Mounting tool set for producing head components, and method for producing head components using the mounting tool set

Abstract

The present invention relates to an attachment tool set for producing a head part of an implantable medical device, which head part can be made of a hardenable injectable material and comprises a head part housing having a blind hole type recess, in which at least one conductive contact ring element and an elastically deformable insulating sealing ring are joined to each other in a coaxial arrangement and axially in-line arrangement along the head part in the form of a press fit under the influence of an axial joining force, and the attachment tool set comprises means for fixing the axial position of a fixation body along the attachment tool set.

Description

[Technical Field]

[0001] Described is an attachment tool set for producing a head component of an implantable medical device and a method for producing the head component using the attachment tool set.

[0002] For example, implantable medical devices, or implantable pulse generators (IPGs) for short, intended for electrical stimulation of localized body regions for cardiac defibrillation, pacemaking, or resynchronization applications, for therapeutic neurostimulation, brain stimulation, or vagus nerve stimulation, to name a few, generally comprise a closed housing in which components for generating electrical pulses are contained, such as at least one energy source and an electrical circuit structure connected thereto, and directly adjacent to the housing is a so-called head part, in which electrical contact devices connected to the energy source and / or the circuit structure are integrated, and to which a plug device, which closes the head part in a fluid-tight manner, can be fitted, contacting power and discharge wires for the purpose of locally applying an electrical stimulation signal within the body and, if applicable, supplying locally picked-up electrical signals to the electrical circuit structure present in the housing. [Background technology]

[0003] Document EP 2 134 418 B1 describes a head element of the type in question for an implantable medical device, comprising two head element housing halves joined together along a joint seam introduced in each of them in series and separated by an intermediate wall. The two head element housing halves are semi-cylindrical recesses into which conductive contact ring elements and insulating sealing rings are inserted in series and alternately in each case. The head element formed by the two joined head element housing halves thus comprises an arrangement of coaxially oriented and insulated contact ring elements, and for electrical contact therewith a lateral access is provided in the head element, through which an electrical plug device can be inserted in a liquid-tight manner into the hollow space surrounded by all of the annular contact ring elements.

[0004] Document DE102012010901A1 discloses a method for positioning and holding electrical contacts and seals in a head component for electrically connecting to an implantable medical device. A head component housing made of a biocompatible insulating material has a blind-hole-type hole formed on one side, and conductive contact rings and annular seal elements are arranged in an alternating arrangement in the head component housing and cooperate to form a hollow space into which a pin-shaped plug device can be inserted. Within the head component, each individual annular contact ring is connected via a connecting wire to an electrical component located within the housing of the implantable medical device.

[0005] In order to achieve the most durable possible liquid-tight seal, and also to insulate the individual contact ring elements relative to one another, the alternating arrangement of electrical contact ring elements and sealing rings must be fixed in the head part with the greatest possible axial joining force, which requires laborious mounting means that can usually only be performed manually with considerable dexterity.

[0006] Document DE202013012073U1 discloses a plug hole module assembly, for which several contact rings and sealing elements are arranged in an alternating sequence along a pin-shaped mounting fixture. All contact rings and sealing elements mounted along the mounting fixture are clamped together using a tensioning device under the application of an axial joining force. The joining force is maintained by a sleeve element, which is firmly axially attached to the mounting fixture by means of a grub screw. In this tensioned state, a hardening casting compound is injected into the device, which captures the joining force in its hardened state.

[0007] DE 102017222364 A1 describes a method for producing a head part of an implantable medical device using a rod-shaped mounting tool, along which conductive contact ring elements and elastically deformable insulating sealing rings are arranged in an axially alternating series arrangement. To establish the axial joining force acting between the ring arrangement along the mounting tool, the mounting tool has a mechanical stop on one side and, on the other side, an external thread on the end of the mounting tool onto which a nut or the like can be screwed. By turning the nut around the external thread on the mounting tool, the joining force acting along the axial ring arrangement can be adjusted in small increments. The mounting tool assembled in this way is then cast with a hardening casting compound to form the head part, with only a small extension of the mounting tool protruding outside the resulting head part after hardening. By rotating the fitting around its longitudinal axis, the fitting is released from the solidified head piece, and the joining forces acting between the missing component and the axial ring arrangement are interrupted and held by the casting compound, so that the nut remains in the head piece.

