Mapping catheter

Abstract

The utility model provides a mapping catheter which 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 utility model relates to medical instrument technical field, especially in kind of mapping catheter. BACKGROUND

[0002] Catheter ablation therapy is 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 develop ablation programs. Among them, the high-density mapping catheter is an advanced cardiac electrical activity technology, which contains a plurality of high-density mapping electrodes, and has significant advantages in improving diagnostic accuracy and target point identification efficiency.

[0003] The setting of the far-field electrode has the effect of improving signal quality, enhancing positioning accuracy, improving imaging, and enhancing anti-interference capability for the high-density mapping catheter, and can provide stronger support for the diagnosis and treatment of complex arrhythmia.

[0004] However, in the prior art, the far-field electrode is generally arranged at the center of the catheter and is bound to be arranged in the perfusion channel, which requires the catheter to have a central perfusion channel, which has a relatively large limitation on the cross-sectional design of the catheter and also limits the layout of the high-density mapping electrode. UTILITY MODEL CONTENT

[0005] The utility model aims at providing a kind of mapping catheter to solve the problem that the layout of far-field electrode of existing mapping catheter leads to the limitation of catheter cross section and electrode layout.

[0006] To solve the above technical problems, the utility model provides a kind of mapping catheter, which comprises: a fixing part, a far-field electrode and a mapping electrode assembly;

[0007] The proximal end of the mapping electrode assembly is connected with the fixing part;The mapping electrode assembly comprises a plurality of branches, and the far-field electrode is arranged in the proximal end region of at least one branch of the mapping electrode assembly;At least part of the far-field electrode is located in the fixing part, and the fixing part has a part open to the outside world, so that the fluid in the outside world flows through the fixing part and contacts the far-field electrode.

[0008] Optionally, the fixing part includes a receiving cavity and a fixing hole, the receiving cavity opens towards the distal end, and the fixing hole communicates with the proximal end of the receiving cavity;The proximal end of the branch is inserted into the receiving cavity and fixed in the fixing hole;At least part of the far-field electrode along the axial direction of the fixing part is located in the receiving cavity.

[0009] Optionally, the cavity side wall of the receiving cavity has a gap between the branch;And / or;At least two branches have a gap between each other.

[0010] Optionally, the fixing member comprises two split members which are split along a radial direction to form the fixing member and to enclose the accommodating cavity.

[0011] Optionally, the fixing member has an isolation portion extending towards a distal end, the isolation portion extending in a part of a circumferential direction of the fixing member to shield the far-field electrode in a radial direction and an axial direction of the fixing member.

[0012] Optionally, the isolation portion satisfies at least one of the following conditions:

[0013] The isolation portion is in a shape of an arc protruding towards the distal end;

[0014] The extension direction of the isolation portion is arranged at an angle with respect to the axial direction of the fixing member;

[0015] The position of the isolation portion in the circumferential direction of the fixing member corresponds to the position of the far-field electrode.

[0016] Optionally, the far-field electrode comprises an electrode body and an end insulator; the electrode body is arranged along the circumferential direction of the branch, the end insulator is arranged at least at one end of the electrode body along the axial direction of the branch, and the end insulator protrudes out of the electrode body along the radial direction of the branch.

[0017] Optionally, the fixing member has a perfusion passage, the perfusion passage comprises a proximal pipeline, a transverse communication pipeline and at least two distal outlet pipelines; the at least two distal outlet pipelines are communicated and collected through the transverse communication pipeline and communicated with the proximal pipeline.

[0018] Optionally, the connection between the plurality of branches and the fixing member is linearly arranged along a first direction perpendicular to the axial line of the fixing member.

[0019] Optionally, the fixing member has a perfusion passage, the perfusion passage comprises at least two distal outlet pipelines, and the at least two distal outlet pipelines are arranged on opposite sides of the connection between the branch and the fixing member along a second direction perpendicular to the first direction.

