Wire device for ventricular assist device and method for producing a wire device

Abstract

The present invention relates to a wire device (105) for a ventricular assist device (100), wherein the wire device (105) has a guide sleeve (145) which is at least partially structured along an extension direction; and the wire device (105) also has a conductive element (145) which is arranged in the guide sleeve (140), and the conductive element (145) has a multilayer structure.

Description

[0001] describe

[0002] The invention is based on a line device or a method as defined in the preambles of the independent claims.A subject of the invention is also a computer program.

[0003] Significant advances in materials science have now made it possible to produce thin, flexible and at the same time complexly structured electrical conductor structures, as described, for example, in the publication by Burkard et al.: "Flexible Technology for Foldable Medical Flip-Chip Devices", IMAPS Conference on Device Packaging, Scottdale, Arizona, March 17-20, 2008. In the field of medical technology, such electrical conductor structures are used, for example, in the form of implantable intraocular pressure sensors or retinal implants.

[0004] Based on the foregoing, it is an object of the present invention to provide a wire device for a ventricular assist system which is simplified and improved with regard to its integration and functionality, and to provide an advantageous method for its production.

[0005] In this context, the method proposed herein can be used to provide a wire device for a ventricular assist system; a method for producing a wire device; furthermore, a device using said method; finally, a corresponding computer program according to the main claim. The measures listed in the dependent claims enable advantageous further developments and improvements of the device disclosed in the independent claim.

[0006] The wire device proposed in this article and intended for a ventricular assist system describes a high-frequency compatible conductive element, for example based on a flexible substrate. The conductive element can integrate the functions of the sensor carrier, the electrical connection line and the connection element in a single subassembly, so that, for example, an additional connection point on the pump of the ventricular assist system can be omitted. As a result, the production process can be simplified; and the reliability of the ventricular assist system can be increased.

[0007] A wire device for a ventricular assist system is proposed, wherein the wire device comprises the following features:

[0008] a guide sleeve which is structured at least partially along the extension direction; and

[0009] An electrically conductive element is arranged in, on or at the guide sleeve, wherein the electrically conductive element comprises a multi-layer structure.

[0010] The wire device can be a component of a ventricular assist system, which is used to integrate high-frequency compatible conductive elements, for example, inside a guide sleeve of the wire device. A ventricular assist system, also called an artificial heart or VAD (ventricular assist device), can be understood to mean a pump device for increasing the pumping capacity of the heart. The ventricular assist system can be inserted into the ventricle or the aorta, for example, by means of a catheter. In particular, the ventricular assist system can be a left ventricular assist system, which can also be designed as a percutaneous assist system, but not necessarily. The guide sleeve can be a cylindrical shell, which can have, for example, a metal-containing alloy and / or a constant outer diameter, but can alternatively also have a taper. Therefore, the guide sleeve can be used to receive the conductive element, or more specifically, to receive the electrical connection wire, and can be used, for example, in the wire device of the ventricular assist system. In addition, the guide sleeve can also have a structured surface or structure in the sheath, which can, for example, be formed as a braid and / or as a spiral or wavy structure cut out by a tube, or as a serrated structure or a zigzag deformation. A conductive element may be understood to mean an electrical connection line which is, for example, arranged in a guide sleeve of a ventricular assist system and which is used to electrically connect a sensor system (e.g., a pressure and / or temperature sensor) in the distal tip of the ventricular assist system and an electrical connection cable at the proximal end of the ventricular assist system. A multilayer structure may be a multilayer structure of a conductive element and / or an electrical connection cable, wherein each individual layer may provide a specific functionality, e.g., a conductive and / or insulating function. Thus, the multilayer structure may be produced, for example, by a thin film process.

[0011] The advantage of the method proposed herein and intended for a wire device for a ventricular assist system is that, for example, the conductive system of the wire device is realized in particular by using a thin film process, wherein in this case the thin film process can reduce the thickness of the applied coating compared to a standard electrical connection cable. In addition, the conductive element can also be realized, for example, in an integral manner, and furthermore, the functions of the sensor carrier, the electrical connection line and the connection element can be combined, for example, in a single subassembly, with the result that this implementation reduces any possible failure points; moreover, any unnecessary contact points are eliminated, which would provide an additional increase in the thickness of the applied coating. In order to avoid contact points, it is also proposed, for example, to use a single (for example, integral) flexible substrate not only as a guide for the conductive element along the guide sleeve in the sensor head unit, but also for making electrical contact with the through-element on the end unit of the ventricular assist system. The flexible substrate, for example a thin film substrate, can be pre-fixed by an adhesive and subsequently coated with a protective lacquer layer, which provides protection for the wire device against possible damage.

