Catheter with temperature sensor system and method for its manufacture

Abstract

The invention relates to a catheter with a temperature sensor system comprising a catheter body having a hollow cylindrical inner lining with an inner lining outer surface, wherein the inner lining extends in a longitudinal direction from a proximal catheter body end to a distal catheter body end of the catheter body, an outer insulation with an insulating inner surface, wherein the outer insulation coaxially surrounds the inner lining, and a flexible printed circuit board which includes a multitude of electrical conductors, wherein the flexible circuit board is arranged between the inner lining outer surface and the insulation inner surface and at least one electrode at the distal end of the catheter body, wherein the electrode is electrically connected to at least one of the electrical conductors, wherein the flexible printed circuit board has at least one temperature sensor, wherein the temperature sensor is electrically connected to at least one of the electrical conductors. The invention further relates to a method for manufacturing such a catheter.

Description

[0001] The invention relates to a catheter with a temperature sensor system comprising a catheter body having a hollow cylindrical inner lining with an inner lining outer surface, wherein the inner lining extends in a longitudinal direction from a proximal catheter body end to a distal catheter body end of the catheter body, an outer insulation with an insulating inner surface, wherein the outer insulation coaxially surrounds the inner lining, and a flexible printed circuit board which includes a multitude of electrical conductors, wherein the flexible circuit board is arranged between the inner lining outer surface and the insulation inner surface and at least one electrode at the distal end of the catheter body, wherein the electrode is electrically connected to at least one of the electrical conductors, wherein the flexible printed circuit board has at least one temperature sensor, wherein the temperature sensor is electrically connected to at least one of the electrical conductors.

[0002] The invention further relates to a method for manufacturing such a catheter. Background of the invention

[0003] Catheters have been used in medical procedures for many years. Among other things, catheters can be used in medical procedures for the examination, diagnosis, and / or treatment of tissue, particularly in areas of the body, such as blood vessels, that are not easily accessible without more invasive procedures. For example, catheters can be used to deliver electrical energy to selected areas in the human body, such as the heart, to selectively destroy tissue, such as heart tissue. This is often referred to as "ablation." Catheters can also be used to stimulate body tissue. In stimulation, the amount of energy delivered to the tissue is typically lower than in ablation.

[0004] In another procedure, often referred to as "mapping", a catheter with sensor electrodes is used to monitor various forms of bioelectrical activity in the human body.

[0005] Catheters can therefore be used both for the transmission (in “ablation” and “stimulation”) and for the absorption (in “mapping”) of energy to or from body tissue.

[0006] Regardless of the direction of energy flow, catheters often have multiple electrodes, i.e., two or more, at a distal end of the catheter body, which is typically the end inserted into the patient. The catheter usually also has an equal number of electrodes at its proximal end, which are electrically connected to those at the distal end. The electrodes at the proximal end are used to connect electrical devices according to the catheter's intended applications.

[0007] Temperature sensors are frequently used, particularly in ablation catheters, to continuously monitor the temperature of the catheter, especially its electrodes, and the tissue being treated. Precise temperature control during ablation is crucial to ensure that the targeted tissue is heated sufficiently to achieve the desired therapeutic effect without harming adjacent healthy tissue. Excessively high temperatures can cause serious damage, including tissue charring, which can lead to adverse effects such as arrhythmias. The use of temperature sensors allows for precise, real-time control of energy delivery, effectively minimizing such risks and maximizing treatment effectiveness.

[0008] The temperature sensors, which are typically located near the distal end of the catheter, are usually electrically connected to the proximal end of the catheter via conductive wires or cables, as are the electrodes located there. These wires or cables typically run within the catheter's internal lumen, a cavity extending axially through the catheter body. This necessitates either a larger catheter diameter or limits the possibilities for using the internal lumen for other purposes, such as inserting additional devices like a guidewire. Larger catheter diameters are disadvantageous because they could damage the patient's blood vessels. Furthermore, the temperature sensors are also usually located within the catheter's internal lumen, which can reduce the measurement accuracy for the ablation procedure performed outside the catheter.Mounting the temperature sensor on the outer surface of the catheter, on the other hand, leads to an uneven outer diameter and can result in, in particular, sharp-edged protrusions or depressions that could damage the patient's blood vessels. Furthermore, the installation of electrically connected temperature sensors via wires or cables, whether inside the catheter lumen or on its outer surface, is complex and therefore costly.

[0009] Therefore, there is a market need for catheters with an improved temperature sensor system. Tasks

[0010] One object of the present invention is to overcome at least some of the disadvantages arising from the prior art.

[0011] In particular, it is an object of the present invention to provide a catheter with a temperature sensor system which has the freest possible internal lumen. Furthermore, the catheter should be able to be manufactured with the smallest possible outer diameter despite the temperature sensor system. The temperature sensor system should be integrated in such a way as to allow the most precise and rapid temperature measurement possible. Finally, the catheter should be designed to be as reliable and cost-effective to manufacture as possible.

[0012] A further object of the present invention is to provide a method for manufacturing such a catheter which is as simple, safe to use and cost-effective as possible. Preferred embodiments of the invention

[0013] The features of the independent claims contribute to at least partially fulfilling at least one of the aforementioned tasks. The dependent claims provide preferred embodiments that contribute to at least partially fulfilling at least one of the tasks.

[0014] A first embodiment of the invention comprises a catheter with a temperature sensor system. comprising a catheter body with a hollow cylindrical inner lining and an inner lining outer surface, wherein the inner lining extends in a longitudinal direction from a proximal catheter body end to a distal catheter body end of the catheter body, an outer insulation with an insulating inner surface, wherein the outer insulation coaxially surrounds the inner lining, and a flexible printed circuit board which includes a multitude, i.e. at least two, electrical conductors, wherein the flexible circuit board is arranged between the inner lining outer surface and the insulation inner surface and at least one electrode at the distal end of the catheter body, wherein the electrode is electrically connected to at least one of the electrical conductors, characterized by the fact that the flexible printed circuit board has at least one temperature sensor, wherein the temperature sensor is electrically connected to at least one of the electrical conductors.

[0015] In a preferred embodiment of the catheter, the temperature sensor is a printed temperature sensor. This embodiment is a second embodiment of the invention, which is preferably dependent on the first embodiment of the invention.

[0016] In a preferred embodiment of the catheter, the flexible circuit board is arranged, at least in sections, in a spiral winding around the inner lining. This embodiment is a third embodiment of the invention, which is preferably dependent on the first or second embodiment of the invention.

[0017] In a preferred embodiment of the catheter, the flexible circuit board is fixed between the inner lining and the outer insulation. This embodiment is a fourth embodiment of the invention, which is preferably dependent on one of the preceding embodiments of the invention.

