High-density mapping catheter

Abstract

The present disclosure provides a high-density mapping catheter. The catheter device of the present disclosure can include a handle, a tube body, a steering structure and a mapping head. The tube body includes a proximal tube body and a distal tube body. The steering structure is used to control the distal tube body to bend in two directions. The mapping head is installed at the distal end of the distal tube body, and has a whole sheet shape, including a support sheet (42) and a flexible electrode film (43). The support sheet (42) is designed as a hollow structure, and the ribs formed by the hollow pattern are interlaced to form a net structure. The flexible electrode film (43) is integrated with electrodes (41) arranged in a horizontal and vertical array, which are used to cooperate with the bending of the distal tube body to perform signal mapping in different directions. The electrodes (41) are symmetrically distributed on both sides of the mapping head (4). In the high-density mapping catheter provided by the present disclosure, the electrodes (41) are arranged in a horizontal and vertical array, which is more efficient than the linear mapping of the prior art.

Description

Technical Field

[0001] This disclosure relates to electrophysiological catheter technology, specifically to a high-density mapping catheter for cardiac electrophysiological mapping. Background Technology

[0002] The electrophysiological activity of the heart is the orderly conduction of electrical signals within the heart. Accurate mapping of electrocardiogram (ECG) signals is beneficial for clarifying the conduction mechanism of local ECG signals and quickly and precisely locating lesions. This is particularly important in the diagnosis of complex arrhythmias. Accurate mapping of local tissues depends on many factors, such as a higher electrode density in the mapping catheter, a greater number of electrodes, relatively stable electrode positions, and good contact between the electrodes and the cardiac tissue.

[0003] The electrophysiological activity of the heart involves the multidirectional transmission of electrical signals across the curved surfaces of the heart chambers, which ordinary one-dimensional mapping catheters can no longer meet. Surface-shaped structures can, to some extent, compensate for the shortcomings of linear mapping catheters, and their manufacturing process is relatively simple, making them more flexible in use and basically meeting the mapping needs of different parts of the heart chambers.

[0004] However, most current surface mapping catheters still employ the traditional linear catheter electrode mounting method, where a ring electrode is fitted onto the catheter shaft to form an electrode arm, and multiple electrode arms are then combined to form the surface mapping area. For high-density mapping catheters with small electrodes and a large number of electrodes, this structure is inefficient during fabrication. Furthermore, the stability of the electrode spacing in the combination of multiple electrode arms still needs improvement. During the process of electrode contact with tissue, the electrode spacing between the electrode arms may change, affecting mapping accuracy. If the electrode spacing in all directions of high-density mapping catheters can be further stabilized, and combined with contact detection and positional morphology display, it will be more conducive to accurate mapping of local tissues. Summary of the Invention

[0005] The purpose of this disclosure is to provide a high-density mapping catheter for cardiac electrophysiological mapping to address the aforementioned problems.

[0006] According to a first aspect of this disclosure, a catheter device is provided. The catheter device may include: a handle; a tube body including a proximal tube body and a distal tube body; a control structure for controlling the distal tube body to bend bidirectionally; and a mapping head end, mounted on the distal end of the distal tube body, which is generally sheet-like and includes a support sheet and a flexible electrode membrane. The support sheet has a hollow design, and the ribs formed by the hollow pattern interweave to form a mesh structure. The flexible electrode membrane integrates electrodes arranged in a horizontal and vertical array for signal mapping in different orientations in conjunction with the bending of the distal tube body. The electrodes are symmetrically distributed on both sides of the mapping head end (4).

[0007] In the catheter device according to the first aspect of this disclosure, preferably, the electrodes arranged in a transverse and longitudinal array on the flexible electrode membrane have the same spacing between adjacent electrodes in the transverse and / or longitudinal directions.

[0008] In the catheter device according to the first aspect of this disclosure, preferably, the support sheet is made of a soft and elastic material.

