Mapping catheter and intervention system

Abstract

The invention provides a mapping catheter and an intervention system. The mapping catheter comprises an electrode section, a magnetic conduction section, a supporting section and a handle which are sequentially connected from the far end to the near end. The electrode section comprises a plurality of branch arms, and each branch arm is sleeved with a plurality of first electrodes used for obtaining electric signals; the magnetic conduction section comprises a magnet assembly used for at least driving the electrode section to move and / or bend in the preset direction under the action of a magnetic field. Compared with the prior art, the magnetic navigation is realized by using the magnet assembly. Namely, the change of the magnetic field direction is utilized to drive the electrode section to point to different directions or advance to different positions in the cavity, so that the displacement accuracy and the bending flexibility of the electrode section can be improved; and moreover, the attaching stability of the electrode section to the measured tissue is effectively improved, the electrode section is facilitated to obtain accurate mapping signals, a corresponding fixed bending shape does not need to be selected according to the size of the cardiac cavity of a patient before an operation, the bending shape matching difficulty is reduced, and the applicable range of the mapping catheter is widened.

Description

Technical Field

[0001] The present invention relates to the technical field of medical device preparation, and in particular to a mapping catheter and an interventional system. Background Art

[0002] An electrophysiological catheter is a tool used to measure and record electrical signals in a living body, and has been widely used in the fields of medicine, biology, and neuroscience. Among them, a mapping catheter is a type of electrophysiological catheter, which extracts electrical signals by attaching several electrodes on the distal branch to the surface of the heart cavity, and can also be used in conjunction with a three-dimensional cardiac electrophysiological mapping system to model the heart cavity. However, in order to be able to mark the complete cardiac electrophysiological activity and to fully model the heart cavity, the distal end of the mapping catheter needs to be able to reach any part of the heart cavity. In this regard, the prior art is to pre-bend the distal end of the mapping catheter into a specific bend, and then cooperate with operations such as pushing and twisting to reach various parts of the heart cavity. However, this method requires a high level of control from the operator, and the bend at the distal end of the mapping catheter is fixed, and the corresponding bend specifications need to be selected according to the size of the patient's heart cavity before surgery.

[0003] Therefore, a new mapping catheter is urgently needed to solve the above technical problems. Summary of the invention

[0004] The object of the present invention is to provide a mapping catheter and an interventional system to solve at least one of the problems of how to improve the flexibility of the distal bending of the mapping catheter, how to improve the mapping efficiency of the mapping catheter, and how to improve the signal acquisition accuracy of the mapping catheter.

[0005] In order to solve the above technical problems, the present invention provides a mapping catheter, comprising an electrode segment, a magnetic guide segment, a support segment and a handle connected in sequence from the distal end to the proximal end; wherein the electrode segment comprises a plurality of branch arms, and each of the branch arms is provided with a plurality of first electrodes for acquiring electrical signals; the magnetic guide segment comprises a magnet assembly for at least driving the electrode segment to move and / or bend in a preset direction under the action of a magnetic field.

[0006] Optionally, in the mapping catheter, the magnet assembly includes a plurality of magnets, and the plurality of magnets are arranged in sequence from the distal end to the proximal end.

[0007] Optionally, in the mapping catheter, the magnetic guide segment also includes a first sleeve, a plurality of second electrodes and a plurality of wires; wherein the first sleeve is sleeved on the proximal end of the electrode segment and the outer surface of the plurality of magnets; the plurality of second electrodes are arranged on the outer surface of the first sleeve, and each of the second electrodes is connected to at least one of the wires, and the wires pass through the first sleeve and part of the magnets, and are led out through the support segment and the handle.

[0008] Optionally, in the mapping catheter, the magnetic guide segment also includes a magnetic sensor; the magnetic sensor is located in the first sleeve and is sleeved on the outer surface of a portion of the magnets; wherein the magnetic sensor is connected to at least one of the wires, and the wires pass through a portion of the magnets and are led out through the support segment and the handle.

[0009] Optionally, in the mapping catheter, the support segment includes a first sub-support segment, a second sub-support segment and a third sub-support segment; the first sub-support segment is connected to the proximal end of the magnetic guide segment and is a flexible structure; the second sub-support segment connects the first sub-support segment and the third sub-support segment, and the stiffness of the second sub-support segment increases from the distal end to the proximal end; the third sub-support segment is connected to the handle, and the stiffness of the third sub-support segment is greater than or equal to the maximum stiffness of the second sub-support segment.

[0010] Optionally, in the mapping catheter, a plurality of magnetic rings are further sleeved on the first sub-support segment, so that under the action of the magnetic field, the support segment cooperates with the movement and / or bending of the electrode segment.

[0011] Optionally, in the mapping catheter, the electrode segment includes a bracket; the distal end of the bracket has a plurality of branch arms, and the proximal end of the bracket is connected to the magnetic guide segment, so that the magnetic guide segment can drive the electrode segment to move and / or bend in a preset direction.

