Fixing assembly of mapping catheter and mapping catheter

Abstract

The utility model 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] This utility model relates to the field of medical device technology, and in particular to a fixation component and a mapping catheter. Background Technology

[0002] Catheter ablation is currently one of the effective treatments for atrial fibrillation. Mapping catheters are important tools for physicians to trace the source of atrial fibrillation and develop ablation plans. To achieve efficient and rapid mapping, various high-density mapping catheters have been developed, with multiple electrode branches at the distal end, each containing multiple mapping electrodes. High-density mapping catheters offer significant advantages in improving diagnostic accuracy and target identification efficiency.

[0003] The placement of far-field electrodes can improve signal quality, enhance positioning accuracy, improve imaging, and enhance anti-interference capabilities for high-density mapping catheters, providing stronger support for the diagnosis and treatment of complex arrhythmias.

[0004] However, far-field electrodes need to be isolated from heart tissue during application. In the prior art, far-field electrodes are generally placed in the center of the catheter and bound to the perfusion channel. This requires the catheter to have a central perfusion channel, which greatly limits the cross-sectional design of the catheter and also limits the layout of the electrode branches. Utility Model Content

[0005] The purpose of this invention is to provide a fixing component for a mapping catheter and a mapping catheter to solve the problem of limited far-field electrode layout in existing mapping catheters.

[0006] To solve the above-mentioned technical problems, this utility model provides a fixing component for a mapping catheter, used to fix the electrode branch of the mapping catheter. The fixing component includes: a fastening component and a fixing component.

[0007] 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 an electrode branch to pass through one end of the opening;

[0008] The fastening member extends along a second direction at an angle to the first direction and is disposed through the receiving cavity to engage with at least a portion of the electrode branches that penetrate the receiving cavity, thereby defining the position of at least a portion of the electrode branches.

[0009] Optionally, the fixing member further has a plurality of electrode fixing holes, which are disposed along the first direction at the end of the receiving cavity away from the opening and communicate with the receiving cavity; the electrode fixing holes are adapted to the electrode branches for receiving and fixing the electrode branches passing through the receiving cavity.

[0010] Optionally, the fastener includes two assembled bodies that are joined together 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.

[0011] Optionally, the plurality of electrode fixing holes are divided into two rows along the second direction;

[0012] 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 number of the two rows of electrode fixing holes is different.

[0013] Optionally, the fastener has at least two injection outlet channels opened along the first direction, and at least two of the injection outlet channels are located on both sides of the receiving cavity along the second direction; the fastener has a transverse channel extending along the second direction; and at least two of the injection outlet channels are connected through the transverse channel.

[0014] Optionally, the fastener includes two assembled bodies that are joined together along the second direction; the fastener includes two bolts that are respectively connected to the two assembled bodies, and the two bolts combine with each other as the two assembled bodies are joined together to form the transverse flow channel isolated from the accommodating cavity.

[0015] Optionally, the two thrombi can be joined together internally or radially.

[0016] Optionally, the fastener has an injection inlet channel extending along the first direction, the injection inlet channel being arranged in communication with one of the injection outlet channels; and / or;

[0017] The fixing component also includes an end cap, which is sleeved on the two assembled bodies along the first direction and forms two chambers located on both sides of the receiving cavity with the two assembled bodies respectively. Each chamber is connected to at least one infusion outlet channel. The distal end face of the end cap has multiple through infusion holes, and each chamber is connected to two or more infusion holes respectively.

[0018] Optionally, the projection of the fastener along the first direction overlaps with at least a portion of the electrode fixing holes.

[0019] To solve the above-mentioned technical problems, the present invention also provides a mapping catheter, which includes a fixing component of the mapping catheter as described above, and a mapping electrode assembly, wherein the mapping electrode assembly includes multiple electrode branches.

[0020] In summary, in the mapping catheter fixing assembly and mapping catheter provided by this utility model, the mapping catheter fixing assembly is used to fix the electrode branches of the mapping catheter. The fixing assembly includes a fastening member and a fixing member. The fixing member has a receiving cavity arranged along a first direction, and the receiving cavity has an opening at one end along the first direction. The receiving cavity is used for the electrode branch to pass through from one end of the opening. The fastening member extends along a second direction at an angle to the first direction and is disposed through the receiving cavity, for engaging with at least a portion of the electrode branch that passes through the receiving cavity, thereby defining the position of at least a portion of the electrode branch.

