Mapping catheter

Abstract

The invention provides a mapping catheter. The mapping catheter comprises a fixing piece, a far-field electrode and a mapping electrode assembly. The near end of the mapping electrode assembly is connected with the fixing piece; the mapping electrode assembly comprises a plurality of branches, and the far-field electrode is arranged in a near-end area of at least one branch of the mapping electrode assembly; at least part of the far-field electrode is located in the fixing piece, and the fixing piece is provided with a part which is open to the outside, so that external fluid is allowed to make contact with the far-field electrode when flowing through the fixing piece. According to the configuration, the far-field electrode is arranged in the near-end area of the branch of the mapping electrode assembly, binding of the far-field electrode and the perfusion channel is removed, the far-field electrode or the perfusion channel is not limited to be arranged in the center of the mapping catheter any more, and the degree of freedom is brought to section design of the mapping catheter; the degree of freedom is brought to the arrangement of a plurality of branches of the mapping electrode assembly, and the cross section of the mapping catheter and the layout of the mapping electrode assembly can be improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a mapping catheter. Background Art

[0002] Catheter ablation is currently one of the effective means of treating atrial fibrillation. The mapping catheter is an important tool for doctors to track the source of atrial fibrillation and formulate ablation plans. Among them, the high-density mapping catheter is an advanced cardiac electrical activity technology that contains several high-density mapping electrodes and has significant advantages in improving diagnostic accuracy and target identification efficiency.

[0003] The setting of far-field electrodes can improve signal quality, enhance positioning accuracy, improve imaging, and enhance anti-interference ability for high-density mapping catheters, and can provide more powerful support for the diagnosis and treatment of complex arrhythmias.

[0004] However, in the prior art, the far-field electrode is generally set at the center of the catheter and bound to the perfusion channel, which requires the catheter to have a central perfusion channel, imposes relatively large restrictions on the cross-sectional design of the catheter and also limits the layout of high-density mapping electrodes. Summary of the invention

[0005] The object of the present invention is to provide a mapping catheter to solve the problem that the far-field electrode layout of the existing mapping catheter leads to the limitation of the catheter cross-section and the electrode layout.

[0006] In order to solve the above technical problems, the present invention provides a mapping catheter, which includes: a fixing member, a far-field electrode and a mapping electrode assembly; The proximal end of the mapping electrode assembly is connected to the fixing member; the mapping electrode assembly includes a plurality of branches, and the far-field electrode is arranged in the proximal region of at least one of the branches of the mapping electrode assembly; at least part of the far-field electrode is located in the fixing member, and the fixing member has a portion open to the outside world, so that the outside fluid can contact the far-field electrode when flowing through the fixing member.

[0007] Optionally, the fixing member includes a accommodating cavity and a fixing hole, the accommodating cavity is open toward the distal end, and the fixing hole is connected to the proximal end of the accommodating cavity; the proximal end of the branch penetrates through the accommodating cavity and is fixed to the fixing hole; the far-field electrode is located in the accommodating cavity at least partially along the axial direction of the fixing member.

[0008] Optionally, there is a gap between the side wall of the accommodating cavity and the branch; and / or; there is a gap between at least two of the branches.

[0009] Optionally, the fixing member includes two assembled members, which are assembled together in radial direction to form the fixing member and simultaneously enclose the accommodating cavity.

[0010] Optionally, the fixing member has an isolating portion extending toward the distal end, and the isolating portion extends in a partial circumferential direction of the fixing member to shield the far-field electrode in radial and axial directions of the fixing member.

[0011] Optionally, the isolation portion satisfies at least one of the following: The isolation portion is in the shape of a sheet that bulges in an arc shape toward the distal end; The extending direction of the isolation portion is arranged at an angle to the axial direction of the fixing member; The position of the isolation portion in the circumferential direction of the fixing member corresponds to the position of the far-field electrode.

[0012] Optionally, the far-field electrode includes an electrode body and an end insulator; the electrode body is arranged along the circumference of the branch, the end insulator is arranged at at least one end of the electrode body along the axial direction of the branch, and the end insulator protrudes outside the electrode body along the radial direction of the branch.

[0013] Optionally, the fixing member has a perfusion passage, which includes a proximal pipeline, a transverse connecting pipeline and at least two distal outlet pipelines; at least two of the distal outlet pipelines are connected and collected through the transverse connecting pipeline and connected to the proximal pipeline.