[0018] In a preferred embodiment of the catheter, the inner lining and the outer insulation are at least partially bonded together. This embodiment is a fifth embodiment of the invention, which is preferably dependent on one of the preceding embodiments of the invention.

[0019] In a preferred embodiment of the catheter, the temperature sensor is designed as a meandering electrical conductor. This embodiment is a sixth embodiment of the invention, which is preferably dependent on one of the preceding embodiments of the invention.

[0020] In a preferred embodiment of the catheter, the meandering electrical conductor comprises a metal selected from the group consisting of silver, platinum, gold, and, preferably, copper. This embodiment is a seventh embodiment of the invention, which is preferably dependent on the sixth embodiment of the invention.

[0021] In a preferred embodiment of the catheter, the temperature sensor is designed as a thermistor. This embodiment is an eighth embodiment of the invention, which is preferably dependent on one of the preceding embodiments of the invention.

[0022] In a preferred embodiment of the catheter, the thermistor is a printed thermistor. This embodiment is a ninth embodiment of the invention, which is preferably dependent on the eighth embodiment of the invention.

[0023] In a preferred embodiment of the catheter, the thermistor comprises a material selected from the group consisting of poly-3,4-ethylenedioxythiophene, polydimethylsiloxane, carbon nanotubes, graphene oxide, silicon carbide, and graphene. This embodiment is a tenth embodiment of the invention, which is preferably dependent on the eighth or ninth embodiment of the invention.

[0024] In a preferred embodiment of the catheter, the temperature sensor has a radial extent, or in other words, a thickness, which is less than the radial extent, or in other words, thickness, of the outer insulation. This embodiment is an eleventh embodiment of the invention, which is preferably dependent on one of the preceding embodiments of the invention.

[0025] In a preferred embodiment of the catheter, the at least one temperature sensor is arranged at the same axial height of the catheter as the at least one electrode. This embodiment is a twelfth embodiment of the invention, which is preferably dependent on one of the preceding embodiments of the invention.

[0026] A thirteenth embodiment of the invention relates to a method for manufacturing a catheter with a temperature sensor system according to one of the preceding embodiments of the invention, comprising the following method steps: a) Providing a hollow cylindrical inner lining with a radially external inner lining outer surface; b) Providing a flexible printed circuit board comprising a plurality of electrical conductors and comprising at least one temperature sensor, wherein the temperature sensor is electrically connected to at least one of the electrical conductors; c) Arranging the flexible printed circuit board on the outer surface of the inner lining; d) Encasing the inner lining and the flexible printed circuit board with an outer insulation; e) Providing at least one electrode; f) Electrical contact of the at least one electrode with at least one of the electrical conductors of the flexible printed circuit board.

[0027] In a preferred embodiment of the method, the sheathing of the inner lining in process step d) comprises drawing at least one hollow cylindrical polymer tube onto the inner lining and the flexible printed circuit board, which, after being drawn, undergoes radial contraction by heating to form the outer insulation. This embodiment is a fourteenth embodiment of the invention, which is preferably dependent on the thirteenth embodiment of the invention.

[0028] In a preferred embodiment of the method, at least one contact opening is created in the outer insulation in process step f) for electrical contacting of the electrode, in order to selectively electrically contact the electrode with at least one electrical conductor of the flexible printed circuit board accessible via the contact opening, in particular accessible from the radial outside. This embodiment is a fifteenth embodiment of the invention, which is preferably dependent on the thirteenth or fourteenth embodiment of the invention. General

[0029] For each embodiment described herein, whose elements "have" or "comprise" a particular feature (e.g., a material), a further embodiment is always considered in which the element in question consists solely of that feature, i.e., it includes no other components. The word "comprise" or "comprise" is used synonymously with the word "have" or "have" in this context. If an element in an embodiment is designated in the singular, an embodiment containing several such elements is also considered. The use of a plural term for an element generally also includes an embodiment containing only a single corresponding element.Unless otherwise stated or clearly excluded from the context, it is generally possible, and hereby expressly considered, that features of different embodiments may also be present in the other embodiments described herein. Likewise, it is generally considered that all features described herein in connection with a method are also applicable to the products and devices described herein, and vice versa. For the sake of brevity, not all of these considered combinations are explicitly listed in every case. Technical solutions that are known to be equivalent to the features described herein are also generally considered to be within the scope of the invention.

[0030] In this description, range specifications also include values ​​referred to as limits. A specification such as "in the range from X to Y" with respect to a quantity A therefore means that A can take on the values ​​X, Y, and values ​​between X and Y. Similarly, a range limited on one side, such as "up to Y" for a quantity A, means that A can take on the values ​​Y and less than Y.

[0031] Some of the described characteristics are linked to the term "essentially." The term "essentially" means that, under real-world conditions and manufacturing techniques, a mathematically exact interpretation of terms such as "superposition," "perpendicular," "diameter," or "parallelism" can never be exact, but only within certain manufacturing tolerances. For example, "essentially perpendicular axes" include an angle of 85 to 95 degrees to each other, and "essentially equal volumes" encompass a deviation of up to 5% by volume.

[0032] For example, a "device consisting substantially of plastic" includes a plastic content of ≥95% to ≤100% by weight. An "essentially complete filling of a volume B" includes, for example, a filling of ≥95% to ≤100% by volume of the total volume of B. Detailed description

[0033] A first object of the invention relates to a catheter with a temperature sensor system comprising comprising a catheter body with a hollow cylindrical inner lining and an inner lining outer surface, wherein the inner lining extends in a longitudinal direction from a proximal catheter body end to a distal catheter body end of the catheter body, an outer insulation with an insulating inner surface, wherein the outer insulation coaxially surrounds the inner lining, and a flexible printed circuit board which includes a multitude of electrical conductors, wherein the flexible circuit board is arranged between the inner lining outer surface and the insulation inner surface and at least one electrode at the distal end of the catheter body, wherein the electrode is electrically connected to at least one of the electrical conductors, characterized by the fact that the flexible printed circuit board has at least one temperature sensor, wherein the temperature sensor is electrically connected to at least one of the electrical conductors.

[0034] The electrical conductor that is electrically connected to the electrode is preferably a different electrical conductor than the electrical conductor that is electrically connected to the temperature sensor.

[0035] The catheter has an elongated, tube-like body which, depending on the application, is equipped with one or a plurality of electrodes, at least at a distal end, preferably at both the distal and a proximal end axially opposite the distal end. The electrodes at the proximal end are sometimes also called connectors. In the present invention, the catheter body comprises a hollow cylindrical inner lining, a flexible circuit board, and outer insulation.

