Head of an implantable device, method for manufacturing the head, and plug assembly that can be fitted into the head

Abstract

The head of an implantable device, its manufacturing method, and a plug assembly fittable into the head are described. The head comprises a head housing. The head housing comprises at least one blind-hole plug contact socket having a socket opening and a socket base disposed axially opposite the socket opening, along which at least one electrically conductive contact ring element and an electrically insulating, elastically deformable seal ring are joined to one another in a coaxially arranged, axially consecutive sequence and surrounded by solidified cast material. The invention also provides a blind-hole plug contact socket, the socket base being limited by a connecting means, the connecting means being at least partially surrounded by solidified cast material, attached to at least one medium channel opening into the blind-hole plug contact socket and at least partially surrounded by solidified cast material, The plug assembly is characterized in that the at least one medium channel has a channel end facing away from the connecting means and is connected to a medium source, the medium source being configured in the form of a fluid line, the medium source being a fluid pump connected to a fluid container. Corresponding to the medium channel, the plug assembly comprises a plug body having at least one internal hollow channel which opens at one end in a distal plug body end. Furthermore, the distal plug body end has a mating contour which, when the plug assembly is fitted into the plug contact socket, ensures a flush fit of the hollow channel to the medium channel which opens into the blind hole type plug contact socket.

Description

Technical Field

[0001] The present invention relates to a head of an implantable medical device, a method for manufacturing the same, and a plug assembly that can be fitted into the head. The head includes a head housing having at least one blind-hole type plug contact socket with a socket opening and a socket base disposed axially opposite to the socket opening, along which at least one conductive contact ring element and an electrically insulating and elastically deformable seal ring (surrounded by a solidified cast material) are joined to each other in a coaxially arranged and axially continuous order.

Background Art

[0002] Implantable medical devices for electrical stimulation of local in-vivo tissues or nerve regions, briefly implantable pulse generators (IPGs) (for example, for cardiac treatment, defibrillation, pacemakers, resynchronization applications, nerve stimulation means (spinal cord stimulation, brain stimulation or vagus nerve stimulation)), generally comprise a self-powered housing that houses components for electrical pulse generation (thus at least one power source and an electrical circuit structure connected thereto). In addition, adjacent to the housing is a so-called head, which houses electrical contact devices connected to the power source and the electrical circuit structure, into which a socket assembly (closing the head in a fluid-tight manner) can be fitted and which contacts electrical supply lines and discharge lines for the application of local electrical stimulation signals in the body (and, if necessary, for supplying locally picked-up electrical signals in the body to the electrical circuit structure present in the housing).

[0003] European Patent No. 2 134 418 describes a head of an implantable medical device of the type in question. Along a coupling seam, it comprises two head housing halves that can be joined to each other, into which quasi-cylindrical recesses separated by an intermediate wall are introduced in a consecutive order, and into which conductive contact ring elements and electrically insulating seal rings are inserted in a consecutive alternating order. The head thus comprises an arrangement of electrically insulating contact ring elements that are coaxially arranged with respect to each other, and for electrical contact thereof, lateral access is provided within the head through which an electrical plug assembly can be fluid-tightly inserted into a hollow space surrounded by an all-round contact ring element.

[0004] German Patent Application Publication No. 10 2012 010 901 discloses a method for positioning and holding electrical contacts and seals within a head for electrically contacting an implantable medical device. On one side of a head housing made of a biocompatible and electrically insulating material, a blind-hole type counterbore is introduced, into which conductive circumferential seal elements are inserted in an alternating order, joining and surrounding a hollow space into which a pin-shaped plug assembly can be fitted. Within the head, each of the circumferential contact rings is connected by an electrical connection line to electrical components arranged within the housing of the implantable medical device.

[0005] German Utility Model Application Publication No. 20 2013 012 073 is a plug counterbore module assembly, for the assembly of which several contact rings and seal elements are arranged in an alternating order along a pin-shaped assembly tool. By means of a clamping device, all the contact rings and seal elements along the assembly tool are clamped to each other by the application of an axial joining force. To preserve the joining force, a sleeve element is used that is attached in such a way as to be axially fixed on the assembly tool by a grub screw, which, together with the head of the assembly tool at the end, axially limits the arrangement of the contact rings and seal elements on both sides. In this clamped state, the arrangement is cast into a casting material that can be cured, which takes up the joining force in the solidified state.

