Lead system for a medical implant

Abstract

Supply system (1) for a medical implant (2) comprising: an intracorporeal supply line section (100), and an extracorporeal supply line section (200); characterized in that the supply line system (1) has a flat cross-sectional profile (11) in a proximal region (112) of the intracorporeal supply line section (100) and in a distal region (114) of the extracorporeal supply line section (200), and wherein the supply line system (1) comprises electrical supply lines (20) and / or pneumatic supply lines (30).

Description

Technical field

[0001] The invention relates to a lead system for a medical implant. In particular, the lead system according to the invention is suitable for a heart assist device for supporting the pumping function of the heart. Background of the invention

[0002] Due to illness, the pumping function of the heart can be reduced, which is also known as heart failure. Heart failure is of great and growing importance from both a medical and an economic perspective. In the second decade of this century, 23 million people worldwide will suffer from heart failure, with the annual incidence rate then reaching 2 million. In the USA alone, around 5 million people currently suffer from heart failure. Here, the annual incidence rate is around 550,000 people. In this decade alone, the number of people over 50 in the USA will double to over 10 million. The same applies to the European continent.

[0003] Heart failure can be caused by impaired contractility or filling of the heart due to damage to the heart muscle. Increased blood pressure can lead to increased pumping resistance, which can also negatively impact the heart's pumping function. The heart's pumping function can also be reduced by leaky valves, such as a leaky aortic or mitral valve.

[0004] Different types of heart failure can be treated with medication or surgery. Among other treatment options, supporting the heart's pumping function with an implant that exerts mechanical pressure on the heart and thus improves its pumping performance represents a promising treatment approach that addresses the various causes of heart failure.

[0005] Such implants usually require a supply system connected to an extracorporeal supply unit to function. In addition to ensuring the operation of the implant, such a supply system can perform other functions, such as data transmission for functional monitoring. Such supply systems typically include pneumatic or hydraulic supply lines to supply expandable units on the implant and electrical supply lines for ECG recording.

[0006] However, current supply systems pose a significant technical and medical challenge, as they can lead to patient complications and system failure. Common complications of supply systems, such as infections, can be fatal for the patient and thus represent a limiting factor in the overall effectiveness of the treatment method. Likewise, an interruption in supply or transmission in a supply system line can lead to system failure, sometimes with serious consequences, such as the need for surgery, heart failure, or even patient death due to system failure and loss of pumping capacity.

[0007] The risk of infection is particularly high in the early postoperative phase. However, the risk of infection remains high throughout the postoperative period, as the percutaneous supply system for the intracorporeal implant remains permanently in the patient's body and thus requires a skin exit opening to access the extracorporeal supply unit. The skin exit area is one of the most vulnerable to infections and tissue injuries. This often leads to long-term hospitalization and frequent readmissions of patients already discharged from the hospital, for example, for intensive antibiotic therapy or even surgical procedures.

[0008] A known delivery system for implanting a heart assist device is shown in DE 10 2013 200 148 A1. US 2016 / 271307 A1 discloses an electrical assembly with an implantable cable element comprising layers that promote tissue ingrowth. DE 10 2010 006 272 A1 discloses a negative pressure patch for treating wounds outside the body.

[0009] The object of the present invention is to provide a supply system for a medical implant which does not have the disadvantages of the known supply systems and increases patient compatibility and system reliability. Summary of the invention

[0010] The present invention relates to a supply system for a medical implant.

[0011] The supply line system according to the invention, in a first variant, comprises an intracorporeal supply line section and an extracorporeal supply line section. The supply line system comprises electrical supply lines and / or pneumatic supply lines. The supply line system has a flat cross-sectional profile in a proximal region of the intracorporeal supply line section and in a distal region of the extracorporeal supply line section. This results in the supply line system, when installed, exiting the skin with a flat cross-sectional profile. This advantageously allows an exit opening of the supply line system in the patient's skin to be kept small, and the risk of infection at an exit point of the supply line system to be reduced.In addition, the reduced extension of the supply line system in a direction parallel to a short side of the supply line system cross-section results in lower tensile forces being exerted on the patient's skin. Thus, the flat cross-section allows for mechanical relief of the skin exit site.

[0012] Furthermore, the flat cross-section in the skin exit area allows the lead system to be bent more easily around an axis parallel to a long side of the lead system cross-section, allowing the extracorporeal lead section to run closer to the patient's body. This can improve wearing comfort and everyday usability. Furthermore, the risk of injury due to snagging on the lead system and subsequent dislocation of the lead system can be minimized.

[0013] In some embodiments, the intracorporeal supply line section can have a transition region from the flat cross-sectional profile to a non-flat cross-sectional profile. Alternatively or additionally, the extracorporeal supply line section can also have a transition region from the flat cross-sectional profile to a non-flat cross-sectional profile. The non-flat cross-sectional profile can preferably be designed as a substantially square, round, or polygonal, particularly preferably as a substantially triangular cross-sectional profile.

[0014] This results in the effect that the supply system can be adapted within the respective transition area to make it compatible with any cross-section of an interface. In the case of an interface with a flat cross-section, the respective section can also include a further transition area from non-flat to flat, or no transition area at all. On the other hand, this allows the creation of a supply system with mechanical properties specifically adapted to the respective area of the supply system. As described above, the supply system can be optimized for a skin exit area thanks to the flat cross-section.Further inside the body, the transition area of the intracorporeal supply line section can then be used to create a cross-sectional profile that is optimized with regard to intracorporeal requirements such as flexibility, rigidity and intracorporeal positioning.

[0015] In embodiments that can be combined with all previously described embodiments, the intracorporeal supply line section can comprise at least one and preferably three intracorporeal anchoring sheaths. The intracorporeal anchoring sheaths are designed to promote tissue ingrowth. This ensures that the patient's tissue can be connected to the intracorporeal anchoring sheaths and thus to the intracorporeal supply line section. Through a tissue connection, the intracorporeal supply line section can be positioned and fixed in the patient's body. As a result, the risk of dislocation of the supply system, in particular of the intracorporeal supply line section, is minimized and both system reliability and patient safety are increased.Particularly in the skin exit area, the fixation of the intracorporeal lead section minimizes the risk of injury due to dislocations and reduces the general transferability of mechanical forces resulting from body movements to the skin exit site, which leads to better healing of the skin exit site and thus to a lower risk of infection.

[0016] In embodiments that can be combined with the previous embodiment, the intracorporeal supply line section comprises a first, a second, and a third anchoring sheath. The first, the second, and the third anchoring sheath are arranged on the intracorporeal supply line section in a proximal-to-distal direction. Multiple anchoring sheaths can achieve greater stability of the intracorporeal supply line section within the patient's body. Furthermore, external forces acting on the supply line system can be better compensated than with only one anchoring sheath or no anchoring sheath at all.

[0017] In embodiments that can be combined with the previous embodiment, the transition region of the intracorporeal supply line section can be arranged between the first and second anchoring sheaths. Since the first anchoring sheath is the most proximal of the three anchoring sheaths, the cross-sectional profile of the supply line system can be adapted to the intracorporeal requirements described above shortly after the skin exit area in the distal direction behind the first anchoring sheath.

[0018] In embodiments that can be combined with the three previous embodiments, the intracorporeal anchoring sheaths can have a porous, fibrous, or textile structure. Such a design of the anchoring sheath structure creates the possibility for tissue to grow into the anchoring sheath. In other words, this open-pore design of the anchoring sheath can create an environment into which tissue can preferentially grow. The intracorporeal anchoring sheaths can have structures such as cavities or hollow spaces with dimensions of 40 µm to 2000 µm, preferably 50 µm to 1000 µm, and particularly preferably 80 µm to 500 µm. This can create optimal dimensional conditions for tissue ingrowth.

