A mapping catheter

Abstract

The present invention relates to the technical field of electrophysiological catheters, and in particular to a mapping catheter, comprising a mapping head end, the mapping head end comprising a support sheet and an electrode membrane, the support sheet being a flexible and elastic member, the support sheet being a hollow design, the two ends of a plurality of support arms formed by the hollowing out respectively intersecting at one place, the electrode membrane being provided with a plurality of electrode sheets and electric traces, a plurality of the electrode sheets being arranged along the support arms, the electric traces being arranged along the positions of the support arms, the width of the support arms being greater than the thickness of the support arms, the electrode membrane being arranged on both sides of the support sheet, the electrode membrane comprising, from the inside to the outside, an insulating layer, a conductive layer and a protective layer, a plurality of the electrode sheets and the electric traces being arranged on the electrode membrane through the conductive layer, and the width of the electrode sheets and the width of the electric trace bundle being less than the width of the support arms. Through this arrangement, the complexity of the electric trace wiring is reduced, making the use of the mapping head end more convenient.

Description

Technical Field

[0001] The present invention relates to the technical field of electrophysiological catheters, and in particular to a mapping catheter. Background Art

[0002] The electrophysiological activity of the heart is the process of orderly conduction of electrical signals in the heart. Abnormal electrical conduction may cause arrhythmias. Electrophysiological mapping and ablation of cardiac tissue are commonly used methods to treat arrhythmias.

[0003] The current electrophysiological mapping catheter's mapping tip generally has two forms: basket-shaped and paddle-shaped. The basket-shaped mapping tip is generally composed of a number of arms, and the two ends of each arm meet at two points of the catheter respectively. The mapping tip is deformed by bending the arms. Since this mapping tip is formed by independent arm components connected to the catheter, each arm will inevitably shift due to force during use, causing the distance between the arms to change, thereby affecting the spacing of the electrodes on the arms and reducing the mapping accuracy. At the same time, when installing the electrodes on this mapping tip, the electrodes need to be installed on each arm one by one, which has low production efficiency and high cost.

[0004] The paddle-shaped mapping tip is generally a sheet-like component shaped like a paddle. The sheet-like component is hollowed out, and the ribs formed by the hollow pattern are a criss-cross network. The electrodes are arranged on the ribs. Since the ribs of the sheet-like structure are integrally formed through the hollow design, the spacing between the ribs is difficult to change during use, so that the spacing between the electrodes is relatively stable and can maintain a high mapping accuracy. At the same time, this mapping tip can improve the production efficiency of the mapping tip by directly bonding the membrane covered with electrodes to the sheet-like structure; but since the ribs of this mapping tip are a criss-cross network, the electrical traces of the electrodes need to be laid on the ribs to achieve connection between the electrodes, resulting in complicated wiring of the electrical traces and prone to failure. In addition, the mapping tip needs to be curled perpendicular to the axial direction of the catheter when in use, and the ribs perpendicular to the axial direction of the catheter will reduce the curling effect of the mapping tip, resulting in inconvenience in the use of the mapping tip. Summary of the invention

[0005] The object of the present invention is to overcome the shortcomings existing in the prior art, that is, the ribs of the paddle-shaped mapping tip are a criss-cross network, and the electrical traces of the electrodes need to be arranged on the ribs to achieve connection between the electrodes, resulting in complex wiring of the electrical traces and prone to failure. In addition, when using, the mapping tip needs to be curled in a direction perpendicular to the axis of the catheter, and the ribs perpendicular to the axis of the catheter will reduce the curling effect of the mapping tip, resulting in inconvenience in the use of the mapping tip, and a mapping catheter is provided.

[0006] The present invention provides a marking head end, which includes a support sheet and an electrode membrane. The support sheet is a flexible and elastic component. The support sheet is a hollow design, and the two ends of a plurality of support arms formed by the hollowing are respectively intersected at one place. The electrode membrane is provided with a plurality of electrode sheets and electric traces. The plurality of electrode sheets are arranged along the support arm, and the electric traces are arranged along the position of the support arm. The width of the support arm is greater than the thickness of the support arm. The electrode membrane is arranged on both sides of the support sheet. The electrode membrane includes, from the inside to the outside, an insulating layer, a conductive layer and a protective layer. The plurality of electrode sheets and the electric traces are arranged on the electrode membrane through the conductive layer, and the width of the electrode sheet and the width of the electric trace bundle are less than the width of the support arm.

[0007] The cross-section of the support arm may be in a rectangular or elliptical shape, etc., preferably in a rectangular shape.

[0008] The width of the support arm is greater than the thickness of the support arm, that is, the support arm is a flat component, the width direction of the support arm is parallel to the plane where the width of the marking head end is located, and the thickness direction of the support arm is perpendicular to the plane where the marking head end is located.

[0009] With this arrangement, when the support arm is subjected to a force, the support arm bends toward the two side faces of the measuring head end, and is less likely to collapse along the width direction of the support arm, thereby increasing the probability of maintaining a stable distance between the electrode sheets on the support arm.

[0010] The electrode film is arranged on both sides of the support sheet, and the electrode film includes: an insulating layer, a conductive layer and a protective layer from the inside to the outside. Several electrode sheets and the electrical traces are arranged on the electrode film through the conductive layer, and the width of the electrode sheet and the width of the electrical trace bundle are smaller than the width of the support arm.

