Conductive structures for medical implants produced using an inkjet plasma process

Abstract

The present invention relates to an implantable medical device (1), comprising a substrate portion (2), and at least one conductive structure (30, 31, 32, 33, 34, 35) arranged on a surface (20a) of the substrate portion (20), the at least one conductive structure being configured to conduct an electrical current, wherein the at least one conductive structure is formed out of a printed metal.

Description

[0001] Applicant: BIOTRONIK SE & Co. KG

[0002] Date: 03.11.2025

[0003] Our Reference: 23.136P-WO

[0004] Conductive structures for medical implants produced using an inkjet plasma process

[0005] The present invention relates to an implantable medical device comprising at least one electrically conductive structure such as an electrically conductive track and to a method for forming an electrically conductive structure of an implantable medical device.

[0006] For providing electrical connections between different components in an implantable medical device, particularly between a header and an electrical feedthrough of a housing of the device, stamped and bent metallic conductor parts are usually employed that are soldered or welded to the electrical contacts of the header and the feedthrough pins of the electrical feedthrough. Furthermore, laser direct structured MID components (LDS MID) are known in the art that can be used to provide electrical connections between different components.

[0007] However, stamped and bent metallic conductor parts typically comprise a relatively large material thickness, and often require a considerable cleaning effort due to contamination of the components with processing aids during manufacture. Corresponding tools for placing the respective part and post-processing / cleaning of the respective part are required.

[0008] Furthermore, LDS MID typically require multi-stage, complex processes involving injection molding, laser pre-treatment, and metallization.

[0009] Based on the above, the problem to be solved by the present invention is to provide an implantable medical device as well as a corresponding method that allow to omit the typically used wiring bands, which are produced externally by stamping and bending or etching. Particularly, it is an objective of the present invention to provide a more efficient process for manufacturing of electrically conductive tracks of an implantable medical device that is more efficient compared to the LDS MID process. Furthermore, particularly, it is an objective of the present invention to be able to use a wider range of possible substrate materials, e.g., due to lower temperatures occurring in the metallization step.

[0010] This problem is solved by an implantable medical device having the features of claim 1 and by a method having the features of claim 9. Preferred embodiments of these aspects of the present invention are stated in the corresponding dependent claims and are described below.

[0011] According to claim 1, an implantable medical device is disclosed, comprising:

[0012] - a header comprising a header body, and

[0013] - at least one electrically conductive structure arranged on a surface of the header body, the at least one electrically conductive structure being configured to conduct an electrical current in particular.

[0014] According to the present invention, the at least one conductive structure comprises a printed metal, particularly an inkjet printed metal.

[0015] In the framework of the present invention, a printed metal is a metal that results from applying, particularly printing, particularly inkjet printing, an ink that is post-processable (processable after being printed) to form the respective metallic electrically conductive structure, wherein post-processing particularly comprises applying a reductive plasma to the applied (particularly printed) ink. Particularly, said ink comprises a metal ionic precursor in a liquid (e.g. solvent) that forms the metal due to said post-processing which yields a reduction of the precursor to the corresponding metal atom, i.e. the metal atom in its elemental form.

[0016] According to one embodiment, the at least one electrically conductive structure is selected from at least one electrically conductive track, an antenna, a labeling, a manufacturer' s ID, or an x-ray marker.

[0017] According to one embodiment of the implantable medical device, the implantable medical device comprises a plurality of electrically conductive structures arranged on the surface of the header body, the respective conductive track being particularly configured to conduct an electrical current, wherein the respective conductive structure is formed out of or comprises

[0018] 23.136P-WO | 03.11.2025 a printed metal, particularly an inkjet printed metal. Particularly, said plurality of electrically conductive structures comprises the at least one electrically conductive track.

[0019] Furthermore, according to one embodiment of the implantable medical device, said surface is planar. Particularly, this is beneficial as an ink applied to form the respective conductive track is less likely to run and can be applied more accurately.

[0020] Further, according to one embodiment of the implantable medical device, the at least one conductive structure (or the respective conductive structure) is arranged in a recess of said surface, wherein particularly the recess is characterized by a depth in the range from 0.01 pm to 1000 pm. In one embodiment, the conductive structure is characterized by a thickness in the range of 0.01 pm to 1000 pm, wherein particularly the thickness of the conductive structure equates to the depth of the recess. Preferably, the conductive structure is characterized by a thickness in the range from 0.1 pm to 100 pm. Furthermore, particularly, in case the at least one electrically conductive structure is an electrically conductive track, the recess is a groove. In one embodiment, the conductive structure is formed two or more layers of material.