[0020] In summary, the mapping catheter provided by the present application comprises a fixing member, a far-field electrode and a mapping electrode assembly; the proximal end of the mapping electrode assembly is connected with the fixing member; the mapping electrode assembly comprises a plurality of branches, the far-field electrode is arranged at the proximal end 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 part open to the outside world so as to facilitate the fluid in the outside world to flow through the fixing member and contact the far-field electrode.

[0021] In this way, the far-field electrode is arranged at the proximal end region of the branch of the mapping electrode assembly, the binding of the far-field electrode and the perfusion channel is released, and the far-field electrode or the perfusion channel is no longer limited to being arranged at the center position of the mapping catheter, thereby bringing freedom to the cross-sectional design of the mapping catheter and the arrangement of the multiple branches of the mapping electrode assembly, and being beneficial to improving the cross section of the mapping catheter and the layout of the mapping electrode assembly. BRIEF DESCRIPTION OF DRAWINGS

[0022] Those skilled in the art will understand that the drawings provided are for a better understanding of the present application, and do not constitute any limitation on the scope of the present application.

[0023] Figure 1 is a schematic diagram of the mapping catheter of the embodiment of the present application.

[0024] Figure 2 is a schematic diagram of the distal end of the mapping catheter of the embodiment of the present application.

[0025] Figure 3 is a schematic diagram of the distal end of the mapping catheter of the embodiment of the present application. Figure 2

[0026] Figure 4a is a schematic diagram of the larger ring-shaped member of the embodiment of the present application.

[0027] Figure 4b is a schematic diagram of the smaller ring-shaped member of the embodiment of the present application.

[0028] Figure 5 is a front view of the distal end of the mapping catheter of the embodiment of the present application.

[0029] Figure 6 is a side view of the distal end of the mapping catheter of the embodiment of the present application.

[0030] Figure 7 is a schematic diagram of the cross section of the proximal end region of the fixing member of the embodiment of the present application.

[0031] Figure 8a , Figure 8b and Figure 8c are schematic diagrams of the cross section of the ridge of the embodiment of the present application.

[0032] Figure 9 is a schematic diagram of the application scene of the mapping catheter of the embodiment of the present application.

[0033] Figure 10 is a schematic diagram of the axial section of the fixing member of the embodiment of the present application.

[0034] Figure 11a and Figure 11b ​Is the two halves of the fixed part of the embodiment of the utility model split piece schematic diagram.

[0035] Figure 12 Is the connection of the branch and the fixed part of the embodiment of the utility model schematic diagram.

[0036] Figure 13 Is the far field electrode of the embodiment of the utility model schematic diagram.

[0037] Figure 14 Is the mapping electrode assembly of the embodiment of the utility model containing two ring type components schematic diagram.

[0038] Figure 15 Is the mapping electrode assembly of the embodiment of the utility model mesh structure schematic diagram.

[0039] Figure 16 And Figure 17 Is the mapping electrode assembly of the embodiment of the utility model multi-branch structure schematic diagram.

[0040] Figure 18 Is the mapping electrode assembly of the embodiment of the utility model net basket type structure schematic diagram.

[0041] Figure 19 Is the mapping electrode assembly of the embodiment of the utility model star type structure schematic diagram.

[0042] In the drawing: 1-fixed part;10-split piece;11-fixed hole;12-irrigation passage;121-distal end outlet pipeline;122-proximal pipeline;123-transverse communication pipeline;13-accommodation cavity;14-gap;15-isolation part;2-far field electrode;21-electrode body;22-end insulator;3-mapping electrode assembly;30-branch;31-ring type component;311-ridge;312-connection part;313-mapping electrode;314-connection block;315-supporting component;316-insulating part;317-wire;321-outer ring;322-axial ridge;4-adjustable bending section;5-catheter body;6-handle. Specific implementation

[0043] In order to make the purpose, advantage and feature of the utility model more clear, the following is combined with the drawing and specific embodiment to make the utility model further detailed description.It is explained that, the drawing all adopts very simplified form and is not drawn according to proportion, just to facilitate, clear and assist the purpose of the utility model embodiment of the present application is explained.In addition, the structure shown in the drawing is often a part of actual structure.Specifically, the emphasis of each drawing needs to be different, sometimes different proportions are used.