[0021] This configuration, through the setting of the thimble, limits the electrode branches, thereby reducing the structure of the fixing components for securing the electrode branches. More space is left within the limited space of the fixing components for the receiving cavity, allowing for the placement of structures such as far-field electrodes. Furthermore, the receiving cavity protects the far-field electrode housed within, reducing or preventing contact between the far-field electrode and cardiac tissue. The far-field electrode is no longer limited to being placed in the central perfusion channel, providing greater freedom in the cross-sectional design of the mapping catheter and the arrangement of the electrode branches, thus facilitating improvements in the cross-section of the mapping catheter and the layout of the electrode branches. Attached Figure Description

[0022] Those skilled in the art will understand that the accompanying drawings are provided to better understand the present invention and do not constitute any limitation on the scope of the present invention.

[0023] Figure 1 This is a partial side view of the distal end of the mapping catheter according to an embodiment of the present invention.

[0024] Figure 2 This is a perspective view of the distal portion of the mapping catheter according to an embodiment of the present invention.

[0025] Figure 3 yes Figure 2 An enlarged schematic diagram of part A.

[0026] Figure 4 This is a perspective view of the fixing component according to an embodiment of the present utility model.

[0027] Figure 5 This is a remote view of the fixing component according to an embodiment of the present invention.

[0028] Figure 6 This is a near-end view of the fixing component according to an embodiment of the present invention.

[0029] Figure 7 This is a schematic diagram of an assembled component according to an embodiment of the present utility model.

[0030] Figure 8This is a schematic diagram of another assembled component according to an embodiment of the present utility model.

[0031] Figure 9 yes Figure 8 The near-end view of the assembled structure shown.

[0032] Figure 10 This is a schematic diagram of the axial cross-section of the fixing component according to an embodiment of the present invention.

[0033] Figure 11 This is a schematic diagram of the axial cross-section of the fixing component and the measuring electrode component after they are connected according to an embodiment of the present invention.

[0034] Figure 12 yes Figure 11 An enlarged schematic diagram of part B.

[0035] Figure 13 This is a schematic diagram of an assembled body according to another embodiment of the present invention.

[0036] Figure 14 This is a schematic diagram of another assembly according to another embodiment of the present invention.

[0037] Figure 15 This is a perspective view of the fixing component according to another embodiment of the present invention.

[0038] Figure 16 This is a schematic diagram of the axial cross-section of the fixing component according to another embodiment of the present invention.

[0039] Figure 17 This is a schematic diagram of the connection between the fixing component and the measuring electrode component according to another embodiment of the present invention.

[0040] Figure 18 yes Figure 17 An enlarged schematic diagram of part C.

[0041] Figure 19 This is a schematic diagram of the axial cross-section of the fixing component of this utility model after it is connected to another calibration electrode component.

[0042] Figure 20 yes Figure 19 An enlarged schematic diagram of part D.

[0043] In the attached figures: 1-Fixing component; 11-Engineer; 11a, 11b-Engineer body; 12-Fixing component; 12a, 12b-Assembled body; 121-Infusion outlet channel; 122-Infusion inlet channel; 123-Transverse channel; 124-Narrowing section; 13-Accommodation cavity; 14-Electrode fixing hole; 15-End cap; 151-Cavity; 152-Infusion hole; 2-Far-field electrode; 3-Mapping electrode assembly; 30-Electrode branch; 31-Fixing section; 32-Clamping section; 33-U-shaped component; 34-Connecting part; 35-Mapping electrode; 4-Catheter body. Detailed Implementation

[0044] To make the objectives, advantages, and features of this utility model clearer, the present utility model will be further described in detail below with reference to 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 facilitate and clarify the explanation of the objectives of the embodiments of this utility model. Furthermore, the structures shown in the drawings are often part of the actual structure. In particular, different drawings may emphasize different aspects and sometimes use different scales.