[0021] According to one embodiment of the implantable medical device, the surface and / or the substrate portion is formed out of one of the following materials: a plastic material, a thermoplastic, TPU (thermoplastic polyurethane), PSU (polysulfone), PEEK (polyether ether ketone), epoxy (i.e. a cured epoxy resin), LCP (liquid crystal polymer).

[0022] Furthermore, according to one embodiment, the implantable medical device further comprises a housing and an electrical feedthrough arranged at the housing, wherein the header is mounted to the housing of the implantable medical device.

[0023] Particularly, in one embodiment, the housing is formed from a biocompatible metal such as titanium and accommodates an electronic circuitry being connected to the feedthrough pins of electrical feedthrough. Thus, via the electrical feedthrough, components accommodated in the header body of the header may be electrically connected to the electronic circuitry via the electrical feedthrough.

[0024] 23.136P-WO | 03.11.2025 According to one embodiment of the implantable medical device, the electrical feedthrough comprises a feedthrough pin, wherein the at least one conductive structure (e.g. an electrically conductive track or an antenna or a portion of an antenna) is connected in an electrically conducting fashion to the feedthrough pin, wherein optionally the feedthrough pin comprises a surface portion that is level with the surface of the substrate portion, wherein optionally the at least one electrically conductive structure is printed onto the surface portion of the feedthrough pin to connect the at least one electrically conductive structure to the feedthrough pin in an electrically conducting fashion. According to an alternative embodiment, connecting the at least one electrically conductive structure and the feedthrough pin in an electrically conducting fashion may also be performed in any other way that allows to establish an electrically conducing connection between the at least one conductive structure and the feedthrough pin, particularly welding, soldering, establishing a mechanical contact, etc.

[0025] Further, in one embodiment of the implantable medical device, the header comprise at least one electrical contact arranged in or integrated into the header body, wherein the at least one electrical contact has an electrically conductive contact surface, wherein the at least one electrically conductive structure (e.g. in form of at least one electrically conductive track) connects the electrically conductive contact surface to the feedthrough pin in an electrically conducting fashion, wherein optionally the electrically conductive contact surface is level with the surface of the header body, and wherein optionally the at least one electrically conductive structure is printed onto the electrically conductive contact surface to connect the electrically conductive contact surface with the at least one electrically conductive structure in an electrically conducting fashion. According to an alternative embodiment, connecting the at least one electrically conductive structure and the electrically conductive contact surface may also be performed in any other way that allows to establish an electrically conducing connection between the at least one conductive structure and the first contact surface, particularly welding, soldering, establishing a mechanical contact.

[0026] Furthermore, according to one embodiment of the implantable medical device, the header comprises at least one socket arranged in or integrated into the header body configured to

[0027] 23.136P-WO | 03.11.2025 receive a plug (e.g. a plug of an electrode lead), wherein the at least one socket comprises said at least one electrical contact. Particularly, the at least one electrical contact is configured to electrically contact a corresponding contact of the plug. Particularly, the connector can comprise a plurality of electrical contacts depending on the number of poles of the connector. In one embodiment, the socket comprises two electrical contacts being configured to electrically contact to corresponding electrical contacts of a plug of an electrode lead, e.g., of an IS-l / DF-1 electrode lead. In another embodiment, the socket comprises four electrical contacts being configured to electrically contact to corresponding electrical contacts of a plug of an electrode lead, e.g., of an IS-4 / DF-4 electrode lead. Each contact surface of the connector may be connected to an associated feedthrough pin as described above. Particularly, the implantable medical device comprises a first and a second connector, each of the first and the second connector comprising at least one electrical contact, particularly two electrical contacts or four electrical contacts.

[0028] Particularly, the implantable medical device comprises a plurality of conductive structures, particularly tracks, as described above (i.e. each formed out of a printed metal), wherein the at least one first electrically conductive track electrically connects a first electrically conductive contact surface of a first electrical contact of the socket with an associated feedthrough pin and a second electrically conductive track may electrically connect a second electrically conductive contact surface of a second electrical contact of the socket to an associated feedthrough pin. Yet a further electrically conductive structure of said plurality of conductive structures may form the antenna (or a portion thereof) as described above. In addition, one, several or all of the further printed metal structures (e.g. x-ray marker, labeling, manufacturer's ID) may be arranged / printed on said surface portion of the substrate structure (e.g. header housing).

[0029] According to one embodiment of the implantable medical device, the at least one electrically conductive structure (e.g. electrically conductive track and / or antenna and / or other electrically conductive structures such as an x-ray marker) is covered with a material layer arranged on the header body, wherein said material layer may comprise or may be formed from: polyurethane (particularly TPU), silicone, epoxy. The material layer may be provided by potting or molding. Furthermore, the material layer may be bonded, or welded or pressed

[0030] 23.136P-WO | 03.11.2025 onto the head body to connect the material layer to the header body and cover the at least one printed conductive track.

