Implant and method of producing an implant

Abstract

The invention relates to an implant having an electrode connection device and a housing, on which a cover for closing the housing is formed. The invention also relates to a method for producing an implant.

Description

Technical Field

[0001] The present disclosure relates to implants and methods of producing implants. Background Art

[0002] Implants such as pacemakers or defibrillators contain, among other things, an electronic module with a chip, a battery for power supply, and a through-hole leading to a plug to which one or more electrodes can be connected. Currently known contact establishment means between the electronic module, the battery and the through-hole are usually implemented by soldered or welded contact establishment strips. In an alternative embodiment, bent battery pins are connected in a plug-in contact establishment means.

[0003] Figure 1 An implant known in the prior art is shown. The implant comprises a housing 50, in which a battery 51 and an electronic module 52 are arranged. An electrode connection device (plug) 53 is arranged on the housing 50. A first electrical contact 54 is formed between the electronic module 52 and the battery 51. A second electrical contact 56 is formed between the electronic module 52 and the through-hole 55. The through-hole 55 is drawn out from the housing 50 and provides an electrical connection between the electronic module 52 and the electrode connection device 53. The elements of the implant (electrode connection device 53, through-hole 55, battery 51 and electronic module 52) are arranged adjacent to each other in a row. This causes each electrical connection between the elements (particularly the first electrical contact 54 and the second electrical contact 56) to pass through an angle of 90 °, so a complex and expensive construction process is required. Figure 1 The production of the implant shown requires complex manufacturing techniques and is difficult to automate.

[0004] Document US9737721B2 discloses an implant for stimulating the spinal cord. The implant comprises a housing in which a battery and an electronic module are arranged. A support frame arranged on the battery accommodates the electronic module and a communication coil. The electronic module is arranged perpendicular to the battery.

[0005] Document US7647110B2 describes a modular implant that can combine different connector modules, electronic modules and battery modules to achieve different functions.

[0006] Document EP2493557B1 discloses a modular plug for an implant. The plug is composed of a plurality of modules connected to each other. The length of the plug can be adjusted by the number of modules.

[0007] Document US2018 / 0054034A1 discloses a modular connector whose length can be adjusted by the number of modules used.

[0008] Document US9713717B2 discloses an implant having an electronic module formed on a substrate. Some components of the electronic module (such as filter capacitors or blocking capacitors) are embedded in the substrate. Summary of the invention

[0009] The aim is to specify improved technologies for implants. In particular, the production of active medical implants will be simplified.

[0010] An implant according to claim 1 and a method according to claim 15 are disclosed. Further embodiments are subject matter of the dependent claims.

[0011] According to one aspect, an implant having a housing is provided. An energy storage device and an electronic module are arranged in the housing. A through-hole to an electrode connection device is formed on the housing. A first contact forms an electrical connection between the energy storage device and the electronic module. A second contact forms an electrical connection between the electronic module and the through-hole. The first contact and the second contact are oriented along the same contact direction.

[0012] The implant may be an active medical implant, such as an implantable pacemaker or an implantable cardioverter-defibrillator (ICD).

[0013] The electrode connection device may also be referred to as a connection head or a plug. The electrode connection device may be designed to accommodate one or more electrode connections.

[0014] The electronics module may have components that ensure operation of the implant, such as a processor and memory.

[0015] The energy storage device may include a main battery, a secondary battery, a capacitor, or any combination of the foregoing elements. The energy storage device may be designed to supply electrical energy to the components of the electronic module. In addition, the energy storage device may be designed to provide electrical energy for defibrillation (shock). The energy storage device may be electrically insulated from the housing, for example, by a cover made of an electrically insulating material (e.g., a thermoplastic, such as PEEK (polyetheretherketone)), a firmly adhered plastic material coating made of an electrically insulating material, a single or multiple insulating films, a coating made of an electrically insulating material (e.g., plastic), or by bonding an insulating film to the energy storage device.

[0016] The through-holes may provide an electrical connection between the electrode connection device and the electronic module. The through-holes may be multi-polar, such as tripolar, quadrupole or pentapolar.

[0017] The housing may comprise or be made of a biocompatible material, such as titanium.

[0018] Equal contact directions are given if the preferred direction of the first contact coincides with the preferred direction of the second contact, i.e. the contacts point in the same direction. The preferred direction of the contacts can be caused by the geometry of the contacts. In the case of pin contacts, the preferred direction is the longitudinal extension of the pins. In the case of planar contacts, the preferred direction is the normal to the surface.

[0019] It can be provided that the energy storage device, the electronic module and the feedthrough are stacked one on top of another in a stacking direction, wherein the stacking direction corresponds to the contact direction. The energy storage device, the electronic module and the feedthrough are assembled in a single assembly direction. Stacking the elements one on top of another can simplify the assembly of the implant and facilitate the automation of the production process. In addition, the electrode connection device can be arranged on the housing in the stacking direction.

[0020] The first contact can be formed between a first planar contact element arranged on the energy storage device and a second planar contact element arranged on the electronic module, wherein the contact direction is the normal direction of the contact area between the first planar contact element and the second planar contact element. The first planar contact element and the second planar contact element can have the same size. The first planar contact element and the second planar contact element can have the same shape, such as a square, a rectangle, a circle or an ellipse. The first planar contact element and the second planar contact element can be symmetrical.

[0021] The second contact can be formed between a third planar contact element arranged on the electronic module and a fourth planar contact element arranged on the through-portion, wherein the contact direction is the normal direction of the contact area between the third planar contact element and the fourth planar contact element. The third planar contact element and the fourth planar contact element can have the same size. The first planar contact element and the second planar contact element can have the same shape, such as a square, a rectangle, a circle or an ellipse. The third planar contact element and the fourth planar contact element can be symmetrical.

[0022] In one embodiment, it can be provided that the first contact is formed between the first pin element and the first pin receptacle, wherein the longitudinal extension of the first pin element determines the contact direction. The first pin element can be arranged on the energy storage device. In this case, the first pin receptacle is arranged on the electronic module. In another variant, the first pin element can be arranged on the electronic module and the first pin receptacle is arranged on the energy storage device. The first pin element may include a plurality of pins oriented parallel to each other. It can be provided that the first pin element is formed as a pair of pins, which are arranged on the energy storage device (for example, as an anode and a cathode of the energy storage device). In this case, the first pin receptacle is formed as a pair of pin receptacles, which can be arranged on the electronic module, for example.

