Assembly tool kit for manufacturing head part and method for manufacturing head part using assembly tool kit

Abstract

The invention relates to an assembly tool kit for producing a head part of an implantable medical device, comprising a head part housing which can be produced from a curable casting material and which has a blind-hole-shaped recess, at least one electrically conductive contact ring element and an electrically insulating, elastically deformable sealing ring are in force-fitting engagement with each other in a coaxial arrangement and in an axial series sequence under the action of an axial engagement force along the slot, and the assembly tool kit comprises means for determining the axial position of the fixing body along the assembly tool.

Description

Technical Field

[0001] An assembly tool kit for making a head component of an implantable medical device and a method of making a head component using the assembly tool kit are described. Background Art

[0002] Implantable medical devices for electrical stimulation of local internal body regions, referred to as implantable pulse generators (IPGs), for example for defibrillation, pacing and resynchronization applications in cardiac therapy, for neurostimulation therapy measures (such as spinal cord stimulation, brain stimulation or vagus nerve stimulation, to name a few), usually have a self-enclosed housing in which components for electrical pulse generation, i.e. at least one electrical energy source and a circuit structure connected thereto, are contained. Furthermore, a so-called head part is directly connected to the housing, in which an electrical contact assembly connected to the energy source or the circuit structure is integrated, into which a plug assembly terminating in a fluid-tight manner with the head part can be engaged, which plug assembly is in contact with the supply and discharge lines in order to apply electrical stimulation signals locally in the body and, if necessary, to supply electrical signals intercepted locally in the body to the circuit structure present on the housing side.

[0003] Document EP 2 134 418 B1 describes a head part of this type for an implantable medical device, which includes two head part housing halves that can be joined together along a seam, into which semi-cylindrical notches are introduced in a series sequence, each separated by an intermediate wall, into which conductive contact ring elements and electrically insulating sealing rings are inserted in a series alternating sequence. Thus, the head part formed by joining the two head part housing halves includes an arrangement of contact ring elements that are coaxially oriented and electrically insulated from one another, and a lateral inlet is provided in the head part for the electrical contact of the contact ring elements, through which the electrical plug assembly can be inserted in a fluid-tight manner into a cavity surrounded by all annular contact ring elements.

[0004] Document DE 10 2012 010 901 A1 discloses a method for positioning and holding electrical contacts and seals in a head part for electrical contact with an implantable medical device. On one side, a blind hole-like borehole is introduced into the housing of the head part made of a biocompatible and electrically insulating material, into which an electrically conductive contact ring and an annular seal are introduced in an alternating sequence, which together surround a cavity into which a pin-shaped plug assembly can be inserted. Each of the individual annular contact rings is connected in the head part via an electrical connection line to an electrical component located in the housing of the implantable medical device.

[0005] In order to achieve a fluid-tight seal that is as long-lasting as possible and also to achieve electrical insulation of the individual electrical contact ring elements from one another, it is necessary to fix the alternating sequence of electrical contact ring elements and sealing rings in the head part with the greatest possible axial engagement force. This requires complex assembly measures that can usually only be performed manually and with considerable finger dexterity.

[0006] Document DE 20 2013 012 073 U1 discloses a plug-in module assembly, for which a plurality of contact rings and sealing elements are arranged in alternating order along a pin-shaped assembly tool. By means of a clamping device, all contact rings and sealing elements installed along the assembly tool are clamped to each other under application of an axial engagement force. A sleeve element, which is axially fixedly mounted on the assembly tool by means of a countersunk screw, serves to maintain the engagement force and is axially limited on both sides together with the sealing element. In this clamped state, the assembly is cast using a hardenable casting compound, which absorbs the engagement force in the solidified state.

[0007] Document DE 10 2017 222 364 A1 describes a method for manufacturing a head component of an implantable medical device using a rod-shaped assembly tool, along which conductive contact ring elements and electrically insulating, elastically deformable sealing rings are arranged in an axially series alternating sequence. In order to establish a joining force acting axially between the ring arrangements along the assembly tool, the assembly tool has a mechanical stop on the one hand, and on the other hand, has an external thread on the end of the assembly tool opposite to the mechanical stop, onto which a nut or the like can be screwed. The joining force acting along the axial ring sequence can be finely metered by rotating the nut around the end-side external thread on the assembly tool. When constructing the head component, the assembly tool prefabricated in this way is subsequently cast with a curable potting compound, wherein only a small continuation of the assembly tool protrudes from the head component formed after curing. By rotating the assembly tool about its longitudinal axis, it is released from the solidified head part, the nut remaining as a lost component in the head part and the joining forces acting between the axial ring sequences being absorbed and maintained by the solidified casting material.