[0019] In embodiments that can be combined with all of the embodiments described so far, the supply line system can comprise at least two and preferably nine electrical supply lines. Alternatively or additionally, the supply line system can comprise at least two and preferably three pneumatic supply lines. Due to the at least two electrical supply lines, the supply system is capable of transmitting an electrical signal between a supply device and the medical implant. For example, an electrical action potential of the heart can be transmitted in the form of electrical voltage from at least two electrodes to the supply device and an ECG signal can be calculated. This can provide direct feedback about the bodily functions in the area of the implant. This means that the medical implant can be better controlled and monitored thanks to the special design of the supply line system.This leads to an increase in system reliability and treatment success as well as an increase in patient safety.

[0020] By using a larger number of electrical leads, action potentials can be transmitted from multiple electrodes on the heart or in the human body to the supply unit, allowing multiple ECG signals to be calculated. Furthermore, cable break detection and electrical shielding can be provided via electrical leads. These preferred advantageous embodiments can further increase system reliability and treatment success. By providing the pneumatic leads in the supply system, a pneumatic implant, for example expandable units, can be supplied with compressed air. Alternatively or additionally, a negative pressure can be generated in such expandable units. Since the supply system with the pneumatic leads extends extracorporeally to the skin exit point, a supply device can thus be arranged outside the patient's body.By eliminating the need for an intracorporeal supply device, another foreign body can be prevented from endangering patient safety.

[0021] In embodiments that can be combined with the previous embodiment, the intracorporeal supply line section can comprise a splitting section that is arranged at a distal end of the intracorporeal supply line section and enables the supply lines to be separated. A proximal end of the splitting section can be delimited by a separation element arranged directly behind the splitting section in the proximal direction. Separating the supply lines ensures that the supply lines can be placed at the correct position on the implant or connected to it. Positioning the splitting section at a distal end of the intracorporeal supply line section also ensures that the individual supply lines are only separated shortly before reaching their destination. This ensures that the supply lines are fed together over a large part of the intracorporeal supply line section.By using a common feeder over most of the intracorporeal lead section, patient exposure can be minimized and resistance to mechanical stress increased. Furthermore, a common feeder reduces the exposed surface area, thus reducing chemical exposure due to the immune reaction and thus improving the fatigue strength of the lead.

[0022] In embodiments that can be combined with the two previous embodiments, at least one of the electrical supply lines can be wound helically in at least one section of the supply line system. Alternatively or additionally, the at least one of the electrical supply lines can be wound helically around at least one of the pneumatic supply lines in at least one section of the supply line system. Alternatively, multiple electrical supply lines can be wound helically. Alternatively, multiple electrical supply lines can be wound helically around a pneumatic supply line. Alternatively, at least one electrical supply line can be wound helically around each pneumatic supply line.

[0023] Helical winding makes the electrical leads less susceptible to changes in distance between the implant and, for example, the skin exit area than non-coiled electrical leads. In the case of an implant as a cardiac assist device, for example, expansion and contraction of the heart can lead to changes in distance between the aforementioned areas. Helical winding of the electrical leads can compensate for changes in distance to a certain extent, similar to a coiled telephone cable. Furthermore, the helical winding can minimize the risk of kinking or breaking the electrical leads. This can increase the service life of the electrical leads. Since the electrical leads can be used to record the ECG, which in turn serves as the control signal for the implant, a break in the electrical leads can lead to the implant losing its function.Since this can have serious consequences for the patient, it must be avoided at all costs. By coiling a pneumatic supply line, the volume displaced by the supply line system can be reduced, as well as the cross-sectional area of the supply line system, which has a positive effect on patient compatibility. Furthermore, the pneumatic supply line can be mechanically stabilized by coiling an electrical supply line around it in a helical manner. In other words, a helical coil can increase kink resistance while maintaining the required flexibility.

[0024] In embodiments that can be combined with the three previous embodiments, at least one of the electrical leads in the proximal region of the intracorporeal lead section and in the distal region of the extracorporeal lead section can be uncoiled. Alternatively, several or all of the electrical leads in this region can be uncoiled. This allows a smaller cross-sectional area of the lead system to be achieved, particularly in the skin exit region, than with helically wound electrical leads. This allows, as already described above, the exit opening of the lead system to be reduced in size.

[0025] In embodiments that can be combined with the four previous embodiments, at least one of the electrical supply lines can be integrated into a sheath of at least one pneumatic supply line. Alternatively, several or all of the electrical supply lines can be integrated into a sheath of at least one pneumatic supply line. This allows, on the one hand, a more compact supply line system to be provided. On the other hand, the integration of the electrical supply lines can strengthen the respective pneumatic supply line and reduce the risk of kinking of the respective pneumatic supply line.

[0026] In embodiments that can be combined with the five previous embodiments, at least one of the pneumatic supply lines can comprise at least one sheath layer into which at least one of the electrical supply lines is embedded. Furthermore, at least one of the pneumatic supply lines can comprise an inner sheath layer and an outer sheath layer. Alternatively, several or all of the pneumatic supply lines can comprise an inner sheath layer and an outer sheath layer. The inner sheath layer can consist of a first material and the outer sheath layer of a second material. The first material can be an elastic material and the second material a less elastic material than the first. For example, the first material can be an elastic material, in particular silicone, and the second material a mechanically more stable material, in particular polyurethane.Alternatively, the first and second materials may also be made of the same material, for example an elastic material.

[0027] These advantageous designs allow specific mechanical properties of the pneumatic supply lines to be adjusted.

[0028] In embodiments that can be combined with the previous embodiment, at least one of the electrical supply lines can be integrated into the outer sheath layer of the respective pneumatic supply line. Alternatively, several electrical supply lines can be integrated into the outer sheath layer of the respective pneumatic supply line. Alternatively, all electrical supply lines can be integrated into the outer sheath layer of a pneumatic supply line. This results in simple and secure integration of the electrical supply lines into the respective pneumatic supply line. If the second material in this case is the same as the first, the pneumatic supply line can comprise an additional sheath layer around the outer sheath layer. This additional sheath layer can be made of a different material than the first and second sheath layers, preferably of a mechanically more stable material.

[0029] In embodiments that can be combined with the seven previous embodiments, the pneumatic supply lines can be connected to one another in a material-to-material manner. This prevents the supply lines from becoming separated. This is particularly relevant in the intracorporeal supply line section, since isolated supply lines can endanger the patient. The pneumatic supply lines can be connected to one another using a material that corresponds to the second material mentioned above. Alternatively or additionally, the pneumatic supply lines can be embedded in a common sheathing layer that encloses all pneumatic supply lines. This sheathing layer can be made of the second material. If the second material is an elastic material, the sheathing layer can also be made of a mechanically more stable material.As mentioned above, the intracorporeal supply line section may have a split section. If this is the case, the pneumatic supply lines in the area of the split section are not firmly connected to each other.

[0030] In embodiments that can be combined with the eight previous embodiments, at least one of the pneumatic supply lines can have at least one and preferably at least three web-shaped elevations on an inner surface of the respective pneumatic supply line. Alternatively, several or all pneumatic supply lines can have at least one and preferably at least three web-shaped elevations on an inner surface of the respective pneumatic supply line. The web-shaped elevations can protrude radially inward from an inner surface of the inner jacket layer. These advantageous embodiments make it possible to prevent a complete closure of the pneumatic supply line in the event of a hose kink. A hose kink with a complete closure of the pneumatic supply line could result in an implant remaining in a condition that is potentially dangerous for the patient.Maintaining a minimal lumen of the pneumatic supply line in the event of a kink can ensure emergency venting of the implant and avoid dangerous conditions.