[0045] As used herein, the singular forms “a,” “an,” “one,” and “the” include plural objects; the term “or” is generally used to mean “and / or”; the term “a number” is generally used to mean “at least one”; and the term “at least two” is generally used to mean “two or more”. Furthermore, the terms “first,” “second,” and “third” are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined as “first,” “second,” or “third” may explicitly or implicitly include one or at least two of that feature; “one end” and “the other end,” and “proximal end” and “distal end” generally refer to two corresponding parts, including not only the endpoints. The terms “proximal end” and “distal end” are defined herein in relation to a mapping catheter having an end for insertion into the human body and a control end extending outside the body. The term "proximal" refers to the position closer to the manipulatory end of the mapping catheter protruding from the body, and the term "distal" refers to the position closer to the end of the mapping catheter inserted into the body and therefore further away from the manipulatory end of the mapping catheter. Optionally, in manual or hand-operated applications, the terms "proximal" and "distal" are defined herein relative to the operator, such as a surgeon or clinician. The term "proximal" refers to the position closer to the operator, and the term "distal" refers to the position closer to the mapping catheter and therefore further away from the operator. Furthermore, as used in this invention, "installed," "connected," "joined," and "set" of one element on another element should be interpreted broadly, generally indicating only a connection, coupling, cooperation, or transmission relationship between the two elements, which can be direct or indirect through an intermediate element, and should not be construed as indicating or implying a spatial positional relationship between the two elements, i.e., one element can be located inside, outside, above, below, or to one side of the other element, unless otherwise expressly stated. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances. Furthermore, directional terms such as above, below, up, down, upward, downward, left, right, etc., are used relative to exemplary embodiments as they are shown in the figures, with upward or up direction pointing towards the top of the corresponding figure, and downward or down direction pointing towards the bottom of the corresponding figure.

[0046] The purpose of this invention is to provide a fixing component for a mapping catheter and the mapping catheter itself, so as to solve the problem of limited far-field electrode layout in existing mapping catheters. The following description refers to the accompanying drawings.

[0047] Please refer to Figures 1 to 3This utility model provides a mapping catheter, which includes: a fixation component 1, a far-field electrode 2, and a mapping electrode assembly 3; the mapping electrode assembly 3 includes multiple flexible electrode branches 30, the proximal ends of which converge and are fixed to the fixation component 1. Each electrode branch 30 is provided with multiple mapping electrodes 35. Thus, the multiple mapping electrodes 35 on the multiple electrode branches 30 constitute a high-density electrode array.

[0048] During mapping of the target area of ​​the heart, the mapping electrode assembly 3 is attached to different areas of the heart tissue, and the flexible electrode branches 30 directly contact the heart tissue, allowing the mapping electrode 35 to acquire intracardiac electrical signals. However, the signals acquired by the mapping electrode 35 also contain other interfering signals, such as far-field signals from blood or other tissue areas. Therefore, a far-field electrode 2, which does not directly contact the heart tissue, can be used to collect electrocardiogram signals conducted in the blood from areas far from the contacted tissue, i.e., far-field signals, thereby supplementing the signals acquired by the mapping electrode assembly 3 and eliminating signal interference during the procedure.

[0049] In some embodiments, the far-field electrode 2 may be disposed in the proximal region of the electrode branch 30. To ensure that the collected far-field signal is more accurate and stable, the far-field electrode 2 should not be in contact with cardiac tissue.

[0050] Based on the above research, please refer to Figures 4 to 12 This embodiment provides a fixing assembly 1 for a mapping catheter, used to fix the electrode branch 30 of the mapping catheter. The fixing assembly 1 includes: a fastening member 11 and a fixing member 12; the fixing member 12 has a first direction ( Figure 4 and Figure 10 The receiving cavity 13 is arranged in the horizontal direction, and one end (far end) of the receiving cavity 13 along the first direction is provided. Figure 4 and Figure 10 The middle (right end) has an opening; please refer to the reference. Figure 2 , Figure 3 , Figures 10 to 12 The accommodating cavity 13 is used for the electrode branch 30 to pass through one end of the opening; the fastening member 11 is along a second direction at an angle to the first direction ( Figure 10 The middle is the vertical direction. Figure 11 and Figure 12 The electrode branch 30 extends (in the direction perpendicular to the paper) and is disposed in the receiving cavity 13 to engage with at least a portion of the electrode branch 30 that penetrates the receiving cavity 13, thereby defining the position of at least a portion of the electrode branch 30.

[0051] In an alternative example, the fastener 12 extends along the first direction, i.e., the axis of the fastener 12 is arranged along the first direction. It should be noted that the angle between the second direction and the first direction can be not less than 60°, preferably not less than 75°, for example, it can be 80°, 85° or 90°, etc. The closer the angle is to 90°, the better the limiting effect of the fastener 11 on the electrode branch 30. Therefore, the second direction is preferably perpendicular to the first direction.