[0044] As used in the present utility model, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. The term "or" is generally employed in its sense including "and / or" unless the context clearly dictates otherwise. The term "plurality" is generally employed in its sense including "at least one" unless the context clearly dictates otherwise. The term "at least two" is generally employed in its sense including "two or more" unless the context clearly dictates otherwise. In addition, the terms "first," "second," "third," etc. are used only to describe a particular one of the features and do not imply relative importance or an implicit indication that the indicated features are of a fixed number. Thus, features qualified by "first," "second," "third," etc. can expressly or implicitly include one or at least two of the features. The terms "proximal" and "distal" generally refer to two portions that correspond to each other, and they include not only end points. The terms "proximal" and "distal" are defined herein with respect to a mapping catheter that has one end for interventional use in a human body and a control end that extends out of the body. The term "proximal" refers to a position closer to the control end of the mapping catheter that extends out of the body, and the term "distal" refers to a position closer to the one end of the mapping catheter for interventional use in the human body and thus farther away from the control end of the mapping catheter. Alternatively, in a manual or hand-operated application scenario, the terms "proximal" and "distal" are defined herein with respect to an operator such as a surgeon or clinician. The term "proximal" refers to a position closer to the operator, and the term "distal" refers to a position closer to the mapping catheter and thus farther away from the operator. In addition, as used in the present utility model, "mounted", "connected", "connected", one element "provided" in another element should be understood broadly, generally only indicates that there is a connection, coupling, cooperation or transmission relationship between the two elements, and the connection, coupling, cooperation or transmission between the two elements can be direct or indirect through intermediate elements, and cannot be understood as indicating or implying the spatial positional relationship between the two elements, that is, one element can be in any orientation inside, outside, above, below or one side of another element, unless the content is otherwise clearly indicated. For those of ordinary skill in the art, the specific meaning of the above terms in the present utility model can be understood according to the 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, upward or upward direction is toward the top of the corresponding drawing, and downward or downward direction is toward the bottom of the corresponding drawing.

[0045] The utility model aims at providing a kind of mapping catheter to solve the problem that the far-field electrode layout of existing mapping catheter leads to the limitation of catheter section and electrode layout.

[0046] Please refer to Figure 1The utility model embodiment provides a kind of mapping catheter, it includes: fixed part 1, far-field electrode 2 and mapping electrode component 3;The proximal end of the mapping electrode component 3 is connected with the fixed part 1;The mapping electrode component 3 includes multiple branches 30, the far-field electrode 2 is arranged in the proximal end area of at least one of the branch 30 of the mapping electrode component 3;At least part of the far-field electrode 2 is located in the fixed part 1, the fixed part 1 has the part that is open with outside, so that outside fluid is contacted with the far-field electrode 2 when flowing through the fixed part 1. Figure 1 The left side is distal end, and the right side is proximal end. So configure, set far-field electrode 2 in the proximal end area of branch 30 of mapping electrode component 3, eliminate the binding of far-field electrode 2 and perfusion channel, far-field electrode 2 or perfusion channel is no longer limited to must be set in the center position of mapping catheter, bring the degree of freedom for the cross section design of mapping catheter, also bring the degree of freedom for the arrangement of multiple branches 30 of mapping electrode component 3, it is favorable to improve the cross section of mapping catheter and the layout of mapping electrode component 3.

[0047] Further, the mapping catheter further includes adjustable bending section 4, catheter body 5 and handle 6 and the like components, the structure and principle of adjustable bending section 4, catheter body 5 and handle 6 and the like components can refer to prior art, this embodiment does not expand the description.

[0048] Research finds that, relative to radial extension or basket extension, when mapping electrode component 3 extends approximately in plane, the accuracy of the collected electrocardiosignal is higher. Therefore, it is preferred to configure mapping electrode component 3 to extend approximately in plane. However, the embodiment does not limit mapping electrode component 3 to extend in plane, and some mapping electrode components 3 extending radially or in basket shape can also be arranged with far-field electrode 2 in the proximal end area of branch 30 in the manner of the embodiment.

