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Title:
ENERGY-REDUCED AND AUTOMATABLE JOINING BY MEANS OF NANOWIRING FOR CONTACTING ELECTRICAL AND MECHANICAL COMPONENTS OF ACTIVE AND MONITORING IMPLANTS
Document Type and Number:
WIPO Patent Application WO/2023/202931
Kind Code:
A1
Abstract:
The present invention relates to an implantable device, comprising: a first component, and a second component, wherein the first and the second component are joined to one another via a connection comprising metallic nanowires.

Inventors:
PFEFFERKORN THOMAS (DE)
HAUER MARC ROBERT (CH)
HAUSER MARKUS (DE)
BINIAS SOFIA (DE)
CLAUSSEN DOMENIC (DE)
KLENNER ROLF (DE)
BOHMEYER MARTIN (DE)
KOEHLER MANUELA ANDREA (DE)
KIRCHNER TIM (DE)
Application Number:
PCT/EP2023/059583
Publication Date:
October 26, 2023
Filing Date:
April 12, 2023
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
BIOTRONIK SE & CO KG (DE)
International Classes:
A61N1/375
Domestic Patent References:
WO2021185617A12021-09-23
WO2021185616A12021-09-23
WO2021185619A12021-09-23
WO2021185618A12021-09-23
WO2021259607A12021-12-30
WO2022012903A12022-01-20
Foreign References:
US20140081070A12014-03-20
US20120065703A12012-03-15
US20190365225A12019-12-05
CN106486288A2017-03-08
EP3592697A12020-01-15
EP3593102A12020-01-15
EP3592696A12020-01-15
EP3711462B12023-01-25
DE102018122007A12020-03-12
Attorney, Agent or Firm:
BIOTRONIK CORPORATE SERVICES SE (DE)
Download PDF:
Claims:
Claims

1. An implantable device (1), comprising

-a first component (3, 5, 8, 202, 203, 204, 207), and

-a second component (4, 7, 5, 203, 200, 204, 205, 206, 207), wherein the first and the second component (3, 4; 5, 7; 8, 5; 202, 203; 203, 200; 202, 204; 204, 205, 206; 202, 207; 207, 205, 206) are joined to one another via a connection (30) comprising metallic nanowires (31).

2. The implantable device according to claim 1, wherein each metallic nanowire (31) comprises a length in the range from 100 nm to 100 pm, and/or a diameter in the range from 10 nm to 10 pm.

3. The implantable device according to claim 1 or 2, wherein the connection (30) comprises a coating of a surface (10a) of the first component with first metallic nanowires (31) and a coating of a surface (20b) of the second component with second metallic nanowires (31), wherein the first and the second metallic nanowires (31) are interlocked with each other.

4. The implantable device according to claim 1 or 2, wherein the connection (30) comprises a coating of a surface (10a) of the first component with said metallic nanowires (31), wherein the metallic nanowires (31) and the surface (20a) of the second component (20) are bonded to one another, or wherein the connection (30) comprises a coating of a surface (20a) of the second component with said metallic nanowires (31), wherein the metallic nanowires and the surface (10a) of the first component are bonded to one another.

5. The implantable device according to claim 1 or 2, wherein the connection (30) comprises an intermediate film (33) having a first side (33a) and a second side (33b) facing away from the first side (33a), wherein the first and the second side (33a, 33b) each comprise a coating with metallic nanowires (31), wherein the metallic nanowires (31) grown on the first side (33 a) are bonded to a surface (10a) of the first component (10), and wherein the nanowires (31) grown on the second side (33b) are bonded to a surface (20a) of the second component (20). The implantable device according to claim 1 or 2, wherein the connection (30) comprises a coating of a surface (10a) of the first component with metallic nanowires

(31) and/or a coating of a surface (20a) of the second component with metallic nanowires, wherein the connection further comprises an intermediate adhesive layer

(32) for connecting the two opposing surfaces (10a, 10b) to one another. The implantable device according to claim 1 or 2, wherein the connection (30) comprises an intermediate film (33) having a first side (33a) and a second side (33b) facing away from the first side (33a), wherein the first and the second side (33a, 33b) each comprise a coating with metallic nanowires (31), wherein the metallic nanowires

(31) grown on the first side (33 a) are bonded to a surface (10a) of the first component via an adhesive layer (32), and wherein the nanowires (31) grown on the second side (33b) are bonded to a surface (20a) of the second component via an adhesive layer