[0052] This configuration, through the setting of the fastening member 11, limits the electrode branch 30, thereby reducing the structure of the fixing member 12 for fixing the electrode branch 30 (such as reducing the fixing hole, see the description below). More space is left in the limited space of the fixing member 12 for the receiving cavity 13, allowing structures such as the far-field electrode 2 to be placed in the receiving cavity 13. Furthermore, the receiving cavity 13 can protect the far-field electrode 2 housed within it, reducing or preventing the far-field electrode 2 from contacting cardiac tissue. This means the far-field electrode 2 is no longer limited to being placed in the perfusion channel at the center, providing freedom in the cross-sectional design of the mapping catheter and the arrangement of the electrode branches 30, which is beneficial for improving the cross-section of the mapping catheter and the layout of the electrode branches 30.

[0053] For further information, please refer to the following: Figures 4 to 10 The fixing member 12 also has a plurality of electrode fixing holes 14, which are disposed along the first direction at the end of the receiving cavity 13 away from the opening (proximal end). Figure 4 and Figure 10 The middle section is the left end, and it communicates with the receiving cavity 13; the electrode fixing hole 14 is adapted to the electrode branch 30 and is used to receive and fix the electrode branch 30 that passes through the receiving cavity 13. Please refer to... Figure 12 Optionally, the electrode branch 30 further includes a fixing segment 31 located at its proximal end, the cross-sectional shape of which preferably matches the cross-sectional shape of the electrode fixing hole 14. After passing through the receiving cavity 13, the fixing segment 31 of the electrode branch 30 passes into the electrode fixing hole 14 and is fixed therein. The fixing method may be, for example, a dimensional fit connection or adhesive bonding.

[0054] Understandably, to ensure the mapping catheter's bending performance, the axial length of the fixation member 12 is limited. If the axial length of the fixation member 12 is too long, it will be difficult for it to pass through some blood vessels with large curvatures. The aforementioned tethering member 11 can effectively limit the electrode branch 30, thereby relatively reducing the axial length of the electrode fixing hole 14. Within the limited axial length of the fixation member 12, the axial length of the receiving cavity 13 can be set relatively larger, forming a deeper cavity. This allows most or all of the far-field electrode 2 to be received in the receiving cavity 13. The cavity wall of the receiving cavity 13 forms a shielding protection for the far-field electrode 2, reducing or avoiding exposure of the far-field electrode 2 and direct contact with cardiac tissue.

[0055] Please refer to Figures 5 to 9 Optionally, the fixing member 12 includes two splicing bodies 12a and 12b, which are spliced ​​together along the second direction. At least a portion of the electrode fixing hole 14 is divided into two half-holes along its own axial direction, with each half-hole located on one of the splicing bodies 12a and 12b. The arrangement of the two splicing bodies 12a and 12b creates a two-part combined structure for the fixing member 12. During installation, the electrode fixing hole 14 is formed by splicing the two splicing bodies 12a and 12b together along the second direction, thereby fixing the electrode branch 30 within it. Simultaneously, since the fastening member 11 also extends along the second direction, it can easily form a concave-convex fit with the electrode branch 30 when spliced ​​together with the two splicing bodies 12a and 12b. It should be noted that this embodiment only limits the fastener 12 to include two assembled bodies 12a and 12b connected along the second direction, but does not limit the fastener 12 to consist only of these two assembled bodies 12a and 12b. In practice, the fastener 12 may also include assembled bodies assembled in other directions. Some electrode fixing holes 14 may also be further formed by these assembled bodies assembled in other directions, individually or collectively.

[0056] 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. Please refer to... Figure 5 It shows an exemplary example containing six electrode fixing holes 14, where 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 along a second direction ( Figure 5 Arranged in a vertical direction (center).

[0057] Studies have found that the accuracy of the ECG signals collected is higher when the mapping electrode assembly 3 extends in a roughly planar shape compared to radial or basket-like extensions. Therefore, it is preferable to configure the mapping electrode assembly 3 in a roughly planar extension configuration. To maintain planar extension, ideally, the proximal ends (the parts connected to the fixation member 12) of the multiple electrode branches 30 of the mapping electrode assembly 3 should also be arranged in a straight line. However, considering the interventional performance of the fixation member 12, its diameter cannot be too large. Similarly, considering the strength and performance of the mapping electrode assembly 3, the diameter of each electrode branch 30 cannot be too small. This makes it somewhat difficult to arrange the proximal ends of the multiple electrode branches 30 in a straight line within the limited diameter of the fixation member 12.