[0012] Optionally, in the mapping catheter, the magnet assembly includes a first magnet, a second magnet and a third magnet; the first magnet, the second magnet and the third magnet are all hollow tubes and are coaxially connected in sequence from the distal end to the proximal end.

[0013] Optionally, in the mapping catheter, the first magnet is coaxially arranged in the cavity of the proximal end of the bracket, and the outer surface of the first magnet has a plurality of positioning posts, the outer surface of the proximal end of the bracket is correspondingly provided with a plurality of positioning grooves, and the positioning posts extend out of the bracket through the positioning grooves; and, the outer surface of the proximal end of the bracket is also provided with a plurality of connecting grooves, each of which is connected to a positioning groove, and the connecting grooves extend along the axial direction of the bracket to the proximal edge of the bracket.

[0014] Optionally, in the mapping catheter, the magnetic guide segment further includes a magnetic sensor, a first sleeve, a second electrode, a wire and a connecting wire; wherein,

[0015] The magnetic sensor is sleeved on the outer surface of the second magnet, the first sleeve is sleeved on the proximal end of the bracket, the magnetic sensor and the outer surface of the third magnet, and one second electrode is sleeved on the outer surface of the opposite ends of the first sleeve respectively; and the magnetic sensor and the second electrode are respectively connected to at least one of the wires to transmit signals through the wires;

[0016] One end of the connecting wire is clamped in the first magnet, and the other end of the connecting wire extends into the handle through the second magnet, the third magnet and the inner cavity of the supporting section.

[0017] Optionally, in the mapping catheter, the electrode segment also includes multiple second sleeves and multiple wires; each of the second sleeves is sleeved on one of the branch arms, and a number of the first electrodes are sleeved on the outer surface of the second sleeve; and each of the first electrodes is connected to at least one of the wires, and the wires pass through the second sleeve and are led out through the magnetic guide segment, the support segment and the handle.

[0018] Optionally, in the mapping catheter, the distribution shapes of the plurality of branch arms include: star shape, mesh shape and claw shape.

[0019] Optionally, in the mapping catheter, the plurality of branch arms extend divergently toward the distal end.

[0020] Optionally, in the mapping catheter, the distal ends of the plurality of branch arms are connected in pairs to form a plurality of frames, and the frames are nested and connected in sequence; or, the plurality of branch arms first diverge toward the distal end and then converge to form a basket-like structure.

[0021] Optionally, in the mapping catheter, the distal ends of the plurality of branch arms are all connected by a distal rod to form a closed mesh structure.

[0022] Optionally, in the mapping catheter, the mapping catheter further includes an irrigation tube; the irrigation tube sequentially passes through the electrode segment, the magnetic guide segment, the support segment and the inner cavity of the handle so as to be able to supply fluid to the distal end.

[0023] Based on the same inventive concept, the present invention also provides an interventional system, including the mapping catheter.

[0024] In summary, the present invention provides a mapping catheter and interventional system. The mapping catheter includes an electrode segment, a magnetic guide segment, a support segment and a handle connected in sequence from the distal end to the proximal end; the electrode segment includes a plurality of branch arms, and each of the branch arms is provided with a plurality of first electrodes for acquiring electrical signals; the magnetic guide segment includes a magnet assembly for at least driving the electrode segment to move and / or bend in a preset direction under the action of a magnetic field. Compared with the prior art, the mapping catheter provided by the present invention is provided with the magnetic guide segment at the distal end to realize magnetic navigation by using the magnet assembly in the magnetic guide segment. That is, the change in the direction of the magnetic field is used to drive the electrode segment to point to different directions or move to different intracavitary positions, which helps to improve the accuracy of the displacement of the electrode segment and the flexibility of bending. At the same time, under the action of magnetic navigation, the stability of the electrode segment against the measured tissue is effectively improved, which is conducive to the electrode segment to obtain more accurate mapping signals and build a more complete and accurate tissue model. In addition, since the mapping catheter provided by the present invention is magnetically navigated and bent, there is no need to select a corresponding fixed-bend mapping catheter according to the size of the patient's heart cavity before surgery, which reduces the difficulty of matching the bend of the mapping catheter and enhances the applicability of the mapping catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] 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.

[0026] Figure 1 Schematic diagram of the structure of the mapping catheter in an embodiment of the present invention.

[0027] Figure 2 Schematic diagram of the structure of the electrode segment in the embodiment of the present invention.

[0028] Figure 3 It is a schematic structural diagram of a star-shaped branch arm in an embodiment of the present invention.

[0029] Figure 4 Schematic diagram of the structure of the claw-shaped branch arm in the embodiment of the present invention.

[0030] Figure 5 It is a structural schematic diagram of a mesh-shaped branch arm in an embodiment of the present invention.

[0031] Figure 6 It is a schematic structural diagram of another mesh-shaped branch arm in an embodiment of the present invention.