(32). The implantable device according to claim 6 or 7, wherein the respective adhesive layer (32) is formed by an anaerobic adhesive, preferably a dimethacrylate ester-based adhesive. The implantable device according to one of the preceding claims, wherein the first component is a housing of the implantable device, and wherein the second component is an X-ray marker that is bonded to the housing via said connection, or wherein the first component is a shell of a housing of the implantable device, particularly a half shell, and wherein the second component is a shell of the housing, particularly a half shell, wherein said connection closes the shells of the housing hermetically. The implantable device according to one of the claims 1 to 8, wherein the implantable device (1) comprises a capacitor (2) comprising an electrical feedthrough pin (3) forming the first component and a circuit (4) arranged on a substrate (5), the circuit (4) forming the second component. The implantable device according to one of the preceding claims 1 to 8, wherein the implantable device comprises a printed circuit board (5) forming the first component, the surface (10a) of the first component (5) forming an electrical contact of the printed circuit board, and wherein the second component (7) is an electronic component. The implantable device according to one of the claims 1 to 8, wherein the implantable device (1) comprises a dump resistor (8) forming the first component and a printed circuit board (5) forming the second component. The implantable device according to one of the claims 1 to 8, wherein the implantable device (1) comprises a housing (200) comprising an electrical feedthrough (201) comprising at least one pin (202) for providing an electrical connection to a header (300) connected to the housing (200), wherein the at least one pin (202) is electrically connected to an electronic module (9) enclosed by the housing (200) of the implantable device (1), and wherein the at least one pin (202) forms the first component, and the second component is an electrically insulating sleeve (203) that surrounds the at least one pin (202) and is connected to the housing (200), or wherein the at least one pin (202) is surrounded by an electrically insulating sleeve (203) that forms the first component, and the second component is formed by the housing (200), or wherein the at least one pin (202) forms the first component, and the second component is arranged in the header (300), wherein particularly the second component is an external wiring (204) arranged outside the housing (200) for connecting the at least one pin (202) to a component of the header (300), or wherein the first component is formed by an external wiring (204) connected to the at least one feedthrough pin (202), and the second component is formed by a header core (205, 206) of the header, wherein particularly the header core (205, 206) is one of a socket, a two-pole socket, a four-pole socket, or wherein the first component is formed by a first header core of the header and the second component is formed by a second header core of the header, or wherein the at least one pin (202) forms the first component, and the second component is an interconnect device (207), particularly a 3D molded interconnect device (MID), that is particularly configured to connect the at least one pin (202) to a header core (205, 206), or wherein the first component is an interconnect device (207), particularly a 3D molded interconnect device (MID), that is particularly configured to connect the at least one pin (202) to a header core (205, 206), and wherein the second component is a header core (205, 206) of the header (300). A method for manufacturing an implantable device, wherein at least one connection is made using nanowires. The method according to claim 14, wherein the at least one connection (30) is an electromechanical connection. The method according to claim 14 or 15, wherein the implantable device (1) comprises a first component and a second component (3, 4; 5, 7; 8, 5; 202, 203; 203, 200; 202, 204; 204, 205, 206; 202, 207; 207, 205, 206) which are connected by the at least one connection (30).

Description:
ENERGY-REDUCED AND AUTOMATABLE JOINING BY MEANS OF NANOWIRING FOR CONTACTING ELECTRICAL AND MECHANICAL COMPONENTS OF ACTIVE AND MONITORING IMPLANTS

The present invention relates to an implantable device comprising a nanowire-based connection, particularly an implantable pulse generator (IPG), an implantable cardioverter defibrillator (ICD), an implantable cardiac monitor (ICM), or the like. Furthermore, the present invention relates to a corresponding method for providing such a connection in an implantable device.

Particularly, a subject matter of the present invention is the manufacture of an electromechanical connection of electronic components to each other, between printed circuit boards, between an electronic component and a printed circuit board, or between outer wiring ribbons and other outer wiring components, like feedthrough pins. Other configurations are also conceivable.

Regarding implantable devices, providing proper connections that are mechanically stable and particularly allow conducting of an electric current through the connection, often requires soldering or laser welding the respective connection.

However, it is desirable to provide connections between components of an implantable device that can be efficiently established during a manufacturing process and achieve a reliable long-lasting connection between the components to be joined, which is particularly important for implants that remain for longer time spans in an implanted state in the respective patient, so that electrical/mechanical connections are not allowed to fail.

Publications EP3592697A1, EP3593102A1, EP3592696A1, EP3711462B1,

DE102018122007A1, WO21185617A1, WO21 185616A1, WO21185619A1, WO21185618A1, WO21259607A1, W022012903A1 provide technical background to the generation of nanowire-based connections.

Based on the above, the problem to be solved by the present invention is to provide an implantable device and a corresponding method that achieves a reliable and efficient connection between components of the device that ideally also allows to conduct an electrical current between the components via the connection.

This problem is solved by an implantable device having the features of claim 1 and by a method having the features of claim 14. Preferred embodiments of these aspects of the present invention are stated in the corresponding dependent claims and are described below.

According to claim 1 an implantable device is disclosed, comprising a first component, and a second component, wherein the first and the second component are joined to one another via a connection comprising metallic nanowires.

Thus, the present invention allows to substitute complex procedures such as laser welding by nanowire-based connections. Furthermore, the components to be joined can be pre- processed to obtain a nanowire coating so that making the connection can be accomplished by simply pressing the components onto one another, which corresponds to a significant simplification compared to a usual welding process (directly from z-axis assembly to joining process). Furthermore, using nanowires provides an alternative material-locking connection, can be accomplished with a sufficient speed (depending on the process parameters) and yields a minimization of the process risk related to joining components of an implantable device. Furthermore, a corrosion of the joining surfaces can be prevented and the nanowirebased connection is sensible for mechanical connections and/or electromechanical connections, such as mounting an antenna to a housing of the implantable device. Furthermore, the nanowire-based connection can also be advantageously applied to an internal structure of a pacemaker, for instance. Furthermore, apart from the required nanowire lawn on the respective surface, no extra parts are typically needed to make the connection and the production costs can be reduced with respect to known techniques such as soldering or laser welding. The necessary joining forces can be kept low enough so that no damage occurs to sensitive components. Furthermore, it is possible to bond planar surfaces as well as curved surfaces to one another. Adhesion to non-metallic surfaces is also conceivable. Further, a minimal size for manufacturing requirements/component design is merely limited by the requirement to hold down/press down connection partners for handling purposes and for forming the respective connection. Furthermore, advantageously, nonvalue-adding activities can be avoided through appropriate material selection, e.g., by applying nanowires directly to suitable surfaces without applying extra-capable metallization. The present invention enables high manufacturing tolerances and allows to conduct nanowiring at component level. Moreover, nanowiring as well as making nanowirebased connections can be automated.

According to a preferred embodiment of the implantable device, the latter is an implantable medical device such as an implantable pulse generator (IPG) (e.g. of a cardiac pacemaker), an implantable cardioverter defibrillator (ICD), an implantable cardiac monitor (ICM). Other types of active implantable devices or components of an implantable device are as well suitable, as for instance a neurostimulator, a medication pump, a stimulation electrode, etc.