[0009] In the conduit device according to the first aspect of this disclosure, preferably, the support sheet has a hollow design, and the ribs formed by the hollow pattern interweave to form a mesh structure.

[0010] Preferably, the lateral and longitudinal support forces formed by the hollow pattern are different, which makes the support piece easy to contract in the lateral direction perpendicular to the catheter axis and has stronger support in the longitudinal direction parallel to the catheter axis.

[0011] In the catheter device according to the first aspect of this disclosure, preferably, the cross-section of the distal end of the support piece is not greater than the cross-section of the proximal end of the support piece.

[0012] In the catheter device according to the first aspect of this disclosure, preferably, the flexible electrode film is symmetrically distributed on both sides of the support sheet, and, centered on the support sheet, comprises, from the inside out: a conductive layer, serving as a distribution layer for electrodes and electrical traces; and a protective layer, covering the conductive layer, for isolating and protecting the electrical traces. The protective layer is designed with a perforated structure, allowing the electrodes to be exposed through the perforations for contact with tissue.

[0013] Preferably, the flexible electrode film may further include a base layer formed between the support sheet and the conductive layer, for carrying the conductive layer and keeping the conductive layer insulated from the support sheet.

[0014] Preferably, the distribution area of ​​the substrate layer is within the distribution area of ​​the conductive layer, and the distribution area of ​​the substrate layer is smaller than the distribution area of ​​the conductive layer.

[0015] In the catheter device according to the first aspect of this disclosure, preferably, the electrodes are symmetrically distributed on both sides of the probe end.

[0016] In a preferred embodiment, the electrodes that are corresponding to each other and symmetrical about the support plate on both sides of the end of the probe can be electrically connected.

[0017] On the other hand, when one electrode on one side of the probe tip is in contact with tissue, one or more electrodes on the other side can serve as reference electrodes for tissue contact detection. In this case, the reference electrode and its corresponding electrode on the opposite side are not electrically connected.

[0018] In the catheter device according to the first aspect of this disclosure, preferably, the catheter device may further include one or more positioning sensors. Preferably, the positioning sensors are located at the junction of the distal tube body and the probe tip.

[0019] In the catheter device according to the first aspect of this disclosure, preferably, the thin sheet formed at the end of the probe is asymmetrical on the two edges at the proximal end.

[0020] In the catheter device according to the first aspect of this disclosure, preferably, the catheter device is a mapping catheter for cardiac electrophysiological mapping.

[0021] As mentioned earlier, high-density mapping catheters have smaller electrode sizes and a larger number of electrodes compared to ordinary electrophysiological catheters, making traditional electrode installation methods inefficient and uneconomical. The high-density mapping catheter provided in this disclosure features electrodes arranged in a transverse and longitudinal array, resulting in higher efficiency compared to the linear mapping techniques of existing technologies. Furthermore, this disclosure also provides solutions to the problems of complex catheter manufacturing processes and the need for improvement in precise mapping. Attached Figure Description

[0022] This disclosure includes accompanying drawings, which are to be considered as included in and form part of the specification, and together with the specification illustrate various exemplary embodiments, features, and aspects of the disclosure and serve to explain the principles of the disclosure. The disclosure will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, wherein similar elements are numbered in a similar manner. Wherein:

[0023] Figure 1 This is a schematic diagram of the overall structure of a high-density mapping catheter according to an embodiment of the present disclosure.

[0024] Figure 2 This is a schematic diagram of the detection and calculation of electrical signals in the horizontal and vertical directions.

[0025] Figure 3A This is an example of a support sheet structure.

[0026] Figure 3B This is another example of a support sheet structure.

[0027] Figure 3C This is yet another example of a support sheet structure.

[0028] Figure 4 This is a schematic diagram of the multi-layer structure of the measuring head.

[0029] Figure 5 This is a schematic diagram of the electrode distribution on the two calibration surfaces at the end of the calibration head.