[0011] The inner side refers to the side close to the supporting sheet, and the outer side refers to the side away from the supporting sheet.

[0012] The insulating layer is used to insulate the supporting sheet from the conductive layer.

[0013] The protective layer can cover the area where the electrode sheet is located, and the protective layer is used to contact with human tissue.

[0014] The material of the insulating layer is a polymer material, such as one or more of polyimide, polyethylene terephthalate, polyetheretherketone or polyparaxylene, preferably polyimide.

[0015] The material of the conductive layer is one or more of copper, gold, silver, platinum or platinum-iridium alloy, preferably gold or gold-plated silver or copper. The conductive layer is the layer where the electrode sheet and the electric trace are located. The pattern of the conductive layer and the bonding method with the insulating layer are well-known technologies in the industry, such as bonding or deposition of the conductive material to the insulating layer, and then etching or engraving to make the required pattern, or directly printing the liquid conductive material on the insulating layer, and curing to obtain the required circuit. The electric trace bundle refers to a bundle formed by a number of electric traces. By making the width of the electrode sheet and the width of the electric trace bundle smaller than the width of the support arm, the electrode sheet and the electric trace bundle can be within the range of the support arm, and there is no electrode film in the gap between the support arms. When the marking tip curls into the vascular sheath, the marking tip curls along the width direction of the support arm. If there is an electrode film between the support arms, the electric trace on the electrode film will be bent and easily damaged during repeated folding. Through this setting, the probability of failure is reduced.

[0016] The function of the protective layer is to increase the specific surface area of ​​the electrode, reduce the electrode impedance, increase the electrode capacitance, enhance the electrode charge storage capacity, and improve the signal-to-noise ratio. The protective layer materials are all materials with stable performance, not easy to corrode or not easy to react with the human body. The protective layer can be a rough layer composed of one or more materials such as gold, platinum, platinum-iridium alloy, etc., and is attached to the conductive layer by photolithography, chemical etching, electrochemical reaction, etc. The protective layer can also be a non-metallic surface with strong charge holding capacity, such as PEDOT, carbon nanotubes, iridium dioxide or titanium nitride coatings formed by vapor deposition, electrochemical methods, etc.

[0017] The support sheet is an insulating component. The support sheet can be made of insulating material or metal material. When metal material is selected, nickel-titanium alloy is preferred. The support sheet needs to be insulated as a whole, such as polymer material coating or sandblasting insulation treatment, or after the entire marking head is assembled, an insulating coating is applied to the exposed metal part. The insulating coating is preferably a parylene coating.

[0018] This arrangement reduces the complexity of electrical trace wiring, thereby reducing the probability of failure of the mapping catheter, while making the mapping tip easier to curl, thereby improving the convenience of using the mapping tip.

[0019] By setting the support sheet as a flexible and elastic component, the mapping head end can be deformed according to the shape of the tissue to be mapped when a force is applied, thereby better fitting the tissue; by setting the support sheet and the electrode membrane, the electrode membrane with the electrode sheet can be directly applied to the support sheet at one time, thereby improving the convenience of installing the electrode sheet on the mapping catheter; by hollowing out the support sheet, the support arm and the support sheet are formed as one piece, thereby improving the ability of the distance between the support arms to maintain a stable distance, thereby improving the probability of the distance between the electrodes on each support arm to maintain a stable distance, thereby improving the mapping accuracy; by making the support sheet a hollow design, the two ends of the several support arms formed by the hollowing are respectively intersected at one point, replacing the criss-cross mesh structure of the prior art, so that the support arms are connected only at the two ends, and the middle sections of the support arms are not connected, so that the support arms are more likely to bend, thereby improving the flexibility of the support sheet when used, while avoiding the criss-crossing layout of the electrical traces through the mesh structure, thereby reducing the probability of failure.

[0020] The mapping catheter further comprises a tube body component, wherein the tube body component comprises a proximal tube body and a distal tube body, wherein the distal tube body is a flexible component, and the mapping head end is arranged at an end of the distal tube body away from the proximal tube body.

[0021] Those skilled in the art should understand that the so-called "proximal end" refers to the end closer to the operator; the so-called "distal end" refers to the end farther from the operator, generally speaking, that is, the end that extends into the patient's body and is closer to the tissue.

[0022] The distal tube body is a flexible member that can be bent so as to better fit against the tissue. Those skilled in the art should understand that the distal tube body can be bent so as to better fit the mapping tip end against the tissue to be mapped.

[0023] The number of the insulating layers and the conductive layers is several, the insulating layers and the conductive layers are alternately stacked, and the electrode sheet is arranged on the outermost conductive layer.

[0024] By staggeredly overlapping the insulating layer and the conductive layer, the electrical traces can be arranged in multiple conductive layers and pass through the multiple conductive layers on the same side of the support sheet. When there are more electrode sheets, there are also more electrical traces connected to the electrode sheets. Through this arrangement, the electrical traces can be arranged in different conductive layers, reducing the number of electrical traces arranged in the same conductive layer, thereby increasing the upper limit of the number of electrode sheets that can be accommodated at the marking head end, and providing the possibility of arranging more electrode sheets to improve the marking accuracy.