[0036] The catheter, in particular the catheter body, comprises a hollow cylindrical inner lining with a radially external inner lining surface. The inner lining extends axially from a proximal end of the catheter body to a distal end and preferably radially surrounds at least one inner lumen running axially through the catheter body. The inner lumen serves to guide and / or introduce various devices or fluids. For example, the inner lumen serves to introduce a guide wire, which facilitates the insertion of the catheter into the patient.

[0037] The inner lining has an inner diameter, for example, in the range of 0.75 to 4 mm, and an outer diameter, for example, in the range of 1 to 4.5 mm. Depending on the application, the inner lining can have different lengths. For example, the inner lining has a length in the range of 30 cm to 200 cm. The inner lining can be made from a variety of different materials, with the use of a flexible material or a flexible material combination being preferred. For example, the inner lining is made of a polymer from the group consisting of silicones, polyolefins (e.g., polyethylene), polyetherblockamide (e.g., PEBAX©), polyurethanes, polyimides, polyamides, polyaryletherketones (e.g., polyetheretherketone), fluorinated polymers (e.g., ...).The inner lining comprises a polymer selected from the group consisting of ethylenetetrafluoroethylene, polytetrafluoroethylene, perfluoroalkoxyalkanes, polyvinylidene fluorides, fluorinated ethylenepropylene, and mixtures thereof. In a preferred embodiment, the inner lining comprises a polymer selected from the group consisting of silicones, polyolefins (e.g., polyethylene), polyetherblockamide (e.g., PEBAX©), polyurethanes, polyimides, polyamides, polyaryletherketone (e.g., polyetheretherketone), fluorinated polymers (e.g., selected from the group consisting of ethylenetetrafluoroethylene, polytetrafluoroethylene, perfluoroalkoxyalkanes, polyvinylidene fluorides, fluorinated ethylenepropylene, and mixtures thereof), and mixtures thereof.

[0038] Coaxially surrounding the inner lining is an outer insulation layer with an insulating inner surface, the insulating inner surface facing the outer surface of the inner lining. The outer insulation is preferably the radially outer layer of the catheter, particularly the catheter body, and serves primarily for the electrical insulation of the catheter from the outside and its mechanical protection. Preferably, the outer insulation has an outer diameter in the range of 200 µm to 5000 µm, more preferably from 300 µm to 3000 µm, and most preferably from 500 µm to 1500 µm. In an exemplary embodiment, the outer diameter of the outer insulation is approximately 700 µm. It is understood that the outer diameter of the outer insulation can also correspond to the outer diameter of the catheter.The outer insulation preferably has a wall thickness in the range of 2 µm to 300 µm, particularly preferably from 5 µm to 150 µm, and most preferably from 20 µm to 100 µm. According to a preferred embodiment of the present invention, the outer insulation has an outer diameter in the range of 300 µm to 3000 µm, particularly preferably from 500 µm to 1500 µm, and a wall thickness in the range of 5 µm to 150 µm, particularly preferably from 20 µm to 100 µm. In an exemplary embodiment, the wall thickness is approximately 60 µm. The outer insulation preferably consists of a polymer from the group consisting of silicones, polyolefins (e.g. polyethylene), polyetherblockamide (e.g. PEBAX©), polyurethanes, polyimides, polyamides, polyaryletherketones (e.g. polyetheretherketone), fluorinated polymers (e.g.The outer insulation comprises a polymer selected from the group consisting of ethylenetetrafluoroethylene, polytetrafluoroethylene, perfluoroalkoxyalkanes, polyvinylidene fluorides, fluorinated ethylenepropylene, and mixtures thereof. In a preferred embodiment, the outer insulation comprises a polymer selected from the group consisting of silicones, polyolefins (e.g., polyethylene), polyurethanes, polyimides, polyamides, polyaryletherketone (e.g., polyetheretherketone), fluorinated polymers (e.g., selected from the group consisting of ethylenetetrafluoroethylene, polytetrafluoroethylene, perfluoroalkoxyalkanes, polyvinylidene fluorides, fluorinated ethylenepropylene, and mixtures thereof), and mixtures thereof, and has an outer diameter in the range of 300 to 3000 µm.

[0039] A flexible printed circuit board (PCB) is arranged radially between the inner lining and the outer insulation, i.e., between the inner surface of the insulation and the outer surface of the inner lining. A flexible PCB, also frequently referred to as a flex circuit ribbon, is a circuit board comprising or consisting of flexible, bendable materials that allow the PCB to be bent, folded, or wound into various shapes. The structure of a typical flexible PCB usually comprises several layers. The core element is one or more electrically conductive layers, for example, made of a metal foil or a printed metal layer, preferably comprising or consisting of copper, which may contain a specific pattern depending on the application. This layer, or a conductive trace within this layer, acts as the electrical conductor of the flexible PCB.The electrically conductive layer(s) are typically embedded between electrically insulating layers made of flexible insulating material, such as polyimides, which can also provide mechanical protection. For example, a flexible printed circuit board has a multitude, i.e., at least two, metallic conductors as electrical conductors, with the electrical conductors embedded in layers of polyimide.

[0040] Flexible printed circuit boards (PCBs) offer advantages in catheter applications, particularly due to their small footprint, light weight, and simplified assembly. Specifically, the use of a flexible PCB eliminates the need for individual conductive wires, especially those embedded within the lumen of the inner lining.

[0041] The flexible circuit board of the catheter body according to the invention comprises at least two electrical conductors. For example, the flexible circuit board comprises two to 20 electrical conductors, each of which can be selectively electrically connected, at least partially, to one or more electrodes. Preferably, the electrical conductors are electrically disjoint from one another. More preferably, the flexible circuit board comprises at least two insulating layers that electrically insulate the at least two electrical conductors from the outside, at least over considerable distances of the respective conductors. The flexible circuit board can have contact surfaces at certain positions that allow the electrical conductors to be electrically contacted from the outside without requiring the prior removal of any part of the insulating layer.

[0042] By placing the flexible circuit board between the inner lining and the outer insulation, the inner lumen of the catheter body remains free for other uses, thus expanding the catheter's application possibilities. Furthermore, this allows for a catheter body with the smallest possible outer diameter. In addition, the flexible circuit board is better protected against damage, as any devices inserted through the inner lumen, such as a guide wire, do not come into direct contact with the flexible circuit board.

[0043] The catheter has at least one electrode. The exact number of electrodes depends on the application of the catheter. For example, the catheter has 1 to 8 electrodes at the distal end of the catheter body, each of which is electrically connected to at least one, preferably exactly one, electrical conductor of the flexible circuit board.

[0044] Preferably, the at least one electrode is a ring electrode. Even more preferably, all electrodes are ring electrodes.