[0032] Figure 7 Schematic diagram of the positions of the second sleeve and the first electrode in an embodiment of the present invention.

[0033] Figure 8 In the embodiment of the present invention Figure 7 A-A' cross-sectional view.

[0034] Fig. 9 It is a schematic structural diagram of the magnetic guide segment in an embodiment of the present invention.

[0035] Fig.10 is a cross-sectional view of a first magnet in an embodiment of the present invention.

[0036] Fig.11 is a cross-sectional view of the second magnet and the third magnet in the embodiment of the present invention.

[0037] Fig.12 Schematic diagram of the bending of the mapping catheter in the embodiment of the present invention.

[0038] And, in the attached drawings:

[0039] 10-electrode segment; 101-branch; 1011-branch arm; 1012-proximal end of the bracket; 1012a-positioning groove; 1012b-connection groove; 1012c-first through hole; 102-second sleeve; 1021-fourth through hole; 103-first electrode; 104-fourth wire;

[0040] 20-magnetic guide section; 201-first magnet; 2011-positioning column; 2012-first gap; 2013-second gap; 202-second magnet; 203-third magnet; 2031-third gap; 2032-fourth gap; 204-magnetic sensor; 205-first sleeve; 2051-second through hole; 2052-third through hole; 206-distal second electrode; 207-proximal second electrode; 208-first wire; 209-second wire; 210-third wire; 211-connecting wire; 2111-distal end of connecting wire;

[0041] 30-supporting section; 301-first sub-supporting section; 302-second sub-supporting section; 303-third sub-supporting section;

[0042] 40-handle; 50-irrigation tube; 60-Luer connector; C-magnetic ring. DETAILED DESCRIPTION

[0043] In order to make the purpose, advantages and features of the present invention clearer, the present invention is further described in detail 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. It should also be understood that, unless otherwise specified or indicated, the terms "first", "second", "third" and the like in the specification are only used to distinguish the various components, elements, steps, etc. in the specification, rather than to represent the logical relationship or sequential relationship between the various components, elements, steps, etc. In addition, the definitions of "proximal end" and "distal end" in this specification are: "distal end" usually refers to the end of the medical device that first enters the patient's body during normal operation, while "proximal end" usually refers to the end of the medical device that is close to the operator during normal operation; "axial" usually refers to the direction from one end of the tube body to the other end. In addition, the "several" described in this specification refers to one, two, three or more than four.

[0044] See also Figure 1 The present embodiment provides a mapping catheter, comprising an electrode segment 10, a magnetic guide segment 20, a support segment 30 and a handle 40 connected in sequence from the distal end to the proximal end; wherein the electrode segment 10 comprises a plurality of branch arms 1011, and each of the branch arms 1011 is provided with a plurality of first electrodes 103 for acquiring electrical signals; the magnetic guide segment 20 comprises a magnet assembly for at least driving the electrode segment 10 to move and / or bend in a preset direction under the action of a magnetic field.

[0045] It can be seen that the mapping catheter provided in this embodiment is provided with the magnetic guide segment 20 at the distal end so as to realize magnetic navigation by using the magnet assembly in the magnetic guide segment 20. That is, the electrode segment 10 is driven to point to different directions or move to different intracavitary positions by using the change in the direction of the magnetic field, which helps to improve the accuracy of the displacement of the electrode segment 10 and the flexibility of bending. At the same time, under the action of magnetic navigation, the stability of the electrode segment 10 relative to the measured tissue is effectively improved, which is conducive to the electrode segment 10 to obtain more accurate mapping signals and construct a more complete and accurate tissue model. In addition, since the mapping catheter provided in this embodiment is a magnetic navigation-controlled bending, there is no need to select the corresponding fixed curved mapping catheter according to the size of the patient's heart cavity before surgery, which reduces the difficulty of matching the bending shape of the mapping catheter and enhances the applicable scope of the mapping catheter.

[0046] The following is combined with Figures 1 to 12 The mapping catheter provided in this embodiment is specifically described.

[0047] Please continue reading Figure 1The mapping catheter provided in this embodiment includes an electrode segment 10, a magnetic guide segment 20, a support segment 30 and a handle 40 which are connected in sequence from the distal end to the proximal end. The electrode segment 10 is used to approach and adhere to the tissue to be measured to obtain the corresponding electrophysiological signal. The magnetic guide segment 20 is used to cooperate with the external magnetic navigation system to control the movement and / or bending of the electrode segment 10 in a preset direction. The support segment 30 is used to at least support the electrode segment 10 and the magnetic guide segment 20. The handle 40 is used to facilitate the operator to hold and manipulate the mapping catheter. It should be noted that this embodiment does not limit the specific connection method between the segments of the mapping catheter, and optional connection methods include welding, bonding, sleeve connection or clamping.