[0030] Figure label:

[0031] 1 handle

[0032] 2 tube body

[0033] 21 Proximal tube body

[0034] 22 distal tube body

[0035] 221 distal end of the distal tube body

[0036] 3 Control Structure

[0037] 4-point probe end

[0038] 40 electric traces

[0039] 41 electrodes

[0040] 41a electrode

[0041] 41b electrode

[0042] 41C electrode

[0043] V ab Potential

[0044] V ac Potential

[0045] The direction of the actual potential α

[0046] 42 support plates

[0047] 420 support plate distal end

[0048] 421 tendon

[0049] 422 Proximal end of the support plate

[0050] 43 Flexible electrode film

[0051] 431 basal layer

[0052] 432 conductive layer

[0053] 433 protective layer

[0054] 6 positioning sensors

[0055] A38 electrode

[0056] B38 electrode Detailed Implementation

[0057] The technical solutions of this disclosure will be further described in detail below through embodiments and in conjunction with the accompanying drawings. However, the scope of the technical solutions of this disclosure and the scope of protection claimed are not limited to the following embodiments.

[0058] Various exemplary embodiments, features, and aspects of this disclosure will now be described in detail with reference to the accompanying drawings. The same reference numerals in the drawings denote elements that have the same or similar functions. Although various aspects of the embodiments are shown in the drawings, they are not necessarily drawn to scale unless specifically indicated otherwise.

[0059] The term “exemplary” as used herein means “serving as an example, embodiment, or illustration.” Any embodiment illustrated herein as “exemplary” is not necessarily to be construed as superior to or better than other embodiments.

[0060] Furthermore, to better illustrate this disclosure, numerous specific details are provided in the following detailed embodiments. Those skilled in the art should understand that the technical solutions of this disclosure can be implemented even without certain specific details. In some instances, methods, means, components, and circuits well known to those skilled in the art have not been described in detail in order to highlight the main points of this disclosure.

[0061] In general, this disclosure provides a catheter device. More specifically, this disclosure provides a mapping catheter for cardiac electrophysiological mapping.

[0062] Figure 1 This is a schematic diagram of the overall structure of a high-density mapping catheter according to an embodiment of the present disclosure.

[0063] The high-density mapping catheter disclosed herein includes a handle 1, a tube body 2, a control structure 3, and a mapping tip 4. The tube body 2 includes a proximal tube body 21 and a distal tube body 22.

[0064] Those skilled in the art should understand that the so-called "proximal end" refers to the end closer to the surgeon, and the so-called "distal end" refers to the end farther from the surgeon, which is generally the end that is inserted into the patient's body and closer to the tissue.

[0065] The distal tube 22 can be bent in both directions under the control of the control structure 3. For example... Figure 1 As shown by the dotted line, under the control of the control structure 3, the distal tube 22 can bend in one of two directions, thereby enabling it to better fit against the tissue.

[0066] The calibration head 4 is installed at the distal end 221 of the distal tube 22, and is generally sheet-shaped, including a support sheet 42 and a flexible electrode film 43 (see...). Figure 4 The support sheet 42 has a hollow design, with varying support strength in the horizontal and vertical directions, gradually increasing in strength from the distal to the proximal end. Electrodes 41, arranged in a horizontal and vertical array, are integrated on the flexible electrode film 43 (see...). Figure 4 and Figure 5 It can be used to perform signal calibration in different directions by bending the distal tube 22.

[0067] Those skilled in the art should understand that the two directions in which the distal tube can be bent are the directions of the two sides of the sheet-like probe tip, thereby allowing one of the two sides of the probe tip to better adhere to the tissue to be mapped.

[0068] Furthermore, the lateral direction mentioned in this disclosure refers to the direction perpendicular to the catheter axis; the longitudinal direction refers to the direction parallel to the catheter axis, that is, the slender direction in which the catheter extends.