[0023] Furthermore, it can be provided that the second contact is formed between the second pin element and the second pin receptacle, wherein the longitudinal extension of the second pin element determines the contact direction. The second pin element can be arranged on the feedthrough, wherein the second pin receptacle is arranged on the electronic module. Alternatively, the second pin element can be arranged on the electronic module and the second pin receptacle is arranged on the feedthrough. The second pin element can include a plurality of pins oriented parallel to each other. For example, a plurality of pins can be arranged on the feedthrough (multi-pole feedthrough). In this case, the second pin receptacle includes, for example, a plurality of pin receptacles arranged on the electronic module.

[0024] The first pin element and the second pin element may be arranged parallel to each other.

[0025] The first contact and / or the second contact can be designed as a plug-in contact, a clamping contact or a soldering contact.

[0026] The electronic module can be arranged on the front side of the energy storage device. The front side is the side of the energy storage device facing the electrode connection device. Therefore, the electronic module is arranged between the electrode connection device and the energy storage device.

[0027] The electronic module can be arranged parallel to or perpendicular to the front side of the energy storage device. The electronic module can have a planar substrate on which the components are arranged. In the case of a planar substrate, the height of the substrate is much smaller than the width and length of the substrate. The substrate can be in the form of a printed circuit board. The planar substrate can be arranged parallel to or perpendicular to the front side of the energy storage device. In particular, the parallel arrangement of the electronic module / substrate can save assembly space. In this case, the electronic module is located on the front side of the energy storage device.

[0028] It can be provided that the electronic module is arranged in a support frame. The support frame can be arranged in the housing so that the energy storage device is fixed by the support frame. The support frame can be arranged on the energy storage device in a press fit so that the energy storage device is pressed against the housing by the support frame and thereby fixed. Alternatively or in addition, it can be provided that the support frame is designed and arranged in the housing so that the support frame reduces or prevents relative movement between the energy storage device and the electronic module. In particular, relative movement is to be avoided, which leads to a loss of electrical connection between the electronic module and the energy storage device. The support frame can include a plastic material or be made entirely of a plastic material. Suitable plastic materials are, for example, polybutylene terephthalate (PBT), polycarbonate (PC) or similar plastic materials.

[0029] The housing can be formed in two parts and have a first housing shell and a second housing shell. It can be provided that the energy store is fixed between the first housing shell and the second housing shell. The first housing shell and the second housing shell can be symmetrical (for example mirror-symmetrical) or identical. The two-part housing can have an integrated welding protection (for example a weld bead).

[0030] In an embodiment, the housing may be formed as one part.The one-piece housing may be made from the base material by direct moulding, for example by deep drawing.

[0031] The housing can have an opening, wherein the energy storage device and the electronic module can be introduced into the housing through the opening. The opening can be formed on the front side (facing the side of the electrode connection device) of the housing. If the housing is divided into two parts, the first housing shell and the second housing shell can be connected to each other (such as welding), thereby forming an opening on the front side. The opening can be open in the contact direction. In this case, all elements (energy storage device, electronic module, feed-through, electrode connection device and housing) of the implant can be assembled in a single stacking direction.

[0032] The energy accumulator can be fastened to the housing. For example, a self-adhesive pad can be attached to the first housing shell and / or the second housing shell, to which the energy accumulator will adhere when the housing shells are connected to form the housing. It can also be provided that the energy accumulator is bonded to the first housing shell and / or the second housing shell by means of an adhesive. The fixing can also be achieved by a clamping action between the first housing shell and the second housing shell. It can also be provided that the housing is welded to the energy accumulator.

[0033] The clamping part can be arranged in the housing, wherein the clamping part is designed to fix the energy accumulator relative to the housing. The clamping part can be arranged in a lower part of the housing, which is opposite to the front side of the housing. The clamping part can be designed to press the energy accumulator against the support frame for fixing. The clamping part can be designed as a spring, a welding protection strip or a solid plastic part filling the space.

[0034] The feedthrough can be attached to the electronic module as an SMD (surface mount device) component. An SMD component is soldered directly to a printed circuit board (e.g. a substrate of the electronic module) via one or more solderable connection areas. In other words: the feedthrough is assembled on the electronic module using SMT (surface mount technology).

[0035] The lead-through may have a second substrate. The second substrate of the lead-through, the electronic module (or the substrate of the electronic module) and the front side of the energy storage may be arranged parallel to one another.

[0036] According to another aspect, a method for assembling an implant is disclosed. The method comprises the following steps: providing an energy storage device, providing an electronic module, providing a through-hole, arranging the electronic module on the energy storage device, and arranging the through-hole on the electronic module. In this case, the through-hole, the electronic module and the energy storage device are stacked one on top of the other along a common assembly direction. The electronic module can be arranged in particular on the front side of the energy storage device.

[0037] The arrangement order is not important. The electronic module can be arranged first on the energy storage device and then the through-hole can be arranged on the electronic module. However, the through-hole can also be arranged first on the electronic module and then the electronic module with the through-hole can be arranged on the energy storage device.

[0038] When the electronic module is arranged on the energy storage device, the electrical connection between the energy storage device and the electronic module can be formed with a first contact. When the through-hole is arranged on the electronic module, the electrical connection between the electronic module and the through-hole can be formed with a second contact. The first contact and the second contact can be oriented in the same contact direction.

[0039] The method may further comprise the steps of arranging the energy store having the electronics module and the lead-through in a housing and closing the housing.

[0040] The method may further comprise the steps of arranging an electrode connection device on the housing and connecting the electrode connection device to the lead-through.

[0041] According to another aspect, an implant is provided that includes an electronic module and an energy storage device, wherein the volume of the electronic module is less than 25% of the volume of the energy storage device. Preferably, the volume of the electronic module is less than 20% of the volume of the energy storage device. More preferably, the volume of the electronic module is less than 16% of the volume of the energy storage device. In one embodiment, the volume of the energy storage device is 3.06 cm 3 , and the volume of the electronic module is 0.46cm 3 .

[0042] The elements of the implant are three-dimensional objects, each having a length, a width and a height. The dimensions of the object are always determined in the same direction. The length of the electronic module is determined in the same direction as the length of the electrode connection device and the length of the battery. The width of the electronic module is determined in the same direction as the width of the electrode connection device and the width of the battery. The height of the electronic module is determined in the same direction as the height of the electrode connection device and the height of the battery. Figure 2 A coordinate system is drawn in the lower left corner for illustration. The x direction corresponds to the length, the y direction indicates the width, and the z direction corresponds to the height.

[0043] The volume of the accumulator is the actual volume of the element.