[0008] Document DE 10 2019 203 273 A1 discloses a method for producing a medical implant, the implant comprising a head part with at least one blind-hole recess in the form of an electrical plug contact socket, along which at least one electrically conductive contact element is arranged, and the implant also provides for a supply part having at least one electrical component, preferably in the form of a microcontroller and / or an electrical energy source, which is firmly connected to the head part and electrically connected to the at least one electrically conductive contact element by at least one conductor structure. Comparable production methods are disclosed in documents DE 10 20 20 112 084 A1 and DE 10 20 20 205 350 A1. Summary of the Invention [Problem to be solved by the invention]

[0009] An object of the present invention is to identify an attachment tool set for producing head components of implantable medical devices, and a method for producing head components using the attachment tool set, in a manner that should enable the production of head components of a target type in large quantities with high quality, consistent reproducibility, and with low or little to no failure rates or rejects. [Means for solving the problem]

[0010] The solution to this problem, which forms the basis of the present invention, is recited in claim 1. The subject of claim 14 is a method for producing a head part of an implantable medical device using an installation tool set according to the solution of claim 1. Features which advantageously further develop the inventive idea are the subject of the dependent claims and can be inferred from the further description with reference to the example embodiments.

[0011] The present invention is based on the idea of ​​simplifying important process and procedural steps in the production of head parts of the type in question, and in particular those measures or work steps that must be taken just before the final stage of completing an implantable medical device, which can lead to the greatest economic losses in the event of a failure, for example, if a large number of particularly time-consuming or expensive production steps have already been carried out. One of these important measures relates to the separation of the above-mentioned attachment tool from the solidified casting compound, in which a freely available blind-hole-shaped plug socket is produced, into which a conical plug part can be fitted for electrical and mechanical contact.

[0012] The mounting tool set according to the invention, on the one hand, offers simplified handling and mounting of at least two, preferably a plurality of, electrically conductive contact rings and elastically deformable insulating sealing rings arranged in series in an axially alternating arrangement, and, on the other hand, makes it possible to reliably and risk-free separate the individual mounting tool components from the solidified casting material that forms the finished head part.

[0013] An attachment tool set according to the present invention for producing a head part of an implantable medical device, which head part can be made of a hardenable injectable material and comprises a head part housing having a blind-hole type recess, along which at least one conductive contact ring element and an insulating sealing ring are joined to each other in the form of a press fit under the influence of an axial joining force, comprises the following tool components: a rod-shaped attachment tool, a fixing body, an adjustment means and a receiving structure.

[0014] The rod-shaped fitting has a rod longitudinal axis and an axially extending rod surface with a local recess introduced along the rod-shaped fitting. A through passage having a passage longitudinal axis passes through the fixture, and the fitting can pass through the through passage at least along a first rod section assigned thereto. Additionally, the fixture has an opening partially therethrough, the opening opening into the through passage and having an opening longitudinal axis oriented perpendicular to the passage longitudinal axis of the through passage, and an internal thread disposed in the fixture about the opening longitudinal axis.

[0015] The adjustment means has a joint profile that is freely available and that terminates on a face side that is reverse-profiled with respect to a local recess in the rod-shaped fitting, and in addition the adjustment means is provided with a reverse thread that can be brought into engagement with the internal thread of the fixed body.

[0016] The receiving structure comprises at least a fixed body and a recess into which a rod-shaped mounting fixture, in which at least one conductive contact ring element and at least one elastically deformable insulating sealing ring are arranged coaxially and in an axially serial arrangement, can be or is inserted under the influence of an axial joining force.

[0017] All of the above mentioned tool components are separate components to be used and stored, and their shapes and sizes are matched to each other for attachment purposes.

[0018] In a first mounting step, at least the fixing body, as well as at least one electrically conductive contact ring element and at least one elastically deformable insulating sealing ring, are arranged along a rod-shaped mounting fixture, which for this purpose has a frusto-conical rod end section adjacent to a first rod section with a constant first rod cross section and an otherwise unstructured flat surface, the first rod section being adjacent in its longitudinal direction to a second rod section, which has a larger rod cross section compared to the first rod section and which is adjacent to the first rod section via an end face extending perpendicular to the rod longitudinal axis and which projects radially beyond the first rod section in an annular manner.