[0014] Optionally, the connection points between the plurality of branches and the fixing member are arranged linearly along a first direction perpendicular to the axis of the fixing member.

[0015] Optionally, the fixing member has a perfusion passage, and the perfusion passage includes at least two distal outlet pipes, and the at least two distal outlet pipes are arranged on opposite sides of the connection between the branch and the fixing member along a second direction perpendicular to the first direction.

[0016] In summary, the mapping catheter provided by the present invention includes a fixing, a far-field electrode and a mapping electrode assembly; the proximal end of the mapping electrode assembly is connected to the fixing; the mapping electrode assembly includes a plurality of branches, and the far-field electrode is arranged in the proximal region of at least one of the branches of the mapping electrode assembly; at least part of the far-field electrode is located in the fixing, and the fixing has a part open to the outside world, so that the outside fluid can contact the far-field electrode when flowing through the fixing.

[0017] With this configuration, the far-field electrode is set in the proximal region of the branch of the mapping electrode assembly, which releases the binding between the far-field electrode and the perfusion channel. The far-field electrode or the perfusion channel is no longer limited to being set at the center position of the mapping catheter, which brings freedom to the cross-sectional design of the mapping catheter and the arrangement of multiple branches of the mapping electrode assembly, which is beneficial to improving the cross-sectional design of the mapping catheter and the layout of the mapping electrode assembly. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Those skilled in the art will appreciate that the drawings are provided for a better understanding of the present invention, but do not constitute any limitation on the scope of the present invention.

[0019] Figure 1 Schematic diagram of the whole mapping catheter according to the embodiment of the present invention.

[0020] Figure 2 It is a schematic diagram of the distal end portion of the mapping catheter according to an embodiment of the present invention.

[0021] Figure 3 yes Figure 2 Enlarged view of part A.

[0022] Figure 4a Schematic diagram of a larger annular member according to an embodiment of the present invention.

[0023] Figure 4b Schematic diagram of a smaller ring-shaped member according to an embodiment of the present invention.

[0024] Figure 5 4 is a front view of a distal end portion of a mapping catheter according to an embodiment of the present invention.

[0025] Figure 6 4 is a side view of a distal end portion of a mapping catheter according to an embodiment of the present invention.

[0026] Figure 7 4 is a schematic cross-sectional view of a proximal region of a fixing member according to an embodiment of the present invention.

[0027] Figure 8a , Figure 8b and Figure 8c is a schematic cross-sectional view of a ridge according to an embodiment of the present invention.

[0028] Fig. 9 It is a schematic diagram of an application scenario of a mapping catheter according to an embodiment of the present invention.

[0029] Fig.10 Schematic diagram of an axial cross-section of a fixing member according to an embodiment of the present invention.

[0030] Fig.11a and Fig.11b Schematic diagram of two-piece assembly of a fixing member according to an embodiment of the present invention.

[0031] Fig.12 Schematic diagram of the connection between the branch and the fixing member according to an embodiment of the present invention.

[0032] Fig.13 Schematic diagram of a far-field electrode according to an embodiment of the present invention.

[0033] Fig.14 Schematic diagram of a mapping electrode assembly including two ring-shaped components according to an embodiment of the present invention.

[0034] Fig.15 It is a schematic diagram of a mesh-structured mapping electrode assembly according to an embodiment of the present invention.

[0035] Fig.16 and Fig.17 It is a schematic diagram of a multi-branch structure mapping electrode assembly according to an embodiment of the present invention.

[0036] Fig.18 It is a schematic diagram of a mapping electrode assembly with a basket-like structure according to an embodiment of the present invention.

[0037] Fig.19 It is a schematic diagram of a star-shaped mapping electrode assembly according to an embodiment of the present invention.

[0038] In the accompanying drawings: 1-fixing part; 10-assembly part; 11-fixing hole; 12-perfusion passage; 121-distal outlet pipeline; 122-proximal pipeline; 123-lateral connecting pipeline; 13-accommodating cavity; 14-gap; 15-isolating part; 2-far-field electrode; 21-electrode body; 22-end insulator; 3-mapping electrode assembly; 30-branch; 31-ring-shaped member; 311-ridge; 312-connecting part; 313-mapping electrode; 314-connecting block; 315-supporting member; 316-insulating part; 317-wire; 321-outer ring; 322-axial ridge; 4-adjustable bend; 5-catheter body; 6-handle. DETAILED DESCRIPTION

[0039] In order to make the purpose, advantages and features of the present invention clearer, the present invention is further described in detail below in conjunction with the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention. In addition, the structure shown in the drawings is often a part of the actual structure. In particular, the emphasis of each drawing is different, and sometimes different scales are used.

