WO2025209749A1 - Header comprising component for compensating the welding force during resistance gap welding - Google Patents

Abstract

The present invention relates to a method for welding at least one first electrical contact member (100) of a first component (2) of a medical device (1) to at least one second electrical contact member (200) of the medical device (1), the method comprising the steps of: arranging a separate support member (5) on a second component (3) of the medical device (1), arranging the first component (2) on the second component (3) thereby arranging the at least one first electrical contact member (100) on the support member (5) so that the support member (5) is arranged between the second component (3) and the at least one first electrical contact member (100), and particularly allows to transfer a mechanical force introduced into the at least one first electrical contact member (100) into the second component (3) and/or the second component (3) is protected against heat via the support member (5), and welding the at least one first electrical contact member (100) to the at least one second electrical contact member (200) to generate an electrically conducting connection between the at least one first electrical contact member (100) and the at least one second electrical contact member (200).

Description

Header comprising component for compensating the welding force during resistance gap welding

The present invention relates to a method for welding at least one first electrical contact member of a first component of a medical device to a second electrical contact member of the medical device. Furthermore, the invention relates to a medical device, particularly an implantable medical device.

When welding one component to another it is often necessary that both sides of the weld metal are accessible. This usually requires a corresponding effort for setting up the welding device and poses a potential error source. Furthermore, longer cycle times result due to the infeed movement of the welding support for each welded joint.

Based on the above, the problem to be solved by the present invention is to provide a simple solution allowing to weld the at least one first electrical contact member to a second electrical contact member in an efficient manner.

This problem is solved by a method having the features of claim 1. Furthermore, an aspect of the present invention relates to a medical device as claimed in claim 10. Preferred embodiments of these aspects of the present invention are stated in the corresponding dependent claims and are described below.

According to claim 1, a method for welding at least one first electrical contact member of a first component of a medical device to a second electrical contact member of the medical device is disclosed, wherein the method comprises the steps of: arranging a separate support member on a second component of the medical device, arranging the first component on the second component thereby arranging the at least one first electrical contact member on the support member so that the support member is arranged between the second component and the at least one first electrical contact member, and welding the at least one first electrical contact member to the second electrical contact member to generate an electrically conducting connection between the at least one first electrical contact member and the second electrical contact member.

Particularly, the support member is arranged between the second component and the at least one first electrical contact member such that support members allows to transfer a mechanical force introduced into the at least one first electrical contact member into the second component via the support member and/or protects the second component against heat generated by the welding process by the support member.

Particularly, in an embodiment, the at least one first electrical contact member is arranged on the support member such that the at least one electrical contact member butts against the support member.

According to an embodiment of the present invention, the at least one first electrical contact member is welded to the second electrical contact member by means of parallel gap resistance welding.

Resistance welding comprises different process variants. These differ in the arrangement of the welding electrodes to the weld metal and the resulting electrical current flow. In the process variant of parallel gap resistance welding, both welding electrodes are positioned parallel on the weld metal (e.g., on the second electrical contact member) from one side. Hence the name parallel gap resistance welding. One advantage of this variant is that the weld metal needs to be accessible only from one side. However, a disadvantage is the need to compensate for the required welding force exerted onto weld metal (e.g. the respective first electrical contact member) to prevent damage to the weld metal and/or to compensate for heat generation exerted on the second component, particularly when the second component consists of or comprises a thermosensitive material, e.g., a plastic material such

23.125P-WO | 04.03.2025 as a thermoplastic. For example, the second component may be a header or a header body of the medical device and may consist of or comprises a plastic material, particularly a thermoplastic material. Due to the separate support member, the welding force by means of which the e.g. second electrical contact member is pressed onto the at least one first electrical contact member (e.g. pins of a feedthrough) may be transferred via the support member into the second component so that the at least one first electrical contact member is prevented from being damaged (e.g. bent) due to said force and/or heat introduced during welding onto the second component may be shielded by the support member so that the second component is prevented from being damaged (e.g., thermally damaged).

In other words, the present invention proposes to absorb this welding force and/or generated heat with an auxiliary component, i.e., the support member, that remains in the medical device after having established the welding connection(s).