[0012] According to one embodiment, the conductive element may include multiple (e.g., coplanar) layers made of conductive and / or insulating materials, in particular, wherein the conductive layer at least partially includes a gold material; and / or the insulating layer is at least partially made of a polyimide material. Such an embodiment of the method proposed herein provides the advantage that, for the purpose of constructing the conductive element, the combination of different layers can produce, for example, new and / or improved properties and application areas of the conductive element. Therefore, the conductive element can be manufactured, for example, using a thin film process, in which case the advantage of realizing the conductive element by a thin film process is that the thickness of the applied coating is reduced. In addition, the production of such a layer, for example by means of a wafer-based lithography process, makes it possible to realize a production process of a line device that saves both resources and energy. The layer is produced, for example, by photolithography (in particular by applying a photoresist, exposure, development, base layer sputtering, electroplating thickening, photoresist removal).

[0013] Polyimide materials are used in electrical engineering, for example, in the form of light brown translucent films due to their heat resistance, low outgassing, radiation resistance and insulating properties. At the same time, the continuous use temperature can be as high as 230°C and as high as 400°C for a short time. Polyimide materials can be used, for example, in particular for particularly thin, but still very stable lacquer insulation of wires in thin film processes. The multilayer construction of conductors on, for example, a glass carrier substrate based on polyimide is particularly advantageous because the polyimide can be applied in liquid form by spin coating. In contrast to polyimide layers laminated with adhesives (commonly used in the flexible printed circuit card industry), the production of insulating layers in a liquid manner makes it possible to seal the metal conductors airtightly, so that moisture cannot enter; and corrosion problems are reduced. In the field of medical technology, polyimide is preferred due to its biocompatibility. Gold materials have the advantage of not forming an oxide layer; as a result, good electrical contact is always ensured. Excellent biocompatibility should be emphasized in particular. Other possible metals are platinum-iridium, or in principle copper due to its high conductivity and low price.

[0014] According to one embodiment, the conductive element may include a shielding element, in particular, wherein the shielding element is implemented using conductive layers and / or through-contacts between individual layers. In this case, the shielding may be produced, for example, by flat through-contacts between metal layers and individual layers of the conductive element. Such an embodiment of the method proposed herein provides the advantage that the shielding may improve the high-frequency characteristics of the line arrangement (e.g. with respect to impedance control).

[0015] According to one embodiment, the conductive element may comprise a plurality of wires, some of which are arranged inside the layer, in particular, most of which are arranged outside the shielding element. Such an embodiment of the method proposed herein provides the advantage that the shielding element, which may comprise, for example, a metallic material, may be formed very simply in the contact region of the conductive element by a process which is also used for producing conductor wires or wires in the conductive element.

[0016] According to one embodiment, the conductive element may include a sensor contact area for contacting at least one sensor and / or a signal generator contact area for contacting at least one signal generator. In this case, the at least one sensor may be, for example, a temperature sensor for measuring the temperature of the blood of a patient suffering from heart disease and / or a pressure sensor (e.g., atmospheric pressure) for detecting the ventricular pressure of a patient suffering from heart disease. The signal generator may be, for example, an ultrasonic element, which allows the volume flow of the blood of a heart patient to be measured. This embodiment of the method proposed herein provides the advantage that this implementation of one end of the conductive element can be used to allow contact with a sensor as well as an ultrasonic element.

[0017] According to one embodiment, the sensor contact area can be designed to receive and / or contact at least two sensors; and / or the sensor contact area can be formed in a rectangular manner, in particular, wherein the sensor contact area comprises at least two edges, wherein the sensor contact area is bent at at least two edges. This embodiment of the method proposed herein provides the advantage that the sensor contact area is bent at two edges so as to surround a groove in the sensor head unit of the ventricular assist system and thereby ensure that a stable and permanent retention is achieved. In order to protect the sensor from blood and mechanical damage, the groove or more specifically the sensor cavity can be filled with a potting compound (e.g. solid and / or gel-like silicone) (e.g. after the sensor is embedded in the groove). In a specific embodiment, the straight areas between the bent edges can be reinforced by a reinforcing element so that bending is only possible in the area of ​​the bent edges.

