WO2024068152A1

WO2024068152A1 - Method for manufacturing of a medical device having at least two electrical conductors

Info

Publication number: WO2024068152A1
Application number: PCT/EP2023/073541
Authority: WO
Inventors: Marc Robert Hauer
Original assignee: Dyconex Ag
Priority date: 2022-09-30
Filing date: 2023-08-28
Publication date: 2024-04-04

Abstract

A method for simpler and more cost-effective manufacturing of a medical device, for example an implantable and/or insertable medical device, having at least two longitudinally extending electrical conductors (3, 30, 300) is described. The method comprises the following steps: • Providing a connecting material (4, 40, 400) and the at least two electrical conductors (3, 30, 300) each being individually electrically insulated and having two ends; • Fixing the position of the at least two electrical conductors (3, 30, 300) with respect to one another by establishing a temporary connection of the at least two electrical conductors (3, 30, 300) using the connecting material (4, 40, 400); • Performing at least one assembling step using the connected at least two electrical conductors (3, 30, 300); and • Disconnecting the at least two electrical conductors (3, 30, 300) by removing and/or decomposing the connecting material (4, 40, 400) and/or by modifying the mechanical integrity of the connecting material (4, 40, 400) over at least part of the longitudinal extension of the at least two electrical conductors (3, 30, 300).

Description

Method for manufacturing of a medical device having at least two electrical conductors

The present invention relates to a method for manufacturing a medical device, for example an implantable or insertable medical device, having at least two longitudinally extending electrical conductors. The invention further relates to an implantable or insertable medical device manufactured accordingly.

There are many implantable medical devices or medical device that are insertable into the patient's body which comprise two or more longitudinally extending electrical conductors. Such medical devices are, for example, electrode leads or catheters.

The term "catheter" generally refers to tubes of various diameter made of various materials that can be used to probe, empty, fill, flush, or otherwise minimally invasively treat hollow organs such as the urinary bladder, stomach, intestine, blood vessel, or the heart. A catheter is also be used, for example, to insert another medical device into the patient's body or to provide ablation treatment using an electromagnetic field. The tubular or hose-shaped section of the catheter to be inserted into the patient's body is referred to as the shaft, with the catheter tip located at its distal end. A special class of catheters comprises longitudinally extending electrical conductors that enable the transfer of electrical energy between the external (proximal) end of the catheter and the target region of the patient's body at the catheters' distal end. Such energy transfer can be used for therapeutic or diagnostic functions. For example, the electrical activity of a patient's heart can be mapped in order to provide data to assist a health care practitioner (HCP) in making a diagnosis.

Herein the term "electrode lead" refers to a medical device which transmits electrical energy. The electrode lead comprises a line having at least one electrical conductor comprising a surrounding insulation, which is often in the form of an insulation tube, and all other functional elements that are firmly connected to the line, for example a plug or another type of connector. In particular, the electrode lead also comprises the so-called electrode tip at its distal end, by means of which the electrical energy is provided to the tissue to be treated or probed. The electrode tip forms a transition point of electrical energy to the tissue as the electrical conductor is not insulated at the tip and may be designed as a conduction, stimulation or measurement electrode.

During manufacturing of a medical device such as an electrode lead or a catheter, several electrical conductors have to be connected at their respective distal and proximal ends or inserted into an outer shaft. Usually, separate electrical conductors are connected at their ends which turns out to be quite complicated if the number of conductors is two or more than two. Similarly, the insertion of such separate conductors is time-consuming. This is because individual conductors need to be flexible and bendable due to medical reasons which makes their assembly within or at the medical device quite complex and tedious.

Accordingly, there is a need to provide an improved method for faster and easier manufacturing of an implantable or insertable medical device having at least two electrical conductors, leading to a more cost-effective medical device.

This objective is solved by a method for manufacturing a medical device (e.g. an implantable and/or insertable medical device) having at least two longitudinally extending electrical conductors having the features of claim 1 and by an implantable medical device having the features of claim 13.