[0044] The volume of an electronic module is considered to be the volume of the housing surrounding the electronic module, wherein the base of the housing is equal to the area of ​​the electronic module and the height of the housing is equal to the height of the highest component on the electronic module. If the electronic module has a rectangular base, the volume is therefore given by a cuboid, wherein the base of the cuboid is equal to the base of the electronic module (the product of the length and the width). The height of the cuboid corresponds to the height of the highest component on the electronic module. If the electronic module is implemented as a planar substrate, the components can be arranged on one side of the substrate. In this case, the above-mentioned volume definition will be used. It can also be provided that the components are arranged on both sides of the base. In this case, the height of the electronic module corresponds to the sum of the heights of the highest components on each side of the substrate.

[0045] The ratio of the length of the electronic module to the width of the electronic module may be 4:1 or greater, preferably 5:1 or greater, and more preferably 6:1 or greater. In this embodiment, the electronic module has a narrow design, which may facilitate the arrangement of the electronic module at the front side of the energy storage device. In one embodiment, the length of the electronic module is greater than 30 mm and the width is less than 5.2 mm.

[0046] It can be provided that the width of the electronic module is less than or equal to the width of the energy store.

[0047] The length of the electronic module may be less than or equal to the length of the energy storage device.

[0048] As described above, the implant may include an electrode connection device, wherein the length of the electronic module is less than or equal to the length of the electrode connection device, and / or wherein the width of the electronic module is less than or equal to the width of the electrode connection device. It may also be provided that the length of the energy reservoir is less than or equal to the length of the electrode connection device and / or the width of the energy reservoir is less than or equal to the width of the electrode connection device.

[0049] The electronic module can have a substrate on which a plurality of components are arranged, wherein an area of ​​the substrate is smaller than or equal to an area of ​​the front side of the energy storage device.

[0050] It can be provided that some of the plurality of components have a minimum structural dimension of F≤90 nm. Alternatively or in addition, it can be provided that some of the plurality of components (or others) have a minimum structural dimension of F≤65 nm, preferably F≤55 nm. It can be provided that all components of the electronic module are manufactured with a uniform structural dimension, for example F≤90 nm, F≤65 nm or F≤55 nm. It can also be provided that the components of the electronic module are manufactured with different structural dimensions mentioned here.

[0051] At least one of the plurality of components may be arranged on a first side of the substrate, and at least another of the plurality of components may be arranged on a second side of the substrate. Thus, the substrate may be placed on one side or on both sides.

[0052] In one embodiment, it may be provided that at least one component on the first side of the substrate and / or at least one other component on the second side of the substrate is encapsulated by the potting tool.

[0053] It can also be provided that some of the plurality of components are arranged on the substrate as SMD components. For example, the components can be arranged in one or more ball grid arrays (BGA) and / or multi-chip modules (MCM) housings and / or as bare integrated circuits (chips). If the substrate is placed on one side, the components can be arranged in the following manner:

[0054] - All components are arranged in a ball grid array package,

[0055] -All parts are arranged in MCM packaging,

[0056] - All components are arranged as a chip,

[0057] - All parts are arranged as SMD components, and

[0058] - one or some or no components are arranged in one or more BGA housings, one or some or no other components are arranged in one or more MCM housings, one or some or no other components are arranged as chips, one or some or no other components are arranged as SMD components.

[0059] In the case of placement on both sides of the substrate, the above arrangement can be implemented for both sides of the substrate.

[0060] It may be provided that some of the plurality of components are arranged side by side or on top of each other on one side of the substrate, wherein the chips / components are respectively bonded to the substrate and wherein the components are encapsulated by a potting device. The connection of the chips / components to the substrate may be in the form of wire bonding, flip chip bumps or flip chip solder ball connections. The potting device may partially cover the substrate. In an embodiment, the potting device may extend along an edge of the substrate. Preferably, the potting device completely covers the side of the substrate on which the components are arranged.

[0061] On a panel used as a substrate, the components can be arranged in a grid so that each grid cell has all the units / chips required for the electronic module. Each chip / component is bonded to the substrate to form an electrical connection. The panel is then encapsulated (overmolded) with a potting device. After covering the panel with the potting device, the individual electronic modules are sawed off the panel. Advantageously, the length of the potting area on the panel is an integer multiple of the length of the electronic module and / or the width of the potting area on the panel is an integer multiple of the width of the electronic module. This allows for optimal utilization of the potting area of ​​the panel. On the other side of the panel / substrate, other components can be arranged, for example as SMD components in chips and / or ball grid array packages.

[0062] A hole for a connecting contact of the energy store and / or for a further connecting contact of the lead-through can be formed in the potting means.

[0063] Electronic modules can be formed as multi-chip modules. A multi-chip module (MCM) consists of a plurality of individual microchips that are housed in a common package in a planar manner (side by side) or on top of each other and that look like one chip from the outside and also like one chip when not functioning and used.

[0064] The through-through to the electrode connection may be formed as:

[0065] - components of electronic modules,

[0066] - SMD components on electronic modules, or

[0067] - Plug-in connection on the electronic module.

[0068] According to another aspect, an implant is provided comprising an electronic module and an electronic component, wherein the electrical connection between the electronic module and the electronic component is formed by a direct plug-in connection.

[0069] The implant may have another electronic component, wherein the electrical connection between the electronic module and the other electronic component is formed by another direct plug-in connection, wherein the direct plug-in connection and the other direct plug-in connection are oriented in the same direction. The features disclosed herein for the direct plug-in connection are similarly applicable to the other direct plug-in connection. Likewise, the explanation of the electronic component is similarly applicable to the other electronic component.

[0070] The electrical connection can be designed as a plug-in contact in whole or in part, so that the contact pin (or multiple contact pins) of the electronic component can be directly inserted into or through the male connector receptacle of the electronic module. The direct plug-in connection does not require an adapter (such as a terminal block); in addition, there is no need to bend the pins.

[0071] The electronic component or the further electronic component may be a feedthrough or an energy store. A plurality of electronic components may be provided, wherein the electrical connection to the electronic module is formed by a direct plug-in connection for each electronic component. The electronic module and the electronic components may be arranged in a package.

[0072] In an embodiment, another electronic module may be arranged on the electronic module. Another electronic module may be connected to the electronic module by a straight plug-in connection. A stack of multiple electronic modules may be formed, wherein each of the multiple electronic modules is connected to each other by a straight plug-in connection.

[0073] The electronic component may comprise a straight pin element, wherein the electronic module comprises a pin receptacle, and wherein the pin element is arranged in the pin receptacle to form an electrical connection.

[0074] Alternatively, the electronic module may comprise a straight pin element, wherein the electronic component comprises a pin receptacle, and wherein the pin element is arranged in the pin receptacle in order to form an electrical connection.

[0075] As described above, the straight pin element may include a plurality of pins. The plurality of pins may be arranged parallel to each other. In this case, a plurality of pin receptacles are provided, wherein each of the plurality of pins is associated with a single one of the plurality of pin receptacles.

