Assembly for a header, header and implant with the header, as well as a method for mounting a header

Description

[0001] The disclosure relates to an assembly for an electrode connection device (also called a header), an electrode connection device, an implant with the electrode connection device, and a method for mounting an electrode connection device on an implant. background

[0002] Currently, headers for active implants are constructed from many individual components. It is crucial that the components are precisely aligned before being cast in resin to form the header. This process is very complex.

[0003] Document US 2017 / 0266,451 A1 discloses a header with a modular implementation.

[0004] Document US 2017 / 0279,238 A1 reveals a header with a pre-built header module.

[0005] Another header is described in document WO 2009 / 009299 A1.

[0006] Document US 2007 / 0087637 A1 reveals a header with a contact socket assembly. Summary

[0007] The objective is to identify improved technologies for implants. In particular, the manufacturing of the electrode connection device should be simplified.

[0008] A component assembly for an electrode connection device of an implant according to claim 1, an electrode connection device according to claim 7, an implant according to claim 8, and a method for forming an electrode connection device on an implant according to claim 9 are disclosed. Further embodiments are the subject of dependent claims.

[0009] An assembly for an electrode connection device of an implant is provided. The assembly comprises a continuous receiving device for a connector. Furthermore, a first connection element is provided, which is arranged in a front region of the receiving device, wherein the first connection element has at least two flat side surfaces. Finally, a second connection element is provided, which is arranged in a rear region of the receiving device, wherein the second connection element has at least two flat side surfaces. The assembly is also at least partially enclosed by a plastic material, wherein a connection region of the first connection element is free of plastic, and a connection region of the second connection element is free of plastic. A positioning device is also formed at a rear end of the receiving device.

[0010] Furthermore, an electrode connection device for an implant is provided with an assembly disclosed herein.

[0011] The disclosure further includes an implant with an electrode connection device and an assembly.

[0012] The electrode connection device can also be called a connection head or header.

[0013] The flat side surfaces allow for a partially angular shape and enable easy gripping of the assembly (manually or automatically). This allows for automation of the manufacturing process.

[0014] As described above, the assembly is at least partially encased in a plastic. For example, the assembly can be partially overmolded with the plastic. The plastic can be a thermoplastic, such as polysulfone. A biocompatible casting resin can also be used. The plastic can provide the assembly with additional stability. This makes it possible to manufacture the assembly as a prefabricated component, which is then processed into an electrode connection device for an implant.

[0015] The plastic may contain a first guide for a first conductor for connection to the connection area of ​​the first connection element and / or a second guide for a second conductor for connection to the connection area of ​​the second connection element.

[0016] The first guide can be formed adjacent to the connection area of ​​the first connection element and / or the second guide can be formed adjacent to the connection area of ​​the second connection element.

[0017] The connection area of ​​the first (second) connection element allows for the connection of a first conductor (second conductor) to an implant from a plug inserted into the receiving device. The connection area of ​​the first and / or the connection area of ​​the second connection element can be designed as flat elements. Alternatively, the connection area of ​​the first and / or the connection area of ​​the second connection element can be circular and, for example, have a diameter of 1 to 5 mm. This provides a large welding surface for attaching the first or second conductor. In one embodiment, both the first and second guides are located adjacent to the respective connection areas. The guides allow the conductors to be connected to the respective connection areas without causing a short circuit.

[0018] It is possible to arrange the first and second connection elements offset from each other. In other words, the first and second connection elements are located on two different planes. This different arrangement makes it easier to connect the conductors to the connection elements without the conductors coming into contact with each other.

[0019] In one embodiment, the assembly can include an antenna, wherein the antenna has a U-shaped profile in an intermediate section formed between the first and second connection elements. This intermediate section can be narrower than the adjacent connection elements. Together with the U-shaped profile of the antenna, this forms a gripping recess for an automatic gripper.

[0020] The positioning device, formed at the rear end of the receiving device, can be angled and, for example, form a right angle to the receiving device. The positioning device can be made of plastic and, for example, be integral with the plastic coating of the assembly. When placing the assembly into a receiving device, the positioning device can be positioned on the housing of the implant to facilitate alignment. The positioning device can have a tapered end.