[0025] The electrode sheets are correspondingly arranged on both sides of the support sheet, and the two electrode sheets corresponding to the support sheet are electrically connected.

[0026] The corresponding two electrode sheets refer to two electrode sheets arranged on opposite sides of the same supporting arm.

[0027] Preferably, the intervals between the electrode sheets located on the same support arm are equal.

[0028] Through this setting, the mapping head can achieve double-sided mapping without occupying too many signal channels, thus reducing the signal processing burden of supporting equipment.

[0029] An intermediate layer is provided between the conductive layer and the protective layer, and the intermediate layer is used to connect the conductive layer and the protective layer or to prevent ion leaching.

[0030] The intermediate layer is used to enhance the bonding force between the conductive layer and the protective layer, or to prevent ion leaching.

[0031] The intermediate layer is made of metal, preferably nickel. The intermediate layer can be arranged on the conductive layer by electroplating or the like to enhance the adhesion effect between the conductive layer and the protective layer. At the same time, when the conductive layer is made of copper or contains copper metal, copper ion precipitation may occur during the long-term use of the mapping catheter. By setting the intermediate layer, the probability of copper ion leaching can be reduced, thereby improving the safety of the mapping catheter during use.

[0032] The marking tip may also be provided with an anti-damage portion, which is arranged at the edge of the marking tip. The anti-damage portion is a polymer material, such as polyurethane, PEBAX, silicone rubber, epoxy resin, etc., and can be set by bonding, hot pressing, dipping, etc.

[0033] The mapping catheter comprises a sleeve, which is slidably sleeved on the tube body component and can be sleeved outside the mapping head end.

[0034] By setting the sleeve, when the marking tip is curled, the sleeve can be sleeved outside the marking tip. When the sleeve is connected to the vascular sheath, the marking tip can be extended along the sleeve to enter the vascular sheath, thereby improving the convenience of using the marking tip.

[0035] When the marking tip is inserted into the casing, the support arm will not be bent.

[0036] The length of the sleeve is greater than or equal to the length of the marking head end along the length direction of the sleeve. The sleeve can be set to be a cone with a larger diameter on the side close to the proximal tube body and a smaller diameter on the side close to the distal tube body. The end of the sleeve with a smaller diameter is used for docking with the vascular sheath, which improves the convenience of grasping and moving the sleeve and also improves the accuracy of docking with the vascular sheath.

[0037] Preferably, a vascular sheath docking port is provided at the end of the sleeve with a small diameter.

[0038] The support arm is provided with a positioning sensor installation groove, and the positioning sensor installation groove is used to accommodate the first positioning sensor. The positioning sensor installation groove includes a wire groove, and the wire groove is a serpentine groove. The wire groove is used to place the wire of the first positioning sensor. The distal tube body is provided with a second positioning sensor, and the second positioning sensor includes a second positioning sensor A and a second positioning sensor B. The second positioning sensor is used to distinguish the bending direction of the marking head end.

[0039] The number of the first positioning sensors can be set to be several, and the distance between two adjacent first positioning sensors can be set to be equidistant or unequal.

[0040] By setting a positioning sensor installation groove, the first positioning sensor can be set in the positioning sensor installation groove, replacing the installation method of directly setting the positioning sensor on the surface of the support arm, reducing the degree of the first positioning sensor protruding from the surface of the support arm when installed on the support arm, and improving the fit between the electrode membrane and the support sheet; by setting the wire groove as a serpentine groove, the wire of the positioning sensor is set in the wire groove in a bent form, and when the marking head end is bent, the wire of the positioning sensor will be pulled. This setting can reduce the probability of the positioning sensor wire being broken.

[0041] The second positioning sensor and the plurality of first positioning sensors are used to determine the position and deformation direction of the marking tip.

[0042] By setting a second positioning sensor A and a second positioning sensor B, and presetting one side of the mapping tip as the front side and the other side as the back side, the front and back sides of the mapping tip can be distinguished by the second positioning sensor A and the second positioning sensor B. This technology is a prior art. The connection between the second positioning sensor A and the second positioning sensor B can determine a plane. The normal of the plane is fixed and can be preset and defined. The terminal system connected to the first positioning sensor and the second positioning sensor can use this normal as a reference to calibrate the bending direction of the mapping catheter. Regardless of whether the mapping catheter is bent or not, the terminal system can display the front and back sides of the mapping tip. Therefore, when the mapping catheter is bent, the terminal system can display the bending direction of the mapping catheter, which is convenient for the operator to judge. The bending degree and bending direction of the mapping tip can be known, thereby improving the accuracy of the mapping catheter operation.

[0043] The marking head end is connected to the distal tube body via a connecting rod, and the connecting rod is provided with a reference electrode.

[0044] By setting a connecting rod, the mapping tip can be connected to the distal tube body through the connecting rod. The connecting rod is used to accommodate the positioning sensor, the extension part of the mapping tip, the perfusion channel, the traction mechanism, etc., thereby improving the compactness of the various components of the mapping catheter; by setting a reference electrode, the noise of the signal collected by the electrode sheet can be filtered out and the signal quality can be improved.

[0045] Furthermore, the second positioning sensor may be replaced by being arranged on the connecting rod.

[0046] Furthermore, the setting position of the reference electrode is replaced by setting the reference electrode at a position close to the distal catheter at the end of the mapping tip.

