Variable density mapping catheter

Abstract

The application provides a variable density mapping catheter, and relates to the technical field of medical devices. The catheter comprises an operating handle, a catheter body and a mapping part, the mapping part comprising a first mapping assembly and a second mapping assembly; the operating handle comprising coaxially arranged and relatively rotatable first and second operating parts; the catheter body comprising an outer sleeve and an inner tube, the proximal end of the outer sleeve being fixedly connected to the second operating part, and the proximal end of the inner tube being fixedly connected to the first operating part; the first mapping assembly comprising a first support and M first electrodes arranged on the surface of the first support; the second mapping assembly comprising a second support and N second electrodes arranged on the surface of the second support; the mapping catheter is provided with multiple mapping assemblies of different density detection electrodes, the mapping density can be adjusted at any time during the detection process, the time for replacing mapping catheters of different specifications is shortened, the mapping efficiency is improved, the pain of the patient is alleviated, and the time for which the operator and the patient are exposed to X-rays is reduced.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a variable density mapping catheter. Background Technology

[0002] During electrophysiological mapping, clinicians may require a variety of mapping catheters of different sizes and types to diagnose cardiac conditions such as arrhythmias and / or verify the effectiveness of treatment regimens. For example, a mapping catheter with a large electrode coverage area and low density can be used for general electrophysiological mapping of cardiac chambers (e.g., the left atrium). For areas requiring detailed examination (e.g., pulmonary veins), a mapping catheter with a small electrode coverage area and high density can be used for more granular electrophysiological mapping.

[0003] However, changing to different types of mapping catheters requires removing the old catheter from the patient and inserting the new one. Changing to different types and sizes of mapping catheters during the procedure takes a considerable amount of time, resulting in low examination efficiency. This not only increases patient discomfort but also increases the time both the surgeon and patient are exposed to X-rays. Summary of the Invention

[0004] The purpose of this invention is to provide a variable density mapping catheter that allows for adjustment of the spacing and number of electrodes, thereby meeting the needs of precise and large-area cardiac electrical signal mapping. This mapping catheter is equipped with multiple mapping components with detection electrodes of different densities. The mapping density can be adjusted at any time during the detection process, shortening the time required to change mapping catheters of different specifications, improving mapping efficiency, reducing patient discomfort, and minimizing the time both the operator and patient are exposed to X-rays.

[0005] In a first aspect, the present invention provides a variable density mapping catheter, comprising: an operating handle, a catheter body, and a mapping section, wherein the mapping section includes a first mapping component and a second mapping component;

[0006] The operating handle includes a first operating part and a second operating part arranged coaxially. The first operating part is located near the second operating part and can rotate relative to the second operating part about an axis.

[0007] The catheter body includes an outer tube and an inner tube. The proximal end of the outer tube is fixedly connected to the second operating part. The inner tube is coaxially inserted inside the outer tube and its two ends protrude from the two ends of the outer tube, respectively. The proximal end of the inner tube is fixedly connected to the first operating part.

[0008] The first calibration assembly includes a first support member and M first electrodes disposed on the surface of the first support member. The first support member is made of an elastic material, and the first calibration assembly is fixedly connected to the outer sleeve through the first end of the first support member.

[0009] The second calibration assembly includes a second support member and N second electrodes disposed on the surface of the second support member. The second support member is made of an elastic material, and the second calibration assembly is fixedly connected to the inner tube through the first end of the second support member.

[0010] The first mapping component can rotate around the first end of the first support towards the proximal end of the catheter body until it is parallel to and fits against the outer wall of the catheter body; the second mapping component can rotate around the first end of the second support towards the proximal end of the catheter body until it is parallel to and fits against the outer wall of the catheter body.

[0011] In its natural state, the end of the first mapping component opposite to the first end extends outward, and the end of the second mapping component opposite to the first end extends outward, forming a petal-like structure;

[0012] Rotating the first operating unit relative to the second operating unit can drive the second calibration component to rotate relative to the first calibration component through the inner tube, thereby changing the distance between the M first electrodes on the first calibration component and the N second electrodes on the second calibration component.

[0013] M≥1, N≥1.

