Fixing assembly of mapping catheter and mapping catheter

Abstract

The invention provides a fixing assembly of a mapping catheter and the mapping catheter, the fixing assembly of the mapping catheter is used for fixing an electrode branch of the mapping catheter, and the fixing assembly comprises a bolting piece and a fixing piece; the fixing piece is provided with a containing cavity arranged in the first direction, and an opening is formed in the end, in the first direction, of the containing cavity. The accommodating cavity is used for allowing an electrode branch to penetrate from one end of the opening; and the bolting piece extends along a second direction forming an angle with the first direction, is arranged in the accommodating cavity in a penetrating manner, and is used for being clamped with at least one part of the electrode branches penetrating into the accommodating cavity in a concave-convex manner so as to limit the position of at least one part of the electrode branches. Through the configuration, the structure of the fixing part for fixing the electrode branches is reduced, and more space is reserved in the limited space of the fixing part for the accommodating cavity, so that structures such as a far-field electrode are allowed to be arranged, and the accommodating cavity can protect the far-field electrode accommodated in the accommodating cavity.

Description

Technical Field

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

[0002] Catheter ablation is currently one of the effective means of treating atrial fibrillation. Mapping catheters are important tools for doctors to track the source of atrial fibrillation and develop ablation plans. In order to achieve efficient and rapid mapping, the existing technology has proposed a variety of different high-density mapping catheters, which have multiple electrode branches at the distal end, and each electrode branch contains multiple mapping electrodes. High-density mapping catheters have 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, the far-field electrodes need to remain isolated from the heart tissue during application. In the prior art, the far-field electrodes are generally set at the center of the catheter and bound to the perfusion channel. This requires that the catheter must have a central perfusion channel, which imposes relatively large restrictions on the cross-sectional design of the catheter and also limits the layout of the electrode branches. Summary of the invention

[0005] The object of the present invention is to provide a fixing assembly of a mapping catheter and a mapping catheter, so as to solve the problem of limited far-field electrode layout of the existing mapping catheter.

[0006] In order to solve the above technical problems, the present invention provides a fixing assembly of a mapping catheter, which is used to fix the electrode branch of the mapping catheter. The fixing assembly includes: a bolting member and a fixing member; The fixing member has a receiving cavity arranged along a first direction, and one end of the receiving cavity along the first direction has an opening; the receiving cavity is used for the electrode branch to pass through one end of the opening; The bolting member extends along a second direction which is angled with the first direction, and is disposed through the accommodating cavity, and is used for engaging with at least a portion of the electrode branches penetrating the accommodating cavity to define the position of at least a portion of the electrode branches.

[0007] Optionally, the fixing member also has a plurality of electrode fixing holes, which are arranged along the first direction at one end of the accommodating cavity away from the opening and are connected to the accommodating cavity; the electrode fixing holes are adapted to the electrode branches and are used to accommodate and fix the electrode branches passing through the accommodating cavity.

[0008] Optionally, the fixing member includes two assembled bodies, and the two assembled bodies are assembled and connected along the second direction; wherein at least a portion of the electrode fixing hole is divided into two half holes along its own axial direction, and the two half holes are respectively located on the two assembled bodies.

[0009] Optionally, the plurality of electrode fixing holes are divided into two rows along the second direction; The centers of the two rows of electrode fixing holes along the second direction are located on the central axis of the fixing member; and / or the numbers of the two rows of electrode fixing holes are different.

[0010] Optionally, the fixing member has at least two perfusion outlet flow channels opened along the first direction, and at least two of the perfusion outlet flow channels are located on both sides of the accommodating cavity along the second direction; the bolt-fitting member has a transverse flow channel passing through along the second direction; and at least two of the perfusion outlet flow channels are connected via the transverse flow channel.

[0011] Optionally, the fixing member includes two assembled bodies, and the two assembled bodies are assembled and connected along the second direction; the bolt-fitting member includes two bolt bodies respectively connected to the two assembled bodies, and the two bolt bodies are combined with each other as the two assembled bodies are assembled and connected to form the transverse flow channel isolated from the accommodating cavity.

[0012] Optionally, the two bolt bodies are internally and externally joined or radially spliced.

[0013] Optionally, the fixing member has a perfusion inlet flow channel opened along the first direction, and the perfusion inlet flow channel is arranged in communication with one of the perfusion outlet flow channels; and / or; The fixing member also includes an end cover, which is sleeved outside the two assembled bodies along the first direction, and is respectively enclosed with the two assembled bodies to form two chambers located on both sides of the accommodating cavity, each of which is connected to at least one of the perfusion outlet flow channels; the distal surface of the end cover has a plurality of through perfusion holes, and each of the chambers is respectively connected to more than two of the perfusion holes.