[0069] Figure 2 This is a schematic diagram of transverse and longitudinal electrical signal detection and calculation. Electrical signal conduction in the heart is directional. The potential difference between electrodes is greatest when the line connecting the electrodes in the electrode array is parallel to the signal conduction direction; conversely, the potential difference is smallest when the line is perpendicular to the signal conduction direction, thus negligible signal conduction. Therefore, signal acquisition in a single direction cannot meet the needs of high-density mapping. Figure 1 The diagram shows the overall structure of the probe tip. The probe tip is mounted on the distal end 221 of the distal tube body, and is generally sheet-like, gradually tapering towards the distal tube body. Electrodes 41 are distributed on both sides of the probe tip, arranged in an array along the transverse and longitudinal directions. Figure 2 As shown, if the three adjacent electrodes in the horizontal and vertical directions are labeled as electrode 41a, electrode 41b, and electrode 41c respectively, then the measuring head end 4 can simultaneously acquire the potential V in the horizontal and vertical directions. ab and V ac The potential is then transmitted to the processing equipment via wires and connectors (not shown). The processing equipment calculates the potential vectors in both the horizontal and vertical directions to determine and indicate the magnitude and direction α of the actual potential.

[0070] The horizontal and vertical array distribution described herein refers to the electrodes being arranged in rows or columns. It should be noted that the spacing between the rows and columns of electrodes can be equidistant or non-equidistant. In a preferred embodiment, the electrodes 41 arranged in the horizontal and vertical array on the flexible electrode film 43 have the same spacing between adjacent electrodes in the horizontal and / or vertical directions. In other words, in the arrayed electrodes, the spacing between adjacent electrodes in the horizontal direction is the same (equal), or the spacing between adjacent electrodes in the vertical direction is the same (equal), or the spacing in both the horizontal and vertical directions is the same (equal).

[0071] The horizontal and vertical array distribution of the electrodes, combined with the multi-layer structure of the flexible thin film mentioned later, ensures that the electrode positions are relatively fixed, the electrode spacing is more stable, and the calibration is more accurate.

[0072] As previously described, the probe tip 4 may include a support sheet 42 and a flexible electrode film 43. The support sheet 42 is made of a soft and elastic material, such as a thermoplastic elastomer or a highly elastic nickel-titanium alloy. The support sheet 42 provides the basic shape for the entire flexible probe tip 4, allowing the probe tip 4 to deform in response to external forces and return to its original shape after the external forces are removed. The support sheet 42 features a hollow design, with the hollowed-out pattern forming interwoven ribs that create a mesh structure.

[0073] Figure 3A , Figure 3B and Figure 3C These are schematic diagrams of three types of perforated support plates. The perforated patterns create different lateral (perpendicular to the catheter axis) and longitudinal (parallel to the catheter axis) support forces, making the support plate easy to contract laterally while providing strong longitudinal support. Furthermore, the cross-section of the distal end 420 of the support plate 42 is no larger than the cross-section of the proximal end 422, ensuring relatively balanced force on the electrodes distributed on both ends of the probe tip during use. Under the action of the support plate 42, the probe tip 4 can adapt to tissue deformation upon contact, allowing the surface-distributed electrodes 41 to conform well to the tissue, and simultaneously contract laterally (e.g., curling or folding) to a smaller size for insertion into the sheath. Laterally and longitudinally distributed ribs 421 ensure that the probe tip 4 is not stretched, thus facilitating a constant electrode spacing in both directions. The probe tip 4 is attached to the distal end 22 of the tube body and is a relatively soft and easily deformable component compared to the tube body 2. During use, all movements are transmitted to the probe tip 4 through the tube body 2. Therefore, the further away from the tube body 2, the larger its lever arm. In order to make the contact force between all electrodes 41 on the probe end 4 and the tissue more even, the cross-section of the distal end 420 of the support plate 42 is not larger than the cross-section of the proximal end 422 of the support plate 42.