[0031] According to a further aspect of the present invention, a method for forming at least one electrically conductive structure (such as an electrically conductive track) of an implantable medical device is disclosed, the at least one conductive track being able to conduct an electrical current, wherein the method comprises the steps of:

[0032] - providing a header body of a header of the implantable medical device, the header body comprising a surface, and

[0033] - applying (particularly printing, particularly inkjet printing) an ink onto the surface for forming the at least one conductive structure, the ink comprising metal ionic precursors and a liquid (particularly for providing structure to the ink),

[0034] - forming the at least one conductive structure by subjecting the ink applied to the surface to a plasma to reduce the metal ionic precursors in the ink to metal atoms and evaporating the solvent.

[0035] Particularly, the ink is applied to a pre-defined area corresponding to the shape of the electrically conductive structure to be formed. Particularly, in case the electrically conductive structure is an electrically conductive track, the area is a path along which the conductive structure / track to be formed extends.

[0036] Particularly, the liquid may help to hold the ink together and adhere it to the surface upon application. The liquid can contribute to the ink's viscosity, adhesion, and drying properties, ensuring that it forms a coherent and durable layer on the substrate.

[0037] According to one embodiment of the method, the ink is applied into a recess of said surface, the recess extending along said area or path, wherein in the latter case, the recess can form a groove, and wherein particularly the recess (or groove) is characterized by a depth in the range from 0.01 pm to 1000 pm.

[0038] Particularly, several electrically conductive structures may be generated with the method according to the present invention, wherein the ink for each conductive structure may be

[0039] 23.136P-WO | 03.11.2025 applied into a respective recess or groove of the surface of the substrate portion, wherein particularly the respective recess or groove comprises a depth in the above-stated depth range.

[0040] Furthermore, according to one embodiment of the method, the surface and / or the header body is formed out of one of the following materials: a plastic material, a thermoplastic, TPU (thermoplastic polyurethane), PSU (polysulfone), PEEK (polyether ether ketone), epoxy (i.e. a cured epoxy resin), LCP (liquid crystal polymer).

[0041] In one embodiment, the method according to the invention further comprises the steps: providing a housing and an electrical feedthrough arranged at the housing, and mounting the header on the housing, the substrate portion is a header housing of a header of the implantable medical device, wherein particularly said ink is applied after mounting the header to the housing.

[0042] Furthermore, according to one embodiment of the method, the electrical feedthrough comprises a feedthrough pin, wherein the ink is applied, particularly printed, along a predefined path that extends towards the feedthrough pin, wherein optionally the feedthrough pin comprises a surface portion that is level with the surface of the header body, wherein particularly the ink is applied onto the surface portion of the feedthrough pin to connect the at least one electrically conductive structure (e.g. electrically conducting track or antenna or portion thereof) to the feedthrough pin in an electrically conducting fashion. Other ways of connecting the conductive structure and the feedthrough pin in an electrically conducting fashion are also conceivable (see also above).

[0043] According to one embodiment of the method, at least one electrical contact is arranged in or integrated into the header body, wherein the at least one electrical contact has an electrically conductive contact surface, wherein said path along which the ink is applied (particularly printed) also extends towards the electrically conductive contact surface, wherein optionally the electrically conductive contact surface is level with the surface of the header body, and wherein optionally the ink is applied (particularly printed) onto the electrically conductive contact surface to connect the electrically conductive contact surface with the at least one

[0044] 23.136P-WO | 03.11.2025 electrically conductive structure (e.g. electrically conductive track) in an electrically conducting fashion.

[0045] Further, in one embodiment of the method according to the present invention, the header comprises at least one socket arranged in or integrated into the header body, the socket being configured to receive a plug (e.g. a plug of an electrode lead), wherein the socket comprises said at least one electrical contact (see also above).

[0046] According to one embodiment of the method, the ink is applied (particularly by printing, particularly inkjet printing) to the surface of the header body, and a metallic x-ray marker is formed by subjecting the applied ink to a plasma to reduce the metal ionic precursors to metal atoms and evaporating the liquid(s).

[0047] According to one embodiment of the method, the ink is applied (particularly by printing, particularly inkjet printing) to the surface of the substrate portion, and a metallic labeling is formed by subjecting the applied ink to a plasma to reduce the metal ionic precursors to metal atoms and evaporating the liquid(s).

[0048] According to one embodiment of the method, the ink is applied (particularly by printing, particularly inkjet printing) to the surface of the substrate portion, and a metallic manufacturer's ID is formed by subjecting the applied ink to a plasma to reduce the metal ionic precursors to metal atoms and evaporating the liquid(s).