[0019] The arrangement of the fixture, at least one electrically conductive contact ring element, and at least one elastically deformable insulating sealing ring along the rod-shaped fitting is preferably carried out so that the annular elastically deformable sealing body is first pressed onto a first rod end section of the fitting and brought into contact with the end face of the second rod section. The fixture is then arranged along the first rod section so that it is axially directly adjacent to the annular sealing body. A plurality of contact ring elements and sealing rings are then preferably arranged along the fitting in an axially alternating manner, forming a kind of ring stack that is adjacent on one side to the fixture directly or indirectly via an additional elastic intermediate ring body.

[0020] In the next installation step, the adjusting means, which is preferably designed in a rod-like manner like the mounting tool and has a mating profile terminating on the surface side, is inserted into the opening of the fixing body, which is located directly radially above a local recess extending axially on the rod surface of the first rod section of the mounting tool. The local recess is preferably designed in the form of a frusto-conical groove circumferentially around the first rod section, into which the mating profile of the adjusting means terminating on the surface side engages locally in a self-centering manner. The fitting process of the rod-shaped adjusting means into the opening of the fixing body is carried out by rotating the adjusting means about its rod longitudinal axis, through the opening, so that the counter-thread provided on the adjusting means comes into contact with the internal thread provided in the area of ​​the opening of the fixing body. In this way, the mating profile of the adjusting means terminating on the surface side enters into the local groove-shaped recess along the rod-shaped mounting tool, forming a force-fit and form-fit connection. In this joined state, the fixture is rigidly fixed or locked axially along the fixture and is non-rotatable about the fixture rod longitudinal axis.

[0021] The local recess, preferably groove-shaped, in the region of the first rod section of the fitting is arranged at a defined first distance from the end face of the second rod section, so that, when the fixing body is arranged along the rod-shaped fitting and the adjusting means is fitted into the opening of the fixing body, as explained above, a defined second distance is formed between the fixing body and the end face of the second rod section. This second distance corresponds exactly to the maximum axial width measurement of a seal designed in the form of an elastomeric sealing ring and arranged around the rod-shaped fitting, axially adjacent to the fixing body on one side and to the end face of the fitting on the other side. The seal designed in the form of an elastomeric sealing ring has a through-opening whose shape and size match the rod cross-section of the first rod section of the fitting. Axial surface contact on both sides of the ring-shaped seal with the end face of the fitting on the one hand and the side of the fixing body on the other hand provides a liquid-tight joint for the polymeric flowable casting compound. That is, when the flowable polymeric molding material is injected around the assembly, it is not possible for the molding material to penetrate between the fixing body and the sealing body, and between the sealing body and the end face.

[0022] In a further step, the mounting tool, together with at least the fixing body and the at least one conductive contact ring element and at least one elastically deformable insulating sealing ring, is inserted into the recess of the receiving structure in order to generate an axial joining force along the at least one conductive contact ring element and the at least one elastically deformable insulating sealing ring. After insertion into the recess of the receiving structure, the joining force, which is initially generated preferably manually and acts axially between the individual contact ring elements and the sealing ring arranged along the mounting tool, is taken up or absorbed by the receiving structure itself. For this purpose, the recess of the receiving structure, which is preferably made of a rigid or solidified material, comprises at least two axially opposing stop surfaces on which the rod ends of the rod-shaped mounting tool or a mounting body optionally arranged therein, on the one hand, and the fixing body, on the other hand, are supported directly or indirectly, so that the at least one conductive contact ring element and the at least one elastically deformable insulating sealing ring are subjected to the axial joining force.

[0023] In a further step, a flowable, hardenable potting material is at least partially injected around at least the receiving structure with the inserted mounting tool, at least the fixing body, at least one conductive contact ring element and at least one electrically deformable insulating sealing ring, and the adjustment means fitted into the local recess of the rod-shaped mounting means by the joint, so that the mounting tool and the adjustment means protrude in some areas from the potting material.