[0018] According to one embodiment, the signal generator contact area can include at least two curved contact points. The signal generator contact area is designed, for example, as a circular printed circuit board, wherein in this case, the at least two curved contact points are designed to receive and / or contact at least one signal generator, such as an ultrasonic element. In addition, the signal generator contact area also includes an edge. This embodiment of the method proposed herein provides the advantage that the signal generator contact area can also be bent at the edges so as to integrate itself into the cylindrical shape of the ventricular assist system in the best possible way.

[0019] According to one embodiment, the conductive element may comprise a connection point element, wherein the connection point element is shaped in a circular, hexagonal, square, triangular, substantially polygonal or U-shaped manner, in particular, wherein the connection point element comprises a plurality of circular connection points and / or connection points which are arranged radially and / or circumferentially on the outer environment of the connection element. Such an embodiment of the method proposed herein provides the advantage that the semicircular connection points can be folded on a thin and / or flexible line of the conductive element between similarly radially and / or circumferentially arranged contact pins of the feed-through element in order to make electrical contact there by welding, conductive adhesive bonding or soldering. The shape of the connection point element as a circle with semicircular connection points allows for convenient contacting, so that even small adjustments in length are possible due to the realization of said shape.

[0020] According to one embodiment, the structured sheath of the guide sleeve can be formed as a braid and / or as a spiral / wavy or tortuous structure cut out by the tube, in particular, wherein the guide sleeve comprises a metal-containing alloy. The advantage provided by this embodiment of the method proposed herein is that the conductive element is mechanically protected and / or supported by means of the braid and / or spiral structure of the guide sleeve. If the cable or more specifically the conductive element is integrated into the braided tube without any other device, a high flexural load will be applied to the cable, which may cause the electrical connection to be disconnected before the time limit of the permanent implant. Therefore, it is advantageous to pre-assemble the cable on a support or protective structure (e.g., a metal strip) and then integrate the latter into the braid. If the guide sleeve is cut out from the tube, the shape of the support or protective structure can be integrated in the cutting procedure so that no separate components are required. In particular, the guiding of the conductive element on the spiral web of the guide sleeve provides extremely high protection for the conductive element to resist long-term mechanical flexural loads.

[0021] According to one embodiment, each layer of the conductive element may have a thickness in the range between 5 μm and 15 μm; and / or the electrical conductor may be formed into a meandering shape. The thickness of each layer of polyimide (PI) or gold may be about 5 to 15 μm. The total thickness of the conductive element is then a function of the number of layers and the thickness of the individual layers, in which case the number of layers also depends on the existing shielding, or more specifically, on the shielding layer. For example, a three-layer system (PI, gold, PI) has a maximum thickness of 15 μm. For example, such a system with shielding may have a maximum thickness of 11 layers with a maximum thickness of 10 μm per layer, i.e. 110 μm. This embodiment of the method proposed herein provides the advantage that, in the case of expansion or compression, the adjustment of the length of the conductive element can be achieved by means of a conductive element formed into a meandering shape.

[0022] Furthermore, the method proposed herein provides a ventricular assist system with a wire device according to the variant proposed herein, wherein the wire device is arranged between a sensor head unit and an end unit of the ventricular assist system, in particular, wherein each connecting element is arranged between the wire device and the sensor head unit and / or between the wire device and the end unit. By means of such an embodiment, the specific advantages of the method proposed herein can also be achieved in a simple and cost-effective manner.

[0023] Finally, a method for a production line device is proposed, wherein the method comprises the following steps:

[0024] - providing said guide sleeve and said conducting element; and

[0025] - Arranging the conducting element inside the guide sleeve in order to produce the wire arrangement.

[0026] The method proposed here for producing a wire device for a ventricular assist system can be implemented, for example, in the form of software or hardware or in the form of a mixture of software and hardware, for example in a control device.

[0027] Furthermore, the method proposed herein also provides a device designed to carry out, trigger or more specifically implement the steps of a variant of the method proposed herein and to produce a wire device for a ventricular assist system in a corresponding device. The problem on which the invention is based can also be solved quickly and effectively by this alternative variant in the form of a device according to the invention.