[0021] The assembly can include a further receiving device for another connector, wherein a third connection element is arranged in a front region of the further receiving device, and wherein a fourth connection element is arranged in a rear region of the further receiving device. The embodiments disclosed herein for the receiving device apply analogously to the further receiving device. Furthermore, the embodiments for the first and second connection elements apply analogously to the third and fourth connection elements.

[0022] According to another aspect, a method for forming an electrode connection device on an implant is disclosed. The method comprises the following steps: Providing the assembly disclosed above, arranging and securing a spring element in the receiving device, sealing openings of the receiving device with potting aids, attaching a first conductor to the first connecting element, attaching a second conductor to the second connecting element, arranging the assembly on a housing of the implant, connecting the first conductor to a feedthrough formed on a housing, connecting the second conductor to the feedthrough, arranging the assembly with the housing in a mold, filling the mold with a synthetic resin, after the synthetic resin has cured, removing the potting aids.

[0023] The procedure may include the following further steps: Arranging and attaching an antenna to the assembly, connecting the antenna to the feedthrough, the further steps are carried out before the assembly is placed on the housing.

[0024] Furthermore, it may be necessary to remove any excess resin after it has hardened, for example by grinding and / or polishing.

[0025] The mold can be a silicone mold.

[0026] The connector can have one or more plug contacts (e.g., pins) for connecting the conductors and / or the antenna.

[0027] The synthetic resin can be an epoxy resin. Epoxy resins are synthetic resins that contain epoxy groups. They are thermosetting resins (reactive resins) that can be reacted with a hardener and, if necessary, other additives to form a thermosetting plastic. Epoxy resins are polyethers with two terminal epoxy groups. The curing agents are reactants and, together with the resin, form a macromolecular plastic.

[0028] The resin can adhere directly to the implant housing, eliminating the need for an additional adhesive. In other words, the contact surface between the cured resin and the implant housing can be free of any adhesive. The implant housing can be made of titanium.

[0029] The electrode connector can be a header for an implantable pacemaker or an implantable cardioverter-defibrillator (ICD). In this case, the electrode connector serves to electrically connect one or more electrode leads to the implant.

[0030] The features disclosed in connection with the assembly and the electrode connection device can be applied analogously to the method and vice versa. Description of exemplary implementations

[0031] Exemplary embodiments are explained in more detail below with reference to the figures. These show: Fig. 1 a perspective view of an embodiment of an assembly for an electrode connection device, Fig. 2 a front view (upper section of Fig. 2 ) and a rear view (lower section of Fig. 2 ) of the assembly Fig. 1 , Fig. 3 the assembly according to Fig. 1 and 2 with potting aids, Fig. 4 the assembly according to Figs. 1 to 3 with an antenna and conductors, Fig. 5 the assembly according to Figs. 1 to 4 arranged on a housing, Fig. 6 the assembly according to Figs. 1 to 5 completely potted (with potting aids) and Fig. 7 the assembly according to Figs. 1 to 5 Completely potted (without potting aids).

[0032] In the following, the same reference symbols are used for identical components.

[0033] In the Figs. 1 to 7The individual steps for mounting an electrode connection device (header) onto an implant are shown. These steps are explained in more detail below.

[0034] Fig. 1 Figure 1 shows an assembly 1 (also referred to as a header core) with a first receiving device 2 for an electrode connector and a second receiving device 13 for another electrode connector. The first receiving device 2 has a front opening 6 through which the electrode connector can be inserted. The first receiving device 2 has a first section 3, a second section 4, and a third section 5. The diameter of the first section 3 is larger than the diameter of the second section 4. The diameter of the second section 4 is, in turn, larger than the diameter of the third section 5. In other words, the first receiving device 2 tapers stepwise from the front opening 6 to the end.