[0024] After the curable, preferably polymeric, material has hardened, the head component housing is formed, from which only the rod-shaped mounting fixture and the rod-shaped adjusting means must be separated in order to finish the head component housing. Separation of the rod-shaped mounting fixture is simply performed using an axial pulling force along the mounting fixture, especially when the rod-shaped mounting fixture is only loosely or mostly loosely fitted to the rest of the component assembly of the head component housing to be produced or already produced. To separate the adjusting means, it is necessary to loosen the threaded engagement between the adjusting means and the fixed body, followed by axial removal of the adjusting means out of the head component housing.

[0025] In a preferred embodiment, a corresponding seal is provided between the fixing body and the end face of the rod-shaped fitting, designed in the form of an elastomeric sealing ring. The seal prevents the flowable casting material from penetrating through the opening into the fixing body, while facilitating the separation of the rod-shaped adjusting means from the solidified head part housing. For this purpose, the adjusting means has, at its rod end, a mating profile terminating on the face side, with a first rod section of the adjusting means adjacent to the mating profile and a counter-thread in the form of an external thread arranged along the first rod section. Directly bounding the first rod section of the adjusting means is a second rod section, which has a larger rod cross section compared to the first rod section and an annular end face facing the first rod section and radially surrounding it.

[0026] The fixing body is preferably cubic or rectangular parallelepiped in shape and has at least two opposing lateral surfaces, first and second lateral surfaces, through which a through-passage passes, each lateral surface having a flat surface area oriented parallel to one another. The fixing body also has a third lateral surface with a flat surface area oriented perpendicular to the first and second lateral surfaces, through which an opening passes. When the rod-shaped adjusting means is fitted into the opening of the fixing body and the mating contour of the face side engages in a conforming manner with the local recess of the rod-shaped mounting, a third distance remains between the end face of the adjusting means and the surface area of ​​the third lateral surface of the fixing body, which third distance corresponds maximally to the axial width dimension of an elastically deformable sealing body arranged around the rod-shaped adjusting means, axially adjacent to the fixing body on the one hand and the end face of the adjusting means on the other hand. Screwing the adjusting means into the mating body compresses the deformable fixing body, which is preferably dimensioned slightly larger than the third distance.

[0027] The casting process for forming the head component housing is preferably carried out by using an injectable polymer casting material so that the casting material is completely injected around the mounting tool placed in the receiving structure together with the components described above, without wetting the parts of both the mounting tool and the adjusting means that protrude from the encapsulation, thus allowing the mounting tool and the adjusting means to be separated without any problems after the head component housing has hardened and been produced.

[0028] The contour-matching fit of the mating contour of the adjustment means, terminating on the face side, in the local recess along the rod surface of the rod-shaped mounting fixture determines the axial position of the fixing body along the mounting fixture, so that the sealing body arranged on the mounting fixture experiences a defined and specified axial compression pressure between the fixing body on the one hand and the end face of the assembly fixture on the other. Furthermore, in this way, the mating force acting between the sealing ring and a plurality of contact ring elements arranged in an axially staggered sequence along the assembly fixture can be adjusted in a predefined and reproducible manner, and this mating force is maintained by the geometry of the recess in the receiving structure, in particular the axial distance between two axially opposing stop surfaces.

[0029] The invention will now be described by way of example only, without limiting the general inventive idea, by means of example embodiments with reference to the drawings. [Brief explanation of the drawings]

[0030] [Figure 1] FIG. 10 shows a bar-shaped fixture with a fixing block placed thereon. [Figure 2] FIG. 10 is a perspective view of a fixing block on a mounting fixture. [Figure 3] FIG. 10 shows the joint assembly of the mounting fixture, the fixing block and the adjustment means. [Figure 4] 10 is an illustration of the interface between the adjustment means and a groove-shaped recess along the fitting. FIG. [Figure 5] 10 is an illustration of the interface between the adjustment means and a groove-shaped recess along the fitting. FIG. [Figure 6] FIG. 10 shows a receiving structure with a component fitting within it. [Figure 7] FIG. 1 shows the completed head assembly housing on top of the implantable medical device. DETAILED DESCRIPTION OF THE INVENTION

[0031] FIG. 1 shows a rod-shaped fitting 1 with a first rod section 2 and an adjacent second rod section 3. Both rod sections 2, 3 have a circular rod cross-section, with the first rod cross-section along the first rod section 2 being smaller in size than the second rod cross-section of the second rod section 3. Along the first rod section 2 there is a local recess 4 in the form of a circumferential groove-like recess, which can also be seen in more detail in FIGS. 4 and 5. The groove-shaped recess 4 is designed in the form of a split swallow-tail profile and has two lateral sides 41, 42. The two lateral sides 41, 42 are angled obliquely with respect to the otherwise flat-formed rod surface 5 along the first rod section 2 and further serve the functions of centering and axial locking.