[0028] To this end, the device may include at least one computing unit for processing signals or data, at least one storage unit for storing signals or data, at least one interface with a sensor or actuator for reading a sensor signal from a sensor or for outputting data or a control signal to an actuator and / or at least one communication interface for reading in or outputting data embedded in a communication protocol. The computing unit may be, for example, a signal processor, a microcontroller, etc.; and the storage unit may be a flash memory, an EEPROM or a magnetic storage unit. The communication interface may be designed to read in or output data wirelessly and / or by wire, in which case the communication interface that can read in or output data by wire may, for example, read in or output said data electrically or optically from a corresponding data transmission line, or may output said data into a corresponding data transmission line.

[0029] In the present case, a device can be understood as an electrical device, which processes sensor signals and outputs control signals and / or data signals according to its function. The device may include an interface that can be configured in hardware and / or software. In the case of a hardware design, the interface may be, for example, part of a so-called ASIC system, which includes a variety of functions of the device. However, the interface may also be a separate integrated circuit or at least partially composed of discrete components. In the case of a software design, the interface may also be a software module present, for example, on a microcontroller, in addition to other software modules.

[0030] Also advantageous is a computer program product or computer program with program code, which can be stored on a machine-readable carrier or storage medium such as a semiconductor memory, hard disk memory or optical memory, and is used to execute, implement and / or trigger the steps of a method according to any of the above-described embodiments, in particular when the program product or program is executed on a computer or device.

[0031] Exemplary embodiments of the method proposed herein are shown in the accompanying drawings and are explained in more detail in the following description. The accompanying drawings show:

[0032] Figure 1 is a schematic diagram of a left ventricular assist system with an integrated wire device according to an exemplary embodiment;

[0033] Figure 2 is a schematic diagram of a sensor head unit of a left ventricular assist system according to an exemplary embodiment;

[0034] Figure 3 is a schematic diagram of a sensor contact area and a signal generator contact area of ​​a conductive element according to an exemplary embodiment;

[0035] Figure 4 is a three-dimensional view of a sensor head unit of a left ventricular assist system according to an exemplary embodiment;

[0036] Figure 5 is a schematic diagram of a sensor head unit of a left ventricular assist system according to an exemplary embodiment;

[0037] 6 is a schematic diagram of a guide sleeve of a wire device according to an exemplary embodiment;

[0038] Figure 7 is a schematic diagram of a connection point element of a conductive element according to an exemplary embodiment;

[0039] Figure 8 is a schematic diagram of a contact connection point element of a conductive element according to an exemplary embodiment;

[0040] Fig. 9is a schematic cross-sectional view of a conductive element according to an exemplary embodiment; and

[0041] Fig.10 is a flow chart of an exemplary implementation of a method for a production line apparatus according to an exemplary embodiment.

[0042] In the following description of advantageous embodiments of the invention, identical or similar reference numerals are used for those elements which are shown in the individual figures and function in a similar manner, so that a repeated description of these elements is omitted.

[0043] Figure 1 A schematic diagram of a left ventricular assist system 100 with an integrated wire device 105 according to an exemplary embodiment is shown. Ventricular assist system 100 comprises a cylindrical elongated structure having a substantially constant outer diameter and rounded tapered ends to facilitate placement via a catheter in a vessel such as the left ventricle or the aorta.

[0044] First, a ventricular assist system 100 (here, for example, a left ventricular assist system 100 for percutaneous implantation in the left ventricle) includes a wire device 105, wherein in this case, the wire device 105 is arranged between the sensor head unit 110 and the motor housing 115, the end unit 120 and the connecting cable 125 of the ventricular assist system 100. In this regard, the wire device can be connected to the sensor head unit 110 and the motor housing 115, or more specifically, the end unit 120 via a connecting element 130 and 135. The connecting elements 130 and 135 include openings for receiving or discharging blood. The connection is achieved, for example, by bonding. The wire device 105 and the connecting element 130 can also consist of one part. This means that they can be manufactured as a whole. In one embodiment, the sensor head unit 110 and the connecting element 130 can also be made of one part (i.e., as a whole).

[0045] The sensor head unit 110 of the ventricular assist system 100 comprises a tip, e.g. in the form of a sensor assembly, e.g. for measuring pressure and / or temperature. The end unit 120 represents, e.g., the proximal end of the ventricular assist system 100 and forms a transition between a motor housing 115 of the ventricular assist system 100 and a connecting cable 125 for connecting the ventricular assist system 100 to an external energy source or an external evaluation device or control device.