[0045] The electrode can comprise or be composed of a variety of different materials. Preferably, the electrode comprises a metal selected from the group consisting of platinum, iridium, tantalum, palladium, titanium, iron, gold, molybdenum, niobium, tungsten, nickel, chromium, cobalt, steel, nitinol, alloys of any of these metals, and composite materials of any of these metals. Suitable electrodes include stainless steel, for example, AISI 316L, AISI 301, or AISI 304. Platinum and platinum alloys, for example, Pt / Ir 10 or Pt / Ir 20, or nickel-cobalt alloys such as MP35N, are also suitable electrodes.

[0046] The choice of metal for the electrode (and for the electrical conductors) may depend on the intended use of the catheter according to the invention. However, it is understood that the application of the catheter is not limited by the use of a specific metal.

[0047] The electrode may also have a coating. Suitable coatings include metal nitrides such as TiN, metal oxides such as IrO2, or conductive polymers, such as poly-3,4-ethylenedioxythiophene (PEDOT). The electrode surface may also be textured, e.g., laser-textured.

[0048] The electrode, preferably a ring electrode, can have an outer diameter in the range of 200 to 5000 µm, in one embodiment in the range of 300 to 3000 µm, and in another embodiment in the range of 500 to 1500 µm. The electrode can have a wall thickness in the range of 10 to 200 µm, in one embodiment 10 to 100 µm, and in another embodiment 30 to 70 µm. Furthermore, the electrode can have a length in the range of 200 to 5000 µm, in one embodiment 300 to 3000 µm, and in another embodiment in the range of 500 to 1500 µm. According to one embodiment, the electrode has an outer diameter in the range of 300 to 3000 µm and in another embodiment in the range of 500 to 1500 µm, a wall thickness in the range of 10 to 100 µm and in another embodiment in the range of 30 to 70 µm and a length in the range of 300 to 3000 µm and in another embodiment in the range of 500 to 1500 µm.

[0049] The flexible circuit board of the catheter has at least one temperature sensor. The at least one temperature sensor is preferably an integral part of the flexible circuit board, i.e., preferably not an additional, separate component mounted on the flexible circuit board.

[0050] The at least one temperature sensor serves to monitor the ambient temperature and / or the temperature of the catheter electrodes, particularly during the proper use of the catheter, especially during ablations of patient tissue.

[0051] The temperature sensor has a sensing element that can be electrically connected to a signal processing unit via one of the electrical conductors on the flexible circuit board. The signal processing unit evaluates the signals from the temperature sensor, preferably in real time, and can thus display the temperature and its changes to the catheter user. The temperature sensor, together with the electrical conductor connected to it, forms the catheter's temperature sensor system.

[0052] The flexible circuit board therefore preferably has at least two electrical conductors: one of the at least two electrical conductors serves for the electrical contact of the at least one electrode of the catheter, the second electrical conductor serves for the electrical contact of the at least one temperature sensor of the catheter.

[0053] The exact number of temperature sensors depends on the catheter's application. For example, the catheter may have between 1 and 100 temperature sensors, particularly at the distal end of the catheter body in the electrode region. In one embodiment, the catheter has as many temperature sensors as electrodes, so that each temperature sensor can measure the temperature in the area of ​​one of the electrodes. The temperature sensor, like the rest of the flexible circuit board, is thus located between the inner lining and the outer insulation. In other words, the at least one temperature sensor is located in the wall of the catheter body. This brings the temperature sensor closer to the patient tissue and the electrodes than is the case with temperature sensors located within the inner lumen, where they are typically positioned.This arrangement thus allows for a more precise and faster measurement of the temperature, especially of the patient tissue, since less "material" of the catheter body lies between the sensor and the patient tissue or the electrode of the catheter.

[0054] Furthermore, the assembly of such a catheter is simplified compared to the classic electrical contacting of a temperature sensor using wires or cables, since it can be provided already pre-wired on the flexible circuit board.

[0055] The temperature sensor, and in particular its sensing element, can be implemented in various ways as part of the flexible printed circuit board. For example, different types of metal foils, such as stamped versions, can be used to construct the temperature sensor.

[0056] A preferred embodiment of the catheter is characterized in that the temperature sensor is a printed temperature sensor. This refers to a temperature sensor constructed using liquid or paste-like compositions. Depending on their viscosity, these compositions can be used to construct the temperature sensor using various printing methods. Low-viscosity to liquid compositions can be printed, for example, using inkjet printing, while higher-viscosity compositions, such as thick-film pastes, can be printed, for example, using stencil or screen printing. Another possibility for creating printed temperature sensors is the application of 3D printing.Printed temperature sensors have a simple design with few to no moving parts, are inexpensive to manufacture, and can be produced with a very low profile, for example, in the range of 0.01 µm to 20 µm. The preferred low profile (in radial dimension relative to the catheter body) in the range of 0.01 µm to 20 µm is particularly advantageous for manufacturing a catheter body with the smallest possible outer diameter.

[0057] Depending on the type of liquid or pasty composition, the construction of the printed temperature sensor may include a curing process, in particular a thermal curing process.

[0058] The flexible circuit board can be arranged in various ways between the inner lining and the outer insulation. For example, the flexible circuit board can run in a straight line along the longitudinal axis of the catheter, particularly the catheter body. This arrangement is especially easy to implement from a manufacturing perspective.

[0059] A preferred embodiment of the catheter is characterized in that the flexible circuit board is arranged in spiral windings around the inner lining, at least partially, and preferably substantially along its entire length. The flexible circuit board thus preferably extends axially in spiral windings between the inner lining and the outer insulation of the catheter body, preferably along substantially the entire length of the catheter body.

[0060] The arrangement in spiral windings has the advantage that the flexible circuit board can adapt particularly well to bending of the catheter body, which can reduce the risk of damage to the flexible circuit board when using the catheter.

[0061] To minimize or even completely prevent unintentional displacement, particularly in the axial direction, of the circuit board during catheter use, a preferred embodiment of the catheter is characterized in that the flexible circuit board is fixed between the inner lining and the outer insulation. This can be achieved, for example, by firmly clamping the flexible circuit board between the inner lining and the outer insulation. In a further embodiment, the flexible circuit board can be attached to the inner lining, the outer insulation, or to the inner lining and the outer insulation by means of an adhesive, such as adhesive tape, in particular double-sided adhesive tape.