[0032] The first rod section 2 is bounded on the one hand by a conical blunt rod end 6 and on the other hand by an annular end face 7 which projects radially beyond the rod surface 5 of the first rod section 2.

[0033] The end of the rod-shaped fitting 1 opposite the conical blunt rod end 6 has a mechanically stable interface 8 on which the fitting contour is provided, and tensile forces acting at least along the rod-shaped fitting 1 can be introduced via the interface 8.

[0034] Further, along the first rod section 2, a fixture 9 is pushed or placed along the rod-shaped fitting 1, which can also be seen in the perspective view of FIG. 2. Like the rod-shaped fitting 1, the fixture 9, which is made of a solid material, preferably a metallic material, has a cubic or rectangular parallelepiped shape and is completely pierced by a through-hole through which the first rod section 2 of the rod-shaped fitting 1 protrudes. The through-hole, which is no longer visible, passes through two lateral surfaces 91, 92 of the fixture 9, which are oriented parallel to one another. In addition, the fixture 9 has an opening 10, the longitudinal axis 11 of which passes perpendicularly through the opening 10 and is perpendicular to the longitudinal axis of the through-hole and thus perpendicular to the rod longitudinal axis 12 of the fitting 1. The opening 10 adjoins a flat lateral surface 93 of the fixture 9, which is also oriented perpendicular to the lateral surfaces 91, 92.

[0035] Furthermore, the fixing body 9 incorporates an internal thread 13 on the inside thereof around the longitudinal axis 11 of the opening, directly adjacent to the opening 10 .

[0036] In addition to the rod-shaped mounting fixture 1 and the fixed body 9 arranged along the first rod section 2 of the mounting fixture 1, Figure 3 shows a rod-shaped adjustment means 14, the end of which protrudes into the opening 10 of the fixed body 9 and is firmly connected to the fixed body 9.

[0037] Both Figures 4 and 5 are detailed views to show the joint connections between the adjustment means 14, the fixed body 9 and the mounting tool 1.

[0038] At its rod end, the rod-shaped adjustment medium 14 has a face-end joining contour 15 that is inversely contoured with respect to the groove-shaped local recess 4. The face-end joining contour 15 also has oblique side flanks 15.1, 15.2, the slope of which corresponds to the side flanks 41, 42 of the local recess 4.

[0039] Directly adjacent to the face-end joint contour 15 is a first rod section 16 of the adjustment means 14, along which an external thread 17 is arranged, which is designed as an inverse thread to the internal thread 13 in the fixed body 9, and which can be brought into engagement with the adjustment means 14 by rotation of the adjustment means 14 along its rod longitudinal axis 18.

[0040] Directly adjacent to the first rod section 16 of the adjustment means 14 is a second rod section 19, which has a larger rod cross section compared to the first rod section 16 and is therefore provided with an annular end face 20 facing the first rod section 16 and radially surrounding the same.

[0041] 5 shows the rod-shaped adjusting means 14 assembled on the rod-shaped mounting fixture 1 by means of the fixing body 9, where the opening 10 of the fixing body 9 is radially centered above the local recess 4, and in the opening 10 the end-face connection contour 15 is removably and fixedly joined in the manner of a form-fit and force-fit by means of a threaded joint between the adjusting means 14 and the fixing body 9. The fixing body 9 is thus axially rigidly fixed to the rod-shaped mounting fixture 1 on the one hand, and is fixed to the mounting fixture 1 in a rotationally non-rotational manner by the contact force prevailing between the end-face connection contour 15 and the local recess 4 on the other hand.