[0049] Particularly, as described in conjunction with the implantable medical device according to the present invention, the method according to the present invention allows to form a plurality of electrically conductive structures, particularly tracks, as described above (i.e. each formed by applying the ink along a certain path or onto a certain area corresponding to the course / shape of the respective conductive structure (particularly track) to be formed, wherein the at least one first conductive track may electrically connect a first electrical contact of the socket via its electrically conductive contact surface with an associated feedthrough pin and a second conductive track may electrically connect a second electrical contact of the socket via its electrically conductive contact surface to an associated

[0050] 23.136P-WO | 03.11.2025 feedthrough pin. Yet a further conductive structure of said plurality of conductive structures may form the antenna (or a portion thereof) as described above. In addition, one, several or all of the further printed metal structures (e.g. x-ray marker, labeling, manufacturer' s ID) may be arranged / printed on said surface portion of the substrate structure (e.g. header housing) by applying the ink and subjecting it to the plasma as described above.

[0051] According to one embodiment of the method according to the present invention, the at least one conductive structure (or the respective conductive structure) is covered with a material layer that is arranged on the header body, wherein said material layer can comprise or can be formed out of: polyurethane (particularly TPU), silicone, epoxy. The material layer may be provided by potting or molding. Furthermore, the material layer may be bonded, or welded or pressed onto the header body to connect the material layer to the header body and cover the at least one (or the respective) printed conductive structure (e.g. one of several of: electrically conductive track(s), antenna, x-ray marker, labeling, manufacturer's ID, etc.).

[0052] According to one embodiment of the method the metal ionic precursor comprises a salt, the salt comprising metal cations and counterions or ligands. Particularly the metal cations are stabilized by a ligand, thereby forming an organometallic complex such that the resulting salt is connected by coordinate bonds.

[0053] According to one embodiment of the method, wherein the metal cations are salts of at least one of: Au, Ag, Pt, Pd, Cu, Ni, Co, Zn, In, Ti, V, Mn, Fe, Cr, Zr, Nb, Mo, W, Ru, Rh, Ca, Re, Os, Ir, Al, Ga, Sn, and Sb.

[0054] According to one embodiment of the method, the counterions and ligands are in the form of at least one of: M(N03)n, M(SO4)n, MCln, HmMCln+m, and MN, where M is a metal atom or metal alloy with a valence of “n”, “N” is alkyl-, alyl-, or aceto-, carbonyl, carboxyl, cyclopentadienyl, phenyl-, biphenyl-, pyridine-, bipyridine-, aromatic, cyano-, amide moieties, and “m” is a valence of the counterion.

[0055] 23.136P-WO | 03.11.2025 According to one embodiment of the method, the liquid has at least one of: a dynamic viscosity between 10 centipoise (cP) and 1000 cP and a vapor pressure between 0 Pa and 100 Pa.

[0056] Furthermore, according to one embodiment of the method according to the present invention, the liquid comprises at least one of: a cyclic alcohol, a sulfoxide, a formamide, an ethylamine, a diol, a glycol, a glycol ether, a glycerol, and a propylene carbonate.

[0057] Further, in one embodiment of the method, the liquid comprises more than 20% by weight of the ink, and the metal ionic precursor comprises between 0.01% and 60% by weight of the ink.

[0058] According to one embodiment of the method, the ink further comprises one of: a spreading liquid (e.g. for facilitating the uniform spreading and wetting of the ink on the surface), a stabilizing liquid (e.g. for helping to maintain the stability of the ink formulation over time), additive(s). Particularly, in a preferred embodiment of the method, spreading liquid comprises at least one of: an alcohol, a toluene, a dioxane, a sulfoxide, a formamide, an ethylamine, a glycol ether, and an acetonitrile. Further, in a preferred embodiment, the spreading liquid has a surface tension between 10 mN / m and 40 mN / m.

[0059] Furthermore, in according to a preferred embodiment of the method, the spreading liquid comprises up to 80% by weight of the crystal growth ink.

[0060] Furthermore, according to one embodiment of the method, the stabilizing liquid comprises at least one of: water, a tetrahydrofurane, a dioxane, a cyclic alcohol, a sulfoxide, a formamide, an ethylamine, a glycol, a glycerol, a propylene carbonate, and an acetonitrile.

[0061] In a further embodiment of the method, the stabilizing liquid comprises up to 50% by weight of the crystal growth ink.

[0062] According to one embodiment of the liquid, the ink is subjected to the plasma in an environment having a pressure in the range from 1 * 104Pa to R I O1Pa.