Furthermore, the method comprises welding each first electrical contact member of a plurality of first electrical contact members of the first component of the medical device to an associated second electrical contact member of a plurality of second electrical contact members of the medical device. All embodiments described herein also apply to a plurality of first and second electrical contact members.

According to a further embodiment, the support member is made out of an electrically insulating material, particularly one of: a ceramic material, AI2O3, zirconium oxide.

Further, according to yet another embodiment of the method, the support member forms a heat shield protecting the second component from heat generated upon said welding. Particularly, the second component may comprise a thermoplastic polyurethane (TPU) which is protected by the heat shield. Particularly, the second component may be a header of the implantable medical, particularly consisting of or comprising thermoplastic polyurethane.

In a further embodiment, the support member is an elongated bar having e.g. a rectangular cross-section perpendicular to a longitudinal axis of the support member.

23.125P-WO | 04.03.2025 According to an embodiment of the method, the at least one first contact member is a feedthrough pin protruding from an electrical feedthrough, wherein particularly the first component forms or comprises the electrical feedthrough. Furthermore, the first component may be or comprises a housing portion of the medical device comprising the feedthrough. Furthermore, the first component may be formed by or comprises a flange of the electrical feedthrough, wherein particularly the flange may also form the aforementioned housing portion.

Furthermore, in an embodiment, the second electrical contact member is comprised by an electrically conducting structure, particularly comprising at least one wiring band or a plurality of such wiring bands. In an embodiment, the electrically conducting structure is electrically connected to the second component, particularly to connect the second component in an electrically conducting fashion to the at least one first electrical contact member of the first component. The electrically conducting structure may comprise multiple wiring bands, each first electrical contact member is connected by a welding to a second electrical contact member formed by a wiring band. The respective wiring band may furthermore be connected to an electrical component provided by the second component (such as connectors accommodated in a header body of the second component, see below).

In an embodiment of the method, the second component may be a header of the medical device comprising a header body and at least one connector for connecting the second component to an electrode lead of the medical device, wherein particularly the header body accommodates the at least one connector, and wherein particularly the electrically conducting structure is electrically connected, particularly welded, to the at least one connector of the header.

In an embodiment, the header body comprises a recess or a groove configured to receive the separate support member and the at least one first contact member, wherein the separate support member is arranged in the recess or groove of the header body.

23.125P-WO | 04.03.2025 In an embodiment, the first component is formed by an electrical feedthrough, or a housing portion comprises the electrical feedthrough, wherein the first component comprises a first connecting member, particularly designed as a mounting rail. In an embodiment, the second component is formed by or comprises a header body, wherein the second component comprises a second connecting member, particularly a groove configured to receive or engage with the first connecting member designed as a mounting rail. In an embodiment, the first connecting member engages with the second connecting member in a slidable manner. In an embodiment, arranging the first component on the second component includes mounting the second component on the first component by means of the first connecting member and the second connecting member, wherein particularly, the first connecting member is designed as a mounting rail engages with the second component designed as a groove in the header body in a slidable manner, wherein particularly, the first connecting component is being slid into the second connecting component.

Yet another aspect of the present invention relates to a medical device, particularly an implantable medical device, comprising: a first component having at least one first electrical contact member, wherein the at least one first electrical contact member is connected to a second electrical contact member via a welding connection, and a second component wherein the second component is connected to the first component, wherein the medical device comprises a separate support member arranged on the second component between the second component and the at least one first electrical contact member so that a mechanical force introduced into the at least one first electrical contact member can be transferred into the second component via the support member.

Particularly, in an embodiment, the at least one first electrical contact member butts against the support member.

Furthermore, according to an embodiment, the medical device comprises a plurality of first electrical contact members and a plurality of second electrical contact members, each first electrical contact member being connected to an associated second electrical contact member by a welding connection, wherein the support member is arranged on the second component

23.125P-WO | 04.03.2025 between the second component and the plurality of first electrical contact members so that a mechanical force introduced into the respective first electrical contact member can be transferred into the second component via the support member and/or the second component may be protected or shielded from heat generated during connecting, e.g., welding, by the support member.

In an embodiment of the medical device, the support member is made out of an electrically insulating material, particularly one of: a ceramic material, AI2O3, zirconium oxide.

Furthermore, according to an embodiment of the medical device, the support member forms a heat shield protecting the second component from heat generated upon said welding.