[0014] In some preferred embodiments of the present invention, the mapping catheter further includes M first leads and N second leads. The outer tube has a first lead cavity in its side wall and the inner tube has a second lead cavity. The M first leads are connected to M first electrodes respectively and then connected to an external electrocardiogram (ECG) detection device through the first lead cavity. The N second leads are connected to N second electrodes respectively and then connected to an external ECG detection device through the second lead cavity.

[0015] In some preferred embodiments of the present invention, the operating handle further includes a third operating part, which is located between the first operating part and the second operating part, and the third operating part is rotatable relative to the first operating part and the second operating part about an axis.

[0016] The catheter body also includes an intermediate tube, which is inserted between the outer tube and the inner tube, and the proximal end of the intermediate tube is fixedly connected to the third operating part.

[0017] The calibration section also includes a third calibration assembly, which includes a third support member and K third electrodes disposed on the surface of the third support member. The third support member is made of an elastic material, and the third calibration assembly is fixedly connected to the outer sleeve through the first end of the third support member.

[0018] The third mapping component can rotate around the first end of the third support towards the proximal end of the catheter body until it is parallel and fits against the outer wall of the catheter body. In its natural state, the end of the third mapping component opposite to the first end extends outward to form a flap-like structure.

[0019] The third operating unit can be rotated relative to the second operating unit and the first operating unit, and the third measurement component can be rotated relative to the first measurement component and the second measurement component through the intermediate tube;

[0020] The mapping catheter also includes K third leads. The middle tube has a third lead cavity in the side wall. The K third leads are connected to K third electrodes respectively, and then connected to an external electrocardiogram monitoring device through the third lead cavity.

[0021] K≥1.

[0022] In some preferred embodiments of the present invention, the mapping catheter further includes a third mapping component, which includes a third support and K third electrodes disposed on the surface of the third support. The third support is made of an elastic material, and a collar is provided at the first end of the third support. The third mapping component is sleeved between the outer tube and the inner tube through the collar and is located axially between the first mapping component and the second mapping component.

[0023] In some preferred embodiments of the present invention, the upper end wall of the collar is provided with a track groove extending in the circumferential direction; the second measuring component also includes a tube head, which is coaxial with and fixedly connected to the inner tube; the second support member is fixedly connected to the tube head.

[0024] The bottom wall of the tube head is provided with a downward protruding lever. The lever can be inserted into the track groove. When the second operating part is rotated relative to the first operating part, the lever can move from one end of the track groove to the other end along the extension direction of the track groove, and then drive the third measuring component to rotate circumferentially.

[0025] In some preferred embodiments of the present invention, the arc of the track groove is 120 degrees.

[0026] In some preferred embodiments of the present invention, the first calibration component, the second calibration component, and the third calibration component have the same shape.

[0027] In some preferred embodiments of the present invention, the first calibration component, the second calibration component, and the third calibration component are arc-shaped or L-shaped.

[0028] In some preferred embodiments of the present invention, the first, second, and third mapping components are strip-shaped or petal-shaped.

[0029] In some preferred embodiments of the present invention, N≠K≠M.

[0030] This invention brings the following beneficial effects:

[0031] This invention provides a variable density mapping catheter, comprising: an operating handle, a catheter body, and a mapping section. The mapping section includes a first mapping component and a second mapping component. The operating handle includes a first operating part and a second operating part coaxially arranged, the first operating part being located proximal to the second operating part and rotatable relative to the second operating part around an axis. The catheter body includes an outer tube and an inner tube, the proximal end of the outer tube being fixedly connected to the second operating part, and the inner tube being coaxially inserted inside the outer tube with both ends extending from the two ends of the outer tube, the proximal end of the inner tube being fixedly connected to the first operating part. The first mapping component includes a first support member and M first electrodes disposed on the surface of the first support member. The first support member is made of an elastic material, and the first mapping component is fixedly connected to the outer tube through a first end of the first support member. The second mapping component includes a second support member and N second electrodes disposed on the surface of the second support member. Made of elastic material, the second mapping component is fixedly connected to the inner tube via the first end of the second support member. The first mapping component can rotate around the first end of the first support member towards the proximal end of the catheter body until it is parallel to and fits against the outer wall of the catheter body. The second mapping component can also rotate around the first end of the second support member towards the proximal end of the catheter body until it is parallel to and fits against the outer wall of the catheter body. In its natural state, the end of the first mapping component opposite to the first end extends outward, and the end of the second mapping component opposite to the first end extends outward, forming a valve-like structure. Rotating the first operating part relative to the second operating part can drive the second mapping component to rotate relative to the first mapping component through the inner tube, thereby changing the distance between the M first electrodes on the first mapping component and the N second electrodes on the second mapping component; M≥1, N≥1. This catheter can adjust the spacing and number of electrodes, thereby meeting the needs of precise and large-area cardiac electrical signal mapping. This mapping catheter is equipped with multiple mapping components with detection electrodes of different densities. The mapping density can be adjusted at any time during the detection process, which shortens the time for changing mapping catheters of different specifications, improves mapping efficiency, reduces patient pain, and reduces the time that the operator and patient are exposed to X-rays. Attached Figure Description

