Installation tool set for producing a head part, and method for producing a head part using the installation tool set

Abstract

The invention relates to an installation tool set for producing a head part of an implantable medical device, comprising a head part housing that can be made of a curable and pourable material and has a blind hole-type recess, along which at least one electrically conductive contact ring element and an electrically insulating and elastically deformable seal ring are joined against each other in a force-fitting manner under the effect of an axial joining force in a coaxial arrangement and in an axially serial sequence, wherein the installation tool set comprises means for fixing the axial position of a fixing body along the installation tool.

Description

[0001] Assembly tool set for producing a headboard and method for producing a headboard using the assembly tool set

[0002] Technical area

[0003] Described are an assembly tool set for producing a head part for an implantable medical device and a method for producing a head part using the assembly tool set.

[0004] State of the art

[0005] Implantable medical devices for the purpose of electrical stimulation of local intracorporeal areas, or implantable pulse generators (IPGs) for short, for example for cardiac therapeutic defibrillation, pacemaker and resynchronization applications, or for neurostimulation therapy measures such as spinal cord stimulation, brain stimulation or vagus nerve stimulation, to name just a few, generally have a self-contained housing containing components for electrical pulse generation, at least an electrical energy source and an electrical circuit structure connected to it. In addition, a so-called head section is directly connected to the housing, in which athe electrical circuit structure is connected to an electrical contact arrangement, into which a plug arrangement which is fluid-tight and terminates with the head part can be inserted, which is contacted with electrical supply and discharge lines for the purpose of the intracorporeal local application of the electrical stimulation signals and, if necessary, the supply of intracorporeally locally tapped electrical signals to the electrical circuit structure present on the housing side.

[0006] EP 2 134 418 B1 describes a generic head part of an implantable medical device, comprising two head part housing halves that can be joined along a joint seam, into which semi-cylindrical recesses are formed in a serial sequence, spaced apart by intermediate walls, into which electrically conductive contact ring elements and electrically insulating sealing rings are inserted in a serially alternating sequence. The head part assembled from the two head part housing halves thus comprises an arrangement of coaxially aligned and electrically insulated contact ring elements, for the electrical contacting of which a lateral access is provided in the head part, through which an electrical connector arrangement can be inserted in a fluid-tight manner into a cavity enclosed by all the annular contact ring elements.

[0007] The publication DE 10 2012 010 901 A1 discloses a method for positioning and holding electrical contacts and seals within a head part for electrically connecting to a medical implantable device. A blind hole-like bore is formed on one side of the head part housing, which is made of a biocompatible and electrically insulating material. Electrically conductive contact rings and annular sealing elements are inserted in alternating sequence into the bore. These sealing elements together form a cavity into which a pin-shaped connector assembly can be inserted. Each of the individual annular contact rings is connected within the head part via an electrical connecting line to electrical components located within the housing of the medically implantable device.

[0008] To ensure the most permanent, fluid-tight seal possible, as well as electrical insulation between the individual electrical contact ring elements, the alternating sequence of electrical contact ring elements and sealing rings must be secured within the head section with the greatest possible axial joining force. This requires complex assembly steps that can usually only be performed manually and with considerable dexterity.

[0009] The publication DE 202013 012 073 U1 discloses a plug-hole module assembly, for which a number of contact rings and sealing elements are arranged in alternating sequence along a pin-shaped assembly tool. Using a clamping device, all contact rings and sealing elements positioned along the assembly tool are clamped against one another by applying an axial joining force. To preserve the joining force, a sleeve element is mounted axially fixedly on the assembly tool by means of a grub screw, which, together with a sealing element, forms an axial boundary on both sides. In this clamped state, the assembly is potted with a hardenable potting compound, which absorbs the joining force when solidified.

[0010] The publication DE 10 2017 222 364 A1 describes a method for producing a head part of an implantable medical device using a rod-shaped assembly tool, along which electrically conductive contact ring elements and electrically insulating, elastically deformable sealing rings are arranged in an axially serial, alternating sequence. To establish a joining force acting axially between the ring arrangement along the assembly tool, the assembly tool has, on the one hand, a mechanical stop and, on the other hand, an external thread at its opposite end, onto which a nut or similar component can be screwed. The joining force acting along the axial ring sequence can be finely adjusted by rotating the nut around the external thread on the end of the assembly tool.The prefabricated assembly tool is then cast with a solidifiable casting compound to form the head portion. Only a small extension of the assembly tool protrudes from the solidified head portion. Rotating the assembly tool around its longitudinal axis separates it from the solidified head portion. The nut remains in the head portion as a salvage component, and the joining force acting between the axial ring sequence is absorbed and retained by the solidified casting material.