According to a preferred embodiment of the present invention, the nanowires are generated by a galvanic process. Particularly the so-called NanoWiring process is preferably used, which is a process for creating a large number of wires on a surface by means of a galvanic process. The nanowires have a length in the range of 100 nm to 100 pm and a diameter of 10 nm to 10 pm. The term diameter refers to a circular base, but the nanowires can also have an oval or polygonal base surface. The process comprises the following process steps:

- Placing a film on a surface, wherein the film has a plurality of continuous pores in which the nanowires can be grown, depositing an agent for providing an electrolyte on the film, and electrolytically growing the plurality of nanowires from the electrolyte.

On the material on which the nanowires are to be created, there is a porous polycarbonate (PC) film. The pores in the film form the cavities in which the nanowires grow. The thickness of the film determines the length of the nanowires and the diameter of the pores determines the thickness of the nanowires. The pores can be created by an ion track etching process. For this purpose, the film is first treated with ions (ions with high mass and electrical charge, which makes them easy to accelerate electrically), after which the pores are enlarged to the desired diameter in an etching process.

On top of the PC film is a sponge that has been soaked in an electrolyte solution. The material to be coated with nanowires, the PC film and the sponge are located in a drawer, which is inserted into a pressing tool. The contact pressure is required, on the one hand, to prevent slippage of the film and to compensate for unevenness in the micro-area of the material surface. The underside of the die serves as the cathode and the substrate as the anode. Applying a voltage between the electrodes triggers the galvanic process. Once the pores are filled with the material, the sponge is removed mechanically and the PC film is removed wet-chemically. Since polycarbonate is used as the film material, it can be dissolved chemically without leaving any residue. This means that the film can be removed without the risk of damaging the nanowire structure.

According to a preferred embodiment of the implantable device according to the present invention, the nanowires are formed out of one of the following metals or comprise one of the following metals: copper (Cu), platinum (Pt), gold (Au), Iridium (Ir), Ruthenium (Ru), Zirconium (Zr).

Furthermore, according to a preferred embodiment of the implantable device, each metallic nanowire comprises a length in the range from 100 nm to 100 pm, and/or a diameter in the range from 10 nm to 10 pm.

Furthermore, according to a preferred embodiment of the implantable device, the connection comprises a coating of a surface of the first component with first metallic nanowires and a coating of a surface of the second component with second metallic nanowires, wherein the first and the second metallic nanowires are interlocked with each other. Preferably, the connection can be generated by pressing the two nanowire coated surfaces onto one another with a pressure in the range from 1 to 1000 MPa, in particular 15 MPa to 200 Mpa over a time period in the range from 0.06 to 300 s, in particular 0.06 s to 60 s. Preferably, a temperature of the surfaces to be joined is about 20°C (room temperature). This process is also known as “KlettWelding”. Advantageously, the joining process can be conducted at room temperature. In contrast to a brazing or welding process, the components do not expand thermally, which ensures stress-free joining. In addition, the process can be automated very well by simple means, since the joining time is just 0.06 s to 60 s long. A shear strength of up to 20 MPa can be achieved with this process.

Particularly, the joining of the components is based on two different modes of action. On the one hand, the contact pressure causes the wires to deform and form a kind of mesh. This is very similar to the way a Velcro fastener works. On the other hand, the contact pressure causes a deformation of the nanowires in the area of the bonding plane. The surfaces of the nanowires are thus spaced apart by an order of magnitude of the atomic distance. Through space change processes as well as through cohesion and adhesion forces between the atoms, a stable bond is achieved. When additional thermal energy is added to the joining process yielding a temperature of the surfaces to be joined in the range from 170°C to 240°C, the process is also denoted as “Klettwelding+” process. Application of thermal energy to the joining process allows to reduce the pressure, which is now preferably in the range from lOMPa to lOOMPa. The contact pressure can thus be reduced and particularly lies between 10 MPa and 100 MPa. The shear strength is significantly increased and is at a maximum of typically 65MPa. Despite the joining temperature of a maximum of 240 °C, the joint is significantly less stressed than comparable welding or soldering processes, since, for example, soft soldering (lead-free solder) is only possible at 221 °C and brazing at 450 °C. The application of thermal energy reduces the place change processes while cohesive and adhesion forces are further enhanced. The process can thus be classified as a diffusion welding process.

Furthermore, according to a preferred embodiment of the implantable device, the connection comprises a galvanic coating of a surface of the first component with said metallic nanowires, wherein a surface of the second component is devoid of a galvanic coating of nanowires, and wherein the metallic nanowires and the surface of the second component are bonded to one another by a cold welding process. Cold welding is a solid-state welding process in which joining takes place without fusion or heating at the interface of the two parts to be welded. Alternatively, the connection comprises a galvanic coating of a surface of the second component with said metallic nanowires, wherein a surface of the first component is devoid of a galvanic coating of nanowires, and wherein the metallic nanowires and the surface of the first component are bonded to one another, as well based on a cold welding process.

Particularly, here, the said connection can be generated by pressing the nanowire coated surface onto the surface that is free of nanowires with a pressure in the range from 10 MPa to 100 MPa over a time period in the range from 120 s to 300 s. Preferably, a temperature of the surfaces to be joined is in the range from about 170°C to 240°C. This process is also denoted as “KlettSintering” process. Here, two components are joined together with only one of the two surfaces having nanowires coated thereon. After positioning, the two surfaces of the components are pressed together under pressure and temperature (as in “KlettWelding+”). The mode of action of the joining process is thus also based on the approach of the surface of the nanowires to the surface of the opposing component, so that diffusion processes take place at the atomic level. Thus, “KlettSintering” can also be classified as a diffusion welding process. It is to be noted that the usual sintering is primarily used to produce layers or entire workpieces and not to join components as described herein.