[0042] The spatial arrangement of the recess 4 along the rod-shaped mounting fixture 1 relative to its face end 7 and the geometric lateral dimensions of the fixing body 9 are matched to one another in such a way that, in the joined state, a distance a is provided between the lateral surface 92 of the fixing body 9 and the end face 7 of the mounting fixture 1. Likewise, a corresponding distance b is provided between the lateral surface 93 of the fixing body 9 and the end face 20 of the adjustment means 14. The two distances a, b allow the additional fitting of one sealing body 21, 22 each designed as an elastomeric sealing ring. Thus, on the one hand, the sealing body 21 is fitted along the rod-shaped mounting fixture 1 and bounds on one side the lateral surface 92 of the fixing body 9 and on the other hand the end face 7 of the rod-shaped mounting fixture 1 in a liquid-tight manner. Similarly, a second sealing body 22 is mounted along the first rod section 16 of the adjusting means 14 and interfaces on one side with the lateral surface 93 of the fixed body 9 and on the other side with the end face 20 of the adjusting means 14 in a liquid-tight manner. The distances a, b and the width dimensions of the annular sealing bodies 21, 22 are adjusted to one another in such a way that the elastomeric compression of both sealing bodies 21, 22 provides a liquid-tight surface seal, at least with respect to the flowable polymer casting material.

[0043] Figure 6 shows an arrangement showing the adjusting means 14 assembled with the rod-shaped mounting fixture 1 by means of the fixed body 9, with an annular seal 22 between the adjusting means 14 and the fixed body 9 and an annular seal 21 between the fixed body 9 and the rod-shaped mounting fixture 1, each under the influence of a pressing force.

[0044] Additionally, a plurality of conductive contact ring elements 23 and elastically deformable insulating sealing rings 24 are arranged in an axially alternating sequence along the first rod section 2 of the rod-shaped mounting fixture 1. The conical blunt rod end 6 of the rod-shaped mounting fixture 1 is loosely inserted on one side into the mounting body 27, which allows the axially acting joining force to be generated by manually axially compressing the serial axial arrangement of contact ring elements 23 and sealing rings 24. In this axially compressed state, the arrangement is inserted into a recess of the receiving structure 26, which essentially has two axially opposed stop surfaces 27, 28 at which the mounting body 25 on the one hand and the fixed body 9 on the other hand can be brought into mutually supporting contact, so that the receiving structure 26 can absorb the joining force.

[0045] Other recesses incorporated in the receiving structure 26 have defined, inverse contours that correspond to the outer contours of the axial arrangement of the contact ring elements 23 and the sealing ring 24, as well as to the fixing body 9. The receiving structure 26 preferably consists of a solidified potting compound that is used to form the head element housing 29 shown in FIG. 7 by means of an injection process. The injection process surrounds the receiving structure 26 with all components fitted therein, and preferably the second rod section 3 of the mounting tool 1 and the second rod section 19 of the adjusting means 14 terminate in a liquid-tight manner in the annular seals 21, 22 so that they are not surrounded by the potting compound during the injection process. This greatly facilitates the separation of the mounting tool 1 and the adjusting means 14 from the assembly, resulting in the head element housing 29 attached to the medically effective implantable device 30 shown in FIG. 7. [Explanation of symbols]

[0046] 1 Rod-shaped mounting tool 2. First Bar Section 3 Second Bar Section 4 Local depression 41, 42 Oblique lateral aspect 5 bar surface 6 Rod end 7 End face 8 Interface 9 Fixed body 91, 92, 93 Lateral surface 10 Opening 11 Opening longitudinal axis 12 Longitudinal axis of penetration path, longitudinal axis of rod 13 Internal thread 14 Adjustment means 15 End face connection outline 15.1, 15.2 Lateral aspect 16 First Bar Section 17 Male thread 18 Rod longitudinal axis 19 Second Bar Section 20 End face 21, 22 Sealing body a, b distance 23 Conductive contact ring element 24 Elastically deformable insulating sealing ring 25 Mounting body 26 Receptive Structure 27, 28 Stop surface 29 Head component housing 30 Implantable devices