[0031] In embodiments that can be combined with all previously described embodiments, the intracorporeal supply line section can comprise a barrier sheath. The barrier sheath can be arranged at a proximal end of the intracorporeal supply line section. A barrier sheath that runs distally from the exit point has the effect of making it more difficult for germs to penetrate the patient's body. The barrier sheath thus contributes to a reduced risk of infection. The barrier sheath can be designed to promote the colonization of macrophages. Furthermore, the barrier sheath can have a porous or fibrous structure. The barrier sheath can have an open-pore structure. Furthermore, the barrier sheath can have cavities, alternatively or additionally also hollow spaces that are preferably open on at least one side.The dimensions of these cavities, in particular the respective diameters, can have dimensions of 10 µm to 100 µm, preferably of 20 µm to 60 µm and particularly preferably of 30 µm to 50 µm.

[0032] These latter features provide specific conditions that enable and promote the colonization of phagocytes. This targeted colonization of phagocytes in the area surrounding the skin exit site represents an active measure against infections caused by germs immediately after they enter the patient's body. This can prevent germs from penetrating deeper into the body and generally minimize the risk of infection. The dimensions of the cavities and hollow spaces represent specific properties for the targeted ingrowth or colonization of macrophages.

[0033] In embodiments that can be combined with all of the embodiments described so far, the supply line system can further comprise a connector system with a first connector part and a second connector part. The first connector part can be arranged at a proximal end of the extracorporeal supply line section and can preferably be female. The second connector part can be arranged proximal to the first connector part and can preferably be male. A connector system can decouple an implant-side supply line from a supply-side supply line. For example, in the event of a repair of a supply device or an existing supply-side supply line, it is not necessary to remove the entire implant-side supply line, but only the purely extracorporeal part of the system. This avoids surgical interventions and increases patient safety.By designing the first connector section as a female connector, damage to the connector pins on the implant side can be prevented. This means that if the connector system is damaged, the second connector section is likely to be damaged, which is much easier and safer for the patient to replace than the first connector section.

[0034] In embodiments that can be combined with previous embodiments, the supply system can further comprise a partial supply section for a supply device. The partial supply section can extend from the second connector part in the proximal direction to a supply device.

[0035] In embodiments that can be combined with the two previous embodiments, the supply line system can comprise a predetermined breaking point in a region proximal to the first connector part. The predetermined breaking point can preferably be arranged in a region of the second connector part. Alternatively, if a partial supply line section is present, the predetermined breaking point can be arranged in a distal region of the partial supply line section.

[0036] In embodiments that can be combined with all previously described embodiments, the extracorporeal lead section can comprise a lead fixation designed to be applied to the skin. Alternatively or additionally, if a partial lead section is present, this can also comprise a lead fixation. A lead fixation can fix the lead system and secure it against dislocation or minimize dislocation, thus reducing the transferability of mechanical forces to the skin exit point. Furthermore, the lead fixation allows the lead system to be guided closer to the body. This increases patient comfort and minimizes the risk of injury and infection.

[0037] In embodiments that can be combined with the fourteen previous embodiments, the flat cross-sectional profile can have a smaller circumference than the non-flat cross-sectional profile. This can reduce the size of the exit opening and provide mechanical relief at the skin exit site. Furthermore, the risk of infection can be reduced.

[0038] In embodiments that can be combined with the fifteen previous embodiments, the flat cross-sectional profile can have greater flexibility in the x-direction than in the y-direction. Alternatively or additionally, the axial area moment of inertia of the flat cross-sectional profile can be smaller in the x-direction than in the y-direction. As described above in connection with the flat cross-section, the extracorporeal lead section can be guided closer to the patient's body immediately after exiting the skin due to greater flexibility or a smaller axial area moment of inertia in the x-direction. This can improve wearing comfort and suitability for everyday use. Furthermore, the risk of injury due to snagging on the lead system and subsequent dislocation of the lead system can be minimized.

[0039] In embodiments that can be combined with the sixteen previous embodiments, the non-flat cross-sectional profile can have greater rigidity than the flat cross-sectional profile. Alternatively or additionally, the non-flat cross-sectional profile can have substantially uniform flexibility in the radial direction. Alternatively or additionally, the non-flat cross-sectional profile can have substantially uniform axial area moment of inertia in the x-direction and the y-direction. These advantageous embodiments can improve the mechanical properties of the supply system in a region with a non-flat cross-sectional profile for this region.For example, the intracorporeal supply line section can meet the intracorporeal requirements with regard to both certain necessary flexibility and stiffness by having a non-flat cross-sectional profile with a substantially uniform axial area moment of inertia in the x-direction and in the y-direction.

[0040] In embodiments that can be combined with all embodiments described so far, the medical implant can be a cardiac assist device. Short description of the characters Fig. 1 shows an isometric view of a first embodiment of the supply system according to the invention Fig. 2a shows cross-sectional views of various non-flat cross-sectional shapes of the supply system according to the invention with electrical and pneumatic supply lines Fig. 2b shows cross-sectional views of various flat cross-sectional shapes of the supply system according to the invention with electrical and pneumatic supply lines Fig. 3a shows an isometric view of the supply system according to the invention with pneumatic supply lines and helically wound electrical supply lines Fig. 3b shows an isometric view of the supply line system according to the invention with two electrical supply lines wound helically around a pneumatic supply line Fig. 4a shows a cross-sectional view of the supply system according to the invention in a flat cross-sectional shape with integrally connected pneumatic supply lines and straight electrical supply lines Fig. 4b shows a cross-sectional view of the supply line system according to the invention in a non-flat cross-sectional shape with integrally connected pneumatic supply lines and straight electrical supply lines Fig. 4c shows a cross-sectional view of the supply line system according to the invention in a non-flat cross-sectional shape with electrical leads helically integrated into the jacket of a pneumatic supply line Fig. 4d shows a cross-sectional view of a pneumatic supply line with a straight integrated electrical supply line of the supply system according to the invention in the area of the splitting section Fig. 4e shows a cross-sectional view of a pneumatic supply line with a coiled integrated electrical supply line of the supply line system according to the invention in the area of the splitting section Fig. 4f shows a cross-sectional view of a pneumatic supply line with decoupled electrical supply lines of a connector system Fig. 5 shows an isometric view of a pneumatic supply line according to the invention with web-shaped elevations Fig. 6 shows an isometric view of the supply system according to the invention with repair plug, partial supply section and supply device Detailed description

[0041] Exemplary embodiments of the supply line system 1 according to the invention are described below with reference to the figures. In the context of this application, the term proximal refers to regions or directions that face or are closer to a supply device or an operator. Distal regions or directions refer to regions and directions that face or are closer to a medical implant. In other words, the proximal direction describes a direction from an implant to a supply unit and the distal direction a direction from a supply unit to an implant. Extracorporeal describes everything that, when installed, is located largely or completely outside the body of a patient, i.e. proximal to a skin exit point.Intracorporeal, on the other hand, describes everything that, when installed, is located largely or entirely within the body of a patient, i.e. distal to a skin exit point.

[0042] Referring to Fig. 1, the supply line system 1 according to the invention comprises an intracorporeal supply line section 100 and an extracorporeal supply line section 200. In a proximal region 112 of the intracorporeal supply line section 100 and in a distal region 214 of the extracorporeal supply line section 200, the supply line system 1 has a flat cross-sectional profile 11. This results in the effect that the supply line system 1 can exit the skin exit region 6 with a flat cross-sectional profile 11 when installed. This advantageously allows an exit opening of the supply line system 1 in the skin of a patient, which is not shown here, to be kept narrow. In addition, due to the smaller extension of the supply line system 1 in a direction parallel to a short side of the supply line system cross-section 10, i.e. in the x-direction 61, lower tensile forces are exerted on the patient's skin.Thus, the skin exit area can be mechanically relieved by the flat cross-section 11.