According to a further embodiment of the medical device, the support member is an elongated bar having e.g. a rectangular cross-section (see also above).

According to a further embodiment of the medical device, the at least one first contact member is a feedthrough pin protruding from an electrical feedthrough of the medical device comprised by the first component of the medical device. Furthermore, according to an embodiment of the medical device the first component is a housing portion of the medical device. Furthermore, in an embodiment of the medical device the first component may be formed by or comprises a flange of the electrical feedthrough, wherein the flange may also form the aforementioned housing portion.

Further, according to an embodiment of the medical device, the second component may be a header of the medical device comprising at least one connector for connecting the second component to an electrode lead of the medical device, and a header body particularly accommodates the at least one connector.

Further, in an embodiment of the medical device, the second electrical contact member is comprised by an electrically conducting structure, that particularly comprises at least one wiring band forming the second electrical contact member, wherein the electrically

23.125P-WO | 04.03.2025 conducting structure is electrically connected to the second component, wherein particularly the electrically conducting structure is electrically connected to said at least one connector.

In an embodiment, the header body comprises a recess or a groove configured to receive the separate support member and the at least one first contact member, wherein the separate support member is arranged in the recess or groove of the header body.

In an embodiment, the first component is formed by an electrical feedthrough, or a housing portion comprises the electrical feedthrough, wherein the first component comprises a first connecting member, particularly designed as a mounting rail. In an embodiment, the second component is formed by or comprises a header body, wherein the second component comprises a second connecting member, particularly a groove configured to receive or engage with the first connecting member designed as a mounting rail. In an embodiment, the first connecting member engages with the second connecting member in a slidable manner.

The method according to the present invention can be further characterized by the features and embodiments described above in conjunction with the implantable medical device and vice versa.

The present invention may be applied to a variety of medical devices, particularly implantable medical devices, wherein the medical device can be one of a pacemaker, a cardiac pacemaker, a cardioverter defibrillator, a neurostimulator, a cardiac monitor. This also applies to the medical device recited in the method according to the present invention.

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

Fig. 1 shows a perspective view of an embodiment of a portion of an implantable medical device according to the present invention having a header body connected to a housing of the device, particularly via an electrical feedthrough of the housing, wherein the device comprises a support member extending

23.125P-WO | 04.03.2025 adjacent a plurality of first electrical contact members formed by pins of the feedthrough, wherein the support member can transfer forces introduced into the pins and heat into the header body for protection of the pins against deformation and the header against melting and discoloration upon welding,

Fig. 2 shows a detail of the support member of Fig. 1,

Fig. 3 shows a cross-section of the support member and adjacent first electrical contact members (e.g. feedthrough pins), and

Fig. 4 shows an embodiment of the method according to the present invention comprising the arrangement of the support member on the header body (second component).

Fig. 1 shows in conjunction with Figs. 2 to 3 an embodiment of a medical device 1 according to the present invention. The medical device 1 may be an implantable medical device, particularly a pacemaker, a cardioverter defibrillator, a neurostimulator, or a cardiac monitoring device.

Particularly, the implantable medical device 1 comprises a first component 2 having at least one first electrical contact member 100, here particularly a plurality of such contact members in form of feedthrough pins 100 of an electrical feedthrough , that is comprised by the first component 2 or forms the first component 2. The feedthrough 4 may comprise a flange 40 holding an electrical insulator 41 through which the pins 100 extend.

Particularly, the first component 2 may be a first housing portion 2 of a housing 400 of the medical device 1, the housing 400 being formed the first housing portion 2 and a second housing portion 2a. The housing 400 accommodates a battery and an electronic circuit of the medical device 1, wherein the electronic circuit may be connected to components outside the housing 400 via the electrical feedthrough 4 of the housing 400. The respective first electrical contact member (e.g., pin) 100 is connected to a second electrical contact member 200 via a welding connection (particularly generated by resistance welding).

23.125P-WO | 04.03.2025 Furthermore, the medical device 1 comprises a second component 3 that is connected to the first component 2. The second component 3 may be a header 3 of the medical device 1 and may comprise a header body 30 that is particularly made out of a thermoplastic polyurethane (TPU).