[0049] Please refer to Figures 2 to 6Fig. 1 shows an exemplary embodiment of a mapping electrode assembly 3, which is a flexible member extending substantially in a plane, comprising three ring-shaped members 31 with flexibility, which can be compressed or folded into a delivery sheath in a delivery state, and which can be released to expand to an initial shape after being delivered to a target site, such as a heart. Each ring-shaped member 31 comprises two spines 311, which extend preferably in parallel along an axial direction of the mapping catheter in the initial shape without external force, and the distal ends of the two spines 311 are connected by a connecting portion 312, and the proximal ends of the two spines 311 are connected to the fixation member 1 after being bent. At least two mapping electrodes 313, such as ring electrodes, are arranged on each spine 311, so that the plurality of mapping electrodes 313 on the six spines 311 of the three ring-shaped members 31 forms a high-density electrode array. Preferably, each mapping electrode 313 is connected to a proximal mapping device by a wire 317 (see Fig. 2) embedded in the spine 311. Figures 8a to 8c ).

[0050] Further, please refer to Figure 2 and Figure 5 , for the convenience of description, the three ring-shaped members 31 are labeled as 31a, 31b and 31c, wherein the ring-shaped member 31a and the ring-shaped member 31b are relatively large (referring to the distance between the two spines 311 of the two ring-shaped members), and are arranged staggered and intersect at the connecting portion 312, and in an embodiment, the intersection of the ring-shaped member 31a and the ring-shaped member 31b can be fixed by a connecting block 314. The ring-shaped member 31c is relatively small (referring to the distance between the two spines 311 of the ring-shaped member 31c), and the two spines 311 of the ring-shaped member 31c are located inside the inner spines 311 of the ring-shaped member 31a and the ring-shaped member 31b. The connecting portion 312 of the ring-shaped member 31c can also be fixed by the connecting block 314. In this way, the entire mapping electrode assembly 3 extends substantially in a plane.

[0051] Please refer to Figure 3 , Figure 7 , Figure 10 , Figure 11a and Figure 11b , in an exemplary embodiment, the fixation member 1 comprises a plurality of fixation holes 11, the shape and size of which are adapted to the outer contour shape and size of the proximal end of the spine 311, and the proximal end of the spine 311 is used to penetrate and be fixed in the fixation hole 11. In this way, each spine 311 can be regarded as a branch 30 of the mapping electrode assembly 3, and at this time the mapping electrode assembly 3 comprises six branches 30. The arrangement of the connection of the branches 30 and the fixation member 1 is defined by the arrangement of the fixation holes 11. Preferably, the connection of the plurality of branches 30 and the fixation member 1 is along a first direction perpendicular to the axis of the fixation member 1 (the direction of the arrow in Fig. 1). Figure 7The six branches 30 of the three ring members 31 of the mapping electrode assembly 3 are linearly arranged.

[0052] In order to keep the plane extension, in ideal case, the proximal ends of the six branches 30 of the three ring members 31 of the mapping electrode assembly 3 should also be linearly arranged with the connection of the fixing member 1, however, considering the intervention performance of the fixing member 1, its diameter cannot be too large, and also considering the strength and performance of the mapping electrode assembly 3, the diameter of each branch 30 cannot be too small (combined with the description below), which leads to certain difficulty in linearly arranging the proximal ends of the six branches 30 under the limited diameter of the fixing member 1. Figures 8a to 8c

[0053] Based on this, the fixing holes 11 in the embodiment are divided into two rows, one row is arranged with four fixing holes 11, and the other row is arranged with two fixing holes 11, and each row of fixing holes 11 is linearly arranged along the first direction. Further, the proximal ends of the two ridges 311 of the ring member 31a are connected to the first and third fixing holes 11 from left to right in the first row, the proximal ends of the two ridges 311 of the ring member 31b are connected to the second and fourth fixing holes 11 from left to right in the first row, and the proximal ends of the two ridges 311 of the ring member 31c are connected to the two fixing holes 11 in the second row. Referring to Figure 6 At this time, the ring member 31a and the ring member 31b are in one plane, and the ring member 31c is in another plane, and the included angle between the two planes is relatively small and can be ignored, so at this time the entire mapping electrode assembly 3 can still be regarded as extending along the plane.