Furthermore, according to a preferred embodiment of the implantable device, the connection comprises an intermediate film having a first side and a second side facing away from the first side, wherein the first and the second side each comprise a galvanic coating of metallic nanowires, wherein the metallic nanowires grown on the first side are bonded to the surface of the first component, and wherein the nanowires grown on the second side are bonded to the surface of the second component.

Particularly, here, the connection can be generated by pressing the surfaces of the first and second component onto one another with the intermediate film arranged between said surfaces. The nanowires protruding from the respective side of the intermediate film then bond to the opposing surface of the first or second component. Particularly, the surfaces are pressed onto one another with a pressure in the range from 10 MPa to 100 MPa over a time period in the range from 120 s to 300 s. Preferably, a temperature of the surfaces to be joined is in the range from about 170°C to 240°C. This process is also denoted as “KlettSintering+” process. Here, neither surface has to be coated with the nanowires. Instead, a thin film is used which has the nanowires grown on both sides. In a preferred embodiment of the present invention, the film is about 10 pm to 30 pm thick, preferably about 20 pm thick. The joining parameters are the same as for “KlettSintering”. Thus, “KlettSintering+” can also be classified as a diffusion bonding process. One advantage of the above-described diffusion bonding processes compared to a normal diffusion bonding process is that in normal diffusion bonding, the two surfaces to be joined have to be prepared in advance. This includes, for example, polishing work to obtain a surface that is as smooth as possible. Only in this way can they be brought to the necessary distance so that the diffusion processes can take place. Through the use of nanowires this preparation can be omitted, as the nanowires are long enough to compensate for unevenness and to enable a two-dimensional connection.

Furthermore, according to a preferred embodiment of the implantable device, the connection comprises a galvanic coating of a surface of the first component with metallic nanowires and/or a galvanic coating of a surface of the second component with metallic nanowires so as to preferably generate an electrical contact between the surfaces, wherein the connection further comprises an intermediate adhesive layer for connecting the two opposing surfaces to one another.

Particularly, here, the connection can be generated by pressing the surfaces of the first and second component onto one another with the intermediate adhesive layer arranged between said surfaces. The nanowires protruding from one or two of the surfaces generate an electrical connection between the surfaces. Particularly, the surfaces are pressed onto one another with a pressure in the range from 1 MPa to 5 MPa over a time period in the range from 0.06 s to 300 s. Preferably, a temperature of the surfaces to be joined and of the adhesive layer is in the range from 20°C to 150°C. This process is also known as “KlettGluing” process. Here, the mechanical bond between the surfaces is not created by the nanowires, but by the use of an adhesive. In this process, the nanowires only serve to create an electrical connection between the two surfaces. The joining parameters and the resulting shear strengths depend only on the adhesive.

Furthermore, according to a preferred embodiment of the implantable device, the connection comprises an intermediate film having a first side and a second side facing away from the first side, wherein the first and the second side each comprise a galvanically grown coating with metallic nanowires, wherein the metallic nanowires grown on the first side are bonded to the surface of the first component via an adhesive layer, and wherein the nanowires grown on the second side are bonded to the surface of the second component via an adhesive layer.

Particularly, here, the connection can be generated by pressing the surfaces of the first and second component onto one another with the intermediate film arranged between said surfaces. The nanowires protruding from the respective side of the intermediate film then bond to the opposing surface of the first or second component via the respective adhesive layer. Particularly, the surfaces are pressed onto one another with a pressure in the range from 10 MPa to 100 MPa over a time period in the range from 120 s to 300 s. Preferably, a temperature of the surfaces to be joined is in the range from about 170°C to 240°C.

In case an additional film is used, the process is also denoted as “KlettGlueing+” process. In the gluing process without an additional intermediate film, at least one of the surfaces of the two components / joining partners is provided with a coating of nanowires. In contrast “KlettGlueing+” uses an additional film with both nanowire coatings being bonded to the respective opposing surface by an adhesive. Due to the use of adhesives, both processes can also be classified as gluing processes.

Furthermore, according to a preferred embodiment of the implantable device, the respective adhesive layer is formed by an anaerobic adhesive, preferably a dimethacrylate ester-based adhesive. Particularly, such anaerobic adhesives belong to the group of chemically curing adhesives and their setting only begins in the absence of oxygen and in the presence of metal ions. Due to this, such adhesives are often used for screw locking or shaft-hub connection (a suitable product that can be used in the framework of the present invention as an adhesive is Loctite 243 of Henkel adhesives)

According to a preferred embodiment, the connection is an electrically conducting connection. Since the connection also allows the transfer of mechanical forces from one component to the other component, this connection can also be denoted as an electromechanical connection.

Furthermore, according to a preferred embodiment of the implantable device, the connection forms a liquid-tight sealing between the first and the second component so as to prevent penetrations of liquids through the sealing (e.g. into a housing of the implantable device).

Furthermore, according to an embodiment of the implantable device, a negative contact of a welding protector for the implant can be connected to the implant.

In each of the following embodiments, the implantable device can be - among other implants - an implantable pulse generator (IPG) such as a cardiac pace maker or an implantable cardioverter defibrillator (ICD).

According to a preferred embodiment of the implantable device, the first component is a housing of the implantable device, and the second component is an X-ray marker that is bonded to the housing via said connection (said connection thus serves for mounting an X- ray detection). Other members can be bonded in the same way to the housing,

In a further preferred embodiment of the implantable device, the first component is a shell of a housing of the implantable device, particularly a half shell, wherein the second component is a shell of the housing, particularly a half shell, and wherein said connection closes the shells of the housing hermetically (i.e. the connection connects the two shells, particularly half shells, hermetically to one another. Thus, the invention achieves pressing housing to housing, e.g. as a substitute for a welded circumferential seam for the assembly of two housing halves of an implant. In this embodiment, nanowires are to be provided on the contact surfaces of the half shells so that they can be joined by assembly. Particularly, in the above, the shells can be titanium shells and the half shells can be titanium half shells. Furthermore, according to a preferred embodiment, said connection closes a battery cover of the implantable device hermetically.