In particular, the method for manufacturing the medical device having at least two longitudinally extending electrical conductors comprises the following steps:

• Providing a connecting material and the at least two electrical conductors each being individually electrically insulated and having two ends;

• Fixing the position of the at least two electrical conductors with respect to one another by establishing a temporary connection of the at least two electrical conductors using the connecting material; • Performing at least one assembling step using the connected at least two electrical conductors; and

• Disconnecting the at least two electrical conductors by removing and/or decomposing the connecting material and/or by modifying the mechanical integrity of the connecting material over at least part of the longitudinal extension of the at least two electrical conductors.

In the first step of the above method at least two electrical conductors are provided. Each one of the at least two electrical conductors is longitudinally extending over a length limited by its two ends. Each electrical conductor comprises a core material with a high electrical conductivity such as a metal or an alloy, e.g. copper or constantan. Each electrical conductor is individually electrically insulated, i.e. comprises a coating of the electrically insulating material forming a shell surface with regard to the electrically conducting core in order to prevent current leakage or short circuits. The coating may be formed as a hollow cylinder and is firmly fixed to the electrically conducting core. The tips at the ends may be skinned from the insulating material in order to electrically connect the conductive core to a plug or to provide the treatment / probe using the respective conductor forming an electrode. At least one layer of electrically insulating material may be extruded around the conducting core. The insulating material may be formed by a thermoplastic material. Additionally or alternatively, the insulating material may have a high flexibility. In one embodiment, the insulating material may comprise or consist of a polymer material, such as LCP, PTFE, Pebax, ETFE or Nylon.

The at least two electrical conductors are then arranged substantially side by side along their length and temporarily connected in this arrangement using the connecting material, whereby their arranged positions are mechanically fixed. The electrical conductors are at least partly embedded in the connecting material which forms a mechanical bridge or clamp causing the mechanical fixation of the at least two electrical conductors. Accordingly, the connecting material may cover the outer surface of the at least two electrical conductors over a part or the full circumference. The connection may be established over the whole longitudinal extension (length) or part of the longitudinal extension of each of the at least two conductors. In one embodiment, the electrically conducting core has a diameter of about 25 pm to 200 pm, the insulating material has a thickness of about 10 gm to 100 gm. When used in high voltage application, the thickness of the insulating material may be greater. The connecting material layer may have a uniform thickness or a varying thickness, both in a range between 1 pm and 100 pm.

The connecting material may comprise or consist of a polymer material, for example a thermoplastic polymer material, e.g. a polycarbonate, polyvinyl alcohol, a polyester, a photoresist or a release film (thermal release sheet) such as, for example, Nittorevalpha, a dicing tape (suitable dicing tapes are, for example, disclosed in EP 0 745 654 Al).

In one embodiment of the method, the temporary connection between the at least two electrical conductors is established by jointly extruding the connecting material around and/or onto the adjacently arranged electrical conductors over at least part of their longitudinal extension thereby fixing their connection with respect to one another. This means that the connecting material is extruded around and/or onto the outer surface of the adjacently arranged electrical conductors, wherein the connecting material is located such in between the adjacently arranged electrical conductors that it connects the electrical conductors with each other. During the extrusion process, the outer surface of the electrical insulation layer, i.e. the circumference of the electrical conductor, may be covered partly or fully by the connecting material. In that manner, an interim assembly similar to a ribbon cable is formed after extrusion.

One possible embodiment for extruding such interim assembly is as follows. Inside a core barrel of an extruder, softened/liquid (thermoplastic) connecting material is directed toward an extrusion die comprising several die channels. The advancing liquid connecting material is evenly distributed over at least part of the outer surface of the flatly and side by side arranged plurality of individually insulated electrical conductors, which are moved toward the end through the core barrel in cylindrical cavities. Each die channel is positioned to provide some of the liquid connecting material to be extruded onto the surface of one electrical conductor. The cavities are arranged side by side inside the core barrel and the die channels are arranged adjacently with regard to the cavities carrying the electrical conductors, so that such interim assembly comprising connecting material in which the at last two electrical conductors spaced at pre-defined distances are embedded is extruded from the extrusion die, wherein the connecting material has a continuous width along the longitudinal extension of the assembly.