[0040] As used in the present invention, the singular forms "one", "an", "one", and "the" include plural objects, the term "or" is generally used in a sense that includes "and / or", the term "several" is generally used in a sense that includes "at least one", and the term "at least two" is generally used in a sense that includes "two or more". In addition, the terms "first", "second", and "third" are used for descriptive purposes only and are not to be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first", "second", and "third" may explicitly or implicitly include one or at least two of the features, and "one end" and "the other end" as well as "proximal end" and "distal end" generally refer to two corresponding parts, which include not only the endpoints. The terms "proximal end" and "distal end" are defined herein with respect to a mapping catheter having an end for intervention in the human body and a manipulation end extending outside the body. The term "proximal end" refers to a position closer to the control end of the mapping catheter extending out of the body, and the term "distal end" refers to a position closer to the end of the mapping catheter that is inserted into the human body and therefore farther from the control end of the mapping catheter. Optionally, in a manual or hand-operated application scenario, the terms "proximal end" and "distal end" are defined herein relative to an operator such as a surgeon or clinician. The term "proximal end" refers to a position closer to the operator, and the term "distal end" refers to a position closer to the mapping catheter and therefore farther from the operator. In addition, as used in the present invention, "installed", "connected", "connected", and one element "set" to another element should be understood in a broad sense, usually only indicating that there is a connection, coupling, matching or transmission relationship between the two elements, and the connection, coupling, matching or transmission between the two elements can be direct or indirect through an intermediate element, and cannot be understood as indicating or implying the spatial position relationship between the two elements, that is, one element can be in any orientation such as inside, outside, above, below or on one side of another element, unless the content clearly indicates otherwise. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances. In addition, directional terms such as above, below, up, down, upward, downward, left, right, etc. are used with respect to the exemplary embodiments as they are shown in the figures, with the upward or upper direction toward the top of the corresponding figure and the downward or lower direction toward the bottom of the corresponding figure.

[0041] The purpose of the present invention is to provide a mapping catheter to solve the problem that the far-field electrode layout of the existing mapping catheter leads to the limitation of the catheter cross section and electrode layout.

[0042] Please refer to Figure 1An embodiment of the present invention provides a mapping catheter, which includes: a fixing part 1, a far-field electrode 2 and a mapping electrode assembly 3; the proximal end of the mapping electrode assembly 3 is connected to the fixing part 1; the mapping electrode assembly 3 includes a plurality of branches 30, and the far-field electrode 2 is arranged in the proximal region of at least one of the branches 30 of the mapping electrode assembly 3; at least part of the far-field electrode 2 is located in the fixing part 1, and the fixing part 1 has a part open to the outside, so that the outside fluid can contact the far-field electrode 2 when flowing through the fixing part 1. Figure 1 The left side is the distal end, and the right side is the proximal end. With such a configuration, the far-field electrode 2 is set in the proximal region of the branch 30 of the mapping electrode assembly 3, which releases the binding between the far-field electrode 2 and the perfusion channel. The far-field electrode 2 or the perfusion channel is no longer limited to being set at the center of the mapping catheter, which brings freedom to the cross-sectional design of the mapping catheter and also brings freedom to the arrangement of the multiple branches 30 of the mapping electrode assembly 3, which is conducive to improving the cross-sectional design of the mapping catheter and the layout of the mapping electrode assembly 3.

[0043] Furthermore, the mapping catheter also includes components such as an adjustable bend section 4, a catheter body 5 and a handle 6. The structures and principles of the components such as the adjustable bend section 4, the catheter body 5 and the handle 6 can be referred to the prior art, and will not be elaborated in this embodiment.

[0044] Research has found that the accuracy of the ECG signals collected by the mapping electrode assembly 3 is higher when it extends roughly in a planar shape, compared with radial extension or basket-shaped extension. Therefore, it is preferred to configure the mapping electrode assembly 3 to extend roughly in a planar shape. However, this embodiment does not limit the mapping electrode assembly 3 to a planar extension. Some mapping electrode assemblies 3 that extend radially or in a basket-shaped shape can also be applied in the manner of this embodiment, with the far-field electrode 2 arranged in the proximal region of its branch 30.