[0011] The document DE 102019203273 A1 discloses a method for producing a medical implant comprising a head part having at least one blind-hole-like recess in the manner of an electrical plug-in contact socket, along which at least one electrically conductive contact element is arranged, and a supply part fixedly connected to the head part, which has at least one electrical component, preferably in the form of a microcontroller and / or an electrical energy source, which are electrically connected to the at least one electrically conductive contact element via at least one electrical conductor structure. Comparable manufacturing methods are disclosed in the documents DE 10 2020 112 084 A1 and DE 10 2020 205 350 A1.

[0012] Description of the invention

[0013] The invention is based on the object of specifying an assembly tool set for producing a head part of an implantable medical device and a manufacturing method for a head part using an assembly tool set in such a way that the production of generic head parts for a high quality, consistent reproducibility and low error rates or few to no reject parts should be possible, in particular in large quantities.

[0014] The solution to the problem underlying the invention is specified in claim 1. The subject matter of claim 14 is a method for producing a head part of an implantable medical device using the assembly tool set according to the solution according to claim 1. Features that advantageously further develop the inventive concept are the subject matter of the subclaims and the further description with reference to the exemplary embodiments.

[0015] The invention is based on the idea of ​​identifying critical process and method steps in the manufacture of generic head parts, which particularly concern measures or work steps that must be performed in the final phase shortly before completion of the implantable medical device and, as such, can lead to maximum economic damage if errors occur, especially since a large number of time-consuming and costly manufacturing steps have already been performed. One of these critical measures concerns the separation of the assembly tool described above from the solidified casting compound, thereby creating the freely accessible, sacklock-shaped plug socket into which a pin-shaped plug part can be inserted for electrical and mechanical contact.

[0016] The assembly tool set according to the solution represents, on the one hand, a simplified handling and assembly of at least two, preferably a plurality of electrically conductive contact ring elements and electrically insulating, elastically deformable sealing rings arranged in serial axially alternating sequence and, on the other hand, enables a reliable and risk-free separation of individual assembly tool components from the solidified casting compound forming the finished head part.

[0017] The assembly tool set according to the solution for producing a head part of an implantable medical device, which has a head part housing that can be manufactured from curable, castable material and has a blind hole-like recess, along which at least one electrically conductive contact ring element and an electrically insulating, elastically deformable sealing ring are force-fitted to one another in a coaxial arrangement and axially serial sequence under axial joining force, comprises the following tool components: a rod-shaped assembly tool, a fixing body, an adjusting means and a receiving structure.

[0018] The rod-shaped assembly tool has a rod longitudinal axis and an axially extending rod surface along which a local recess is formed. The fixing body is penetrated by a through-channel with a channel longitudinal axis, through which the rod-shaped assembly tool can be passed at least along at least one first rod section associated with it. Furthermore, the fixing body has an opening that at least partially penetrates the through-channel, opens into the through-channel, and has a longitudinal opening axis oriented orthogonally to the longitudinal axis of the through-channel, around which an internal thread is arranged within the fixing body.

[0019] The alignment tool has a joining contour that ends at the front, is freely accessible and counter-contoured to the local recess within the rod-shaped assembly tool. The alignment tool also has a counter-thread that can be engaged with the internal thread of the fixing body.

[0020] The receiving structure has a recess into which the rod-shaped assembly tool, along which at least the fixing body and the at least one electrically conductive contact ring element and the at least one electrically insulating, elastically deformable sealing ring are arranged in a coaxial arrangement and axially serial sequence, can be inserted or is inserted by applying the axial joining force.

[0021] All of the above tool components represent components that must be handled and stored separately, and whose shape and size are coordinated for assembly purposes.