[0048] For details, please refer to Figure 1 and Figure 2 , the electrode segment 10 includes: a bracket 101, a second sleeve 102, a first electrode 103 and a wire. Among them, the bracket 101 is the supporting skeleton of the electrode segment 10, and its material is preferably a metal material with shape memory function, so that the electrode segment 10 has better softness, which is convenient for attachment to the measured tissue to obtain accurate electrophysiological signals. Furthermore, the distal end of the bracket 101 is laser cut into a plurality of branch arms 1011, which are used to carry the first electrode 103 and expand the signal acquisition range; the proximal end of the bracket 101 is in the shape of a hollow tube, and is connected to the distal end of the magnetic guide segment 20, so that the magnetic guide segment 20 can drive the electrode segment 10 to move and / or bend in a preset direction. Among them, this embodiment does not limit the specific connection method between the bracket 101 and the magnetic guide segment 20, which can be a fixed connection or a detachable connection.

[0049] Furthermore, the present embodiment does not specifically limit the distribution shape of the plurality of branch arms 1011, which may be in a star shape, a claw shape, a net shape, etc. For example, the plurality of branch arms 1011 extend toward the distal end and are distributed divergently. Figure 2 and Figure 3 That is, the plurality of branch arms 1011 are evenly distributed along the circumference of the bracket 101 and extend in a direction away from the central axis of the bracket 101. Alternatively, Figure 4 That is, the plurality of branch arms 1011 are parallel to each other and arranged in parallel, and each branch arm 1011 extends along its own axis toward the distal end. Figure 5 As shown, the distal ends of the multiple branch arms 1011 are connected in pairs to form multiple frames, and the frames are nested and connected in sequence. Of course, the multiple branch arms 1011 can also diverge toward the distal end first and then converge to form a basket-like structure as a whole. And the multiple branch arms 1011 can also be Figure 6The morphology shown is that the distal ends of the branch arms 1011 are all connected by a distal rod to form a closed mesh structure. It should be noted that the embodiment does not specifically limit the number of the multiple branch arms 1011, and can be 4, 5, 6 or 7 or more, so as to construct different density distribution structures according to the signal extraction requirements of the coverage area, so as to obtain the required electrophysiological signals.

[0050] For further information, see Figure 1 , Figure 7 and Figure 8 , each of the branch arms 1011 is sleeved with a second sleeve 102, and the outer surface of each of the second sleeves 102 is sleeved with a plurality of the first electrodes 103. Among them, the second sleeve 102 is used to prevent the cut branch arm 1011 from damaging the measured tissue, and to constrain the wire connected to the first electrode 103 in the tube. Preferably, the material of the second sleeve 102 is a polymer material with better softness and toughness to increase the bending ability of the electrode segment 10 and improve the adhesion ability of the electrode segment 10. The first electrode 103 is used to obtain electrophysiological signals. And preferably, the first electrode 103 is a ring electrode. It should be noted that this embodiment does not limit the specific number of the first electrodes 103 sleeved on each of the second sleeves 102, and when the number of the first electrodes 103 is greater than 2, each of the first electrodes 103 is spaced apart along the axial direction of the second sleeve 102 to avoid electrical interference. Further, each of the first electrodes 103 is connected to at least one of the wires. The wire passes through the second sleeve 102 and is led out through the magnetic guide section 20, the support section 30 and the handle 40 to transmit the signal to an external electronic device. It should be noted that the wire in this embodiment is not limited to a wire group or a single wire.

[0051] For example, Figure 8 As shown, each of the first electrodes 103 is connected to a fourth wire 104. In addition, the second sleeve 102 is provided with a plurality of fourth through holes 1021, one end of the fourth wire 104 is connected to the corresponding first electrode 103 through the fourth through hole 1021, and the other end of the fourth wire 104 is led out through the second sleeve 102, the magnetic guide section 20, the support section 30 and the inner cavity of the handle 40 in sequence to achieve signal transmission.

[0052] Furthermore, the magnet assembly includes a plurality of magnets, and the plurality of magnets are arranged in sequence from the distal end to the proximal end. Preferably, the magnets are made of permanent magnetic materials with more residual magnetism, and there are relatively movable gaps between adjacent magnets to facilitate the movement of the electrode segment 10 and ensure better bending flexibility. Also, this embodiment does not limit the specific shape of the magnet, which may be arc-shaped or tubular, etc.; and this embodiment does not limit the specific size and quantity of the magnet, and one, two, three or four magnets may be provided. For example, Figure 1 , Figure 2 and Fig. 9 As shown, the magnet assembly includes a first magnet 201, a second magnet 202 and a third magnet 203. Among them, the first magnet 201, the second magnet 202 and the third magnet 203 are all hollow tube-shaped, and the first magnet 201, the second magnet 202 and the third magnet 203 are coaxially connected in sequence from the distal end to the proximal end. It can be understood that the magnet assembly provided in this embodiment is divided into a three-section magnet structure, which has better bending flexibility. And optionally, the first magnet 201, the second magnet 202 and the third magnet 203 are directly abutted in pairs, or a silicone cushion is set between the first magnet 201 and the second magnet 202, and between the second magnet 202 and the third magnet 203, so as to play a role of motion buffering, avoid collision and wear of the magnets, and enhance the bending ability of the magnetic guide section 20.