[0045] Please refer to Figures 2 to 6, which shows an exemplary embodiment of a mapping electrode assembly 3, which is a flexible component extending in a roughly planar shape, and includes three annular components 31 with a certain degree of flexibility. The annular components 31 can be compressed or folded into a delivery sheath in the delivery state, and released after being delivered to the target position (such as the heart), and then expanded and restored to the initial shape. Each annular component 31 includes two ridges 311. When the annular component 31 is not subjected to external force and is in the initial shape, the two ridges 311 preferably extend parallel to the axial direction of the mapping catheter, and the distal ends of the two ridges 311 are connected by a connecting portion 312. The proximal ends of the two ridges 311 are bent and connected to the fixing member 1. At least two mapping electrodes 313 (such as ring electrodes) are arranged on each ridge 311, so that the multiple mapping electrodes 313 on the six ridges 311 of the three annular components 31 constitute a high-density electrode array. Preferably, each mapping electrode 313 is connected to the ridge 311 through a wire 317 (see Figures 8a to 8c ) connected to the proximal mapping device.

[0046] For further information, please refer to Figure 2 and Figure 5 For the convenience of description, the three annular components 31 are respectively labeled as 31a, 31b and 31c, wherein the annular component 31a and the annular component 31b are relatively large (referring to the relatively large distance between the two ridges 311 of the two annular components), the two are staggered and intersect at the connecting portion 312, and in one embodiment, for example, the intersection of the annular component 31a and the annular component 31b can be fixed by a connecting block 314. The annular component 31c is relatively small (referring to the relatively small distance between the two ridges 311 of the annular component 31c), and the two ridges 311 of the annular component 31c are located on the inner side of the inner ridges 311 of the annular component 31a and the annular component 31b. The connecting portion 312 of the annular component 31c can also be optionally fixed by a connecting block 314. With such a configuration, the entire mapping electrode assembly 3 extends roughly in a planar shape.

[0047] Please refer to Figure 3 , Figure 7 , Fig.10 , Fig.11a and Fig.11b In an exemplary embodiment, the fixing member 1 includes a plurality of fixing holes 11, and the shape and size of the fixing holes 11 are adapted to the outer contour shape and size of the proximal end of the ridge 311, and the proximal end of the ridge 311 is used to penetrate and be fixed to the fixing hole 11. Thus, each ridge 311 can be regarded as a branch 30 of the mapping electrode assembly 3, that is, the mapping electrode assembly 3 includes 6 branches 30 at this time. The arrangement of the connection between the branch 30 and the fixing member 1 is also defined by the arrangement of the fixing holes 11. Preferably, the connection between the plurality of branches 30 and the fixing member 1 is along a first direction perpendicular to the axis of the fixing member 1 ( Figure 7The horizontal direction in the middle) is arranged in a linear manner.

[0048] In order to maintain the plane extension, ideally, the connection between the proximal ends of the six branches 30 of the three ring-shaped members 31 of the mapping electrode assembly 3 and the fixing member 1 should also be arranged in a straight line. However, considering the interventional performance of the fixing member 1, its diameter cannot be too large, and considering the strength and performance of the mapping electrode assembly 3, the diameter of each branch 30 cannot be too small (combined with the diameter of the fixing member 1). Figures 8a to 8c , and see the following description), which results in certain difficulties in arranging the proximal ends of the six branches 30 in a straight line under the limited diameter of the fixing member 1.

[0049] Based on this, the present embodiment divides the fixing holes 11 into two rows, one row is arranged with 4 fixing holes 11, and the other row is arranged with 2 fixing holes 11, and the fixing holes 11 in each row are arranged linearly along the first direction. Further, the proximal ends of the two ridges 311 of the annular member 31a are connected to the first and third fixing holes 11 from the left in the first row, the proximal ends of the two ridges 311 of the annular member 31b are connected to the second and fourth fixing holes 11 from the left in the first row, and the proximal ends of the two ridges 311 of the annular member 31c are connected to the two fixing holes 11 in the second row. Figure 6 At this time, the annular component 31a and the annular component 31b are on one plane, and the annular component 31c is on another plane. The angle between the two planes is relatively small and can be basically ignored. Therefore, at this time, the entire mapping electrode assembly 3 can still be roughly regarded as extending along the plane.