[0054] 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 insulation part 316 and a wire 317, wherein the support member 315 is used to provide support strength for the ridge 311, and the material thereof can be a metal material with certain support performance, such as nickel alloy or nickel-titanium alloy, etc. The cross-sectional shape of the support member 315 can be rectangular, which is beneficial to the adhesion of the ring member 31 to the target tissue (such as heart tissue). The wire 317 is connected to the mapping electrode 313 and extends proximally to realize the transmission of electrical signals. The insulation part 316 wraps the support member 315 and the wire 317. The material of the insulation part 316 is preferably a high-molecular polymer, such as pebax or polyurethane, etc., and the outer diameter of the entire ridge 311 is preferably not greater than 3F, so as to facilitate the use of the entire mapping catheter with an 8F or 8.5F delivery sheath. The outer diameter of the entire ridge 311 cannot be too small, so as to ensure a certain strength and meet the arrangement of multiple wires 317.

[0055] Please refer to Figure 3 ​The proximal end region of the branch 30 refers to the region close to the connection between the branch 30 and the fixing member 1. The distal end region of the branch 30 refers to the region close to the connection between the branch 30 and the connecting part 312. The proximal end region of the branch 30 can be 1 / 3 of the total length of the branch 30, and more preferably, the distal field electrode 2 is arranged in the region of 1 / 10 of the total length of the branch 30. Figures 2 to 6 In the exemplary embodiment shown, the distal end of the branch 30 (i.e., the distal end of the ridge 311) is connected to the connecting part 312. In other embodiments, the distal end of the branch 30 can also be a free end (as shown in Figure 16 and Figure 19 ). 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 (i.e., the starting point of the fixing hole 11) and the connection point of the ridge 311 and the connecting part 312. The proximal end region of the branch 30 can refer to the region of 1 / 3 of the total length close to the proximal end. More preferably, the distal field electrode 2 is arranged in the region of 1 / 10 of the total length of the branch 30 close to the proximal end along its own axial extension direction. The number of distal field electrodes 2 is preferably one, but the number of distal field electrodes 2 is not limited in this embodiment, and in some cases, the number of distal field electrodes 2 can be more than two and can be arranged on different branches 30.

[0056] Please refer to Figure 9 , which shows the application scenario of the mapping electrode assembly 3 in mapping the target region of the heart. The soft mapping electrode assembly 3 is in contact with different regions of the heart tissue, and the intracardiac electrical signals can be obtained. At this time, the distal field electrode 2 can collect the electrical signals conducted in the blood from the heart tissue region far away from the contacted tissue region, i.e., the distal field signal, so as to supplement the signals obtained by the mapping electrode assembly 3 and eliminate the signal interference in the operation process. In order to make the collected distal field signal more accurate and stable, the distal field electrode 2 should not be in contact with the heart tissue. In this embodiment, the distal field electrode 2 is arranged in the proximal end region of the branch 30, and at least part of the distal field electrode 2 is located in the fixing member 1. The distal end region and the middle region of the mapping electrode assembly 3 and part of the fixing member 1 can be used to shield the distal field electrode 2, so that when the mapping electrode assembly 3 is in contact with the heart tissue, the distal field electrode 2 is not easy to directly contact and be in contact with the heart tissue.

[0057] Please refer to Figure 7 , Figure 10 , Figure 11a and Figure 11bFurthermore, to reduce or prevent thrombus formation near the fixation element 1, the fixation element 1 has a perfusion passage 12 for spraying perfusion fluid (such as saline). Since this embodiment places the far-field electrode 2 in the proximal region of the branch 30 of the mapping electrode assembly 3, the binding between the far-field electrode 2 and the perfusion passage 12 is removed. The far-field electrode 2 or the perfusion passage 12 is no longer limited to being located at the center of the mapping catheter. This provides freedom in the cross-sectional design of the mapping catheter and in the arrangement of the multiple branches 30 of the mapping electrode assembly 3, which is beneficial for improving the cross-section of the mapping catheter and the layout of the mapping electrode assembly 3.