[0035] A first connecting element is formed between the first section 3 and the second section 4 (i.e., in a front region of the first receiving device 2). A second connecting element 8 is formed between the second section 4 and the third section 5 (in a rear region of the first receiving device 2). Both the first connecting element 7 and the second connecting element 8 have at least two flat side surfaces. This allows for easy gripping of the assembly 1 during assembly and enables automation of the assembly steps. In the illustrated embodiment, the first connecting element 7 and the second connecting element 8 are essentially cuboid in shape. The second connecting element 8 has a chamfered edge 17, which serves to save material and to ensure proper flow of the epoxy resin. A recess 12a is formed in the plastic coating on the rear side of the first connecting element 7.A rear opening 12b is formed on the rear side of the second connecting element 8.

[0036] The assembly is partially enclosed by a plastic 11. In the illustrated embodiment, the assembly is partially overmolded with polysulfone. Recesses for a first contact surface 9 and a second contact surface 10 are formed in the plastic 11. The first and second contact surfaces are circular. Adjacent to the first and second contact surfaces 9 and 10, a guide 16 is formed. The guide 16 serves to receive a connecting element (e.g., a wiring strip). The guides on the contact surfaces prevent connecting elements from different contact surfaces from touching each other.

[0037] The second receiving device 13 is constructed analogously to the first receiving device 2. For the sake of clarity, the components of the second receiving device (an opening, the three stepped tapered sections, and the two connection elements) are not labeled. The second receiving device also has two contact surfaces (third contact surface 14 and fourth contact surface 15) for connections. Guides are again formed adjacent to the contact surfaces.

[0038] At one end of the second receiving device, a positioning device 18b is formed, which is designed as a pin with a tapered end. When mounting the assembly 1 onto a housing 29 (see Figure 1), the positioning device 18b is formed. Fig. 5The pointed end of the positioning device 18b can be inserted into a receptacle in the housing to facilitate the precise alignment of the assembly on the housing. However, the assembly can also be manufactured without the positioning device 18b.

[0039] Positioning pins 18a are formed on one underside of the assembly (see below). Fig. 2 The positioning pins can be arranged in corresponding receptacles when mounting the assembly on the implant housing. The illustrated embodiment shows two positioning pins, but other numbers of positioning pins are possible.

[0040] The first receiving device 2 and the second receiving device 13 each have a spring sleeve and a connector receptacle. The first receiving device 2 and the second receiving device 13 can be configured as IS-1 connectors.

[0041] A spring element 20 is arranged in the first receiving device 2 and attached there (left side of Fig. 3 The recess 12a in the plastic is used to weld the spring element 20, located inside the first receiving device 2, into the first connecting element 7 by means of resistance welding. Similarly, another spring element is arranged and attached in the second receiving device 13 (not shown). The openings of the assembly 1 are then closed and sealed with potting compounds 21, 22, 23 (right side of Fig. 3 ).

[0042] In Fig. 4 A further assembly step is shown. A wire strip 24 is attached to the third contact surface 14 (e.g., welded). At its rear end, the wire strip 24 has a wire strip connector 25, which is connected to a pin contact of a feedthrough 30 (see figure). Fig. 4) can be connected and, for example, plugged onto the pin contact. Further wire strips are connected to the other contact surfaces 9, 10, 15.

[0043] An antenna 26 is attached to the assembly 1. The antenna 26 partially surrounds the first section 3 of the first receiving device 2 and is clipped to it. In an area between the first connecting element 7 and the second connecting element 8, the antenna 26 has a U-shaped section 27. This forms a grip recess that can be used, for example, with an automated gripper to hold and transport the assembly. An antenna connector 28 is provided at a rear end of the antenna for connection to the feedthrough 30.

[0044] The assembly with the wire strips and the antenna is then arranged in a mold (e.g., a silicone mold) (not shown). The wire strip connectors and the antenna connector 28 are inserted onto corresponding pins of the feedthrough 30 and connected to the pins (e.g., welded). The mold is closed and filled with a synthetic resin 31 (e.g., epoxy resin). This creates a mold of the electrode connection device (see figure). Fig. 6 ).

[0045] The casting aids 21, 22, 23 are removed and any excess resin is removed from the outer surfaces, e.g. by grinding and / or polishing. The implant with the electrode connection device is now fully assembled ( Fig. 7 ).