[0032] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0033] Figure 1 This is a schematic diagram of a variable density mapping catheter provided in an embodiment of the present invention.

[0034] Figure 2 A cross-sectional view showing the connection between the variable density mapping catheter operating handle and the catheter body, provided in an embodiment of the present invention.

[0035] Figure 3 This is a schematic diagram of the structure connecting the mapping section of a variable density mapping catheter to the catheter body, provided in an embodiment of the present invention.

[0036] Figure 4 This is a schematic diagram of the assembly of the mapping section and the catheter body of a variable density mapping catheter, provided as an embodiment of the present invention.

[0037] Figure 5 This invention provides a schematic diagram of the structure of a variable density mapping catheter mapping section when unfolded.

[0038] Figure 6 A schematic diagram of the structure of the third mapping component of a variable density mapping catheter provided in an embodiment of the present invention.

[0039] Figure 7 This is a schematic diagram of the structure of a second mapping component of a variable density mapping catheter provided in an embodiment of the present invention.

[0040] Figure 8 This is a schematic diagram of the shape of the calibration component provided in an embodiment of the present invention.

[0041] Figure 9 The mapping component provided in this embodiment of the invention is a petal-shaped variable density mapping catheter.

[0042] Icons: 1-Operating handle; 11-First operating part; 111-First fixing groove; 112-First connecting part; 12-Second operating part; 121-Second fixing groove; 2-Conduit body; 21-Outer tube; 22-Inner tube; 3-Marking part; 31-First marking component; 311-First support member; 312-First electrode; 32-Second marking component; 321-Second support member; 322-Second electrode; 323-Tube head; 323a-Lever; 33-Third marking component; 331-Third support member; 332-Third electrode; 333-Rotating ring; 333a-Rail groove; 4-Connector. Detailed Implementation

[0043] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0044] Therefore, the following detailed description of the embodiments of the invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the invention without inventive effort are within the scope of protection of the invention.

[0045] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0046] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship commonly used when the product of this invention is in use. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention. In addition, the terms "first," "second," and "third," etc., are only used to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0047] Furthermore, terms such as "horizontal," "vertical," and "sag" do not imply that components must be absolutely horizontal or suspended, but rather that they can be slightly tilted. For example, "horizontal" simply means that its direction is more horizontal relative to "vertical," and does not mean that the structure must be completely horizontal, but can be slightly tilted.

[0048] In the description of this invention, it should also be noted that, unless otherwise explicitly specified and limited, the terms "set," "install," "connect," and "link" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0049] In this invention, "proximal end" refers to the end closer to the operator during the surgery; "distal end" refers to the end further away from the operator during the surgery.

[0050] A cardiac mapping electrode catheter is a medical device used to measure the electrical activity inside the heart. It typically consists of a thin tube and an electrode assembly. The device is inserted into the heart via a vein after being punctured through the skin. The electrode assembly is then placed in a specific location, recording the heart's electrical activity to help doctors assess cardiac function and diagnose heart disease. During the procedure, the patient receives local anesthesia and sedation, and blood pressure and heart rate are monitored. This technique is commonly used to treat heart conditions such as arrhythmias, heart failure, and coronary artery disease.