[0050] Please refer to Figures 8a to 8c , which shows three exemplary cross-sections of the ridge 311, the ridge 311 includes a support member 315, an insulating portion 316 and a wire 317, wherein the support member 315 is used to provide support strength for the ridge 311, and its material can be a metal material with certain support properties, such as nickel alloy or nickel-titanium alloy. The cross-sectional shape of the support member 315 can be, for example, a rectangle, which facilitates the abutment of the annular member 31 against the target tissue (such as cardiac tissue). The wire 317 connects the mapping electrode 313 and extends toward the proximal end to achieve the transmission of electrical signals. The insulating portion 316 wraps the support member 315 and the wire 317. The material of the insulating portion 316 is preferably a polymer, such as pebax or polyurethane, and the outer diameter of the entire ridge 311 is preferably not greater than 3F, so that the entire mapping catheter can be used with an 8F or 8.5F delivery sheath. The outer diameter of the entire ridge 311 cannot be too small to ensure a certain strength and meet the arrangement of multiple wires 317.

[0051] Please refer to Figure 3, the far-field electrode 2 is arranged in the proximal region of at least one branch 30. The far-field electrode 2 can be, for example, annularly sleeved on the outer periphery of the branch 30. Here, the proximal region of the branch 30 needs to be explained. For each branch 30, its proximal end is connected to the fixing member 1, and its distal end has some variations, such as Figures 2 to 6 In the illustrated example, the distal end of the branch 30 (i.e., the distal end of the ridge 311) is connected to the connecting portion 312. In other embodiments, the distal end of the branch 30 may also be a free end (e.g., Fig.16 and Fig.19 As shown). Further, the total length of the branch 30 along its own axial extension direction is the distance between the connection point of the branch 30 and the fixing member 1 (referring to the starting point of extending out of the fixing hole 11) to the connection point of the ridge 311 and the connecting portion 312. The proximal region of the branch 30 may refer to an area within a length range of 1 / 3 of the total length close to the proximal end. More preferably, the far-field electrode 2 is arranged in an area within a length range of 1 / 10 of the proximal end of the branch 30 along its own axial extension direction. The number of far-field electrodes 2 is preferably one, but the present embodiment does not limit the number. In some cases, the number of far-field electrodes 2 may also be more than two, and may be arranged on different branches 30.

[0052] Please refer to Fig. 9 , which shows the application scenario of the mapping electrode assembly 3 for mapping the target area of ​​the heart. The soft mapping electrode assembly 3 is in close contact with different areas of the heart tissue to obtain intracardiac electrical signals; at this time, the far-field electrode 2 can collect the electrocardiographic signals conducted in the blood from the area far away from the contacted tissue, that is, the far-field signal, so as to supplement the signal obtained by the mapping electrode assembly 3 and eliminate signal interference during the operation. In order to make the collected far-field signal more accurate and stable, the far-field electrode 2 should not be in close contact with the heart tissue. In this embodiment, the far-field electrode 2 is set in the proximal area of ​​the branch 30, and at the same time, it is limited that at least part of the far-field electrode 2 is located in the fixing part 1. The far-field electrode 2 can be shielded by the distal area and the middle area of ​​the mapping electrode assembly 3 and the partial area of ​​the fixing part 1, so that when the mapping electrode assembly 3 is in close contact with the heart tissue, the far-field electrode 2 is not easy to directly come into contact with the heart tissue.

[0053] Please refer to Figure 7 , Fig.10 , Fig.11a and Fig.11bFurthermore, in order to reduce or prevent the formation of thrombus near the fixing member 1, the fixing member 1 has a perfusion passage 12, which is used to spray perfusion fluid (such as saline, etc.). Since the far-field electrode 2 is set in the proximal region of the branch 30 of the mapping electrode assembly 3 in this embodiment, the binding between the far-field electrode 2 and the perfusion passage 12 is released, and the far-field electrode 2 or the perfusion passage 12 is no longer limited to being set at the center position of the mapping catheter, which brings freedom to the cross-sectional design of the mapping catheter and also brings freedom to the arrangement of the multiple branches 30 of the mapping electrode assembly 3, which is conducive to improving the cross-sectional design of the mapping catheter and the layout of the mapping electrode assembly 3.