[0046] The assembly / electrode connection device can offer the following advantages: No penetration of resin and / or other particles into the first (and possibly second) receiving device, therefore no rework is required; insulation distances of the wire strips are predetermined by the assembly design, thus reducing or even eliminating the risk of an electrical short circuit; the design enables automated manufacturing of the electrode connection device; compared to previously known manufacturing methods, manufacturing steps are eliminated, resulting in a reduction of manufacturing time.

[0047] The features disclosed in the description, claims and figures may be relevant for the realization of embodiments both individually and in any combination with one another. Reference symbol list:

[0048] 1 Assembly 2 First receiving device 3 First section of the first receiving device 4 Second section of the first receiving device 5 Third section of the first receiving device 6 Front opening 7 First connection element 8 Second connection element 9 First contact surface 10 Second contact surface 11 Plastic 12a Recess 12b Rear opening 13 Second receiving device 14 Third contact surface 15 Fourth contact surface 16 Guide 17 Beveled edge 18a Positioning pins 18b Positioning device 20 Spring element 21 First potting compound 22 Second potting compound 23 Third potting compound 24 Wire strip 25 Wire strip connection 26 Antenna 27 U-shaped section of the antenna 28 Antenna connection 29 Housing 30 Feedthrough 31 Resin

Claims

1. An assembly (1) for an electrode connection device of an implant, comprising: - a continuous receiving unit (2) for a plug; - a first connecting element (7), which is arranged in a front region of the receiving unit (2), wherein the first connecting element (7) includes at least two flat lateral surfaces; and - a second connecting element (8), which is arranged in a rear region of the receiving unit (2), wherein the second connecting element (8) includes at least two flat lateral surfaces; wherein the assembly (1) is at surrounded by a plastic material (11) at least in sections, and a connecting region (9) of the first connecting element (7) is free of plastic material (11) and a connecting region (10) of the second connecting element (8) is free of plastic material (11), and a positioning unit (18b) is formed at a rear end of the receiving unit.

2. The assembly (1) according to claim 1, wherein a first guide for a first conductor for connection to the connecting region (9) of the first connecting element (7) is formed in the plastic material (11) and / or wherein a second guide for a second conductor for connection to the connecting region (10) of the second connecting element (8) is formed in the plastic material (11).

3. The assembly (1) according to claim 2, wherein the first guide is formed so as to adjoin the connecting region (9) of the first connecting element (7) and / or wherein the second guide is formed so as to adjoin the connecting region (10) of the second connecting element (8).

4. The assembly (1) according to any one of the preceding claims, wherein the first connecting element (7) and the second connecting element (8) are arranged offset from one another.

5. The assembly (1) according to any one of the preceding claims, further comprising an antenna (26), the antenna (26) having a U-shaped progression (27) in an intermediate region, which is formed between the first connecting element (7) and the second connecting element (8).

6. The assembly (1) according to any one of the preceding claims, further comprising a further receiving unit (13) for a further plug, a third connecting element being arranged in a front region of the further receiving unit, and a fourth connecting element being arranged in a rear region of the further receiving unit.

7. An electrode connection device for an implant, comprising an assembly (1) according to any one of the preceding claims.

8. An implant comprising an electrode connection device according to claim 7.

9. A method for forming an electrode connection device of an implant, comprising the following steps: - providing an assembly (1) according to claim 1; - arranging and attaching a spring element (20) in the receiving unit (2) of the assembly (1); - sealing openings (2, 12b) of the receiving unit using potting aids (21, 22, 23); - attaching a first conductor to the first connecting element (7) of the assembly (1); - attaching a second conductor to the second connecting element (8) of the assembly (1); - arranging the assembly (1) on a housing (29) of the implant; - connecting the first conductor to a feedthrough (30) which is formed on the housing (29); - connecting the second conductor to the feedthrough (30); - arranging the assembly (1), together with the housing (29), in a casting mold; - filling the casting mold with a synthetic resin (31); and - after the synthetic resin (31) has cured, removing the potting aids (21, 22, 23).

10. The method according to claim 9, comprising the further steps: - arranging and attaching an antenna (26) to the assembly (1); and - connecting the antenna (26) to the feedthrough (30), wherein the further steps are carried out before the assembly (1) is arranged on the housing (29).