Terminal head assembly, terminal head, implant with terminal head, and terminal head installation method

Abstract

The invention relates to a component (1) of an electrode connection device for an implant, comprising: a continuous receiving part (2) for a plug; a first connection element (7) arranged in the front area of ​​the receiving part (2), wherein the first connection element (7) has at least two flat sides; a second connection element (8) arranged in the rear area of ​​the receiving part (2), wherein the second connection element (8) has at least two flat sides. In addition, an electrode connection device, an implant and a method for installing an electrode connection device are disclosed.

Description

Technical Field

[0001] The present invention relates to an assembly for an electrode connection device (also called a terminal head), an electrode connection device, an implant having the electrode connection device, and a method for mounting the electrode connection device on an implant. Background Art

[0002] Until now, terminal heads have been constructed for active implants consisting of many individual parts. It is important that these components are aligned accurately with one another before they are cast in resin to form the terminal head. This method is very costly.

[0003] Document US2017 / 0266,451A1 discloses a terminal head with a modular through-structure.

[0004] Document US2017 / 0279,238A1 discloses a terminal head having a prefabricated terminal head module.

[0005] Another terminal head is described in document WO 2009 / 009299 A1. Summary of the invention

[0006] The object is to specify an improved implant technology. In particular, the production of the electrode connection device should be simplified.

[0007] Disclosed are an assembly of an electrode connection device for an implant according to claim 1, an electrode connection device according to claim 10 and an implant according to claim 11 as well as a method for forming an electrode connection device on an implant according to claim 12. Further embodiments are subject matter of the dependent claims.

[0008] An assembly for an electrode connection device for an implant is provided. The assembly comprises a continuous receiving part for a plug. In addition, a first connection element is provided, which is arranged in the front area of ​​the receiving part, wherein the first connection element has at least two flat sides. Finally, a second connection element is provided, which is arranged in the rear area of ​​the receiving part, wherein the second connection element has at least two flat sides.

[0009] Additionally, an electrode wiring device for an implant is provided, which has the components disclosed herein.

[0010] Also included herein is an implant having an electrode wiring device and assembly.

[0011] The electrode wiring device may also be referred to as a wiring terminal or a terminal head.

[0012] The flat sides allow an at least partially polygonal shape and allow a simple gripping of the component (manual or automatic). Automation of the manufacturing process can thereby be achieved.

[0013] The component can be surrounded at least partially by plastic. For example, the component can be partially encapsulated by plastic injection molding. The plastic can be a thermoplastic such as polysulfone. Biocompatible casting resins can also be used. The plastic can give the component additional stability. This allows the component to be manufactured as a prefabricated part, which is then processed into an electrode wiring device for an implant.

[0014] The connection region of the first connection element may be free of plastic. Alternatively or additionally, the connection region of the second connection element may be free of plastic.

[0015] A first guide structure for a first conductor connected to a connection pad of a first connection element may be formed in the plastic and / or a second guide structure for a second conductor connected to a connection pad of a second connection element may be formed in the plastic.

[0016] The first guide structure may be formed adjacent to the connection region of the first connection element and / or the second guide structure may be formed adjacent to the connection region of the second connection element.

[0017] The first conductor (second conductor) can be connected to the wiring area of ​​the first wiring element (second wiring element) to achieve the connection between the plug inserted into the accommodating component and the implant. The wiring area of ​​the first wiring element and / or the wiring area of ​​the second wiring element can be designed as a flat piece. The wiring area of ​​the first wiring element and / or the wiring area of ​​the second wiring element can be circular and have a diameter of 1-5 mm, for example. A large welding surface for fixing the first conductor or the second conductor is thus obtained. In one embodiment, the first guide structure and the second guide structure are both arranged adjacent to their respective wiring areas. The guide structure allows the conductor to be connected to the respective wiring area without causing a short circuit.