[0043] Furthermore, the supply system 1 can be bent more easily around an axis parallel to a long side of the supply system cross-section due to the flat cross-section 11 in the skin exit area 6, whereby the extracorporeal supply line section 200 can run closer to the patient's body. This can improve wearing comfort and suitability for everyday use. Furthermore, the risk of injury due to snagging on the supply system 1 and subsequent dislocation of the supply system 1 can be minimized. The skin exit area 6 represents the area of the epidermis and dermis of a patient that must be pierced by the supply system 1. The exit opening is the necessary opening in the patient's skin to allow the supply system 1 to pass through and is therefore dependent on the cross-sectional geometry 11 of the supply system 1. Fig. 1 also shows a relative coordinate system 60 of the supply system 1. The x-direction 61 defines a direction that runs parallel to a short edge of the flat cross-section 11. The y-direction 62, on the other hand, runs along a long edge of the flat cross-section 11.

[0044] How Fig. 1, the intracorporeal supply line section 100 has a transition region 113 from the flat cross-sectional profile 11 to a non-flat cross-sectional profile 12. Furthermore, the extracorporeal supply line section 200 also has a transition region 213 from the flat cross-sectional profile 11 to a non-flat cross-sectional profile 12. In the illustrated embodiment of the Fig. 1, the non-flat cross-sectional profile 12 of the intracorporeal supply line section 100 is designed as a substantially triangular cross-sectional profile 12d (see Fig. 2a). The non-flat cross-sectional profile 12 of the extracorporeal supply line section 200 is designed as a round cross-sectional profile 12b (see Fig. 2a).

[0045] In other embodiments, the non-flat cross sections 12 of the intracorporeal supply line section 100 and the extracorporeal supply line section 200 may also be designed in other cross-sectional shapes. Fig. Figure 2a illustrates four different non-flat cross-sections (12a, 12b, 12c, 12d) as examples. For example, the non-flat cross-sections 12 can be essentially square 12a, round 12b, polygonal 12c, or triangular 12d. "Essentially" refers here to a cross-sectional shape that has the basic shape of one of the aforementioned shapes but also slight deviations, for example, due to curves (see, for example, the dashed lines of the cross-sectional shape 12d in Fig. 2a).

[0046] The terms "flat cross-section 11" and "non-flat cross-section 12" refer to two-dimensional shapes of a cross-section 10 in which a ratio of the extent of a shorter dimension 63 to the extent of a longer dimension 64 falls below (flat) or exceeds (non-flat) a limit value of 0.5. For a flat cross-section 11, the ratio can fall below a limit value of preferably 0.4 and particularly preferably 0.3. For a non-flat cross-section 12, the ratio can exceed a limit value of preferably 0.6 and particularly preferably 0.7. For a better understanding, the shorter (63a, 63b) and longer dimensions (64a, 64b) of the cross-sectional shapes 12a and 12b are shown in Fig. 2a. To determine the ratio value, the minimum extension of the respective shape should be used as the shorter dimension 63, and the maximum extension of the respective shape in a direction orthogonal to the direction of the shorter dimension 63 should be used as the longer dimension 64.

[0047] Through the respective transition area (113, 213), the supply system 1 can be adapted to be compatible with any cross-section 10 of an interface. In the case of an interface with a flat cross-section 11, the respective section (100, 200) can also include a further transition area from non-flat to flat, which is not shown here. Even if in Fig. 1 shows the preferred embodiment, in alternative designs the respective supply line section (100, 200) can also comprise no transition region (113, 213) at all. In addition to interface compatibility, a supply line system 1 can be created with mechanical properties specifically adapted to the respective region (113, 213) of the supply line system 1. As described above, the supply line system 1 can be optimized for a skin exit region 6 by the flat cross-section 11. Further inside the body, the transition region 113 of the intracorporeal supply line section 100 can then, for example, create a cross-sectional profile 10 that is optimized with regard to intracorporeal requirements such as flexibility, rigidity and intracorporeal positioning.

[0048] As will be explained in detail later, the supply system 1 may also comprise a partial supply section 300 (see Fig. 6). If this is the case, alternatively or in addition to the extracorporeal supply line section 200, the partial supply line section 300 may also comprise a transition region 313 from a flat cross-sectional profile 11 to a non-flat cross-sectional profile 12.

[0049] Fig. 1 further shows that the intracorporeal supply line section 100 comprises a plurality of intracorporeal anchoring sheaths 120. In detail, a first 120a, a second 120b, and a third 120c anchoring sheath are arranged one behind the other in the distal direction 4a on the intracorporeal supply line section 100. In alternative embodiments, the intracorporeal supply line section 100 can also comprise more or fewer than three anchoring sheaths 120. As shown in Fig. As schematically indicated in Figure 1, the intracorporeal anchoring sheaths (120; 120a, 120b, 120c) have a porous, fibrous, or textile structure 121. This particularly advantageous configuration of the structure 121 creates the possibility for collagen-rich connective tissue to grow into the anchoring sheaths (120; 120a, 120b, 120c). In alternative embodiments, the intracorporeal anchoring sheaths (120; 120a, 120b, 120c) can also be designed differently to promote the ingrowth of connective tissue.

[0050] An open-pore design of the anchoring sheaths (120; 120a, 120b, 120c) creates an environment into which connective tissue can preferentially grow. This ensures that the patient's connective tissue can be connected to the intracorporeal anchoring sheaths 120 and thus to the intracorporeal supply line section 100. A connective tissue connection allows the intracorporeal supply line section 100 to be positioned and fixed in the patient's body. As a result, the risk of dislocation of the supply line system 1, in particular of the intracorporeal supply line section 100, is minimized, and both system reliability and patient safety are increased. Especially in the skin exit area 6, the fixation of the intracorporeal supply line section 100 minimizes the general transferability of mechanical forces resulting from dislocations, thus reducing the risk of injury.In addition, healing of the skin exit site is improved, which can reduce the risk of infection. Furthermore, external forces acting on the supply line system 1 can be better compensated because they can be absorbed by the connective tissue via the anchoring sheaths (120; 120a, 120b, 120c). The multiple anchoring sheaths 120 can provide greater stability for the intracorporeal supply line section 100. Thus, relative movements between the supply line system 1 and the connective tissue are minimized. A length 123 of the respective anchoring sheaths (120; 120a, 120b, 120c) can be adjusted, in particular, depending on the requirements for fixation and mobility or flexibility of the intracorporeal supply line section 100. For example, multiple shorter anchoring sheaths 120 can provide multiple fixation points with lower force absorption capacity.By using a smaller number of longer anchoring sheaths 120, a smaller number of fixation points can be provided, which can, however, absorb greater forces. The term "length 123" of an anchoring sheath 120 refers to a dimension in a longitudinal direction of the supply line system 1. The length 123 of an anchoring sheath (120; 120a, 120b, 120c) can be in a range from 0.5 cm to 20 cm, preferably in a range from 1 cm to 10 cm, and particularly preferably in a range from 3 cm to 6 cm. In a preferred embodiment, the length 123 of an anchoring sheath (120; 120a, 120b, 120c) is 5 cm.