[0053] Please continue reading Figure 1 , Figure 2 and Fig. 9 , the distal end of the magnet assembly is connected to the proximal end 1012 of the bracket. That is, among the plurality of magnets, the magnet located at the distal end is connected to the proximal end 1012 of the bracket, and preferably, the connection method is a detachable connection. Exemplarily, the first magnet 201 is the magnet located at the distal end of the magnet assembly. The first magnet 201 is coaxially arranged in the cavity of the proximal end 1012 of the bracket. And as Figure 2 , Fig.10 and Fig.11 As shown, the outer surface of the first magnet 201 has a plurality of positioning posts 2011, and the outer surface of the proximal end 1012 of the bracket is correspondingly provided with a plurality of positioning grooves 1012a. The positioning posts 2011 extend out of the outer surface of the proximal end 1012 of the bracket through the positioning grooves 1012a. Then, under the clamping connection between the positioning grooves 1012a and the positioning posts 2011, the position of the first magnet 201 relative to the proximal end 1012 of the bracket is fixed, thereby avoiding axial displacement of the first magnet 201 and the bracket 101 during the marking process, thereby ensuring the stability of the marking.

[0054] Based on this, in order to facilitate the installation of the first magnet 201, the outer surface of the proximal end 1012 of the bracket is also provided with a plurality of connecting grooves 1012b. Each of the connecting grooves 1012b is connected to a positioning groove 1012a, and the connecting grooves 1012b extend along the axial direction of the bracket 101 to the edge of the proximal end 1012 of the bracket. It can be understood that when installing the first magnet 201, the positioning column 2011 is first extended into the connecting groove 1012b at the edge of the proximal end 1012 of the bracket, and then moved along the extension direction of the connecting groove 1012b to the connected positioning groove 1012a. Finally, the positioning column 2011 is moved radially by a certain displacement so that the positioning column 2011 moves into the positioning groove 1012a, and then the first magnet 201 is installed in place. Preferably, the connecting groove 1012b is formed by laser cutting, and the connecting groove 1012b is an elongated through groove, and the groove width is smaller than the groove width of the positioning groove 1012a, so as to prevent the first magnet 201 from sliding through the connecting groove 1012b during the marking movement. And because the material of the bracket 101 is preferably a metal material with shape memory, after the first magnet 201 is assembled in place, the connecting groove 1012b can be restored to its original state, further preventing the first magnet 201 from sliding off, thereby improving the stability of the marking process. Furthermore, this embodiment does not limit the specific number of the positioning column 2011, the positioning groove 1012a, and the connecting groove 1012b. And, this embodiment does not limit the connection method between the first magnet 201 and the proximal end 1012 of the bracket, and in other embodiments, the first magnet 201 and the proximal end 1012 of the bracket can also be connected by adhesive.

[0055] Please continue reading Figure 1 , Fig.10 and Fig.11In order to strengthen the control of the distal end of the magnet assembly, the magnetic guide segment 20 is also provided with a connecting wire 211. Exemplarily, the first magnet 201 has a first gap 2012, and the connecting wire 211 runs through the first gap 2012. That is, the connecting wire 211 is accommodated in the first gap 2012, and the opposite ends of the connecting wire 211 extend out of the first gap 2012. Further, the diameter of the distal end 2111 of the connecting wire is larger than the diameter of the first gap 2012, so that the connecting wire 211 is clamped in the first magnet 201, and the proximal end of the connecting wire 211 extends to the handle 40 through the second magnet 202, the third magnet 203 and the support segment 30 in sequence, so as to provide a pulling force to the electrode segment 10 through the handle 40, so as to prevent the electrode segment 10 from falling off during the operation, and further improve the stability of the mapping catheter. Optionally, the distal end 2111 of the connecting line is spherical, rectangular or other shapes.

[0056] Furthermore, the magnetic guide section 20 also includes a magnetic sensor 204, a first sleeve 205, a plurality of second electrodes and a plurality of wires. The magnetic sensor 204 is sleeved on the outer surface of a portion of the magnets to obtain electromagnetic signals during the mapping process, so that the mapping catheter can be compatible with the three-dimensional mapping system, and driven by the magnetic navigation system, the measured tissue can be completely modeled to assist the operator in accurately identifying the lesion site. Based on this, the magnetic sensor 204 is connected to at least one of the wires, and the wire passes through a portion of the magnets and is led out through the inner cavity of the support section 30 and the handle 40 to achieve signal transmission. Exemplarily, the magnetic sensor 204 is in the shape of a hollow tube and is sleeved on the outer surface of the second magnet 202. The first sleeve 205 serves as a protective sleeve for the magnetic guide segment 20, and is sleeved on the proximal end of the electrode segment 10, the plurality of magnets, and the outer surface of the magnetic sensor 204 to protect the magnet assembly and the magnetic sensor 204, and to strengthen the connection between the magnet assembly and the electrode segment 10. Preferably, the first sleeve 205 is coated on the outer surface of the magnet assembly by hot blowing technology, and is made of polymer material with good softness and toughness to facilitate the bending of the magnetic guide segment 20. The plurality of second electrodes are arranged on the outer surface of the first sleeve 205, and each of the second electrodes is connected to at least one of the wires, which passes through the first sleeve 205 and part of the magnets, and is led out through the inner cavity of the support segment 30 and the handle 40 to achieve signal transmission.