[0074] Here, those skilled in the art should recognize that the support structure of the support sheet 42 is not limited to a strip shape; it can have ribs 421 in both the transverse and longitudinal directions, which is more conducive to maintaining a constant electrode spacing in the transverse and longitudinal directions. The distribution of the ribs in the transverse and longitudinal directions is oriented, without affecting transverse curling or folding. The shape and thickness of the strip can be gradually varied, becoming softer towards the distal end, resulting in a more uniform contact force between the electrode and the tissue.

[0075] The support plate 42 defines the basic outline of the entire mapping tip. The initial overall outline of the mapping tip 4 is a soft, smooth, leaf-like shape. The proximal end of the mapping tip 4 gradually converges and connects with the distal tube 22, reducing resistance to entry and exit from the sheath. After the proximal end contracts (curls or folds) into the sheath, the middle and distal ends of the mapping tip 4 deform accordingly. For example, the mapping tip 4 may be laterally curled into a smaller cylindrical shape and enter the sheath longitudinally. Correspondingly, when the mapping tip 4 exits the sheath longitudinally, it rapidly unfolds into its original sheet-like structure due to the resilience of the support plate 42 and the flexible electrode film 43.

[0076] Figure 4 This is a schematic diagram of the multi-layer structure of the measuring head.

[0077] The flexible electrode film 43 has a multilayer structure and is symmetrically distributed on both sides of the support sheet 42. For example... Figure 4 As shown, with the support sheet 42 as the center, from the inside out are the base layer 431, the conductive layer 432 and the protective layer 433.

[0078] The substrate layer 431 is used to support the conductive layer 432 and keep the conductive layer 432 insulated from the support sheet 42. The conductive layer 432 is the distribution layer of the electrode 41 and the electrical trace 40. The protective layer 433 is used to protect the electrical trace 40 and insulate the electrical trace 40 from the outside environment. Figure 4 The electrode and electrical traces are distributed in the same layer. In reality, the flexible electrode film can have more layers, such as alternating insulating and conductive layers. Electrodes and electrical traces can be distributed in different conductive layers, and even in cases with a large number of electrical traces, they can be arranged in multiple layers.

[0079] The conductive layer 432 is the distribution layer for the electrodes 41 and the electrical traces 40. It is made of a material with good conductivity, such as gold, silver, platinum, copper, or their alloys, or a non-metallic material with excellent conductivity, such as graphene. Preferably, the material of the conductive layer 432 is gold, or gold-plated silver and copper, to obtain better flexibility, conductivity, and corrosion resistance. The pattern of the conductive layer 432 and the bonding method with the substrate layer 431 are well-known technologies in the industry. For example, the conductive material is bonded to the substrate layer 431 by adhesive or deposition, and then the desired pattern is created by etching or engraving techniques. Alternatively, liquid conductive material can be directly printed onto the substrate layer 431, and the desired circuit is obtained after curing.

[0080] A protective layer 433 covers the conductive layer 432 and serves to isolate and protect the electrical traces 40. The protective layer 433 has a perforated design, with electrodes 41 exposed through the perforations for easy contact with tissue. Here, the perforation design of the protective layer 433 needs to be coordinated with the electrode array so that all electrodes 41 are properly exposed. In other words, the array of perforated points in the protective layer 433 is consistent with the horizontal and vertical array of the electrodes 41.

[0081] The flexible electrode film 43 and the support sheet 42, as well as the layers of the flexible electrode film 43, can be fixed together to form a whole by one or more of the following methods: pressing, bonding, and hot melting.

[0082] It should also be noted that the support sheet 42 and the base layer 431 are not necessarily required to coexist. When the support sheet 42 is a thermoplastic elastomer, the conductive layer 432 can be directly bonded to the support sheet 42. That is, in this case, the base layer 431 is not required.