[0062] To provide a catheter body that is as mechanically stable as possible, a preferred embodiment of the catheter is characterized in that the inner lining and the outer insulation are at least partially bonded together. Preferably, the inner lining and the outer insulation are bonded together in the spaces between the preferred helical turns of the flexible circuit board, for example by fusing. This has the advantage, for example, that the flexible circuit board is at least partially fixed spatially by this bond and cannot, for example, slip between the inner lining and the outer insulation, which could occur with layers that are not bonded together.To facilitate the fabrication of the catheter body, the flexible printed circuit board (PCB) can be wrapped around the inner lining as desired using an adhesive, such as glue or double-sided tape, and fixed to the outer surface of the inner lining before the outer insulation, in the form of a hollow cylindrical tube or pipe, is applied to the inner lining and the flexible PCB. A subsequent heat treatment can then form a metallurgical bond between the inner lining and the outer insulation in the spaces between the windings of the flexible PCB. Preferably, the flexible PCB itself does not include a layer that forms a metallurgical bond with the inner lining or the outer insulation through this heat treatment.For example, the flexible printed circuit board consists, at least on the outside, only of polymer layers made of a polyimide.

[0063] The temperature sensor, especially in the form of a printed temperature sensor, can use different technologies for temperature measurement.

[0064] A preferred embodiment of the catheter is characterized in that the temperature sensor, and in particular its sensing element, is designed as a meandering electrical conductor. Such a temperature sensor has meandering electrically conductive paths, i.e., repeating turns, bends, or curves in a, preferably continuous, pattern made of an electrically conductive material, wherein a temperature-changing resistance of this conductor is used for temperature measurement. The meandering arrangement of the electrically conductive conductor serves to maximize its length in a limited space. Such a temperature sensor is often inexpensive to manufacture and can also be easily applied to larger areas, preferably as a printed temperature sensor.

[0065] Preferably, the electrical conductor has a specific resistance value of 10 mOhms / square / mil or lower.

[0066] The meandering electrical conductor of the temperature sensor can consist of different electrically conductive materials or material combinations.

[0067] A preferred embodiment of the catheter is characterized in that the meandering electrical conductor comprises at least one metal selected from the group consisting of silver, platinum, gold, and, preferably, copper. Preferably, the conductor consists of one of these metals or a combination thereof. Copper is preferred because the electrical conductors of the flexible circuit board preferably also comprise copper or, more preferably, consist of copper, so that the electrical conductors and the meandering electrical conductor can be formed in the same way, preferably even in the same process step, for example, a printing process of a thick-film paste.

[0068] A preferred embodiment of the catheter is characterized in that the temperature sensor is designed as a thermistor. Preferably, the thermistor is manufactured using a thermistor paste. The temperature sensor is thus a temperature sensor made of a hardened thermistor paste.

[0069] Such temperature sensors preferably contain a mixture of electrically conductive materials, preferably silver or copper, as well as special materials, such as certain polymers, whose resistance properties are strongly temperature-dependent. In contrast to temperature sensors made of meandering, electrically conductive traces, there is usually no need to maximize the length of the electrical resistance, since it is inherently more sensitive to temperature changes. Thermistors, their materials, and their construction are known to those skilled in the art.

[0070] The specific resistance value of the thermistor is preferably in the range of 100 mOhms / square / mil or higher.

[0071] A preferred embodiment of the catheter is characterized in that the thermistor is a printed thermistor. This type of thermistor is preferably manufactured using a thermistor paste by means of stencil printing or screen printing.

[0072] A preferred embodiment of the catheter is characterized in that the thermistor comprises at least one material selected from the group consisting of poly-3,4-ethylenedioxythiophene, polydimethylsiloxane, carbon nanotubes, graphene oxide, silicon carbide, and graphene. More preferably, the thermistor comprises a conductive metal selected from the group consisting of silver, platinum, gold, and copper.

[0073] A preferred embodiment of the catheter is characterized in that the temperature sensor has a radial extent, in particular an extent perpendicular to the longitudinal axis of the catheter body, or in other words, a "thickness," which is less than the radial extent of the outer insulation. Since the temperature sensor is arranged between the inner lining and the outer insulation, such a temperature sensor allows the manufacture of a catheter body with a uniform outer diameter. The catheter body thus has as few protrusions or depressions as possible, which facilitates insertion into a patient's blood vessels and minimizes the risk of vascular damage. Preferably, the temperature sensor has a radial extent in the range between 0.01 µm and 20 µm.

[0074] The arrangement of the at least one temperature sensor relative to the at least one electrode can be freely chosen depending on the application. For example, one temperature sensor can be arranged axially between two axially adjacent electrodes.

[0075] A preferred embodiment of the catheter is characterized in that the at least one temperature sensor is arranged at the same axial height of the catheter, in particular the catheter body, as the at least one electrode. In this embodiment, the temperature sensor is thus arranged radially below the electrode, which allows for fast and precise temperature measurement of the electrode or, during catheter use, of the body tissue surrounding the electrode. The temperature sensor positioned in this way is located closer to the electrode than would be the case, for example, with a temperature sensor arranged in the inner lumen of the catheter body.

[0076] Preferably, the electrical contact between the electrode and an electrical conductor of the flexible circuit board is spatially separated from the temperature measurement using the temperature sensor of the flexible circuit board. Preferably, the electrode is a ring electrode, so that the electrical contact between the ring electrode and an electrical conductor of the flexible circuit board can be achieved at one circumferential position of the ring electrode, and the temperature measurement using the temperature sensor can be achieved at another circumferential position of the ring electrode, thus keeping them spatially separate.

[0077] Another object of the invention relates to a method for manufacturing a catheter with a temperature sensor system according to one of the preceding embodiments of the invention, comprising the method steps: a) Providing a hollow cylindrical inner lining with a radially external inner lining outer surface; b) Providing a flexible printed circuit board comprising a plurality of electrical conductors and comprising at least one temperature sensor, wherein the temperature sensor is electrically connected to at least one of the electrical conductors; c) Arranging the flexible printed circuit board on the outer surface of the inner lining; d) Encasing the inner lining and the flexible printed circuit board with an outer insulation; e) Providing at least one electrode; f) Electrical contact of the at least one electrode with at least one of the electrical conductors of the flexible printed circuit board.

[0078] To avoid repetition, reference is made to the previous description for the characteristics of the individual elements of the catheter.

[0079] In process step a), the hollow cylindrical inner lining with a radially external inner lining outer surface is provided.

[0080] In process step b), the flexible printed circuit board is provided. Preferably, this provisioning includes a printing process by which the temperature sensor is applied to the flexible printed circuit board. More preferably, this printing process is carried out with a thick-film conductive paste, such as a copper paste to form a meandering conductor track, or a thermistor paste containing, for example, silver and carbon nanotubes to form a thermistor.