[0058] Based on this, in this embodiment, the electrode fixing holes 14 are preferably divided into two rows. A portion of the electrode branches 30 can be fixed in one row of electrode fixing holes 14, and the other portion of the electrode branches 30 can be fixed in the other row of electrode fixing holes 14. The distal ends of all electrode branches 30 can be on the same plane. (Refer to...) Figure 1 At this point, the entire calibration electrode assembly 3 appears as two planes from the side, but the included angle between the two planes is relatively small and can be basically ignored. Therefore, the entire calibration electrode assembly 3 can still be roughly regarded as extending along a plane. Thus, by dividing the electrode fixing holes 14 into two rows, the problem of maintaining the calibration electrode assembly 3 in a roughly planar extension shape is solved, and a larger number of electrode fixing holes 14 can be arranged within the limited diameter of the fixing member 12, thereby meeting the requirement of a larger number of electrode branches 30.

[0059] Optionally, the two rows of electrode fixing holes 14 may have different numbers. For example, in Figure 5 In the illustrated example, the number of electrode fixing holes 14 in the two rows are 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 test electrode assembly 3, the number of electrode fixing holes 14 can be selected from four to eight, preferably six. Preferably, each row of electrode fixing holes 14 has no more than four.

[0060] Furthermore, the four electrode fixing holes 14 in a row are located precisely on the mating surfaces of the two assembled bodies 12a and 12b. Specifically, since the centers of the two rows of electrode fixing holes 14 are located precisely at the center of the entire fixing component 12, the four electrode fixing holes 14 in a row are actually off-center. Therefore, the two assembled bodies 12a and 12b are unevenly spaced (i.e., the two assembled bodies are asymmetrically arranged), with assembled body 12a being relatively smaller and assembled body 12b being relatively larger. The mating surface of both penetrates precisely through the center of the four electrode fixing holes 14 (a, b, c, d). Arranging the row of electrode fixing holes 14 with more holes as half-holes facilitates assembly and positioning.

[0061] It needs to be explained that, Figure 5 The illustrated example is merely one example of the fixing member 12 and not a limitation thereof. In other embodiments, the fixing member 12 may include a different number of electrode fixing holes 14, or the electrode fixing holes 14 may be arranged in different numbers. This embodiment is not limited in this respect. Furthermore, the number of electrode fixing holes 14 is not limited to a one-to-one correspondence with the number of electrode branches 30. The number of electrode fixing holes 14 may be greater than the number of electrode branches 30, meaning that some electrode fixing holes 14 may be left unused. For example… Figure 5 The illustrated example includes six electrode fixing holes 14, but four of them can be used to house electrode branches 30, while the other two remain empty. Furthermore, the mating surfaces of the two composite bodies 12a and 12b are not limited to being planar; for example, they can also be curved surfaces. Correspondingly, the row of electrode fixing holes 14 arranged as half-hole composite bodies is also arranged along the curved surface.

[0062] Because the mapping catheter in this embodiment contains a high-density electrode array and a large number of mapping electrodes 35, it requires a relatively large amount of perfusion fluid (such as saline) to reduce or avoid thrombus formation. Therefore, please refer to [further details needed]. Figures 4 to 10 Optionally, the fixing member 12 has at least two injection outlet channels 121 opened along the first direction, and the at least two injection outlet channels 121 are located on both sides of the receiving cavity 13 along the second direction; the fastening member 11 has a transverse channel 123 extending along the second direction; the at least two injection outlet channels 121 are connected through the transverse channel 123.

[0063] Furthermore, the infusion inlet channel 122 and one of the infusion outlet channels 121 are arranged in a continuous manner. In this way, after the infusion fluid flows in through the infusion inlet channel 122, it can be diverted via the transverse channel 123 and finally flow out from at least two infusion outlet channels 121, forming bilateral infusion of the calibration electrode assembly 3, reducing the possibility of thrombosis due to the complex branching morphology of the electrode branches 30. Preferably, the fixing member 12 includes only one infusion inlet channel 122, which is preferably eccentrically arranged. It should be noted that the infusion inlet channel 122 and the infusion outlet channel 121 are arranged in a continuous manner along the axial direction of the fixing member 12, and it is not limited that the cross-sections of the infusion inlet channel 122 and the infusion outlet channel 121 must be the same; as long as their cross-sections overlap, they can be considered directly connected. Furthermore, since the transverse flow channel 123 is formed in the fastener 11, the fastener 11 can not only be used to define the position of the electrode branch 30, but also to connect the infusion outlet flow channel 121 located on both sides of the accommodating cavity 13, making the fastener 11 a multi-purpose component and further improving the compactness of the entire fixing assembly 1.

