Lead system for a medical implant

Abstract

The invention relates to a lead system for a medical implant. The lead system according to the invention comprises an intracorporeal lead section (100) and an extracorporeal lead section (200). The lead system (1) here has a flattened cross-sectional profile (11) in the proximal region (112) of the intracorporeal lead section (100) and in the distal region (214) of the extracorporeal lead section (200), so that the lead system (1) can exit in the implanted state with the flattened cross-sectional profile (11) in the skin exit region (6).

Description

Technical Field

[0001] This invention relates to a lead system for medical implants. In particular, the lead system according to the invention is suitable for use in cardiac assist devices to assist the heart's pumping function. Background Technology

[0002] Heart failure (or heart insufficiency) is a condition that weakens the heart's pumping ability. Its importance is significant and growing, both medically and economically. By the 2020s, 23 million people worldwide will have heart failure, with 2 million new cases each year. In the United States alone, approximately 5 million people currently have heart failure, with about 550,000 new cases annually. In the past decade alone, the number of people over 50 in the United States has more than doubled to 10 million. This trend also applies to continental Europe.

[0003] Heart failure can be caused by damage to the heart muscle, resulting in impaired or incomplete heart contraction. Elevated blood pressure increases pumping resistance, which also negatively impacts the heart's pumping function. The heart's pumping function can also be reduced due to non-sealing valves (such as a non-sealing aortic or mitral valve).

[0004] Different types of heart failure can be treated with medication or surgery. Among other treatment options, implants that assist the heart's pumping function are a promising approach across a wide range of causes of heart failure, applying mechanical pressure to the heart to improve its pumping performance.

[0005] Such implants typically require a lead system for their function, which connects to an external delivery unit. In addition to ensuring the operation of the implant, this lead system can also perform additional functions, such as data transmission for functional monitoring. Typically, such a lead system includes pneumatic or hydraulic leads for supplying a scalable unit at the implant site and electrical leads for receiving ECG (electrocardiogram) data.

[0006] However, current lead systems face significant technical and medical challenges because they can lead to both patient complications and system failure. Common complications of lead systems, such as infections, can have fatal consequences for patients and are therefore a limiting factor in the overall effectiveness of treatments. Similarly, interruptions in the supply or transmission of blood through the lead can cause system failure and lead to serious consequences, such as the need for surgical intervention, heart failure due to system failure and impaired pumping performance, or even death.

[0007] The risk of infection is particularly high in the early postoperative period. However, a high risk of infection also exists in other procedures because the percutaneous suture system used for implants remains permanently inside the patient, requiring a skin exit opening to guide the external delivery unit. The skin exit area is one of the most susceptible areas to infection and tissue damage. This often leads to prolonged hospitalizations and frequent readmissions of discharged patients, especially with intensive antibiotic treatment or even surgical interventions. Summary of the Invention

[0008] The object of this invention is to provide a lead system for medical implants that does not have the disadvantages of known lead systems and increases patient compatibility and system reliability.

[0009] This invention relates to a lead system for medical implants.

[0010] The lead system according to the invention in the first embodiment includes an in vivo lead segment and an external lead segment. Here, the lead system has a flat cross-sectional profile in the proximal region of the in vivo lead segment and in the distal region of the external lead segment. This produces the effect that the lead system, in the inserted state, can exit the skin exit region with a flat cross-sectional profile. Therefore, it is advantageous to keep the exit opening of the lead system in the patient's skin small and to reduce the risk of infection at the exit site of the lead system. Furthermore, since the lead system has a small extension in the direction parallel to the short side of the lead system's cross-section, the tensile force applied to the patient's skin is small. Therefore, mechanical decompression of the skin exit site can be achieved through the flat cross-section.

[0011] Furthermore, the flat cross-section of the lead system in the skin exit area allows it to bend more easily around an axis parallel to the long side of the lead system's cross-section, thus enabling the external lead segment to extend closer to the patient's body. This improves carrying comfort and daily usability. Additionally, the risk of injury due to snagging on the lead system and subsequent displacement of the lead system can be minimized.

[0012] In various design schemes, the lead segment inside the body can have a transition region from a flat cross-sectional profile to a non-flat cross-sectional profile. Alternatively or additionally, the lead segment outside the body can also have a transition region from a flat cross-sectional profile to a non-flat cross-sectional profile. Here, the non-flat cross-sectional profile can preferably be configured as a generally square, circular, or polygonal cross-sectional profile, and is particularly preferably configured as a generally triangular cross-sectional profile.

[0013] Therefore, the following effects are achieved: the lead system can be adapted within the corresponding transition region so that it can be compatible with any cross-section of the interface. In the case of a flat cross-section of the interface, the corresponding segment may also include an additional transition region from a non-flat region to a flat region, or may not include a transition region at all. On the other hand, it is therefore possible to provide a lead system with mechanical properties specifically adapted to the corresponding region of the lead system. As described above, the lead system can be optimized for the skin exit region through a flat cross-section. Furthermore, within the body, the transition region of the lead segment within the body can, for example, generate a cross-sectional profile optimized for requirements within the body (such as flexibility, rigidity, and storage within the body).

[0014] In designs that can be combined with all the design schemes described so far, the in-body guide segment can include at least one, and preferably three, in-body anchoring sheaths. Here, the in-body anchoring sheaths are designed to promote tissue ingrowth. This ensures that the patient's tissue can connect with the in-body anchoring sheaths and thus with the in-body guide segment. Through tissue connection, the in-body guide segment can be stored and secured within the patient's body. Therefore, the risk of displacement of the guide system, especially the in-body guide segment, is minimized, and both system reliability and patient safety are increased. Particularly in the skin exit area, the risk of injury due to displacement and the normal transmissibility of mechanical forces from body movement to the skin exit site are reduced by the fixation of the in-body guide segment, leading to better healing at the skin exit site and consequently a lower risk of infection.

[0015] In a design that can be combined with previous designs, the in-body lead segment includes first, second, and third anchoring sheaths. These first, second, and third anchoring sheaths are positioned on the in-body lead segment in a direction from proximal to distal. Multiple anchoring sheaths enable greater stability of the in-body lead segment within the patient. Furthermore, external forces acting on the lead system are compensated for better than with only one anchoring sheath or without any anchoring sheaths at all.

[0016] In a design scheme that can be combined with previous design schemes, the transition area of ​​the lead section within the body can be located between the first and second anchoring sheaths. Because the first anchoring sheath is the closest of the three anchoring sheaths, the cross-sectional profile of the lead system can be matched to the body requirements described above, downstream of the first anchoring sheath in the distal direction, not far after the skin exit area.

[0017] In designs that can be combined with the three aforementioned design schemes, the in vivo anchoring sheath can be a porous, fibrous, or fabric structure. This design of the anchoring sheath structure provides the possibility that tissue can grow into the anchoring sheath. In other words, this open configuration of the anchoring sheath can provide an environment conducive to tissue ingrowth. The in vivo anchoring sheath can here be a structure, such as a cavity or hollow space having a size of 40 μm to 2000 μm, preferably 50 μm to 1000 μm, and more preferably 80 μm to 500 μm. Therefore, optimal dimensional conditions can be provided for tissue ingrowth.

[0018] In designs that can be combined with all the designs described to date, the lead system can include at least two, preferably nine, electrical leads. Alternatively or additionally, the lead system can include at least two, preferably three, pneumatic leads. Through these at least two electrical leads, the lead system can transmit electrical signals between the delivery device and the medical implant. For example, the action potential of the heart in the form of a voltage at at least two electrodes can thus be transmitted to the delivery device, and the ECG signal can be calculated. Therefore, direct feedback regarding bodily function in the implant region is possible. In other words, through the specific design of the lead system, the medical implant can be better controlled and monitored. This results in increased system reliability and treatment success rate, as well as improved patient safety.

[0019] By using a large number of electrical leads, the action potentials of multiple electrodes at the heart or within the body can be transmitted to the delivery unit, thereby calculating multiple ECG signals. Furthermore, cable breakage detection can be provided via the electrical leads, and electrical shielding can be achieved. These preferred advantageous designs further increase system reliability and treatment success rates. By providing pneumatic leads in the lead system, pneumatic implants, such as expandable units, can be supplied with compressed air. Alternatively or additionally, negative pressure can be generated in such expandable units. Because the lead system extends externally to the skin exit site via pneumatic leads, the delivery device can be placed outside the patient's body. By eliminating the need for an internal delivery device, the risk of other foreign objects endangering patient safety can be prevented.