[0022] In a first assembly step, at least the fixing body, at least one electrically conductive contact ring element, and at least one electrically insulating, elastically deformable sealing ring are arranged along the rod-shaped assembly tool. For this purpose, the rod-shaped assembly tool has a truncated cone-shaped rod end section, to which a first rod section with a constant first rod cross-section is connected, which otherwise has an unstructured, smooth surface. In its longitudinal direction, the first rod section adjoins a second rod section, which has a larger rod cross-section than the first rod section and is also adjoined to the first rod section via an end face extending orthogonally to the rod's longitudinal axis and projecting radially beyond the first rod section in an annular manner.

[0023] Preferably, the arrangement of the fixing body, the at least one electrically conductive contact ring element, and the at least one electrically insulating, elastically deformable sealing ring along the rod-shaped assembly tool is carried out in such a way that an annular, elastically deformable sealing body is first pushed over the first rod end section of the assembly tool and brought into contact with the end face of the second rod section. The fixing body is then arranged along the first rod section, axially directly adjacent to the annular sealing body. Subsequently, a plurality of contact ring elements and sealing rings are preferably arranged along the assembly tool, each in axial alternation, forming a type of ring stack that bears against the fixing body on one side, directly or indirectly via an additional elastic intermediate ring body.

[0024] In a next assembly step, the adjusting means, which is preferably rod-shaped in the same way as the assembly tool, is guided with its joining contour ending at the front into the opening within the fixing body, which is arranged directly radially above the local recess in the axially extending rod surface of the first rod section of the assembly tool. The local recess is preferably designed as a frustoconical groove running circumferentially around the first rod section of the assembly tool, into which the joining contour of the adjusting means ending at the front engages locally and in a self-centering manner. The joining process of the rod-shaped adjusting means into the opening of the fixing body takes place while rotating the adjusting means about its longitudinal rod axis, whereby the counter thread attached to the adjusting means engages with the internal thread provided in the region of the opening of the fixing body.The joining contour of the adjusting element, which ends at the front, flows into the local, groove-shaped recess along the rod-shaped assembly tool, forming a force-locking and form-locking connection. In this joining situation, the fixing body is axially fixed along the assembly tool and also rotationally fixed around the rod's longitudinal axis.

[0025] The local, preferably groove-shaped depression in the region of the first rod section of the assembly tool 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 assembly tool and the adjusting means is inserted into the opening of the fixing body, as described above, a second defined distance is formed between the fixing body and the end face of the second rod section. This second distance corresponds at most to an axial width dimension of the sealing body designed as an elastomeric sealing ring, which is arranged around the rod-shaped assembly tool, axially abutting one side against the fixing body and the other side against the end face of the assembly tool. The sealing body designed as a sealing ring has an annular opening whose shape and size are adapted to the rod cross-section of the first rod cross-section of the assembly tool.Due to the axial two-sided surface contact of the annular sealing body on the one hand to the assembly tool side end face, and on the other hand to the sides of the fixing body, a fluid-tight joint is provided with respect to a polymeric, flowable casting material, ie when the arrangement is cast with a flowable polymeric casting material, penetration of casting material between the fixing body and the sealing body as well as between the latter and the end face is excluded.

[0026] In a further step, the assembly tool, including at least the fixing body, the at least one electrically conductive contact ring element, and the at least one electrically insulating, elastically deformable sealing ring, is inserted into the recess of the receiving structure, forming an axial joining force along the at least one electrically conductive contact ring element and the at least one electrically insulating, elastically deformable sealing ring. The axially acting joining force, initially preferably generated manually, between the individual contact ring elements and sealing rings arranged along the assembly tool is absorbed or intercepted by the receiving structure itself after insertion into the recess of the receiving structure.For this purpose, the recess of the receiving structure, which preferably consists of a rigid or solidified material, has at least two axially opposite stop surfaces, on which the rod end of the rod-shaped assembly tool or an assembly body optionally additionally arranged on it and, on the other hand, the fixing body are supported in such a way that the at least one electrically conductive contact ring element and the at least one electrically insulating, elastically deformable sealing ring are exposed to an axial joining force.

[0027] In a further step, at least one region-by-region casting of at least the receiving structure with the assembly tool inserted therein, together with at least the fixing body and the at least one electrically conductive contact ring element and the at least one electrically insulating, electrically deformable sealing ring, as well as the adjusting means joined into the local recess of the rod-shaped assembly means by means of the joining body, takes place with a flowable, solidifiable casting material in such a way that the assembly tool and the adjusting means protrude from the casting material in regions.