In another embodiment of the method, the temporary connection between the at least two electrical conductors with respect to one another may be established by jointly dipping the adjacently arranged electrical conductors within a dipping bath containing the connecting material thereby providing the connecting material over at least part of their longitudinal extension. For this, a bath containing liquefied connecting material is provided, e.g. by heating the connecting material. As soon as the layer has cooled down and solidified after the dipping process, the conductors are connected by a layer of the connecting material. Alternatively, a bath containing the connecting material dissolved in a solvent may be used in which the insulating material is not soluble. The individual electrical conductors arranged adjacently are dipped into a bath containing the dissolved connecting material. As soon as the solvent has evaporated after the dipping process, the individual conductors are mechanically connected or interlinked by the connecting material thereby forming the interim assembly. Alternatively, the connecting material may be applied on the adjacently arranged electrical conductor by spray coating or inkjet coating.

For above-described extrusion process or dipping, spray coating or inkjet coating process, the connecting material preferably has a lower softening/melting point than the insulating material, i.e. in the temperature range of the above-described extrusion process or dipping process, the connecting material should be softened/liquid and the insulating material solid.

Further, for the extrusion process and dipping, spray coating or inkjet coating process, the connecting material is preferably provided such that it is located at least partly in between the adjacently arranged electrical conductors so that the at least two electrical conductors are connected to each other and the positions of the conductors are fixed. In both cases, the electrical conductors are at least partly embedded in the connecting material.

In another embodiment of the method, the connecting material is an adhesive and the temporary connection between the at least two electrical conductors is established by dispensing the adhesive at the insulator surface of each of the at least two electrical conductors over at least part of their longitudinal extension. Here, the at least two electrical conductors are arranged beside each other such that when dispensing the connecting material or the connecting material dissolved in a solvent, an interlinking of the adhesive of adjacent electrical conductors is provided thereby forming a temporary mechanical connection. This may be realized, for example, by winding at least one insulated electrical conductor on a cable drum side by side at least twice. Then a dissolved or softened/molten adhesive is applied by dispensing and is dried or soldified. Then, the at least two windings may be cut at one point and to obtain a temporarily mechanically connected at least two electrical conductors (interim assembly). One example of an adhesive connecting material is a polyvinyl alcohol (PVA) which has excellent film-forming, emulsifying and adhesive properties along with high tensile strength and flexibility.

In another embodiment of the method, an additional carrier layer is provided onto which the at least two electrical conductors are arranged such that an interlinking of the adhesive with the carrier layer is provided. Alternatively, the carrier layer may provide an adhesive at its surface at which the at least two electrical conductors may be fixed adjacently to each other. The carrier layer may provide additional mechanical stabilization of the connection of the at least two electrical conductors.

In another embodiment, the above-mentioned connecting methods using extrusion and dipping may be combined with a carrier layer, as well, such that a connection of the connecting material with the carrier layer is provided. For example, the extruded at least two electrical conductors may be fully or partially adhered to the carrier layer, or the electrical conductors may be joined together with the carrier layer during the dipping process.

The carrier layer may be self-supporting. Further, the carrier layer may be flexible or rigid, depending on the requirements during the subsequent assembling step. For example, the carrier layer may be formed by (thermal) releasing film (or sheet), such as for example, a Revalpha Foil of Nitto, which is very sticky at room temperature and which completely loses its adhesion force after a short heating above 100 degrees Celsius. Alternatively, the carrier layer may be formed by a dicing tape. After establishing the temporary connection between the at least two electrical conductors, at least one assembling step is provided using this connected at least two electrical conductors. The result of the at least one assembling step is an assembly being the implantable or insertable medical device or a part of it. The connected conductors that are precisely and firmly connected to each other are now easily handled as their position relative to each other is fixed, namely their position with regard to the longitudinal direction as well as their position perpendicular to the longitudinal direction. Additionally, a better force distribution is provided by the fixation of the electrical conductors relative to each other. Accordingly, it is less complicated and time-consuming to perform the assembling step. In one embodiment, the assembling step comprises inserting of the temporarily connected at least two conductors into a sleeve (shaft, hose), e.g., of a catheter. Alternatively, or additionally, the assembling step comprises assembling the temporarily connected conductors on a substrate. In yet another embodiment of the method, the assembling step comprises the step of connecting the electrical conductors with a plug. As the position of the at least two electrical conductors is fixed during the whole assembling step(s) the manufacturing of the implantable or insertable medical device is more reliable and precise due to a smaller chance of mixing the at least two electrical conductors up and due to avoidance of shifting and slipping of the at least two conductors relative to each other, in particular in longitudinal direction.