[0008] Document DE 10 2019 203 273 A1 discloses a method for producing a medical implant having a head part with at least one blind hole-shaped slot in the form of an electrical plug contact sleeve, 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 is electrically connected to the at least one electrically conductive contact element via at least one electrical conductor structure. Similar production methods are disclosed in documents DE 10 2020 112 084 A1 and DE 10 2020 205 350 A1. Summary of the invention

[0009] The invention is based on the following object: to provide an assembly tool kit for producing a head part of an implantable medical device and a method for producing a head part using the assembly tool kit, so that the production of such a head part should be possible, especially in large-scale production, with high quality, consistent reproducibility and low error rates or few or even no scrap parts.

[0010] The solution to the problem on which the invention is based is given in claim 1. The subject matter of claim 14 is a method for producing a head part of an implantable medical device using an assembly tool kit according to the solution according to claim 1. Features that expand the inventive concept in an advantageous manner are the subject matter of the dependent claims and can be gathered from the further description with reference to the exemplary embodiments.

[0011] The invention is based on the idea that critical process and method steps in the production of such head components are, in particular, measures or work steps that should be performed in the final stage shortly before the completion of the production of the implantable medical device and that can lead to the greatest economic losses in the event of an error, primarily because a large number of time-consuming and expensive production steps have already been performed. One of these critical measures involves separating the previously described assembly tool from the solidified casting material, thereby forming a freely accessible blind hole-shaped socket into which a pin-shaped plug-in can engage for the purpose of achieving electrical and mechanical contacting.

[0012] The assembly tool kit according to the present solution, on the one hand, illustrates simplified handling and assembly of at least two, preferably more, electrically conductive contact ring elements and electrically insulating, elastically deformable sealing rings arranged in an axially series alternating sequence, and on the other hand enables reliable and risk-free separation of the individual assembly tool components from the solidified potting material forming the finished head component.

[0013] According to the present solution, an assembly tool kit for manufacturing a head component of an implantable medical device comprises the following tool components: a rod-shaped assembly tool, a fixing body, an adjustment device and a receiving structure, wherein the medical device has a head component shell that can be made of a hardenable casting material, the head component shell having a blind hole-shaped slot, at least one conductive contact ring element and an electrically insulating, elastically deformable sealing ring are force-lockedly engaged with each other along the slot in a coaxial arrangement and in an axial series sequence under the action of an axial engagement force.

[0014] The rod-shaped assembly tool has a rod longitudinal axis and an axially extending rod surface, along which the local recess is introduced. The fixing body is penetrated by a through-channel having a channel longitudinal axis, and the rod-shaped assembly tool can be passed through the through-channel at least along at least one first rod section assigned to the rod-shaped assembly tool. In addition, the fixing body has an opening that at least partially penetrates the fixing body, the opening leads into the through-channel and has an opening longitudinal axis oriented orthogonally to the channel longitudinal axis of the through-channel, and the internal thread is arranged in the fixing body around the opening longitudinal axis.

[0015] The adjusting device has an engagement profile that ends at the end side, which is freely accessible and configured to correspond to the local recessed profile in the rod-shaped assembly device. In addition, the adjusting device also has a mating thread that can cooperate with the internal thread of the fixing body.

[0016] The receiving structure has a slot, into which a rod-shaped assembly tool can be inserted or inserted under application of an axial engagement force, along which at least the fixing body and the at least one electrical contact ring element and the at least one electrically insulating, elastically deformable sealing ring are arranged in a coaxial arrangement and in an axially serial sequence.

[0017] All of the above-mentioned tool parts are presented as individually manipulable and storable components, the shapes and sizes of which are coordinated with one another for assembly purposes.