[0064] Please refer to Figure 4and in conjunction with references Figures 1 to 3 In one example, the proximal end of the fixing member 12 includes a constricted section 124, which can be inserted into the catheter body 4 to form a connection. Due to the limited cross-sectional diameter of the catheter body 4 of the mapping catheter, it is necessary to arrange the wires for multiple mapping electrodes 35 corresponding to the mapping electrode assembly 3, as well as the bending control wires for manipulating the bending of the adjustable bend. In addition to various sheaths, there is insufficient space within the cross-section of the catheter body 4 of the mapping catheter to accommodate more than two infusion channels. Based on the aforementioned analysis, providing two or more infusion outlet channels 121 at the distal end of the fixing member 12 is beneficial for improving the infusion effect. Therefore, this embodiment uses the transverse flow channel 123 to divert the infusion channels within the fixing member 1, simultaneously resolving the conflict between a single proximal channel and multiple distal branch outlets in the infusion pathway.

[0065] Please continue to refer to this. Figures 4 to 10 Optionally, the fastening member 11 includes two bolts 11a and 11b respectively connected to the two assembled bodies 12a and 12b. The two bolts 11a and 11b combine with each other as the two assembled bodies 12a and 12b are assembled and connected, forming the transverse flow channel 123 isolated from the accommodating cavity 13. Figure 7 and Figure 8 As shown, in one embodiment, the thrombus 11a is disposed on the assembly 12a, and the thrombus 11b is disposed on the assembly 12b. When the two assemblies 12a and 12b are assembled and connected, the two thrombuses 11a and 11b can be combined with each other.

[0066] Please refer to Figures 7 to 10 Optionally, the two plugs 11a and 11b are fitted together. In an alternative example, each of the two assembled bodies 12a and 12b is provided with an infusion outlet channel 121. The plugs 11a and 11b each have an inner cavity communicating with the infusion outlet channel 121 along a second direction, and the inner contour shape of the inner cavity of the plug 11b is adapted to the outer contour shape of the plug 11a. When the two assembled bodies 12a and 12b are joined, the plug 11a can be inserted into the inner cavity of the plug 11b, forming a tight fit. The inner cavity of the plug 11a is thus isolated from the receiving cavity 13 and can be configured as a transverse flow channel 123. It is understood that in some embodiments, the length of the plug 11a along the second direction may be slightly shorter, in which case the inner cavity of the plug 11a can together with the inner cavity of the plug 11b to form the transverse flow channel 123.

[0067] Optionally, in other embodiments, the two plugs 11a and 11b may also be radially joined (meaning joined perpendicular to the second direction). For example, the cross-sections of the two plugs 11a and 11b are respectively C-shaped. When they are joined and connected with the two assembled bodies 12a and 12b, they are joined radially and sealed together, and the internal space enclosed by the two C-shapes forms the transverse flow channel 123. In other embodiments, the two plugs 11a and 11b may also be axially joined (meaning joined along the second direction). In this case, the axial joining surfaces of the two plugs 11a and 11b can be sealed, for example, by a flange or a sealing ring.

[0068] Please refer to Figure 5 , Figure 6 , Figure 11 and Figure 12 Optionally, the projection of the fastening member 11 along the first direction overlaps with at least a portion of the electrode fixing holes 14. In one embodiment, the electrode branch 30 includes a locking section 32, which has a C-shaped notch in its cross-section along the first direction. The shape of the C-shaped notch preferably matches the cross-sectional shape of the fastening member 11 along the second direction. Because the projection of the fastening member 11 along the first direction overlaps with the electrode fixing holes 14, the fastening member 11 can be inserted into the C-shaped notch of the locking section 32, forming a concave-convex locking fit. Since both ends of the C-shaped notch of the locking section 32 are locked by the fastening member 11, the electrode branch 30 cannot move along the first direction. Further, the fixing section 31 located near the end of the locking section 32 is inserted into the electrode fixing hole 14, and subsequently fixed by, for example, glue injection, to further limit the electrode branch 30. Optionally, the C-shaped notch of the locking section 32 can also be fixed with the fastening member 11 by glue.