[0051] The variable-density mapping catheter provided by this invention improves the efficiency of cardiac modeling and abnormal potential mapping during electrophysiological surgery. Through the variable-density design of the mapping electrodes, surgeons can adjust the density of the electrodes intraoperatively according to the actual situation. They can either expand the electrode flap to increase the mapping component domain and improve cardiac mapping efficiency, or retract the electrodes for localized mapping. This eliminates the need to change mapping catheters of different sizes, shortens surgical time, and reduces the time both the surgeon and patient are exposed to X-rays.

[0052] The following detailed description of some embodiments of the present invention is provided in conjunction with the accompanying drawings. Unless otherwise specified, the following embodiments and features can be combined with each other.

[0053] Example 1

[0054] This invention provides a variable density mapping catheter, see [link to documentation]. Figure 1 The schematic diagram shown in this embodiment of the invention provides a variable density mapping catheter. The variable density mapping catheter includes: an operating handle 1, a catheter body 2, and a mapping part 3. The mapping part 3 includes a first mapping component 31 and a second mapping component 32.

[0055] Further, see Figure 2 The cross-sectional view of the connection between the variable density mapping catheter operating handle and the catheter body provided in the embodiment of the present invention is shown. Figure 3 The diagram shown illustrates the structural connection between the mapping section and the catheter body of a variable density mapping catheter according to an embodiment of the present invention. The operating handle 1 includes a first operating section 11 and a second operating section 12 coaxially arranged. The first operating section 11 is located proximal to the second operating section 12, and a first connecting section 112 is provided on the first operating section 11. The second operating section 12 is sleeved on the first connecting section 112, and the first operating section 11 can rotate relative to the second operating section 12 about an axis. The catheter body 2 includes an outer tube 21 and an inner tube 22. The proximal end of the outer tube 21 is fixedly connected to the second operating section 12 via a second fixing groove 121. The inner tube 22 is coaxially inserted inside the outer tube 21, with both ends protruding from both ends of the outer tube 21. The proximal end of the inner tube 22 is fixedly connected to the first operating section 11 via the first fixing groove 111.

[0056] The inner tube 22 can be directly bonded to the first fixing groove 111. In some preferred embodiments of the present invention, a first protrusion is provided on the outer wall of the inner tube 22 near its proximal end, which can be fixedly connected to the first fixing groove 111. During assembly, the inner tube 22 can be inserted into the first operating part 11 until the first protrusion reaches the first fixing groove 111 and engages with it. A second protrusion is provided on the outside of the outer tube 21, which can engage with the second fixing groove 121.

[0057] Further, see Figure 4 The diagram shown is a schematic of the assembly of the mapping section and the catheter body of a variable density mapping catheter provided by an embodiment of the present invention. The first end of the first mapping component 31 is fixedly connected to the outer tube 21, and the first end of the second mapping component 32 is fixedly connected to the inner tube 22.

[0058] Further, see Figure 5 The diagram shown is a schematic representation of the structure of a variable density mapping catheter mapping section when deployed, according to an embodiment of the present invention. The first mapping component 31 includes a first support member 311 and M first electrodes 312 disposed on the surface of the first support member 311. The second mapping component 32 includes a second support member 321 and N second electrodes 322 disposed on the surface of the second support member 321; both the first support member 311 and the second support member 321 are made of elastic material.

[0059] The first mapping component 31 can rotate around the first end of the first support member 311 towards the proximal end of the catheter body 2 until it is parallel and attached to the outer wall of the catheter body 2; the second mapping component 32 can rotate around the first end of the second support member 321 towards the proximal end of the catheter body 2 until it is parallel and attached to the outer wall of the catheter body 2; in its natural state, the end of the first mapping component 31 opposite to the first end extends outward; the end of the second mapping component 32 opposite to the first end extends outward, forming a petal-like structure; the first operating part 11 can rotate relative to the second operating part 12, and the second mapping component 32 can be driven to rotate relative to the first mapping component 31 through the inner tube 22, thereby changing the distance between the M first electrodes on the first mapping component 31 and the N second electrodes on the second mapping component 32; M≥1; N≥1.