[0018] In a first assembly step, at least the fixing body and at least one electrically conductive contact ring element and at least one electrically insulating, elastically deformable sealing ring are arranged along a 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. The first rod section adjoins a second rod section in its longitudinal direction, which second rod section has a larger rod cross section than the first rod section and adjoins the first rod section via an end face extending orthogonally to the rod longitudinal axis and which protrudes radially from the first rod section in an annular manner.

[0019] Preferably, 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 along the rod-shaped assembly tool in such a way that the annular elastically deformable sealing body is first pushed onto the first rod end section of the assembly tool and abuts against the end face of the second rod section. Subsequently, the fixing body is arranged along the first rod section so as to be axially directly adjacent to the annular sealing body. Subsequently, preferably a plurality of contact ring elements and sealing rings are arranged along the assembly tool in an axially alternating manner, the plurality of contact ring elements and sealing rings forming a kind of ring stack, which abuts against the fixing body on one side directly or indirectly via an additional elastic intermediate ring body.

[0020] In the next assembly step, the adjusting device, which is preferably rod-shaped like the assembly tool, is introduced into the opening in the fixed body with its engagement contour terminating at the end side, which is arranged radially above the local recessed portion in the axially extending rod surface of the first rod section of the assembly tool. The local recessed portion is preferably constructed in the form of a truncated cone-shaped groove around the first rod section of the assembly tool in the circumferential direction, and the engagement contour of the adjusting device terminating at the end side is locally and self-centeringly fitted into the groove. The engagement process of the adjusting device of the rod-shaped structure to the opening of the fixed body is realized when the adjusting device rotates around its rod longitudinal axis, so that the mating thread arranged on the adjusting device enters into engagement with the internal thread arranged in the area of ​​the opening of the fixed body. Here, in the case of constructing a force-locking connection and a form-locking connection, the engagement contour of the adjusting device terminating at the end side passes into the local groove-shaped recessed portion along the rod-shaped assembly tool. In this engagement, the fixed body is fixed or locked axially along the assembly tool and is also fixed or locked in a torsion-proof manner around the rod longitudinal axis of the assembly tool.

[0021] The local (preferably groove-shaped) recess in the region of the first shaft section of the assembly tool is arranged at a first defined distance from the end face of the second shaft section, so that when the fixing body is arranged along the rod-shaped assembly tool and the adjusting device is engaged in the opening of the fixing body (as described above), a defined second distance is formed between the fixing body and the end face of the second shaft section. It is precisely this second distance that corresponds at most to the axial width dimension of the sealing body formed in the form of an elastomeric sealing ring, which is arranged around the rod-shaped assembly tool so as to axially abut on the fixing body on one side and on the end face of the assembly tool on the other side. The sealing body formed in the form of an elastomeric sealing ring has an annular opening, the shape and size of which are adapted to the shaft cross section of the first shaft section of the assembly tool. Due to the axial two-sided planar contact of the annular sealing body with the end face on the assembly tool side on the one hand and with the side face of the fixing body on the other hand, a fluid-tight connection with respect to the polymer flowable casting material is produced, that is, when the arrangement is encapsulated with the flowable polymer casting material, the penetration of the casting material between the fixing body and the sealing body and between the sealing body and the end face is excluded.

[0022] In a further step, the assembly tool together with 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 is inserted into the notch of the receiving structure while an axial engagement force is being generated along the at least one electrically conductive contact ring element and the at least one electrically insulating, elastically deformable sealing ring. The engagement forces, which are first preferably manually generated, acting axially between the individual contact ring elements and the sealing rings arranged along the assembly tool are absorbed or intercepted by the receiving structure itself after insertion into the notch of the receiving structure. For this purpose, the notch of the receiving structure, which is preferably made of a rigid or solidifying material, has at least two axially opposite stop surfaces, on which the rod end of the rod-shaped assembly tool or the optionally additionally arranged assembly body on the rod end is supported indirectly or directly on one side and the fixing body is supported on the other side, so that the at least one electrically conductive contact ring element and the one electrically insulating, elastically deformable sealing ring are subjected to an axial engagement force.