[0076] The pin receptacle may be annular. The pin receptacle may be implemented as a disk. The pin receptacle may be soldered to an electronic module or an electronic component. The pin element may be soldered in the pin receptacle.

[0077] The pin receptacle can be fastened to the electronic module using one of the following fastening methods: welding, gluing, embedding, clamping and crimping. Crimping is understood to mean a connection process in which two parts are connected together by plastic deformation, for example by flanging, pressing, corrugating or folding. When embedding, a part of the pin receptacle is surrounded by the material of the electronic module.

[0078] The pin receptacle may be fastened to the electronic component using one of the following fastening methods: soldering, gluing, embedding, clamping, and crimping.

[0079] It may be provided that the pin element has a spring element.

[0080] The electronic component may be an energy storage device, a feedthrough or a capacitor. The electronic component may also be implemented as a high voltage capacitor or a capacitor stack. In one embodiment, the electronic component is an energy storage device and the other electronic component is a feedthrough.

[0081] The plug-in connection can be formed as a detachable connection, for example a plug-in connection.

[0082] The plug-in connection can be formed as a non-detachable connection, for example a welded connection or a soldered connection.

[0083] The electrical connection may be formed using a connection selected from the following connection types: spring contact, insulation displacement contact, solder contact, welding contact, press fit and adhesive. Conductive adhesives may be used for adhesive connections.

[0084] The plug-in connection can be designed to compensate for relative movement between the electronic component and the electronic module without interrupting the electrical connection. For example, the pin element can be long and flexible enough to compensate for relative movement of the electronic component relative to the electronic module. Alternatively or in addition, the male connector receptacle can be flexible enough and / or mounted in a flexible enough manner to compensate for relative movement of the electronic component relative to the electronic module. For example, the length of the pin element can be greater than the height of the pin receptacle. In this case, the pin element extends out of the pin receptacle in the inserted state, so that movement along the direction of the pin element can be compensated within a certain range.

[0085] According to a further aspect, a method for producing an electrical connection between an electronic module and an electronic component of an implant is provided, wherein the electronic component and the electronic module move towards each other in a relative motion, and the electrical connection is formed with a straight plug-in connection between the electronic component and the electronic module. The relative motion may be a straight relative motion. This facilitates the implementation of an automated process for assembling the implant.

[0086] Plug-in connections can be designed as redundant connections to increase reliability.

[0087] According to another aspect, an implant comprising an electrode connection device and a housing is disclosed, wherein a cover for closing the housing is formed on the electrode connection device.

[0088] The cover can be welded to the housing. Provision can be made for a flange to be formed on the cover. The flange can extend partially or completely along the circumference of the cover.

[0089] The weld protection device may be formed on the cover, for example, in the form of a partial or complete circumferential weld bead.

[0090] The cover can also be fastened to the housing by means of a plug-in connection, a spring connection or a clamping connection.

[0091] The cover may be formed from a biocompatible material such as titanium.

[0092] The cover and housing may be formed from the same material, such as titanium.

[0093] A breakthrough may be formed in the cover, wherein the breakthrough forms an electrical connection between the electrode connection device and an electronic module arranged in the housing.

[0094] The lead-through can be electrically connected to the electronic module via a plug-in connection or via a spring contact.

[0095] The electrode connection device may include a preassembled assembly. The assembly may include the following components: a continuous receiving device for a male connector; a first connecting element, which is arranged in the front part of the receiving device, wherein the first connecting element has at least two flat sides; and a second connecting element, which is arranged in the rear area of ​​the receiving device, wherein the second connecting element has at least two flat sides.

[0096] According to another aspect, an assembly for an electrode connection device for an implant is provided. The assembly comprises a continuous receiving device for a male connector. A first connecting element arranged in the front region of the receiving device is also provided, wherein the first connecting element has at least two flat sides. Finally, a second connecting element is provided and arranged in the rear region of the receiving device, wherein the second connecting element has at least two flat sides.

[0097] Also provided is an electrode connection device for an implant including the assembly disclosed herein.

[0098] The present disclosure further includes implants having electrode connection devices and assemblies.

[0099] The flat sides enable at least partially angled shapes and allow easy gripping of the component (manually or automatically). This can enable automation of the production process.

[0100] The assembly may be surrounded by a plastic material at least in some parts. For example, the assembly may be overmoulded with a plastic material in some parts. The plastic material may be a thermoplastic, such as polysulfone. Biocompatible casting resins may also be used. The plastic material may provide additional stability to the assembly. Thus, the assembly may be produced as a prefabricated component, which is subsequently processed into an electrode connection device for an implant.

[0101] The connection region of the first connection element may be free of plastic material.Alternatively or additionally, the connection region of the second connection element may be free of plastic material.

[0102] A first guide of a first conductor for connecting to a connection region of a first connecting element may be formed in the plastic material and / or a second guide of a second conductor for connecting to a connection region of a second connecting element may be formed in the plastic material.

[0103] The first guide may be formed adjacent to the connection region of the first connection element and / or the second guide may be formed adjacent to the connection region of the second connection element.

[0104] The first conductor (second conductor) can be connected to the connection area of ​​the first connecting element (second connecting element) so that the male connector inserted into the receiving device can be connected to the implant. The connection area of ​​the first connecting element and / or the connection area of ​​the second connecting element can be implemented as a planar element. The connection area of ​​the first connecting element and / or the connection area of ​​the second connecting element can be circular and have a diameter of, for example, 1 to 5 mm. This provides a large welding area for fastening the first conductor or the second conductor. In one embodiment, the first guide and the second guide are both formed adjacent to their respective connection areas. The guide allows the conductor to be connected to their respective connection areas without causing a short circuit.

[0105] It can be provided that the first connecting element and the second connecting element are arranged offset from each other. In other words, the first connecting element and the second connecting element are at two different levels. The different arrangements make it easier to connect the conductors to the connecting elements without the conductors coming into contact with each other.

[0106] In one embodiment, the assembly may include an antenna, wherein the antenna has a U-shaped configuration in an intermediate region formed between a first connecting element and a second connecting element. The intermediate region may be narrower than adjacent connecting elements. Thus, together with the U-shaped configuration of the antenna, a gripping recess for an automatic gripper is formed.

[0107] The positioning device may be formed at the rear end of the receiving device. The positioning device may be formed as an angled structure and may, for example, be at right angles to the receiving device. The positioning device may be formed of a plastic material and may be integrally formed with, for example, a plastic material coating of the assembly. When the assembly is arranged in a container, the positioning device may be arranged on the housing of the implant to facilitate orientation of the assembly. The positioning device may have a tapered end.