[0014] Optionally, a projection of the bolting member along the first direction overlaps with at least a portion of the electrode fixing hole.

[0015] In order to solve the above technical problems, the present invention also provides a mapping catheter, which includes the fixing assembly of the mapping catheter as described above, and also includes a mapping electrode assembly, wherein the mapping electrode assembly includes a plurality of electrode branches.

[0016] To summarize, in the fixing assembly of the mapping catheter and the mapping catheter provided by the present invention, the fixing assembly of the mapping catheter is used to fix the electrode branch of the mapping catheter, and the fixing assembly includes a bolting member and a fixing member; the fixing member has a accommodating cavity arranged along a first direction, and the accommodating cavity has an opening at one end along the first direction; the accommodating cavity is used for the electrode branch to penetrate from one end of the opening; the bolting member extends along a second direction at an angle to the first direction, and is arranged through the accommodating cavity, and is used to engage with at least a part of the electrode branch inserted into the accommodating cavity to limit the position of at least a part of the electrode branch.

[0017] With such configuration, the electrode branches can be limited by setting the bolting parts, thereby reducing the structure of the fixing parts fixing the electrode branches, leaving more space for the accommodating cavity within the limited space of the fixing parts, thereby allowing the arrangement of structures such as far-field electrodes, and the accommodating cavity can protect the far-field electrodes accommodated therein, reducing or avoiding the far-field electrodes from contacting the heart tissue. The far-field electrodes are no longer limited to the perfusion channels that must be set in the center, which brings freedom to the cross-sectional design of the mapping catheter and the arrangement of the electrode branches, which is conducive to improving the cross-sectional design of the mapping catheter and the layout of the electrode branches. 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 4 is a side view of a distal end portion of a mapping catheter according to an embodiment of the present invention.

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

[0021] Figure 3 yes Figure 2 An enlarged schematic diagram of part A.

[0022] Figure 4 is a three-dimensional diagram of a fixing assembly according to an embodiment of the present invention.

[0023] Figure 5 is a distal end view of a fixation assembly according to an embodiment of the present invention.

[0024] Figure 6 is a proximal end view of a fixation assembly according to an embodiment of the present invention.

[0025] Figure 7 Schematic diagram of a spliced ​​body of an embodiment of the present invention.

[0026] Figure 8 Schematic diagram of another assembled body according to an embodiment of the present invention.

[0027] Fig. 9 yes Figure 8 A proximal view of the assembly is shown.

[0028] Fig.10 Schematic diagram of an axial cross section of a fixing assembly according to an embodiment of the present invention.

[0029] Fig.11 It is a schematic diagram of an axial section after the fixing assembly and the mapping electrode assembly according to an embodiment of the present invention are connected.

[0030] Fig.12 yes Fig.11 An enlarged schematic diagram of part B.

[0031] Fig.13 It is a schematic diagram of a spliced ​​body according to another embodiment of the present invention.

[0032] Fig.14 Schematic diagram of another assembled body according to another embodiment of the present invention.

[0033] Fig.15 It is a three-dimensional diagram of a fixing assembly according to another embodiment of the present invention.

[0034] Fig.16 It is a schematic diagram of an axial cross-section of a fixing assembly according to another embodiment of the present invention.

[0035] Fig.17 It is a schematic diagram of another embodiment of the present invention after the fixing component is connected to the mapping electrode component.

[0036] Fig.18 yes Fig.17 An enlarged schematic diagram of part C.

[0037] Fig.19 It is a schematic diagram of an axial section after the fixing assembly of an embodiment of the present invention is connected to another mapping electrode assembly.

[0038] Fig. 20 yes Fig.19 An enlarged schematic diagram of part D.

[0039] In the accompanying drawings: 1-fixing assembly; 11-bolt-on; 11a, 11b -bolt body; 12-fixing piece; 12a, 12b-assembled body; 121-infusion outlet channel; 122-infusion inlet channel; 123-lateral channel; 124-narrowing section; 13-accommodating cavity; 14-electrode fixing hole; 15-end cover; 151-chamber; 152-infusion hole; 2-far-field electrode; 3-mapping electrode assembly; 30-electrode branch; 31-fixing section; 32-clamping section; 33-U-shaped member; 34-connecting part; 35-mapping electrode; 4-catheter body. DETAILED DESCRIPTION

[0040] 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.

[0041] 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.

[0042] The object of the present invention is to provide a fixing assembly of a mapping catheter and a mapping catheter to solve the problem of limited far-field electrode layout of existing mapping catheters.