[0051] The intracorporeal anchoring sheaths 120 have structures, such as cavities or interstices with dimensions of 40 µm to 2000 µm, preferably 50 µm to 1000 µm, and particularly preferably 80 µm to 500 µm. This allows optimal dimensional conditions for the ingrowth of connective tissue to be created. These structures can be provided by manufacturing the intracorporeal anchoring sheaths 120, for example, from so-called "surgical felts," fabrics, or other woven, braided, spun, felted, or foamed products, preferably products made of plastics. In addition to the advantages already mentioned, the intracorporeal anchoring sheaths 120 contribute to improved biocompatibility of the supply system 1. Furthermore, the anchoring sheaths 120 can also serve as a protective measure against kinking of the intracorporeal supply line section 100.

[0052] The transition region 113 of the intracorporeal supply section 100 is in the embodiment of the Fig. 1 is arranged between the first 120a and the second 120b anchoring sheath. In alternative embodiments, the transition region 113 of the intracorporeal supply line section 100 can also be arranged in a different region of the intracorporeal supply line section 100. Due to the transition region 113 being located relatively close to the skin exit region 6, the cross-sectional profile 10 of the supply line system 1 can be adapted to the intracorporeal requirements described above in the distal direction 4a behind the first anchoring sheath 120a.

[0053] As in particular the Fig. 1 and Fig. 2, the supply line system 1 according to the invention can, in a preferred embodiment, comprise at least nine electrical supply lines 20 and three pneumatic supply lines (30a, 30b, 30c). In other embodiments, however, the supply line system can also comprise more or fewer than nine electrical supply lines 20 and three pneumatic supply lines 30. In the illustrated embodiment, two electrical supply lines 20 each serve to transmit a signal from a bipolar electrode of the implant 2. In the preferred embodiment, these are three pairs, each with two electrical supply lines 20 for signal transmission. The signal can, for example, comprise an analog signal for monitoring vital functions, in particular an ECG signal of a patient. Two further electrical supply lines 20 are used for cable break detection, and a further electrical supply line 20 is used for electrical shielding.These preferred advantageous embodiments can further increase system reliability and treatment success. In other embodiments, the electrical leads 20 can also perform functions other than those just described. In this case, more or fewer than nine electrical leads 20 can be present. For example, the lead system 1 can also have only electrical leads 20 that are used to transmit an ECG signal.

[0054] Thanks to the at least two electrical supply lines 20, the supply system 1 is able to exchange an electrical signal between a supply device 3 and the medical implant 2. For example, an electrical action potential of the heart can be transmitted in the form of electrical voltage from at least two electrodes to the supply device, and an ECG signal can be calculated. This allows direct feedback about the bodily functions in the area of the implant. This allows direct feedback about the bodily functions, in particular the heart function, in the area of the implant 2. This means that the special design of the supply system 1 allows the medical implant 2 to be better controlled and monitored. This leads to an increase in system reliability and treatment success, as well as to increased patient safety.By using a larger number of electrical leads 20, multiple electrical signals, in particular action potentials, can be transmitted from multiple electrodes on the heart or in the human body to the supply unit, and multiple ECG signals can be calculated. As mentioned above, cable break detection and electrical shielding can be provided via electrical leads 20.

[0055] By providing the pneumatic supply lines 30 in the supply line system 1, a pneumatic implant, for example one with expandable units, can be supplied with compressed air. The implant 2 can be supplied with positive pressure. Alternatively or additionally, the implant 2 can be supplied with negative pressure. In an implant with expandable units, the individual expandable units can thus be alternately expanded and compressed. In the case of an implant 2 for cardiac support, for example, the pumping function of the heart can thus be supported. Since the supply line system 1 with the pneumatic supply lines 30 runs extracorporeally to the skin exit point, a supply device 3 can thus be arranged outside the patient's body. By eliminating the need for an intracorporeal supply device, it is thus possible to prevent another foreign body from endangering patient safety.In alternative designs, hydraulic supply lines can also be used instead of pneumatic supply lines.

[0056] Furthermore, the intracorporeal supply line section 100 comprises a splitting section 130. The splitting section 130 is arranged at a distal end 115 of the intracorporeal supply line section 100. The fact that the splitting section 130 is arranged at a distal end 115 of the intracorporeal supply line section 100 ensures that the individual supply lines (20, 30) are only separated shortly before their destination. This ensures that the supply lines (20, 30) are fed together over a large portion of the intracorporeal supply line section 100. By feeding them together over a large portion of the intracorporeal supply line section 100, patient stress can be minimized. Furthermore, the stability of the supply line can be improved, thus reducing the likelihood of a malfunction.In the extracorporeal supply line section 200, the supply lines (20, 30) are routed together throughout, except in the case of selected connector designs. In alternative embodiments, the supply lines (20, 30) can also be routed separately in partial areas of the supply line system 1 or in the entire supply line system 1. For example, the pneumatic supply lines 30 can be routed separately from the electrical supply lines 20. Alternatively, two or three electrical supply lines 20 can each be routed with one pneumatic supply line 30.

[0057] The electrical 20 and pneumatic supply lines 30 are separated in the area of the splitting section 130 by the splitting section 130. In the embodiment of the Fig. 1, the three pneumatic supply lines 30 are first separated in the distal direction 4a. Further in the distal direction 4a towards the implant, the respective electrical supply lines 20 are separated from the respective pneumatic supply line 30 and guided to their intended position on the implant 2. In alternative embodiments, these can be guided together for a longer or shorter length and separated earlier or later in the distal direction 4a. Especially with a different number of electrical supply lines 20 and / or pneumatic supply lines 30, the splitting section 130 can be designed differently. By separating the supply lines (20, 30), it is ensured that the supply lines (20, 30) can each be placed in the correct position on the implant 2 or connected to it. A proximal end of the splitting section 130 is delimited by a separating element 150 arranged directly behind the splitting section 130 in the proximal direction 5a.In the illustrated embodiment, the splitting element 150 is realized by the third anchoring sheath 120c. In alternative embodiments, the splitting element 150 can also be a different anchoring sheath 120, for example, a fourth anchoring sheath 120 not shown here, or another element. The splitting element 150 enables separation of the supply lines in the distal direction 4a of the splitting element 150 and / or prevents separation in the proximal direction 5a of the splitting section 130.

[0058] As in Fig. 3a, the electrical supply lines 20 can be wound helically in at least one section of the supply line system 1. The electrical supply lines 20 can be wound helically around themselves (see Fig. 3a) or helically around at least one of the pneumatic supply lines 30 (see Fig. 3b) be twisted. In the representation of the Fig. 3b, an electrical supply line 20 is wound into a sheath of the pneumatic supply line 30. Alternatively, an electrical supply line 20 can also be wound around a sheath of the pneumatic supply line 30 (not shown here). In a preferred embodiment, three electrical supply lines 20 can be wound around each of the three pneumatic supply lines (30a, 30b, 30c) (not visible in the Fig. 1 and Fig. 6). Two of the three electrical supply lines 20 can be designed for signal transmission of a bipolar electrode and can thus each form an electrical supply line group (21a, 21b, 21c). The corresponding supply line groups (21a, 21b, 21c) are led away from the respective pneumatic supply line (30a, 30b, 30c) in a distal region of the splitting section 130 and separated only shortly before reaching a destination on the medical implant (see Fig. 1 and Fig. 6). The other electrical supply line 20 on the pneumatic supply lines 30a and 30b is a break detection line (22a, 22b), which in the embodiment of the Fig. 1 and Fig. 6 are short-circuited in the area of the separating element 140 and are thus not visible. The provision and short-circuiting of two break detection lines (22a, 22b) makes it possible to differentiate between an electrical zero line and a defect in an electrical supply line. The third electrical supply line 20, which is wound around the pneumatic supply line 30c, represents a shielding line 23 that ends in the area of the separating element 140. For reasons of clarity, the wound electrical supply lines just described are not shown in the Fig. 1 and Fig. 6 visible. Fig. 4b shows examples of straight break detection lines (22a, 22b) and a shielding line 23. In Fig. 4b, the electrical supply lines (22a, 22b, 23) are shown, by way of example, centrally in cross-section 12. Alternatively, these electrical supply lines (22a, 22b, 23) can also be arranged at other positions in a cross-section (10; 11, 12). In an alternative embodiment, more than three or all electrical supply lines 20 can be wound around a pneumatic supply line 30. In alternative designs, one or more electrical supply lines 20 can also be wound around all pneumatic supply lines 30. This can in particular be a shielding line 23. In alternative designs, the break detection lines (22a, 22b) can also be led to one, in particular the same, electrode and short-circuited at this point. A short circuit at another position of the supply line system 1 is also conceivable.Ideally, the short-circuit location of the break detection lines (22a, 22b) should be as distal as possible to cover a large area of the supply line system 1. In further alternative embodiments, no or more than two break detection lines 22 can be used. The same applies to the shielding line 23. The above-described embodiments regarding coiled electrical supply lines 26 can also be applied analogously to non-coiled electrical supply lines 28, insofar as they are then applicable. For example, non-coiled, essentially straight break detection lines (22a, 22b) can also be routed near a respective pneumatic line (30a, 30b) and short-circuited in the area of a separating element 140.