[0020] In designs that can be combined with previous designs, the in-body lead segment may include a dispersing segment located at the distal end of the in-body lead segment and capable of lead separation. Here, the proximal end of the dispersing segment can be limited by a separation element directly downstream of the dispersing segment along the proximal direction. Dispersing the leads ensures that each lead is positioned at a specific location on the implant or can be connected to the implant. Positioning the dispersing segment at the distal end of the in-body lead segment also ensures that each lead is dispersed only a short distance before its specific location. This ensures co-delivery of the leads over a large portion of the in-body lead segment. Co-delivery over a large portion of the in-body lead segment minimizes patient load and improves resistance to mechanical loads. Furthermore, co-delivery reduces the freely accessible surface area, thereby reducing chemical load due to immune responses and further improving lead durability.

[0021] In a design that can be combined with two previous design options, at least one of the electrical leads can be spirally wound in at least one segment of the lead system. Alternatively or additionally, at least one of the electrical leads can be spirally wound around at least one pneumatic lead in at least one segment of the lead system. Alternatively, multiple electrical leads can be spirally wound. Alternatively, multiple electrical leads can be spirally wound around a pneumatic lead. Alternatively, at least one electrical lead can be spirally wound around a pneumatic lead, respectively.

[0022] With its spiral coil, the lead is less susceptible to changes in distance between the implant and, for example, the skin exit area, compared to an unwound lead. In the case of an implant used as a cardiac assist device, distance changes between these areas occur due to the expansion and contraction of the heart. The spiral coil of the lead can compensate for these distance changes to some extent, similar to a wound telephone cord. Furthermore, the spiral coil minimizes the risk of the lead bending or breaking, increasing its lifespan. Since the lead receives ECG signals and serves as a control signal for the implant, breakage could lead to functional loss of the implant. This is extremely dangerous for patients and must be avoided at all costs. Wrapping the pneumatic lead reduces the volume displaced by the lead system and decreases its cross-sectional area, positively impacting patient compatibility. Additionally, the pneumatic lead is mechanically stabilized by the spirally wound lead. In other words, the spiral winding increases bending stiffness while maintaining the required flexibility.

[0023] In the design that can be combined with the three previous design options, at least one of the electrical leads is unwound in the proximal region of the lead segment inside the body and in the distal region of the lead segment outside the body. Alternatively, multiple or all of the electrical leads may be unwound in this region. Therefore, a smaller cross-section can be obtained, particularly in the skin outlet region, compared to the case of spirally wound electrical leads. Thus, as already described above, the outlet opening of the lead system can be reduced.

[0024] In a design that can be combined with the four previous design options, at least one of the electrical leads can be integrated into the sheath of at least one pneumatic lead. Alternatively, multiple or all electrical leads can be integrated into the sheath of at least one pneumatic lead. This provides a more compact lead system. Furthermore, integrating the electrical leads strengthens the corresponding pneumatic leads and reduces the risk of bending of the corresponding pneumatic leads.

[0025] In a design that can be combined with the five previous design options, at least one of the pneumatic leads includes at least one sheath layer, and at least one of the electrical leads is embedded in said sheath layer. Furthermore, at least one of the pneumatic leads can include an inner sheath layer and an outer sheath layer. Alternatively, multiple or all pneumatic leads include an inner sheath layer and an outer sheath layer. The inner sheath layer can be made of a first material, and the outer sheath layer can be made of a second material. The first material can be an elastic material, and the second material is a material with less elasticity than the first material. For example, the first material can be an elastic material, especially silicone, and the second material can be a more mechanically stable material, especially polyurethane. Alternatively, the first and second materials can also be made of the same material, such as an elastic material.

[0026] These advantageous design schemes enable the setting of specific mechanical characteristics for pneumatic leads.

[0027] In designs that can be combined with previous designs, at least one electrical lead is integrated into the outer sheath of the corresponding pneumatic lead. Alternatively, multiple electrical leads can be integrated into the outer sheath of the corresponding pneumatic lead. Alternatively, all electrical leads can be integrated into the outer sheath of the pneumatic lead. This results in the safe and reliable integration of the electrical leads into the corresponding pneumatic lead. If the second material is the same as the first material in this case, the pneumatic lead may include an additional sheath surrounding the outer sheath. This additional sheath may be made of a material different from the first and second material layers, preferably a more mechanically stable material.

[0028] In the design scheme that can be combined with the seven previous design schemes, the pneumatic leads can be connected to each other in a material-locking manner. This prevents the leads from separating. This is particularly important in the lead sections within the body, as separated leads can endanger the patient. The pneumatic leads can be interconnected via a material corresponding to the second material described above. Alternatively or additionally, the pneumatic leads can be embedded in a common sheath layer that surrounds all the pneumatic leads. Here, the sheath layer can be made of the second material. If the second material is an elastic material, then the sheath layer can also be made of a more mechanically stable material. As already described above, the lead sections within the body can have dispersive sections. If this is the case, then the pneumatic leads are not material-locking connected to each other in the regions of the dispersive sections.

[0029] In a design that can be combined with the eight previous design options, at least one of the pneumatic leads has at least one, and preferably at least three, web-like ridges on the inner surface of the sheath of the respective pneumatic lead. Alternatively, multiple or all pneumatic leads may have at least one, and preferably at least three, web-like ridges on the inner surface of the sheath of the respective pneumatic lead. Here, the web-like ridges may extend radially inward from the inner surface of the sheath of the inner sheath layer. This advantageous design prevents complete closure of the pneumatic leads when the tubing is bent. Tube bending combined with complete closure of the pneumatic leads may result in the implant being held in a potentially hazardous state for the patient. Maintaining a minimum volume of the pneumatic leads in the event of bending ensures emergency venting of the implant and avoids dangerous situations.

[0030] In designs that can be combined with all designs described so far, the lead segment within the body can include a blocking sheath. Here, the blocking sheath can be positioned at the proximal end of the lead segment within the body. The blocking sheath extending distally from the exit point has the effect of making it difficult for pathogens to enter the patient's body. Thus, the blocking sheath helps reduce the risk of infection. Here, the blocking sheath can be designed to promote macrophage colonization. Furthermore, the blocking sheath can have a porous or fibrous structure. The blocking sheath can here have an open structure. In addition, the blocking sheath can have cavities, alternatively or additionally, said cavities preferably open to at least one side. The size of said cavities, especially the diameters, can here have a size of 10 μm to 100 μm, preferably 20 μm to 60 μm, and particularly preferably 30 μm to 50 μm.

[0031] The final features provide specific conditions for achieving and facilitating phagocyte colonization. Targeted colonization of phagocytes in the surrounding environment of the skin exit area provides an effective measure against infection caused by pathogens that have just entered the patient's body. This prevents pathogens from penetrating deeper into the body and generally minimizes the risk of infection. The size of the cavities and lumens here represents specific properties for the targeted ingrowth or colonization of macrophages.

[0032] In designs that can be combined with all described designs, the lead system may further include a connector system having a first connector component and a second connector component. The first connector component can be located at the proximal end of the lead segment outside the body and is preferably configured as female. The second connector component can be located at the proximal end of the first connector component and is preferably configured as male. The connector system allows for the decoupling of the implant-side lead from the supply-side lead. For example, in the event of repair of the supply device or existing supply-side lead, it is not necessary to remove the entire implant-side lead; instead, only the external portion of the system is removed. This avoids surgical intervention and improves patient safety. The female design of the first connector component prevents damage to the connector pins on the implant side. That is, if the connector system is damaged, it is likely that the second connector component is damaged, and the second connector component can be replaced significantly more easily and less dangerously for the patient than the first connector component.

[0033] In a design that can be combined with previous design schemes, the lead system can also include a sub-lead section for the supply device. Here, the sub-lead section can extend from the second connector component in the proximal direction to the supply device.

[0034] In a design that can be combined with two previous design options, the lead system can include a rated breakage portion in the proximal region of the first connector component. The rated breakage portion is preferably located in the region of the second connector component. Alternatively, if a sub-lead segment is present, the rated breakage portion can be located in the distal region of the sub-lead segment.