After finishing the at least one assembling step, the at least two electrical conductors are disconnected by removing and/or decomposing the connecting material and/or by modifying the mechanical integrity of the connecting material over at least part of the longitudinal extension of the at least two electrical conductors. For example, the connecting material is completely removed over a pre-defined part of the longitudinal extension. Any residue may be left at the outer surface of the insulating material. The connecting material may lose its mechanical integrity due to a chemical and/or physical reaction (e.g. dissolution, hydrolysis, gas development during decomposition) comprising the connecting material. For example, a polycarbonate as connecting material may be decomposed by heating to 80 to 200 degrees Celsius, a polyvinyl alcohol as connecting material may be dissolved in hot water (e.g. 60 to 100 degrees Celsius for 120 min), a polyester as connecting material may be solved with an acid (e.g. at a pH below 5), a release film such as Revalpha may be removed by heat (e.g. heating to 80 to 150 degrees Celsius for 1 to 5 mins), and a dicing tape may be removed by UV radiation (e.g. at a wavelength in the range of 200 - 405nm, with 25 - 1000 mJ/cm²). After disconnecting the at least two electrical conductors, each of the at least two electrical conductors is more flexible because the connecting material is removed/decomposed/modified in its mechanical integrity. Additionally, the at least two electrical conductors may now move relative to each other so that more flexibility is given to the assembly in this regard, as well. Further assembly steps may be performed with regard to the medical device after disconnecting the at least two electrical conductors.

Accordingly, the above-described method combines the simple and more cost-effective manufacturing of the medical device due to the fixed connection of the electrical conductors and the high flexibility of the electrical conductors after finishing the manufacturing steps in which the fixed connection of the electrical conductors is needed. The method allows automation of the manufacturing steps.

In one embodiment of the method, the connecting material is removed and/or decomposed and/or the mechanical integrity of the connecting material is modified by application of a solvent or of a gas to the connecting material. For example, the solvent decomposes the connecting material or modifies its mechanical integrity by changing its chemical structure and/or chemical composition. The chemical structure and/or chemical composition may also be changed by inserting the assembly with the connecting material into a gas atmosphere. For example, if the connecting material is polyvinyl alcohol (PVA) water may be used as the solvent. In one embodiment, the solvent or gas should not attack the insulating material of the at least two electrical conductors. The solvent may be applied by dispensing it over the temporarily connected at least two conductors or by dipping the connected at least two conductors into a bath of the solvent.

In another embodiment of the method, the at least two electrical conductors are disconnected by thermally removing and/or decomposing the connecting material and/or by thermally modifying the mechanical integrity of the connecting material. A thermal decomposition may e.g. be provided if the interim assembly containing comprising the connected at least two electrical conductors is arranged in an oven or in a water bath at an elevated temperature for a pre-defined time. The interim assembly may also be heated by the thermal energy produced by at least one current pulse transmitted through the electrically conducting material of the at least two conductors. For example, a Polycarbonate may be used as the connecting material as its decomposition temperature is low, e.g. about 80 °C - 180 °C.

In a further embodiment of the method, the connecting material is removed and/or decomposed and/or the mechanical integrity of the connecting material is modified by application of electromagnetic radiation to the connecting material. For example, high energy UV radiation may decompose the connecting material thereby disconnecting the at least two electrical conductors.

In one embodiment, several of the above-explained disconnection steps may performed at the same time or one after another. For example, if a PVA is used as the connecting material, the decomposition may be accelerated by heating the material before or during the dipping process in water.

An implantable or insertable medical device such as a catheter or electrode lead may be manufactured automatically using the above-explained method.