[0069] Please refer to Figures 13 to 18In another embodiment, the fixing member 12 includes two assembled bodies 12a and 12b, and also includes an end cap 15. The end cap 15 is fitted over the assembled two assembled bodies 12a and 12b along the first direction, and together with the two assembled bodies 12a and 12b, forms two chambers 151 located on both sides of the receiving cavity 13. Each chamber 151 communicates with at least one infusion outlet channel 121. The distal end face of the end cap 15 has multiple through infusion holes 152, and each chamber 151 communicates with two or more infusion holes 152. Optionally, the assembled bodies 12a and 12b have a recessed step on their distal side. When the end cap 15 is fitted over the assembled bodies 12a and 12b, it is sealed to the outer periphery of the assembled bodies 12a and 12b, thereby closing the recessed step and enclosing the chamber 151. With this configuration, the infusion fluid enters the chamber 151 through the infusion outlet channel 121 and can be ejected from multiple infusion holes 152. The multiple infusion holes 152 can increase the infusion density and flow rate, achieving the effect of bilateral microporous saline infusion.

[0070] This utility model embodiment also provides a mapping catheter, which includes a fixing component 1 of the mapping catheter as described above, and a mapping electrode assembly 3, wherein the mapping electrode assembly 3 includes a plurality of electrode branches 30. Several embodiments are described below.

[0071] Please refer to Figure 11 and in conjunction with references Figure 2 In one embodiment, the mapping electrode assembly 3 includes two U-shaped members 33, which have a certain degree of flexibility and self-recovery. They can be compressed or folded into the delivery sheath during delivery and released after being delivered to the target location (such as the heart), thereby expanding back to their initial shape.

[0072] The two U-shaped components 33 are of different sizes and are roughly arranged inside and outside each other. The closed end of the U-shaped component 33 faces the distal end, and the vertex region of the closed end of the U-shaped component 33 is connected and fixed by the connecting block 34. The two open ends of each U-shaped component 33 are regarded as two electrode branches 30, and are bent towards the proximal end and fixed to the fixing component 1.

[0073] For further details, please refer to the following references. Figure 5Two electrode branches 30 of one U-shaped component 33 are inserted into a row of electrode fixing holes 14 (holes b and c), and two electrode branches 30 of the other U-shaped component 33 are 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. These four electrode fixing holes 14 overlap with the projection of the fastening member 11, so the four electrode branches 30 of the two U-shaped components 33 can be limited by the fastening member 11. At this time, the side of the entire calibration electrode assembly 3 is as shown... Figure 1 As shown, it extends in a roughly planar shape.

[0074] Please refer to Figures 17 to 20 In another embodiment, the mapping electrode assembly 3 includes three U-shaped members 33, which are labeled 33a, 33b, and 33c for ease of description. U-shaped members 33a and 33b are relatively large (meaning the distance between their two sides is relatively large), and they are staggered and intersect at their closed ends. The intersecting portion of U-shaped members 33a and 33b is then fixed by a connecting block 34. U-shaped member 33c is relatively small (meaning the distance between its two sides is relatively small), and its two sides are located inside the inner sides of U-shaped members 33a and 33b. The closed end of U-shaped member 33c can also be fixed by the connecting block 34. With this configuration, the entire mapping electrode assembly 3 extends in a generally planar shape.

[0075] For further details, please refer to the following references. Figure 5 In this configuration, the two electrode branches 30 of U-shaped component 33a are inserted into holes a and c, respectively; the two electrode branches 30 of U-shaped component 33b are inserted into holes b and d, respectively; and the two electrode branches 30 of U-shaped component 33c are inserted into holes e and f, respectively. It is understandable that both electrode branches 30 of U-shaped component 33c are limited by the fastener 11 at this time. Although each of U-shaped components 33a and 33b has one electrode branch 30 limited by the fastener 11, this limited electrode branch 30 can exert a linkage limiting effect on the other electrode branch 30 that is not limited by the fastener 11, thus also providing a certain degree of limitation for the entire U-shaped components 33a and 33b.

[0076] In another alternative embodiment, the mapping electrode assembly 3 includes two U-shaped members 33, which are connected to... Figure 19 and Figure 20 Similar to the U-shaped components 33a and 33b in the illustrated embodiment, the four branches 30 of the two U-shaped components 33 are arranged intersectingly in the same row of four electrode fixing holes 14, and... Figure 19 and Figure 20The difference in the illustrated embodiment is that the U-shaped member 33c is not provided.