[0108] The assembly may have another receiving device for another male connector, wherein the third connecting element is arranged in the front region of the other receiving device, and wherein the fourth connecting element is arranged in the rear region of the other receiving device. For the further receiving device, the explanations disclosed herein apply analogously to the receiving device. In addition, the explanations of the first connecting element and the second connecting element apply analogously to the third connecting element and the fourth connecting element.

[0109] According to another aspect, a method for forming an electrode connection device on an implant is disclosed. The method comprises the following steps:

[0110] - Provides components having:

[0111] - a continuous receiving device for a male connector,

[0112] - a first connecting element arranged in the front region of the receiving device, wherein the first connecting element has at least two flat sides, and

[0113] - a second connecting element arranged in the rear region of the receiving device, wherein the second connecting element has at least two flat sides,

[0114] - arranging and fixing the spring element in the receiving device,

[0115] - closing the opening of the receiving device with a potting aid,

[0116] - fastening the first conductor to the first connecting element,

[0117] - fastening the second conductor to the second connecting element,

[0118] - arranging the assembly on the housing of the implant,

[0119] - connecting the first conductor to a through-hole formed in the housing,

[0120] - connecting the second conductor to the feedthrough,

[0121] - Arrange the components and the housing in the mold,

[0122] - fill the mould with synthetic resin,

[0123] - After the resin has cured, remove the potting aid.

[0124] The method can also be used to form electrode connections on the cover of the implant.

[0125] The method may comprise the following further steps:

[0126] - Arrange and fasten the antenna to the assembly,

[0127] - connect the antenna to the feedthrough,

[0128] In this case, further steps are carried out before the component is arranged on the housing.

[0129] Furthermore, provision may be made for any protruding resin to be removed after curing, for example by grinding and / or polishing.

[0130] The mold may be a silicone mold.

[0131] The leadthrough can have one or more plug-in contacts (eg pins) for connecting a conductor and / or an antenna.

[0132] The synthetic resin may be an epoxy resin. Epoxy resins are synthetic resins with epoxy groups. They are curable resins (reactive resins) that can react with hardeners and other necessary additives to form thermosetting plastic materials. Epoxy resins are polyethers with two terminal epoxy groups. The hardener is a reaction partner and forms a polymer plastic material together with the resin.

[0133] The synthetic resin can be directly adhered to the shell of the implant or the cover of the implant, so no additional adhesive is needed. In other words, the contact area between the solidified resin and the shell / cover of the implant can be free of adhesive.

[0134] The electrode connection device can be a plug for an implantable cardiac pacemaker or an implantable cardioverter defibrillator (ICD). In this case, the electrode connection device is used to electrically connect one or more electrode leads to the implant.

[0135] Antennas, charging coils, X-ray markers, communication coils and / or color markings can be arranged in the electrode connection device.

[0136] Another aspect relates to a method for producing an implant, comprising the steps of providing a housing, providing an electrode connection device, wherein a cover for closing the housing is formed on the electrode connection device, the cover is arranged on the housing, and the cover is connected to the housing. The connection between the cover and the housing can be formed as a material connection, for example by welding.

[0137] The aspect that relates to the implant and assembly for electrode connection device disclosed here and the aspect that relates to method can be combined with each other in any way, to realize different embodiments of implant or method.In addition, explanation about implant and assembly is similarly applicable to method, and vice versa. BRIEF DESCRIPTION OF THE DRAWINGS

[0138] Exemplary embodiments are described in more detail below with reference to the accompanying drawings, in which:

[0139] Figure 1 shows a schematic diagram of an implant according to the prior art,

[0140] Figure 2 shows an exploded view of an embodiment of an implant according to the invention,

[0141] Figure 3 Shown according to Figure 2 A perspective view of a portion of an implant,

[0142] Figure 4 shows a side view of the implant,

[0143] Figure 5 shows the details of the electronic module,

[0144] Figure 6 shows further details of the electronics module,

[0145] Figure 7 shows a block diagram of an implant according to the invention,

[0146] Figure 8 shows a side view of the electronic module ( Figure 8 ), view of the electronics module from below ( Figure 8 ) and a view of the electronics module from above ( Figure 8 ),

[0147] Fig. 9 A perspective view showing the top side of the electronic module ( Fig. 9 ) and a perspective view of the bottom side of the electronics module ( Fig. 9 ),

[0148] Figures 10A-10E shows the production process of electronic modules,

[0149] Fig.11 shows a perspective view of an embodiment of an assembly for an electrode connection device,

[0150] Fig.12 Shown according to Fig.11 Front view of the component ( Fig.12 ) and posterior view ( Fig.12 ),

[0151] Fig.13 Shown is a potting aid according to Fig.11 and 12 Components,

[0152] Fig.14 shows an antenna and a conductor according to Figures 11 to 13 Components,

[0153] Fig.15 The arrangement on the housing is shown Figures 11 to 14 Components,

[0154] Fig.16 Shows the basis for complete potting (with potting aids) Figures 11 to 15 Components,

[0155] Fig.17 The basis for complete potting (without potting aids) is shown Figures 11 to 15 components, and

[0156] Fig.18 A further embodiment of an implant according to the invention is shown. DETAILED DESCRIPTION

[0157] Figure 2 An embodiment of an implant according to the present invention is shown. The implant comprises a two-part housing 60 having a first housing shell 60a and a second housing shell 60b. An electronic module 61 and an energy storage device 62 (e.g., a battery) are arranged in the housing 60. The energy storage device 62 is electrically insulated from the housing 60 by an insulating cover 64. The electronic module 61 is arranged on the front side 68 of the energy storage device 62. The first pin element is arranged on the front side 68 of the energy storage device 62 and comprises two pins 66a, 66b oriented parallel to each other. Associated with the first pin element is a first pin receptacle, which comprises two annular pin receptacles 67a, 67b and is arranged on the electronic module 61. An electrical connection is formed between the energy storage device 62 and the electronic module 61 by means of the first pin element 66a, 66b and the first pin receptacle 67a, 67b. The electronic module 61 is connected to the through-portion 65. The details of the connection will be described in more detail below. The electrode connection device 63 is arranged on the housing 60 and is connected to the electronic module 61 via a lead-through 65 .

[0158] The through-hole 65 , the electronic module 61 and the energy storage 62 are assembled along an axis (here along the z direction). The direction of the axis is determined by the electrical connection direction between the through-hole 65 and the electronic module 61 and the electrical connection direction between the electronic module 61 and the energy storage 62 .

[0159] In the embodiment shown, the electronic module 61 is arranged parallel to the front side 68 of the energy storage device 62. This arrangement uses the space in the housing very efficiently. The electronic module 61 can be inserted onto the front side 68 of the energy storage device 62 and / or glued to the front side 68.