In a further preferred embodiment of the implantable device, the implantable device comprises a capacitor, particularly a high voltage capacitor, comprising an electrical feedthrough pin forming the first component and a circuit arranged on a substrate, particularly in form of a printed circuit board, forms the second component, wherein said connection connects the electrical feedthrough pin to the circuit, particularly to the surface of a contact member of the circuit.

Furthermore, according to a preferred embodiment of the implantable device, the implantable device comprises a printed circuit board forming the first component, the surface of the first component forming an electrical contact of the printed circuit board, and wherein the second component is an electronic component (i.e., said connection electrically connects the electronic component to the printed circuit board).

According to a preferred embodiment of the implantable device, the implantable device comprises a dump resistor forming the first component and a printed circuit board forming the second component. Particularly, the dump resistor comprises an electrical contact member comprising a surface that is connected via said connection to a surface of an electrical contact member of the printed circuit board. The other electrical contact member can be connected to another electrical contact member of the printed circuit board in the same fashion.

According to yet another preferred embodiment of the implantable device, the implantable device comprises a housing comprising an electrical feedthrough comprising at least one pin (particularly nail head pin) for providing an electrical connection to a header connected to the housing, wherein particularly the header is configured for providing an electrical connection to at least one electrode lead, and wherein the at least one pin is electrically connected to an electronic module enclosed by the housing of the implantable device, and wherein the at least one pin forms the first component, and the second component is an electrically insulating sleeve (e.g., out of a ceramic material) that surrounds the at least one pin and is connected to the housing, wherein particularly said connection connects a surface of a head of the pin to a surface of the sleeve.

In a further preferred embodiment of the implantable device, the at least one pin is surrounded by an electrically insulating sleeve (e.g., out of a ceramic material) that forms the first component, and the second component is formed by the housing, wherein particularly said connection connects a bottom surface of the sleeve to a circumferential surface of the housing.

In a further preferred embodiment of the implantable device, the at least one pin forms the first component, and the second component forms part of the header, wherein particularly the second component is an external wiring arranged outside the housing (e.g. an electrically conducting band) for connecting the at least one pin to a component of the header.

In a further preferred embodiment of the implantable device, the first component is formed by an external wiring connected to the at least one feedthrough pin, and the second component is formed by a header core of the header, wherein particularly the header core is one of: a socket, a two-pole socket, a four-pole socket. Particularly, these sockets are configured to receive a plug of an electrode lead, respectively.

In a further preferred embodiment of the implantable device, the first component is formed by a first header core of the header and the second component is formed by a second header core of the header. Particularly, the first and/or second header core is a socket.

In a further preferred embodiment of the implantable device, the at least one pin forms the first component, and the second component is an interconnect device, particularly a 3D molded interconnect device (MID), that is particularly configured to connect the at least one pin to a header core.

In a further preferred embodiment of the implantable device, the first component is an interconnect device, particularly a 3D molded interconnect device (MID), that is particularly configured to connect the at least one pin to a header core, and wherein the second component is a header core of the header.

According to a preferred embodiment, the at least one pin of the above-described electrical feedthrough comprises a head that is flush with an outside of the housing.

Furthermore, according to yet another preferred embodiment, the external wiring is a flexible connector comprising a flat flexible substrate and at least one conductive track arranged thereon.

Furthermore, according to a preferred embodiment, the first component can be a lug connected to a connector and the second component an electrical contact member (e.g. of a PCB) that is connected via said connection to the lug.

Furthermore, according to a preferred embodiment, the first component is a battery of the implantable device and the second component is a circuit of the implantable device.

Furthermore, according to a preferred embodiment, the first component is a battery of the implantable device and the second component is a circuit of the implantable device.

Furthermore, according to a preferred embodiment, the first component is an antenna of the implantable device and the second component is a housing of the implantable device.

Further, said nanowire-based connection according to the present invention as claimed in claim 1 can also be used in other devices, for instance external devices, particularly as replacement for screw processes. Furthermore, electrodes can be connected to a supporting structure via said nanowire-based connection. The nanowire-based connection according to the present invention as described herein can also be used as an alternative for fractal coating, e.g. of electrical functional surfaces (e.g., ring electrode Pt/Ir, titanium housing of miniaturized implants such as leadless pacemaker). According to a preferred embodiment, the nanowires are made out of one of the following metals: copper (Cu), platinum (Pt), gold (Au).

Furthermore, according to a preferred embodiment, said external wiring can comprise or be formed out of suitable metals such as titanium (e.g. for feedthrough pins, and electrically conducting bands) and NiCoCrMo (particularly MP35N).

Furthermore, according to a preferred embodiment, electrically conducting bands, circuit substrates (e.g. PCB) and flexible connectors connected to feedthrough pins comprise or are formed out of niob (Nb).

Furthermore, the respective electrically conducting band connected to a circuit or tab can comprise nanowires, wherein the tab can comprise CuNi, and the band can comprise CuNi oder Ni. Particularly, a plate can be coated for CuNi tabs and cut afterwards.

Furthermore, 4-pole modules (4-pole connector sockets) can comprise NiCoCrMo (particularly MP35N). Here, the components are all located in the header of the implant, i.e. outside the titanium housing; the area is encapsulated with resin; the pacemaker electrodes are configured to be connected to the connector sockets, which conduct the electrical signals from ("sense") and to ("pace") the heart.

According to yet another aspect of the present invention a method for manufacturing an implantable device is disclosed, wherein at least one connection is made using nanowires.

Particularly, regarding the embodiments of the method it is also referred to the abovedescribed processes and their parameters for making a nanowire-based connection that also apply to the embodiments of the method according to the present invention as described herein.