[0063] 23.136P-WO | 03.11.2025 According to a further embodiment of the method, subjecting the ink to the plasma further comprises: subjecting the ink to plasma based on parameters, the parameters including: plasma power, plasma frequency, and time of exposure of the ink to that plasma. Particularly in a preferred embodiment, the plasma frequency is between 50 Hz and 5 GHz.

[0064] Furthermore, according to one embodiment of the method, said additive(s) comprise up to 5% by weight of the ink, and can further comprises at least one of: solvents, organic molecules, oxidants, reductants, acids, bases, stabilizers, polymers, conductive polymers, microparticles, nanoparticles, carbon nanotubes (CNT), densifiers, surfactants, propellants, dispersing agents, binder resins, adhesion promoters, wetting agents, and leveling agents.

[0065] Further, according to one embodiment of the method, the plasma comprises an ionized gas consisting of the group of: argon, nitrogen, oxygen, hydrogen, air, helium, neon, xenon, ammonia, ethane (C2H5), carbon dioxide, carbon monoxide, methane (CH4), propane (CsHs), silane (SiH4), nitrogen dioxide, nitrogen monoxide and their combinations.

[0066] According to one embodiment of the method, the stabilizing liquid is configured to dissolve the metal ionic precursor to between 5 g [grams] and 300 g per 100 g of the ink.

[0067] Particularly, the features and embodiments described in conjunction with the implantable medical device according to the present invention may also be used to further specify the method according to the present invention and vice versa.

[0068] In the following, embodiments of the present invention as well as further features and advantages of the present invention shall be described with reference to the Figures, wherein

[0069] Fig. 1 shows an embodiment of the method and implantable medical device according to the present invention,

[0070] Fig. 2 shows a schematic cross-section along the line II-II of Fig. 1, and

[0071] 23.136P-WO | 03.11.2025 Fig. 3 shows a schematic cross-section of the substrate portion having a recess formed in the surface of the substrate portion for accommodating at least a portion of a printed electrically conductive structure of the implantable medical device.

[0072] Fig. 1 shows an embodiment of an implantable medical device 1 according to the present invention. The implantable medical device 1 comprises a header body 20 of a header 2 of the medical device 1, and at least one electrically conductive structure 30, 31, 32, 33, 34, 35 arranged on a surface 20a of the substrate portion 20. Particularly, as indicated in Fig. 1 the implantable medical device 1 comprises a plurality of electrically conductive structures 30, 31, 32, 33, 34, 35. According to the present invention the at least one electrically conductive structure or said plurality of electrically conductive structures is / are formed out of a printed metal, particularly an inkjet-printed metal.

[0073] According to an embodiment of the method according to the present invention, the respective conductive structure 30, 31, 32, 33, 34, 35 may be formed by providing the header body 20 and applying an ink onto the surface 20a on a pre-defined area (particularly path) corresponding to the shape or course of the respective conductive structure (particularly track) to be formed, wherein the ink comprises metal ionic precursors and a liquid, wherein the respective conductive structure is eventually formed by subjecting the ink applied to the surface 20a on the respective area (e.g. path) to a plasma to reduce the metal ionic precursors to metal atoms and evaporating the liquid, particularly solvent. This results in solid electrically conductive structures, particularly tracks, that are formed out of a metal. Particularly, the metal ionic precursors stated above can be used. In example, ions of one of gold, silver, palladium, titanium, MP35N, platinum / iridium and their alloys are used as precursor. Furthermore, the plasma can have the characteristics described above.

[0074] In order to be able to apply the ink in an accurate manner it is beneficial to provide the header body 20 with a planar surface 20a so as to avoid running of the ink. Furthermore, as exemplary shown in Fig. 3, the respective conductive track 30, 31, 32, 33, 34, as well as all other metallic structures formed from the printed metal (i.e. based on a said ink described above), can be at least partially accommodated in a recess 20b (particularly an elongated groove 20b in case of a conductive track 30, 31, 32, 33 or antenna 34), wherein the recess

[0075] 23.136P-WO | 03.11.2025 (particularly groove) 20b provided in the surface 20a of the header body 20 helps to apply the ink more accurately as it reduces the risk of running of the ink. Particularly, the respective recess or groove 20b can be formed upon injection molding of the substrate portion 20. Particularly, the respective recess or groove 20b may be characterized by a depth D in the range from 0.01 pm to 1000 pm.

[0076] Particularly, the header body 20 may be formed from one of the following materials: a plastic material, a thermoplastic, TPU (thermoplastic polyurethane), PSU (polysulfone), PEEK (polyether ether ketone), epoxy (i.e. a cured epoxy resin), LCP (liquid crystal polymer). Particularly, the header body 20 as shown in Fig. 1, is preferably formed form one of a plastic material, a thermoplastic, TPU (thermoplastic polyurethane), PSU (polysulfone), PEEK (poly ether ether ketone).