The implantable medical device 1 further comprises a separate support member 5 that is arranged on the second component 3, particularly between the header body 30 and the pins 100 so that a mechanical force F introduced into the pins 100 upon welding the connection between the respective pin 100 and the associated second electrical contact member 200 can be transferred by the support member 5 into the second component 3/header body 30. Particularly, the separate support member 5 is arranged in a recess or groove of the header body 30. Particularly, the recess or groove in the header body 30 is sized such that also the feedthrough pins 100 can be accommodated in the recess or groove.

Particularly, the pins 100 protrude in an axial direction out of the insulator 41 of the feedthrough 4, wherein the support member 5 is arranged laterally to the pins 100 in a direction perpendicular to the axial direction, so that it can absorb forces F that run perpendicular to the axial direction of the pins 100 and transfer them into the header body 30. Thus, the support member 5 prevents bending of the pins (or even breaking of the pins 100) out of the respective axial direction due to the welding force applied by a welding system (e.g. parallel gap resistance welding).

As the header body 30 may be made out of a plastic material such as TPU, the support member 5 particularly also acts as a heat shield. Furthermore, the support member 5 is an electrical insulator, in particular. The support member 5 can be made out of materials such as: a ceramic material, AI2O3, zirconium oxide.

As shown in Fig. 2 and 3, the support member 5 can be an elongated bar having a rectangular cross section (cf. Fig. 3).

23.125P-WO | 04.03.2025 Furthermore, the header body 40 may accommodate at least one connector, here e.g. two connectors 7, 8. Particularly, the medical device 1 may be configured to provide therapy in form of electrical stimulation. In this case, the connectors 7, 8 are particularly configured to receive a plug of an electrode lead via which therapy may be applied to a patient and/or sensing can be achieved.

Further, the implantable medical device 1 comprises an electrically conducting structure 6. The electrically conducting structure 6 may comprise wire bands 60, wherein each wire band 60 comprises a first end forming the respective second electrical contact member 200 that is welded to the associated pin 100 of the feedthrough 4 / first component 2 (cf. Fig. 2). The opposing second end of the respective wire band 60 is connected to one of the contacts 70, 71, 80, 81 of the connectors 7, 8 (cf. Fig. 1) so that the electrically conducting structure 6 connects the connectors 7, 8 to the pins 100. The feedthrough pins 100 and the second electrical contact members 200 may be formed out of a titanium alloy or other suitable metals. Instead of the above described wire bands also other electrical conductors can be used.

Furthermore, Fig. 4 shows an embodiment of the method according to the present invention, wherein the separate support member 5 is placed on the second component 3, namely on the header body 30, particularly in a recess of the header body 30, and the first component 2, that may consist of or comprise the feedthrough 4, the feedthrough flange 40, a housing portion 2 or may also comprise the entire housing 400, is arranged on the second component 3 (e.g. on its header body 30) thereby arranging the electrical contact members (feedthrough pins) 100 on the support member 5 (cf. Fig. 3) so that the support member 5 is arranged between the header body 30 of the second component 3 and the pins 100. Then, the electrically conducting structure 6, that can comprise multiple wire bands 60, is arranged on the second component 3, particularly on the header body 30 so that the second electrical contact members 200, that are formed by first ends of the wire bands 60 rest on the pins 100 and the opposing second ends of the wire bands 60 rest on the contacts 70, 71, 80, 81 of the connectors 7, 8 accommodated in the header body 30. Now, the second electrical contact members 200 may be welded to the pins 100, particularly by parallel gap resistance welding, wherein a mechanical force F (cf. Fig. 3) introduced into the respective pin 100 during the

23.125P-WO | 04.03.2025 welding process can be transferred into the header body via the support member 5, and the header body 30 is protected against heat generated by said welding via the support member 5 which is left in pace after welding. After having connected the electrically conducting structure 6 to the pins 100 and contacts 70, 71, 80, 81 of the header body, the header body 30 may be processed further, e.g., by covering the electrically conducting structure 6.

The present invention offers the advantage that the weld metal (e.g., first and second electrical contact members) only needs to be accessible from one side (e.g. from above). Furthermore, the effort of configuring a support being integrated into the welding device can be omitted. The risk of a collision and corresponding production of scrap can be reduced.