[0046] The wire device 105 comprises a guide sleeve 140, which comprises a structure at least partially along the extension direction, or more specifically, a structured surface here. For example, the guide sleeve 140 comprises a spiral surface structure. An electrically conductive element 145 is arranged inside the guide sleeve 140, wherein in this case, the electrically conductive element 145 is used to electrically connect the sensor head unit 110 to the connecting cable 125 at the proximal end of the ventricular assist system 100.

[0047] According to an exemplary embodiment, the conductive element 145 may include a meandering portion in order to achieve its length adjustment. In this case, the meandering portion is preferably placed in the region of the motor housing 115.

[0048] Figure 2 A schematic diagram of a sensor head unit 110 of a left ventricular assist system 100 is shown according to an exemplary embodiment.

[0049] The sensor head unit 110 of the ventricular assist system 100 includes a tip, for example, in the form of a sensor assembly, which is used, for example, to measure pressure and / or temperature in a patient suffering from a heart disease. For this purpose, the sensor head unit 110 according to an exemplary embodiment includes two sensors 205 and a signal generator 210. The two sensors 205 can be, for example, pressure sensors and / or temperature sensors. The signal generator 210 can be, for example, an ultrasonic element. According to one embodiment, both sensors 205 are arranged in a sensor cavity 215, which is filled with a potting compound for protecting the sensors 205 from blood and / or mechanical damage. Therefore, the potting compound can be, for example, solid and / or gel-like silicone and / or silicone oil.

[0050] As shown in the schematic diagram of the sensor head unit 110 shown in this embodiment, the sensor head unit 110 is connected to the line device 105 via a connecting element 130, wherein in this case, the connecting element 130 includes a plurality of inlet windows 220, through which the blood of the heart patient enters the ventricular assist system.

[0051] Figure 3 A schematic diagram of a sensor contact area 305 and a signal generator contact area 310 of a conductive element is shown according to an exemplary embodiment.

[0052] According to an exemplary embodiment, the conductive element comprises, for example, a structure on at least one of its ends; the structure is used as a sensor contact area 305 for directly mounting and / or contacting at least one sensor, and / or as a signal generator contact area 310 for contacting at least one signal generator by bonding, soldering and / or bonding with a conductive adhesive. In this case, the sensor contact area 305 and the signal generator contact area 310 are arranged on a sensor head unit 110, which is used, for example, to measure the pressure and / or temperature of a heart patient. The sensor contact area 305 is designed, for example, as a rectangular printed circuit board in order to receive and / or contact at least two sensors. In addition, the sensor contact area comprises two edges 315 and 320, wherein in this case, the sensor contact area 305 can be bent at these two edges 315 and 320 in order to surround a groove 325 in the sensor head unit 310. The signal generator contact area 310 is designed, for example, as a circular printed circuit board in order to receive and / or contact at least one signal generator, for example an ultrasonic element. For this purpose, the signal generator contact area 310 according to an exemplary embodiment comprises two bent contact points 330 in order to contact the ultrasonic element. Furthermore, the signal generator contact region 310 also comprises an edge 335 at which it can be bent in order to integrate itself into the cylindrical shape of the ventricular assist system in the best possible way.

[0053] Figure 4 A three-dimensional view of a sensor head unit 110 of a left ventricular assist system according to an exemplary embodiment is shown. The sensor head unit 110 comprises a sensor head 405, which is formed, for example, in a mushroom-shaped manner; furthermore, a sensor contact area 305, on which a sensor 205 is mounted; and finally, a connecting element 130 comprising a plurality of inlet windows 220, through which the blood of a cardiac patient enters the ventricular assist system. Furthermore, a joining area 410 is provided, which serves to press-fit the connecting element 130 to the sensor head unit 110. The inlet windows 220 are defined by three webs 610, two of which are located at Figure 4 In order to minimize possible pressure losses, the inlet window is designed to be as large as possible so that the thin web 610 remains in the area 130. As shown in the schematic diagram of the sensor head unit 110 shown in this embodiment, the sensor head unit 110 is connected to the line device 105 in a fluid-tight manner via the connecting element 130.