[0077] Furthermore, the header 2 is preferably mounted or connected to a housing 5 of the implantable medical device 1. The housing 5 may be formed from a biocompatible metal such as a titanium or a titanium alloy. Particularly, the housing 5 accommodates an electronic circuitry of the implantable medical device 1, wherein the electronic circuitry may be connected in an electrically conducting fashion to components such as sockets 7, 8 arranged in or integrated into the header body 20 or an antenna 34 that are accommodated in the header 2via an electrical feedthrough 6. The feedthrough 6 is connected to the casing 5 and may comprise an electrical insulator 600 into which a plurality of feedthrough pins 60 are embedded as shown in Fig. 1. The electrical feedthrough pins 60 in turn may be connected to the electronic circuitry. In this way, electrical currents can be passed into and out of the casing 5 while the latter is hermetically sealed from the environment.

[0078] According to the embodiment shown in Fig. 1, the implantable medical device 1 may be an implantable cardiac pacemaker 1, wherein the header body 20 of the header 2 comprises two sockets 7, 8 that are each configured to receive a plug of an electrode lead of the pacemaker 1 that may be used to apply electrical stimulation to the heart of the patient. Particularly, each socket 7, 8 comprises a first electrical contact 40, 42 and a second electrical contact 41, 43 that may be embedded in the header body 20 such that an electrically conductive surface 40a, 41a, 42a, 43a of the first and second electrical contact 40, 41, 42, 43 is exposed

[0079] 23.136P-WO | 03.11.2025 to the outside of the header body, i.e., is not covered by the material of the header body and is accessible from the outside of the header body 20. Particularly, the first electrical contact 40. 42 is designed as a pin receptacle, while the second electrical contact 41, 42 is designed as spring sleeve having an electrically conductive spring, wherein the spring may be designed as a leaf spring or a coiled spring.

[0080] As can be inferred from Fig. 1, the respective conductive track 30, 31, 32, 33, is connected to an associated feedthrough pin 60 of the electrical feedthrough 6, to connect the sockets 7, 8, particularly the electrical contacts 40, 41, 42, 43 thereof, to the electronic circuitty accommodated in the housing 5.

[0081] Furthermore, according to Fig. 1, the implantable medical device 1 may comprise a conductive track 34 arranged on the surface 20a of the header portion 20 forming an antenna. In order to connect the antenna 34 to the electronic circuitry accommodated in the housing 5, the corresponding conductive track 34 is connected to an associated feedthrough pin 60 of the electrical feedthrough 6.

[0082] Furthermore, the device 1 may comprise an electrically conductive structure such as a labeling, a manufacturer' s ID, and / or an x-ray marker 35 that may also be formed from a conductive layer or track, respectively, printed on the surface 20a of the header body 20.

[0083] Particularly, the conductive tracks 30, 31, 32, 33, 34 described above as well as other labelling(s), manufacturer' s ID(s) or x-ray marker(s) 35 may be formed using the abovedescribed (e.g. inkjet) printing process, wherein an ink with metal ionic precursors is applied to the surface 20a of the substrate portion 20 in the desired geometric shape. The respective electrically conductive track 30, 31, 32, 33, 34 or structure 35 may then be created by treatment with a reductive plasma. Particularly, gold, silver, palladium, titanium, MP35N, platinum / iridium and their alloys are preferably produced from the ink in metallic form for the conductive tracks 30, 31, 32, 33, 34, and structure(s) 35 on preferably biocompatible plastics such as TPU which is preferably used for the header housing 20. Generally, conductive tracks and other structures of an implantable medical device according to the present invention may be printed on biocompatible plastics (e.g. rigid or flexible) .

[0084] 23.136P-WO | 03.11.2025 Particularly, in the embodiment shown in Fig. 1, the conductive paths 30, 31, 32, 33 forming a so-called external wiring 30, 31, 32, 33 connecting the sockets 7, 8, particularly the electrical contacts 40, 41, 42, 43 thereof, to the feedthrough 6, the x-ray marker 35, the labeling, and the antenna 34 are printed directly onto a surface 20a of a plastic header body 20 (e.g. made of TPU, particularly Pellethane® 2363-75D TPU orTecothane® TT-1075D- M).