[0043] Please refer to Figures 1 to 3The embodiment of the present invention provides a mapping catheter, which includes: a fixing component 1, a far-field electrode 2 and a mapping electrode component 3; the mapping electrode component 3 includes a plurality of soft electrode branches 30, and the proximal ends of the plurality of electrode branches 30 are gathered and fixed to the fixing component 1. A plurality of mapping electrodes 35 are arranged on each electrode branch 30. In this way, the plurality of mapping electrodes 35 on the plurality of electrode branches 30 constitute a high-density electrode array.

[0044] When mapping the target area of ​​the heart, the mapping electrode assembly 3 is placed against different areas of the heart tissue, and the soft electrode branch 30 directly contacts the heart tissue, so that the intracardiac electrical signal can be obtained through the mapping electrode 35; however, the signal obtained by the mapping electrode 35 also contains other interference signals, such as far-field signals containing blood or other regional tissues. Based on this, a far-field electrode 2 that is not in direct contact with the heart tissue can be set to collect the ECG signal 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.

[0045] In some embodiments, the far-field electrode 2 may be disposed in the proximal region of the electrode branch 30. In order to make the collected far-field signal more accurate and stable, the far-field electrode 2 should not be in contact with the heart tissue.

[0046] Based on the above research, please refer to Figures 4 to 12 This embodiment provides a fixing assembly 1 of a mapping catheter, which is used to fix the electrode branch 30 of the mapping catheter. The fixing assembly 1 includes: a bolt 11 and a fixing member 12; the fixing member 12 has a first direction ( Figure 4 and Fig.10 The accommodating cavity 13 is arranged in the horizontal direction, and the accommodating cavity 13 is arranged at one end (the far end, Figure 4 and Fig.10 The middle is the right end) has an opening; please refer to Figure 2 , Figure 3 , Figures 10 to 12 The accommodating cavity 13 is used for the electrode branch 30 to penetrate from one end of the opening; the bolting member 11 is arranged along a second direction ( Fig.10 The middle is the vertical direction, Fig.11 and Fig.12 The electrode branch 30 extends from the receiving cavity 13 (in the direction perpendicular to the paper surface) and is disposed through the receiving cavity 13 to engage with at least a portion of the electrode branch 30 that penetrates the receiving cavity 13 to define the position of at least a portion of the electrode branch 30.

[0047] In an alternative exemplary embodiment, the fixing member 12 extends along the first direction, that is, the axis of the fixing member 12 is arranged along the first direction. It should be noted that the angle between the second direction and the first direction here can be selected to be not less than 60°, preferably not less than 75°, for example, it can be 80°, 85° or 90°, etc. The closer the angles are to 90°, the better the limiting effect of the bolting member 11 on the electrode branch 30, so the second direction is preferably perpendicular to the first direction.

[0048] With such configuration, the electrode branch 30 can be limited by setting the bolting member 11, thereby reducing the structure of the fixing member 12 for fixing the electrode branch 30 (such as reducing the fixing hole, see the following description for details), leaving more space for the accommodating cavity 13 within the limited space of the fixing member 12, thereby allowing structures such as the far-field electrode 2 to be set in the accommodating cavity 13, and the accommodating cavity 13 can protect the far-field electrode 2 accommodated therein, reducing or avoiding the far-field electrode 2 from contacting the heart tissue. The far-field electrode 2 is no longer limited to the perfusion channel that must be set in the center position, which brings freedom to the cross-sectional design of the mapping catheter and the arrangement of the electrode branch 30, which is conducive to improving the cross-sectional design of the mapping catheter and the layout of the electrode branch 30.

[0049] For further information, please continue to refer to Figures 4 to 10 The fixing member 12 further has a plurality of electrode fixing holes 14, and the electrode fixing holes 14 are arranged along the first direction at one end (proximal end, Figure 4 and Fig.10 The electrode fixing hole 14 is adapted to the electrode branch 30 and is used to accommodate and fix the electrode branch 30 passing through the accommodating cavity 13. Fig.12 Optionally, the electrode branch 30 further includes a fixing section 31 at the proximal end, and the cross-sectional shape of the proximal end of the fixing section 31 is preferably adapted to the cross-sectional shape of the electrode fixing hole 14. After the proximal end of the electrode branch 30 passes through the accommodating cavity 13, the fixing section 31 penetrates into the electrode fixing hole 14 and is fixed in the electrode fixing hole 14. The fixing method may be, for example, size matching connection or adhesive fixing.