[0058] For further details, please refer to... Figures 10 to 11b The infusion passage 12 includes at least two distal outlet pipes 121, and the at least two distal outlet pipes 121 are arranged along a second direction perpendicular to the first direction. Figure 10 The mapping electrode assembly 3 (in the horizontal direction) is arranged on both sides of the connection between the branch 30 and the fixing member 1. It is understandable that since the mapping electrode assembly 3 extends roughly along the plane, it can easily block blood flow at the connection with the fixing member 1. By arranging at least two distal outlet tubes 121 opposite each other on both sides of the fixing member 1 along the second direction, perfusion can be performed simultaneously on both wings of the mapping electrode assembly 3, improving the perfusion effect and effectively reducing thrombus formation.

[0059] Furthermore, the infusion passage 12 also includes a proximal conduit 122 and a lateral connecting conduit 123. At least two of the distal outlet conduits 121 are connected and converged through the lateral connecting conduit 123 and are connected to the proximal conduit 122.

[0060] Due to the limited cross-sectional diameter of the mapping catheter, especially in the sections of the adjustable bend 4 and the catheter body 5, it is necessary to arrange the wires 317 of multiple mapping electrodes 313 corresponding to the mapping electrode assembly 3, as well as the bending control wires for manipulating the bending of the adjustable bend 4. In addition to various protective tubes, there is insufficient space within the cross-section of the adjustable bend 4 and the catheter body 5 to accommodate more than two infusion channels. Based on the aforementioned analysis, providing two or more distal outlet pipes 121 at the distal end of the fixing member 1 is beneficial for improving the infusion effect. Therefore, this embodiment uses the transverse connecting pipe 123 to divert the infusion channels within the fixing member 1, simultaneously resolving the conflict between the single proximal channel and the multiple distal branch outlets of the infusion pathway 12.

[0061] The proximal conduit 122 of the fixing member 1 can be connected to the corresponding injection channel in the adjustable bend 4. In some embodiments, the proximal conduit 122 and a distal outlet conduit 121 are directly connected along the axial direction of the fixing member 1. Of course, it is not required that the cross-sections of the proximal conduit 122 and the distal outlet conduit 121 be the same; as long as their cross-sections overlap, they are considered to be directly connected. Figure 10In the shown exemplary embodiment, the fixing member 1 comprises two distal outlet conduits 121, which are communicated by a transverse communication conduit 123, one of the distal outlet conduits 121 directly penetrates the proximal conduit 122.

[0062] Optionally, please refer to Figure 11a , Figure 11b and Figure 12 , and in combination with the reference of Figure 10 , the fixing member 1 comprises a receiving cavity 13, which is open towards the distal end, the fixing hole 11 is communicated with the proximal end of the receiving cavity 13; the proximal end of the branch 30 penetrates into the fixing hole 11 through the receiving cavity 13 and is fixed in the fixing hole 11; at least part of the distal field electrode 2 along the axial direction of the fixing member 1 is located in the receiving cavity 13. In an embodiment, in order to facilitate assembly, the fixing member 1 is configured as a two-leaf type, that is, the fixing member 1 comprises two split members 10, which are split along the radial direction after being split, thereby forming a complete fixing member 1, and at the same time, the receiving cavity 13 is formed. The arrangement of the receiving cavity 13 can accommodate at least part of the distal field electrode 2, thereby further improving the shielding effect of the distal field electrode 2 and reducing the possibility of contact between the distal field electrode 2 and the heart tissue.

[0063] Please continue to refer to Figure 12 Optionally, the fixing member 1 has an isolation portion 15 extending towards the distal end, the isolation portion 15 extends in part of the circumferential direction of the fixing member 1, and is used to shield the distal field electrode 2 in the radial and axial directions of the fixing member 1. The arrangement of the isolation portion 15 can effectively protect the distal field electrode 2, form a shield for the distal field electrode 2 in the radial and axial directions, and further reduce or avoid the contact between the distal field electrode 2 and the heart tissue.