[0085] To this end, in one embodiment, the feed-through pins 60, and the electrically contact surfaces 40a, 41a, 42a, 43a of the first and second electrical contact 40, 41, 42, 42 of the sockets 7, 8 lie in one plane with the surrounding (e.g. plastic) surface 20a of the header housing 20 that corresponds to the printing plane. Particularly, the feedthrough pins 60 and the electrical contact 40, 41, 42, 43 may be connected to the header body 20 by way of a positive connection. Particularly, as indicated in Fig. 2, the electrically conductive contact surfaces 40a, 41a, 42a, 43a of the electrical contacts 40, 41, 42, 43 may be flush with the surface 20a of the header body 20 and the feedthrough pins 60 may also comprise a surface portion 60a that is flush with the surface 20a of the header body 20. An electrical connection between the electrically conductive contact surfaces 40a, 41a, 42a, 43a and the respective feedthrough pin 60 may then be accomplished by applying the ink (e.g. by way of an inkjet printer 100) along a path extending from the electrically conductive contact surface 40a, 41a, 42a, 43a, to the feedthrough pin’s surface portion 60a, wherein the respective conductive track 30, 31, 32, 33 is printed on top of the respective electrically conductive contact surface portion 40a, 41a, 42a, 43a and surface portion 60a of the associated feedthrough pin 60. In the same fashion, the antenna 34 may be connected to its feedthrough pin 60 shown in Fig. 1. As described above, the forming of the metal forming the final conductive track 30-34 or structure 35 may take place during the subsequent plasma process (growth of the metal layer) so that the conductive track gets automatically connected to the associated contact surface 40, 41, 42, 43 or feedthrough pin 60.

[0086] However, an electrical connection between a conductive track 30, 31, 32, 32, 34 and a feedthrough pin 60 and / or another contact surface such as the first and second contact

[0087] 23.136P-WO | 03.11.2025 surfaces 40, 41, 42, 43 may also be formed after the plasma process in a subsequent bonding or contacting process (e.g. by methods known in the state of the art).

[0088] In order to protect the metallic surface from environmental influences such as body fluids and environmental influences and to insulate it electrically, polyurethane can be bonded, encapsulated, overmolded, welded or pressed with polyurethanes, particularly thermoplastic polyurethane, a liquid crystal polymer, silicone or similar.

[0089] As an alternative to the two-stage printing and plasma process (batch process), the conductive tracks may also be produced in a single stage using the atmospheric pressure plasma process (in-line process) with precursors introduced into the plasma stream.

[0090] Furthermore, for providing electrical insulation and particularly for ensuring biocompatibility, the generated electrically conducting structures 30, 31, 32, 33, 34, 35 can be covered with material layer such as an epoxy resin, polyurethane, silicone and the like, by gluing, potting, molding, welding or pressing.

[0091] The process according to the present invention offers significantly more flexibility and efficiency compared to current technologies. This leads to a reduction in procurement, storage, cleaning and incoming goods costs. The effort involved in product and process development is reduced. New design possibilities arise, particularly through the use of flex substrates. If necessary, the technology can also be used to produce intermetallic connections and thus replace welded and soldered connections.

[0092] 23.136P-WO | 03.11.2025

Claims

Claims1. An implantable medical device (1), comprising- header (2) comprising a header body (20), and- at least one electrically conductive structure (30, 31, 32, 33, 34, 35) arranged on a surface (20a) of the header body (20), characterized in that, the at least one electrically conductive structure is formed out of a printed metal.

2. The implantable medical device according to claim 1, wherein the at least one electrically conductive structure is selected from at least one electrically conductive track (30, 31, 32, 33), an antenna (34), a labeling, a manufacturer' s ID, or an x-ray marker.

3. The implantable medical device according to one of the preceding claims, wherein the at least one conductive structure (30, 31, 32, 33, 34) is printed in a recess of said surface (20a), wherein particularly the recess is characterized by a depth (D) in the range from 0.01 pm to 1000 pm.

4. The implantable medical device according to one of the preceding claims, wherein the surface (20a) is formed out of one of the following materials: a plastic material, a thermoplastic, TPU, PSU, PEEK, epoxy, LCP.

5. The implantable medical device according to one of the preceding claims, further comprising a housing (5), and an electrical feedthrough (6) arranged at the housing (5), wherein the header (2) is mounted to a housing (5 and providing an electrical connection to an electrical feedthrough (6) of the housing (5).

6. The implantable medical device according to claim 5, wherein the electrical feedthrough (6) comprises a feedthrough pin (60), wherein the at least one conductive structure (30, 31, 32, 33, 34) is connected in an electrically conducting fashion to the feedthrough pin (60), wherein particularly the feedthrough pin (60) comprises a23.136P-WO | 03.11.2025surface portion (60a) that is level with the surface (20a) of the header body (20), wherein particularly the at least one conductive structure (30, 31, 32, 33, 34) is printed onto the surface portion (60a) of the feedthrough pin (60) to connect the at least one conductive structure (30, 34) to the feedthrough pin (60) in an electrically conducting fashion, wherein particularly the at least one conductive structure is a conductive track (30, 31, 32, 33) or an antenna (34) arranged on the surface (20a) of the substrate portion (20).