[0054] For further information, please refer to Figure 10 to Figure 11b The perfusion passage 12 includes at least two distal outlet pipes 121, and at least two of the distal outlet pipes 121 are connected along a second direction perpendicular to the first direction ( Fig.10 The second direction is horizontal) and arranged on opposite sides of the connection between the branch 30 and the fixing member 1. It can be understood that since the mapping electrode assembly 3 extends roughly along the plane, it is easy to form a barrier to blood at the connection with the fixing member 1. At least two distal outlet pipelines 121 are arranged relatively on both sides of the fixing member 1 along the second direction, and perfusion can be performed simultaneously on both wings of the mapping electrode assembly 3, thereby improving the perfusion effect and effectively reducing thrombus formation.

[0055] Furthermore, the perfusion passage 12 further includes a proximal pipeline 122 and a transverse connecting pipeline 123. At least two distal outlet pipelines 121 are connected and collected through the transverse connecting pipeline 123 and are connected to the proximal pipeline 122.

[0056] Due to the limited cross-sectional diameter of the mapping catheter, especially in the section of the adjustable bend section 4 and the catheter body 5, it is necessary to arrange the wires 317 corresponding to the multiple mapping electrodes 313 of the mapping electrode assembly 3, and also to arrange the bending control wire for manipulating the bending of the adjustable bend section 4. In addition to various protective tubes, there is not enough space in the cross-sectional area of ​​the adjustable bend section 4 and the catheter body 5 to set more than two perfusion channels. Based on the above analysis, setting more than two distal outlet pipelines 121 at the distal end of the fixing part 1 is conducive to improving the perfusion effect. For this reason, this embodiment divides the perfusion channel in the fixing part 1 by setting a transverse connecting pipeline 123, and at the same time satisfies the contradiction between the proximal single channel and the distal multi-branch outlet of the perfusion passage 12.

[0057] The proximal pipeline 122 of the fixing member 1 can be arranged in communication with the corresponding perfusion channel in the adjustable bend 4. In some embodiments, the proximal pipeline 122 and a distal outlet pipeline 121 are directly connected along the axial direction of the fixing member 1. Of course, the cross-section of the proximal pipeline 122 and the cross-section of the distal outlet pipeline 121 are not limited to be the same. As long as the cross-sections of the two overlap, they are considered to be directly connected. Fig.10In the illustrated example, the fixture 1 includes two distal outlet pipes 121 , which are connected via a transverse connecting pipe 123 , and one of the distal outlet pipes 121 is directly connected to the proximal pipe 122 .

[0058] Optional, please refer to Fig.11a , Fig.11b and Fig.12 , and combined with reference Fig.10 The fixing member 1 includes a receiving cavity 13, which opens toward the distal end, and the fixing hole 11 is connected to the proximal end of the receiving cavity 13; the proximal end of the branch 30 penetrates through the receiving cavity 13 and is fixed to the fixing hole 11; at least part of the far-field electrode 2 along the axial direction of the fixing member 1 is located in the receiving cavity 13. In one embodiment, in order to facilitate assembly, the fixing member 1 is configured as a two-petal type, that is, the fixing member 1 includes two splicing pieces 10, and the two splicing pieces 10 are spliced ​​together in the radial direction to form a complete fixing member 1, and the receiving cavity 13 is enclosed at the same time. The provision of the receiving cavity 13 allows at least a part of the far-field electrode 2 to be accommodated therein, further improving the shielding effect of the far-field electrode 2 and reducing the possibility of the far-field electrode 2 contacting the heart tissue.

[0059] Please continue to refer to Fig.12 Optionally, the fixture 1 has an isolating portion 15 extending toward the distal end, and the isolating portion 15 extends partially around the fixture 1 to shield the far-field electrode 2 in the radial and axial directions of the fixture 1. The provision of the isolating portion 15 can effectively protect the far-field electrode 2, shield the far-field electrode 2 in the radial and axial directions, and further reduce or avoid contact between the far-field electrode 2 and the heart tissue.

[0060] Optionally, there is a gap 14 between the side wall of the accommodating cavity 13 and the branch 30. Optionally, there is a gap 14 between at least two of the branches 30. Optionally, there is a gap 14 between the isolation portion 15 and the branch 30. The provision of the gap 14 promotes smooth flow of blood therebetween and improves the accuracy of far-field detection.