[0064] Optionally, there is a gap 14 between the cavity side wall of the receiving cavity 13 and the branch 30. Optionally, there is a gap 14 between at least two branches 30. Optionally, there is a gap 14 between the isolation portion 15 and the branch 30. The arrangement of the gap 14 facilitates smooth blood flow therebetween and improves the accuracy of the distal field detection.

[0065] In an embodiment, the isolation portion 15 is an arc-shaped protruding sheet towards the distal end. The isolation portion 15 is preferably a thin-walled arc-shaped protruding sheet, which is shaped like a tile, for example, can be formed by extending the cavity side wall 131 of the receiving cavity 13 of the fixing member 1 towards the distal end. At this time, the entire isolation portion 15 can be understood as being parallel to the axis of the fixing member 1. Optionally, the position of the isolation portion 15 in the circumferential direction of the fixing member 1 corresponds to the position of the distal field electrode 2. Here, the correspondence can be close, or can be arranged in combination with the arrangement relationship of the distal field electrode 2 and the branches 30. For example, Figure 12As shown, the far-field electrode 2 is arranged at the proximal end region of the ridge 311 of the ring member 31b, at this time the far-field electrode 2 is shielded by the ridge 311 of the ring member 31c along the second direction, thus at this time the isolation portion 15 can be arranged at the side of the ridge 311 of the ring member 31b which is away from the ring member 31c along the second direction, that is, the isolation portion 15 and the ring member 31c jointly form the shielding for the far-field electrode 2.

[0066] In other embodiments, the extension direction of the isolation portion 15 can also be arranged at an angle with the axial direction of the fixing member 1. For example, the isolation portion 15 is inclined to the outside direction of the fixing member 1, thus it can reduce the resistance when the mapping electrode assembly 3 is adhered, and provide the function of buffering the force value while protecting the far-field electrode 2.

[0067] Please refer to Figure 13 Optionally, the far-field electrode 2 comprises an electrode body 21 and an end insulator 22; the electrode body 21 is arranged along the circumferential direction 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 out of 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 preferably, the end insulator 22 is 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 adhering to the heart tissue.

[0068] Please refer to Figures 14 to 19 It shows several different exemplary mapping electrode assemblies 3. Figure 14 The mapping electrode assembly 3 shown is substantially the same as the foregoing Figures 2 to 6 The embodiment shown is substantially the same, the difference is that it only contains two ring members 31, and the two ring members 31 are substantially nested inside and outside.

[0069] Figure 15 The mapping electrode assembly 3 shown is substantially a mesh structure, which contains 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 at the proximal end region of an axial ridge 322, preferably at the proximal end region of the axial ridge 322 located at the center. Further, at this time the fixing member 1 can also optionally contain an isolation portion 15, and further, the isolation portion 15 preferably contains two oppositely arranged thin-walled arc-shaped tabs, which are arranged in the vertical direction of the extension plane of the mesh structure mapping electrode assembly 3, so as to form effective shielding for the far-field electrode 2.

[0070] Figure 16 And Figure 17The mapping electrode assembly 3 shown is a multi-branch structure, which comprises a plurality of branches 30 and extends substantially along a plane. Figure 16 In the example shown, the distal ends of the branches 30 are free ends. Figure 17 In the example shown, the distal ends of the branches 30 are connected to each other by closed connections. The mapping electrode assembly 3 of the multi-branch structure can optionally extend substantially along a plane. The far-field electrode 2 is arranged at the proximal end region of one or more of the branches 30, preferably at one branch 30 close to the axis of the fixing member 1. Further, the fixing member 1 can also optionally comprise an isolation portion 15, which can be arranged in the manner described in the foregoing examples and will not be described again here.