[0054] Figure 5A schematic diagram of a sensor head unit 110 of a left ventricular assist system according to an exemplary embodiment is shown. According to an exemplary embodiment, the sensor head unit 110 comprises a sensor head 405, for example formed in a mushroom-shaped manner; furthermore, a sensor contact area 305 on which at least one sensor is mounted and / or contacted; and furthermore, a signal generator contact area 310 on which at least one signal generator is contacted. In the schematic diagram of the sensor head unit 110 shown in this embodiment, it is shown that the sensor contact area 305 and / or the signal generator contact area of ​​the conductive element are assembled in the sensor head unit 110, wherein in this case the sensor contact area 305 is bent at at least two of its edges so as to surround a recess 325 of the sensor head unit 110. Furthermore, the signal generator contact area 310 is also bent at its edges so as to integrate itself into the cylindrical shape of the ventricular assist system in the best possible way.

[0055] FIG. 6 shows a schematic diagram of a guide sleeve 140 of a wire device according to an exemplary embodiment.

[0056] According to an exemplary embodiment, the inlet sleeve 140 is formed in the type of a flexible cylindrical feed tube with a continuous, structured surface 605 for guiding the conductive element. In this case, the flexible guide sleeve 140 is designed, for example, as a structure cut out of a tube and comprising a constant outer diameter, wherein in this case the cutting pattern comprises a continuous spiral 605 for supporting and protecting the conductive element. In addition, the guide sleeve comprises, for example, an integrated connection element 130, which consists of a joint area 410 and a plurality of webs 610 as a transition area, to which the guide sleeve 140 is integrally connected to the connection element 130. In this regard, the connection element 130 is made, for example, of the same material as the metal alloy. The connection element 130 forms an inlet window in the area between the joint area 410 and the guide sleeve, which is separated from each other by thin webs 610 (to which the conductive element 145 can be guided) and through which the blood of the heart patient enters the ventricular assist system.

[0057] In an alternative exemplary embodiment of the guide sleeve 140, the guide sleeve is formed as a braid, wherein a flat strip is embedded as a support for the conductive element, for example to protect the conductive element. The flat strip may also comprise a metal alloy, for example a nickel titanium alloy.

[0058] 6B shows a schematic diagram of a ventricular assist system 100 with a wire device 105. In this embodiment, the sensor head 110 and the guide sleeve 140 can also be seen, which are made of NiTiNol material, for example, and include a connecting element 130 and a wire device 105. At the front in the area of ​​the connecting element 130, blood flows between the webs 610 into the ventricular assist system 100 in a state of insertion into the patient's body. For manufacturing reasons, for example, the connecting element 135 is designed here as a separate part. The motor housing 115 and the end unit 120 (which can, for example, contain contact pins that are not shown in FIG. 6B and are intended for contacting a cable that passes through the patient's body) are welded to each other in a gas-tight manner, or more specifically, are connected to each other in a fluid-tight manner at the rear of the motor housing 112. The conductive element 145 is guided outside the device or more specifically on the guide sleeve 140 from the tip of the sensor head 110 on the web 610 of the inlet cage, or more specifically from the connecting element 130 and the spiral wire as part of the guide sleeve 140, to the storage cage, or more specifically to the additional connecting element 135, there on another web 620 corresponding to the web 610, and then through the motor, or more specifically through the motor housing 115 to the end unit 120, where the conductive element 145 can then be electrically contacted with the wire 125.

[0059] Figure 7 A schematic diagram of a connection point element 705 of a conductive element 145 is shown according to an exemplary embodiment.

[0060] According to an exemplary embodiment, the conductive element 145 comprises a connection point element 705 at one of its ends. In this case, the connection point element 705 is formed, for example, in a circular shape. However, in alternative exemplary embodiments, it can also be formed in an O-shaped or U-shaped, hexagonal, square, triangular or substantially polygonal manner. Furthermore, according to an exemplary embodiment, the connection point element 705 comprises a plurality of connection points 710, which are arranged radially and / or circumferentially on the outer environment of the connection point element 705. In this case, the connection points 710 are designed to be circular or semicircular, so that a plurality of thin and flexible wires 715 of the conductive element 145 can be folded between similarly radially arranged contact pins of a through element (not shown) so as to be contacted therewith by welding, conductive adhesive bonding and / or soldering.