[0028] After the settable, preferably polymeric, material has hardened, the head housing is formed. To complete the assembly, only the rod-shaped assembly tool and the rod-shaped adjustment element need to be separated. The rod-shaped assembly tool is separated by simply applying axial tensile force along the assembly tool, especially since it is only loosely or largely loosely joined to the rest of the component assembly of the head housing being manufactured or already manufactured. Separating the adjustment element requires loosening the threaded engagement between the adjustment element and the fixing body, followed by axial removal of the adjustment element from the head housing.

[0029] In a preferred embodiment, in addition to providing a sealing body designed in the manner of an elastomeric sealing ring between the fixing body and the end face of the rod-shaped assembly tool, a corresponding sealing body is additionally arranged between the fixing body and an end face associated with the rod-shaped adjusting means. This sealing body serves to prevent the penetration of flowable cast material through the opening into the interior of the fixing body; on the other hand, the sealing body facilitates separation of the rod-shaped adjusting means from the solidified head part housing. For this purpose, the adjusting means provides a joining contour at its end face, to which a first rod section of the adjusting means adjoins, along which the mating thread in the form of an external thread is arranged.Directly adjacent to the first rod section of the adjusting means is a second rod section which, compared to the first rod section, has a larger rod cross-section and an annular end face facing the first rod section and radially surrounding it.

[0030] The fixing body is preferably cube-shaped or cuboid-shaped and has at least two opposing side surfaces, a first and a second side surface, through which the through-channel passes and each having a flat surface region oriented parallel to one another. Furthermore, the fixing body provides a third side surface with a flat surface region oriented orthogonally to the first and second side surfaces, through which the opening passes.In the case of complete joining of the rod-shaped adjusting means within the opening of the fixing body, in which the frontal joining contour engages with the local recess of the rod-shaped mounting means, a third distance remains between the frontal surface of the adjusting means and the surface area of ​​the third side surface of the fixing body, which distance corresponds at most to an axial width dimension of an elastically deformable sealing body, which is arranged around the rod-shaped adjusting means, axially abutting one side of the fixing body and the other side of the frontal surface of the adjusting means. By screwing the adjusting means into the joining body, the deformable fixing body, which preferably has a slight oversize relative to the third distance, is compressed.

[0031] Preferably, the casting process forming the head part housing is carried out with a preferably castable, polymeric casting material such that the assembly tool inserted in the receiving structure, including the aforementioned components, are completely encapsulated without wetting the areas of both the assembly tool and the adjustment means that protrude from the sealing bodies with casting material. In this way, the assembly tool and the adjustment means can be easily separated after curing and production of the head part housing.

[0032] By accurately joining the end-face joining contour of the adjusting element within the local recess along the rod surface of the rod-shaped assembly tool, the axial position of the fixing body along the assembly tool is determined, whereby the sealing body arranged on the assembly tool experiences a defined, predetermined axial compression pressure between the fixing body on one side and the end face of the assembly tool on the other side. Furthermore, this allows the joining force acting between the multitude of contact ring elements and sealing rings arranged in an axially alternating sequence along the assembly tool to be predetermined and reproducibly adjusted. This force is maintained by the geometry of the recess within the receiving structure and, in particular, the axial distance between the two axially opposing stop surfaces.

[0033] Brief description of the invention

[0034] The invention is described below without limiting the general inventive concept by means of exemplary embodiments with reference to the drawings. Therein: Fig. 1 shows a rod-shaped assembly tool with

[0035] Fixing block,

[0036] Fig. 2 perspective view of a fixing block on a

[0037] assembly tools,

[0038] Fig. 3 Joining assembly of assembly tool, fixing block and

[0039] Adjusting devices,

[0040] Fig. 4, 5 Joining representation between adjusting means and groove-shaped

[0041] Recess along the assembly tool,

[0042] Fig. 6 Support structure with components inserted therein and

[0043] Fig. 7 Illustration of a finished header housing on an implantable medical device.