[0047] A main perfusion tube, a first branch perfusion tube and a second branch perfusion tube are arranged in the connecting rod. One end of the first branch perfusion tube and one end of the second branch perfusion tube are both connected to the main perfusion tube, and the other end of the first branch perfusion tube and the other end of the second branch perfusion tube are respectively located on both sides of the supporting plate.

[0048] By setting up the perfusion tube, the first perfusion tube and the second perfusion tube, perfusion liquid can be injected into the two sides of the marking tip end through the perfusion tube, reducing the probability of blood clotting at the marking tip end and improving the convenience of using the marking tip end.

[0049] Compared with the prior art, the present invention has the following beneficial effects:

[0050] 1. The present invention provides a mapping catheter, including a mapping tip, the mapping tip including a support sheet and an electrode membrane, the support sheet is a flexible and elastic member, the support sheet is a hollow design, the two ends of a plurality of support arms formed by the hollowing are respectively intersected at one point, the electrode membrane is provided with a plurality of electrode sheets and electrical traces, the plurality of electrode sheets are arranged along the support arms, and the electrical traces are arranged along the positions of the support arms. Through this arrangement, the complexity of the wiring of the electrical traces is reduced, thereby reducing the probability of failure of the mapping catheter, and at the same time, the mapping tip is easier to curl perpendicular to the axial direction of the catheter, thereby improving the convenience of using the mapping tip. BRIEF DESCRIPTION OF THE DRAWINGS

[0051] Figure 1 It is a three-dimensional schematic diagram of the mapping catheter of Example 1 provided by the present invention.

[0052] Figure 2 This is a main schematic diagram of the sleeve of Example 1 provided by the present invention.

[0053] Figure 3 This is a main schematic diagram of Example 1 provided by the present invention, in which the marking tip end is curled and placed in a sleeve.

[0054] Figure 4 This is the main schematic diagram of the marking tip end of Example 1 provided by the present invention.

[0055] Figure 5 for Figure 4 Schematic diagram of the cross-section AA in the figure.

[0056] Figure 6 It is a three-dimensional schematic diagram of the positional relationship between the first positioning sensor and the second positioning sensor when the end of the marking tip is bent according to Example 1 of the present invention.

[0057] Figure 7 This is the main schematic diagram of the positioning sensor installation slot of Example 1 provided by the present invention.

[0058] Figure 8 for Figure 7 Schematic diagram of the cross-section of the middle support arm.

[0059] Fig. 9 This is a main schematic diagram of the electrode membrane of Example 1 provided by the present invention.

[0060] Fig.10 for Fig. 9 A magnified schematic diagram of center A.

[0061] Fig.11 This is a schematic diagram of disassembling the electrode membrane of Example 1 provided by the present invention (the protective layer is not shown).

[0062] Fig.12 It is a cross-sectional schematic diagram of the protective layer and the conductive layer of Example 1 provided by the present invention.

[0063] Fig.13 It is a schematic diagram of the connection method of the electrode sheets correspondingly arranged on both sides of the same arm according to the first embodiment of the present invention.

[0064] Fig.14 This is a three-dimensional schematic diagram of the cross-section of the connecting rod of Example 1 provided by the present invention.

[0065] Fig.15 It is a three-dimensional schematic diagram of the longitudinal section of the connecting rod of Example 1 provided by the present invention.

[0066] Fig.16 This is a main schematic diagram of the connecting rod of Example 2 provided by the present invention.

[0067] Fig.17 It is a cross-sectional schematic diagram of the protective layer, the intermediate layer and the conductive layer of Example 3 provided by the present invention.

[0068] Fig.18 It is a cross-sectional schematic diagram of the protective layer, the intermediate layer and the conductive layer of Example 4 provided by the present invention.

[0069] Fig.19It is a schematic diagram of the connection method of the electrode sheets arranged on both sides of the same arm according to the fifth embodiment provided by the present invention.

[0070] Fig. 20 It is a schematic diagram of the connection method of the electrode sheets arranged on both sides of the same arm according to the sixth embodiment of the present invention.

[0071] Markings in the figure:

[0072] 1-tube component, 11-proximal tube body, 12-distal tube body, 2-sleeve, 21-vascular sheath docking port, 3-marking tip, 31-support plate, 32-support arm, 33-electrode plate, 34-electrical trace, 35-electrode membrane, 351-insulating layer, 3511-first insulating layer, 3512-second insulating layer, 352-conductive layer, 3521-first conductive layer, 3522-second conductive layer, 353-middle layer, 354-protective layer, 36-positioning sensor mounting slot, 361-wire slot, 4-connecting rod, 41-main perfusion tube, 42-first branch perfusion tube, 43-second branch perfusion tube, 5-second positioning sensor, 51-second positioning sensor A, 52-second positioning sensor B, 6-first positioning sensor, 7-reference electrode, 8-anti-damage part, 9-developing electrode. DETAILED DESCRIPTION

[0073] The present invention is further described in detail below in conjunction with specific embodiments. However, this should not be understood as the scope of the above subject matter of the present invention being limited to the following embodiments, and all technologies realized based on the content of the present invention belong to the scope of the present invention.