7. The implantable medical device according to one of the preceding claims, wherein the header (2) comprises at least one electrical contact (40, 41, 42, 43) arranged in the header body (20), the at least one electrical contact (40, 41, 42, 43) having an electrically conductive contact surface (40a, 41a, 42a, 43a) , wherein the at least one conductive structure (30, 31, 32, 33) electrically connects the electrical conductive contact surface (40a, 41a, 42a, 43 a) to the feedthrough pin (60), wherein particularly the electrically conductive contact surface (40) is level with the surface (20a) of the header body (20), and wherein particularly the at least one conductive structure (30, 31, 32, 33) is printed onto the electrically conductive contact surface (40a, 41a, 42a, 43a)to connect the electrically conductive contact surface (40a, 41a, 42a, 43a)with the at least one conductive structure (30, 31, 32, 33) in an electrically conducting fashion, wherein particularly the at least one conductive structure is an electrically conductive track (30, 31, 32, 33).

8. The implantable medical device according to claim 7, wherein the header (2) comprises at least one socket (7, 8) arranged the header body (20) configured to receive a plug of an electrode lead, the at least one socket (7, 8) comprising said at least one electrical contact (40, 41, 42, 43).

9. A method for forming at least one electrically conductive structure (30, 31, 32, 33, 34, 35) of an implantable medical device (1), wherein the method comprises the steps of providing a header body (20) of a header (2) of the implantable medical device (1), the header body (20) comprising a surface (20a), and23.136P-WO | 03.11.2025- 19 - applying an ink onto the surface (20a) for forming the at least one electrically conductive structure (30, 31, 32, 33, 34, 35), the ink comprising metal ionic precursors and a liquid, forming the at least one electrically conductive structure (30, 31, 32, 33, 34) by subjecting the ink to a plasma to reduce the metal ionic precursors to metal atoms and evaporating the liquid.

10. The implantable medical device according to claim 9, wherein the at least one electrically conductive structure is selected from at least one electrically conductive track (30, 31, 32, 33), an antenna (34), a labeling, a manufacturer' s ID, or an x-ray marker (35), an.

11. The method according to claim 9 or 10, wherein the ink is applied into a recess (20b) of said surface (20a), wherein particularly the recess (20b) is characterized by a depth (D) in the range from 0.01 pm to 1000 pm.

12. The method according to one of the claims 9 to 11, further comprising the steps:- providing a housing (5) and an electrical feedthrough (6) arranged at the housing (5),- mounting the header (2) on the housing (5), wherein particularly said ink is applied after the header (2) has been mounted to the housing (5).

13. The method according to claim 12, wherein the electrical feedthrough (6) comprises a feedthrough pin (60), wherein the ink is applied along a path, the path extending towards the feedthrough pin (60), wherein particularly the feedthrough pin (60) comprises a surface portion (60a) that is level with the surface (20a) of the header body (20), wherein particularly the ink is applied onto the surface portion (60a) of the feedthrough pin (60) to connect the at least one electrically conductive structure (30, 31, 32, 33, 34, 35) to the feedthrough pin (60) in an electrically conducting fashion, wherein particularly the at least one electrically conductive structure (30, 31, 32, 33, 34) is an electrically conductive track (30, 31, 32, 33) or an antenna (34).23.136P-WO | 03.11.202514. The implantable medical device according to claim 13, wherein an at least one electrical contact (40, 41, 42, 43) is arranged in the header body (20), the at least one electrical contact (40, 41, 42, 43) having an electrically conductive contact surface (40a, 41a, 42a, 43a), wherein said path further extends towards the electrically conductive contact surface (40a, 41a, 42a, 43a), wherein particularly the electrically contact surface (40a, 41a, 42a, 43a) is level with the surface (20a) of the header body (20), and wherein particularly the ink is applied onto the electrically conductive contact surface (40a, 41a, 42a, 43a)to connect the electrically conductive contact surface (40a, 41a, 42a, 43a)with the at least one conductive structure (30, 31, 32, 33) in an electrically conducting fashion, wherein particularly the at least one electrically conductive structure is an electrically conductive track.

15. The method according to claim 14, wherein the header (2) comprises at least one socket (7, 8) arranged in the header body (20) for receiving a plug, the at least one connector (7) comprising said electrical contact (40, 41, 42, 43) .23.136P-WO | 03.11.2025

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