[0044] Ways of implementing the invention, industrial applicability

[0045] Figure 1 shows a rod-shaped assembly tool 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, wherein the first rod cross-section along the first rod section 2 is smaller than the second rod cross-section in the second rod section 3. Along the first rod section 2 there is a local depression 4 in the form of a circumferential groove-shaped cutout, which can also be seen in more detail in Figures 4 and 5. The groove-shaped depression 4 is designed in the manner of a dovetail contour and has two side flanks 41, 42 which are angled obliquely with respect to the otherwise smooth rod surface 5 along the first rod section 2 and which also serve for the purpose of a centering and axial locking function.The first rod section 2 is delimited on the one hand by a conically blunt rod end 6 and on the other hand by an annular end face 7 projecting radially beyond the rod surface 5 of the first rod section 2.

[0046] The end opposite the conically blunt rod end 6 of the rod-shaped assembly tool 1 has a mechanically stable interface 8 to which a tool contour is attached, via which tensile forces acting at least along the rod-shaped assembly tool 1 can be introduced.

[0047] Furthermore, a fixing body 9 is pushed onto or arranged along the first rod section 2 along the rod-shaped assembly tool 1, which fixing body can also be seen in a perspective view in Figure 2. The fixing body 9, which, like the rod-shaped assembly tool 1, is made of solid material, preferably of a metallic material, has a cube-shaped or cuboid-shaped basic shape, which is completely penetrated by a through-channel through which the rod-shaped assembly tool 1 protrudes with its first rod section 2. The through-channel, which is not further visible, protrudes through the two side surfaces 91, 92 of the fixing body 9, which are oriented parallel to one another. In addition, the fixing body 9 has an opening 10, with a longitudinal opening axis 11 which passes perpendicularly through the opening 10 and is oriented orthogonal to the longitudinal axis of the through-channel and thus to the longitudinal axis 12 of the rod of the assembly tool 1.The opening 10 is adjacent to a flat side surface 93 of the fixing body 9, which is also oriented orthogonally to the side surfaces 91, 92.

[0048] Furthermore, an internal thread 13 is provided on the inside of the fixing body 9, directly adjacent to the opening 10, around the opening's longitudinal axis 11.

[0049] In Figure 3, in addition to the rod-shaped assembly tool 1 and the fixing body 9 arranged along the first rod section 2 of the assembly tool 1, a rod-shaped adjusting means 14 is illustrated, which at its end is inserted into the opening 10 of the

[0050] Fixing body 9 protrudes and is in a firm joint connection with it.

[0051] Figures 4 and 5 each show detailed representations to illustrate the joining connection between the adjusting means 14, the fixing body 9 and the assembly tool 1.

[0052] The rod-shaped adjusting means 14 has a front-side joining contour 15 at its rod end, which is shaped to counter-contour the groove-shaped, local recess 4. Thus, the front-side joining contour 15 also has beveled side flanks 15.1, 15.2, the bevel of which corresponds to the side flanks 41, 42 of the local recess 4.

[0053] Directly adjoining the frontal joining contour 15 is a first rod section 16 of the adjusting means 14, along which an external thread 17 is arranged, which is designed as a counter-thread to the internal thread 13 within the fixing body 9 and can be brought into engagement therewith by rotating the adjusting means 14 about its rod longitudinal axis 18.

[0054] Directly adjoining the first rod section 16 of the adjusting means 14 is a second rod section 19 having a larger rod cross-section than the first rod section 16, so that an annular end face 20 is provided facing the first rod section 16 and radially surrounding it.

[0055] Figure 5 illustrates the mounted state of the rod-shaped adjusting means 14 by means of the fixing body 9 on the rod-shaped assembly tool 1. The opening 10 of the fixing body 9 is located radially centrally above the local recess 4, into which the front-side joining contour 15 is releasably and firmly joined by means of a threaded connection between the adjusting means 14 and the fixing body 9, forming a positive and non-positive connection. The fixing body 9 is thus, on the one hand, axially fixed relative to the rod-shaped assembly tool 1 and, on the other hand, fixed to the assembly tool 1 in a rotationally fixed manner due to the contact forces prevailing between the front-side joining contour 15 and the local recess 4.