[0006] Instead of a grub screw as a fixing aid at the end to preserve the axial joining force acting on a series of contact rings and seal ring elements arranged along a pin-shaped assembly tool, WO 2019 / 115176 proposes using an assembly plate provided with an opening and an internal thread, into the internal thread opening of which a pin-shaped assembly tool with an external thread at its end is inserted.

[0007] US 2008 / 0077190 discloses a head for electrical contact of a medical implant, inside of which a plug unit can be fitted in a fluid-tight manner and can be electrically contacted. In addition to the contact electrodes provided on the plug and the head, these two components are each provided with an optical transmission channel, and when the two components are fitted to each other, they are optically coupled to each other to transmit an optical signal.

SUMMARY OF THE INVENTION

PROBLEM TO BE SOLVED BY THE INVENTION

[0008] An object of the present invention is to modify the head of an implantable medical device, a method for manufacturing the same, and a plug assembly that can be fitted into the head in such a manner that, in addition to the known generation, transmission, and application of electrical stimulation signals, the functional range of an implantable pulse generator (IPG) can be increased without substantially changing the size.

[0009] The solution to the task forming the basis of the present invention is set forth in claim 1. The subject matter of claim 11 is an implantable plug assembly designed to be fitted into the head. Claim 13 describes a method for manufacturing the head. Features that further advantageously develop the inventive concept form the subject matter of each dependent claim and can be gathered from this description (in particular, with reference to the examples of the illustrated embodiments).

[0010] The head of the implantable medical device according to this solution comprises a head housing, said head housing having at least one socket-type plug contact socket, said socket-type plug contact socket comprising a socket opening and a socket base arranged axially opposite to said socket opening, along which at least one conductive contact ring element and an electrically insulating and elastically deformable seal ring are joined to each other in a coaxial and axially continuous order, said at least one conductive contact ring element and said electrically insulating and elastically deformable seal ring being surrounded by a solidified casting material. In the head, the head is such that the socket base is restricted by connecting means, said connecting means being at least partially surrounded by the solidified casting material and attached to at least one media channel, said at least one media channel opening into the socket-type plug contact socket and being at least partially surrounded by the solidified casting material and having a channel end, said channel end facing away from the connecting means and being connected to a media source. Said at least one media channel is designed in the form of a fluid line. Preferably, the media source is connected to a fluid pump, preferably it is connected to a fluid container. Alternatively, instead of being connected to a media source, the media channel is connected to a media sink, along which active conveying means having a plurality of collecting containers or just one collecting container intended to contain fluid are arranged.

[0011] The idea forming the basis of the present invention utilizes the opening in the assembly plate provided with an internal thread as described in the above-mentioned WO 2019 / 115176 pamphlet, in which, after removing the assembly tool from the completed head (otherwise it would not function), in order to direct any kind of media flow through the opening. The assembly plate (which in the above-mentioned prior art could be considered a kind of lost component, completely surrounded within the cast material by the cast material of the head and otherwise having no function for further operation of the head and an implantable pulse generator (IPG) connected to the head) forms the central component of the modified head according to this solution, which, in addition to its function as the coupling opening through which the media flow is directed, also functions as a mechanical holding or supporting structure for applying a media channel to the end.

[0012] The media channel (designed as a hollow channel in the simplest form of the embodiment) terminates on one side of the assembly plate (hereinafter referred to as "connecting means"), which maintains its original function as an auxiliary component for generating an axial engagement force by providing an internal thread as described in the introduction.

[0013] The media channel starting from the connecting means is surrounded by the cast material of the head and, in a preferred embodiment, protrudes through the head in the form of a continuous hollow line, the end of which is connected to a media source. In a first example of the embodiment, the media channel outside the head and the media source connected to the media channel at the end are arranged and designed separately from both the head and an implantable medical device directly adjacent thereto. A pulse generator is housed therein. Alternatively, a further example of the embodiment envisages the integration of the media channel and the media source connected thereto inside the implantable medical device.

[0014] The media channel leading into and out of the head and the media source connected to the media channel at one end are designed to be adapted to the type of media.

[0015] The media channel is designed as a fluid channel. That is, the media is a gas or a liquid and is conveyed fluid-tightly from a media source (which is preferably combined with a fluid container in the form of a structural unit in the direction of the blind-hole type plug contact socket into which the media channel opens or is supported by a fluid conveyance unit arranged along the media channel) through the media channel.