[0160] exist Figure 3 In the embodiment of the present invention, the elements of the implant are partially assembled. The electronic module 61 is assembled on the energy storage device 62. In addition, the through-hole 65 is connected to the electronic module 61. The energy storage device 62 (in the insulating cover 64) with the electronic module 61 is arranged in the second housing shell 60b. In the next step, the first housing shell 60a is arranged on the second housing shell 60b, and the housing shells 60a, 60b are joined together, for example, welded (not shown). Subsequently, the electrode connection device 63 is placed on the housing 60 and connected to the through-hole 65 (not shown).

[0161] Figure 4 shows that the basic Figure 2 A side view of an implant of the invention. Therefore, similar elements are indicated by similar reference numerals. Figure 4In the embodiment of the present invention, the electronic module 61 is arranged in a support frame 69. The support frame 69 is arranged on the front side of the energy storage device 62. The support frame 69 serves to center the energy storage device 62 in the housing 60 and press it against the housing base. This prevents vibrations and the transmission of compression and tension forces. Thus, the support frame 69 protects the components on the electronic module 61 and the electrical connection between the energy storage device 62 and the electronic module 61 from damage and / or loss of electrical contact.

[0162] exist Figure 5 The details of the electronic module 61 are shown in Figure 5 The lower part of the figure shows an enlarged detail of the upper part). The through-portion 65 is formed as a multi-pole through-portion with a plurality of pins 70. In the embodiment shown, five pins 70 are formed on the through-portion 65, but a different number of pins is also possible. Each pin 70 is inserted into a pin receptacle 71 to form an electrical connection between the electronic module 61 and the electrode connection device 63 through the through-portion 65.

[0163] exist Figure 6 6 shows another detail of the electronic module and a detail of the energy storage device 62. First pin elements 66a, 66b (e.g. anode and cathode of a battery) are formed on the energy storage device. First pin receptacles 67a, 67b are arranged on the electronic module 61. By inserting the first pin elements 66a, 66b into the first pin receptacles 67a, 67b, the electronic module 61 is electrically connected to the energy storage device 62 via a straight plug-in connection. The connection can be implemented as a redundant connection, for example the first pin receptacles 67a, 67b each include two pin receptacles (two rings) stacked on top of each other (not shown).

[0164] The electrical connection between the electronic module 61 and the energy storage device 62 can be achieved by the following techniques:

[0165] - as a cylinder with a hole welded by laser (see Figure 6 ),

[0166] - as spring contacts in plug-in connections, and

[0167] - As an angle with the resistors welded on the electronic module.

[0168] The pins 70 of the lead-through 65 and the first pin elements 66a, 66b point in the same direction (contact direction), which determines the assembly direction of the elements.

[0169] The SMD components 72 are arranged on the rear side of the electronic module (see Figure 8 and 9 ).

[0170] Figure 7A block diagram of the implant is shown. The functionality of the electronic module is enclosed by a frame 80 and is implemented as a unit / chip on the electronic module and is described in more detail below.

[0171] The radio transceiver 81 is coupled to an antenna 82. The radio transceiver 81 is used to communicate with an external device, in particular a programming device. Here, for example, measured values ​​and / or parameters of the implant can be transmitted to the programming device. Parameters for changes of the implant can also be received from the programming device.

[0172] The electronic module also includes a control unit 83 (controller). The control unit 83 has a processor, such as a digital signal processor (DSP), a memory such as a RAM (random access memory) and / or a ROM (read only memory), and a timer. As other functions, memory access such as DMA (direct memory access) and / or network functions such as MAC (media access control) can be integrated into the control unit 83.

[0173] A measuring unit 86 (sensing unit) is provided as another component on the electronic module. The measuring unit 86 is configured to perform measurements from the heart 91 .

[0174] The pacemaker unit 85 (pacing unit) is configured to generate stimulation pulses for the heart 91.

[0175] The electronic module may optionally include a shock unit 84 (shock unit) and a HV unit 87 (HV-high voltage), in particular if the implant is designed as an ICD. The shock unit 84 is configured to control the HV unit 87. The HV unit 87 is configured to deliver a shock (defibrillation) at a voltage of 700-800V, for example.

[0176] An EMC (electromagnetic compatibility) unit 88 is provided, which is designed to minimize or suppress the effects of electromagnetic fields. The electromagnetic fields may include stray radiation, shock fields delivered by the HV unit 87, fields of stimulation pulses delivered by the pacemaker unit 85, fields of external shocks, fields of external stimulation, and fields from other external sources (e.g., high frequency measurements). The EMC unit 88 is coupled to the housing 92 of the implant.

[0177] The electronic module is coupled to a battery 90. The power supply unit 89 of the electronic module comprises a switching power supply (SMPS) and is configured for power management.

[0178] The functions / units of the electronic module are implemented in various integrated circuits, i.e. chips mounted on the electronic module. The size of the chip depends on the complexity of its functions. The higher the complexity, the larger the planar dimensions of the chip. The size of the chip largely determines the size of the electronic module and its orientation in the implant (parallel to the energy reservoir). The size of the electronic module also depends on the number of electrical connections between the chips, between the chips and non-integrated passive components and all other connections on the electronic module.

[0179] Which therapeutic functions can be monolithically integrated with each other on one chip by which production process or how many chips the electronic module contains depends on its operating voltage range, its data and signal complexity and its characteristics, i.e. whether they have analog time continuous or digital time discrete or analog digital mixed signal behavior. In principle, all functions listed above can be integrated monolithically, in particular digital control functions, analog digital mixed sensing functions for ECG signal amplification and evaluation (ECG-electrocardiogram), pacing for stimulation pulse generation, power management for optimal power supply of the implant and shock for voltage generation and control of defibrillation shocks. However, the currently used production processes with minimum structural dimensions of F = 130nm and F = 180nm result in chips that are too large to be arranged vertically in the implant housing and whose data storage capacity (RAM) is too small or must be supplemented with another memory chip to enable all necessary therapeutic and diagnostic functions. Therefore, for the present implant, some or all functions of the electronic module are realized by chips manufactured with a minimum structural dimension of F ≤ 90nm, preferably F ≤ 65nm or F ≤ 55nm.

[0180] One objective is to design the electronic module so that it no longer determines the volume, shape and size of the implant (as in the prior art). To this end, at least one of the following rules applies:

[0181] 1. The electronic module is arranged parallel to the front side of the energy storage device.

[0182] 2. The length of the electronic module is less than or equal to the length of the electrode connection device.

[0183] 3. The width of the electronic module is less than or equal to the width of the energy storage device (or the width of the housing).

[0184] 4. The length of the energy storage device is equal to the length of the electrode connection device (maximum volume utilization).