[0023] In a further step, at least the receiving structure together with the assembly tool inserted therein together with at least the fixing body as well as the at least one electrically conductive contact ring element and the at least one electrically insulating, elastically deformable sealing ring and the adjusting device engaged in the local recessed portion of the rod-shaped assembly device by means of a coupling body are at least partially encapsulated with a flowable, curable casting material so that the assembly tool and the adjusting device partially protrude beyond the casting material.

[0024] After the curable material, preferably a polymer material, has hardened, a head housing is formed, which can be completed by simply separating the rod-shaped assembly tool and the rod-shaped adjustment device from the head housing. The separation of the rod-shaped assembly tool is achieved only by means of an axial pulling force along the assembly tool, mainly because the rod-shaped assembly tool is only loosely or largely loosely engaged in the remaining component assembly structure of the head housing to be manufactured or manufactured. In order to separate the adjustment device, it is necessary to loosen the threaded fit between the adjustment device and the fixing body and then remove the adjustment device axially from the head housing.

[0025] In a preferred embodiment, similar to the sealing body constructed in the form of an elastomeric sealing ring between the fixed body and the end face of the rod-shaped assembly tool, a corresponding sealing body is additionally arranged between the fixed body and the end face assigned to the rod-shaped adjusting device. The sealing body is also used to prevent the flowable casting material from entering the interior of the fixed body through the opening. On the other hand, the sealing body can easily separate the rod-shaped adjusting device from the head component housing after solidification. For this purpose, the adjusting device is provided with a joint contour terminating at the end side on its rod end, and the first rod section of the adjusting device is connected to the joint contour, and a mating thread in the form of an external thread is arranged along the first rod section. The second rod section is adjacent to the first rod section of the adjusting device, and the second rod section has a larger rod cross section than the first rod section and has an annular end face facing the first rod section and radially surrounding the first rod section.

[0026] The fixing body is preferably designed in a cubic or cuboid shape and has at least two opposite side faces, namely a first side face and a second side face, which are penetrated by a through-channel and each have a flat surface area oriented parallel to one another. In addition, the fixing body is provided with a third side face, which has a flat surface area oriented orthogonally to the first and second side faces and penetrated by an opening. In the case of complete engagement of the rod-shaped adjusting element in the opening of the fixing body, in which case the end-side engagement contour fits into the local recess of the rod-shaped mounting element in a contour-accurate manner, a third spacing is left between the end face of the adjusting element and the surface area of ​​the third side face of the fixing body, which third spacing corresponds at most to the axial width dimension of the elastically deformable sealing body, which is arranged around the rod-shaped adjusting element so as to axially abut on the fixing body on one side and on the end face of the adjusting element on the other side. By screwing the adjusting element into the engaging body, the deformable fixing body is compressed, which deformable fixing body preferably has a slightly larger size than the third spacing.

[0027] Preferably, the casting process for forming the head part housing is carried out with a preferably castable polymer casting material, so that the assembly tool inserted into the receiving structure is completely enclosed together with the aforementioned components, without the need to wet the areas of the assembly tool and the adjusting device protruding from the sealing body with the casting material. In this way, after the head part housing has been hardened and manufactured, the adjusting device can also be easily separated by the assembly tool.

[0028] By engaging the end-end engagement contour of the adjusting element in the local recess in a contour-accurate manner along the shank surface of the shank-shaped assembly tool, the axial position of the fixing body along the assembly tool is determined, so that the sealing body arranged on the assembly tool is subjected to a defined, predetermined axial compressive pressure between the fixing body on the one hand and the end face of the assembly tool on the other hand. In addition, in this way, the engagement force acting between a plurality of contact ring elements and the sealing ring arranged in an axially alternating sequence along the assembly tool can be predetermined and reproducibly set, which engagement force is maintained by the geometry of the notch in the receiving structure and, in particular, the geometry of the axial spacing of two axially opposite stop surfaces. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] In the following, without limiting the general inventive concept, the present invention is exemplarily described based on embodiments with reference to the accompanying drawings. It shows:

[0030] Figure 1 a rod-shaped assembly tool with a fixing block arranged thereon,

[0031] Figure 2 Perspective view of the fixing block on the assembly tool,

[0032] Figure 3 The joint combination structure consisting of assembly tools, fixing blocks and adjustment devices,