[0016] In combination with the above-described embodiments, the media channel (along which the light-guiding fluid flows) preferably also acts as an optical waveguide. A light source that emits light guided through an optical waveguide extending along the media channel to a light-guide end opening into the blind-hole type plug contact socket acts as the media source in this case.

[0017] For the mechanically robust positioning of the media channel connected to the connection means at the end, the connection means assumes a joining outer shape, which surrounds the media channel. The media channel opens into the blind-hole type plug contact socket, and the blind-hole type plug contact socket is designed and arranged such that a second media channel disposed within the plug contact socket can be connected to the media channel opening into the blind-hole type plug contact socket. The second media channel disposed within the plug contact socket is part of an embeddable plug assembly designed by a solution that is designed and adapted to join into the blind-hole type plug contact socket of the above-described head. More specifically, the plug assembly comprises a plug body having at least one internal hollow channel (corresponding to the second media channel described above and opening at one end to the distal plug body end). Further, the distal plug body end has a joining outer shape, which ensures a flush transition of the hollow channel to the media channel opening into the blind-hole type plug contact socket when the plug assembly is fitted into the plug contact socket. As a result, a coupling with as little loss as possible and, further, the conveyance or transmission of the media from the first media channel into the hollow channel serving as the second media channel should be made possible.

[0018] Alternatively, the implantable plug assembly is designed in a known manner for the transmission of electrical signals and comprises a continuous series of plug contact rings and seal rings or electrically insulating rings along the plug assembly contact socket in the longitudinal extent of the plug, depending on the number and arrangement of the electrical contact ring elements and seal rings.

[0019] In the state where the implantable plug assembly is joined in the plug contact socket provided on the head side, the electrical function of the implantable device for the application of electrical stimulation signals is maintained without constraint, regardless of the modified head and the modified plug assembly. Additional in-body locally applicable media outputs (e.g., in the form of a gas or liquid flow) can be provided, optionally in combination with additional light transmission, via additional media channels provided additionally on the head side and the plug side (starting either together with or separated from the discharge electrical line).

[0020] In a further preferred form of the embodiment, at least one sensor is integrated along the media channel within the head (which is at least partially surrounded by the solidified casting material), which can detect or sense at least quantitatively the media conveyed within the media channel in terms of the conveyance volume, conveyance rate or light intensity. Depending on the type and design of this at least one sensor, it should be appropriately arranged within the head along the media channel. For example, it is a good idea to connect the at least one sensor directly or indirectly electrically and / or mechanically to at least one conductive contact ring element applied within the head. Possible sensors that can be considered include sensors from the following groups: ultrasonic sensors, optical sensors, pressure sensors, Hall effect sensors, flow sensors, stylus sensors, fluorescence sensors, pressure sensors, etc.

[0021] This at least one sensor arranged along the media channel is preferably connected to an electrical energy source that supplies electrical energy to the pulse generator within the medical device. Further, this at least one sensor is connected to an evaluation and control unit that is connected to an additional memory unit and / or a media source. In this way, it is possible to record the actual state of the media flowing or being conveyed along the media channel and to control or adjust the media source as a function of the actual state.

[0022] The head assembled by this solution and the functionally modified plug assembly for additional transmission of media in the form of fluid (and preferably light) do not change the shape and size of known medical implants of the type of problem very much, but substantially expand the functionality and therapeutic mode of the action of related comparable implants. Therefore, in addition to electrical stimulation of local tissue and / or nerve regions in the body, it is also possible to apply fluid (and light if necessary).

[0023] Such an innovative manufacturing method of the head is brought about by using in combination a connecting means acting as an assembly plate as a support structure and a connecting flange for two adjacent media channels in an abutting manner with each other. Thus, in the first processing step, the connecting means acts as a support plate in the conventional sense, that is, along a rod-shaped assembly tool, the connecting means is arranged together with at least one contact ring element and at least one sealing ring, and along this rod-shaped assembly tool, they are joined to each other in a positive manner through the generation of an axial clamping force.

[0024] In the next step, the media channel is connected to the connecting means at its end such that the media channel is directly or indirectly adjacent at the opening within the connecting means in the form of a hollow line or a hollow cannula. For example, the media channel can be accurately fitted in a surrounding manner to the end of a rod-shaped assembly tool protruding at the rear of the connecting means.