[0035] In designs that can be combined with all designs described so far, the external lead segment can include a lead fixation member designed to be applied to the skin. Alternatively or additionally, if a sub-lead segment is present, that sub-lead segment can also include a lead fixation member. The lead fixation member secures the lead system and ensures prevention of displacement or minimizes displacement, thereby reducing the transmission of mechanical forces to the skin exit site. Furthermore, the lead system can be guided closer to the body via the lead fixation member. Therefore, patient comfort is improved and the risk of injury and infection is minimized.

[0036] In the design scheme that can be combined with the fourteen previous design options, the flat cross-sectional profile can have a smaller perimeter than the non-flat cross-sectional profile. Therefore, it is possible to reduce the size of the outlet opening and mechanically depressurize the skin outlet site. Furthermore, it can reduce the risk of infection.

[0037] In the design scheme that can be combined with the fifteen previous design options, the flat cross-sectional profile can have greater flexibility in the x-direction than in the y-direction. Alternatively or additionally, the axial planar moment of inertia of the flat cross-sectional profile in the x-direction is smaller than that in the y-direction. As described above in conjunction with the flat cross-section, the external lead segment can be guided directly towards the patient's body after detachment from the skin due to its easier flexibility in the x-direction or smaller axial planar moment of inertia. This improves carrying comfort and daily usability. Furthermore, it minimizes the risk of injury due to snagging on the lead system and subsequent displacement of the lead system.

[0038] In the design scheme that can be combined with the sixteen previous design schemes, 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 has substantially uniform bendability in the radial direction. Alternatively or additionally, the non-flat cross-sectional profile can have substantially uniform axial planar rotational inertia in both the x and y directions. With these advantageous design schemes, the mechanical properties of the lead system can be improved in the region having the non-flat cross-sectional profile. For example, the lead segment within the body can meet the body requirements regarding a certain degree of necessary bendability and rigidity by using a non-flat cross-sectional profile with substantially uniform axial planar rotational inertia in both the x and y directions.

[0039] In a design that can be combined with all the previously described design options, the medical implant can be a cardiac assist device. Attached Figure Description

[0040] Figure 1 An isometric view is shown of a first embodiment of the lead system according to the present invention;

[0041] Figure 2a Cross-sectional views showing different non-flat cross-sectional shapes of lead systems according to the invention having electrical and pneumatic leads;

[0042] Figure 2b Cross-sectional views showing different flat cross-sectional shapes of lead systems according to the invention, having electrical and pneumatic leads;

[0043] Figure 3aAn isometric view of a lead system according to the invention, having pneumatic leads and helically wound electrical leads;

[0044] Figure 3b An isometric view of a lead system according to the invention, showing two helical electrical leads wound around a pneumatic lead;

[0045] Figure 4a A cross-sectional view of the flat cross-sectional shape of the lead system according to the invention, showing a pneumatic lead and a straight electrical lead connected by material locking;

[0046] Figure 4b A cross-sectional view of the non-flat cross-sectional shape of the lead system according to the invention, showing a pneumatic lead and a straight electrical lead connected by material locking;

[0047] Figure 4c A cross-sectional view of the non-flat cross-sectional shape of the lead system according to the invention, showing an electrical lead having a sheath spirally integrated into a pneumatic lead;

[0048] Figure 4d A cross-sectional view of the pneumatic lead with a straight integrated electrical lead of the lead system according to the invention is shown in the region of the distributed section.

[0049] Figure 4e A cross-sectional view of the pneumatic lead with wound integrated electrical lead of the lead system according to the invention is shown in the region of the dispersion section.

[0050] Figure 4f A cross-sectional view of the pneumatic leads with decoupled electrical leads is shown in the connector system.

[0051] Figure 5 An isometric view of the pneumatic lead according to the invention, having web-like ridges, is shown;

[0052] Figure 6 An isometric view of the lead system according to the invention, including a maintenance connector, a sub-lead section, and a supply device, is shown. Detailed Implementation

[0053] Embodiments of the lead system 1 according to the present invention are described below with reference to the accompanying drawings. Within the scope of the invention, the term "proximal" refers to a region or direction that faces or is close to the supply device or operator. "Distal region or direction" refers to a region or direction that faces or is close to the medical implant. In other words, "proximal direction" describes the direction from the implant to the supply unit, while "distal direction" describes the direction from the supply unit to the implant. "External" describes all components that are substantially or completely located outside the patient's body in the implanted state, i.e., the proximal end located at the skin exit site. "Internal" describes all components that are substantially or completely located inside the patient's body in the implanted state, i.e., the distal end located at the skin exit site.

[0054] refer to Figure 1 The lead system 1 according to the invention includes an in vivo lead segment 100 and an external lead segment 200. The lead system 1 has a flat cross-sectional profile 11 in the proximal region 112 of the in vivo lead segment 100 and in the distal region 214 of the external lead segment 200. This results in the lead system 1 being able to exit in the skin exit region 6 with a flat cross-sectional profile 11 when inserted. Therefore, the exit opening of the lead system 1, which is not shown here, is advantageously held narrowly in the patient's skin. Furthermore, due to the smaller extension of the lead system 1 in the direction parallel to the short side of the lead system cross-section 10 (i.e., along the x-direction), a smaller tensile force is applied to the patient's skin. Therefore, the skin exit region can be mechanically decompressed by the flat cross-section 11.

[0055] Furthermore, the lead system 1 can be easily bent around an axis parallel to the long side of the lead system's cross-section by means of a flat cross-section 11 in the skin exit region 6, thereby allowing the external lead segment 200 to extend close to the patient's body. This improves carrying comfort and daily usability. Additionally, it minimizes the risk of injury due to snagging on the lead system 1 and subsequent displacement of the lead system 1. Here, the skin exit region 6 represents the area of ​​the patient's epidermis and dermis that must be pierced by the lead system 1. Here, the exit opening can be a necessary opening in the patient's skin to allow the lead system 1 to be guided through and thus relates to the cross-sectional geometry 11 of the lead system 1. Figure 1 The relative coordinate system 60 of the lead system 1 is also shown. Here, the x-direction 61 defines the direction of extension parallel to the short edge of the flat cross-section 11. The y-direction 62 extends along the long edge of the flat cross-section 11.

[0056] As from Figure 1As can be seen, the lead segment 100 inside the body has a transition region 113 from a flat cross-sectional profile 11 to a non-flat cross-sectional profile 12. Furthermore, the lead segment 200 outside the body also has a transition region 213 from a flat cross-sectional profile 11 to a non-flat cross-sectional profile 12. Figure 1 In the illustrated embodiment, the non-flat cross-sectional profile 12 of the lead segment 100 within the body is configured as a generally triangular cross-sectional profile 12d (see [reference]). Figure 2a The non-flat cross-sectional profile 12 of the external lead segment 200 is configured as a circular cross-sectional profile 12b (see...). Figure 2a ).

[0057] In other embodiments, the non-flat cross-section 12 of the lead segment 100 inside the body and the lead segment 200 outside the body is also configured with other cross-sectional shapes. Figure 2a Four different non-flat cross sections (12a, 12b, 12c, 12d) are illustrated exemplarily. Exemplarily, the non-flat cross section 12 can be configured as a generally square 12a, a circle 12b, a polygon 12c, or a triangle 12d. The word "generally" indicates that the cross-sectional shape at this location is, for example, a basic shape of one of the mentioned shapes, but also has slight deviations caused, for example, by rounding (see example...). Figure 2a (The dashed line representing the cross-sectional shape 12d in the diagram).

[0058] The terms "flat cross-section 11" or "non-flat cross-section 12" refer here to the two-dimensional shape of cross-section 10, wherein the ratio of the extension of the shorter dimension 63 to the extension of the longer dimension 64 is below a limit of 0.5 (flat) or above a limit of 0.5 (non-flat). In the case of flat cross-section 11, this ratio can be below a limit preferably 0.4 and particularly preferably 0.3. In the case of non-flat cross-section 12, this ratio can be above a ratio preferably 0.6 and particularly preferably 0.7. Regarding this, for a better understanding, in Figure 2a The diagram shows the shorter dimensions (63a, 63b) and longer dimensions (64a, 64b) of cross-sectional shapes 12a and 12b. To determine the ratio, 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.