[0018] It can be provided that the first terminal element and the second terminal element are arranged staggered relative to each other. In other words, the first terminal element and the second terminal element are located on two different planes. The different arrangements simplify connecting the conductors to the terminal elements without making the conductors contact each other.

[0019] In one embodiment, the component can have an antenna, wherein the antenna has a U-shaped course in the middle region formed between the first terminal element and the second terminal element. The middle region can be designed to be narrower than the adjacent terminal elements. Thus, together with the U-shaped course of the antenna, a groove for the automatic clamping jaw is formed.

[0020] A positioning member can be formed on the rear end of the accommodating member. The positioning member can be designed to a bending structure and for example form a right angle relative to the accommodating member. The positioning member can be made of this plastic and for example form an integral part with the plastic skin of the assembly. The positioning member can be placed on the housing of the implant when the assembly is placed in the groove, so as to simplify the assembly alignment. The positioning member can have a tip that becomes pointed.

[0021] The assembly can be used for another receiving part of another plug, wherein a third terminal element is arranged in the front area of ​​the other receiving part and a fourth terminal element is arranged in the rear area of ​​the other receiving part. The embodiments disclosed here with respect to the receiving part apply analogously to the other receiving part. Furthermore, the embodiments with respect to the first terminal element and the second terminal element apply analogously to the third terminal element and the fourth terminal element.

[0022] According to another aspect, a method for forming an electrode wiring device on an implant is disclosed. The method comprises the following steps:

[0023] -Provide a component having:

[0024] A continuous receiving part for the plug,

[0025] a first terminal element arranged in a front region of the receiving element, wherein the first terminal element has at least two flat side surfaces, and

[0026] a second terminal element, which is arranged in the rear region of the receiving element, wherein the second terminal element has at least two flat side surfaces,

[0027] - a spring element is arranged and fixed in the receiving part,

[0028] - closing the opening of the receiving part with a casting compound,

[0029] - a first conductor is fixed to the first terminal element,

[0030] - fixing the second conductor to the second terminal element,

[0031] - placing the assembly on the housing of the implant,

[0032] - connecting the first conductor to a through-channel formed in the housing,

[0033] - connecting a second conductor to the through-channel,

[0034] - placing the assembly together with the housing in a casting mold,

[0035] - filling the casting mould with artificial resin,

[0036] - After the artificial resin has hardened, remove the casting aid.

[0037] The method may further comprise the steps of:

[0038] - Arrange and fix the antenna on the module,

[0039] - connect the antenna to the through-channel,

[0040] In this case, the further steps are carried out before the component is mounted on the housing.

[0041] Furthermore, it can be provided that any protruding resin is removed after hardening, for example by means of grinding and / or polishing.

[0042] The casting mold may be a silicone mold.

[0043] The through-channel can have one or more plug-in contacts (eg pins) for connecting a conductor and / or an antenna.

[0044] The synthetic resin may be an epoxy resin. Epoxy resins are synthetic resins with epoxy groups. They are hardenable resins (reaction resins) that can react with a curing agent and possibly other auxiliary agents to form a thermosetting plastic. Epoxy resins are polyethers with two terminal epoxy groups. The hardener is a reactive component and forms a polymer plastic together with the resin.

[0045] This artificial resin can directly adhere to the shell of this implant, thereby does not need additional adhesive. In other words, the contact surface between the hardened artificial resin and the implant shell can not have adhesive. The shell of this implant can be made of titanium.

[0046] The electrode connection device can be a terminal head for an implantable cardiac pacemaker or an implantable cardioverter-defibrillator. In this case, the electrode connection device is used to electrically connect one or more electrode wires to the implant.