Furthermore, the invention enables the cycle time of the process to be reduced.

23.125P-WO | 04.03.2025

Claims

Claims

1. Method for welding at least one first electrical contact member (100) of a first component (2) of a medical device (1) to at least one second electrical contact member (200) of the medical device (1), the method comprising the steps of: arranging a separate support member (5) on a second component (3) of the medical device (1), arranging the first component (4) on the second component (3) thereby arranging the at least one first electrical contact member (100) on the support member (5) so that the support member (5) is arranged between the second component (3) and the at least one first electrical contact member (100) and, particularly allows to transfer a mechanical force introduced into the at least one first electrical contact member (100) into the second component (3) and/or protects the second component (3) against heat generated by the welding process by the support member (5), and welding the at least one first electrical contact member (100) to the at least one second electrical contact member (200) to generate an electrically conducting connection between the at least one first electrical contact member (100) and the at least one second electrical contact member (200).

2. The method according to claim 1 , wherein the at least one first electrical contact member (100) is welded to the at least one second electrical contact member (200) by parallel gap resistance welding.

3. The method according to one of the preceding claims, wherein the support member (5) is made out of an electrically insulating material, particularly one of: a ceramic material, AI2O3, zirconium oxide.

4. The method according to one of the preceding claims, wherein the support member (5) forms a heat shield protecting the second component (200) from heat generated upon said welding.

23.125P-WO | 04.03.2025

5. The method according to one of the preceding claims, wherein the support member (5) is an elongated bar.

6. The method according to one of the preceding claims, wherein the at least one first contact member (100) is a feedthrough pin of an electrical feedthrough (4) comprised by the first component (4), wherein particularly the first component (2) is formed as or comprises a housing portion (4) or a flange (40) of the electrical feedthrough (4).

7. The method according to one of the preceding claims, wherein the second electrical contact member (200) is comprised by an electrically conducting structure (6), wherein particularly the electrically conducting structure (6) comprises at least one wiring band (60) forming the second electrical contact member (200).

8. The method according to claim 7, wherein the electrically conducting structure (6) is electrically connected to the second component (3).

9. The method according to claim 7 or 8, wherein the second component (3) comprises a header body (30), wherein particularly the header body (30) accommodates at least one connector (7, 8) for an electrode lead of the medical device (1), and wherein particularly the electrically conducting structure (6) is electrically connected to the at least one connector (7, 8).

10. A medical device (1), comprising: a first component (2) having at least one first electrical contact member (100), wherein the at least one first electrical contact member (100) is connected to a second electrical contact member (200) via a welding connection, and a second component (3) wherein the second component (3) is connected to the first component (2), characterized in that the medical device (1) comprises a separate support member (5) arranged on the second component (3) between the second component (3) and the at least one first electrical contact member (100), particularly so that a mechanical force introduced into

23.125P-WO | 04.03.2025 the at least one first electrical contact member (100) can be transferred into the second component (3) via the support member (5) and/or the second component (3) is protected against heat by the support member (5).

11. The medical device according to claim 10, wherein the support member (5) is made out of an electrically insulating material, particularly one of a ceramic material, AI2O3, zirconium oxide.

12. The medical device according to claim 10 or 11, wherein the support member (5) forms a heat shield protecting the second component (3) from heat generated upon said welding.

13. The medical device according to one of the claims 10 to 12, wherein the support member (5) is an elongated bar.

14. The medical device according to one of the claims 10 to 13, wherein the at least one first contact member (100) is a feedthrough pin of an electrical feedthrough (4) comprised by the first component (2), wherein particularly the first component (2) is formed by or comprises a housing portion (2) or a flange (40) of the electrical feedthrough (4) and/or wherein the second component (3) comprises a header body (30), wherein particularly the header body (30) accommodates at least one connector (7, 8) for an electrode lead of the medical device (1).

15. The medical device according to one of the claims 10 to 14, wherein the second electrical contact member (200) is comprised by an electrically conducting structure (6), wherein particularly the electrically conducting structure (6) comprises at least one wiring band (60) forming the second electrical contact member (200), wherein the electrically conducting structure (6) is electrically connected to the second component, wherein particularly the electrically conducting structure (6) is electrically connected to said at least one connector (7, 8).

23.125P-WO | 04.03.2025