[0071] Figure 18 The mapping electrode assembly 3 shown is a basket structure, in which the distal ends of the plurality of branches 30 are connected together. Figure 19 The mapping electrode assembly 3 shown is a star structure, in which the distal ends of the plurality of branches 30 are divergent. Figure 18 And Figure 19 In the example shown, the mapping electrode assembly 3 is in a spatial three-dimensional form rather than extending along a plane. For such a mapping electrode assembly 3 in a spatial three-dimensional form, the far-field electrode 2 can also be arranged at the proximal end region of one or more of the branches 30 thereof. Further, the fixing member 1 can also optionally comprise an isolation portion 15 to shield and protect the far-field electrode 2.

[0072] In summary, the mapping catheter provided by the present application comprises 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 comprises a plurality of branches; the far-field electrode is arranged at the proximal end 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 as to facilitate the fluid in the outside world to flow through the fixing member and contact the far-field electrode. In this way, the far-field electrode is arranged at the proximal end region of the branches of the mapping electrode assembly, which eliminates the binding of the far-field electrode and the perfusion channel, and the far-field electrode or the perfusion channel is no longer limited to being arranged at the central position of the mapping catheter, which brings freedom to the cross-sectional design of the mapping catheter and the arrangement of the plurality of branches of the mapping electrode assembly, and is beneficial to improving the cross section of the mapping catheter and the layout of the mapping electrode assembly.

[0073] 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 application and does not limit the scope of the present application in any way. Any modification or modification of the above-mentioned embodiments by a person skilled in the art falls within the protection scope of the present application.

Claims

1. A mapping catheter, characterized in that, The application relates to a fixation member, a far-field electrode and a mapping electrode assembly. The proximal end of the mapping electrode assembly is connected to the fixation member; the mapping electrode assembly comprises a plurality of branches, and the far-field electrode is arranged at the proximal end 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 fixation member, and the fixation member has an opening part to the outside so as to facilitate the contact between the far-field electrode and external fluid when the external fluid flows through the fixation member. The fixation member comprises a receiving cavity and a fixing hole; the receiving cavity is open towards the distal end; the fixing hole is in communication with the proximal end of the receiving cavity; the proximal end of the branch penetrates through the receiving cavity and is fixed in the fixing hole; and at least part of the far-field electrode is located in the receiving cavity along the axial direction of the fixation member.

2. The mapping catheter of claim 1, wherein, The cavity side wall of the receiving cavity has a gap with the branch; and / or at least two of the branches have a gap therebetween.

3. The mapping catheter of claim 2, wherein, The fixation member comprises two split members which are split along the radial direction to form the fixation member and to enclose the receiving cavity.

4. The mapping catheter of claim 2, wherein, The fixation member has an isolation part extending towards the distal end; the isolation part extends in part of the circumferential direction of the fixation member and shields the far-field electrode in the radial and axial directions of the fixation member.

5. The mapping catheter of claim 1, wherein, The isolation part satisfies at least one of the following conditions:

6. The mapping catheter of claim 5, wherein, The isolation part is in the form of an arc-shaped protruding sheet towards the distal end; The extension direction of the isolation part is arranged at an angle with the axial direction of the fixation member; The position of the isolation part in the circumferential direction of the fixation member corresponds to the position of the far-field electrode. The far-field electrode comprises an electrode body and an end insulator; the electrode body is arranged along the circumferential direction of the branch; the end insulator is arranged at least at one end of the electrode body along the axial direction of the branch, and the end insulator protrudes outwards from the electrode body along the radial direction of the branch.

7. The mapping catheter of claim 1, wherein, The fixation member has a perfusion passage; the perfusion passage comprises a proximal pipeline, a transverse communication pipeline and at least two distal outlet pipelines; the at least two distal outlet pipelines are communicated and collected through the transverse communication pipeline and are in communication with the proximal pipeline.

8. The mapping catheter of claim 1, wherein, The connection positions of the plurality of branches and the fixation member are linearly arranged along a first direction perpendicular to the axial line of the fixation member.

9. The mapping catheter of claim 1, wherein, The fixation member has a perfusion passage; the perfusion passage comprises at least two distal outlet pipelines; the at least two distal outlet pipelines are arranged on opposite sides of the connection positions of the branches and the fixation member along a second direction perpendicular to the first direction.

10. The mapping catheter of claim 9, wherein, ​

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