[0059] Through corresponding transition regions (113, 213), the lead system 1 can be matched to accommodate any cross-section 10 of the interface. In the case of an interface with a flat cross-section 11, the corresponding sections (100, 200) can also include another transition region from non-flat to flat (not shown here). Even when in Figure 1 When the preferred embodiment is shown, the corresponding lead system (100, 200) can also completely exclude the transition region (113, 213) in alternative embodiments. In addition to interface compatibility, a lead system 1 with mechanical characteristics specifically adapted to the corresponding region (113, 213) of the lead system 1 can be provided. As described above, the lead system 1 can be optimized for the skin exit region 6 through its flat cross-section 11. Furthermore, inside the body, the transition region 113 of the lead segment 100 can, for example, produce a cross-sectional profile 10 optimized for in vivo requirements (e.g., flexibility, rigidity, and in vivo storage).

[0060] As will be explained in detail later, lead system 1 can also include sub-lead segments 300 (see below). Figure 6 If this is the case, alternatively, or in addition to the external lead segment 200, the sub-lead segment 300 may also include a transition region from the flat cross-sectional profile 11 to the non-flat cross-sectional profile 12.

[0061] Figure 1 It is also known that the lead wire segment 100 within the body includes a plurality of internal anchoring sleeves 120. Specifically, first 120a, second 120b, and third 120c anchoring sleeves are sequentially distributed along the distal direction 4a on the lead wire segment 100 within the body. In alternative embodiments, the lead wire segment 100 within the body may also include more or fewer than three anchoring sleeves 120. For example, in... Figure 1 As schematically shown, the in vivo anchoring sheath (120; 120a, 120b, 120c) has a porous, fibrous, or fabric structure 121. The particularly advantageous design of structure 121 allows for the ingrowth of collagen-rich connective tissue into the anchoring sheath (120; 120a, 120b, 120c). In alternative embodiments, the in vivo anchoring sheath (120; 120a, 120b, 120c) can also be designed differently to promote connective tissue ingrowth.

[0062] The porous configuration of the anchoring sheaths (120; 120a, 120b, 120c) provides an optimal environment for connective tissue to ingrain. This ensures that the patient's connective tissue can connect with the anchoring sheaths 120 within the body and, consequently, with the lead segment 100 within the body. Through this connective tissue connection, the lead segment 100 within the body can be supported and secured within the patient's body. This minimizes the risk of displacement of the lead system 1 (especially the lead segment 100 within the body) and improves system reliability and patient safety. Particularly in the skin exit region 6, the usual transmissibility of mechanical forces caused by displacement is minimized by securing the lead segment 100 within the body, thereby reducing the risk of injury. Furthermore, improved healing at the skin exit site further reduces the risk of injury. Additionally, external forces acting on the lead system 1 can be better compensated, as these forces can be absorbed by the connective tissue via the anchoring sheaths (120; 120a, 120b, 120c). The use of multiple anchoring sleeves 120 provides greater stability to the lead segment 100 within the body. This minimizes relative movement between the lead system 1 and the connective tissue. The length 123 of the corresponding anchoring sleeves (120; 120a, 120b, 120c) can be matched specifically to the requirements for fixation and mobility, or flexibility, of the lead segment 100 within the body. For example, multiple shorter anchoring sleeves 120 can provide multiple fixation points with lower force absorption capacity. A smaller number of longer anchoring sleeves 120 can provide a smaller number of fixation points, yet these fixation points can absorb greater forces. Here, the “length 123” of the anchoring sleeve 120 can be understood as its dimension in the longitudinal direction of the lead system 1. The length 123 of the anchoring sleeves (120; 120a, 120b, 120c) can be in the range of 0.5 cm to 20 cm, preferably in the range of 1 cm to 10 cm, and particularly preferably in the range of 3 cm to 6 cm. In a preferred embodiment, the length 123 of the anchoring sleeve (120; 120a, 120b, 120c) is 5cm.

[0063] Here, the in-body anchoring sheath 120 has a structure, such as a cavity or intermediate space, having a size of 40 μm to 2000 μm, preferably 50 μm to 1000 μm, and particularly preferably 80 μm to 500 μm. This provides optimal dimensional conditions for connective tissue ingrowth. This structure can be provided by the in-body anchoring sheath 120 being made, for example, of so-called "surgical felt," fabric, or other woven, braided, spun, felted, or foamed products, preferably plastic products. In addition to the advantages already mentioned, the in-body anchoring sheath 120 helps improve the biocompatibility of the lead system 1. Furthermore, the anchoring sheath 120 can also serve as a protective measure against bending of the in-body lead segment 100.

[0064] The transition region 113 of the lead segment 100 in the body is Figure 1 In one embodiment, the lead wire is positioned between the first 120a and the second 120b anchoring sheaths. In an alternative embodiment, the transition region 113 of the lead wire segment 100 within the body can also be positioned in other regions of the lead wire segment 100 within the body. Through the transition region 113 positioned relatively close to the skin exit region 6, the cross-sectional profile 10 of the lead wire system 1 can match the aforementioned body requirements in the distal direction 4a downstream of the first anchoring sheath 120a.

[0065] Especially in Figure 1 As can be seen in section 2, in a preferred embodiment of the lead system 1 according to the invention, it can include at least nine electrical leads 20 and at least three pneumatic leads (30a, 30b, 30c). However, in other embodiments, the lead system can also include more or fewer than nine electrical leads 20 and three pneumatic leads 30. In the illustrated embodiment, every two electrical leads 20 are used to transmit signals from the bipolar electrodes of the implant 2. In this preferred embodiment, this is three pairs with two electrical leads each for signal transmission. The signals can include, for example, analog signals for monitoring vital functions, particularly the patient's ECG signal. Two additional electrical leads 20 are used for cable breakage detection, and another electrical lead 20 is used for electrical shielding. This preferred advantageous design can further improve system reliability and treatment success rate. In other embodiments, the electrical leads 20 can also perform functions different from those just described. Here, there can also be more or fewer than nine electrical leads 20. For example, the lead system 1 can also have only electrical leads 20 used for transmitting ECG signals.

[0066] Through the at least two electrical leads 20, the lead system 1 can exchange electrical signals between the supply device 3 and the medical implant 2. For example, it is thus possible to transmit the action potential of the heart in the form of voltages from at least two electrodes to the supply device and thereby calculate the ECG signal. This enables direct feedback regarding bodily function in the implant region. Specifically, it enables direct feedback regarding bodily function, particularly cardiac function in the implant 2 region. That is, through the special design of the lead system 1, the medical implant 2 can be better controlled and monitored. This results in increased system reliability and treatment success rate, as well as improved patient safety. With a larger number of electrical leads 20, multiple electrical signals, especially action potentials, from multiple electrodes at the heart or within the body can be transmitted to the supply unit and multiple ECG signals can be calculated. As described above, the leads 20 can improve cable breakage detection and achieve electrical shielding.

[0067] By providing a pneumatic lead 30 in the lead system 1, compressed air can be used to supply compressed air to a pneumatic implant, such as a pneumatic implant with expandable units. Here, the implant 2 can be supplied with overpressure. Alternatively or additionally, the implant 2 can be supplied with negative pressure. Therefore, in an implant with expandable units, each expandable unit can be alternately expanded and compressed. In the implant 2 used for cardiac assistance, this thus assists, for example, the pumping function of the heart. Because the lead system 1 extends externally to the skin outlet site via the pneumatic lead 30, the supply device 3 can therefore be placed externally to the patient's body. By eliminating the need for an internal supply device, it is possible to prevent other foreign objects from endangering patient safety. In an alternative embodiment, a hydraulic lead can also be used instead of a pneumatic lead.

[0068] Furthermore, the lead segment 100 within the body includes a dispersing segment 130. The dispersing segment 130 is disposed on the distal end 115 of the lead segment 100 within the body. Because the dispersing segment 130 is disposed on the distal end 115 of the lead segment 100 within the body, it is ensured that each lead (20, 30) is separated only a short distance before its designated location. This ensures that each lead (20, 30) is co-transported over a large portion of the lead segment 100 within the body. By co-transporting over a large portion of the lead segment 100 within the body, patient load can be minimized. Furthermore, lead stability can be improved, thereby reducing the probability of functional failure. In the lead segment 200 outside the body, except in the case of a selected connector embodiment, the leads (20, 30) are continuously co-guided. In alternative embodiments, the leads (20, 30) can also be guided separately in a portion of the lead system 1 or throughout the entire lead system 1. For example, the pneumatic lead 30 can be guided separately from the electrical lead 20. Alternatively, every two or three electrical leads 20 can be guided together with a pneumatic lead 30.