[0061] Figure 8A schematic diagram of a contact connection point element 705 of a conductive element 145 according to an exemplary embodiment at the proximal end 120 of a ventricular assist system is shown. According to an exemplary embodiment, the connection point element 705 shown is a full contact connection point of the conductive element 145. In this view, the multi-layer structure of the conductive element 145 is clearly visible. The connection point element 705 comprises a plurality of semicircular connection points 710, which are radially and / or circumferentially arranged on the outer environment of the connection point element 705. In this case, each connection point 710 is connected to each contact pin 805 of a through-element (not shown) at the proximal end 120 of the support system, wherein in this case the through-element is also a conductive element for connecting, for example, a power line of an electric motor 115 to a power supply cable 125. In this case, the initial contact of the conductive element 145 at the metal pin at the rear end 120 allows a stable mechanical connection as a common connection element of the flexible conductor of the connection cable 125 and the conductive element. It is not recommended to mechanically connect the conductor of the connection cable directly to the conductive element.

[0062] Fig. 9 A schematic cross-sectional view of a conductive element 145 is shown according to an exemplary embodiment.

[0063] According to an exemplary embodiment, the conductive element 145 includes a plurality of coplanar layers 905 made of conductive and / or insulating materials. In this case, the conductive layer, for example, at least partially includes a gold material; and the insulating layer is at least partially made of a polyimide material. In addition, the conductive element 145 also includes a shielding element 910, which is implemented using a conductive layer and is based on a gold material. The shielding element 910 has a width of, for example, 470 m and a thickness of 10 m. As an alternative to the exemplary embodiment of the shielding element 910 shown in this embodiment, the shielding element 910 can also be implemented using direct contact between the various layers. In this case, the shielding element 910 is used to shield the individual conductors or conductor pairs of the electrical connection element in order to prevent any electrical and / or magnetic field coupling into the line of the electrical connection element, especially at higher frequencies, or conversely reduce electromagnetic radiation from the electrical connection element. In addition, for reasons of high-frequency compatibility, shielding can be used to adjust the specific wave impedance of the electrical connection element and reduce the impact of the environment.

[0064] Furthermore, the conductive element 145 comprises a plurality of wires 715, wherein in this case the wires 715 are arranged inside the layer and have, for example, a width of 410 m and a thickness of 10 m. Thus, according to an exemplary embodiment, the conductive element 145 comprises four digital wires 915 arranged outside the shielding element 910, and two ultrasound wires 920 arranged inside the shielding element 910.

[0065] Fig.10A flow chart of an exemplary embodiment of a method 1000 for a production line device according to an exemplary embodiment is shown. According to an exemplary embodiment, the method 1000 is executed and / or triggered on a device 1010 for a production line device.

[0066] In step 1020, a guide sleeve and a conductive element are provided. In step 1030 of method 1000, the conductive element is arranged inside the guide sleeve for production line installation.

[0067] If an exemplary embodiment includes an “and / or” conjunction between a first feature and a second feature, such conjunction should be understood to mean that the exemplary embodiment includes the first and second features according to one embodiment and only the first feature or only the second feature according to another embodiment.

Claims

1. A wire device for a heart assist system, the wire device comprising: a guide cannula including a sheath; and A conductive element attached to the sheath of the guide sleeve, wherein the conductive element comprises a plurality of layers, the plurality of layers comprising at least one conductive layer and at least one insulating layer, the width of each layer being greater than its thickness, and a sensor contact area configured to contact at least one sensor. 2 . The thread arrangement according to claim 1 , wherein the at least one electrically conductive layer is at least partially made of a gold material. 3 . The wire arrangement according to claim 1 , wherein the at least one insulating layer is at least partially made of a polyimide material. The wire arrangement of claim 1 , wherein the conductive element comprises a shielding element. The wire arrangement according to claim 4 , wherein the shielding element comprises a conductive layer. The line arrangement according to claim 5 , wherein the shielding element comprises through contacts between the conductive layers.

7. The wire arrangement of claim 4, wherein the conductive element comprises a plurality of wires, wherein at least one wire of the plurality of wires is arranged inside a layer of the plurality of layers, and wherein at least one wire of the plurality of wires is arranged outside the shielding element. 8 . The wire arrangement according to claim 1 , wherein the conductive element comprises a signal generator contact region configured to contact at least one signal generator.

9. The wire device of claim 1, wherein the sensor contact area is configured to receive at least two sensors, wherein the sensor contact area is rectangular in shape and includes at least two edges, and wherein the sensor contact area is curved at the at least two edges.

10. The wire device of claim 8, wherein the signal generator contact region comprises at least two curved contact points.

11. The wire arrangement of claim 1, wherein the conductive element comprises a connection point element, wherein the connection point element comprises a plurality of connection points circumferentially arranged on an outer edge of the connection point element.