[0074] Unless otherwise specified, in the description of the specific embodiments of the present invention, the terms indicating the orientation or position relationship such as "up", "down", "left", "right", "center", "inside", "outside", etc. are all expressions based on the orientation or position relationship shown in the drawings, or are the orientation or position relationship when the invented product / equipment / device is usually used. These terms of orientation or position relationship are only for the convenience of describing the scheme of the present invention or simplifying the description in the specific embodiments, so as to facilitate the technicians to quickly understand the scheme, and do not indicate or imply that a specific device / component / element must have a specific orientation, or be constructed and operated in a specific position relationship, and therefore cannot be understood as a limitation on the present invention.

[0075] In addition, if the terms "horizontal", "vertical", "overhanging", "parallel" and the like appear, it does not mean that the corresponding devices / components / elements are required to be absolutely horizontal or vertical or overhanging or parallel, but may be slightly tilted or have deviations. For example, "horizontal" only means that its direction is more horizontal than "vertical", and does not mean that the structure must be completely horizontal, but may be slightly tilted. Alternatively, it can be simplified to mean that the corresponding devices / components / elements are set in directions such as "horizontal", "vertical", "overhanging", "parallel", etc., and can have an error / deviation of ±10% relative to the corresponding direction setting, more preferably an error / deviation within ±8%, more preferably an error / deviation within ±6%, more preferably an error / deviation within ±5%, and more preferably an error / deviation within ±4%. As long as the corresponding device / component / element is within the error / deviation range, it can still achieve its role in the scheme of the present invention.

[0076] In addition, the expressions “first”, “second”, “third”, etc., which appear in the terms, are merely used to distinguish the description of the same or similar components and should not be understood as emphasizing or implying the relative importance of specific components.

[0077] In addition, in the description of the embodiments of the present invention, "several", "plurality" and "a number" represent at least 2. It can be any number such as 2, 3, 4, 5, 6, 7, 8, 9, and even more than 9.

[0078] In addition, in the description of the technical solution of the present invention, unless otherwise clearly specified / defined / restricted, the terms "set", "install", "connect", "connected", "provided with", "laid", and "arranged" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection, and can be welding, riveting, bolting, threading, and other commonly used connection means in the field. This connection can be a mechanical connection, an electrical connection, or a communication connection; it can be a direct connection, or an indirect connection through an intermediate medium, and it can be the internal connection of two elements.

[0079] Example 1

[0080] As attached Figure 1-15 As shown, this embodiment provides a mapping catheter, including a mapping tip 3, the mapping tip 3 includes a support sheet 31 and an electrode membrane 35, the support sheet 31 is a flexible and elastic component, the support sheet 31 is a hollow design, and the two ends of a plurality of support arms 32 formed by the hollowing are respectively intersected at one point, the electrode membrane 35 is provided with a plurality of electrode sheets 33 and electrical traces 34, the plurality of electrode sheets 33 are arranged along the support arm 32, and the electrical traces 34 are arranged along the position of the support arm 32.

[0081] By setting the support sheet 31 as a flexible and elastic component, the mapping tip 3 can be deformed according to the shape of the tissue to be mapped when a force is applied, so as to better fit the tissue; by setting the support sheet 31 and the electrode membrane 35, the electrode membrane 35 with the electrode sheet 33 can be directly applied to the support sheet 31 at one time, thereby improving the convenience of installing the electrode sheet 33 on the mapping catheter; by hollowing out the support sheet 31, the support arms 32 and the support sheet 31 are integrally formed, thereby improving the ability of the distance between the support arms 32 to maintain stability, thereby improving the The distance between the electrodes on each support arm 32 is kept stable, thereby improving the accuracy of the marking. By making the support sheet 31 a hollow design, the two ends of the several support arms 32 formed by the hollowing are respectively intersected at one place, replacing the criss-cross mesh structure of the prior art, so that the support arms 32 are only connected at the two ends, and the middle sections of the support arms 32 are not connected, making the support arms 32 easier to bend, thereby improving the flexibility of the support sheet 31 when in use, and at the same time avoiding the criss-crossing layout of the electrical traces 34 through the mesh structure, thereby reducing the probability of malfunctions.

[0082] The mapping catheter further includes a tubular body component 1, which includes a proximal tubular body 11 and a distal tubular body 12. The distal tubular body 12 is a flexible component, and the mapping tip 3 is arranged at an end of the distal tubular body 12 away from the proximal tubular body 11.

[0083] Those skilled in the art should understand that the so-called "proximal end" refers to the end closer to the operator; the so-called "distal end" refers to the end farther from the operator, generally speaking, that is, the end that extends into the patient's body and is closer to the tissue.

[0084] The support sheet 31 is made of nickel-titanium alloy, and the support sheet 31 needs to be subjected to overall insulation treatment, such as polymer material coating or oxidation insulation treatment, or after the entire marking tip 3 is assembled, a parylene coating is applied to the exposed metal part.

[0085] The marking tip 3 may also be provided with an anti-damage portion 8 , which is provided at the edge of the marking tip 3 . The anti-damage portion 8 is epoxy resin and may be provided by coating.

[0086] This arrangement reduces the complexity of wiring the electrical traces 34 , thereby reducing the probability of failure of the mapping catheter. It also makes it easier to curl the mapping tip 3 in a direction perpendicular to the catheter axis, thereby increasing the convenience of using the mapping tip 3 .