The above objective is further solved by an implantable and/or insertable medical device having at least two longitudinally extending electrical conductors which is manufactured as described above. For example, a catheter or an electrode lead comprising at least two electrodes may be manufactured using above method. The elements of the implantable or insertable medical device and their properties as well as their embodiments are already described above in connection with the method for manufacturing the implantable or insertable medical device. It is therefore referred to the above explanation and description of the method. Further, such implantable or insertable medical device has the same advantages as the method explained above. In this description the term "insertable" medical device means a medical device that may be inserted into or placed at the patient's body, e.g. for treatment and/or sensing a bodily parameter and afterwards removed from the patient's body. The present invention will now be described in further detail with reference to the accompanying schematic drawings, wherein

Fig. 1 shows a first embodiment of an assembly during manufacturing of the medical device in a cross-sectional view,

Fig. 2 shows a second embodiment of an assembly during manufacturing of the medical device in a cross-sectional view, and

Fig. 3 shows a third embodiment of an assembly during manufacturing of the medical device in a cross-sectional view.

As indicated above, for a medical device such as a catheter or an electrode lead that comprises at least two electrical conductors 3, 30, 300, the at least two electrical conductors

3, 30, 300 may temporarily be fixed in their position during manufacturing of the medical device by a connecting material 4, 40, 400. For that, in the first step, the at least two conductors, for example, four electrical conductors 3, 30, 300 and the connecting material

4, 40, 400 are provided. Then, the position of the, for example, four electrical conductors 3, 30, 300 is fixed using the connecting material 4, 40, 400 thereby forming an interim assembly 1, 10, 100. After fixing the position of the, for example, four electrical conductors 3, 30, 300 an assembly step is performed using the interim assembly 1, 10, 100. After finishing the assembly step, the temporary connection is disconnected and the manufacturing of the medical device is pursued.

Fig. 1 to Fig. 3 show three different embodiments of the interim assembly 1, 10, 100 after the step of establishing a temporary connection between the four longitudinally extending electrical conductors 3, 30, 300 using the connecting material 4, 40, 400. Each of the four electrical conductors 3, 30, 300 comprises a cylindrical and electrically conducting core material 2, 20, 200 with a high electrical conductivity such as copper. Each electrical conductor 3, 30, 300 further comprises an electrically insulating layer of electrically insulating material 3.1, 31, 310, forming a hollow cylindrical shell surface with regard to the conducting core 2, 20, 200, wherein the electrically insulating material 3.1, 31, 310 is firmly and directly attached to the core material 2, 20, 200.

The insulated electrical conductor 3, 30, 300, is manufactured, for example, by extrusion of a layer of insulating material 3.1, 31, 310 around the conducting core 2, 20, 200. The insulating material 3.1, 31, 310 may be a thermoplastic material, particularly a polymer material, such as LCP, PTFE, Pebax, ETFE or Nylon.

In order to provide the interim assembly 1, 10, 100, generally the individually insulated electrical conductors 3, 30, 300 are arranged side by side in a pre-defined configuration so that the surface of the insulating material layers 3.1, 31, 310 of adjacently located electrical conductors 3, 30, 300 are slightly spaced from each other or touch each other along a line at the surface of the respective insulating material layer 3.1, 31, 310. In this position, the conductors 3, 30, 300 are temporarily connected by the connecting material 4, 40, 400 forming connecting regions 4.1, 41, 410 between the conductors 3, 30, 300 as explained below in detail.

In one embodiment of the method, the temporary connection between the conductors 3 is established by extruding the connecting material 4 around the adjacently arranged conductors 3 over at least part of their longitudinal extension thereby forming the interim assembly 1 as shown in Fig. 1. Alternatively, the connecting material 40 may be extruded onto the surface of the adjacently arranged electrical conductors 30 at a part of their circumference (see, for example, Fig. 2). In both cases, the connecting material 4, 40 has a lower melting point than the insulating material 3.1, 31 so that the insulating material layer 3.1, 31 remains solid during the extrusion process. For that, the extrusion temperature is below the melting temperature of the insulating material layer 3.1, 31. The connecting material 4, 40 may be a polyvinyl alcohol (PVA), a polycarbonate or an adhesive.