In a further preferred embodiment of the method, the at least one connection is an electromechanical connection. Furthermore, according to a preferred embodiment of the method, the implantable device comprises a first component and a second component which are connected by the at least one connection.

Further, according to a preferred embodiment of the method, a galvanic coating of metallic nanowires is grown on a surface of the first component, and a galvanic coating of metallic nanowires is grown on a surface of the second component, wherein the first and the second metallic nanowires are interlocked with each other by pressing the two surfaces against one another (see also above, particularly regarding pressure, time and temperature of the process).

According to yet another preferred embodiment of the method, a galvanic coating of metallic nanowires is grown on a surface of the first component, wherein a surface of the second component is left devoid of a galvanic coating of nanowires, and wherein the surface of the first component with the metallic nanowires thereon and the surface of the second component are pressed against one another to bond the two surfaces to one another. Alternatively, a galvanic coating of metallic nanowires is grown on a surface of the second component, wherein a surface of the first component is left devoid of a galvanic coating of nanowires, and wherein the surface of the second component with the metallic nanowires thereon and the surface of the first component are pressed against one another to bond the two surfaces to one another (see also above, particularly regarding pressure, time and temperature of the process).

According to a further preferred embodiment of the method, an intermediate film having a first side and a second side facing away from the first side, wherein the first and the second side each comprise a galvanic coating of metallic nanowires, is provided between the surfaces of the first and the second component, and wherein the two surfaces are pressed against one another with the film therebetween to bond the two surfaces to one another (see also above, particularly regarding pressure, time and temperature of the process).

According to a further preferred embodiment of the method, a galvanic coating of nanowires is grown on the surface of the first component and/or on the surface of the second component, wherein the two surfaces are bonded to one another via an intermediate adhesive layer (see also above, particularly regarding pressure, time and temperature of the process, as well as suitable adhesives).

Furthermore, according to a preferred embodiment of the method, an intermediate film having a first side and a second side facing away from the first side is provided between the surfaces of the first and second component, wherein the first and the second side of the film each comprise a galvanic coating of metallic nanowires, wherein the metallic nanowires grown on the first side are bonded to the surface of the first component via an adhesive layer, and wherein the nanowires grown on the second side are bonded to the surface of the second component via an adhesive layer (see also above, particularly regarding pressure, time and temperature of the process).

In the following, preferred embodiments of the present invention as well as further features and advantages of the present invention are described with reference to the Figures, wherein

Fig. 1 shows an embodiment of an implantable device according to the present invention, wherein an electrical feedthrough pin is connected via nanowirebased connections to a housing of the implantable device; particularly different configurations of said connection are shown,

Fig. 2 shows a further embodiment of an implantable device according to the present invention, wherein an electrical feedthrough pin is connected via an electrically conducting band to a header core using nanowire-based connections,

Fig. 3 shows a further embodiment of an implantable device according to the present invention, wherein the header comprises an interconnect device, particularly an MID, that connects an electrical feedthrough to header cores of the header of the implantable device, wherein connections between feedthrough, interconnect and header cores can be nanowire-based connections, Figs. 4A-4B show a further embodiment of an implantable device according to the present invention, wherein an electrical feedthrough pin is connected via an electrically conducting band to a header core of a header of the implantable device,

Figs. 5 show a modification of the embodiment of Fig. 4, wherein here a flexible connector is used to connect feedthrough pins to a curved header core,

Figs. 6A-6B show external wiring of two-pole header cores connected to feedthrough via a printed circuit board; header cores are connected to PCB via nanowirebased connections; PCB is connected via nanowire-based connection to feedthrough pins,

Fig. 6C shows contacting a cylindrical 4-pole header core by resistance welding an electrically conducting band to the header core wherein the band is configured to provide a nanowire-based connection to the header core via the resistance welded seams, and

Fig. 7 shows an embodiment of an implantable device, wherein battery and capacitor are connected to a printed circuit board via nanowire-based connections.

Fig. 1 shows an embodiment of an implantable device 1 (e.g. an implantable pulse generator (IPG) or an implantable cardioverter defibrillator (ICD)) according to the present invention, having a first component, here preferably in form of a feedthrough pin 202 of an electrical feedthrough 201 of a housing 200 of the implantable device 1, wherein the pin 202 is connected to a second component via a connection 30, wherein the second component is a ceramic sleeve 203 that electrically insulates the pin 202 with respect to the housing 200. The connection 30 comprises metallic nanowires 31 and - as shown in the detail of Fig. 1 - the connection 30 can have different preferred configurations. According to a first preferred embodiment, the pin 202 comprises a surface 10a, that is preferably formed by a circumferential bottom side of a head of the pin, which surface 10a faces a surface 20a of the sleeve 203, wherein both surfaces 10a, 20a can be coated with nanowires 31 (e.g. as described herein) and pressed onto one another to generate connection 30. Optionally, according to a second embodiment, an adhesive layer 32 can be arranged between the two surfaces 10a, 20a to bond the two surfaces 10a, 20a by means of the adhesive (see above) to one another. According to a third embodiment, one of the nanowire coatings 31 can be omitted so that one of the surfaces 10a, 20a is free of nanowires initially. Also, here, the connection 30 can be made with or without adhesive layer 32. Furthermore, instead of coating the surfaces 10a, 20a, a film 33 can be placed between the surfaces 10a, 20a, wherein now the film 33 is coated on both sides 33a, 33b of the film 33 with a nanowire coating 31. The surfaces 10a, 20a are now pressed against each other and connect via the intermediate double-sided nanowire film 33. Also, here, an adhesive layer 32 can optionally be used between each surface 10a, 20a and the corresponding opposing surface 33a, 33b of the film. Herein, these connections 30 are briefly denoted as nanowire-based connections 30 or simply as connections 30. Each time a nanowire-based connection 30 is mentioned herein, this connection can be designed according to one of these embodiments that are also described in detail further above. Also, all connections described herein can be combined in any sensible way. For instance, apart from the nanowire-based connection 30 between pin 202 and sleeve 203, a further nanowire-based connection 30 can be provided between a circumferential bottom surface of sleeve 203 and a circumferential opposing surface of housing 200 of the implantable device 1. Particularly, the implantable device 1 comprises a titanium housing 200, wherein preferably the housing 200 comprises five electrical feedthrough pins 202 which can be formed as nail head pins 202 and may be flush with the housing 200. In Fig. 1 all surfaces that are connected to one another via nanowires 31 are preferably planar surfaces. The connection between the (e.g. titanium) housing 200 (or a flange) and ceramic sleeve 203 and between feedthrough pin 202 and ceramic sleeve 203 are provided to create a hermetically sealed and electrically insulating connection between housing 200 and feedthrough pin 201. The pins 201 establish a hermetically sealed connection through the housing 200 between the electronics inside and the area outside the housing. Fig. 2 shows a further embodiment of an implantable device 1 (e.g. an IPG or ICD) comprising an external wiring to connect a feedthrough pin 202 via an electrically conducting band 204 to a header core (here a two-pole header core) 205. As indicated in the cross-section A-A of Fig. 2, electrically conducting band 204 is connected via a nanowirebased connection 30 to pin 202 of feedthrough 201, namely to a planar top side of the head of pin 202, and via a further nanowire-based connection 30 to cuboidal shaped header core 205 which comprises a rectangular cross-section and planar wall for connecting to the band