[0087] like Figure 2-3 As shown, the mapping catheter includes a sleeve 2 , which is slidably mounted on the tubular body component 1 , and the sleeve 2 can be mounted outside the mapping tip 3 .

[0088] By setting the sleeve 2, when the marking tip 3 is curled, the sleeve 2 can be sleeved outside the marking tip 3. When the sleeve 2 is connected to the vascular sheath, the marking tip 3 can be extended along the sleeve 2 to allow the marking tip 3 to enter the vascular sheath, thereby improving the convenience of using the marking tip 3. When the marking tip 3 is extended into the sleeve 2, the support arm 32 will not be bent.

[0089] The length of the sleeve 2 is greater than or equal to the length of the marking head end 3 along the length direction of the sleeve 2. The sleeve 2 can be set to be a cone with a large proximal diameter and a small distal diameter. The distal end of the sleeve 2 is used to dock with the vascular sheath, which improves the convenience of grasping and moving the sleeve 2 and also improves the accuracy of docking with the vascular sheath.

[0090] Preferably, a vascular sheath docking port 21 is provided at the distal end of the sleeve 2.

[0091] like Figure 4 As shown, the marking head end 3 is connected to the distal tube body 12 via a connecting rod 4 , and the connecting rod 4 is provided with a reference electrode 7 .

[0092] By setting the connecting rod 4, the mapping tip 3 can be connected to the distal tube body 12 through the connecting rod 4. The connecting rod 4 is used to accommodate the positioning sensor, the extension part of the mapping tip, the perfusion channel, the traction mechanism, etc., thereby improving the compactness of the various components of the mapping catheter; by setting the reference electrode 7 on the connecting rod 4, the distance between the reference electrode 7 and each electrode sheet 33 is increased, the interference of the electrode sheet 33 on the reference electrode 7 is reduced, and the mapping accuracy of the mapping catheter is improved.

[0093] like Figure 6 As shown, the connecting rod 4 is provided with a second positioning sensor 5, and the marking head end 3 is provided with a first positioning sensor 6. The number of the first positioning sensors 6 can be set to be several, such as Fig.14 As shown, the second positioning sensor 5 includes a second positioning sensor A51 and a second positioning sensor B52 , and the second positioning sensor 5 is used to distinguish the bending direction of the marking head end 3 .

[0094] By setting a second positioning sensor A51 and a second positioning sensor B52, and presetting one side of the mapping tip 3 as the front side and the other side as the back side, the front and back sides of the mapping tip 3 can be distinguished by the second positioning sensor A51 and the second positioning sensor B52. This technology is a prior art. The connection between the second positioning sensor A51 and the second positioning sensor B52 can determine a plane. The normal of the plane is fixed and can be preset and defined. The terminal system connected to the first positioning sensor 6 and the second positioning sensor 5 can use this normal as a reference to calibrate the bending direction of the mapping catheter. Regardless of whether the mapping catheter is bent or not, the terminal system can display the front and back sides of the mapping tip 3. Therefore, when the mapping catheter is bent, the terminal system can display the bending direction of the mapping catheter, which is convenient for the operator to judge. The bending degree and bending direction of the mapping tip 3 can be known, thereby improving the accuracy of the mapping catheter operation.

[0095] like Figure 7 As shown, the support arm 32 is provided with a positioning sensor installation groove 36, and the positioning sensor installation groove 36 is used to accommodate the first positioning sensor 6. The positioning sensor installation groove 36 includes a wire groove 361, and the wire groove 361 is a serpentine groove. The wire groove 361 is used to place the wire of the first positioning sensor 6.

[0096] By setting the positioning sensor installation groove 36, the positioning sensor can be set in the positioning sensor installation groove 36, instead of directly setting the positioning sensor on the surface of the support arm 32, reducing the degree of the positioning sensor protruding from the surface of the support arm 32 when installed on the support arm 32, and improving the fit between the electrode membrane 35 and the support sheet 31; by setting the wire groove 361 as a serpentine groove, the wire of the positioning sensor is set in the wire groove 361 in a curved form. When the marking head end 3 is bent, the wire of the positioning sensor will be pulled. This setting can reduce the probability of the positioning sensor wire being broken.

[0097] As attached Figure 8 As shown, the width W of the support arm 32 is greater than the thickness T of the support arm 32, that is, the support arm 32 is a flat component, the width direction of the support arm 32 is parallel to the plane where the width of the marking head end 3 is located, and the thickness direction of the support arm 32 is perpendicular to the plane where the marking head end 3 is located.

[0098] The cross-section of the support arm 32 is rectangular.

[0099] With this arrangement, when the support arm 32 is subjected to a force, the support arm 32 bends toward the two side surfaces of the measuring head end 3, and is less likely to collapse along the width direction of the support arm 32, thereby increasing the probability of maintaining a stable distance between the electrode sheets 33 on the support arm 32.

[0100] The electrode film 35 is arranged on both sides of the support sheet 31, and the electrode film 35 includes, from the inside to the outside, an insulating layer 351, a conductive layer 352 and a protective layer 354. Several electrode sheets 33 and the electrical traces 34 are arranged on the electrode film 35 through the conductive layer 352, and the width of the electrode sheet 33 and the width of the electrical trace bundle 34 are smaller than the width of the support arm 32.