[0185] 5. The area of ​​the electronic module corresponds to the area of ​​the front side of the energy storage device.

[0186] 6. The volume of the electronic module is required to be less than 1 / 4 of the volume of the energy storage device (or less than 1 / 4 of the total metal packaging volume of the implant).

[0187] Applying one or more of these rules results in electronic modules with narrow strips, which are equipped with components whose maximum edge length (including their connections) does not exceed the electronic module. Improved optical imaging and photolithography processes in semiconductor production allow more and more functions per silicon area. The minimum structural size of components sufficient to produce implants is F ≤ 90 nm. This allows analog, digital, mixed analog and digital and high-voltage circuits to be increasingly integrated monolithically on one chip. This reduces the number of chips and the number of connections on the electronic module, thus compensating for the smaller available area of ​​the now narrow strip modules to realize the known functional complexity.

[0188] For producing an integrated circuit on an electronic module, a production process is selected having the following characteristics: at least one chip is produced in a process with a minimum structural size F ≤ 90 nm. Alternatively, at least one chip is produced in a process with a minimum structural size F ≤ 65 nm. Alternatively, at least one chip is produced in a process with a minimum structural size F ≤ 65 nm, to which a voltage of ≥ 10 V relative to its substrate can be connected simultaneously. Alternatively, at least one chip is produced in a process with a minimum structural size F ≤ 65 nm, to which a voltage of ≥ 10 V relative to its substrate can be connected simultaneously, and the SRAM (static random access memory, static RAM) storage function of the chip has a capacity of ≥ 3 Mbits.

[0189] The electronic module with the form factor described here is suitable for installation in the cross section of a flat implant, in particular between the energy reservoir and the electrode connection device. This assembly position results in the further functions of the electronic module being achievable individually or in any combination with one another:

[0190] - vertical connection of wired components on the top and / or bottom side of the electronic module,

[0191] - holes into or through which connections of components (e.g. battery connections and / or plug connections) can be inserted,

[0192] - A hole suitable for receiving a cutting sleeve and / or a clamping sleeve.

[0193] The straight edge of the saw cut also makes it possible to optimize the manufacturing of electronic modules in panelized form using standard packaging technology for ball grid array packaging (μBGA). In μBGA, the chips are assembled on a printed circuit board substrate (PCB substrate), bonded in a transfer overmolding process and covered with molding compound. Solder balls are applied to the back of the substrate for SMD assembly. Packaging is carried out in a panelized state. The printed circuit board substrate always has a uniform panel size for all chip sizes, which depends only on the molding tool of the transfer molding machine. Depending on the chip size, more or fewer chips are mounted on the panel and then, after potting and equipped with solder balls, they are sawn out of the panel in their final package size.

[0194] In one embodiment, there are three square potting areas on a 205 mm x 70 mm panel, each with an edge length of 56 mm, in which the chips are assembled and wire bonded (see Fig. 10A and 10B ). Applying this μBGA packaging process to electronic modules leads to further characterization and extension of the packaging process, such as Figures 10A to 10E After transfer molding, the holes or fits for the cutting sleeve and / or clamping sleeve are drilled (see Fig. 10C ). Potting is not only used to cover the chip, but also forms part of the mechanical stability of the electronic module, especially the resulting plug-in connections. Instead of solder balls, the panel is equipped with SMD components of the electronic module in panelized form (see Fig. 10D ). The edge length of the electronic module satisfies an integer division ratio of the edge of the potting surface of the panel minus sawing losses. The components of the electronic module may be provided as an ASIC (Application Specific Integrated Circuit).

[0195] Some of the production steps are summarized below:

[0196] - Fig. 10A ASIC 101 in panelized form is assembled and bonded to a first side (front side) of the panel 100 .

[0197] - Fig. 10B : Transfer overmolding of assembled ASIC 101 with potting device 102.

[0198] - Fig. 10C : Drill hole 103 to connect the energy storage device.

[0199] - Fig. 10D : Filling of the second side (rear side) of the panel 100 with the SMD components 104.

[0200] - Fig.10E : Sawing out the completed electronic module.

[0201] Figures 11 to 17 The various steps for assembling the electrode connection device (plug) on ​​the implant are shown. These steps will be described in more detail below.

[0202] Fig.11 An assembly 1 (also referred to as a plug core) is shown having a first receiving device 2 for a male electrode connector and a second receiving device 13 for another male electrode connector. The first receiving device 2 has a front opening 6 through which the male electrode connector can be inserted. The first receiving device 2 has a first part 3, a second part 4 and a third part 5. The diameter of the first part 3 is greater than the diameter of the second part 4. The diameter of the second part 4 is in turn greater than the diameter of the third part 5. In other words, the first receiving device 2 tapers from the front opening 6 toward the end.

[0203] A first connecting element is formed between the first part 3 and the second part 4 (i.e. in the front area of ​​the first receiving device 2). A second connecting element 8 is formed between the second part 4 and the third part 5 (in the rear area of ​​the first receiving device 2). The first connecting element 7 and the second connecting element 8 each have at least two flat sides. This makes it easy to grip the assembly 1 during assembly and automates the assembly steps. In the illustrated embodiment, the first connecting element 7 and the second connecting element 8 are generally cuboid-shaped. The second connecting element 8 has an inclined edge 17, which is used to save material and observe the flow direction of the epoxy resin. A recess 12a is formed in the plastic material coating on the rear side of the first connecting element 7. A rear opening 12b is formed on the rear side of the second connecting element 8.

[0204] The assembly is partially surrounded by a plastic material 11. In the embodiment shown, the assembly is partially overmolded by polysulfone. Recesses for the first contact surface 9 and the second contact surface 10 are formed in the plastic material 11. The first and second contact surfaces are formed as rounded surfaces. A guide 16 is formed adjacent to each of the first and second contact surfaces 9, 10. The guide 16 is used to accommodate a connection element (e.g. a terminal block). The guides on the contact surfaces prevent connection elements of different contact surfaces from contacting each other.

[0205] The second receiving device 13 is constructed similarly to the first receiving device 2. For the sake of clarity, the components of the second receiving device (opening, three stepped conical parts and two connecting elements) are not provided with reference numerals. The second receiving device also has two contact surfaces for connection (third contact surface 14 and fourth contact surface 15). The guide is again formed adjacent to the contact surface.

[0206] The positioning means 18b is formed at one end of the second receiving means and is implemented as a pin with a pointed end. Fig.15 ), the tip of the positioning device 18b can be inserted into the receptacle of the housing so that the component can be accurately assembled and arranged on the housing. However, the component can also be implemented without the positioning device 18b.