[0060] Before use, the first mapping component 31 and the second mapping component 32 are attached to the outer wall of the catheter body 2, so that the catheter can reach the heart via the vein through the delivery sheath. After the catheter is delivered to the target site, the catheter is released from the delivery sheath, and the first mapping component 31 and the second mapping component 32 are unfolded to their natural state.

[0061] In this embodiment, since the second mapping component 32 is located at the farthest end, the electrical activity of the heart can be recorded through the second electrode 322. To meet other measurement needs, the first operating part 11 is rotated relative to the second operating part 12, which drives the first mapping component 31 and the second mapping component 32 to move relative to each other through the inner tube 22 and the outer tube 21, exposing the first electrode 312 on the first mapping component 31, increasing the electrode density of the mapping catheter, thereby improving the mapping efficiency.

[0062] Furthermore, in some preferred embodiments of the present invention, the mapping catheter further includes M first leads and N second leads. The outer tube 21 has a first lead cavity in its side wall and the inner tube 22 has a second lead cavity. The M first leads are connected to M first electrodes 312 respectively and then connected to an external electrocardiogram detection device through the first lead cavity. The N second leads are connected to N second electrodes 322 respectively and then connected to an external electrocardiogram detection device through the second lead cavity.

[0063] For details, please refer to [link / reference]. Figure 1 The variable density mapping catheter is also equipped with a connector 4, and both the first lead cavity and the second lead cavity are connected to the connector 4. The connector 4 can be connected to an external electrocardiogram monitoring device.

[0064] This invention provides a variable density mapping catheter, comprising: an operating handle 1, a catheter body 2, and a mapping section 3. The mapping section 3 includes a first mapping component 31 and a second mapping component 32. The operating handle 1 includes a first operating part 11 and a second operating part 12 coaxially arranged, the first operating part 11 being located proximal to the second operating part 12, and the first operating part 11 being rotatable relative to the second operating part 12 about an axis. The catheter body 2 includes an outer tube 21 and an inner tube 22, the proximal end of the outer tube 21 being fixedly connected to the second operating part 12, and the inner tube 2... 2. A coaxial device is inserted inside the outer tube 21, with its two ends protruding from both ends of the outer tube 21. The proximal end of the inner tube 22 is fixedly connected to the first operating part 11. The first calibration assembly 31 includes a first support member 311 and M first electrodes 312 disposed on the surface of the first support member 311. The first support member 311 is made of elastic material, and the first calibration assembly 31 is fixedly connected to the outer tube 21 through the first end of the first support member 311. The second calibration assembly 32 includes a second support member 321 and M first electrodes 312 disposed on the surface of the second support member 321. N second electrodes 322, a second support member 321 made of elastic material, and a second mapping component 32 fixedly connected to the inner tube 22 through the first end of the second support member 321; the first mapping component 31 can rotate around the first end of the first support member 321 towards the proximal end of the catheter body 2 to be parallel and attached to the outer wall of the catheter body 2, and the second mapping component 32 can rotate around the first end of the second support member 321 towards the proximal end of the catheter body 2 to be parallel and attached to the outer wall of the catheter body 2; in the natural state, the end of the first mapping component 31 opposite to the first end extends outward, and the end of the second mapping component 32 opposite to the first end extends outward, forming a flap-like structure; rotating the first operating part 11 relative to the second operating part 12 can drive the second mapping component 32 to rotate relative to the first mapping component 31 through the inner tube 22, thereby changing the distance between the M first electrodes on the first mapping component 31 and the N second electrodes on the second mapping component 32; M≥1, N≥1; the catheter can adjust the spacing and number of electrodes, thereby meeting the needs of accurate and large-area cardiac electrical signal mapping. This mapping catheter is equipped with multiple mapping components with detection electrodes of different densities. The mapping density can be adjusted at any time during the detection process, which shortens the time for changing mapping catheters of different specifications, improves mapping efficiency, reduces patient pain, and reduces the time that the operator and patient are exposed to X-rays.