[0083] Because the substrate (i.e., "base layer 431") used in flexible electrode films 43 is generally quite rigid, if it is mounted as a single piece on the support sheet 42, the force required for lateral retraction into the smaller sheath, while ensuring sufficient support strength during calibration, will be relatively large. This is because although the support sheet 42 has an orientation (it provides support during deflection and facilitates lateral retraction), the electrode film is a single unit, and its rigidity affects the entire calibration surface. In this case, the following two preferred embodiments can be used to improve the sheath entry / exit resistance:

[0084] In a preferred embodiment, the blade profile is asymmetrically distributed near the proximal end; that is, the thin sheet formed by the measuring head end 4 is asymmetrical on its two proximal edges to facilitate smoother entry into the sheath. Upon entry into the sheath, the two edges near the proximal end of the measuring head end 4 will curl first. Due to the asymmetry of the two edges, the degree of curling differs, allowing the two edges to be staggered to avoid collision and difficulty in curling.

[0085] In another preferred embodiment, the distribution area of ​​the rigid substrate layer 431 is minimized. The function of the substrate layer 431 is to support the conductive layer 432 and provide good insulation between it and the support sheet. The substrate layer 431 can be present only within a certain range of the conductive layer 432 distribution area, with the rest removed. That is, the distribution area of ​​the substrate layer 431 is within the distribution area of ​​the conductive layer 432, and the distribution area of ​​the substrate layer 431 is smaller than the distribution area of ​​the conductive layer 432. This minimizes the rigidity of the film. Without affecting the insulation, the flexibility of the measuring head 4 can be increased.

[0086] As described above, the mapping head 4 has electrodes 41 distributed on both sides, allowing for the acquisition of electrophysiological signals from both sides. The electrodes 41 are symmetrically distributed on both sides, and their size, number, and spacing can be adjusted as needed. Figure 5 This is a schematic diagram of the electrode distribution on the two calibration surfaces at the end of the calibration head. (See diagram below.) Figure 5As shown, the flexible electrode films 43 on both sides of the mapping tip 4 are unfolded and laid flat along the catheter axis to obtain two mapping planes, A and B. The electrode in the x-th row and y-th column of plane A can be named Axy, and the electrode in the x-th row and y-th column of plane B can be named Bxy. Axy and Bxy correspond to each other and are symmetrical about the support sheet 42. The corresponding electrodes on both sides of the mapping tip 4, symmetrical about the support sheet 42, can be electrically connected; for example, A11 and B11 are electrically connected, and A12 and B12 are electrically connected. Thus, the potentials collected by the two corresponding electrodes on both sides are the same, equivalent to one electrode. The purpose of this design is that, in actual use, the probability of both sides simultaneously contacting the tissue is small; in most cases, only one side is in contact with the tissue. Connecting the two symmetrical electrodes on both sides can reduce the amount of data processing and improve computational efficiency. Furthermore, in actual use, the electrical signal of the same electrode area can be observed without switching channels, which is beneficial for the surgeon to quickly select effective mapping information. In other words, interconnecting symmetrical electrodes can improve the utilization efficiency of electrode and supporting equipment resources.

[0087] Furthermore, the high-density mapping catheter described above, with the aid of a supporting system, can also identify the contact relationship between the electrodes and the tissue. Simply put, the system collects impedance information of the surrounding tissue at different frequencies through each electrode, and then calculates the frequency response coefficient of each electrode's location. Because the impedance responses of heart tissue and blood to frequency differ, it can identify whether the electrodes are in contact with the heart tissue. An example of a detailed detection method can be found in Chinese Invention Patent Application Publication CN115886976A, the entire contents of which are incorporated herein by reference and become part of this disclosure.

