, or 25 mm. It is understood that the specific values ​​of the second distance in some examples of the embodiments of this application are merely illustrative examples and are not intended to limit the specific value of the second distance.

[0101] In some examples, the second spacing can be determined based on the distance between the apex of the right ventricle of the human heart and the His bundle.

[0102] In some examples, a second electrode group 122 is disposed near the proximal end of the first electrode group 121, with a second distance of 10mm-25mm between the distal end of the second electrode group 122 and the proximal end of the first electrode group 121. This facilitates contact between the second electrode group 122 and the His beam, thereby enabling the calibration of the His beam.

[0103] In some examples, refer to Figure 1 As shown, the second electrode group 122 may include multiple electrode pairs 1221.

[0104] In some examples, electrode pair 1221 may include two second ring electrodes 1221a. The second ring electrodes 1221a may be sleeved on the outer periphery of the first pipe segment 11. The arrangement of the second ring electrodes 1221a may be the same as, similar to or similar to the arrangement of the first ring electrodes 1212. For details, please refer to the detailed description of the first ring electrodes 1212 in the foregoing embodiments of this application. The embodiments of this application will not repeat the details here.

[0105] In some examples, the spacing between adjacent second ring electrodes 1221a can be 2mm-5mm. Specifically, the spacing between adjacent second ring electrodes 1221a can be 2mm, 3mm, 4mm, or 5mm. It is understood that the spacing between adjacent second ring electrodes 1221a is only shown as specific examples and is not a limitation on the spacing between second ring electrodes 1221a.

[0106] In some examples, the spacing between adjacent electrode pairs 1221 can be 4mm-10mm. The spacing between adjacent electrode pairs 1221 can be 4mm, 6mm, 8mm or 10mm.

[0107] In some examples, the second electrode group 122 may include three electrode pairs 1221.

[0108] In some examples of embodiments of this application, a second electrode group 122 is formed by setting multiple electrode pairs 1221. Each electrode pair 1221 includes a second ring electrode 1221a, which is sleeved on the outer periphery of the first tube segment 11. The spacing between adjacent second ring electrodes 1221a is set to 2mm-5mm, and the distance between adjacent electrode pairs 1221 is set to 4mm-10mm. This facilitates contact between the second electrode group 122 and the His beam, and enables the calibration of the electrical signal of the His beam.

[0109] In some examples, refer to Figure 1 As shown, the plurality of electrode groups 12 may include a third electrode group 123. The third electrode group 123 may be located near the end of the second electrode group 122.

[0110] In some examples, the third distance between the distal end of the third electrode group 123 and the proximal end of the first electrode group 121 can be 150mm-300mm.

[0111] In some examples, the third distance between the distal end of the third electrode group 123 and the proximal end of the first electrode group 121 can be 150 mm, 200 mm, 250 mm or 300 mm.

[0112] In some examples, the third electrode group 123 can be used to detect electrical signals within the inferior vena cava of the heart to provide an empty electrical signal. That is, in some examples of embodiments of this application, after the first tube segment 11 is inserted into the human heart, the third electrode group 123 can be located within the inferior vena cava of the heart, thereby using the electrical signals within the inferior vena cava as an empty electrical signal. The electrical signals mapped by the first electrode group 121 and the second electrode group 122 can be calibrated by controlling the electrical signals, which can improve the accuracy of the mapping catheter in mapping the right ventricle and His bundle.

[0113] In some examples, the third electrode group 123 may include two third ring electrodes 1231, and the distance between the two third ring electrodes 1231 may be 2mm-10mm.

[0114] In some examples, the spacing between the two third ring electrodes 1231 can be 2 mm, 4 mm, 8 mm or 10 mm.

[0115] In some examples, the arrangement of the third ring electrode 1231 may be the same as, similar to or similar to the arrangement of the first ring electrode 1212 in the foregoing embodiments of this application. For details, please refer to the detailed description of the first ring electrode 1212 in the foregoing embodiments of this application. This application will not repeat the details in this embodiment.

[0116] In some examples, refer to Figure 1 As shown, the mapping catheter may include a handle 14. The handle 14 may be attached to the proximal end of the second tubing segment 13.

[0117] In some examples, the handle 14 may be made of polymer materials, inorganic non-metallic materials, or metallic materials. The handle 14 can be held by the operator to move and position the first pipe section 11 and the second pipe section 13.

[0118] In some examples of embodiments of this application, by connecting a handle 14 to the proximal end of the second tube segment 13, it is convenient for the operator to move and position the first tube segment 11 and the second tube segment 13 through the handle 14, thereby improving the convenience of the calibration catheter operation.

[0119] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0120] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. A mapping catheter, characterized in that, include: The first tube segment has multiple electrode groups at its distal end, including a first electrode group, a second electrode group, and a third electrode group. The first electrode group is configured to map electrical signals at the apex of the right ventricle, the second electrode group is configured to map the His bundle, and the third electrode group is used to detect electrical signals in the inferior vena cava of the heart to provide vacant electrical signals. The first pipe segment is an elastic pipe segment, and the proximal end of the first pipe segment is provided with one of an enlarged hole or a boss along the axial direction of the first pipe segment. The second pipe section has one of the enlarged hole or the boss provided at its distal end along the axial direction of the second pipe section. The boss is inserted into the enlarged hole and is connected to the first pipe section and the second pipe section by welding. The second pipe section is made of the same material as the first pipe section. A support layer is provided in the second pipe section. The stiffness of the support layer is greater than that of the first pipe section.

2. The mapping catheter according to claim 1, characterized in that, Either the first pipe segment or the second pipe segment comprises a block copolymer structure with alternating rigid and flexible segments.

3. The mapping catheter according to claim 2, characterized in that, Either the first pipe segment or the second pipe segment comprises a polyether block amide component.

4. The mapping catheter according to any one of claims 1-3, characterized in that, The support layer includes a woven mesh interlayer.

5. The mapping catheter according to claim 4, characterized in that, The woven mesh interlayer comprises a double-layer alloy wire woven mesh.

6. The mapping catheter according to any one of claims 1-3, characterized in that, The first electrode group is located at the far end of the first pipe segment.

7. The mapping catheter according to claim 6, characterized in that, The first electrode assembly includes a head electrode and a first ring electrode. The head electrode is located at the distal end of the first pipe segment. The first ring electrode is sleeved on the outer periphery of the first pipe segment and is located at the proximal end of the head electrode. The first distance between the first ring electrode and the head electrode is 4mm-10mm.

8. The mapping catheter according to claim 6, characterized in that, The second electrode group is located near the first electrode group, and the second distance between the far end of the second electrode group and the near end of the first electrode group is 10mm-25mm.

9. The mapping catheter according to claim 8, characterized in that, The second electrode group includes multiple electrode pairs, each electrode pair including two second ring electrodes. The second ring electrodes are sleeved on the outer periphery of the first pipe segment, and the spacing between adjacent second ring electrodes is 2mm-5mm. The spacing between adjacent electrode pairs is 4mm-10mm.

10. The mapping catheter according to claim 8, characterized in that, The third electrode group is located near the end of the second electrode group, and the third distance between the distal end of the third electrode group and the proximal end of the first electrode group is 150mm-300mm. The third electrode group includes two third ring electrodes, and the distance between the two third ring electrodes is 2mm-10mm.

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