[0065] Example 2

[0066] Based on the above embodiment 1, this embodiment of the invention provides another variable density mapping catheter, wherein the operating handle 1 further includes a third operating part, which is located between the first operating part 11 and the second operating part 12, and the third operating part can rotate relative to the first operating part 11 and the second operating part 12 about an axis; see continue. Figure 3The catheter body 2 also includes an intermediate tube, which passes between the outer tube 21 and the inner tube 22. The proximal end of the intermediate tube is fixedly connected to the third operating part. The mapping part 3 also includes a third mapping component 33, which includes a third support 331 and K third electrodes disposed on the surface of the third support 331. The third support is made of an elastic material. The third mapping component 33 is fixedly connected to the outer tube 21 through the first end of the third support 331. The third mapping component 33 can rotate around the first end of the third support 331 toward the proximal end of the catheter body 2. Parallel to the outer wall of the catheter body 2, in its natural state, the end of the third mapping component 33 opposite to the first end extends outward to form a flap-like structure; rotating the third operating part relative to the second operating part 12 and the first operating part 11 can drive the third mapping component 33 to rotate relative to the first mapping component 31 and the second mapping component 32 through the intermediate tube; the mapping catheter also includes K third leads, and the side wall of the intermediate tube is provided with a third lead cavity. After the K third leads are respectively connected to K third electrodes 332, they are connected to an external electrocardiogram monitoring device through the third lead cavity; K≥1.

[0067] For details, please refer to [link / reference]. Figure 5 The first operating part 11, the second operating part 12 and the third operating part are nested together and can rotate relative to each other on the same axis. By driving the inner tube 22, the outer tube 21 and the intermediate tube respectively connected to them, the relative rotation of the first measuring component 31, the second measuring component 32 and the third measuring component 33 is realized.

[0068] Furthermore, in some preferred embodiments of the present invention, a third protrusion is provided on the outside of the intermediate tube, which can be engaged with the third fixing groove on the third operating part.

[0069] Example 3

[0070] Based on the above embodiment one, this invention provides another variable density mapping catheter, see below. Figure 4 and Figure 5 as well as Figure 6 The schematic diagram shown in this embodiment of the invention provides a structural diagram of a third mapping component of a variable density mapping catheter. The mapping catheter also includes a third mapping component 33. The third mapping component 33 includes a third support member 331 and K third electrodes disposed on the surface of the third support member 331. The third support member is made of an elastic material. The first end of the third support member 331 is also provided with a collar. The third mapping component 33 is sleeved between the outer tube 21 and the inner tube 22 through the collar, and is located axially between the upper first mapping component 31 and the second mapping component 32.

[0071] Specifically, the third calibration component 33 can be directly fitted onto the outer tube 21 via the rotating ring 333. In some preferred embodiments of the present invention, the diameter of the distal end of the outer tube 21 can be appropriately smaller than the diameter of most of the tube body to match the inner diameter of the rotating ring 333 of the third calibration component 33.

[0072] Furthermore, in some preferred embodiments of the present invention, see also... Figure 6 The upper end wall of the collar is provided with a circumferentially extending track groove 333a. See also Figure 7 The schematic diagram shown in this embodiment of the invention provides a second mapping component of a variable density mapping catheter. The second mapping component 32 also includes a tube head 323, which is coaxial with and fixedly connected to the inner tube 22. The second support member 321 is fixedly connected to the tube head 323. The bottom wall of the tube head 323 is provided with a downwardly protruding lever 323a, which can be inserted into the track groove 333a. When the second operating part 12 is rotated relative to the first operating part 11, the lever 323a can move from one end of the track groove 333a to the other end along the extension direction of the track groove 333a, and then drive the third mapping component 33 to rotate circumferentially.

[0073] Specifically, rotating the second operating part 12 causes the tube head 323 to move, and the lever 323a moves within the track groove 333a. When the lever 323a moves to one end of the track groove 333a, the second operating part 12 is rotated again, and the lever 323a causes the rotating ring 333 to move, so that the third measuring component 33 moves relative to the first measuring component 31.

[0074] Furthermore, in some preferred embodiments of the present invention, the arc of the track groove 333a is 120 degrees.

[0075] Specifically, when the lever 323a moves to its limit position, the first operating part 11 continues to rotate. If the arc of the track groove 333a is 120 degrees, the first calibration component 31, the second calibration component 32, and the third calibration component 33 can eventually be set relative to each other at an angle of 120 degrees. This allows for the uniform setting of calibration electrodes and improves the accuracy of the measurement.