[0056] The spatial arrangement of the recess 4 along the rod-shaped assembly tool 1 relative to its end face 7 as well as the geometric lateral dimensions of the fixing body 9 are coordinated with one another in such a way that, in the joined state, a distance a is provided between the side surface 92 of the fixing body 9 and the end face 7 of the assembly tool 1. Similarly, a corresponding distance b is provided between the side surface 93 of the fixing body 9 and the end face 20 of the adjusting means 14. Both distances a, b allow the additional insertion of a sealing body 21, 22, each of which is designed as an elastomeric sealing ring. Thus, on the one hand, the sealing body 21 sits along the rod-shaped assembly tool 1 and borders on the side surface 92 of the fixing body 9 on the one hand and on the end face 7 of the rod-shaped assembly tool 1 in a fluid-tight manner.Similarly, the second annular sealing body 22 sits along the first rod section 16 of the adjusting means 14 and borders, on the one hand, the side surface 93 of the fixing body 9 and, on the other hand, the end surface 20 of the adjusting means 14 in a fluid-tight manner. The distances a, b as well as the width dimensions of the annular sealing bodies 21, 22 are coordinated with one another in such a way that elastomeric compression of both sealing bodies 21, 22 ensures at least a fluid-tight surface seal with respect to a flowable polymeric casting compound.

[0057] Figure 6 shows an arrangement which shows the assembled state of the adjusting means 14 by means of the fixing body 9 with the rod-shaped assembly tool 1, wherein the annular sealing body 22 is arranged between the adjusting means 14 and the fixing body 9 and the annular sealing body 21 is arranged between the fixing body 9 and the rod-shaped assembly tool 1, each subjected to a pressing force.

[0058] In addition, along the first rod section 2 of the rod-shaped

[0059] Assembly tool 1, a plurality of electrically conductive contact ring elements 23 and electrically insulating, elastically deformable sealing rings 24 are arranged in an axially alternating sequence. The conical, blunt rod end 6 of the rod-shaped assembly tool 1 is loosely inserted on one side into an assembly body 27, by means of which an axially acting joining force can be generated by manually axially pressing the serial axial sequence of contact ring elements and sealing rings 23, 24. In this axially compressed state, the arrangement is inserted into the recess of a receiving structure 26, which essentially has two axially opposite stop surfaces 27, 28, against which the assembly body 25 on the one hand and the fixing body 9 on the other hand can be brought into mutually supporting contact, so that the receiving structure 26 can absorb the joining force.

[0060] The recess otherwise provided within the receiving structure 26 is correspondingly adapted to the outer contour of the axial sequence of the contact ring elements and sealing rings 23, 24 as well as to the fixing body 9 with a counter-contour. The receiving structure 26 preferably consists of a solidified potting material that is used to form the head part housing 29 shown in Figure 7 by means of a casting process. The casting process encloses the receiving structure 26 with all components joined therein and preferably forms a fluid-tight seal against the annular sealing body 21, 22, so that the second rod sections 3, 19 of the assembly tool 1 and the adjusting means 14 are not enclosed by the casting material during the casting process.This considerably facilitates the separation of the assembly tool 1 and the adjustment means 14 from the arrangement, resulting in the head part housing 29 shown in Figure 7, which is seated on a medically active implantable device 30. List of reference symbols: rod-shaped assembly tool, first rod section, second rod section, local recess, 42, oblique side flank.

[0061] Rod surface

[0062] Bar end

[0063] frontal surface

[0064] interface

[0065] Fixing body ,92,93 side surface

[0066] opening

[0067] Opening longitudinal axis

[0068] Through-channel longitudinal axis, rod longitudinal axis

[0069] internal thread

[0070] Adjusting means frontal joining contour .1 ,15.2 Side flank first bar section