[0047] Features disclosed in connection with the assembly and electrode connection arrangement may be applied in a similar manner to the method, and vice versa. BRIEF DESCRIPTION OF THE DRAWINGS

[0048] Hereinafter, embodiments are described in detail with reference to the accompanying drawings, wherein:

[0049] Figure 1 A perspective view showing an embodiment of an assembly for an electrode wiring device,

[0050] Figure 2 Show according to Figure 1 Front view of the component ( Figure 2 The upper part) and rear view ( Figure 2 ),

[0051] Figure 3 Show according to Figure 1 and Figure 2 Components with casting aids,

[0052] Figure 4 Show according to Figure 1-3 An assembly having an antenna and a conductor,

[0053] Figure 5 Show according to Figure 1-4 The components are placed on the housing.

[0054] Figure 6 Show according to Figure 1-5 Completely cast components (with casting aids), and

[0055] Figure 7 Show according to Figure 1-5 Completely cast component 5 (without casting aids). DETAILED DESCRIPTION

[0056] Hereinafter, the same reference numerals are used for the same components.

[0057] exist Figure 1-7 Several individual steps for installing the electrode wiring device (terminal head) on the implant are shown in FIG. These steps will be described in detail below.

[0058] Figure 1 The assembly 1 (also referred to as a terminal head) is shown, which has a first receiving part 2 for one electrode plug and a second receiving part 13 for another electrode plug. The first receiving part 2 has a front opening 6, through which the electrode plug can be guided. The first receiving part 2 has a first part 3, a second part 4 and a third part 5. The diameter of the first part 3 is greater than the diameter of the second part 4. The diameter of the second part 4 is greater than the diameter of the third part 5. In other words, the first receiving part 2 is gradually reduced from the front opening 6 to the end.

[0059] Between the first part 3 and the second part 4 (i.e. in the front area of ​​the first receiving part 2), a first terminal element is formed. Between the second part 4 and the third part 5 (i.e. in the rear area of ​​the first receiving part 2), a second terminal element 8 is formed. The first terminal element 7 and the second terminal element 8 both have at least two flat sides. This allows for simple gripping of the assembly 1 during installation and allows for automation of the installation steps. In the illustrated embodiment, the first terminal element 7 and the second terminal element 8 are substantially cube-shaped. The second terminal element 8 has an inclined edge 17, which is used for material saving and for paying attention to the direction of epoxy resin flow. On the back of the first terminal element 7, a notch 12a is formed in the plastic skin. A rear opening 12b is formed on the back of the second terminal element 8.

[0060] The component is partially surrounded by plastic 11. In the embodiment shown, the component is partially encapsulated with polysulfone. Several notches are formed in the plastic 11 for the first contact surface 9 and the second contact surface 10. The first and second contact surfaces are designed as round surfaces. A guide structure 16 is formed adjacent to the first and second contact surfaces 9, 10. The guide structure 16 is used to accommodate wiring elements (such as wiring tapes). These guide structures on the contact surface prevent the wiring elements of different contact surfaces from contacting each other.

[0061] The second receiving part 13 has a similar structure to the first receiving part 2. For the sake of clarity, the components of the second receiving part (an opening, three stepped narrowing parts and two terminal elements) are not provided with reference numerals. The second receiving part also has two contact surfaces for the terminal (third contact surface 14 and fourth contact surface 15). Guide structures are again formed adjacent to these contact surfaces.

[0062] A positioning member 18b is formed at one end of the second receiving member, which is designed to have a pin with a pointed end. Figure 5 ), the tip of the positioning member 18b can be inserted into the housing groove to simplify the accurate placement of the assembly on the housing. But the assembly can also be designed without the positioning member 18b.

[0063] A plurality of positioning pins 18a are formed on the bottom surface of the assembly (see Figure 2 ). These locating pins can be arranged in corresponding grooves when the assembly is placed on the implant shell. In the illustrated embodiment, two locating pins are shown, but other numbers of locating pins are also feasible.

[0064] The first receiving component 2 and the second receiving component 13 each have a spring sleeve and a plug receiving groove. The first receiving component 2 and the second receiving component 13 can be designed as an IS-1 connector.