[0059] Thanks to a helical winding 26, the electrical leads 20 are less susceptible to changes in distance between the implant 2 and, for example, the skin exit area 6 than non-coiled electrical leads 28. In the case of an implant 2 that serves as a cardiac assist device, expansion and contraction of the heart can lead to changes in distance, for example, between the areas just mentioned. A helical winding 26 of the electrical leads 20 can compensate for changes in distance to a certain extent, similar to a coiled telephone cable. Furthermore, the helical winding 26 can minimize the risk of kinking or breaking the electrical leads 20. Since the ECG can be recorded through the electrical leads, which in turn serves as a control signal for the implant 2, a break in the electrical leads 20 can lead to a loss of function of the implant 2.Since this can have serious consequences for the patient, it must be avoided at all costs. This can increase the service life of the electrical supply lines 20. By winding a pneumatic supply line 30, the volume displaced by the supply line system 1 can be reduced, as well as the cross-sectional area 10 of the supply line system 1, which has a positive effect on patient compatibility. Furthermore, the pneumatic supply line 30 can be mechanically stabilized by a helically wound electrical supply line 20 around it. In other words, a helical winding 26 can increase the kink resistance while simultaneously maintaining the required flexibility.

[0060] In one embodiment, the electrical leads 20 are uncoiled in the proximal region 112 of the intracorporeal lead section 100 and in the distal region 214 of the extracorporeal lead section 200. This means that the electrical leads 20 run essentially straight in these regions (112, 214). Fig. 4a shows a flat cross-sectional profile 11 of the supply line system 1 with nine straight electrical supply lines 20 and three pneumatic supply lines 30. The arrangement of the electrical supply lines 20 in the cross-section 10 of the supply line system 1 can be different for both flat and non-flat cross-sectional profiles (10; 11, 12) than in Fig. 4a shown arrangement. Fig. 4b shows an alternative arrangement of rectilinear electrical supply lines 20 in a non-flat cross-sectional profile 12 of the supply line system 1. In alternative embodiments, the electrical lines can also run rectilinearly in other or only other areas of the supply line system 1. Alternatively, only selected electrical supply lines 20 can run rectilinearly in a specific area of the supply line system 1. The preferred embodiment allows a smaller cross-sectional area 10 of the supply line system 1 to be achieved, particularly in the skin exit area 6, than with helically wound electrical supply lines 20. As already described above, the exit opening of the supply line system 1 can be reduced in size.

[0061] In the preferred embodiment (see for example Fig. 4c), the pneumatic supply lines 30 each comprise an inner sheath layer 31a and an outer sheath layer 31b. The inner sheath layer 31a consists of a first material 32a and the outer sheath layer 31b of a second material 32b. Three electrical supply lines 20 are each integrated into the outer sheath layer 21b of the respective pneumatic supply line 30. This is shown schematically in Fig. 4c, in which, for example, an electrical supply line 20 is integrated into a pneumatic line 30. It can also be seen that the pneumatic supply lines 30 are connected to one another in a material-to-material manner. As already mentioned above, the intracorporeal supply line section 100 comprises a splitting section 130. In the area of the splitting section 130, the pneumatic supply lines 30 are not connected to one another in a material-to-material manner. Fig. 4d and the Fig. 4e each shows a pneumatic supply line 30 with an electrical supply line 20 integrated into the outer sheath layer 31b. By way of example, only one electrical supply line 20 is shown. However, it should be clear that several, in particular three or four, electrical supply lines 20 can also be integrated into the outer sheath layer 31b. This applies both to individual pneumatic supply lines 30 (see, for example, Fig. 4d and Fig. 4e) as well as for pneumatic supply lines 30 which are connected to each other by a material fit (see for example Fig. 4c).

[0062] The first material 32a can be an elastic material and the second material 32b a less elastic material than the first. For example, the first material 32a can be an elastic material, in particular silicone, and the second material 32b can be a mechanically more stable material, in particular polyurethane. Mechanically more stable here refers to a material with greater strength, in particular with greater cut resistance, greater abrasion resistance and / or with better tear propagation properties. Alternatively, the first material 32a and the second material 32b can also be made of the same material. By using an elastic material for the inner sheath layer 31a, for example, the risk of stress whitening of the outer sheath layer 31b made of a mechanically more stable material can be minimized. In alternative embodiments, a pneumatic supply line 30 can also comprise only one sheath layer 31 or more than two sheath layers 31.In particular, if the second material 32b is the same as the first material 32a, a pneumatic supply line 30 may comprise an additional sheath layer 31 around the outer sheath layer 31b. This additional sheath layer may be made of the same or a different material than the first 31a and second sheath layers 31b, preferably of a mechanically more stable material than the first material 32a.

[0063] By integrating one or more electrical supply lines 20 into the outer sheath layer 31b of a pneumatic supply line 30, a more compact supply line system 1 can be provided. On the other hand, by integrating the electrical supply lines 20, the respective pneumatic supply line 30 can be reinforced and the risk of kinking of the respective pneumatic supply line 30 can be reduced. This is particularly the case when one or more electrical supply lines 20 are integrated in a helically wound manner into the outer sheath layer 31b of a pneumatic supply line 30. In addition, the (wound or unwound) embedding of an electrical supply line 20 in the outer sheath layer 31b ensures simple and secure integration of the electrical supply lines 20 into the respective pneumatic supply line 30.In alternative embodiments, one or more electrical supply lines 20 can also be wound around one or more pneumatic supply lines 30. In alternative embodiments, the electrical supply lines 20 can also be embedded in multiple sheath layers 31 of a pneumatic supply line 30 and / or in a sheath layer other than the outer sheath layer 31b of a pneumatic supply line 30. These advantageous design options for different sheath layers and the possibility of integrating electrical supply lines 20 allow specific mechanical properties of the pneumatic supply lines to be adjusted.