[0077] It should be noted that the above examples are merely demonstrations of the mapping electrode assembly 3, and not limitations thereof. In other embodiments, the mapping electrode assembly 3 is not limited to including a number of U-shaped members 33. The mapping electrode assembly 3 may also have a mesh structure, a multi-branch structure, a basket structure, or a star structure, etc. Those skilled in the art can configure the shape of the mapping electrode assembly 3 differently according to actual needs.

[0078] In summary, in the mapping catheter fixation assembly and mapping catheter provided by this utility model, the mapping catheter fixation assembly is used to fix the electrode branches of the mapping catheter. The fixation assembly includes a fastening member and a fixing member. The fixing member has a receiving cavity arranged along a first direction, and the receiving cavity has an opening at one end along the first direction. The receiving cavity is used for the electrode branch to pass through the opening. The fastening member extends along a second direction at an angle to the first direction and is disposed through the receiving cavity, for engaging with at least a portion of the electrode branch inserted into the receiving cavity to limit the position of at least a portion of the electrode branch. With this configuration, the electrode branch can be limited by the fastening member, thereby reducing the structure of the fixing member for fixing the electrode branch. More space is left in the limited space of the fixing member for the receiving cavity, thereby allowing the installation of structures such as far-field electrodes. Furthermore, the receiving cavity can protect the far-field electrode housed therein, reducing or preventing the far-field electrode from contacting the heart tissue. Far-field electrodes are no longer limited to the perfusion channel that must be placed in the center, which brings freedom to the cross-sectional design of the mapping catheter and the arrangement of electrode branches, which is conducive to improving the cross-section of the mapping catheter and the layout of electrode branches.

[0079] It should be noted that the above embodiments can be combined with each other. The above description is only a description of preferred embodiments of the present utility model and is not intended to limit the scope of the present utility model in any way. Any changes or modifications made by those skilled in the art based on the above disclosure shall fall within the protection scope of the present utility model.

Claims

1. A fixing assembly for a mapping catheter, used to fix the electrode branches of the mapping catheter, characterized in that, The fixing assembly includes: a fastening element and a fixing element; 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 an electrode branch to pass through one end of the opening; The fastening member extends along a second direction at an angle to the first direction and is disposed through the receiving cavity to engage with at least a portion of the electrode branches that penetrate the receiving cavity, thereby defining the position of at least a portion of the electrode branches.

2. The fixation assembly for the mapping catheter according to claim 1, characterized in that, The fixing member also has a plurality of electrode fixing holes, which are disposed along the first direction at the end of the receiving cavity away from the opening and communicate with the receiving cavity; the electrode fixing holes are adapted to the electrode branches and are used to receive and fix the electrode branches passing through the receiving cavity.

3. The fixation assembly for the mapping catheter according to claim 2, characterized in that, The fastener includes two assembled bodies that are joined together 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.

4. The fixation assembly for 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 number of the two rows of electrode fixing holes is different.

5. The fixation assembly for the mapping catheter according to claim 1, characterized in that, The fastener has at least two injection outlet channels opened along the first direction, and at least two of the injection outlet channels are located on both sides of the receiving cavity along the second direction; the fastener has a transverse channel extending along the second direction; and at least two of the injection outlet channels are connected through the transverse channel.

6. The fixation assembly for the mapping catheter according to claim 5, characterized in that, The fastener includes two assembled bodies that are joined together along the second direction; the fastener includes two bolts that are respectively connected to the two assembled bodies. The two bolts combine with each other as the two assembled bodies are joined together, forming the transverse flow channel that is isolated from the accommodating cavity.

7. The fixation assembly for the mapping catheter according to claim 6, characterized in that, The two thrombi are joined together internally or radially.

8. The fixation assembly for the mapping catheter according to claim 6, characterized in that, The fastener has an injection inlet channel extending along the first direction, the injection inlet channel being arranged in communication with one of the injection outlet channels; and / or; The fixing component also includes an end cap, which is sleeved on the two assembled bodies along the first direction and forms two chambers located on both sides of the receiving cavity with the two assembled bodies respectively. Each chamber is connected to at least one infusion outlet channel. The distal end face of the end cap has multiple through infusion holes, and each chamber is connected to two or more infusion holes respectively.

9. The fixation assembly for the mapping catheter according to claim 2, characterized in that, The projection of the fastener along the first direction overlaps with at least a portion of the electrode fixing holes.

10. A mapping catheter, characterized in that, The device includes a fixation assembly for the mapping catheter according to any one of claims 1 to 9, and further includes a mapping electrode assembly, wherein the mapping electrode assembly includes a plurality of electrode branches.

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