[0065] The spring element 20 is arranged in the first receiving part 2 and is fixed there ( Figure 3 The recess 12a in the plastic is used to weld the spring element 20 arranged in the first receiving part 2 to the first terminal element 7 by means of resistance welding. Another spring element is similarly arranged and fixed in the second receiving part 13 (not shown). The opening of the component 1 is then closed and sealed with a casting compound 21, 22, 23 ( Figure 3 on the right side of the screen).

[0066] exist Figure 4 Another installation step is shown in FIG. The conductor strip 24 is fixed to the third contact surface 14 (e.g., welded). At its rear end, the conductor strip 24 has a conductor strip terminal 25, which can be connected to a contact pin (see FIG. 2 ) of the through channel 30. Figure 4) is connected and can be plugged onto the contact pin, for example. Other conductor tracks are connected to other contact surfaces 9, 10, 15.

[0067] The antenna 26 is fixed to the component 1. The antenna 26 partially encloses the first part 3 of the first receiving part 2 and is clamped thereto. In the area between the first terminal element 7 and the second terminal element 8, the antenna 26 has a U-shaped section 27. This forms a groove, which can be used, for example, with an automated gripper to grasp and transport the component. The antenna terminal 28 is formed on the rear end of the antenna to connect to the through-channel 30.

[0068] The assembly with the conductor strip and the antenna is then placed (not shown) in a casting mold (e.g., a silicone mold). The conductor strip terminals and the antenna terminals 28 are inserted into corresponding pins of the through-channel 30 and connected to the pins (e.g., welded). The casting mold is closed and filled with an artificial resin 31 (e.g., epoxy resin). Thus, the electrode connection device is copied (see Figure 6 ).

[0069] The casting aids 21, 22, 23 are removed and any excess resin on the outer surface is removed, for example by grinding and / or polishing. The implant with the electrode connection device is now installed ( Figure 7 ).

[0070] The assembly / electrode connection device may have the following advantages:

[0071] - resin and / or other particles do not enter the first (and possibly second) containment part, so no secondary processing is required;

[0072] - The insulation distance of the conductor tracks is predetermined by the component design, so that the risk of electrical short circuits is reduced or even eliminated;

[0073] - The design allows automated manufacturing of electrode wiring devices;

[0074] Compared to the production known to date, processing steps are omitted, which results in a reduction in processing time.

[0075] The features disclosed in the description, the claims and the drawings may be relevant for the implementation of the embodiments both individually and in any combination with one another.