12. The wire device of claim 1, wherein the sheath is cylindrical and comprises a helical structure, and wherein the sheath of the introducer cannula comprises an alloy containing a metal. 13 . The wire arrangement according to claim 1 , wherein each of the plurality of layers of the conductive element has a thickness of 5 μm to 15 μm, and wherein the conductive element is formed in a meandering manner.

14. A heart assist system comprising: a wire device disposed between the sensor head unit and the end unit; a first connection element disposed between and connected to the line device and the sensor head unit, the first connection element including an opening for receiving blood; a second connection element disposed between and connected to the line device and the end unit, the second connection element including an opening for draining blood; and A conductive element is connected to the wire device, the conductive element comprises a plurality of layers, the plurality of layers comprises at least one conductive layer and at least one insulating layer, and the width of each layer is greater than the thickness thereof.

15. The heart assist system according to claim 14, wherein: The wire device also includes a guide cannula including a sheath having a helical structure; The conductive element is connected to the helical structure of the sheath of the guide sleeve; and The conductive element includes a sensor contact area configured to contact at least one sensor.

16. A method for producing a wire device for a heart assist system, the method comprising: providing a guide cannula including a sheath; and Applying a conductive element in a meandering manner on at least a portion of the sheath of the guide sleeve to achieve length adjustment of the conductive element, the conductive element comprising: a plurality of layers, the plurality of layers comprising at least one conductive layer and at least one insulating layer, the width of each layer being greater than its thickness; and A sensor contact area is configured to contact at least one sensor.

17. The method of claim 16, wherein the sheath is cylindrical and comprises a helical structure, and wherein the conductive element is applied to at least a portion of the helical structure of the sheath.

18. A system for producing a wire device for a heart assist system, the system comprising: a machine-readable storage device having computer-readable instructions stored thereon; and A processor, wherein the computer readable instructions, when executed by the processor, cause the processor to perform the following steps: Applying a conductive element on at least a portion of the sheath of the guide sleeve, the conductive element comprising: In a zigzag shape; a plurality of layers, the plurality of layers comprising at least one conductive layer and at least one insulating layer, each layer having a width greater than its thickness; and A sensor contact area for contacting at least one sensor.

19. The system of claim 18, wherein the sheath is cylindrical and includes a helical structure, and wherein the conductive element is applied to at least a portion of the helical structure of the sheath.

20. A non-transitory computer storage device having computer readable instructions stored thereon, which, when executed by a processor of a production device, cause the processor to perform the following steps: A conductive element is applied to at least a portion of the jacket of the guide sleeve, said conductive element: Form a zigzag shape; comprising a plurality of layers, the plurality of layers comprising at least one conductive layer and at least one insulating layer, the width of each layer being greater than its thickness; and A sensor contact area for contacting at least one sensor.

21. The wire device of claim 1, wherein at least a portion of the conductive element is helical.

22. The wire arrangement of claim 1, wherein the conductive element comprises a plurality of wires, and wherein at least one of the plurality of wires is a digit wire.

23. The wire device of claim 1, wherein the conductive element is configured to be guided along at least one web of the sheath.

24. The wire device of claim 23, wherein the at least one web at least partially defines an inlet and / or an outlet of the heart assist system.

25. The wire device of claim 1, wherein the sheath of the introducer sleeve is cut into a tube, formed into a braid, formed into a spiral or wavy structure, formed into a zigzag structure, and / or formed into a zigzag deformation.

26. The wire arrangement of claim 4, wherein the conductive element comprises a plurality of wires, and wherein at least one wire of the plurality of wires is arranged within the shielding element.

27. The wire device of claim 1, wherein the plurality of layers are coplanar.

28. The wire arrangement of claim 1, wherein at least one of the at least one electrically conductive layer comprises one or more electrically conductive portions and one or more electrically insulating portions.

29. The system of claim 14, further comprising at least one sensor.

30. The system of claim 14, wherein the wire arrangement is integrally manufactured with the first connection element and / or the second connection element.

31. The system of claim 14, wherein the conductive element is guided along a web defining an opening in the first and / or second connection element.

32. The system of claim 14, wherein at least a portion of the conductive element is helical.

33. The system of claim 14, wherein the plurality of layers are coplanar.

34. The system of claim 14, wherein at least one of the at least one conductive layer comprises one or more electrically conductive portions and one or more electrically insulating portions.

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