[0050] It is understandable that in order to ensure the bending performance of the mapping catheter, the axial length of the fixing member 12 is subject to certain restrictions. If the axial length of the fixing member 12 is too long, it will be difficult for it to pass through some blood vessels with large curvatures. The setting of the aforementioned bolting member 11 can effectively limit the electrode branch 30, thereby relatively reducing the axial length of the electrode fixing hole 14, so that within the space range of the limited axial length of the fixing member 12, the axial length of the accommodating cavity 13 is set relatively larger to form a deeper concave cavity, thereby allowing most or all of the far-field electrode 2 to be accommodated in the accommodating cavity 13, and the cavity wall of the accommodating cavity 13 forms a shielding protection for the far-field electrode 2, reducing or avoiding the exposure of the far-field electrode 2 and direct contact with the heart tissue.

[0051] Please refer to Figures 5 to 9 Optionally, the fixing member 12 includes two splicing bodies 12a and 12b, and the two splicing bodies 12a and 12b are spliced ​​and connected along the second direction; wherein at least a portion of the electrode fixing hole 14 is divided into two half holes along its own axial direction, and the two half holes are respectively located on the two splicing bodies 12a and 12b. The arrangement of the two splicing bodies 12a and 12b enables the fixing member 12 to form a two-petal combination structure. During installation, the electrode fixing hole 14 can be enclosed by splicing and connecting the two splicing bodies 12a and 12b along the second direction, thereby fixing the electrode branch 30 therein. At the same time, since the bolting member 11 also extends along the second direction, it can easily form a concave-convex fit with the electrode branch 30 when the two splicing bodies 12a and 12b are spliced ​​and connected. It should be noted that this embodiment only limits the fixing member 12 to include two spliced ​​bodies 12a and 12b spliced ​​and connected along the second direction, but does not limit the fixing member 12 to only consist of the two spliced ​​bodies 12a and 12b. In practice, the fixing member 12 may also include spliced ​​bodies spliced ​​in other directions. Some electrode fixing holes 14 may also be further enclosed and formed by these spliced ​​bodies spliced ​​in other directions, either individually or collectively.

[0052] Optional, such as Figure 5 and Figure 6 As shown, the plurality of electrode fixing holes 14 are divided into two rows along the second direction; the centers of the two rows of electrode fixing holes 14 along the second direction are located on the central axis of the fixing member 12. Figure 5 , which shows an example including six electrode fixing holes 14, wherein four electrode fixing holes 14 (a, b, c, d) are in one row, and the other two electrode fixing holes 14 (e, f) are in another row. The two rows of electrode fixing holes 14 are arranged along the second direction ( Figure 5 The middle one is arranged vertically up and down).

[0053] The study found that, compared with radial extension or basket-shaped extension, the accuracy of the ECG signals collected by the mapping electrode assembly 3 is higher when it is roughly planarly extended. Therefore, it is preferred to configure the mapping electrode assembly 3 to be roughly planarly extended. In order to maintain the planar extension, ideally, the proximal ends of the multiple electrode branches 30 of the mapping electrode assembly 3 (referring to the part connected to the fixing member 12) should also be arranged in a straight line. However, considering the interventional performance of the fixing member 12, its diameter cannot be too large, and also considering the strength and performance of the mapping electrode assembly 3, the diameter of each electrode branch 30 cannot be too small. This leads to certain difficulties in arranging the proximal ends of the multiple electrode branches 30 in a straight line under the limited diameter of the fixing member 12.

[0054] Based on this, the present embodiment preferably divides the electrode fixing holes 14 into two rows, wherein a portion of the electrode branches 30 can be fixed in one row of electrode fixing holes 14, and another portion of the electrode branches 30 can be fixed in another row of electrode fixing holes 14, and the distal ends of all electrode branches 30 can be on the same plane, refer to Figure 1 , at this time, the entire mapping electrode assembly 3 appears to form two planes in the lateral direction, but the angle between the two planes is relatively small and basically negligible, so at this time the entire mapping electrode assembly 3 can still be roughly regarded as extending along the plane. Therefore, by dividing the electrode fixing holes 14 into two rows, it is solved that the mapping electrode assembly 3 is roughly maintained in a plane-shaped extension, and it is also solved that a larger number of electrode fixing holes 14 are arranged under the limited diameter of the fixing member 12, thereby meeting the demand for a larger number of electrode branches 30.

[0055] Optionally, the number of the electrode fixing holes 14 in the two rows is different. Figure 5 In the illustrated example, the number of the two rows of electrode fixing holes 14 is four and two respectively. Considering the intervention performance and diameter of the fixing member 12, the diameter of each electrode branch 30, and the performance requirements of the actual mapping electrode assembly 3, the number of electrode fixing holes 14 can be selected to be 4 to 8, preferably 6. Preferably, the number of electrode fixing holes 14 in each row does not exceed 4.