[0076] Furthermore, in some preferred embodiments of the present invention, the first calibration component 31, the second calibration component 32, and the third calibration component 33 have the same shape.

[0077] Specifically, the first mapping component 31, the second mapping component 32, and the third mapping component 33 are identical in shape, meaning that regardless of which mapping catheter the surgeon uses, the operational experience and electrode layout are consistent. This consistency reduces the time surgeons spend adapting to different devices during surgery, improving surgical efficiency.

[0078] The use of standardized calibration components simplifies the manufacturing process, as these parts can be produced using uniform molds and manufacturing processes. This not only reduces production costs but also helps maintain consistent product quality.

[0079] Furthermore, in some preferred embodiments of the present invention, the first calibration component 31, the second calibration component 32, and the third calibration component 33 are arc-shaped or L-shaped.

[0080] For details, see Figure 8 The diagram shown is a shape schematic of a calibration component provided by an embodiment of the present invention. The calibration component can be designed as a semi-circle, ellipse or L-shape.

[0081] Furthermore, the main body of the calibration component is an extruded polymer tube, specifically made of materials such as polyether block amide, TPU, and PE.

[0082] Furthermore, in some preferred embodiments of the present invention, the first mapping component 31, the second mapping component 32, and the third mapping component 33 are strip-shaped or petal-shaped.

[0083] Specifically, the forward projection of the mapping component provided in this embodiment of the invention is a strip-shaped rectangle, and it can also be extended to be an ellipse or petal-shaped irregular shape.

[0084] See Figure 9 The embodiment of the present invention shown provides a mapping component that is a petal-shaped variable density mapping catheter. The petals of the mapping catheter are spherical after unfolding, which better fits the anatomical structure of the pulmonary veins. It can measure the pulmonary veins without the need for the doctor to replace it with a ring-shaped mapping catheter specifically for measuring pulmonary veins during the operation, which simplifies the operation and greatly shortens the operation time.

[0085] Furthermore, in some preferred embodiments of the present invention, N≠K≠M.

[0086] Specifically, setting different numbers of mapping electrodes on different mapping components can be applied to various measurement scenarios. During the initial scan, a mapping component with fewer mapping electrodes can be selected for a large-area, coarse, and rapid scan. To meet other measurement requirements, the mapping component can be rotated by rotating the operating unit. In some preferred embodiments of the invention, rotating the operating unit exposes more electrodes, thereby enabling more precise scanning based on a larger number of mapping electrodes.

[0087] Furthermore, in some preferred embodiments of the present invention, N > K > M.

[0088] Specifically, the second mapping component 32 has 5 electrodes evenly distributed within a 40mm length range, which can map the heart within a 40mm range. However, each electrode is spaced 10mm apart. If there are abnormal potentials within this 10mm range, it is not easy to detect them accurately.

[0089] At this point, a higher density mapping catheter can be used, such as a third mapping catheter with 11 electrodes in the third mapping component 33, with a 4mm spacing between each electrode, which can achieve a mapping accuracy of 4mm.

[0090] Furthermore, the first calibration conduit with 21 electrodes within the first calibration component 31 can be replaced, with each electrode spaced 2mm apart, thus achieving a calibration accuracy of 2mm.

[0091] With high electrode density and a large number of electrodes, the algorithm time on the device is also longer. Therefore, a catheter with low electrode density can be used at the beginning to quickly map the entire heart. When a potentially abnormal area is found, a catheter with high precision can be used instead.