[0025] Subsequently, a connecting means arranged along and positively joined to a rod-shaped assembly tool, at least one contact ring element, at least one sealing ring, and at least one media channel applied directly or indirectly to the connecting means are at least partially surrounded by a curable casting material present in a shape that allows it to flow. The rod-shaped assembly tool is then released and removed from the connecting means, at least one contact ring element, and at least one sealing ring after the casting material (which forms a dimensionally stable matrix forming at least part of the head housing and absorbs the axial joining force) has solidified. By removing the assembly tool, the media channel applied directly or indirectly to the connecting means opens on one side into a blind-hole type plug contact socket (formed by removing the assembly tool) in the head.

[0026] [Brief Description of the Invention] The present invention will be described below by way of example embodiments with reference to the accompanying drawings without limiting the general inventive concept. [Brief Description of the Drawings]

[0027]

Figure 1

[0028] [Method of Carrying Out the Invention, Industrial Application] FIG. 1 shows a schematic view of the head 1 in combination with an implantable medical device 2 designed as a pulse generator for forming components. A plurality of electrically insulating and electrically deformable seal rings 3 and conductive contact ring elements 4 are arranged in the head 1 made of a curable casting material in an alternating order and in an axially continuous order. The seal ring 3 and the electrical contact ring element 4 surround a stop-hole type plug contact socket 5 having an accessible socket opening 6 on the outer wall of the head 1. The socket base 7 on the opposite side of the socket opening 6 is restricted by a connecting means 8 that serves as a mechanical abutment for an assembly tool used for assembly purposes (for manufacturing the head 1 and, in particular, for axially aligning the plurality of seal rings 3 and electrical contact ring elements 4). For this purpose, the connecting means 8 assumes an opening 9, along which an internal thread 10 is incorporated at least partially.

[0029] A media channel 11 exists that fits into or is within the connecting means 8 in the region of the opening 9. The media channel 11 opens into the stop-hole type plug contact socket 5. The media channel 11 extends partially within the head 1 and is thus surrounded by the cured casting material of the head 1. The media channel 11 configured as a hollow channel projects laterally from the head 1 and is connected at its end to a media source 12. The media source 12 is, for example, a media container from which a media (such as a gas or a liquid) is conveyed along the media channel 11 by a conveying unit in a controlled manner. In this case, the media channel 11 is designed as a hollow channel through which a gaseous or liquid media is conveyed in a direction towards the head 1 in as lossless a manner as possible.

[0030] The media source 12 can also be designed as a light source. In this case, a fluid that is as transparent as possible to light is conveyed through the media channel 11, which constitutes a kind of light guide along which a combined media of fluid and light from the media source 12 is conveyed in a direction towards the head 1 in a roughly lossless manner.

[0031] In the blind-hole type plug contact socket 5, a plug assembly 13 completed according to the invention having a plug body 14 conforming to the dimensions and shape of the plug contact socket 5 is also fitted. On its outer periphery, corresponding opposing contact elements 15 are arranged corresponding to the arrangement of the electrical contact ring elements 4. An electrically insulating plug body region 16 is provided between the opposing contact elements 15. Regarding the electrical contact of the plug contact assembly 13 in the blind-hole type plug contact socket 5 of the head 1, the device shown in FIG. 1 is no different from a comparable plug assembly of the type in question.

[0032] According to this solution, the plug contact assembly 13 assumes a second medium channel 17 which projects centrally through the plug body 14 and abuts flush in the form of an abutment against the medium channel 11 which opens into the blind-hole type plug contact socket 5 in the region of the socket base 7. Depending on the type and design of the medium channels 11, 17, the head-side medium channel 11 and the plug-side second medium channel 17 should be connected for low-loss or lossless connection and transmission of the respective medium. For this purpose, an additional seal and / or joining profile 18 is optionally introduced into the connecting means 8 to ensure a seamless transition between the medium channels 11 and 17.

[0033] Along the medium channels 11 and / or 17, a sensor 19 is optionally arranged in the head 1 to detect and / or monitor the medium conveyed along the medium channels 11, 17. Depending on the type and design of the sensor 19, it is arranged directly in the connecting means 8, on at least one of the seal rings 3, or on at least one of the electrical contact ring elements 4, along or integrated with the medium channel 11. The type and application of at least one sensor 19 are guided by the medium (such as gas, liquid and possibly light) transmitted along the medium channels 11, 17. The sensor 19 can be appropriately selected from the following types of sensors: Hall effect sensor, optical sensor, flow sensor, ultrasonic sensor, temperature sensor, pressure sensor, etc.