[0057] For example, Fig.10 and Fig.11As shown, the magnetic guide section 20 is provided with two second electrodes, namely, a distal second electrode 206 and a proximal second electrode 207. The distal second electrode 206 and the proximal second electrode 207 are respectively sleeved on the outer surfaces of the opposite ends of the first sleeve 205. That is, the distal second electrode 206 is sleeved on the distal end of the first sleeve 205, and the proximal second electrode 207 is sleeved on the proximal end of the first sleeve 205. As can be seen from the above, the positioning post 2011 on the first magnet 201 protrudes from the outer surface of the proximal end 1012 of the bracket, and the first sleeve 205 correspondingly covered on the positioning post 2011 is also in a convex state. In order to ensure that the morphology of the magnetic guide section 20 is regular, preferably, the distal second electrode 206 is arranged corresponding to the positioning post 2011 to cover the convex part of the distal end of the first sleeve 205. Further, the distal second electrode 206 is connected to the first wire 208 to transmit the signal of the distal second electrode 206 through the first wire 208. Based on this, at the same cross-sectional position of the positioning groove 1012a, the proximal end 1012 of the bracket is also provided with a first through hole 1012c, the first sleeve 205 is also correspondingly provided with a second through hole 2051, and the first magnet 201 also has a second slit 2013, then one end of the first wire 208 is connected to the distal second electrode 206 through the second slit 2013, the first through hole 1012c and the second through hole 2051 in sequence, and the other end of the first wire 208 is led out through the second magnet 202, the third magnet 203, the support section 30 and the inner cavity of the handle 40 in sequence to connect with an external electronic device to achieve signal transmission. Furthermore, in order to realize the connection between the second wire 209 and the proximal second electrode 207, the third magnet 203 has a third slit 2031, and the distal end of the first sleeve 205 has a third through hole 2052; one end of the second wire 209 is connected to the proximal second electrode 207 through the third slit 2031 and the third through hole 2052 in turn, and the other end of the second wire 209 is led out through the inner cavity of the support section 30 and the handle 40 in turn to connect with an external electronic device to realize signal transmission. Furthermore, the third magnet 203 also has a fourth slit 2032, one end of the third wire 210 is connected to the magnetic sensor 204 through the fourth slit 2032, and the other end of the third wire 210 is led out through the inner cavity of the third magnet 203, the support section 30 and the handle 40 in turn to transmit the signal of the magnetic sensor 204 to the external electronic device. Preferably, the first gap 2012, the second gap 2013, the third gap 2031 and the fourth gap 2032 are all arranged at an angle with respect to the central axis of the corresponding magnet, so as to facilitate the assembly of the wires in each gap.

[0058] Please continue reading Figure 1 , the support segment 30 is used to provide support force to the electrode segment 10 and the magnetic conductivity segment 20, and cooperate with the movement of the electrode segment 10 and the magnetic conductivity segment 20. Specifically, the support segment 30 includes a first sub-support segment 301, a second sub-support segment 302 and a third sub-support segment 303. The first sub-support segment 301 is connected to the proximal end of the magnetic conductivity segment 20, and is a flexible structure with strong bendability. The second sub-support segment 302 connects the first sub-support segment 301 and the third sub-support segment 303, and the stiffness of the second sub-support segment 302 increases from the distal end to the proximal end; that is, the stiffness of the second sub-support segment 302 increases gradually. The third sub-support segment 303 is connected to the handle 40, and the stiffness of the third sub-support segment 303 is greater than or equal to the maximum stiffness of the second sub-support segment 302. Preferably, the tube wall of the third sub-support segment 303 is a multi-layer structure, including at least a polymer material layer and a metal braided layer, so that the third sub-support segment 303 has better toughness and support function, and can provide sufficient propulsion force. Based on this, the gradual stiffness of the support segment 30 achieves both the support force and flexibility required by the mapping catheter. Furthermore, the first sub-support segment 301, the second sub-support segment 302 and the third sub-support segment 303 in the support segment 30 referred to in this embodiment are all tubular structures with a through inner cavity, and the handle 40 also has a cavity to enable the wires and connecting wires 211 connected to the electrode segment 10 and the magnetic guide segment 20 to pass through.