[0056] Furthermore, the four electrode fixing holes 14 in one row are exactly located on the joint surface of the two assembled bodies 12a and 12b. Specifically, since the center of the two rows of electrode fixing holes 14 is exactly located at the center of the entire fixing member 12, the four electrode fixing holes 14 in one row are actually biased to one side, so the two assembled bodies 12a and 12b are unevenly separated (that is, the two assembled bodies are asymmetrically arranged), the assembled body 12a is relatively small, and the assembled body 12b is relatively large, and the joint surface of the two just passes through the center of the four electrode fixing holes 14 (a, b, c, d). The row of electrode fixing holes 14 with more holes is arranged as half-hole joints, which is more convenient for assembly and positioning.

[0057] Need to explain, Figure 5 The example shown is only an example of the fixing member 12 and is not a limitation thereof. In other embodiments, the fixing member 12 may include other different numbers of electrode fixing holes 14, or the electrode fixing holes 14 may be arranged in different numbers, which is not limited in this embodiment. In addition, the number of electrode fixing holes 14 must correspond to the number of electrode branches 30. The number of electrode fixing holes 14 may be greater than the number of electrode branches 30, that is, a part of the electrode fixing holes 14 may be vacant. For example Figure 5 The example shown includes six electrode fixing holes 14, but four of them can be selected to arrange electrode branches 30, while the other two are vacant. Furthermore, the joint surface of the two joint bodies 12a and 12b is not limited to being a plane, for example, it can also be a curved surface. Correspondingly, the row of electrode fixing holes 14 arranged as half-hole joints is also arranged along the curved surface accordingly.

[0058] The mapping catheter of this embodiment includes a high-density electrode array and a large number of mapping electrodes 35, and needs to be perfused with a large amount of perfusion fluid (such as saline) to reduce or avoid thrombus formation. Figures 4 to 10 Optionally, the fixing member 12 has at least two perfusion outlet flow channels 121 opened along the first direction, and at least two of the perfusion outlet flow channels 121 are located on both sides of the accommodating cavity 13 along the second direction; the bolt-fitting member 11 has a transverse flow channel 123 passing through along the second direction; at least two of the perfusion outlet flow channels 121 are connected through the transverse flow channel 123.

[0059] Furthermore, the perfusion inlet channel 122 is arranged in a through-connection with one of the perfusion outlet channels 121. In this way, after the perfusion fluid flows in through the perfusion inlet channel 122, it can be diverted through the lateral channel 123, and finally flows out from at least two perfusion outlet channels 121, forming a bilateral perfusion of the mapping electrode assembly 3, reducing the possibility of thrombosis due to the complex branching morphology of the electrode branch 30. Preferably, the fixing member 12 includes only one perfusion inlet channel 122, which is preferably eccentrically arranged. It should be noted that the perfusion inlet channel 122 and the perfusion outlet channel 121 are arranged in a through-connection along the axial direction of the fixing member 12, and the cross-section of the perfusion inlet channel 122 is not limited to the same as the cross-section of the perfusion outlet channel 121. As long as the cross-sections of the two overlap, they can be regarded as directly connected. Furthermore, since the transverse flow channel 123 is opened in the bolting component 11, the bolting component 11 can not only be used to limit the position of the electrode branch 30, but also be used to connect the perfusion outlet flow channels 121 located on both sides of the accommodating cavity 13, so that the bolting component 11 can be used for multiple purposes, further improving the compactness of the entire fixing assembly 1.

[0060] Please refer to Figure 4, and combined with reference Figures 1 to 3 In one exemplary embodiment, the proximal end of the fixing member 12 includes a tapered section 124, and the tapered section 124 can be inserted into the catheter body 4 to form a connection. Since the cross-sectional diameter of the catheter body 4 of the mapping catheter is limited, it is necessary to arrange the wires of the multiple mapping electrodes 35 corresponding to the mapping electrode assembly 3, and it is also necessary to arrange the control line for manipulating the bending of the adjustable bending section. In addition to various protective tubes, there is not enough space in the cross-section of the catheter body 4 of the mapping catheter to set more than two perfusion channels. Based on the above analysis, setting more than two perfusion outlet flow channels 121 at the distal end of the fixing member 12 is conducive to improving the perfusion effect. To this end, this embodiment divides the perfusion channel in the fixing assembly 1 by setting a transverse flow channel 123, while satisfying the contradiction between the proximal single channel and the distal multi-branch outlet of the perfusion pathway.