[0207] Positioning pins 18a are formed on the underside of the assembly (see Fig.12 ). When the assembly is arranged on the housing of the implant, the positioning pins can be arranged in the relevant receptacles. In the embodiment shown, two positioning pins are shown, but other numbers of positioning pins are also possible.

[0208] The first receiving device 2 and the second receiving device 13 respectively have a spring sleeve and a male connector receptacle. The first receiving device 2 and the second receiving device 13 can be designed as IS-1 connectors.

[0209] The spring element 20 is arranged in the first receiving device 2 and fastened there ( Fig.13 The left side of the component 1 is shown in FIG. 1 ). The recess 12 a in the plastic material is used to weld the spring element 20 arranged inside the first receiving device 2 into the first connecting element 7 by resistance welding. Similarly, another spring element is arranged and fastened in the second receiving device 13 (not shown). The opening of the component 1 is then closed and sealed with potting aids 21, 22, 23 ( Fig.13 on the right side of the seal.

[0210] exist Fig.14 A further assembly step is shown in FIG. 2 . The strap 24 is fastened (eg welded) to the third contact surface 14. The strap 24 has a strap connection 25 at its rear end, which can be connected to a through-hole 30 (see FIG. 2 ). Figure 4 ) and can, for example, be inserted into the pin contacts. Additional wire strips are connected to the other contact surfaces 9, 10, 15.

[0211] The antenna 26 is attached to the assembly 1. The antenna 26 partially surrounds the first part 3 of the first receiving device 2 and is clamped thereon. The antenna 26 has a U-shaped section 27 in the area between the first connection element 7 and the second connection element 8. This forms a gripping recess, which can be used, for example, with an automatic gripper to hold and transport the assembly. An antenna connection 28 is formed at the rear end of the antenna for connection to a feed-through 30.

[0212] The assembly with the tape and antenna is then placed in a mold (e.g. a silicone mold) (not shown). The tape connection and antenna connection 28 are placed on the associated pins of the feedthrough 30 and connected to the pins (e.g. soldered). The mold is closed and filled with synthetic resin 31 (e.g. epoxy). This forms the electrode connection device (see Fig.16 ).

[0213] The potting aids 21, 22, 23 are removed and any excess resin on the outer surface is removed, for example by grinding and / or polishing. The implant with the electrode connection device is now fully assembled ( Fig.17 ).

[0214] Fig.18 Another embodiment of an implant is shown. The electrode connection device 53 is attached to the cover 121. The energy storage device 62 is accommodated in the housing 120. The housing 120 can be configured as a deep-drawn part. The cover 121 is welded to the housing 120 along a circumferential weld 122 to close the housing 120. The support frame 69 is arranged on the energy storage device. The support frame 69 accommodates the electronic module. The electrode connection device 53 can be, for example, according to Figures 11 to 17 The embodiment shown is formed in that the lead-through 65 with the pins 70 is welded into the cover 121 .

[0215] Embodiments of the implants and methods disclosed herein may have the following advantages:

[0216] The internal structure of the electronic implant is greatly simplified, thus reducing the production costs. Likewise, the number and complexity of the required production processes are reduced, thus facilitating the scalability of production (e.g. simplified transfer to other locations, reduced training needs for employees, reduced requirements for the required manufacturing environment and accompanying engineering). Furthermore, when using detachable connection technology, rework becomes possible or is simplified.

[0217] The form factor of the electronic module allows the implant to be made smaller, or the volume gained can be used to increase the battery capacity, thus extending the life of the implant. The production of the electronic module using μBGA technology allows to increase the panel's practicality and save the associated production costs. The vertical assembly of the electronic module (parallel to the front side of the energy storage) enables an angle-free electrical connection, resulting in a simpler and more economical structure of the implant, optimized for automated manufacturing on one axis.

[0218] Features disclosed in the description, claims and drawings may be relevant to the implementation of the embodiments and may be implemented separately or in any combination with each other.

Claims

1. An implant comprising an electrode connection device and a housing, wherein: A cover for closing the housing is formed on the electrode connection device, wherein: A through-portion is formed in the cover, wherein the through-portion forms an electrical connection between the electrode connection device and an electronic module arranged in the housing, and The electrode connection device has a preassembled component, wherein the component comprises: - a continuous receiving device for a male connector, a first connecting element, which is arranged in the front region of the receiving device, wherein the first connecting element has at least two flat sides, and a second connecting element, which is arranged in the rear region of the receiving device, wherein the second connecting element has at least two flat sides, The component is surrounded by plastic at least in some parts, and The connection region of the first connection element is free of plastic material and the connection region of the second connection element is free of plastic material.

2. The implant according to claim 1, wherein The cover is welded to the housing.

3. The implant according to claim 1 or 2, wherein: A welding protector is formed on the cover.

4. The implant according to claim 1 or 2, wherein: The cover is formed from a biocompatible material.

5. The implant according to claim 1 or 2, wherein: The cover and the housing are formed of the same material.

6. The implant according to claim 1, wherein The lead-through is electrically connected to the electronic module via a plug-in connection or a spring contact.

7. The implant according to claim 1 or 2, wherein: A first guide of a first conductor for connection to the connection region of the first connection element is formed in plastic and / or wherein a second guide of a second conductor for connection to the connection region of the second connection element is formed in plastic.

8. The implant according to claim 7, wherein The first guide is formed adjacent to a connection region of the first connection element, and / or wherein the second guide is formed adjacent to a connection region of the second connection element.

9. The implant according to claim 1 or 2, wherein: The positioning device is formed at the rear end of the receiving device.

10. The implant according to claim 1 or 2, wherein: The assembly further comprises a further receiving device for a further male connector, wherein the third connecting element is arranged in a front region of the further receiving device, and wherein the fourth connecting element is arranged in a rear region of the further receiving device.

11. The implant according to claim 1 or 2, wherein: Antennas, charging coils, X-ray markers, communication coils and / or color markings are arranged in the electrode connection device.

12. A method for producing an implant comprising the steps of: - provide a housing, - an electrode connection device is provided, wherein a cover for closing the housing is formed on the electrode connection device, wherein a through-hole is formed in the cover, wherein the through-hole forms an electrical connection between the electrode connection device and an electronic module arranged in the housing, and the electrode connection device has a preassembled assembly, wherein the assembly comprises: a continuous receiving device for a male connector, a first connecting element, which is arranged in a front area of ​​the receiving device, wherein the first connecting element has at least two flat sides, and a second connecting element, which is arranged in a rear area of ​​the receiving device, wherein the second connecting element has at least two flat sides, the assembly is surrounded by plastic at least in some parts, and the connecting area of ​​the first connecting element is free of plastic material, and the connecting area of ​​the second connecting element is free of plastic material; - arranging the cover on the housing, and - Attach the cover to the housing.

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