[0033] Figure 4 , 5 Illustration of the engagement between the adjusting means and the groove-shaped recess along the mounting tool,

[0034] Figure 6 a receiving structure with a component inserted therein, and

[0035] Figure 7 Illustration of a finished head piece housing on an implantable medical device. DETAILED DESCRIPTION

[0036] Embodiments and Industrial Applicability of the Invention

[0037] Figure 1A rod-shaped assembly tool 1 is shown, which has a first rod section 2 and an adjoining 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 dimensioned to be smaller than the second rod cross section in the second rod section 3. A local recess 4 in the form of a circumferential groove-like notch is introduced along the first rod section 2, which is located at the bottom of the rod section 3. Figure 4 and 5 The groove-like recess 4 is designed in the form of a dovetail profile and has two side edges 41 , 42 that are angled along the first shaft section 2 relative to the otherwise smoothly designed shaft surface 5 and that also serve the function of centering and axial locking.

[0038] The first shaft section 2 is delimited on the one hand by a frustoconical shaft end 6 and on the other hand by an annular end face 7 which projects radially beyond the shaft surface 5 of the first shaft section 2 .

[0039] The end opposite the frustoconical shank end 6 of the shank-shaped assembly tool 1 has a mechanically stable interface 8 , on which a tool contour is seated, via which tensile forces acting at least along the shank-shaped assembly tool 1 can be introduced.

[0040] Furthermore, along the first shaft section 2, a fixing body 9 is pushed or arranged along the shaft-shaped assembly tool 1, which fixing body can also be seen in the perspective view. Figure 2 . The fixing body 9, which is also made of solid material (preferably metal material) like the rod-shaped assembly tool 1, has a basic shape in the form of a cube or cuboid, 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 (not further visible) here extends through two mutually parallel oriented side surfaces 91, 92 of the fixing body 9. In addition, the fixing body 9 has an opening 10 with an opening longitudinal axis 11 extending perpendicularly through the opening 10 and oriented orthogonally to the through-channel longitudinal axis and thus to the rod longitudinal axis 12 of the assembly tool 1. The opening 10 adjoins a flat side surface 93 of the fixing body 9, which is also oriented orthogonally to the side surfaces 91, 92.

[0041] Furthermore, an internal thread 13 is introduced on the inner side of the fixing body 9 immediately adjacent to the opening 10 and around the longitudinal axis 11 of the opening.

[0042] exist 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 element 14 is shown which projects at one end into the opening 10 of the fixing body 9 and is fixedly connected thereto.

[0043] exist Figure 4 and Figure 5Detailed illustrations are shown in each case in order to illustrate the joining connection between the adjusting means 14 , the fixing body 9 and the assembly tool 1 .

[0044] The rod-shaped adjusting means 14 has an end-side engagement contour 15 on its rod end, which is shaped corresponding to the contour of the groove-shaped partial recess 4. Therefore, the end-side engagement contour 15 also has chamfered side edges 15.1, 15.2, the chamfers of which correspond to the side edges 41, 42 of the partial recess 4.

[0045] Adjoining the end-side engagement contour 15 is a first shaft section 16 of the adjustment means 14 , along which an external thread 17 is arranged which is designed as a mating thread relative to the internal thread 13 in the fixing body 9 and can cooperate with the internal thread by rotating the adjustment means 14 about its shaft longitudinal axis 18 .

[0046] A second shaft section 19 having a larger shaft cross section than the first shaft section 16 adjoins the first shaft section 16 of the adjusting means 14 , so that an annular end face 20 is provided which faces the first shaft section 16 and radially surrounds the same.

[0047] Figure 5 The figure shows the assembled state of the rod-shaped adjusting means 14 on the rod-shaped assembly tool 1 by means of the fixing body 9. Here, the opening 10 of the fixing body 9 is located radially centered above the partial recess 4, and the end-side engagement contour 15 is releasably fixedly engaged in the partial recess by means of a positive and non-positive engagement structure between the adjusting means 14 and the fixing body 9. Therefore, the fixing body 9 is, on the one hand, axially fixedly locked relative to the rod-shaped assembly tool 1, and, on the other hand, is fixed to the assembly tool 1 in a rotationally fixed manner due to the pressing force between the end-side engagement contour 15 and the partial recess 4.