[0081] In process step c), the inner lining's outer surface is arranged. For example, the flexible printed circuit board (PCB) is placed axially onto the inner lining, particularly the inner lining's outer surface. In a preferred embodiment of the process, the flexible PCB is wound spirally around the inner lining, preferably over its entire length. To simplify the arrangement and / or improve the stability of the finished catheter, the flexible PCB can be fixed to the inner lining, for example, by means of an adhesive or an adhesive tape, such as double-sided tape. This fixation preferably remains on the catheter, so that the flexible PCB is secured within the finished catheter between the inner lining and the outer insulation.

[0082] In process step d), the inner lining and the flexible printed circuit board mounted on it are encased with the outer insulation. This encasement can be carried out in various ways. For example, it can involve coaxially extruding the outer insulation around the inner lining and the flexible printed circuit board.

[0083] A preferred embodiment of the method is characterized in that the sheathing of the inner lining, and simultaneously also of the flexible printed circuit board, in process step d) comprises drawing a hollow cylindrical polymer tube, preferably made of a silicone, polyolefin (e.g. polyethylene), polyetherblockamide (e.g. PEBAX©), polyurethane, polyimide, polyamide, polyaryletherketone (e.g. polyetheretherketone), fluorinated polymer (e.g. selected from the group consisting of ethylenetetrafluoroethylene, polytetrafluoroethylene, perfluoroalkoxyalkanes, polyvinylidene fluorides, fluorinated ethylenepropylene and mixtures thereof) and mixtures thereof, onto the inner lining and the flexible printed circuit board, wherein the polymer tube undergoes radial contraction by heating after drawing it on in order to form the outer insulation.In this embodiment, a polymer tube that contracts radially under thermal influence and has an inner diameter at least equal to the outer diameter of the inner lining and the flexible circuit board arranged therein is pushed onto the inner lining. Once the polymer tube has reached the desired position, it is heated, whereupon the polymer tube contracts radially and forms the outer insulation of the catheter, in particular the catheter body. The radial contraction is preferably carried out at a temperature in the range between 120 °C and 180 °C.

[0084] In process step e), at least one electrode is provided. The exact number of electrodes depends on the application of the catheter.

[0085] Preferably, the electrode is a ring electrode. Even more preferably, all electrodes provided are ring electrodes.

[0086] The electrode can comprise or be composed of a variety of different materials. Preferably, the electrode comprises a metal selected from the group consisting of platinum, iridium, tantalum, palladium, titanium, iron, gold, molybdenum, niobium, tungsten, nickel, chromium, cobalt, steel, nitinol, alloys of any of these metals, and composite materials of any of these metals. Suitable electrodes include stainless steel, for example, AISI 316L, AISI 301, or AISI 304. Platinum and platinum alloys, for example, Pt / Ir 10 or Pt / Ir 20, or nickel-cobalt alloys such as MP35N, are also suitable electrodes.

[0087] The choice of metal for the electrode (and for the electrical conductors) may depend on the intended use of the catheter according to the invention. However, it is understood that the application of the catheter is not limited by the use of a specific metal.

[0088] The electrode may also have a coating. Suitable coatings include metal nitrides such as TiN, metal oxides such as IrO2, or conductive polymers. The electrode surface may also be textured, e.g., laser-textured.

[0089] The electrode, preferably a ring electrode, can have an outer diameter in the range of 200 to 5000 µm, in one embodiment in the range of 300 to 3000 µm, and in another embodiment in the range of 500 to 1500 µm. The electrode can have a wall thickness in the range of 10 to 200 µm, in one embodiment 10 to 100 µm, and in another embodiment 30 to 70 µm. Furthermore, the electrode can have a length in the range of 200 to 5000 µm, in one embodiment 300 to 3000 µm, and in another embodiment in the range of 500 to 1500 µm. According to one embodiment, the electrode has an outer diameter in the range of 300 to 3000 µm and in another embodiment in the range of 500 to 1500 µm, a wall thickness in the range of 10 to 100 µm and in another embodiment in the range of 30 to 70 µm and a length in the range of 300 to 3000 µm and in another embodiment in the range of 500 to 1500 µm.

[0090] In process step f), the at least one electrode is electrically contacted with at least one of the electrical conductors of the flexible printed circuit board. For example, this electrical contact can be achieved by simply bringing them into physical contact. In further embodiments, the electrical contact can include a contacting medium, such as a conductive adhesive or a conductive paste, which provides both electrical contact and mechanical fixation. Furthermore, the mechanical stability of the electrical contact can be achieved by means of a welding process, for example, laser welding. Preferably, the electrode is a ring electrode, and the electrical contact comprises radially compressing the ring electrode towards the inner lining.

[0091] The procedural steps d), e) and f) can be carried out in different orders.

[0092] If process step d) is carried out before process step f), it may be necessary to remove parts of the outer insulation in order to form an electrical contact between the electrode and the electrical conductor.

[0093] A preferred embodiment of the method is characterized in that, in process step f), at least one contact opening is created in the outer insulation to electrically contact the electrode, preferably in the form of a ring electrode, in order to selectively electrically contact the electrode with at least one electrical conductor of the flexible printed circuit board accessible via the contact opening. To create the contact opening, a portion of the outer insulation and, if necessary, a portion of the insulating layer of the flexible printed circuit board is removed at the corresponding position, so that the at least one electrical conductor is exposed radially from the outside and electrically contactable via the contact opening.Removing portions of the insulating layer of the flexible printed circuit board (PCB) is particularly necessary if the PCB does not already have an accessible electrical conductor at the contact opening location or a contact surface through which the conductor can be electrically connected from the outside without removing any insulating layer. At the contact opening location, an electrode can be selectively, or in other words, deliberately, electrically connected to the conductor during the subsequent process. If the catheter body is to have more than one electrode, particularly at the distal end, it is preferred that a separate contact opening be created for each of these electrodes, with each of these contact openings selectively connecting one of the conductors of the flexible PCB.The flexible circuit board preferably has at least as many electrical conductors as there are electrodes to be attached to the distal end of the catheter body. The contact opening can be created in various ways. For example, the contact opening can be created by cutting, punching, or, preferably, by laser ablation.

[0094] In further embodiments, the outer insulation is selectively encased around the inner lining and the flexible printed circuit board, so that the positions where an electrode is to be electrically contacted with at least one electrical conductor of the flexible printed circuit board remain free of the outer insulation. This can be achieved, for example, by using two or more polymer tubes that contract radially upon heating. These tubes are slid onto the inner lining at axial intervals and then heated. In these embodiments, the gap between two of these axially adjacent polymer tubes serves as a space for inserting an electrode, preferably a ring electrode. Preferably, the width of the gap corresponds to the width of the electrode inserted there.