[0034] The plug contact assembly 13 is connected to the delivery line 20, which comprises a delivery medium channel 17 in addition to at least one electrical line. Via the delivery medium channel 17, the medium can be applied in a controlled manner, i.e., administered for therapeutic purposes in a selected body region.

[0035] The example of the embodiment illustrated in FIG. 1 shows a medium channel 11 extending from the head, which is separately connected to the medium source 12 with respect to the IPG 2. As shown by the dashed line in FIG. 1, it is also possible to guide the medium channel 11 within the head 1 and within the IPG 2 and connect it to the medium source arranged within the IPG.

[0036] The evaluation and control unit 22 (connected to at least one sensor 19 and generating a control or adjustment signal that affects the medium source 12 as a function of at least one sensor signal) is arranged within the implantable medical device 2 designed as a pulse generator in addition to the components 22 necessary for pulse generation. In this way, the flow and / or intensity of the material directed via the medium channels 11, 17 can be affected.

Explanation of Reference Numerals

[0037] 1 Head 2 Implantable medical device designed as a pulse generator IPG 3 Seal ring 4 Electrical contact ring element 5 Stop-hole type plug contact socket 6 Socket opening 7 Socket base 8 Connecting means 9 Opening 10 Internal thread 11 Medium channel 12 Medium source 13 Plug contact assembly 14 Plug body 15 Opposing contact element 16 Insulating intermediate region 17 Second medium channel 18 Seal joint outer shape 19 Sensor 20 Discharge line 21 Electrical components of IPG 22 Evaluation and control unit

Claims

1. A head of an implantable medical device, comprising a head housing, said head housing having at least one socket-type plug contact socket, said socket-type plug contact socket comprising a socket opening and a socket base disposed axially opposite to said socket opening, at least one conductive contact ring element and an electrically insulating and elastically deformable seal ring are joined to each other in a coaxial and axially continuous order along said socket-type plug contact socket, said at least one conductive contact ring element and said electrically insulating and elastically deformable seal ring are surrounded by a solidified cast material, in the head, said head, said socket base is surrounded by connecting means, said connecting means is at least partially surrounded by said solidified cast material and is attached to at least one medium channel, said at least one medium channel opens into said socket-type plug contact socket, is at least partially surrounded by said solidified cast material, has a channel end, said channel end is directed away from said connecting means and is connected to a medium source, characterized in that, said at least one medium channel is configured such that a fluid flows therein, along said medium channel at least partially surrounded by said solidified cast material, at least one sensor is applied to detect a medium present in said medium channel by said sensor, said at least one sensor is connected to an evaluation and control unit, said evaluation and control unit is connected to a memory unit and / or said medium source, characterized head.

2. said medium source is a fluid pump connected to a fluid container, or said medium source is designed as a medium sink, characterized head according to claim 1.

3. One end of said medium channel is connected to said connecting means, said medium channel projects outwardly through said head housing and is connected to said medium source outside said head housing, characterized head according to claim 1 or 2.

4. characterized head according to claim 1, wherein at least one sensor is electrically and / or mechanically connected to said at least one conductive contact ring element.

5. The at least one sensor is selected from the group of sensors consisting of ultrasonic sensors, optical sensors, pressure sensors, Hall effect sensors, and flow sensors The head according to claim 4, characterized in that.

6. The connecting means surrounds the medium channel, The medium channel opens into the blind hole type plug contact socket, The blind hole type plug contact socket is designed and arranged such that a second medium channel disposed within the blind hole type plug contact socket can be connected to the medium channel opening into the blind hole type plug contact socket. The head according to claim 1, characterized in that.

7. The head housing is mechanically and electrically connected to an implantable medical device designed as a pulse generator, The head according to claim 1, characterized in that.

8. The medium source is integrated with the implantable medical device, The head according to claim 7, characterized in that.

9. An implantable plug assembly designed and adapted to be inserted into a blind hole type plug contact socket within the head according to any one of claims 1 to 8, The plug assembly includes a plug body having at least one internal hollow channel, and the at least one internal hollow channel opens at one end at the distal end of the plug body. When the plug assembly is fitted into the blind hole type plug contact socket, the distal end of the plug body ensures a flush joint of the hollow channel with the medium channel opening into the blind hole type plug contact socket. An implantable plug assembly, characterized in that.

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