[0069] Through the dispersing section 130, the electrical lead 20 and the pneumatic lead 30 are separated in the region of the dispersing section 130. Figure 1In one embodiment, the three pneumatic leads 30 are first separated along the distal direction 4a. Furthermore, along the distal direction 4a toward the implant, each electrical lead 20 is separated from its corresponding pneumatic lead 30 and guided at its specific location on the implant 2. In an alternative embodiment, the leads can be guided together in longer or shorter lengths and separated earlier or later along the distal direction 4a. The dispersing segment 130 can be constructed differently, especially with other numbers of electrical leads 20 and / or pneumatic leads 30. Separation of the leads (20, 30) ensures that the leads (20, 30) can be positioned at specific locations on the implant 2 or connected to the implant. The proximal end of the dispersing segment 130 is limited by a separating element 150 directly disposed downstream of the dispersing segment 130 along the proximal direction 5a. In the illustrated embodiment, the separating element 150 is implemented by a third anchoring sheath 120c. In alternative embodiments, the separating element 150 can also be other anchoring sleeves 120, such as a fourth anchoring sleeve 120 not shown herein, or other elements. The separating element 150 enables separation of the lead wire along the distal direction 4a of the separating element 150 and / or prevents separation along the proximal direction 5a of the dispersing segment 130.

[0070] As in Figure 3a As schematically shown, the electrical lead 20 can be spirally wound in at least one segment of the lead system 1. The electrical lead 20 can spirally wrap around itself (see...). Figure 3a ) or spirally wound around at least one of the pneumatic leads 30 (see Figure 3b ) Entangled. In Figure 3b In the view, the electrical leads 20 are integrated into the sheath of the pneumatic leads 30 in a wound manner. Alternatively, the electrical leads 20 can also be wound around the sheath of the pneumatic leads 30 (not shown here). In a preferred embodiment, every three electrical leads 20 can be wound around one of the three pneumatic leads (30a, 30b, 30c) (in... Figure 1 and 6 (Not visible in the image). Here, each pair of the three electrical leads 20 can be designed for signal transmission of the bipolar electrode and can thus form a lead group (21a, 21b, 21c). The corresponding lead groups (21a, 21b, 21c) are guided away from the corresponding pneumatic leads (30a, 30b, 30c) and separated very close to the specific location of the medical implant in the distal region of the dispersion section 130 (see image). Figure 1 and 6 The corresponding other electrical leads 20 on pneumatic leads 30a and 30b are each a circuit breaker identification line (22a, 22b), which are in... Figure 1 and 6In this embodiment, the circuit is short-circuited in the region of the separating element 140 and is therefore invisible. Providing two open circuit identification lines (22a, 22b) and short-circuiting these two open circuit identification lines enables the differentiation of defects in the neutral wire and the lead wire. The third lead wire 20, which is wound around the pneumatic lead wire 30c, is a shield wire 23, which terminates in the region of the separating element 140. For clarity, the wound lead wire described above is... Figure 1 and 6 It is not visible in the middle. Figure 4b Exemplary examples show straight-lined open-circuit identification lines (22a, 22b) and shielding line 23. In Figure 4b In the diagram, electrical leads (22a, 22b, 23) are exemplarily shown centered in cross-section 12. Alternatively, however, the electrical leads (22a, 22b, 23) can also be positioned in other locations within cross-sections (10; 11, 12). In an alternative embodiment, more than three or all electrical leads 20 can be wound around pneumatic leads 30. In an alternative embodiment, one or more electrical leads 20 can also be wound around all pneumatic leads 30. This can be, in particular, the shielding wire 23. In an alternative embodiment, the break-circuit identification lines (22a, 22b) can also be directed toward, in particular, the same electrode and short-circuited at that location. Similarly, short-circuiting at other locations in the lead system 1 is conceivable. Ideally, the short-circuit locations of the break-circuit identification lines (22a, 22b) should be located as far as possible to cover a large area of ​​the lead system 1. In alternative embodiments, the circuit breaker identification line 22 may be omitted, or more than two circuit breaker identification lines may be used. This similarly applies to the shielding line 23. The embodiments described above regarding the wound electrical leads 26 can also be similarly applied to the unwound electrical leads 28, provided the leads are applicable. For example, the unwound, generally straight circuit breaker identification lines (22a, 22b) are guided near the corresponding pneumatic leads (30a, 30b) and short-circuited in the region of the separating element 140.

[0071] With the spiral coil 26, the electrical lead 20 is less susceptible to changes in distance between the implant 2 and, for example, the skin exit region 6, compared to the unwound electrical lead 28. In the case of the implant 2 used as a cardiac assist device, the expansion and contraction of the heart can cause changes in distance between, for example, the aforementioned regions. The spiral coil 26 of the electrical lead 20 can compensate for these distance changes to some extent, similar to a wound telephone cord. Furthermore, the spiral coil 26 minimizes the risk of bending or breaking of the electrical lead 20. Since the electrical lead receives ECG signals, which are used as control signals for the implant 2, breakage of the electrical lead 20 would lead to loss of function of the implant 2. This is to be avoided at all costs, as it would have serious consequences for the patient. This increases the lifespan of the electrical lead 20. The coil surrounding the pneumatic lead 30 reduces the volume displaced by the lead system 1 and the cross-section 10 of the lead system 1, which has a positive effect on patient compatibility. In addition, the pneumatic lead 30 is mechanically stabilized by the helically wound electrical lead 20 around it. In other words, the bending stiffness can be increased by using the spiral coil 26 while maintaining the required flexibility.

[0072] In one embodiment, the electrical lead 20 is unwound in the proximal region 112 of the lead segment 100 inside the body and in the distal region 214 of the lead segment 200 outside the body. That is, the electrical lead 20 extends substantially in a straight line in said regions (112, 214). Regarding this, Figure 4a The flat cross-sectional profile 11 of the lead system 1 is shown, which has nine straight electrical leads 20 and three pneumatic leads 30. The arrangement of the electrical leads 20 in the cross-section 10 of the lead system 1 is also possible for both flat and non-flat cross-sectional profiles (10; 11, 12). Figure 4a The arrangements shown are configured differently. Figure 4b An alternative arrangement of straight electrical leads 20 in the non-flat cross-sectional profile 12 of the lead system 1 is shown. In an alternative embodiment, the electrical leads may also extend straight in other areas of the lead system 1 or only in other areas. Alternatively, only selected electrical leads 20 may extend straight in a specific area of ​​the lead system 1. With the preferred embodiment, a smaller cross-section 10 of the lead system 1 can be obtained, particularly in the skin outlet region 6, than with spirally wound electrical leads 20. This allows for a reduction in the outlet opening of the lead system 1, as already described above.

[0073] In the preferred embodiment (see, for example, see...) Figure 4cThe pneumatic leads 30 each include an inner sheath layer 31a and an outer sheath layer 31b. The inner sheath layer 31a is made of a first material 32a, and the outer sheath layer 31b is made of a second material 32b. Three electrical leads 20 are integrated into the outer sheath layer 21b of the corresponding pneumatic lead 30. This is in Figure 4c The diagram schematically illustrates how an electrical lead 20 is exemplarily integrated into a pneumatic lead 30. Furthermore, it is visible that the pneumatic leads 30 are interconnected in a material-locking manner. As already described above, the lead segment 100 within the body includes a dispersive segment 130. Within the region of the dispersive segment 130, the pneumatic leads 30 are interconnected in a material-locking manner. Figure 4d and Figure 4e A single pneumatic lead 30 is schematically shown, which has electrical leads 20 integrated into an outer sheath layer 31b. Only one electrical lead 20 can be identified exemplarily. However, it should be understood that multiple, particularly three or four electrical leads 20, can also be integrated into the outer sheath layer 31b. This applies to a single pneumatic lead 30 (see, for example...). Figure 4d and Figure 4e The pneumatic lead 30 (see example) is interconnected with the material in a locking manner with the material. Figure 4c Both are applicable.