[0092] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit them. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A variable density mapping catheter, characterized in that, include: The device includes an operating handle, a catheter body, and a mapping unit, wherein the mapping unit comprises a first mapping component and a second mapping component; The operating handle includes a first operating part and a second operating part arranged coaxially. The first operating part is located near the second operating part, and the first operating part can rotate relative to the second operating part about an axis. The catheter body includes an outer tube and an inner tube. The proximal end of the outer tube is fixedly connected to the second operating part. The inner tube is coaxially inserted inside the outer tube and its two ends protrude from the two ends of the outer tube, respectively. The proximal end of the inner tube is fixedly connected to the first operating part. The first calibration assembly includes a first support member and M first electrodes disposed on the surface of the first support member. The first support member is made of an elastic material, and the first calibration assembly is fixedly connected to the outer sleeve through a first end of the first support member. The second calibration assembly includes a second support member and N second electrodes disposed on the surface of the second support member. The second support member is made of an elastic material, and the second calibration assembly is fixedly connected to the inner tube through a first end of the second support member. The first mapping component can rotate about the first end of the first support member toward the proximal end of the catheter body until it is parallel to and attached to the outer wall of the catheter body; the second mapping component can rotate about the first end of the second support member toward the proximal end of the catheter body until it is parallel to and attached to the outer wall of the catheter body. In its natural state, the end of the first mapping component opposite to the first end extends outward, and the end of the second mapping component opposite to the first end extends outward, forming a petal-like structure; Rotating the first operating part relative to the second operating part can drive the second mapping component to rotate relative to the first mapping component through the inner tube, thereby changing the distance between the M first electrodes on the first mapping component and the N second electrodes on the second mapping component; M≥1, N≥1.

2. The variable density mapping catheter according to claim 1, characterized in that, The mapping catheter also includes M first guide wires and N second guide wires. The outer tube has a first guide wire cavity inside its side wall, and the inner tube has a second guide wire cavity. After M first leads are connected to M first electrodes respectively, they are connected to an external ECG detection device through the first lead cavity. After N second leads are connected to N second electrodes respectively, they are connected to an external ECG detection device through the second lead cavity.

3. The variable density mapping catheter according to claim 2, characterized in that, The operating handle further includes a third operating part, which is located between the first operating part and the second operating part, and the third operating part is rotatable about an axis relative to the first operating part and the second operating part; The catheter body also includes an intermediate tube, which is inserted between the outer tube and the inner tube, and the proximal end of the intermediate tube is fixedly connected to the third operating part. The calibration unit further includes a third calibration component, which includes a third support member and K third electrodes disposed on the surface of the third support member. The third support member is made of an elastic material, and the third calibration component is fixedly connected to the outer sleeve through the first end of the third support member. The third mapping component can rotate around the first end of the third support towards the proximal end of the catheter body until it is parallel and attached to the outer wall of the catheter body. In its natural state, the end of the third mapping component opposite to the first end extends outward to form a petal-shaped structure. Rotating the third operating unit relative to the second operating unit and the first operating unit can drive the third measurement component to rotate relative to the first measurement component and the second measurement component through the intermediate tube; The mapping catheter also includes K third leads. The middle tube has a third lead cavity in its side wall. The K third leads are connected to K third electrodes respectively, and then connected to an external electrocardiogram monitoring device through the third lead cavity. K≥1.

4. The variable density mapping catheter according to claim 1, characterized in that, The mapping catheter also includes a third mapping component, which includes a third support and K third electrodes disposed on the surface of the third support. The third support is made of an elastic material, and a collar is provided at the first end of the third support. The third mapping component is sleeved between the outer tube and the inner tube through the collar, and is located axially between the first mapping component and the second mapping component.

5. The variable density mapping catheter according to claim 4, characterized in that, The upper end wall of the collar is provided with a track groove extending in the circumferential direction; the second measuring component also includes a tube head, which is coaxial with and fixedly connected to the inner tube; the second support member is fixedly connected to the tube head; The bottom wall of the tube head is provided with a downward protruding lever. The lever can be inserted into the track groove. When the second operating part is rotated relative to the first operating part, the lever can move from one end of the track groove to the other end along the extension direction of the track groove, and then drive the third measuring component to rotate circumferentially.

6. The variable density mapping catheter according to claim 5, characterized in that, The arc of the track groove is 120 degrees.

7. The variable density mapping catheter according to claim 3, characterized in that, The first, second, and third mapping components have the same shape.

8. The variable density mapping catheter according to claim 7, characterized in that, The first, second, and third calibration components are arc-shaped or L-shaped.

9. The variable density mapping catheter according to claim 7, characterized in that, The first, second, and third mapping components are strip-shaped or petal-shaped.

10. The variable density mapping catheter according to claim 3, characterized in that, N≠K≠M.

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