[0061] In one embodiment, the isolating portion 15 is in the form of a sheet that is arc-shaped and bulges toward the distal end. The isolating portion 15 is preferably a thin-walled arc-shaped convex sheet, shaped like a tile, which can be formed by, for example, the side wall 131 of the accommodating cavity 13 of the fixing member 1 extending toward the distal end. At this time, the entire isolating portion 15 can be understood as being parallel to the axis of the fixing member 1. Optionally, the circumferential position of the isolating portion 15 on the fixing member 1 corresponds to the position of the far-field electrode 2. The correspondence here can be, for example, close proximity, or it can be arranged in combination with the arrangement relationship between the far-field electrode 2 and each branch 30. Fig.12As shown, the far-field electrode 2 is arranged in the proximal area of ​​the ridge 311 of the annular member 31b. At this time, the far-field electrode 2 is blocked by the ridge 311 of the annular member 31c along the second direction. Therefore, at this time, the isolation part 15 only needs to be arranged on the side of the ridge 311 of the annular member 31b away from the annular member 31c along the second direction, that is, the isolation part 15 and the annular member 31c jointly form a shield for the far-field electrode 2.

[0062] In other embodiments, the extending direction of the isolation portion 15 may also be arranged at an angle to the axial direction of the fixing member 1. For example, the isolation portion 15 is inclined toward the outside of the fixing member 1, so that it can protect the far-field electrode 2 while reducing the resistance of the mapping electrode assembly 3 when it is attached, providing a force buffering effect.

[0063] Please refer to Fig.13 Optionally, the far-field electrode 2 includes an electrode body 21 and an end insulator 22; the electrode body 21 is arranged along the circumference of the branch 30, the end insulator 22 is arranged at at least one end of the electrode body 21 along the axial direction of the branch 30, and the end insulator 22 protrudes outside the electrode body 21 along the radial direction of the branch 30. In one embodiment, the end insulator 22 can be formed by coating with insulating glue, and the end insulator 22 is preferably arranged at both axial ends of the electrode body 21, so that the outer peripheral surface of the electrode body 21 is recessed relative to the end insulator 22, further reducing the probability of the electrode body 21 being attached to the heart tissue.

[0064] Please refer to Figures 14 to 19 , which shows several different examples of the mapping electrode assembly 3. Fig.14 The mapping electrode assembly 3 shown is similar to the aforementioned Figures 2 to 6 The embodiment shown is substantially the same, except that it only comprises two annular components 31 , which are substantially arranged inside and outside.

[0065] Fig.15 The mapping electrode assembly 3 shown is generally a mesh structure, which includes an outer ring 321 and an inner axial ridge 322. At this time, the axial ridge 322 can be regarded as a branch 30, and the far-field electrode 2 can be arranged in the proximal region of a certain axial ridge 322, preferably in the proximal region of the axial ridge 322 located in the center. Further, at this time, the fixing member 1 may also optionally include a separation portion 15, and further, the separation portion 15 preferably includes two relatively arranged thin-walled arc-shaped protrusions, which are arranged in a direction perpendicular to the extension plane direction of the mapping electrode assembly 3 of the mesh structure, so as to effectively shield the far-field electrode 2.

[0066] Fig.16 and Fig.17The mapping electrode assembly 3 shown is a multi-branch structure, which includes a plurality of branches 30 and extends substantially along a plane. Fig.16 In the example shown, the distal end of the branch 30 is a free end. Fig.17 In the example shown, the distal ends of the branches 30 are connected and closed to each other by closed connectors. The multi-branch structure of the mapping electrode assembly 3 can be optionally extended roughly in the plane direction. The far-field electrode 2 is arranged in the proximal region of one or more branches 30, preferably arranged in a branch 30 close to the axis of the fixing member 1. Further, at this time, the fixing member 1 can also optionally include an isolation portion 15, and its setting method can refer to the previous demonstration example, which will not be repeated here.

[0067] Fig.18 The mapping electrode assembly 3 shown is a basket-like structure, and the distal ends of a plurality of branches 30 thereof are connected together. Fig.19 The mapping electrode assembly 3 shown is a star-shaped structure, and the distal ends of its multiple branches 30 are divergent. Fig.18 and Fig.19 In the illustrated example, the mapping electrode assembly 3 is in a three-dimensional form, rather than extending along a plane. For such a three-dimensional mapping electrode assembly 3, the far-field electrode 2 can also be arranged in the proximal region of one or more branches 30. Furthermore, the fixing member 1 can also optionally include an isolation portion 15 to shield and protect the far-field electrode 2.