[0074] Here, the first material 32a can be an elastic material, and the second material 32b can be a material with less elasticity than the first material. For example, the first material 32a can be an elastic material, especially silicone, and the second material 32b can be a mechanically stable material, especially polyurethane. Here, mechanical stability involves materials with higher strength, especially materials with higher cut strength, higher abrasion resistance, and / or better tear resistance. Alternatively, the first material 32a and the second material 32b can also be made of the same material. The elasticity of the inner sheath layer 31a, for example, can minimize the risk of complete breakage of the outer sheath layer 31b, which is made of a mechanically stable material. In alternative embodiments, the pneumatic lead 30 can also include only one sheath layer 31 or more than two sheath layers 31. Especially when the second material 32b is the same material as the first material 32a, the pneumatic lead 30 can include another sheath layer 31 surrounding the outer sheath layer 31b. The additional sheath layer can be made of the same or different material as the first 31a and the second sheath layer 31b, preferably of a material that is more mechanically stable than the first material 32a.

[0075] By integrating one or more electrical leads 20 into the outer sheath layer 31b of the pneumatic lead 30, a compact lead system 1 can be provided. Furthermore, integrating the electrical leads 20 can enhance the corresponding pneumatic lead 30 and reduce the risk of bending. This is especially true when one or more electrical leads 20 are integrated into the outer sheath layer 31b of the pneumatic lead 30 in a helical winding manner. Moreover, the (wound or unwound) embedding of the electrical leads 20 results in the outer sheath layer 31b easily and reliably integrating the electrical leads 20 into the corresponding pneumatic lead 30. In alternative embodiments, one or more electrical leads 20 can also be wound around one or more pneumatic leads 30. In alternative embodiments, the electrical leads 20 can also be embedded in multiple sheath layers 31 of the pneumatic lead 30 and / or embedded in a sheath layer different from the outer sheath layer 31b of the pneumatic lead 30. By exploring the feasibility of these advantageous design schemes with different sheath layers and the feasibility of integrating the electrical leads 20, specific mechanical characteristics of the pneumatic leads can be defined.

[0076] The pneumatic leads 30 are prevented from separating by a material locking connection. This is especially important in the lead section 100 inside the body, as a separated lead (20, 30) could cause harm to the patient. For example, in Figures 4a to 4c As can be seen, the material-locking connection portion 31c surrounds all leads (20, 30). Here, the material-locking connection portion 31c is constructed such that, preferably, no concave outer surface is formed on the lead system 1. In an alternative embodiment, the material-locking connection portion 31c is also provided only between the leads (20, 30) (see [link]). Figure 4c (See dashed line 65 in the text). In other alternative embodiments, the pneumatic leads 30 can also be pressed together in a contact manner and connected by material locking only at the contact points (not shown). In the last mentioned case, the concave exterior of the lead system 1 is feasible. In embodiments where the electrical lead 20 is not integrated into one or more pneumatic leads 30, the electrical lead 20 can be directly integrated into the material-locking connection 31c (see...). Figure 4a and Figure 4b Here, the electrical lead 20 also includes a material-locking connection portion 31c (not shown) that is integrated into the material-locking connection portion by means of spirally winding around itself or winding around the sheath of the pneumatic lead 30.

[0077] Furthermore, the material-locking connection 31c of the pneumatic lead 30 can ensure a specific cross-sectional shape 10, for example in Figure 2a and 2bThe cross-sectional shapes (11a, 11b, 11c, 12a, 12b, 12c, 12d) are shown in the diagram. Here, the pneumatic leads 30 can be interconnected via a material corresponding to the second material 32b described above. Alternatively, the material-locking connection 31c can also be made of the first material 32a. Alternatively or additionally, each pneumatic lead can be embedded in a common sheath layer that surrounds all pneumatic leads. This sheath layer can here be made of the second material. If the second material 32b is an elastic material, then the sheath layer can also be made of a mechanically more stable material, such as a mechanically more stable thermosetting or thermoplastic material or other materials.

[0078] In alternative implementations, the leads can also be interconnected in a form-locked or force-locked manner.

[0079] exist Figure 5 In a preferred embodiment shown, a pneumatic lead 30 has a plurality of web-like protrusions 33 on the inner surface 35 of its sheath. Regarding this, Figure 5 An isometric view of a portion of the pneumatic lead 30 is shown in cross-section. Even in Figure 5 The diagram shows five web-like ridges 33. In alternative embodiments, the pneumatic lead 30 may include more or fewer web-like ridges 33. Preferably, the pneumatic lead 30 includes at least one, and particularly preferably three, five, or seven web-like ridges 33. Here, the web-like ridges 33 extend radially inward from the inner surface 35 of the inner sheath layer 31a. In an alternative embodiment where the pneumatic lead 30 includes only one sheath layer, the web-like ridges 33 also extend radially inward from the inner surface of the sheath. Here, the web-like ridges 33 extend longitudinally in at least one segment of the pneumatic lead 30. Here, the web-like ridges 33 may extend continuously or intermittently in the longitudinal direction 34b. Figure 5The embodiment shown is an intermittent arrangement. When the abdominal ridge 33 extends intermittently along the longitudinal direction 34b, the ridge can be positioned at different locations along the circumferential direction 34c after one or more interruptions. The abdominal ridge 33 helps stabilize the pneumatic lead 30 and prevents complete closure of the pneumatic lead 30 when the tubing is bent. Tube bending with the pneumatic lead 30 completely closed would cause the implant 2 to remain in a potentially dangerous state for the patient. Maintaining the minimum inner diameter of the pneumatic lead 30 during bending ensures emergency venting of the implant and avoids dangerous situations. Rigidity or flexibility can be set to a certain degree by the corresponding defined dimensions of the intermittent abdomen 33 and / or abdominal plate 33. The abdominal plate 33 can be made of the same material as the inner sheath layer 31a, i.e., the same material as the first material 32a. In an alternative embodiment, the abdominal plate 33 can be made of a different material than the first material 32a.

[0080] For example, especially from Figure 1 and Figure 6 As can be seen, the lead segment 100 inside the body also includes a blocking sheath 140. Here, the blocking sheath 140 is disposed on the proximal end 111 of the lead segment 100 inside the body. Here, "proximal end 111" can be understood as the region of the closest end of the lead segment 100 inside the body. Here, the blocking sheath 140 extends from the proximal end 111 in the distal direction 4a. Preferably, the blocking sheath 140 extends in the distal direction 4a within a range of 5 mm to 35 mm, and particularly preferably within a range of 10 mm to 20 mm. Here, the blocking sheath 140 is configured such that it is preferably at least 5 mm away from the external side of the epidermis. Particularly preferably, the blocking sheath 140 extends only on the internal side of the epidermis when inserted. The blocking sheath 140, extending in the distal direction 4a from the exit portion, has the effect that pathogens have difficulty entering the patient's body.

[0081] As in Figure 1 and Figure 6 As schematically shown, the barrier sheath 140 has a porous or fibrous structure 141. This particularly advantageous opening structure 141 provides the feasibility that macrophages can colonize the barrier sheath 140. In alternative embodiments, the barrier sheath 140 can also be designed differently to promote macrophage colonization. Macrophages, in turn, serve as an effective measure against pathogens. Thus, the barrier sheath 140 helps reduce the risk of infection.

[0082] Here, the barrier sheath 140 has a structure, such as a cavity 142 or a cavity. The size of the cavity 142, particularly its corresponding diameter, can be from 10 μm to 100 μm, preferably from 20 μm to 60 μm, and particularly preferably from 30 μm to 50 μm. Therefore, optimal size conditions for macrophage colonization can be provided. The structure can be provided such that the barrier sheath 140 is made, for example, of a framework with a porous structure or a foam-like material. This final feature provides specific conditions that enable and promote macrophage colonization. This targeted colonization of macrophages in the surrounding environment of the skin exit area 6 is an effective measure against infection caused by pathogens that have just entered the patient's body. Therefore, it is possible to prevent pathogens from penetrating deeper into the body and generally minimize the risk of infection. The size of the cavity 142 and the cavity here represents specific characteristics for the targeted ingrowth or colonization of macrophages. The thickness of the barrier sheath 140 should be at least the same as the size of the hole in the barrier sheath 140 (see the dimensions of the cavity 142 of the barrier sheath 140 above) and thinner than 2 mm, thinner than 1 mm, and especially thinner than 500 μm, so that the skin barrier is only lightly loaded.