As shown in Fig. 1 the temporary connection between the adjacently arranged electrical conductors 3 is formed during the extrusion process, where the outer surface of each of the four adjacently arranged electrical conductors 3 is covered by the connecting material 4 over the full circumference. For example, the extruded layer of connecting material 4 has a thickness in a range between 1 gm and 100 gm, while the conducting core 2 has a diameter of about 25 gm to 200 gm and the insulating material 3.1 has a thickness of about 10 gm to 100 gm. In the connecting regions 4.1 between two adjacent electrical conductors 3, the connecting material layers of every two adjacent conductors 3 merge so that the thickness of these layers in the connecting region 4.1 may vary.

Fig. 2 shows the embodiment, where the connecting material 40 is extruded in between every two spaced adjacent conductors 30 thereby forming connecting regions 41. The connecting material 40 joins the adjacent conductors 30 by covering their outer surface over part of their circumferences and filling the space in between the closest surface section of each two adjacent electrical conductors 30.

In another embodiment of the method, the temporary connection between the conductors is established by jointly dipping the adjacently arranged conductors within a dipping bath. The dipping bath contains the liquified connecting material or a solution comprising the connecting material. In the latter case, the solvent dissolves the connecting material but not the insulating material. A dipping solution may comprise PVA (as connecting material) and water as its corresponding solvent or alternatively an adhesive as connecting material with a respective solvent. After jointly dipping the conductors, the connecting material solidifies or the respective solvent evaporates, so that the conductors are interlinked by the connecting material.

As indicated above, in case the connecting material 4, 40, 400 is an adhesive, the adhesive may be provided by extrusion or dipping. Alternatively, the interlinking of adjacent electrical conductors may be provided using a carrier layer as shown in Fig. 3. In all cases the layer of adhesive is as thin as possible, for example in the range of 1 pm to 100 pm.

In the embodiment shown in Fig. 3 the adhesive is dispensed on one of the surfaces of a self- supporting carrier layer 500. Depending on the requirements of the subsequent assembly steps, the carrier layer may be a REV ALPHA foil of Nitto Deutschland GmbH. The electrical conductors 300 are arranged at the adhesive covered surface such that an interlinking of the conductors 300 with the adhesive is provided. Alternatively, the adhesive may be dispensed on a part of the circumference of each conductor 300 and the coated conductors may then be fixed side by side on one surface of the carrier layer 500.

After establishing the temporary connection of the electrical conductors 3, 30, 300 forming an interim assembly 1, 10, 100 at least one assembling step is performed, for example one to five assembling steps. For example, during manufacturing of a catheter, the electrical conductors 3, 30, 300 of the interim assembly 1, 10, 100 are mounted to the proximal assembly of the catheter on their first ends, then, the interim assembly 1, 10, 100 is inserted into the outer shaft of the catheter and finally, the second ends of the electrical conductors 3, 30, 300 are mounted to the distal assembly of the catheter. The mounting and the insertion of the interim assembly 1, 10, 100 is easier, more cost-effective and more reliable than performing the same steps with separate electrical conductors.

After assembling the interim assembly 1, 10, 100, the temporary connection of the electrical conductors 3, 30, 300 is disconnected. This is provided by removing and/or decomposing the connecting material layer 4, 40, 400 and/or by modifying the mechanical integrity of the connecting material 4, 40, 400 over at least part of the longitudinal extension of the electrical conductors 3, 30, 300. Particularly, the temporary connection in the connecting regions 4.1, 41, 410 between the adjacent electrical conductors 3, 30, 300 is disconnected. This is by application of a solvent or a gas, by heating or use of electromagnetic radiation.

For example, with regard to the embodiment of Fig. 3 using the REV ALPHA foil of Nitto Deutschland GmbH the interim assembly is heated at 100°C for 1 minute. Thereby the adhesive at the surface of the foil is decomposed.