[0064] The integral connection of the pneumatic supply lines 30 prevents the pneumatic supply lines 30 from becoming separated. This is particularly relevant in the intracorporeal supply line section 100, since isolated supply lines (20, 30) can endanger the patient. As, for example, in the Fig. 4a to Fig. 4c, the integral connection 31c encloses all supply lines (20, 30). The integral connection 31c is designed in such a way that preferably no concave outer surfaces of the supply line system 1 are created. In alternative embodiments, the integral connection 31c can also be arranged only between the supply lines (20, 30) (see dashed line 65 in Fig. 4c). In further alternative embodiments, the pneumatic supply lines 30 can also be brought together in a contacting manner and connected by a material fit only at the contact points (not shown). In the latter case, concave outer surfaces of the supply line system 1 would be possible. In embodiments in which the electrical supply lines 20 are not integrated into one or more pneumatic supply lines 30, the electrical supply lines 20 can be integrated directly into the material fit 31c (see Fig. 4a and Fig. 4b). The electrical supply lines 20 could also be wound helically around themselves or wound around a sheath of a pneumatic supply line 30 and integrated into the material-to-material connection 31c (not shown).

[0065] Furthermore, the material connection 31c of the pneumatic supply lines 30 enables the securing of a specific cross-sectional shape 10, such as one of the Fig. 2a and Fig. 2b. The pneumatic supply lines 30 can be connected to one another using a material that corresponds to the second material 32b mentioned above. Alternatively, the material-to-material connection 31c can also consist of the first material 32a. Alternatively or additionally, the pneumatic supply lines can be embedded in a common sheathing layer that encloses all pneumatic supply lines. This sheathing layer can be made of the second material. If the second material 32b is an elastic material, the sheathing layer can also be made of a mechanically more stable material, for example, a mechanically more stable thermosetting or thermoplastic material or another material.

[0066] In alternative designs, the supply lines can also be connected to each other in a form-fitting or force-fitting manner.

[0067] In a preferred embodiment, which is Fig. 5, a pneumatic supply line 30 can have several web-shaped elevations 33 on an inner surface 35 of the pneumatic supply line 30. In this regard, Fig. 5 is an isometric view of a section of a pneumatic supply line 30 in cross section. Even if in Fig. 5 five web-shaped elevations 33 are shown, a pneumatic supply line 30 can also comprise more or fewer web-shaped elevations 33 in alternative embodiments. Preferably, a pneumatic supply line 30 comprises at least one and particularly preferably three, five or seven web-shaped elevations 33. The web-shaped elevations 33 protrude inwards from an inner surface 35 of the inner jacket layer 31a in the radial direction 34a. In alternative embodiments in which a pneumatic supply line 30 comprises only one jacket layer, the web-shaped elevations 33 also protrude inwards from an inner surface in the radial direction. The web-shaped elevations 33 extend in at least one section of the pneumatic line 30 along a longitudinal direction 34b. The web-shaped elevations 33 can run continuously or intermittently in the longitudinal direction 34b. In the embodiment of the Fig. 5 shows an intermittent arrangement. If the web-shaped elevations 33 run intermittently in the longitudinal direction 34b, they can also be arranged at different positions in the circumferential direction 34c after one or more interruptions. The web-shaped elevations 33 contribute to stabilizing the pneumatic lines 30 and make it possible to prevent complete closure of the pneumatic supply line 30 in the event of a hose kink. A hose kink with complete closure of the pneumatic supply line 30 could result in an implant 2 remaining in a condition that is potentially dangerous for the patient. Maintaining a minimum lumen of the pneumatic supply line 30 in the event of a kink can ensure emergency venting of the implant and avoid dangerous conditions. By means of intermittent webs 33 and / or appropriate dimensioning of the webs 33, rigidity and / orFlexibility can be adjusted to a certain extent. The webs 33 can be made of the same material as the inner cladding layer 31a, i.e., the first material 32a. In alternative embodiments, the webs 33 can be made of a different material than the first material 32a.

[0068] As in particular the Fig. 1 and the Fig. 6, the intracorporeal supply line section 100 further comprises a barrier sheath 140. The barrier sheath 140 is arranged at a proximal end 111 of the intracorporeal supply line section 100. The proximal end 111 here is to be understood as the most proximal region of the intracorporeal supply line section 100. The barrier sheath 140 runs from this proximal end 111 in the distal direction 4a. The barrier sheath 140 preferably extends in the distal direction 4a in a range from 5 mm to 35 mm and particularly preferably from 10 mm to 20 mm. The barrier sheath 140 is configured such that it is preferably at least 5 mm away from the extracorporeal side of the epidermis. Particularly preferably, the barrier sheath 140, when installed, extends exclusively on the intracorporeal side of the epidermis.A barrier sheath 140, which runs in the distal direction 4a from the exit point, has the effect of making it more difficult for germs to penetrate the patient's body.

[0069] As in Fig. 1 and Fig. As schematically indicated in Figure 6, the barrier coating 140 has a porous or fibrous structure 141. This particularly advantageous open-pore structure 141 creates the possibility for macrophages in particular to settle in the barrier coating 140. In alternative embodiments, the barrier coating 140 can also be designed in other ways to promote the settlement of macrophages. The macrophages, in turn, serve as an effective measure against germs. The barrier coating 140 thus contributes to a reduced risk of infection.

[0070] The barrier sheath 140 has structures such as cavities 142 or hollow spaces. The dimensions of these cavities 142, in particular the respective diameters, can have dimensions of 10 µm to 100 µm, preferably from 20 µm to 60 µm, and particularly preferably from 30 µm to 50 µm. This allows optimal dimensional conditions for the settlement of macrophages to be created. These structures can be provided by producing the barrier sheath 140, for example, from scaffolds with a porous structure or from foam-like materials. The latter features provide specific conditions that enable and promote the settlement of macrophages. This targeted settlement of macrophages in the vicinity of the skin exit area 6 represents an active measure against infections caused by germs directly after entry into a patient's body.This can prevent germs from penetrating deeper into the body and generally minimize the risk of infection. The dimensions of the cavities 142 and hollow spaces represent specific properties for targeted ingrowth or settlement of macrophages. The thickness of the barrier coating 140 should be at least as large as the pore size of the barrier coating 140 (see dimensions of the cavities 142 of the barrier coating 140 above) and thinner than 2 mm, thinner than 1 mm, and especially thinner than 500 µm, in order to minimize stress on the skin barrier.

[0071] As in particular Fig. 6, the supply line system 1 further comprises a connector system 40 with a first connector part 41 and a second connector part 42. The first connector part 41 is arranged at a proximal end 211 of the extracorporeal supply line section 200 and is preferably female. The second connector part 42 is arranged proximal to the first connector part 41 and is preferably male. The supply line system 1 further comprises a partial supply line section 300 for a supply device 3. The partial supply line section 300 extends between the supply device 3 and the second connector part 42. The partial supply line section 300 is connected directly to the supply device 3. In alternative embodiments, the partial supply line section 300 can also be connected to the supply device 3 via a further connector system.In further alternative embodiments, the second plug part 42 can also be integrated into the supply device 3 and thus the supply device 3 can be connected directly to the first plug part 41.

[0072] In the embodiment of the Fig. 6, the connector system 40 is designed as a hybrid connector system with pneumatic supply lines 30 and electrical supply lines 20. In alternative embodiments, the connector system 40 can also comprise two separate connectors, one for the pneumatic supply lines 30 and one for the electrical supply lines 20. In a further alternative embodiment, the connector system 40 can also comprise only one connector for the electrical supply lines 20. In the latter case, the pneumatic supply lines 30 are continuous. For this purpose, the electrical supply lines 20 are decoupled from the pneumatic supply lines in the area of the connector system 40. Such a configuration is shown in Fig. 4f.

[0073] In the latter alternative embodiment, the pneumatic supply lines 30 can be separated in the event of repair and connected to a new pneumatic supply line part via sleeves. The defective electrical supply lines 20 on a proximal side of the connector system 40 can be terminated via the connector system 40, replaced with new electrical supply lines 20, and reconnected to the connector system. This configuration has the advantage of being smaller than a hybrid connector system and thus significantly contributes to patient comfort.