[0083] For example, especially from Figure 6 As can be seen, the lead system 1 further includes a connector system 40 having a first connector component 41 and a second connector component 42. The first connector component 41 is disposed on the proximal end 211 of the lead segment 200 outside the body and is preferably configured to be female. The second connector component 42 is disposed on the proximal end of the first connector component 41 and is preferably configured to be male. Furthermore, the lead system 1 includes a sub-lead segment 300 for the supply device 3. The sub-lead segment 300 extends between the supply device 3 and the second connector component 42. The sub-lead segment 300 is directly connected to the supply device 3. In an alternative embodiment, the sub-lead 300 can also be connected to the supply device 3 via another connector system. In yet another alternative embodiment, the second connector component 42 can also be integrated into the supply device 3, thereby allowing the supply device 3 to be directly connected to the first connector component 41.

[0084] exist Figure 6 In one embodiment, the connector system 40 is configured as a hybrid connector system having a pneumatic lead 30 and an electrical lead 20. In an alternative embodiment, the connector system 40 may also include two separate connectors, one for the pneumatic lead 30 and the other for the electrical lead 40. In another alternative embodiment, the connector system 40 may also include only one connector for the electrical lead 20. In the last mentioned case, the pneumatic lead 30 is continuous. For this purpose, the electrical lead 20 is decoupled from the pneumatic lead in the connector system 40. Figure 4f This configuration is shown in the image.

[0085] In the last mentioned alternative implementation, the pneumatic lead 30 is detached for maintenance and connected to a new pneumatic lead assembly via a sleeve. A defective electrical lead 20 on the proximal side of the connector system 40 can be shut off via the connector system 40, replaced with a new electrical lead 20, and reconnected to the connector system. This configuration has the advantage of a smaller size than hybrid connector systems and thus significantly improves patient comfort.

[0086] Typically, the implant-side leads can be decoupled from the supply-side leads via the connector system 40. "Implant-side leads" is understood here as the region of the lead system 1 along the distal direction 4a of the connector system 40. In the illustrated embodiment, this refers to the external lead segment 200 and the internal lead segment 100. For example, when repairing the supply device 3 or the sub-lead segment 300, it is not necessary to remove the entire implant-side leads; instead, only the purely external components of the system, i.e., the supply-side leads, are removed. Here, "supply-side leads" can be understood as the region of the lead system 1 along the proximal direction 5a of the connector system 40. In the illustrated embodiment, this refers to the sub-lead segment 300.

[0087] By decoupling the feasibility, surgical intervention in repair situations can be avoided and patient safety can be improved. This is achieved in particular by positioning the connector system 40 as close as possible to the skin exit area 6. The negative design of the first connector component 41 prevents damage to the leads on the implant side by the connector pins. That is, if the connector system is damaged, then it is possible that the second connector component 42 is also damaged, and the second connector component is significantly simpler and less dangerous to replace than the first connector component 41.

[0088] Furthermore, the lead system 1 can include a rated break portion 50 in the region of the proximal end 5a of the first connector member 41. The rated break portion 50 is preferably located in the region of the second connector member 42. Alternatively, the rated break portion 50 can be located in the distal region of the sub-lead segment 300. In another alternative embodiment, the connector system 40 can be configured as a rated break portion 50. Exemplarily, in Figure 6 In the middle, the rated fracture part 50 is located in the area of ​​the second connector component 42.

[0089] The external lead segment 200 also includes a lead fixation member 270, which is designed to be applied to the skin. Alternatively or additionally, the sub-lead segment 300 may also include a lead fixation member 370. With the lead fixation members (270, 370), the lead system 1 can be secured in an external area and fixed to prevent or minimize displacement. Furthermore, the lead system 1 can be guided close to the body via the lead fixation members (270, 370). This improves patient comfort, minimizes the risk of injury, and reduces the risk of infection by reducing movement of the lead at the skin exit site.

[0090] In alternative embodiments, the lead system 1 may also include a fixation plaster not shown in any of the accompanying drawings. The fixation plaster may be applied to the patient's skin surface, particularly in the skin exit area 6. The fixation plaster may include an antibacterial area protecting the skin exit area 6 from infection. Furthermore, the fixation plaster reduces the risk of injury in the skin exit area 6. Additionally, the fixation plaster keeps the exit site clean and free from contamination, minimizes inflammation / injury to the skin exit area 6, and helps reduce movement of the lead system 1.

[0091] In an alternative embodiment, the flat cross-sectional profile 11 can have a smaller perimeter than the non-flat cross-sectional profile 12. This is, for example, when the area utilization of the flat cross-sectional profile 11 is significantly higher than that of the non-flat cross-sectional profile 12 due to the appropriate arrangement of the leads. Therefore, the outlet opening can be reduced and mechanical decompression at the skin opening site can be achieved. Furthermore, the risk of infection can be reduced. This is achieved, for example, by the fact that the area utilization of the cross-section of the flat cross-sectional profile 11 is improved compared to that of the non-flat cross-sectional profile 12 due to the appropriate arrangement of the pneumatic leads 30 and the electrical leads 20.

[0092] In an alternative embodiment, the flattened cross-sectional profile 11 is capable of greater flexibility in the X direction 61 than in the Y direction. Alternatively or additionally, the planar moment of inertia of the flattened cross-sectional profile 11 in the X direction 61 is smaller than that in the Y direction 62. As described above in conjunction with the flattened cross-section 11, the external lead segment 200 can be guided directly towards the patient's body after detachment from the skin by means of easier flexibility or a smaller planar moment of inertia in the X direction. This improves carrying comfort and daily usability. Furthermore, it minimizes the risk of injury due to snagging on the lead system and subsequent displacement of the lead system.

[0093] 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 has substantially uniform flexibility in a direction orthogonal to the longitudinal direction of the inlet piping system. Alternatively or additionally, the non-flat cross-sectional profile 12 can have substantially uniform planar rotational inertia in the x-direction 61 and in the y-direction 62. With these advantageous designs, the mechanical properties of the lead system 1 can be improved in the region having the non-flat cross-sectional profile 12. For example, the lead segment 100 within the body can meet the body requirements regarding necessary flexibility and rigidity through the non-flat cross-sectional profile 12 having substantially uniform axial planar rotational inertia in the x-direction 61 and in the y-direction 62.

[0094] In a preferred embodiment, the medical implant 2 is a cardiac assist device. In alternative embodiments, the medical implant 2 may be other devices.

[0095] Although the invention has been described above and defined in the appended claims, it should be understood that the invention may also be defined according to the following embodiments:

[0096] 1. A lead system for medical implants, comprising:

[0097] The lead section inside the body, and

[0098] External lead section;

[0099] Its features are,

[0100] The lead system has a flat cross-sectional profile in the proximal region of the lead segment inside the body and in the distal region of the lead segment outside the body.

[0101] 2. The lead system according to embodiment 1, characterized in that the lead segment inside the body and / or the lead segment outside the body each have a transition region from a flat cross-sectional profile to a non-flat cross-sectional profile, especially the non-flat cross-sectional profile being a generally square, circular or polygonal cross-sectional profile, particularly a generally triangular cross-sectional profile.

[0102] 3. The lead wire system according to embodiment 2, characterized in that the lead wire segment in the body includes at least one in-body anchoring sheath, said anchoring sheath being designed to promote tissue ingrowth.

[0103] 4. The lead wire system according to embodiment 3, characterized in that the lead wire section inside the body includes a first, second and third anchoring sheaths, each anchoring sheath being disposed on the lead wire section inside the body from the proximal end to the distal end.

[0104] 5. The lead wire system according to embodiment 4, characterized in that the transition region of the lead wire section within the body is located between the first and second anchoring sheaths.

[0105] 6. The lead wire system according to any one of embodiments 3 to 5 above, characterized in that the anchoring sheath inside the body has a porous, fibrous or woven structure.

[0106] 7. The lead wire system according to any one of embodiments 3 to 6 above, characterized in that the anchoring sheath inside the body has cavities and / or hollows having a size of 40 μm to 1000 μm, preferably 50 μm to 800 μm, and particularly preferably 200 μm to 500 μm.