Claims

1. 1. An assembly tool set for manufacturing a head of an implantable medical device, comprising a head housing (29) that can be made of a hardenable, injectable material and has a blind-hole recess along which at least one electrically conductive contact ring element (23) and an electrically insulating seal ring (24) are joined together in a coaxial arrangement and axially consecutive order in a press-fit manner under the influence of an axial joining force, the assembly comprising the following tool components: A rod-shaped installation tool (1) having a rod longitudinal axis (12) and an axially extending rod surface (5) along which local recesses (4) are introduced; the fixture (9) is penetrated by a through-channel having a longitudinal channel axis, through which a rod-shaped installation tool (1) can pass at least along the assigned first rod section (2), and in which an opening (10) opens at least partially through the fixture (9), the longitudinal axis (11) of the opening being perpendicular to the longitudinal axis of the channel, and around which longitudinal axis (11) an internal thread (13) is arranged in the fixture (9); the adjusting means (14) has a mating profile (15) on the surface thereof, which has a profile opposite to that of the local recess (4) of the rod-like mounting means (1), and has a counter-thread (17) engageable with the internal thread (13) of the fixing body (9); The installation tool set further comprises a receiving structure (26) having a recess, into which a rod-shaped installation tool (1) having at least a fixed body (9), at least one conductive contact ring element (23), and at least one electrically insulating and elastically deformable seal ring (24) coaxially arranged in axial succession can be inserted under the action of an axial joining force.

2. the local recess (4) is located in the region of the first rod section (2); the first rod section (2) assigned to the rod-shaped fitting (1) has, apart from the local recess (4), a constant first rod cross section and is delimited on the one hand by a rod end section (6) of the fitting (1) and on the other hand by a second rod section (3) having a second rod cross section larger than the first rod cross section; the second rod section (3) adjoins the first rod section (2) via an end face (7) extending perpendicular to the rod longitudinal axis (12); The installation tool set according to claim 1 ,

3. the local recess (4) is designed in the form of a frusto-conical groove that goes around the first rod section in the circumferential direction; The installation tool set according to claim 1 ,

4. The rod end section (6) of the mounting tool (1) is designed in a frusto-conical manner and has an unstructured flat surface (6).

4. The attachment tool set according to claim 2 or 3,

5. the local recess (4) is arranged along the rod longitudinal axis (12) relative to the end face (7) of the second rod section (3) of the mounting device (1) such that a first distance (a) is provided between the fixed body (9) and the end face (7) of the second rod section (3) of the mounting device (1) when the fixed body (9) is arranged along the rod-shaped mounting device (1) and the adjusting means (14) is fitted into the opening (10) of the fixed body (9) so that the mating contour (15) of the adjusting medium (14) terminating at the end face enters into the local recess (4) along the rod-shaped mounting device (1) and together forms a force-fit and form-fit connection between the fixed body (9). The installation tool set according to any one of claims 2 to 4, characterized in that

6. the first distance (a) corresponds maximally to the axial width measurement of an elastically deformable sealing body (21) arranged around the rod-shaped mounting fixture (1) axially adjacent to the fixed body (9) on one side and to the end face (7) of the mounting fixture (1) on the other side; 6. The installation tool set according to claim 5,

7. the sealing body (21) is designed in the form of an elastomer sealing ring with a through opening having a shape and size that matches the rod cross section of the first rod section (2) of the fitting (1); 7. The installation tool set according to claim 6,

8. the adjusting means (14) is designed in the form of a rod with a rod end realizing the joining contour (15) terminating in the face end, a first rod section (16) adjacent to the joining contour, in which the reverse thread (17) is arranged in the form of an external thread, a second rod section (19) adjacent to the first rod section (16) and having a larger rod cross section compared to the first rod section (16), and an end face (20) facing the first rod section (16) and surrounding the first rod section (16) in the radial direction; The installation tool set according to any one of claims 1 to 7, characterized in that

9. the fixed body (9) is cubic or rectangular parallelepiped in shape and has at least two opposing lateral surfaces, first and second lateral surfaces (91, 92), the through-path passing through the first and second lateral surfaces (91, 92), each lateral surface having a flat surface area oriented parallel to one another; The fixture (9) also has a third lateral surface (93) with a flat surface area oriented orthogonally with respect to the first and second lateral surfaces (91, 92), and the opening (10) passes through the third lateral surface (93). The installation tool set according to any one of claims 1 to 8, characterized in that