204.

As before, the nanowire-based connection 30 can be one of the configurations described herein and further explained in conjunction with Fig. 1 above, i.e. nanowires 31 are provided on both opposing surfaces of header core 205 and band 204 or only on one of these surfaces. Alternatively, a film 33 as described above can be used and arranged between header core 205 and band 204. Optionally, an adhesive layer can be arranged between each two opposing surfaces, e.g., between header 205 and band 204 or between a nanowire coated film and the respective surface of header 205 and band 204 (see also above). As can also be seen in the lowermost cross-section B-B of Fig. 2, due to a certain length of the nanowires 31 a curvature of the essentially cylindrical 4-pole header core 206 can be compensated for to a certain degree. Here, the nanowires can be provided on the electrically conducting band 204’ and/or on the header core 206, too. Also, here, adhesive layer(s) and/or an intermediate nanowire coated film may be used. Based on the nanowires, an efficient and reliable connection between an electrical feedthrough 201 comprising e.g. nail head feedthrough pins 202 and the contacts of the header cores (2-pole female connectors 205 and 4-pole female connector 206) can be established. The involved components are all located in the header of the implant, i.e. outside the titanium housing 200. Particularly, the area, i.e., the header cores

205, 206 and wiring 204 is encapsulated with resin to form the header. The pacemaker electrodes are configured to be connected to the connector sockets 205, 206, which conduct the electrical signals from ("sense") and to ("pace") the heart. The titanium housing can comprise e.g. 9 feedthrough pins 202 on the lateral circumferential shoulder of the titanium housing 200. Fig. 3 shows a further embodiment of an implantable device 1 according to the present invention relating to an external wiring of the device 1. Particularly, the implantable device 1 can be an IPG or an ICD, wherein here nanowire-based connections 30 are made between an electrical feedthrough 201 (e.g. nail head feedthrough pins 202), a printed circuit board or interconnect device 207, particularly a 3D molded interconnect device (MID), and the contacts of the header cores, particularly 2-pole female connector 205 and 4-pole female connector 206. The components are all located in the "header" of the implant, i.e., outside the housing 200; the area, i.e., the header cores 205, 206 and printed circuit board 207, is encapsulated with resin to form the header; the pacemaker electrodes are configured to be connected to the connector sockets 205, 206, which conduct the electrical signals from ("sense") and to ("pace") the heart. Particularly, the housing 200 can be a titanium housing

200 with e.g. nine electrical feedthrough pins 202 on the top of the housing 200, two 2-pole female header cores 205 with two planar contact points, and a 4-pole female connector 206 with four curved contact points. Particularly, the MID 207 comprises contact surfaces 208 that can each connect via a nanowire-based connection to a surface of an associated pin 202 of the feedthrough 201, wherein nanowires can be provided on the surfaces of pins 202 and/or on the surfaces of contact points 208 of the MID 207. As described before, optional adhesive layers can be provided between the surfaces of contact points 208 and pins 202. Generally, all nanowire-based connections described herein can be applied to pins 202 and contacts 208. The headers 205, 206 now connect with their contact point surfaces 205a, 206a to corresponding contact point surfaces 209, 211 and 210 of the MID 207 as shown in Fig. 3, wherein each pair of opposing contact point surfaces 205a, 209, 206, 210, 205a, 211 can comprise nanowires on both sides or just on one side. Intermediate adhesive layers and films can also be used as described in detail above.