[0048] The spatial arrangement of the recessed portion 4 along the rod-shaped assembly tool 1 relative to its end face 7 and the geometric lateral dimensions of the fixing body 9 are coordinated with each other so that in the joined state, a spacing a is provided between the side face 92 of the fixing body 9 and the end face 7 of the assembly tool 1. In a similar manner, a corresponding spacing b is provided between the side face 93 of the fixing body 9 and the end face 20 of the adjusting device 14. Both spacings a, b allow the additional insertion of corresponding sealing bodies 21, 22, which are each configured as an elastomeric sealing ring. Thus, on the one hand, the sealing body 21 is placed along the rod-shaped assembly tool 1 and is adjacent to the side face 92 of the fixing body 9 on the one hand and to the end face 7 of the rod-shaped assembly tool 1 on the other hand in a fluid-tight manner. In a similar manner, the second annular sealing body 22 is placed along the first rod section 16 of the adjusting device 14 and is adjacent to the side face 3 of the fixing body 9 on the one hand and to the end face 20 of the adjusting device 14 on the other hand in a fluid-tight manner. The distances a, b and the width dimensions of the annular sealing bodies 21 , 22 are coordinated with one another so that at least a fluid-tight surface seal with respect to the flowable polymer potting compound is ensured by the elastomeric compression of the two sealing bodies 21 , 22 .

[0049] exist Figure 6 , an assembly is shown which shows the assembled state of the adjusting device 14 with the aid of the fixing body 9 and the rod-shaped assembly tool 1, wherein an annular sealing body 22 and an annular sealing body 21 are arranged between the adjusting device 14 and the fixing body 9 and between the fixing body 9 and the rod-shaped assembly tool 1 in a manner loaded with pressing force.

[0050] In addition, a plurality of electrically conductive contact ring elements 23 and electrically insulating, elastically deformable sealing rings 24 are arranged in an axially alternating sequence along the first shaft section 2 of the shaft-shaped assembly tool 1. The truncated cone-shaped shaft end 6 of the shaft-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 series axial sequence of contact ring elements and sealing rings 23, 24. In this axially compressed state, the assembly is inserted into a notch 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 rest in a mutually supporting manner, so that the receiving structure 26 can absorb the joining force.

[0051] The grooves otherwise introduced in the receiving structure 26 are adapted accordingly in a contour-corresponding manner to the outer contour of the axial sequence of the contact ring elements and sealing rings 23, 24 and to the fixing body 9. The receiving structure 26 is preferably made of a solidified casting material for forming the fixing body 9 by a casting process. Figure 7The casting process encapsulates the receiving structure 26 and all the components joined therein and preferably seals them fluid-tightly to the annular sealing bodies 21, 22, so that the respective second shaft sections 3, 19 of the assembly tool 1 and the adjusting device 14 are not encapsulated by the casting material during the casting process. This greatly simplifies the separation of the assembly tool 1 and the adjusting device 14 from the assembly, so that Figure 7 , the headpiece housing 29 is shown placed on a medical active energy implant device 30.