10. When the adjusting medium (14) is fully fitted into the opening (10) of the fixed body (9), the end face joining contour (15) of the adjusting means (14) engages with the local recess (4) of the rod-shaped assembly tool (1) in a manner that the contours match, and the end surface (20) of the adjusting means (14) has a second distance (b) relative to the surface area of ​​the third side surface (93) of the fixed body (9). The mounting set according to any one of claims 5 to 8 and claim 9, characterized in that

11. the second distance (b) corresponds maximally to the axial width measurement of an elastically deformable sealing body (22) arranged around the rod-shaped adjusting means (14) axially adjacent on one side to the fixed body (9) and on the other side to the end face (20) of the adjusting means (14); The fitting set according to claim 10, characterized in that

12. the sealing body (22) is designed in the form of an elastomer sealing ring with a through opening having a shape and size that matches the rod section of the first rod section (16) of the adjusting means (14); The fitting set according to claim 11, characterized in that

13. The recess of the receiving structure (26), made of a rigid or solidified material, comprises at least two axially opposing stop surfaces (27, 28) on which the rod end (6) of the rod-shaped mounting device (1) on the one hand and the fixed body (9) on the other hand are supported, directly or indirectly, so that the at least one electrically conductive contact ring element (24) and the at least one elastically deformable insulating sealing ring (24) are subjected to an axial joining force captured by the two axially opposing stop surfaces (27, 28). The installation tool set according to any one of claims 1 to 12, characterized in that

14. 14. A method for producing a head part of an implantable medical device, using an attachment set according to any one of claims 1 to 13, with a head part housing (29) that can be made of a hardenable injectable material and that has a blind-hole type recess, in which at least one electrically conductive contact ring element (23) and an insulating sealing ring (24) are joined to each other in a coaxial arrangement and in an axially serial arrangement along the head part in the form of a press fit under the influence of an axial joining force, comprising the following process steps: placing at least the fixing body (9), as well as the at least one electrically conductive contact ring element (23) and the at least one elastically deformable insulating sealing ring (24) along the rod-shaped mounting fixture (1); fitting the mating profile (15) of the adjustment means (14) terminating at the end face into the defined local recess (4) of the rod-shaped mounting means (1) by means of the engagement of the reverse thread (17) of the adjustment means (1) with the internal thread (13) of the fixed body (9); inserting the mounting tool (1) together with at least the fixed body (9) and at least one conductive contact ring element (23) and at least one elastically deformable insulating sealing ring (24) into the recess of the receiving structure (26) to generate an axial joining force along the at least one conductive contact ring element (23) and the at least one elastically deformable insulating sealing ring (24); injecting a flowable and hardenable potting material at least partially around at least the receiving structure (26) with the fitting (1) inserted, at least the fixing body (9), the at least one electrically conductive contact ring element (23) and the at least one electrically deformable insulating sealing ring (24), and the adjusting means (14) placed in the local recess (4) of the rod-shaped fitting means (1) by the joining body (9), so that the fitting (1) and the adjusting means (14) partially protrude from the potting material; hardening the hardenable material to form the head assembly housing (29), and separating the mounting tool (1) and the adjustment means (14) from the head assembly housing (29); A method characterized by:

15. Prior to the placing step, an elastomer sealing ring type seal (21) is fitted along the first rod section (2) of the mounting tool (1) and brought into contact with the end face (7) of the mounting tool (1).

15. The fitting set according to claim 14,

16. After the positioning step and before the fitting step, a mounting body (25) is attached to the rod end section (6) of the mounting tool (1) and together with the fixing body (9) delimits at least one electrically conductive contact ring element (23) and at least one elastically deformable insulating sealing ring (24) axially along the mounting tool (1) on both sides; the mounting body (25), together with the mounting fixture (1), at least the fixed body (9), and the at least one conductive contact ring element (23) and the at least one elastically deformable insulating sealing ring (24), are inserted into the recess of the receiving structure (26); 16. The method according to claim 14 or 15, characterized in that

17. before the joining step, a seal (22) of the elastomer sealing ring type is fitted along the first rod section (16) of the adjusting means (14) and brought into contact with the end face (20) of the adjusting means (14); The step of fitting the adjusting means (14) is carried out so that the seal (22) applied to the adjusting means (14) for the flowable potting material is in fluid-tight contact with both the fixed body (9) and the end surface (20) of the adjusting medium (14). The method according to any one of claims 14 to 16, characterized in that

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