[0101] The inner side refers to a side close to the support sheet 31 , and the outer side refers to a side away from the support sheet 31 .

[0102] The insulating layer 351 is used to insulate the support sheet 31 from the conductive layer 352;

[0103] The protective layer 354 can cover the area where the electrode sheet 33 is located, and the protective layer 354 is used to contact with human tissue.

[0104] The material of the insulating layer 351 is a polymer material, preferably polyethylene terephthalate.

[0105] The conductive layer 352 is made of gold. The conductive layer 352 is the layer where the electrode sheet 33 and the electrical trace 34 are located. The pattern of the conductive layer 352 and the bonding method with the insulating layer 351 are well-known technologies in the industry. For example, the conductive material is bonded to the insulating layer 351 by bonding or deposition, and then etched or engraved to form the desired pattern, or the liquid conductive material is directly printed on the insulating layer 351, and the desired circuit is obtained after solidification. The electrical trace 34 bundle refers to a bundle of several electrical traces 34. By making the width of the electrode sheet 33 and the width of the electrical trace 34 bundle smaller than the width of the support arm 32, the electrode sheet 33 and the electrical trace 34 bundle can be within the range of the support arm 32 and can be displaced with the bending of the support arm 32, thereby improving the reliability of the marking head 3 when in use.

[0106] The function of the protective layer 354 is to increase the specific surface area of ​​the electrode, reduce the electrode impedance, increase the electrode capacitance, enhance the electrode charge storage capacity, and improve the signal-to-noise ratio. The materials of the protective layer 354 are all stable in performance and are not easy to corrode or react with the human body. The protective layer 354 is a rough layer composed of gold and is attached to the conductive layer 352 by photolithography, chemical etching, electrochemical reaction, etc.

[0107] The number of the insulating layer 351 and the number of the conductive layer 352 are both 2. Fig.11As shown, the insulating layer 351 and the conductive layer 352 are alternately overlapped, the electrode sheet 33 is arranged on the first conductive layer 3521, and the electrical trace 34 is arranged on the second conductive layer 3522. From the first conductive layer 3521 to the supporting sheet 31, there are the first conductive layer 3521, the first insulating layer 3511, the second conductive layer 3522 and the second insulating layer 3512 in sequence.

[0108] By staggering and overlapping the insulating layer 351 and the conductive layer 352, the electric traces 34 can be arranged in multiple conductive layers 352 and pass through the multiple conductive layers 352 on the same side of the support sheet 31. When there are more electrode sheets 33, there are also more electric traces 34 connected to the electrode sheets 33. Through this arrangement, the electric traces 34 can be arranged in different conductive layers 352, which reduces the number of electric traces 34 arranged in the same conductive layer 352, thereby increasing the upper limit of the number of electrode sheets 33 that the marking head 3 can accommodate, and providing the possibility of arranging more electrode sheets 33 to improve the marking accuracy.

[0109] The electrode sheets 33 are correspondingly disposed on both sides of the support sheet 31 , and the two electrode sheets 33 corresponding to the support sheet 31 are electrically connected.

[0110] The corresponding two electrode sheets 33 refer to two electrode sheets 33 on the same support arm 32 that are arranged on opposite sides of the support arm 32 .

[0111] Through this arrangement, the mapping head 3 can achieve double-sided mapping without occupying too many signal channels, thus reducing the signal processing burden of the supporting equipment. The electrical traces 34 are connected to the electrode sheets 33 located on both sides of the same support arm 32, and the connection method is as follows: Fig.13 shown.

[0112] like Figure 14-15 As shown, a main perfusion tube 41, a first branch perfusion tube 42 and a second branch perfusion tube 43 are provided in the connecting rod 4, one end of the first branch perfusion tube 42 and the second branch perfusion tube 43 are both connected to the main perfusion tube 41, and the other end of the first branch perfusion tube 42 and the other end of the second branch perfusion tube 43 are respectively located on both sides of the support plate 31.

[0113] By providing the perfusion tube, the first perfusion tube 42 and the second perfusion tube 43 , perfusion liquid can be injected into the two sides of the marking tip 3 through the perfusion tube, thereby reducing the probability of blood clotting at the marking tip 3 and improving the convenience of using the marking tip 3 .

[0114] Example 2

[0115] As attached Fig.16 As shown, the difference between this embodiment and embodiment 1 is that the connecting rod 4 is provided with a developing electrode 9 for indicating the entering and exiting of the vascular sheath.

[0116] Example 3

[0117] As attached Fig.17 As shown, the difference between this embodiment and embodiment 1 and embodiment 2 is that an intermediate layer 353 is provided between the conductive layer 352 and the protective layer 354, and the intermediate layer 353 is used to enhance the adhesion between the conductive layer 352 and the protective layer 354 or to prevent ion leaching, and the protective layer 354 is carbon nanotubes, which are attached to the conductive layer 352 by vapor deposition.

[0118] The intermediate layer 353 is made of metal, preferably nickel. The intermediate layer 353 can be set on the conductive layer 352 by electroplating or other methods to enhance the bonding effect between the conductive layer 352 and the protective layer 354. At the same time, when the conductive layer 352 is made of copper or contains copper metal, copper ion precipitation may occur during the long-term use of the mapping catheter. By setting the intermediate layer 353, the probability of copper ion leaching can be reduced, thereby improving the safety of the mapping catheter during use.