[0095] In further embodiments of the method, a contacting element can be used. This contacting element serves to electrically connect the electrical conductor of the flexible printed circuit board to an electrode via the contact opening. The contacting element is a conductive material, at the latest after heat treatment, which can simultaneously, at least after heat treatment, mechanically fix the electrical conductor to the electrode. Furthermore, the contacting element also serves to bridge the depth of the contact opening, which corresponds at least to the thickness of the outer insulation, so that neither the electrical conductor nor the electrode to be connected to it has to overcome the radial depth of the contact opening alone.Without a contacting device, for example, the electrical conductor would have to be pulled at least partially radially outwards and / or the electrode would have to have a radially inwards directed projection that can overcome at least significant parts of the depth of the contacting opening.

[0096] The contacting medium can be designed in various ways. Preferably, the contacting medium is a solder, for example in the form of a solder paste, a conductive paste, or a sintering paste. This type of contacting medium allows an electrical connection between the electrical conductor and the electrode and, after heat treatment, can simultaneously serve as a mechanical fastening element between the electrical conductor and the electrode.

[0097] The properties and features disclosed in the description can be essential for various embodiments of the invention, both separately and in any combination. The properties and features disclosed for the catheter are also disclosed for the method, and vice versa. Figures

[0098] The invention is further illustrated below by means of figures. The invention is not limited to the figures.

[0099] They show Fig. 1 a schematic longitudinal section of a section of an exemplary catheter, Fig. 2 a schematic cross-section of the catheter Fig. 1, and Fig. 3 An exemplary flowchart of a procedure for manufacturing a catheter. Description of the characters

[0100] Fig. Figure 1 shows a section of an exemplary catheter 100, in particular a section of a catheter body 105 of the catheter 100, in a schematic longitudinal section. The catheter 100 has a hollow cylindrical inner lining 110, which encloses an inner lumen 106 of the catheter 100. An outer insulation 130 is arranged coaxially around the inner lining 110. A flexible circuit board 120 is arranged in helical turns between the inner lining 110 and the outer insulation 130 (shown in plan view for clarity). The inner lining 110 and the outer insulation 130 are bonded together between the turns of the flexible circuit board 130, so that the flexible circuit board 120 is fixed between the inner lining 110 and the outer insulation 130 and is protected against slippage, particularly in the axial direction.

[0101] In the embodiment shown, the flexible printed circuit board 130 comprises six electrically insulated conductors 121. In other embodiments not shown, the flexible conductor 130 can have up to twenty or more electrical conductors.

[0102] The catheter 100 has an electrode 140 in the form of a ring electrode in the section shown (the position of the ring electrode is indicated by the black-bordered rectangle; for further details, see also the figure). Fig. 2 referred to).

[0103] Electrode 140 is electrically connected to one of the electrical conductors 121 of the flexible circuit board, namely the second from the right. For this purpose, an electrically conductive bridge, which is electrically insulated from the other electrical conductors, was branched off towards electrode 140. This bridge terminates in a contact surface 125, through which the electrical contact with electrode 140 is established (shown from above for clarity; see further details). Fig. 2).

[0104] Furthermore, the flexible printed circuit board 120 has a temperature sensor 150, for example in the form of a meandering conductor or a printed thermistor, which is electrically connected to one of the electrical conductors 121, namely the electrical conductor 121 on the far right of the flexible printed circuit board 120 (shown in top view for clarity). For this purpose, two externally insulated, electrically conductive paths 155 branch off from the electrical conductor 121 on the far right to the temperature sensor 150.

[0105] In the embodiment shown, the temperature sensor 150 is arranged at the same axial height as the electrode 140, which allows for the smallest possible distance between these two elements and thus enables the most precise and rapid temperature measurement of the electrode 140 and the patient tissue surrounding the electrode 140 when using the catheter 100.

[0106] Fig. Figure 2 shows the catheter 100, in particular the catheter body 105 of the catheter 100, made of Fig. Figure 1 shows a schematic cross-section at the axial height of the electrode 140. The inner lumen 106 is shown, coaxially surrounded by the inner lining 110, which in turn is coaxially surrounded by the outer insulation 130 (delimited by a dashed line), which is itself coaxially surrounded by the electrode 140 in the form of a ring electrode. The flexible circuit board 120 is arranged between the inner lining 110 and the outer insulation 130. The flexible circuit board 120 has a radial extent, or in other words, a thickness, which is less than the radial extent of the outer insulation 120, thus providing a catheter 100, in particular a catheter body 105, with a uniform outer diameter.

[0107] The cross-section clearly shows that, in the illustrated embodiment, the main part of the flexible printed circuit board 120 (directly designated with reference numeral 120) is spatially spaced from both the contact surface 125 and the temperature sensor 150, located between the inner lining 110 and the outer insulation 130. The temperature sensor 150 is positioned almost on the opposite side of the contact surface 125.

[0108] The cross-section shows that a contact opening 145 filled with a contacting medium was created in the outer insulation to electrically connect the contact surface 125 to the electrode 140. The contacting medium is an electrically conductive medium, in the illustrated embodiment a conductive adhesive, which bridges the gap between the electrode 140 and the contact surface 125.

[0109] Fig.Figure 3 shows a flowchart of an exemplary procedure 200 for the production of a catheter 100, comprising procedure steps 210 to 260.

[0110] In process step 210, a hollow cylindrical inner lining 110 with a radially external inner lining outer surface is provided.

[0111] In process step 220, a flexible printed circuit board (PCB) comprising a plurality of electrical conductors 121 and comprising at least one temperature sensor 150 is provided. The temperature sensor 150 is electrically connected to at least one of the electrical conductors 121, preferably to exactly one of the electrical conductors 121. Preferably, the temperature sensor 150 is applied to the flexible PCB 120 by a printing process, such as stencil printing, screen printing, or inkjet printing. The temperature sensor 150 is preferably an integral part of the flexible PCB 120.

[0112] In process step 230, the flexible printed circuit board 120 is arranged on the outer surface of the inner lining 110. In a preferred embodiment of the process 200, the flexible printed circuit board 120 is wound spirally in turns around the inner lining 110, preferably over the entire length of the flexible printed circuit board 110.

[0113] After process step 230, process 200 can be carried out in different ways, two of which are illustrated here as examples.