[0088] It is worth noting that in tissue contact detection methods based on the principle of different frequency responses to different biological tissue impedances, the selection of the reference electrode is particularly important. As is well known, different parts of the heart have different tissue impedances and different surrounding environments. If the reference electrode and the detection electrode are too far apart, it cannot provide an accurate reference for the detection process and eliminate possible interference factors. The high-density mapping catheter disclosed in this invention has electrodes distributed on both planes A and B at its mapping tip 4. When one plane contacts the tissue for signal acquisition, the electrode on the other plane is essentially in a non-contact state. In this way, the electrodes on planes A and B can serve as reference electrodes for each other in tissue contact detection. Compared with traditional electrode-tissue contact detection methods based on impedance or phase data statistical analysis, this method offers higher reliability.

[0089] Therefore, not all corresponding electrodes at the aforementioned calibration head end 4 need to be interconnected. For example, Figure 5Electrodes A38 and B38 in the probe tip are unlikely to simultaneously adhere to tissue and can be connected independently to the accompanying equipment. Thus, when one side of the probe tip 4 is adhered to the tissue, for example, when signal acquisition is performed using the electrode on side A, electrode B38 on the other side can serve as a reference electrode for tissue adhesion detection. Similarly, when the probe tip B is adhered to the tissue, i.e., when signal acquisition is performed using the electrode on side B, electrode A38 on the opposite side can serve as a reference electrode for tissue adhesion detection. However, it is clear that the reference electrode B38 (or A38) is not electrically connected to its corresponding counterpart on the opposite side. A38 and B38 are merely examples; the number and position of reference electrodes are not unique and can be selected as needed. In other words, the electrodes can serve as reference electrodes for each other due to their specific positional relationship, improving the accuracy of tissue adhesion detection.

[0090] As described above, the mapping catheter can be equipped with one or more positioning sensors 6 at locations within the mapping plane or at the distal end of the catheter. Each positioning sensor 6 is connected to a connector. When the catheter is electrically connected to the accessory device, the positional data collected by the positioning sensors 6 is transmitted to the accessory device via the connector. After calculation and processing, the operator can visualize the position and shape of the mapping tip 4 within the patient's body. The number and location of the positioning sensors 6 can be selected as needed. At least one positioning sensor 6 is present at the junction of the distal catheter body 22 and the mapping tip 4. Figure 5 As shown, plane A also illustrates the possible positional relationship between the positioning sensor 6 and the electrode 41. Impedance detection combined with morphological visualization allows the surgeon to clearly identify the contact and positional relationship between each electrode and the tissue during use, which will greatly facilitate the surgeon's control and mastery of the precise model.

[0091] The tube body 2 has a multi-segment structure, internally housing wires, traction mechanisms, etc. The distal tube body 22 is a multi-lumen flexible tube, with its distal end 221 housing the traction mechanism. The traction wire runs through the entire tube body 2 and is connected to the control structure 3. By controlling the control structure 3, the distal tube body 22 can be deflected in two directions perpendicular to the mapping plane. This allows switching between the two mapping surfaces in contact with the tissue without rotating the tube body 2.

[0092] Furthermore, as mentioned earlier, the probe tip 4 contains an electrical trace. In one embodiment of this disclosure, the electrical trace 40 in the probe tip 4 only extends to the distal tube body 22, and typically needs to be connected to the connector via a wire in the tube body 2. In other embodiments, the electrical trace can be made long enough to extend directly from the tube body to the connector, further simplifying the catheter manufacturing process.

[0093] Therefore, the high-density mapping catheter device provided in this disclosure can have the following technical effects:

[0094] 1. Integrating electrodes into a flexible thin film simplifies the electrode installation process for multi-electrode conduits and improves production efficiency.

[0095] 2. The catheter device disclosed herein has a unique support structure and an integral sheet-like mapping area, which makes the electrode position relatively fixed, the electrode spacing more stable, and the mapping more accurate.

[0096] 3. The electrodes are printed on both sides and are interconnected. This achieves double-sided calibration without increasing the amount of data processing or consuming more equipment resources.