[0071] external thread

[0072] Bar longitudinal axis second bar section

[0073] Front face 21 , 22 Sealing body a, b Distance

[0074] 23 electrically conductive contact ring element

[0075] 24 electrically insulating, elastically deformable sealing ring

[0076] 25 mounting bodies

[0077] 26 Recording structure

[0078] 27, 28 Stop surface

[0079] 29 headboard housing

[0080] 30 implantable devices

Claims

Patent claims 1. Assembly tool set for producing a head part of an implantable medical device, with a head part housing (29) which can be manufactured from a hardenable, castable material and which has a blind hole-like recess along which at least one electrically conductive contact ring element (23) and an electrically insulating, elastically deformable sealing ring (24) are non-positively joined to one another in a coaxial arrangement and axially serial sequence under axial joining force, comprising the following tool components: rod-shaped assembly tool (1) with a rod longitudinal axis (12) and an axially extending rod surface (5) along which a local recess (4) is introduced, Fixing body (9) which is penetrated by a through-channel having a channel longitudinal axis, through which the rod-shaped assembly tool (1) can be guided at least along at least one first rod section (2) assigned thereto and into which an opening (10) opens which at least partially penetrates the fixing body (9) and has an opening longitudinal axis (11) oriented orthogonally to the channel longitudinal axis, around which an internal thread (13) is arranged within the fixing body (9), Adjusting means (14) with a joining contour (15) ending at the front, which is designed to be counter-contoured to the local recess (4) in the rod-shaped mounting means (1), as well as a counter-thread (17) which can be brought into engagement with the internal thread (13) of the fixing body (9), and Receiving structure (26) with a recess into which the rod-shaped assembly tool (1), along which at least the fixing body (9) and the at least one electrically conductive contact ring element (23) and the one electrically insulating, elastically deformable sealing ring (24) are arranged in a coaxial arrangement and axially serial sequence, can be inserted by applying the axial joining force.

2. Assembly tool set according to claim 1, characterized in that the local recess (4) is arranged in the region of the first rod section (2), that the first rod section (2) assigned to the rod-shaped assembly tool (1), with the exception of the local recess (4), otherwise has a constant first rod cross-section and is delimited on the one hand by a rod end section (6) of the assembly tool (1) and on the other hand by a second rod section (3) with a second rod cross-section which is larger than the first rod cross-section, and that the second rod section (3) adjoins the first rod section (2) via an end face (7) extending orthogonally to the rod longitudinal axis (12).

3. Assembly tool set according to claim 1, characterized in that the local recess (4) is designed in the manner of a frustoconical groove running circumferentially around the first rod section.

4. Assembly tool set according to claim 2 or 3, characterized in that the rod end section (6) of the assembly tool (1) is frustoconical and has an unstructured, smooth surface (6).

5. Assembly tool set according to one of claims 2 to 4, characterized in that the local recess (4) is arranged relative to the end face (7) of the second rod section (3) along the rod longitudinal axis (12) in such a way that when the fixing body (9) is arranged along the rod-shaped assembly tool (1) and the adjusting means (14) is inserted into the opening (10) of the fixing body (9) in such a way that the joining contour (15) of the adjusting means (14) ending at the end face opens into the local recess (4) along the rod-shaped assembly tool (1) and forms a force and form fit with it. forms, a first distance (a) is provided between the fixing body (9) and the end face (7) of the second rod section (3) of the assembly tool (1).

6. Assembly tool set according to claim 5, characterized in that the first distance (a) corresponds at most to an axial width dimension of an elastically deformable sealing body (21) which is arranged around the rod-shaped assembly tool (1) in each case axially on one side on the fixing body (9) and on the other hand on the end face (7) of the assembly tool (1).

7. Assembly tool set according to claim 6, characterized in that the sealing body (21) is designed in the manner of an elastomeric sealing ring, with a passage opening whose shape and size are adapted to the rod cross-section of the first rod section (2) of the assembly tool (1).

8. Assembly tool set according to one of claims 1 to 7, characterized in that the adjusting means (14) is rod-shaped, with a rod end which provides the joining contour (15) ending at the front, a first rod section (16) adjoining the joining contour, along which the counter thread (17) is arranged in the form of an external thread, and with a second rod section (19) adjoining the first rod section (16), which second rod section has a larger rod cross-section than the first rod section (16) and an end face (20) facing the first rod section (16) and radially surrounding it.

9. Assembly tool set according to one of claims 1 to 8, characterized in that the fixing body (9) is cube-shaped or cuboid-shaped is formed and has at least two opposing side surfaces (91, 92), a first and a second side surface which are penetrated by the through-channel and each have a flat surface area which are oriented parallel to one another, and in that the fixing body (9) provides a third side surface (93) with a flat surface area which is oriented orthogonally to the first and second side surfaces (91, 92) and which is penetrated by the opening (10).

10. Assembly tool set according to one of claims 5 to 8 and according to claim 9, characterized in that when the adjusting means (14) is completely joined within the opening (10) of the fixing body (9), in which the frontal joining contour (15) of the adjusting means (14) engages in the local recess (4) of the rod-shaped assembly tool (1) in a contour-true manner, the front surface (20) of the adjusting means (14) has a second distance (b) from the surface area of ​​the third side surface (93) of the fixing body (9).