[0059] Furthermore, the first sub-support segment 301 is not only used to transmit the supporting force, but also used as an adaptable segment of the magnetic guide segment 20. Among them, the outer surface of the first sub-support segment 301 is sleeved with a plurality of magnetic rings C. The plurality of magnetic rings C are sleeved on the outer surface of the first sub-support segment 301 at intervals, so that under the action of the magnetic field, at least the support segment 30 cooperates with the movement and / or bending of the electrode segment 10. Specifically, each of the magnetic rings C can alleviate the influence of gravity or other forces on the support segment 30 under the action of the external magnetic field, avoid adverse interference with the distal movement of the mapping catheter, thereby ensuring that the support segment 30 can move with the movement of the electrode segment 10, and at the same time ensure effective support for the electrode segment 10 and the magnetic guide segment 20, thereby enhancing the overall adaptability and stability of the magnetic navigation process.

[0060] Furthermore, the mapping catheter also includes an irrigation tube 50. The irrigation tube 50 sequentially passes through the inner cavities of the electrode segment 10, the magnetic guide segment 20, the support segment 30 and the handle 40, and the proximal end of the irrigation tube 50 is connected to a Luer connector 60, so that a syringe can inject liquid into the irrigation tube 50 through the Luer connector 60, and the liquid flows out through the distal end of the irrigation tube 50. Optionally, the liquid is physiological saline, which can be sprayed during the operation to avoid thrombosis at the connection of the branch arm 1011 and affect signal mapping.

[0061] It can be seen that in this embodiment, the magnetic guide segment 20 is arranged at the proximal end of the electrode segment 10, so as to realize electromagnetic navigation by using the magnetic guide segment 20, and then flexibly control the bending degree and travel position of the electrode segment 10, without the need to select a fixed bending shape for the distal end of the mapping catheter before surgery, and the operator's control ability is not required to be high, which is conducive to improving the success rate of the surgery. Fig.12 As shown, the magnetic guide segment 20 can directly adjust the electrode segment 10 to point to the target tissue under the action of the magnetic field force. Also, the first sub-support segment 301 in the support segment 30 serves as an adaptable segment of the magnetic guide segment 20, which enables the support segment 30 to cooperate with the movement and / or bending of the electrode segment 10, thereby enhancing the overall adaptability and stability of the magnetic navigation process. Obviously, compared with a fixed-bend mapping catheter, the distal end of the mapping catheter provided in this embodiment can achieve a large range of arbitrary bends, and the distal end has a higher degree of freedom and better adhesion, which is conducive to obtaining more accurate electrical signals and tissue modeling.

[0062] Based on the same inventive concept, this embodiment also provides an interventional system, including the above-mentioned mapping catheter.

[0063] In summary, the mapping catheter and interventional system provided in this embodiment are provided with a magnetic guide segment 20. The magnetic guide segment 20 has several built-in magnets, so that the electrode segment 10 can be displaced and driven and bent under the control of the magnetic navigation system, so that the electrode segment 10 can reach different positions of the heart cavity to extract ECG signals. In addition, a magnetic sensor 204 is also provided in the magnetic guide segment 20, which is used to be compatible with the three-dimensional mapping system, realize the complete modeling of the heart cavity, and help the operator to accurately identify the lesion site. In addition, the first sub-support segment 301 in the support segment 30 is sleeved with several magnetic rings C, so that the support segment 30 can fully cooperate with the movement of the electrode segment 10 under magnetic navigation, and improve the feasibility and stability of magnetic navigation. Based on this, the operator does not need to select the corresponding fixed curved mapping catheter according to the size of the patient's heart cavity before the operation, which effectively reduces the difficulty of matching the bending of the mapping catheter and enhances the applicable scope of the mapping catheter.

[0064] In addition, it should be recognized that although the present invention has been disclosed as a preferred embodiment, the above embodiment is not intended to limit the present invention. For any technician familiar with the art, without departing from the scope of the technical solution of the present invention, the technical content disclosed above can be used to make many possible changes and modifications to the technical solution of the present invention, or modified into equivalent embodiments of equivalent changes. Therefore, any simple modification, equivalent change and modification made to the above embodiment according to the technical essence of the present invention without departing from the content of the technical solution of the present invention still belongs to the scope of protection of the technical solution of the present invention.

Claims

1. A mapping catheter, It is characterized in that It includes an electrode segment, a magnetic guide segment, a support segment and a handle which are connected in sequence from the distal end to the proximal end; wherein the electrode segment includes a plurality of branch arms, and each of the branch arms is provided with a plurality of first electrodes for acquiring electrical signals; the magnetic guide segment includes a magnet assembly for at least driving the electrode segment to move and / or bend in a preset direction under the action of a magnetic field.

2. The mapping catheter according to claim 1, It is characterized in that The magnet assembly includes a plurality of magnets, and the plurality of magnets are arranged in sequence from the distal end to the proximal end.