[0074] In general, a connector system 40 can be used to decouple an implant-side supply line from a supply-side supply line. The term "implant-side supply line" refers to a region of the supply line system 1 in the distal direction 4a of the connector system 40. In the illustrated embodiment, this is the extracorporeal supply line section 200 and the intracorporeal supply line section 100. For example, in the event of a repair of the supply device 3 or the partial supply line section 300, not the entire implant-side supply line needs to be removed, but only the purely extracorporeal part, i.e., a supply-side supply line of the system. The term "supply-side supply line" refers to a region of the supply line system 1 in the proximal direction 5a of the connector system 40. In the illustrated embodiment, this is the partial supply line section 300.

[0075] The decoupling option allows surgical interventions to be avoided in the event of repairs and increases patient safety. This is achieved precisely by positioning the connector system 40 as close as possible to the skin exit area 6. A female design of the first connector part 41 prevents damage to connector pins on the implant-side supply line. This means that if the connector system is damaged, the second connector part 42 is likely to be damaged, which is much easier to replace and poses less risk to the patient than the first connector part 41.

[0076] Furthermore, the supply line system 1 can comprise a predetermined breaking point 50 in a region proximal 5a of the first plug part 41. The predetermined breaking point 50 can preferably be arranged in a region of the second plug part 42. Alternatively, the predetermined breaking point 50 can be arranged in a distal region of the partial supply line section 300. In further alternative embodiments, the plug system 40 can be designed as a predetermined breaking point 50. By way of example, in the Fig. 6 a predetermined breaking point 50 is arranged in an area of the second plug part 42.

[0077] The extracorporeal lead section 200 further comprises a lead fixation 270, which is designed to be applied to the skin. Alternatively or additionally, the partial lead section 300 can also comprise a lead fixation 370. By means of a lead fixation (270, 370), the lead system 1 can be fixed in the extracorporeal area and secured against dislocation or minimized dislocation. Furthermore, the lead fixation (270, 370) allows the lead system 1 to be guided closer to the body. This increases wearing comfort for a patient, minimizes the risk of injury, and lowers the risk of infection by reducing movement of the lead at the skin exit point.

[0078] In alternative embodiments, the supply system 1 may further comprise fixation patches, which are not shown in any of the figures. The fixation patch may be applied to the skin surface of a patient, particularly in the skin exit area 6. The fixation patch may comprise an antiseptic area that protects the skin exit area 6 from infection. Furthermore, the fixation patch may reduce the risk of injury in the skin exit area 6. Furthermore, the fixation patch may keep the exit site clean of contaminants, minimize irritation / injury to the skin exit area 6, and contribute to reduced movement of the supply system 1.

[0079] In alternative embodiments, the flat cross-sectional profile 11 can have a smaller circumference than the non-flat cross-sectional profile 12. This can be the case, for example, if the area utilization of the flat cross-sectional profile 11 is significantly higher than the area utilization of the non-flat cross-sectional profile 12 through a clever arrangement of the supply lines. This can reduce the size of an outlet opening and mechanically relieve the pressure on the skin exit point. Furthermore, the risk of infection can be reduced. This can be achieved, for example, by increasing the area utilization of a cross-sectional area of the flat cross-sectional profile 11 through appropriate arrangement of the pneumatic supply lines 30 and the electrical supply lines 20 compared to the area utilization of a cross-sectional area of the non-flat cross-sectional profile 12.

[0080] In alternative embodiments, the flat cross-sectional profile 11 can have greater flexibility in the x-direction 61 than in the y-direction 62. Alternatively or additionally, an axial area moment of inertia of the flat cross-sectional profile 11 can be smaller in the x-direction 61 than in the y-direction 62. As described above in connection with the flat cross-section 11, the extracorporeal supply line section 200 can be guided closer to the patient's body directly after exiting the skin due to greater flexibility or a smaller axial area moment of inertia in the x-direction 11. This can improve wearing comfort and suitability for everyday use. Furthermore, the risk of injury due to snagging on the supply line system 1 and subsequent dislocation of the supply line system 1 can be minimized.

[0081] In alternative embodiments, the non-flat cross-sectional profile 12 can have greater rigidity than the flat cross-sectional profile 11. Alternatively or additionally, the non-flat cross-sectional profile 12 can have substantially uniform flexibility in a direction orthogonal to the longitudinal direction of the supply line system. Alternatively or additionally, the non-flat cross-sectional profile 12 can have a substantially uniform axial area moment of inertia in the x-direction 61 and in the y-direction 62. Through these advantageous embodiments, the mechanical properties of the supply line system 1 in a region with a non-flat cross-sectional profile 12 can be improved for this region.For example, the intracorporeal supply line section 100 can meet the intracorporeal requirements with regard to both necessary flexibility and rigidity by means of a non-flat cross-sectional profile 12 with a substantially uniform axial area moment of inertia in the x-direction 61 and in the y-direction 62.

[0082] In a preferred embodiment, the medical implant 2 is a cardiac assist device. In alternative embodiments, the medical implant 2 may also be another device.

Claims

[1] Supply system (1) for a medical implant (2) comprising: an intracorporeal supply line section (100), and an extracorporeal supply line section (200); characterized by , that the supply line system (1) has a flat cross-sectional profile (11) in a proximal region (112) of the intracorporeal supply line section (100) and in a distal region (114) of the extracorporeal supply line section (200), and wherein the supply line system (1) comprises electrical supply lines (20) and / or pneumatic supply lines (30). [2] Supply system (1) according to claim 1, characterized by that the intracorporeal supply line section (100) and / or the extracorporeal supply line section (200) each have a transition region (113, 213) from the flat cross-sectional profile (11) to a non-flat cross-sectional profile (12). [3] Supply system (1) according to claim 2, characterized bythat the non-flat cross-sectional profile (12) has a substantially square, round, polygonal or triangular cross-sectional profile (12a, 12b, 12c, 12d). [4] Supply system (1) according to any one of claims 1 or 2, characterized by in that the intracorporeal supply line section (100) comprises at least one intracorporeal anchoring sheath (120) which is designed to promote tissue ingrowth and which has a porous, fibrous or textile structure (121). [5] Supply system (1) according to one of the preceding claims, characterized by in that the intracorporeal supply line section (100) comprises a splitting section (130) which is arranged at a distal end (115) of the intracorporeal supply line section (100) and enables the supply lines (20, 30) to be separated. [6] Supply system (1) according to one of the preceding claims, characterized bythat at least one of the electrical supply lines (20) is wound helically around at least one of the pneumatic supply lines (30). [7] Supply system (1) according to one of the preceding claims, characterized by that at least one of the electrical supply lines (20) is integrated into a sheath of at least one pneumatic supply line (30). [8] Supply system (1) according to one of the preceding claims, characterized by that at least one of the pneumatic supply lines (30) has at least one web-shaped elevation (33) on an inner surface (35) of the pneumatic supply line (30), which projects radially (34a) into the pneumatic supply line (30). [9] Supply system (1) according to one of the preceding claims, characterized byin that the intracorporeal supply line section (100) comprises a barrier sheath (140) arranged at a proximal end (111) of the intracorporeal supply line section (100), wherein the barrier sheath (140) is designed to promote settlement of macrophages. [10] Supply system (1) according to one of the preceding claims, characterized by that the supply line system (1) further comprises a plug system (40) with a first plug part (41) and a second plug part (42), wherein the first plug part (41) is arranged at a proximal end (211) of the extracorporeal supply line section (200) and is preferably female, and wherein the second plug part (42) is arranged proximal to the first plug part (41) and is preferably male.

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