[0076] Reference numerals list

[0077] 1 Components

[0078] 2 First receiving part

[0079] 3. First part of the first receiving member

[0080] 4 The second part of the first receiving member

[0081] 5 The third part of the first receiving part

[0082] 6 Front opening

[0083] 7 First connection element

[0084] 8 Second connection element

[0085] 9 First contact surface

[0086] 10 Second contact surface

[0087] 11 Plastic

[0088] 12a Gap

[0089] 12b Rear opening

[0090] 13. Second receiving part

[0091] 14 Third contact surface

[0092] 15 Fourth contact surface

[0093] 16. Guide structure

[0094] 17 Bevel Edge

[0095] 18a Locating pin

[0096] 18b Positioning components

[0097] 20 Spring parts

[0098] 21. First pouring auxiliary material

[0099] 22 Second pouring auxiliary material

[0100] 23 The third pouring auxiliary material

[0101] 24 Wire tape

[0102] 25 wire with terminal

[0103] 26 Antenna

[0104] 27 U-shaped part of the antenna

[0105] 28 Antenna terminal

[0106] 29 Shell

[0107] 30 Through Channel

[0108] 31 Resin

Claims

1. An electrode wiring device for an implant, comprising a component (1), the component comprising: - a continuous receiving part (2) for a plug, the receiving part comprising a first part (3), a second part (4) and a third part (5), the diameter of the first part (3) being greater than the diameter of the second part (4), the diameter of the second part (4) being greater than the diameter of the third part (5); a first terminal element (7) which is arranged in the front region of the receiving part (2) between the first part (3) and the second part (4), wherein the first terminal element (7) has at least two flat sides, and a second terminal element (8) which is arranged in the rear region of the receiving element (2) and between the second part (4) and the third part (5), wherein the second terminal element (8) has at least two flat sides, wherein the component (1) is at least partially surrounded by plastic (11), and the plastic forms some parts of the first part (3), the second part (4) and the third part (5); The connection area (9) of the first connection element (7) is free of plastic (11), and / or the connection area (10) of the second connection element (8) is free of plastic (11), and the synthetic resin (31) surrounds the component 1 and the plastic (11).

2. The electrode wiring device according to claim 1, wherein: A first guide structure for a first conductor connected to a terminal area (9) of a first terminal element (7) is formed in the plastic (11), and / or wherein: A second guide structure for a second conductor connected to a connection area (10) of a second connection element (8) is formed in the plastic (11).

3. The electrode wiring device according to claim 2, wherein: The first guide structure is formed adjacent to the connection area (9) of the first connection element (7), and / or wherein: The second guide structure is formed adjacent to the connection region (10) of the second connection element (8).

4. The electrode wiring device according to any one of claims 1 to 3, wherein: The first wiring element (7) and the second wiring element (8) are arranged in a staggered manner relative to each other.

5. The electrode connection device according to claim 1, further comprising an antenna (26), wherein: The antenna (26) has a U-shaped course (27) in a central region formed between the first terminal element (7) and the second terminal element (8).

6. The electrode wiring device according to claim 1, wherein: A positioning component (18b) is formed at the rear end of the accommodating component.

7. The electrode connection device according to claim 1 further comprises another receiving part (13) for another plug, wherein: A third connecting element is arranged in the front region of the further receiving part, wherein a fourth connecting element is arranged in the rear region of the further receiving part.

8. An implant having an electrode connection device according to any one of the preceding claims 1-7.

9. A method for forming an electrode wiring device for an implant, comprising the steps of: - providing a component (1) having: A continuous receiving component (2) for a plug, the receiving component comprising a first part (3), a second part (4) and a third part (5), the diameter of the first part (3) being greater than the diameter of the second part (4), and the diameter of the second part (4) being greater than the diameter of the third part (5); A first terminal element (7) is arranged in the front region of the receiving component (2) between the first part (3) and the second part (4), wherein: The first terminal element (7) has at least two flat sides, and a second terminal element (8) which is arranged in the rear region of the receiving part (2) and between the second part (4) and the third part (5), wherein the second terminal element (8) has at least two flat side surfaces, The component (1) is at least partially surrounded by a plastic (11), and the plastic forms parts of the first part (3), the second part (4) and the third part (5), wherein the connection area (9) of the first connection element (7) is free of plastic (11), and / or wherein the connection area (10) of the second connection element (8) is free of plastic (11), and an artificial resin (31) surrounds the component 1 and the plastic (11); - a spring element (20) is arranged and fixed in the receiving part (2), - closing the opening (12, 12b) of the receiving part with a casting compound (21, 22, 23), - fixing the first conductor on the first terminal element (7), - fixing the second conductor on the second terminal element (8), - placing the assembly (1) on the housing (29) of the implant, - connecting the first conductor to a through-channel (30) formed in the housing (29), - connecting a second conductor to the through-channel (30), - placing the assembly (1) together with the housing (29) in a casting mold, - filling the casting mould with artificial resin (31), - After the artificial resin (31) has hardened, the casting aids (21, 22, 23) are removed.

10. The method according to claim 9, further comprising the following steps: - arranging and fixing the antenna (26) on the component (1), - connecting the antenna (26) to the through-channel (30), in, The further steps are carried out before the assembly ( 1 ) is mounted on the housing ( 29 ).

Images