[0052] Reference numerals list

[0053] 1 Rod assembly tool

[0054] 2 First Segment

[0055] 3 Second Segment

[0056] 4 Local deep digging

[0057] 41, 42 Sloped side edges

[0058] 5-bar surface

[0059] 6 Rod ends

[0060] 7 End face

[0061] 8 Interfaces

[0062] 9 Fixed body

[0063] 91, 92, 93 side

[0064] 10 Opening

[0065] 11 Opening longitudinal axis

[0066] 12Through channel longitudinal axis, rod longitudinal axis

[0067] 13 Internal thread

[0068] 14. Regulating device

[0069] 15 Sealing contour on the end side

[0070] 15.1, 15.2 side edges

[0071] 16 First Segment

[0072] 17 External thread

[0073] 18 rod longitudinal axis

[0074] 19 Second Segment

[0075] 20 End face

[0076] 21, 22 Sealing body

[0077] a, b spacing

[0078] 23 Conductive contact ring element

[0079] 24 Electrically insulating, elastically deformable sealing ring

[0080] 25 Assembly

[0081] 26 Receiving Structure

[0082] 27, 28 stop surface

[0083] 29 Head housing

[0084] 30 Implantable Devices

Claims

1. An assembly tool kit for producing a head part of an implantable medical device, the head part having a head part housing (29) which can be made of a hardenable casting material, the head part housing having a blind hole-shaped slot, along which at least one electrically conductive contact ring element (23) and an electrically insulating, elastically deformable sealing ring (24) are force-lockedly engaged with each other in a coaxial arrangement and in an axially serial sequence under the action of an axial engagement force, the assembly tool kit comprising the following tool parts: a rod-shaped assembly tool (1) having a rod longitudinal axis (12) and an axially extending rod surface (5) along which the local recess (4) is introduced, a fixing body (9) penetrated by a through-channel having a channel longitudinal axis, the rod-shaped assembly tool (1) being able to pass through the through-channel at least along at least one first rod section (2) assigned to the rod-shaped assembly tool and at least partially penetrate an opening (10) in the fixing body (9) into the through-channel, the opening having an opening longitudinal axis (11) oriented orthogonally to the channel longitudinal axis, and an internal thread (13) being arranged in the fixing body (9) around the opening longitudinal axis, an adjusting device (14) having an engagement contour (15) terminating at the end side and a mating thread (17) which can cooperate with the internal thread (13) of the fixing body (9), the engagement contour being configured to correspond to the contour of the local recess (4) in the rod-shaped mounting device (1), as well as - a receiving structure (26) with a notch, into which the rod-shaped assembly tool (1) can be inserted under application of an axial engagement force, and along which at least the fixing body (9) and the at least one electrically conductive contact ring element (23) and the electrically insulating, elastically deformable sealing ring (24) are arranged in a coaxial arrangement and in an axially serial sequence.

2. The assembly tool kit according to claim 1, It is characterized in that The local deepening (4) is arranged in the region of the first shaft section (2), The first rod section (2) assigned to the rod-shaped assembly tool (1) has a constant first rod cross section except for the local recess (4) 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) having a second rod cross section, which is larger than the first rod cross section, and the second rod section (3) is adjacent to the first rod section (2) via an end face (7) extending orthogonally to the rod longitudinal axis (12).

3. The assembly tool kit according to claim 1, It is characterized in that The local depression (4) is designed in the form of a truncated cone-shaped recess surrounding the first shaft section in the circumferential direction.

4. The assembly tool kit according to claim 2 or 3, It is characterized in that The shaft end section (6) of the mounting tool (1) is embodied in a frustoconical manner and has an unstructured smooth surface (6).

5. An assembly tool kit according to any one of claims 2 to 4, It is characterized in that The local recessed portion (4) is arranged along the rod longitudinal axis (12) relative to the end face (7) of the second rod section (3) so that when the fixing body (9) is arranged along the rod-shaped assembly tool (1) and the adjusting device (14) is engaged in the opening (10) of the fixing body (9), the engaging contour (15) of the adjusting device (14) terminating at the end side extends along the rod-shaped assembly tool (1) into the local recessed portion (4) and forms a force-locking and form-locking portion with the local recessed portion, and 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. The assembly tool kit according to claim 5, It is characterized in that The first spacing (a) corresponds at most to the axial width dimension of an elastically deformable sealing body (21), which is arranged around the rod-shaped assembly tool (1) so as to axially abut on the fixing body (9) on one side and on the end face (7) of the assembly tool (1) on the other side.

7. The assembly tool kit according to claim 6, It is characterized in that The sealing body (21) is designed in the form of an elastomeric sealing ring with a through-opening whose shape and size are adapted to the shaft cross section of the first shaft section (2) of the assembly tool (1).

8. An assembly tool kit according to any one of claims 1 to 7, It is characterized in that The adjusting device (14) is of rod-shaped construction and comprises: a rod end, the rod end being provided with the engaging contour (15) terminating at the end side; a first rod section (16) adjoining the engaging contour, along which the mating thread (17) in the form of an external thread is arranged; and a second rod section (19) adjacent to the first rod section (16), the second rod section having a larger rod cross section than the first rod section (16) and having an end face (20) facing the first rod section (16) and radially surrounding the first rod section.