[0114] In a first method (left path), process step 240 follows process step 230. This step involves encasing the inner lining 110 and the flexible printed circuit board 120 arranged on it with an outer insulation 130. Preferably, the encasing of the inner lining 110, and simultaneously also of the flexible printed circuit board 120, comprises drawing a hollow cylindrical polymer tube, preferably made of a polyether block amide, onto the inner lining 110 and the flexible printed circuit board 120. After being drawn on, the polymer tube is subjected to radial contraction by heating in order to form the outer insulation 130. In this embodiment, a polymer tube that contracts radially under thermal influence and has an inner diameter that corresponds at least to the outer diameter of the inner lining and the flexible printed circuit board arranged therein is thus pushed onto the inner lining 110.Once the polymer tube has reached the desired position, it is heated, whereupon the polymer tube contracts radially and forms the outer insulation 130 of the catheter 100, in particular of the catheter body 105. In this embodiment of the method, therefore, in order to electrically contact the flexible circuit board 120, in particular its electrical conductor 121, with an electrode 140, at least partial removal of the outer insulation 130 is necessary, exposing the corresponding electrical conductor 121.

[0115] In process step 250, at least one electrode 140 is provided, preferably in the form of a ring electrode. Preferably, all provided electrodes 140 are ring electrodes.

[0116] In process step 260, the at least one electrode 140 is electrically contacted with at least one of the electrical conductors 121 of the flexible printed circuit board 120. For example, this electrical contact can be carried out by simply bringing the electrodes into physical contact. In further embodiments, the electrical contact can include a contacting medium, such as a conductive adhesive or a conductive paste, which provides both electrical contact and mechanical fixation. Furthermore, the mechanical stability of the electrical contact can be achieved by means of a welding process, for example, by laser welding. Preferably, the electrode 140 is a ring electrode, and the electrical contact comprises radially compressing the ring electrode in the direction of the inner lining 110.

[0117] As already mentioned, the electrical contact in process step 260 requires the removal of parts of the outer insulation 130 for the first method. For this purpose, a contact opening is created in the outer insulation 130 to selectively electrically contact the electrode 140 with at least one electrical conductor 121 of the flexible printed circuit board 120 accessible via the contact opening. To create the contact opening, a portion of the outer insulation 130 and, if necessary, a portion of the insulating layer of the flexible printed circuit board 120 are removed at the corresponding position, so that the at least one electrical conductor 121 is exposed radially from the outside and electrically contactable via the contact opening.

[0118] In a second method, the subsequent process steps 240, 250, and 260 are carried out in a different order. Here, process steps 250 and 260 are performed first, and for process step 260, it is not necessary to remove any parts of the outer insulation 130, which is formed later in this method. Only in process step 240 is the outer insulation 130 applied. Depending on the embodiment of this method, it may be necessary to remove the subsequently formed outer insulation 130 from the previously electrically contacted electrodes 140. Such process steps are familiar to those skilled in the art. Reference sign 100 catheters 105 catheter bodies 110 Interior lining 120 flexible printed circuit boards 121 electrical conductor 122 contact surface 130 external insulation 140 electrode 145 Contact opening with contact medium 150 temperature sensor 200 methods for manufacturing a catheter 210 Providing an interior lining 220 Providing a flexible printed circuit board with a temperature sensor 230 Order 240 Wrapping 250 Providing an electrode 260 Electrical contacting of the electrode

Claims

Catheter (100) comprising a temperature sensor system, a catheter body (105) having a hollow cylindrical inner lining (110) with an inner lining outer surface, wherein the inner lining (110) extends longitudinally from a proximal catheter body end to a distal catheter body end of the catheter body (105), an outer insulation (130) with an insulating inner surface, wherein the outer insulation (130) coaxially surrounds the inner lining (110), and a flexible printed circuit board (120) comprising a plurality of electrical conductors (121), wherein the flexible printed circuit board (120) is arranged between the inner lining outer surface and the insulating inner surface, and at least one electrode (140) at the distal catheter body end, wherein the electrode (140) is electrically conductively connected to at least one of the electrical conductors (121), characterized in that the flexible printed circuit board (120) comprises at least one temperature sensor (150) shows,wherein the temperature sensor (150) is electrically connected to at least one of the electrical conductors (121). Catheter (100) according to claim 1, wherein the temperature sensor (150) is a printed temperature sensor (150). Catheter (100) according to claim 1 or 2, wherein the flexible circuit board (120) is arranged at least sectionally in a spiral shape in turns around the inner lining (110). Catheter (100) according to one of the preceding claims, wherein the flexible circuit board (120) is fixed between the inner lining (110) and the outer insulation (130). Catheter (100) according to claim one of the preceding claims, wherein the inner lining (110) and the outer insulation (130) are at least partially bonded together. Catheter (100) according to one of the preceding claims, wherein the temperature sensor (150) is designed as a meandering electrical conductor. Catheter (100) according to claim 6, wherein the meandering electrical conductor comprises at least one metal selected from the group consisting of silver, platinum, copper, gold. Catheter (100) according to one of the preceding claims, wherein the temperature sensor (150) is designed as a thermistor. Catheter (100) according to claim 8, wherein the thermistor is a printed thermistor. Catheter (100) according to claim 8 or 9, wherein the thermistor comprises at least one material selected from the group consisting of poly-3,4-ethylenedioxythiophene, polydimethylsiloxane, carbon nanotubes, graphene oxide, silicon carbide and graphene. Catheter (100) according to one of the preceding claims, wherein the temperature sensor (150) has a radial extent which is less than a radial extent of the outer insulation (130). Catheter (100) according to one of the preceding claims, wherein the at least one temperature sensor (150) is arranged at the same axial height of the catheter (100) as the at least one electrode (140). Method (200) for manufacturing a catheter (100) with a temperature sensor system according to any one of claims 1 to 12, comprising the process steps: a) providing (210) a hollow cylindrical inner lining (110) with a radially outer inner lining surface; b) providing (220) a flexible printed circuit board (120) comprising a plurality of electrical conductors (121) and comprising at least one temperature sensor (150), wherein the temperature sensor (150) is electrically connected to at least one of the electrical conductors (121); c) arranging (230) the flexible printed circuit board (120) on the inner lining surface; d) encasing (240) the inner lining (110) and the flexible printed circuit board (120) with an outer insulation (130); e) providing (250) at least one electrode (140); f) electrically (260) contacting the at least one electrode (140) with at least one of the electrical conductors (121) of the flexible printed circuit board (120). Method (200) according to claim 13, wherein the sheathing (240) of the inner lining (110) in process step d) comprises drawing on at least one hollow cylindrical polymer tube onto the inner lining (110) and the flexible circuit board (120), which, after being drawn on, undergoes radial contraction by heating in order to form the outer insulation (130). Method (200) according to claim 13 or 14, wherein, for electrical contacting (260) of the electrode (140) in process step f), at least one contact opening is created in the outer insulation (130) in order to selectively electrically contact the electrode (140) with at least one electrical conductor (121) of the flexible printed circuit board (120) accessible via the contact opening.

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