11. Assembly tool set according to claim 10, characterized in that the second distance (b) corresponds at most to an axial width dimension of an elastically deformable sealing body (22) which is arranged around the rod-shaped adjusting means (14) in axially one side on the fixing body (9) and on the other side on the end face (20) of the adjusting means (14).

12. Assembly tool set according to claim 11, characterized in that the sealing body (22) is designed in the manner of an elastomeric sealing ring, with a passage opening whose shape and size is adapted to the rod cross-section of the first rod cross-section (16) of the adjusting means (14) 13. Assembly tool set according to one of claims 1 to 12, characterized in that the recess of the receiving structure (26) consisting of a rigid or solidified material has at least two axially opposite stop surfaces (27, 28) on which the rod end (6) of the rod-shaped assembly tool (1) and on the other hand the fixing body (9) are supported in such a way that the at least one electrically conductive contact ring element (23) and the one electrically insulating, elastically deformable sealing ring (24) are exposed to an axial joining force which is absorbed by the two axially opposite stop surfaces (27, 28).

14. A method for producing a head part of an implantable medical device, comprising a head part housing (29) which can be manufactured from a solidifiable, castable material and which has a blind hole-like recess, along which at least one electrically conductive contact ring element (23) and an electrically insulating, elastically deformable sealing ring (24) are non-positively joined to one another in a coaxial arrangement and axially serial sequence under axial joining force, using an assembly tool set according to one of claims 1 to 13, characterized by the following method steps: Arranging at least the fixing body (9) and the at least one electrically conductive contact ring element (23) and the at least one electrically insulating, elastically deformable sealing ring (24) along the rod-shaped assembly tool (1), Joining the joining contour (15) of the adjusting means (14) ending at the front into the counter-contoured local recess (4) in the rod-shaped mounting means (1) by means of engagement of the counter-thread (17) of the adjusting means (1) with the internal thread (13) of the fixing body (9), Inserting the assembly tool (1) together with at least the fixing body (9) and the at least one electrically conductive contact ring element (23) and the at least one electrically insulating, elastically deformable sealing ring (24) into the recess of the receiving structure (26) while forming an axial joining force along the at least one electrically conductive contact ring element (23) and the at least one electrically insulating, elastically deformable sealing ring (24), Casting at least partially around at least the receiving structure (26) with the assembly tool (1) inserted therein, together with at least the fixing body (9) and the at least one electrically conductive contact ring element (23) and the at least one electrically insulating, elastically deformable sealing ring (24) and the adjusting means (14) joined by means of the joining body (9) into the local recess (4) of the rod-shaped assembly means (1), with a flowable, solidifiable casting material in such a way that the assembly tool (1) and the adjusting means (14) protrude partially from the casting material, and Hardening of the solidifiable material to form the head part housing (29) and separating the assembly tool (1) and adjusting means (14) from the head part housing (29).

15. Method according to claim 14, characterized in that before the arrangement, a sealing body (21) in the manner of an elastomeric sealing ring is joined along the first rod cross-section (2) of the assembly tool (1) and brought into contact with the end face (7) of the assembly tool (1).

16. Method according to claim 14 or 15, characterized in that after the arrangement and before the joining on the rod end section (6) of the assembly tool (1) a mounting body (25) is placed, which together with the fixing body (9) axially delimits the at least one electrically conductive contact ring element (23) and the at least one electrically insulating, elastically deformable sealing ring (24) along the assembly tool (1) on both sides, and that the mounting body (25) together with the mounting tool (1) together with at least the fixing body (9) and the at least one electrically conductive contact ring element (23) and the at least one electrically insulating, elastically deformable sealing ring (24) is inserted into the recess of the receiving structure (26).

17. Method according to one of claims 14 to 16, characterized in that before joining, a sealing body (22) in the manner of an elastomeric sealing ring is joined 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), and in that the joining of the adjusting means (14) is carried out in such a way that the sealing body (22) attached to the adjusting means (14) for the flowable casting material rests in a fluid-tight manner both on the fixing body (9) and on the end face (20) of the adjusting means (14).

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