Reference numbers

1 interim assembly

2 conducting core

3 electrical conductor

3.1 insulating material

4 connecting material

4.1 connecting region

10 interim assembly

20 conducting core

30 electrical conductor

31 insulating material

40 connecting material

41 connecting region

100 interim assembly

200 conducting core

300 electrical conductor

310 insulating material

400 connecting material

410 connecting region

500 carrier layer

Claims

1. A method for manufacturing of a medical device, for example an implantable and/or insertable medical device, having at least two longitudinally extending electrical conductors (3, 30, 300), wherein the method comprises the following steps:

• Providing a connecting material (4, 40, 400) and the at least two electrical conductors (3, 30, 300) each being individually electrically insulated and having two ends;

• Fixing the position of the at least two electrical conductors (3, 30, 300) with respect to one another by establishing a temporary connection of the at least two electrical conductors (3, 30, 300) using the connecting material (4, 40, 400);

• Performing at least one assembling step using the connected at least two electrical conductors (3, 30, 300); and

• Disconnecting the at least two electrical conductors (3, 30, 300) by removing and/or decomposing the connecting material (4, 40, 400) and/or by modifying the mechanical integrity of the connecting material (4, 40, 400) over at least part of the longitudinal extension of the at least two electrical conductors (3, 30, 300).

2. The method according to claim 1, wherein the connecting material (4, 40, 400) comprises or consists of a polymer material.

3. The method according to any one of the previous claims, wherein the temporary connection between the at least two electrical conductors (3, 30, 300) is established by jointly extruding the connecting material (4, 40, 400) around and/or onto the adjacently arranged electrical conductors (3, 30, 300) over at least part of their longitudinal extension and/or over at least part of their circumference thereby fixing their position with respect to one another.

4. The method according to any one of the claims 1 to 2, wherein the temporary connection between the at least two electrical conductors (3, 300) is established by - jointly dipping the adjacently arranged electrical conductors (3, 300) within a dipping bath containing the connecting material (4, 400) thereby providing the connecting material (4, 400) over at least part of their longitudinal extension thereby fixing their position with respect to one another, or

- Applying the connecting material (4, 400) on the adjacently arranged electrical conductors (3, 300) via spray coating or inkjet coating. The method according to any one of the claims 1 to 2, wherein the connecting material (4, 40, 400) is an adhesive and the temporary connection between the at least two electrical conductors (3, 30) is established by dispensing the adhesive at the insulator (3.1, 31, 310) surface of each of the at least two electrical conductors (3, 30, 300) over at least part of their longitudinal extension, arranging the at least two electrical conductors (3, 30, 300) beside each other such that an interlinking of the adhesives of adjacent electrical conductors (3, 30, 300) is provided. The method according to any one of the claims 3 to 5, wherein a carrier layer (500) is provided, wherein additionally the at least two electrical conductors (300) are arranged such that an interlinking of the adhesive (400) with the carrier layer (500) or a connection of the connecting material (400) with the carrier layer (500) is provided. The method according to any one of the previous claims, wherein the connecting material (4, 40, 400) is removed and/or decomposed and/or the mechanical integrity of the connecting material (4, 40, 400) is modified by application of a solvent or of a gas to the connecting material (4, 40, 400). The method according to any one of the claims 1 to 6, wherein the at least two electrical conductors (3, 30, 300) are disconnected by thermally removing and/or decomposing the connecting material (4, 40, 400) and/or by thermally modifying the mechanical integrity of the connecting material (4, 40, 400). The method according to any one of the claims 1 to 6, wherein the connecting material (4, 40, 400) is removed and/or decomposed and/or the mechanical integrity of the connecting material (4, 40, 400) is modified by application of electromagnetic radiation to the connecting material (4, 40, 400). The method according to any one of the previous claims, wherein the at least one assembling step comprises inserting of the temporarily connected at least two electrical conductors (1, 10, 100) into a sleeve. The method according to any of the previous claims, wherein the at least one assembling step comprises assembling the temporarily connected at least two electrical conductors (1, 10, 100) on a substrate. The method according to any of the previous claims, wherein the at least one assembling step comprises connecting the electrical conductors (3, 30, 300) with a Plug. An implantable and/or insertable medical device (1, 10, 100) having at least two longitudinally extending electrical conductors (3, 30, 300) which is manufactured according to the method of any one of the claims 1 to 12. The medical device of claim 13 being a catheter or an electrode lead comprising at least two electrodes.