[0119] Example 4

[0120] As attached Fig.18 As shown, the difference between this embodiment and the above embodiment is that an intermediate layer 353 is provided between the conductive layer 352 and the protective layer 354, and the protective layer 354 is titanium nitride, iridium oxide, platinum black, etc., and can be attached to the conductive layer 352 by magnetron sputtering or electrochemical methods.

[0121] Example 5

[0122] As attached Fig.19 As shown, the difference between this embodiment and the above embodiment is that the connection between the electrical trace 34 and the electrode sheets 33 located on both sides of the same support arm 32 is as follows: Fig.19 As shown, two electrical traces 34 are respectively arranged on both sides of the support arm 32 and connected to two electrode sheets 33 on both sides of the support arm 32. The two electrode sheets 33 are electrically connected at one end of the marking head end 3 close to the distal tube body 12 through the electrical traces 34.

[0123] Example 6

[0124] As attached Fig. 20 As shown, the difference between this embodiment and the above embodiment is that the connection between the electrical trace 34 and the electrode sheets 33 located on both sides of the same support arm 32 is as follows: Fig. 20 As shown, the two electrode sheets 33 are connected to each other, and an electrical trace 34 extends along one of the conductive layers 352 and is connected to one of the electrode sheets 33 .

[0125] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in the protection scope of the present invention.

Claims

1. A mapping catheter, comprising a mapping tip (3), characterized in that: The mapping tip (3) comprises a support sheet (31) and an electrode membrane (35); the support sheet (31) is a flexible and elastic member; the support sheet (31) is hollowed out to form a plurality of support arms (32); the support arms (32) and the support sheet (31) are integrally formed; all the hollowed-out support arms (32) are arranged longitudinally along the mapping catheter, and both ends of all the support arms (32) meet at one point; the electrode membrane (35) is provided with a plurality of electrode sheets (33) and electrical traces (34); the plurality of electrode sheets (33) are arranged along the support arms (32) and the electrode membrane (35) is provided with a plurality of electrode sheets (33) and electrical traces (34); The electric trace (34) is arranged along the position of the support arm (32), the width of the support arm (32) is greater than the thickness of the support arm (32), the electrode film (35) is arranged on both sides of the support sheet (31), the electrode film (35) comprises, from the inside to the outside, an insulating layer (351), a conductive layer (352) and a protective layer (354), a plurality of the electrode sheets (33) and the electric trace (34) are arranged on the electrode film (35) through the conductive layer (352), and the width of the electrode sheet (33) and the width of the bundle of the electric trace (34) are less than the width of the support arm (32).

2. A mapping catheter according to claim 1, characterized in that: The device further comprises a tubular body component (1), wherein the tubular body component (1) comprises a proximal tubular body (11) and a distal tubular body (12), wherein the distal tubular body (12) is a flexible component, and the marking head end (3) is arranged at an end of the distal tubular body (12) away from the proximal tubular body (11).

3. A mapping catheter according to claim 1, characterized in that: The number of the insulating layers (351) and the conductive layers (352) is several, the insulating layers (351) and the conductive layers (352) are alternately stacked, and the electrode sheet (33) is arranged on the outermost conductive layer (352).

4. The mapping catheter according to claim 1, characterized in that: The electrode sheets (33) are correspondingly arranged on both sides of the support sheet, and the two electrode sheets (33) corresponding to the support sheet (31) are electrically connected.

5. The mapping catheter according to claim 1, characterized in that: An intermediate layer (353) is provided between the conductive layer (352) and the protective layer (354), and the intermediate layer (353) is used to connect the conductive layer (352) and the protective layer (354) or to prevent ion leaching.

6. A mapping catheter according to claim 2, characterized in that: It comprises a sleeve (2), wherein the sleeve (2) is slidably sleeved on the tubular body component (1), and the sleeve (2) can be sleeved outside the marking head end (3).

7. The mapping catheter according to claim 2, characterized in that: The support arm (32) is provided with a positioning sensor installation slot (36), the positioning sensor installation slot (36) is used to accommodate a first positioning sensor (6), the positioning sensor installation slot (36) comprises a wire slot (361), the wire slot (361) is a serpentine slot, the wire slot (361) is used to place a wire of the first positioning sensor (6), the distal tube body (12) is provided with a second positioning sensor (5), the second positioning sensor (5) comprises a second positioning sensor A (51) and a second positioning sensor B (52), the second positioning sensor (5) is used to distinguish the bending direction of the marking head end (3).

8. The mapping catheter according to claim 2, characterized in that: The marking head end (3) is connected to the distal tube body (12) via a connecting rod (4), and the connecting rod (4) is provided with a reference electrode (7).

9. The mapping catheter according to claim 8, characterized in that: A main perfusion tube (41), a first branch perfusion tube (42) and a second branch perfusion tube (43) are arranged in the connecting rod (4); one end of the first branch perfusion tube (42) and one end of the second branch perfusion tube (43) are both in communication with the main perfusion tube (41); and the other end of the first branch perfusion tube (42) and the other end of the second branch perfusion tube (43) are respectively located on both sides of the support plate (31).

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