[0061] Please continue to refer to Figures 4 to 10 Optionally, the bolt assembly 11 includes two bolt bodies 11a and 11b respectively connected to the two spliced ​​bodies 12a and 12b, and the two bolt bodies 11a and 11b are combined with each other as the two spliced ​​bodies 12a and 12b are spliced ​​and connected to form the transverse flow channel 123 isolated from the accommodating cavity 13. Figure 7 and Figure 8 As shown, in one embodiment, the bolt body 11a is arranged on the assembled body 12a, and the bolt body 11b is arranged on the assembled body 12b. When the two assembled bodies 12a and 12b are assembled and connected, the two bolt bodies 11a and 11b can be combined with each other.

[0062] Please refer to Figures 7 to 10 , optionally, the two bolt bodies 11a, 11b are connected inside and outside. In an alternative exemplary embodiment, a perfusion outlet flow channel 121 is respectively provided in the two assembled bodies 12a, 12b, and the bolt body 11a and the bolt body 11b respectively have an inner cavity that penetrates the perfusion outlet flow channel 121 along the second direction, and the inner contour shape of the inner cavity of the bolt body 11b is adapted to the outer contour shape of the bolt body 11a. When the two assembled bodies 12a, 12b are assembled and connected, the bolt body 11a can be inserted into the inner cavity of the bolt body 11b and form a closed fit. The inner cavity of the bolt body 11a is isolated from the accommodating cavity 13 and can be configured as a transverse flow channel 123. It can be understood that in some embodiments, the length of the bolt body 11a along the second direction may be slightly shorter, and at this time, the inner cavity of the bolt body 11a can form a transverse flow channel 123 together with the inner cavity of the bolt body 11b.

[0063] Optionally, in some other embodiments, the two bolt bodies 11a and 11b may also be radially spliced ​​(meaning spliced ​​perpendicular to the second direction). For example, the cross-sections of the two bolt bodies 11a and 11b are respectively C-shaped, and when the two spliced ​​bodies 12a and 12b are spliced ​​and connected, they are spliced ​​and tightly matched in the radial direction, and the internal spaces enclosed by the two C-shaped forms a transverse flow channel 123. In some other embodiments, the two bolt bodies 11a and 11b may also be axially butted (meaning spliced ​​along the second direction), and in this case, the axial butt surfaces of the two bolt bodies 11a and 11b may be sealed, for example, by flanges or sealing rings.

[0064] Please refer to Figure 5 , Figure 6 , Fig.11 and Fig.12 , optionally, the projection of the bolting member 11 along the first direction overlaps with at least a portion of the electrode fixing hole 14. In one embodiment, the electrode branch 30 includes a snap-fit ​​section 32, and the snap-fit ​​section 32 has a C-shaped notch on the cross section in the first direction, and the shape of the C-shaped notch is preferably adapted to the cross-sectional shape of the bolting member 11 along the second direction. Since the projection of the bolting member 11 along the first direction overlaps with the electrode fixing hole 14, the bolting member 11 can be inserted into the C-shaped notch of the snap-fit ​​section 32 to form a concave-convex snap-fit. Since both ends of the C-shaped notch of the snap-fit ​​section 32 are clamped by the bolting member 11, the electrode branch 30 cannot move along the first direction. Further, the fixing section 31 located at the proximal end of the snap-fit ​​section 32 is inserted into the electrode fixing hole 14, and can be subsequently fixed by, for example, glue injection to further limit the position of the electrode branch 30. Optionally, the C-shaped notch of the snap-fit ​​section 32 can also be glued and fixed to the bolting member 11.

[0065] Please refer to Figures 13 to 18In another embodiment, the fixing member 12 includes not only two assemblies 12a and 12b, but also an end cap 15. The end cap 15 is sleeved outside the two assemblies 12a and 12b after assembly along the first direction, and is respectively enclosed with the two assemblies 12a and 12b to form two chambers 151 located on both sides of the accommodating cavity 13, each of which is connected with at least one of the injection outlet channels 121; the distal end surface of the end cap 15 has a plurality of through injection holes 152, and each of which is respectively connected with more than two injection holes 152. Optionally, the assemblies 12a and 12b have a concave step on one side of the distal end, and when the end cap 15 is sleeved outside the assemblies 12a and 12b, it is sealed and connected with the outer periphery of the assemblies 12a and 12b, thereby closing the concave step and enclosing to form the chamber 151. With such configuration, after the perfusion liquid enters the chamber 151 through the perfusion outlet flow channel 121, it can be ejected from the multiple perfusion holes 152. The provision of multiple perfusion holes 152 can increase the perfusion density and flow rate, and achieve the effect of bilateral microporous saline perfusion.