[0068] In summary, the mapping catheter provided by the present invention includes a fixing, a far-field electrode and a mapping electrode assembly; the proximal end of the mapping electrode assembly is connected to the fixing; the mapping electrode assembly includes a plurality of branches, and the far-field electrode is arranged in the proximal region of at least one of the branches of the mapping electrode assembly; at least part of the far-field electrode is located in the fixing, and the fixing has a portion open to the outside world, so that the outside fluid can contact the far-field electrode when flowing through the fixing. With such a configuration, the far-field electrode is arranged in the proximal region of the branch of the mapping electrode assembly, which releases the binding between the far-field electrode and the perfusion channel. The far-field electrode or the perfusion channel is no longer limited to being arranged at the center of the mapping catheter, which brings freedom to the cross-sectional design of the mapping catheter and also brings freedom to the arrangement of the multiple branches of the mapping electrode assembly, which is conducive to improving the cross-sectional design of the mapping catheter and the layout of the mapping electrode assembly.

[0069] It should be noted that the above embodiments can be combined with each other. The above description is only a description of the preferred embodiments of the present invention, and does not limit the scope of the present invention. Any changes and modifications made by ordinary technicians in the field of the present invention based on the above disclosure are within the protection scope of the present invention.

Claims

1. A mapping catheter, characterized in that: include: Fixtures, far-field electrodes, and mapping electrode assemblies; The proximal end of the mapping electrode assembly is connected to the fixing member; the mapping electrode assembly includes a plurality of branches, and the far-field electrode is arranged in the proximal region of at least one of the branches of the mapping electrode assembly; at least part of the far-field electrode is located in the fixing member, and the fixing member has a portion open to the outside world, so that the outside fluid can contact the far-field electrode when flowing through the fixing member.

2. The mapping catheter according to claim 1, characterized in that: The fixing member includes a accommodating cavity and a fixing hole, wherein the accommodating cavity opens toward the distal end and the fixing hole is connected to the proximal end of the accommodating cavity; the proximal end of the branch penetrates through the accommodating cavity and is fixed to the fixing hole; and at least part of the far-field electrode along the axial direction of the fixing member is located in the accommodating cavity.

3. The mapping catheter according to claim 2, characterized in that: There is a gap between the side wall of the accommodating cavity and the branches; and / or there is a gap between at least two of the branches.

4. The mapping catheter according to claim 2, characterized in that: The fixing member comprises two assembled members, which are assembled together in radial direction to form the fixing member and enclose the accommodating cavity.

5. The mapping catheter according to claim 1, characterized in that: The fixing member has a partition extending toward the distal end, wherein the partition extends in a partial circumferential direction of the fixing member to shield the far-field electrode in the radial direction and the axial direction of the fixing member.

6. The mapping catheter according to claim 5, characterized in that: The isolation portion satisfies at least one of the following: The isolation portion is in the shape of a sheet that bulges in an arc shape toward the distal end; The extending direction of the isolation portion is arranged at an angle to the axial direction of the fixing member; The position of the isolation portion in the circumferential direction of the fixing member corresponds to the position of the far-field electrode.

7. The mapping catheter according to claim 1, characterized in that: The far-field electrode includes an electrode body and an end insulator; the electrode body is arranged along the circumference of the branch, the end insulator is arranged at at least one end of the electrode body along the axial direction of the branch, and the end insulator protrudes outside the electrode body along the radial direction of the branch.

8. The mapping catheter according to claim 1, characterized in that: The fixing member has a perfusion passage, which includes a proximal pipeline, a transverse connecting pipeline and at least two distal outlet pipelines; at least two distal outlet pipelines are connected and collected through the transverse connecting pipeline and communicated with the proximal pipeline.

9. The mapping catheter according to claim 1, characterized in that: The connection points between the plurality of branches and the fixing member are arranged linearly along a first direction perpendicular to the axis of the fixing member.

10. The mapping catheter according to claim 9, characterized in that: The fixing member has a perfusion passage, and the perfusion passage includes at least two distal outlet pipes, and the at least two distal outlet pipes are arranged on opposite sides of the connection between the branch and the fixing member along a second direction perpendicular to the first direction.

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