Fig. 4A shows a further embodiment of an implantable device 1 (e.g. an IPG or ICD) according to the present invention. The device 1 comprises an electrically conducting band 204 that provides an electrical connection between a pin 202 of an electrical feedthrough

201 of a housing 200 of the device 1 and a header core 206, here in form of a 4-pole female connector (also 2-pole headers may be connected in this way). Fig. 4B shows a cross- sectional view of the device of Fig. 4A, wherein band 204 is connected laterally to the pin

202 via a nanowire-based connection 30 that is preferably established according to the embodiments described herein in detail, i.e., both surfaces of the pin 204 and of the band 204 can be provided with a nanowire coating or merely just one of them. Furthermore, the nanowire coatings can also be arranged on an intermediary film arranged between the pin 202 and the band 204, wherein the film may carry two nanowire coatings on each side that can connect to the pin 202 on one side and to the band 204 on the other side. Optionally, an adhesive layer can be provided between each opposing surface involved in the connection as described in detail above (cf. also Fig. 1). Furthermore, as indicated in Fig. 4B, the band 204 is connected to a curved header core 206 (here 4-pole female connector), wherein also here the nanowires can be provided an both surfaces, i.e., on the header core 206 and on the band 204 or only on one of the two surfaces that shall be connected. In the same manner a film with nanowire coatings on both sides may be provided between the two surfaces to be connected instead. Again, optionally, an adhesive layer may be provided between each two opposing surfaces of the connection 30 between header core 206 and band 204 as described above. Particularly, the components involved in the connections 30 are all located in the header of the implant 1, i.e. outside the housing 200; the header cores 205, 206 and the external wiring (band) 204 are encapsulated with resin to form the header; the pacemaker electrodes are configured to be connected to the connector sockets 205, 206, which conduct the electrical signals from ("sense") and to ("pace") the heart. Particularly, the housing 200 can be a titanium housing, and the feedthrough pin 202 can be a nail head pin as nail head pins have the advantage that they have a head and thus a larger joining surface.

As shown in Fig. 5, generally, electrical connections can be made with a flexible connector 204. The flexible connector 204 can comprise multiple conductive tracks 240 arranged on a flexible substrate 241. Each conductive track 240 connects two opposing contact pads 242 that each comprise coating of nanowires 31 thereon. The flexible connector 204 can therefore be connected to corresponding contacts by pressing the nanowire coated pads 242 of the flexible connector 204 against opposing contact surfaces.

The advantage of this design is that the conductor 204 is flat, but due to slots 243 (e.g. cut with laser) formed in the substrate 241 adjacent the nanowire pads 242, the pads 242 with nanowires thereon can be easily pressed onto curved surfaces. Flexible connector as shown in Fig. 5 is therefore particularly suitable to be used as connecting conductor 204 in Figs. 4A, 4B since it can conform to the contour of the header core 206 (e.g. four-pole female connector). However, flexible connector 204 according to Fig. 5 may also be used inside the implant, i.e., in the interior space of the implant enclosed by its housing.

Fig. 6A and 6B show a further embodiment of an implantable device 1 comprising an external wiring to connect header cores 205, here in form of two-pole female connectors 205, to an electrical feedthrough 201 of a housing (not shown) of the device 1. However, the same technique may be used to connect 4-pole connectors to the feedthrough 201. The respective header core 205 can comprise an Au-coating 31a on Ti as substrate without an intermediate Ni layer. This Au-coating can be a nanowire coating. The header cores 205 can be connected to a printed circuit board (PCB) 212 via nanowire-based connections 30, and the PCB 212 in turn can be connected to pins of a feedthrough of the housing of the implant 1 via nanowire-based connections 30, too. However, the PCB 212 may also be connected to the feedthrough 201 without the use of nanowires 31. Particularly, the pins of the feedthrough 201 can be formed as nail head pins (not shown).

The components are all located in the header of the implant 1, i.e. outside its (e.g. titanium) housing; the area, i.e., the header cores 205 and PCB 212, are encapsulated with resin to form the header. Further, pacemaker electrodes are configured to be connected to the connector sockets 205, which conduct the electrical signals from ("sense") and to ("pace") the heart.

In order to connect the header cores 205 to the PCB 212, the nanowires can be coated onto the pads 31a and/or on the PCB 212 just as described before. Furthermore, also a film may be used for each header core 205 that provides two nanowire coatings facing away from one another to connect opposing surfaces, here of the respective header core 205 and the PCB 212. Again, optionally, an adhesive layer may be arranged between opposing surfaces that shall be connected to one another using nanowires. Ad indicated in Fig. 6C, in case a four-pole connector / header core 206 shall be connected to PCB 212, a wiring band / conductor 204 is preferably resistance welded to the header core 206 at to opposing ends, wherein a central region of the conductor 204 comprises nanowire coating 31a comprising Au nanowires.

Finally, Fig. 8 shows an application of the present invention to an internal wiring of an implantable device such as an IPG or an ICD. Particularly, a nanowire coating can be provided by growing nanowires on tabs 13, which are preferably CuNi tabs 13. However, other tab materials are also conceivable. With respect to internal wiring virtually everything inside the encapsulated housing 200 can be connected to one another based on nanowire connections as described herein.

Particularly, a battery 90 of the device 1 can be electrically connected to an electronic module 9 of the device 1 by means of a nanowire-based connection between tabs 13 of the battery 90 and printed circuit board 5. For this, the nanowires can be applied to the tabs 13 and the latter pressed on corresponding contacts on the printed circuit board 5 (of the electronic module 9). Thus, the electronic module 9 can be supplied with electrical energy via battery 90, so that the module 9 can provide therapy to the patient by pacing or shocking the heart of the patient.

Furthermore, the electronic module / circuit 9 can be connected to a capacitor 2 in the same fashion by having nanowires grown on the tabs 13 (e.g. CuNi tabs 13) of the capacitor 2 and pressing the nanowire tabs 13 against corresponding contacts of the printed circuit board 5. The capacitor 2 allows to generate higher voltages for shocks (in case of an ICD).

Furthermore, the implantable device 1 preferably comprises a dump resistor 8 to convert unneeded shock energy to heat. The dump resistor 8 can also be connected to the PCB 5 and circuit 9 thereon by having nanowires grown on the tabs 13 (e.g. CuNi tabs 13) of the dump resistor 8 and pressing these tabs 13 against corresponding contacts on the printed circuit board 5. Regarding the implantable device 1 of Fig. 7 the nanowires are preferably grown on said tabs 13 however, the respective nanowire-based connection can be established based on all other configurations of nanowire coatings, films with nanowire coatings and optional adhesive layers as described herein.