9. An assembly tool kit according to any one of claims 1 to 8, It is characterized in that The fixing body (9) is designed in a cubic or cuboid shape and has at least two opposite side surfaces (91, 92), namely a first side surface and a second side surface, which are penetrated by a through-channel and each have a flat surface area oriented parallel to each other, and The fixing body (9) is provided with a third side surface (93) which has a flat surface area oriented orthogonally to the first and second side surfaces (91, 92) and which is penetrated by the opening (10).

10. An assembly tool kit according to any one of claims 5 to 8 and according to claim 9, It is characterized in that When the adjusting device (14) is fully engaged in the opening (10) of the fixing body (9), the end face (20) of the adjusting device (14) has a second distance (b) from the surface area of ​​the third side face (93) of the fixing body (9), and in the case of the full engagement, the engagement contour (15) on the end side of the adjusting device (14) fits into the local recessed portion (4) of the rod-shaped assembly tool (1) in a contour-precise manner.

11. The assembly tool kit according to claim 10, It is characterized in that The second spacing (b) corresponds at most to the axial width dimension of the elastically deformable sealing body (22), which is arranged around the rod-shaped adjusting device (14) so ​​as to axially abut on the fixing body (9) on one side and on the end face (20) of the adjusting device (14) on the other side.

12. The assembly tool kit according to claim 11, It is characterized in that The sealing body (22) is designed in the form of an elastomeric sealing ring and has a through-opening whose shape and size are adapted to the shaft cross section of the first shaft cross section (16) of the adjusting means (14).

13. An assembly tool kit according to any one of claims 1 to 12, It is characterized in that The notch of the receiving structure (26) made 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) is indirectly or directly supported on one side and the fixing body (9) is supported on the other side, so that the at least one electrically conductive contact ring element (23) and the electrically insulating, elastically deformable sealing ring (24) are subjected to an axial engagement force which is intercepted by the two axially opposite stop surfaces (27, 28).

14. A method for manufacturing a head component of an implantable medical device using an assembly tool kit according to any one of claims 1 to 13, wherein the head component has a head component shell (29) that can be made of a hardenable casting material, the head component shell has a blind hole-shaped groove, at least one conductive contact ring element (23) and an electrically insulating, elastically deformable sealing ring (24) are force-lockedly engaged with each other in a coaxial arrangement and axial series sequence along the groove under the action of an axial engagement force, characterized in that The method comprises the following steps: - at least the fixing body (9) and the at least one electrically conductive contact ring element (23) and at least one electrically insulating, elastically deformable sealing ring (24) are arranged along the rod-shaped assembly tool (1), - by means of the mating thread (17) of the adjusting element (1) cooperating with the internal thread (13) of the fixing body (9), the engaging contour (15) of the adjusting element (14) terminating at the end side is engaged in a local recess (4) corresponding to the contour in the rod-shaped mounting element (1), - 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 a notch of a receiving structure (26) while building up an axial engagement force along the at least one electrically conductive contact ring element (23) and the at least one electrically insulating, elastically deformable sealing ring (24), - encapsulating 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 element (14) engaged in the local recessed portion (4) of the rod-shaped assembly element (1) by means of the engaging body (9) at least partially with a flowable, curable casting material, so that the assembly tool (1) and the adjusting element (14) protrude partially from the casting material, and During the construction of the head part housing (29), the curable material is cured and the mounting tool (1) and the adjusting means (14) are separated from the head part housing (29).

15. The method according to claim 14, It is characterized in that Prior to the arrangement, a sealing body (21) in the form of an elastomeric sealing ring is engaged along the first shank cross section (2) of the assembly tool (1) and is placed against the end face (7) of the assembly tool (1).

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

17. The method according to any one of claims 14 to 16, It is characterized in that Prior to the joining, a sealing body (22) in the form of an elastomeric sealing ring is joined along the first shaft section (16) of the adjusting element (14) and abuts against the end face (20) of the adjusting element (14); and The joining of the adjusting element (14) is carried out such that a sealing body (22) for a flowable potting material, which is arranged on the adjusting element (14), bears against the fixing body (9) and the end face (20) of the adjusting element (14) in a fluid-tight manner.

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