3. The mapping catheter according to claim 2, It is characterized in that The magnetic guide segment also includes a first sleeve, a plurality of second electrodes and a plurality of wires; wherein the first sleeve is sleeved on the proximal end of the electrode segment and the outer surface of the plurality of magnets; the plurality of second electrodes are arranged on the outer surface of the first sleeve, and each of the second electrodes is connected to at least one of the wires, and the wires pass through the first sleeve and part of the magnets, and are led out through the support segment and the handle.

4. The mapping catheter according to claim 3, It is characterized in that The magnetic guide section also includes a magnetic sensor; the magnetic sensor is located in the first sleeve and is sleeved on the outer surface of a portion of the magnets; wherein the magnetic sensor is connected to at least one of the wires, and the wire passes through a portion of the magnets and is led out through the support section and the handle.

5. The mapping catheter according to claim 1, It is characterized in that The support segment includes a first sub-support segment, a second sub-support segment and a third sub-support segment; the first sub-support segment is connected to the proximal end of the magnetic conductivity segment and is a flexible structure; the second sub-support segment connects the first sub-support segment and the third sub-support segment, and the stiffness of the second sub-support segment increases from the distal end to the proximal end; the third sub-support segment is connected to the handle, and the stiffness of the third sub-support segment is greater than or equal to the maximum stiffness of the second sub-support segment.

6. The mapping catheter according to claim 5, It is characterized in that The first sub-support segment is also sleeved with a plurality of magnetic rings, so that under the action of the magnetic field, the support segment can cooperate with the movement and / or bending of the electrode segment.

7. The mapping catheter according to any one of claims 1 to 6, It is characterized in that The electrode segment comprises a bracket; the distal end of the bracket has a plurality of branch arms, and the proximal end of the bracket is connected to the magnetic guide segment, so that the magnetic guide segment can drive the electrode segment to move and / or bend in a preset direction.

8. The mapping catheter according to claim 7, It is characterized in that The magnet assembly comprises a first magnet, a second magnet and a third magnet; the first magnet, the second magnet and the third magnet are all in the shape of hollow tubes and are coaxially connected in sequence from the distal end to the proximal end.

9. The mapping catheter according to claim 8, It is characterized in that The first magnet is coaxially arranged in the cavity of the proximal end of the bracket, and the outer surface of the first magnet has a plurality of positioning posts, and the outer surface of the proximal end of the bracket is correspondingly provided with a plurality of positioning grooves, and the positioning posts extend out of the bracket through the positioning grooves; and, the outer surface of the proximal end of the bracket is also provided with a plurality of connecting grooves, each of which is connected to a positioning groove, and the connecting grooves extend along the axial direction of the bracket to the proximal edge of the bracket.

10. The mapping catheter according to claim 8, It is characterized in that The magnetic guide segment also includes a magnetic sensor, a first sleeve, a second electrode, a conductor and a connecting wire; wherein, The magnetic sensor is sleeved on the outer surface of the second magnet, the first sleeve is sleeved on the proximal end of the bracket, the magnetic sensor and the outer surface of the third magnet, and one second electrode is sleeved on the outer surface of the opposite ends of the first sleeve respectively; and the magnetic sensor and the second electrode are respectively connected to at least one of the wires to transmit signals through the wires; One end of the connecting wire is clamped in the first magnet, and the other end of the connecting wire extends into the handle through the second magnet, the third magnet and the inner cavity of the supporting section.

11. The mapping catheter according to claim 1, It is characterized in that The electrode segment also includes a plurality of second sleeves and a plurality of conductive wires; each of the second sleeves is sleeved on one of the branch arms, and a plurality of the first electrodes are sleeved on the outer surface of the second sleeve; and each of the first electrodes is connected to at least one of the conductive wires, and the conductive wires pass through the second sleeve and are led out through the magnetic guide segment, the support segment and the handle.

12. The mapping catheter according to claim 1, It is characterized in that The distribution shapes of the plurality of branch arms include: star shape, net shape and claw shape.

13. The mapping catheter according to claim 1 or 12, It is characterized in that The plurality of branch arms are distributed and spread out toward the distal end.

14. The mapping catheter according to claim 1 or 12, It is characterized in that The distal ends of the plurality of branch arms are connected in pairs to form a plurality of frames, and the frames are nested and connected in sequence; or, the plurality of branch arms first diverge toward the distal end and then converge to form a basket-like structure.

15. The mapping catheter according to claim 1 or 12, It is characterized in that The distal ends of the plurality of branch arms are all connected by a distal rod to form a closed network structure.

16. The mapping catheter according to claim 1, It is characterized in that The mapping catheter also includes an irrigation tube; the irrigation tube sequentially passes through the electrode segment, the magnetic guide segment, the support segment and the inner cavity of the handle so as to be able to supply liquid to the distal end.

17. An intervention system, It is characterized in that It comprises the mapping catheter as described in any one of claims 1 to 16.

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