[0066] The embodiment of the present invention further provides a mapping catheter, which includes the above-mentioned fixing assembly 1 of the mapping catheter, and also includes a mapping electrode assembly 3, wherein the mapping electrode assembly 3 includes a plurality of electrode branches 30. The following is a description in conjunction with several embodiments.

[0067] Please refer to Fig.11 , and combined with reference Figure 2 In one embodiment, the mapping electrode assembly 3 includes two U-shaped components 33. The U-shaped components 33 have certain flexibility and self-recovery. In the delivery state, they can be compressed or folded into the delivery sheath, and released after being delivered to the target location (such as the heart), and then expanded and recovered to the initial shape.

[0068] The two U-shaped members 33 are of different sizes and are arranged roughly inside and outside. The closed end of the U-shaped member 33 faces the distal end, and the vertex area of ​​the closed end of the U-shaped member 33 is connected and fixed by a connecting block 34. The two open ends of each U-shaped member 33 are regarded as two electrode branches 30, which are bent toward the proximal end and fixed to the fixing assembly 1.

[0069] For further information, please refer to Figure 5, the two electrode branches 30 of one U-shaped member 33 are respectively inserted into one row of electrode fixing holes 14 (holes b and c), and the two electrode branches 30 of the other U-shaped member 33 are respectively inserted into another row of electrode fixing holes 14 (holes e and f). It can be understood that holes b, c, e, and f are four electrode fixing holes 14 relatively close to the center of the fixing member 12, and these four electrode fixing holes 14 overlap with the projection of the bolting member 11, so the four electrode branches 30 of the two U-shaped members 33 can be limited by the bolting member 11. At this time, the side of the entire mapping electrode assembly 3 is as shown Figure 1 As shown, it extends in a generally planar shape.

[0070] Please refer to Figures 17 to 20 In another embodiment, the mapping electrode assembly 3 includes three U-shaped members 33. For the convenience of description, the three U-shaped members 33 are respectively labeled as 33a, 33b and 33c, wherein the U-shaped member 33a and the U-shaped member 33b are relatively large (referring to the relatively large distance between the two side edges of the two U-shaped members 33). The two are staggered and intersect at the closed end, and then the intersection of the U-shaped member 33a and the U-shaped member 33b is fixed by the connecting block 34. The U-shaped member 33c is relatively small (referring to the relatively small distance between the two side edges of the U-shaped member 33c). The two side edges of the U-shaped member 33c are located on the inner side of the inner side edges of the U-shaped member 33a and the U-shaped member 33b. The closed end of the U-shaped member 33c can also be optionally fixed by the connecting block 34. With such a configuration, the entire mapping electrode assembly 3 extends roughly in a planar shape.

[0071] For further information, please refer to Figure 5 , wherein the two electrode branches 30 of the U-shaped member 33a are respectively inserted into holes a and c, the two electrode branches 30 of the U-shaped member 33b are respectively inserted into holes b and d, and the two electrode branches 30 of the U-shaped member 33c are respectively inserted into holes e and f. It can be understood that at this time, the two electrode branches 30 of the U-shaped member 33c are both limited by the bolting member 11. Although one electrode branch 30 of each of the U-shaped members 33a and 33b is limited by the bolting member 11, the limited electrode branch 30 can produce a linkage limiting effect on the other electrode branch 30 that is not limited by the bolting member 11, thereby also providing a certain effect on the limiting of the entire U-shaped members 33a and 33b.

[0072] In another alternative embodiment, the mapping electrode assembly 3 includes two U-shaped members 33, which are connected to the Fig.19 and Fig. 20 The U-shaped members 33a and 33b in the illustrated embodiment are similar, that is, the four branches 30 of the two U-shaped members 33 are cross-arranged in the four electrode fixing holes 14 in the same row, Fig.19 and Fig. 20The embodiment shown differs in that no U-shaped member 33c is provided.

[0073] It should be noted that the above-mentioned examples are only demonstrations of the mapping electrode assembly 3, and are not limitations thereon. In some other embodiments, the mapping electrode assembly 3 is not limited to including a plurality of U-shaped components 33, and the mapping electrode assembly 3 may also be in a mesh structure, a multi-branch structure, a basket structure, or a star structure, etc. Those skilled in the art may configure the shape of the mapping electrode assembly 3 differently according to actual conditions.