[0097] 4. The unique electrode position relationship and reference electrode selection make it easier to accurately identify the adhesion relationship between the electrode and the tissue.

[0098] The embodiments of this disclosure have been described above. These descriptions are exemplary and not exhaustive, and the scope of this disclosure is not limited to the embodiments described above. Many modifications and variations will be apparent to those skilled in the art without departing from the spirit and scope of this disclosure. That is, those skilled in the art can make various changes and improvements to this disclosure in form and detail, and all of these are considered to fall within the protection scope of this disclosure. The terminology used herein is chosen to best explain the principles, practical applications, or improvements to the technology in the market of the embodiments, or to enable those skilled in the art to understand the embodiments disclosed herein.

Claims

1. A catheter device, characterized in that, The catheter device includes: Handle (1); The tube body (2) includes a proximal tube body (21) and a distal tube body (22); The control structure (3) is used to control the distal tube (22) to bend in both directions; The measuring head (4) is installed at the distal end (221) of the distal tube (22), and is in the shape of a thin sheet, including a support sheet (42) and a flexible electrode film (43). The support piece (42) has a hollow design, and the ribs formed by the hollow pattern interweave to form a mesh structure. The flexible electrode film (43) is integrated with electrodes (41) arranged in a horizontal and vertical array, which are used to perform signal calibration in different directions in conjunction with the bending of the distal tube (22). The electrodes (41) are symmetrically distributed on both sides of the probe end (4), wherein the corresponding electrodes on both sides of the probe end (4) and symmetrical about the support plate (42) are electrically connected. The flexible electrode film (43) is symmetrically distributed on both sides of the support sheet (42), with the support sheet (42) as the center.

2. The catheter device according to claim 1, characterized in that, The electrodes (41) arranged in a transverse and longitudinal array on the flexible electrode film (43) have the same spacing between adjacent electrodes in the transverse and / or longitudinal directions.

3. The catheter device according to claim 1, characterized in that, The support sheet (42) is made of a soft and elastic material.

4. The catheter device according to claim 1, characterized in that, The different lateral and longitudinal support forces formed by the hollow pattern make the support piece (42) easy to contract in the lateral direction perpendicular to the catheter axis and have stronger support in the longitudinal direction parallel to the catheter axis.

5. The catheter device according to claim 1, characterized in that, The cross-section of the distal end (420) of the support piece (42) is not greater than the cross-section of the proximal end (422) of the support piece (42).

6. The catheter device according to claim 1, characterized in that, The flexible electrode film (43) is symmetrically distributed on both sides of the support sheet (42), and from the inside to the outside, it includes the following components with the support sheet (42) as the center: The conductive layer (432) is a distribution layer of electrodes (41) and traces (40); A protective layer (433) covers the conductive layer (432) and is used to isolate and protect the electrical traces (40). The protective layer (433) is designed with a cutout so that the electrodes (41) are exposed from the cutouts to make contact with the tissue.

7. The catheter device according to claim 6, characterized in that, The flexible electrode film (43) further includes a base layer (431) formed between the support sheet (42) and the conductive layer (432) for carrying the conductive layer (432) and keeping the conductive layer (432) insulated from the support sheet (42).

8. The catheter device according to claim 7, characterized in that, The distribution area of ​​the base layer (431) is within the distribution area of ​​the conductive layer (432), and the distribution area of ​​the base layer (431) is smaller than the distribution area of ​​the conductive layer (432).

9. The catheter device according to claim 1, characterized in that, The catheter device further includes: One or more positioning sensors (6).

10. The catheter device according to claim 9, characterized in that, The positioning sensor (6) is located at the junction of the distal tube body (22) and the measuring head end (4).

11. The catheter device according to claim 1, characterized in that, The thin sheet formed by the end of the measuring head (4) is asymmetrical on the two edges near the end.

12. The catheter device according to claim 1, characterized in that, The catheter device is a mapping catheter used for cardiac electrophysiological mapping.

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