[0107] 8. The lead system according to one of the above embodiments, characterized in that the lead system comprises at least two, preferably nine, electrical leads and / or at least two, preferably three, pneumatic leads.

[0108] 9. The lead system according to embodiment 8, characterized in that the lead section within the body includes a dispersing section, the dispersing section being disposed at the distal end of the lead section within the body and capable of separating each lead.

[0109] 10. The lead system according to embodiment 9, characterized in that the proximal end of the dispersion section is limited by a separation element directly disposed downstream of the dispersion section along the proximal direction.

[0110] 11. The lead wire system according to embodiment 10, wherein the separating element is an anchoring sleeve.

[0111] 12. The lead system according to any one of embodiments 8 to 11 above, characterized in that at least one of the electrical leads is spirally wound in at least one segment of the lead system.

[0112] 13. The lead system according to any one of embodiments 8 to 12 above, characterized in that at least one of the electrical leads is spirally wound around at least one of the pneumatic leads in at least one segment of the lead system.

[0113] 14. The lead system according to any one of embodiments 8 to 13 above, characterized in that at least one of the electrical leads is unwound in the proximal region of the lead segment inside the body and in the distal region of the lead segment outside the body.

[0114] 15. The lead system according to any one of embodiments 8 to 14 above, characterized in that at least one of the electrical leads is integrated into the sheath of at least one pneumatic lead.

[0115] 16. The lead system according to any one of embodiments 8 to 15 above, characterized in that at least one of the pneumatic leads includes at least one sheath layer, and at least one of the electrical leads is embedded in the sheath layer.

[0116] 17. The lead wire system according to any one of embodiments 8 to 16 above, characterized in that at least one of the pneumatic leads includes an inner sheath layer and an outer sheath layer.

[0117] 18. The lead system according to embodiment 17, characterized in that the inner sheath layer is made of a first material, particularly an elastic material, and the outer sheath layer is made of a second material, the second material being less elastic and particularly mechanically more stable.

[0118] 19. The lead system according to embodiment 17, characterized in that the first and second materials are made of elastic materials, particularly silicone resin.

[0119] 20. The lead system according to any one of embodiments 17 to 19, characterized in that at least one of the electrical leads is integrated into the outer sheath layer of at least one pneumatic lead.

[0120] 21. The lead system according to any one of embodiments 8 to 20, characterized in that the pneumatic lead materials are interlocked with each other.

[0121] 22. The lead wire system according to any one of embodiments 8 to 21 above, characterized in that at least one of the pneumatic leads has at least one, preferably at least three, web-like ridges on the inner surface of the respective pneumatic lead, the ridges extending radially into the respective pneumatic lead.

[0122] 23. The lead system according to one of the above embodiments, characterized in that the lead section inside the body includes a blocking sheath disposed on the proximal end of the lead section inside the body.

[0123] 24. The lead system according to embodiment 23, wherein the blocking sheath is designed to promote the colonization of macrophages.

[0124] 25. The lead system according to embodiment 23 or 24, characterized in that the blocking sheath has a porous or fibrous structure.

[0125] 26. The lead system according to any one of embodiments 23 to 25 above, characterized in that the blocking sheath has cavities and / or hollows having a size of 20 μm to 60 μm, and preferably 30 μm to 40 μm.

[0126] 27. The lead system according to one of the above embodiments, characterized in that the lead system further includes a connector system having a first connector component and a second connector component, wherein the first connector component is disposed on the proximal end of the lead segment outside the body and is preferably configured to be female, and the second connector component is disposed on the proximal end of the first connector component and is preferably configured to be male.

[0127] 28. The lead system according to embodiment 27, characterized in that the lead system further includes a sub-lead section for a supply device, the sub-lead section extending from the second connector component in a proximal direction to the supply device.

[0128] 29. The lead system according to embodiment 27 or 28 above, characterized in that the lead system includes a rated breakage portion in the distal region of the sub-lead section, preferably in the region of the second connector component.

[0129] 30. The lead system according to one of the above embodiments, characterized in that the external lead segment and / or sub-lead segment includes a lead fixing member, the lead fixing member being designed to be applied to the skin.

[0130] 31. The lead system according to any one of embodiments 2 to 30 above, characterized in that the flat cross-sectional profile has a smaller perimeter than the non-flat cross-sectional profile.

[0131] 32. The lead wire system according to any one of embodiments 2 to 31 above, characterized in that the flat cross-sectional profile has greater flexibility in the x-direction than in the y-direction.

[0132] 33. The lead wire system according to any one of embodiments 2 to 32 above, characterized in that the axial planar rotational inertia of the flat cross-sectional profile in the x-direction is smaller than the axial planar rotational inertia in the y-direction.

[0133] 34. The lead system according to any one of embodiments 2 to 33 above, characterized in that the non-flat cross-sectional profile has greater rigidity than the flat cross-sectional profile.

[0134] 35. The lead system according to any one of embodiments 2 to 34 above, characterized in that the non-flat cross-sectional profile has substantially uniform flexibility in the radial direction outward.

[0135] 36. The lead wire system according to any one of embodiments 2 to 34 above, characterized in that the non-flat cross-sectional profile has a substantially uniform axial planar moment of inertia in the x-direction and in the y-direction.

[0136] 37. The lead system according to one of the above embodiments, wherein the medical implant is a cardiac assist device.

Claims

1. A lead system (1) for a medical implant (2), the lead system comprising: The lead segment (100) inside the body, and External lead section (200); Its features are, The lead system (1) has a flat cross-sectional profile (11) in the proximal region (112) of the lead segment (100) inside the body and in the distal region (214) of the lead segment (200) outside the body, so that the lead system (1) can exit in the skin exit region (6) with a flat cross-sectional profile (11) when inserted, wherein the lead segment (100) inside the body has a transition region (113) from the flat cross-sectional profile (11) to the non-flat cross-sectional profile (12).

2. The lead wire system (1) according to claim 1, characterized in that, The lead section (200) outside the body has a transition region (213) from a flat cross-sectional profile (11) to a non-flat cross-sectional profile (12).

3. The lead wire system (1) according to claim 2, characterized in that, The non-flat cross-sectional profile (12) includes generally square, circular or triangular cross-sectional profiles (12a, 12b, 12c, 12d).

4. The lead wire system (1) according to any one of claims 1 to 3, characterized in that, The lead section (100) within the body includes at least one in-body anchoring sheath (120) designed to promote tissue ingrowth.

5. The lead wire system (1) according to claim 4, characterized in that, The anchoring sheath (120) inside the body has a porous, fibrous or fabric structure (121).

6. The lead wire system (1) according to any one of claims 1 to 3, characterized in that, The lead system (1) includes electrical leads (20) and / or pneumatic leads (30).

7. The lead wire system (1) according to claim 6, characterized in that, At least one of the electrical leads (20) is spirally wound around at least one of the pneumatic leads (30).

8. The lead wire system (1) according to claim 6, characterized in that, At least one of the electrical leads (20) is integrated into the sheath of at least one pneumatic lead (30).

9. The lead system (1) according to claim 6, characterized in that, At least one of the pneumatic leads (30) has at least one web-like ridge (33) on the inner surface (35) of the pneumatic lead (30), the ridge extending radially (34a) into the pneumatic lead (30).

10. The lead system according to any one of claims 1 to 3, characterized in that, The lead segment (100) in the body includes a blocking sheath (140) disposed on the proximal end (111) of the lead segment (100) in the body, wherein the blocking sheath (140) is designed to promote the colonization of macrophages.

11. The lead wire system (1) according to any one of claims 1 to 3, characterized in that, The lead system (1) further includes a connector system (40) having a first connector component (41) and a second connector component (42), wherein the first connector component (41) is disposed on the proximal end (211) of the lead segment (200) outside the body, and the second connector component (42) is disposed on the proximal end of the first connector component (41).

12. The lead wire system (1) according to any one of claims 1 to 3, characterized in that, The lead system (1) further includes a connector system (40) having a first connector component (41) and a second connector component (42), wherein the first connector component (41) is disposed on the proximal end (211) of the lead segment (200) outside the body and is configured to be female, while the second connector component (42) is disposed on the proximal end of the first connector component (41) and is configured to be male.

13. The lead wire system (1) according to claim 2, characterized in that, The non-flat cross-sectional profile (12) includes a polygonal cross-sectional profile.

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