[0074] In summary, in the fixing assembly of the mapping catheter and the mapping catheter provided by the present invention, the fixing assembly of the mapping catheter is used to fix the electrode branch of the mapping catheter, and the fixing assembly includes a bolt and a fixing member; the fixing member has a housing cavity arranged along a first direction, and one end of the housing cavity along the first direction has an opening; the housing cavity is used for the electrode branch to penetrate from one end of the opening; the bolt extends along a second direction that is angled with the first direction, and is arranged through the housing cavity, and is used to engage with at least a part of the electrode branch that penetrates the housing cavity to define the position of at least a part of the electrode branch. With such a configuration, the electrode branch can be limited by the setting of the bolt, thereby reducing the structure of the fixing member to fix the electrode branch, leaving more space for the housing cavity within the limited space of the fixing member, thereby allowing the setting of structures such as far-field electrodes, and the housing cavity can protect the far-field electrode accommodated therein, reducing or avoiding the far-field electrode from contacting the heart tissue. The far-field electrode is no longer limited to the perfusion channel that must be set in the central position, which brings freedom to the cross-sectional design of the mapping catheter and the arrangement of the electrode branches, which is conducive to improving the cross-sectional design of the mapping catheter and the layout of the electrode branches.

[0075] 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 fixing assembly for a mapping catheter, used for fixing an electrode branch of a mapping catheter, characterized in that: The fixing assembly comprises: a bolting member and a fixing member; The fixing member has a receiving cavity arranged along a first direction, and one end of the receiving cavity along the first direction has an opening; the receiving cavity is used for the electrode branch to pass through one end of the opening; The bolting member extends along a second direction which is angled with the first direction, and is disposed through the accommodating cavity, and is used for engaging with at least a portion of the electrode branches penetrating the accommodating cavity to define the position of at least a portion of the electrode branches.

2. The fixing assembly of the mapping catheter according to claim 1, characterized in that: The fixing member also has a plurality of electrode fixing holes, which are arranged along the first direction at one end of the accommodating cavity away from the opening and are connected to the accommodating cavity; the electrode fixing holes are adapted to the electrode branches and are used to accommodate and fix the electrode branches passing through the accommodating cavity.

3. The fixing assembly of the mapping catheter according to claim 2, characterized in that: The fixing member comprises two assembled bodies, and the two assembled bodies are assembled and connected along the second direction; wherein at least a part of the electrode fixing hole is divided into two half holes along its own axial direction, and the two half holes are respectively located on the two assembled bodies.

4. The fixing assembly of the mapping catheter according to claim 2, characterized in that: The plurality of electrode fixing holes are divided into two rows along the second direction; The centers of the two rows of electrode fixing holes along the second direction are located on the central axis of the fixing member; and / or the numbers of the two rows of electrode fixing holes are different.

5. The fixing assembly of the mapping catheter according to claim 1, characterized in that: The fixing member has at least two perfusion outlet flow channels opened along the first direction, and at least two of the perfusion outlet flow channels are located on both sides of the accommodating cavity along the second direction; the bolt-fitting member has a transverse flow channel passing through along the second direction; at least two of the perfusion outlet flow channels are connected through the transverse flow channel.

6. The fixing assembly of the mapping catheter according to claim 5, characterized in that: The fixing member includes two assembled bodies, which are assembled and connected along the second direction; the bolt-fitting member includes two bolts respectively connected to the two assembled bodies, and the two bolts are combined with each other as the two assembled bodies are assembled and connected to form the transverse flow channel isolated from the accommodating cavity.

7. The fixing assembly of the mapping catheter according to claim 6, characterized in that: The two bolt bodies are internally and externally joined or radially spliced.

8. The fixing assembly of the mapping catheter according to claim 6, characterized in that: The fixing member has a perfusion inlet flow channel opened along the first direction, and the perfusion inlet flow channel is arranged in communication with one of the perfusion outlet flow channels; and / or; The fixing member also includes an end cover, which is sleeved outside the two assembled bodies along the first direction, and is respectively enclosed with the two assembled bodies to form two chambers located on both sides of the accommodating cavity, each of which is connected to at least one of the perfusion outlet flow channels; the distal surface of the end cover has a plurality of through perfusion holes, and each of the chambers is respectively connected to more than two of the perfusion holes.

9. The fixing assembly of the mapping catheter according to claim 1, characterized in that: A projection of the bolting member along the first direction overlaps with at least a portion of the electrode fixing hole.

10. A mapping catheter, characterized in that: A fixing assembly comprising a mapping catheter according to any one of claims 1 to 9, further comprising a mapping electrode assembly, wherein the mapping electrode assembly comprises a plurality of electrode branches.

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