Active implantable medical device

The flexible housing with defined bending zones and rigid regions allows active implantable medical devices to securely fit patient anatomy, addressing adaptation challenges and ensuring reliable implantation and component protection.

DE102024101582B3Active Publication Date: 2025-07-10OSYPKA AG
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Patent Information

Application Number
DE102024101582
Authority / Receiving Office
DE · DE
Patent Type
Patents
Current Assignee / Owner
Filing Date
2024-01-19
Publication Date
2025-07-10
Estimated Expiration
2044-01-19

AI Technical Summary

Technical Problem

Existing active implantable medical devices struggle to adapt easily to the anatomical variations of individual patients, leading to unreliable fixation and potential dislodgment from the intended implant site.

Method used

The device features a flexible housing with defined bending zones and rigid receiving regions, allowing targeted deformation to fit anatomical contours, protected electronic components, and hermetic sealing through weld seams and interfaces in LTCC technology.

Benefits of technology

Enables reliable, space-saving, and non-noticeable implantation by adapting to patient anatomy, ensuring secure fixation and protection of electronic components while maintaining hermetic integrity.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention relates to an active implantable medical device (1) with a housing (2) made of metal, which contains at least one electronic component (5) of the device (1), is hermetically sealed and at least partially flexible.
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Description

The invention relates to an active implantable medical device.US 2008 / 0183230 A1 discloses a subcutaneous extracardial implantable medical device (EID) comprising: a housing made at least partially of an electrically conductive material; at least one active circuit disposed in the housing; an electrical power source connected to the at least one active circuit; an isolated elongate conductive member connected to the at least one active circuit; and a voltage limiting member connected to the elongate conductive member between the at least one active circuit and the source of electrical power.An active implantable medical device in the sense of the claimed invention can be any active medical device which is designed to be wholly or partly introduced into the human body by a surgical or medical intervention or into a natural body opening by a medical intervention and is intended to remain there at least temporarily after the intervention. Such devices are used, for example, for the treatment and / or monitoring of patients.It is an object of the invention to provide an active implantable medical device which can be adapted particularly easily to anatomical circumstances of a patient to whom the device is implanted and can be reliably fixed in the body of the patient.To achieve this object, an active implantable medical device is proposed having the features of the independent claim directed to such a device.In order to achieve the object, an active implantable medical device having a housing made of metal is thus proposed, which contains at least one electronic component of the device, is hermetically sealed and is flexible at least in sections.Because the housing of the device is flexible at least in sections, the housing of the device can be deformed in a targeted manner. This allows the device to be adapted to the anatomical conditions of a patient and to be reliably fixed in the body of the patient.If the active implantable medical device is designed, for example, as an electromedical pulse generator for the treatment of migraine and / or parkinsonism, the device can be deformed, for example, in a manner adapted to the shape of the patient's skull bone and then arranged on an outer side of the patient's skull bone. This enables a particularly reliable, space-saving and non-noticeable implantation of the device in the patient's body.According to the invention, the housing comprises at least one defined bending zone and at least one receiving region which is rigid in comparison with the bending zone and in which the at least one electronic component of the device is arranged.The defined bending zone of the housing allows the housing of the device to be deformed in a targeted manner in order to adapt the device to the anatomical conditions of a patient and reliably fix it in the body of the patient.The at least one rigid receiving region provided by the housing for an electronic component of the device serves to protect the electronic component from external influences. Because the receiving region is rigid in comparison with the defined bending zone of the housing, a deformation of the housing in the receiving region, which would possibly pose a risk to at least one electronic component of the device arranged in the receiving region, can be prevented in a targeted manner.The deformation of the housing is preferably limited to the at least one defined bending zone, whereas the at least one rigid receiving region for the at least one electronic component of the device remains undeformed even in the case of a deformed housing. In this way, the at least one electronic component in the rigid receiving region of the housing is reliably protected from mechanical stress and possibly damage.The device can thus have a metallic housing, which is flexible through the at least one bending zone, for the hermetic encapsulation of at least one electronic component of the device, which housing enables a defined deformation. This allows patient-specific adaptation of the geometry of the housing by permanent plastic deformation of the housing.The housing can have different wall thicknesses in the at least one bending zone and in the at least one receiving region. The housing can furthermore have at least one stiffening, in particular a stiffening geometry, and / or a filling for stiffening the housing. This promotes the targeted provision of at least one bending zone on the housing, which can be deformed, while the at least one receiving region for the at least one electronic component is configured to be specifically more rigid or more rigid and thus resists deformation in comparison with the bending zone.As a stiffening, the housing can have, for example, at least one rib. The rib can be produced, for example, by a specific deformation of a wall of the housing. In one embodiment of the device, a synthetic resin, in particular an epoxy resin, is applied to the housing as a stiffening. The epoxy resin can be applied to the housing in a planar manner or, for example, in the form of a rib or along a line or else in other forms, in order to stiffen a specific section of the housing in a targeted manner.In one embodiment of the device, it is provided that the housing has at least one stiffening structure, for example a rib and / or a thickening, in or on its at least one receiving region. This stiffening structure can contribute to making the receiving region of the housing rigid and deformation-resistant. This can improve the protective effect of the receiving region of the housing for an electronic component of the device arranged therein.In one embodiment of the device, the housing has at least one bending line in the at least one bending zone. The bending line can be produced by a specific shaping of the housing. It is thus possible, for example, for the housing to have a wall which along the at least one bending line has a distance, in particular a mean distance, from a neutral fiber and / or from a longitudinal axis, preferably from a longitudinal central axis, of the housing which is less than the distance of the wall in a section of the housing adjoining the bending line. Walls of the housing on both sides of the neutral fiber can thus alternately approach the neutral fiber in the at least one bending zone.The housing of the device can comprise at least two bending zones, for example. This promotes a targeted adaptation of the shape of the housing to the anatomical conditions of a patient. The at least two bending zones of the housing can specify the same bending direction or else different bending directions. In one embodiment of the device, it is provided that its housing comprises a plurality of bending zones which specify at least two different bending directions and thus enable a deformation of the housing of the device in different bending directions. This can further improve the adaptation of the shape of the housing to the anatomical conditions of a patient.In this case, bending lines which are assigned to different bending zones can be oriented parallel to one another or point in different directions. If two bending zones present the same bending direction, their bending lines are oriented parallel to one another. If the bending lines of two bending zones point in different directions, the bending zones specify different bending directions.According to the invention, the housing is designed to be corrugated in its at least one bending zone. Due to the corrugated shaping of the bending zone, the housing is flexible in the bending zone and can be deformed there in a particularly simple and targeted manner in order to adapt the device to the anatomical conditions of a patient.Due to the deformability of the housing at least in the region of its at least one bending zone, it is possible, for example, to adapt the device to the shape of a bony structure in the body of the patient and, for example, to at least partially encircle the bony structure with the device. This facilitates reliable positioning and fixing of the device in its implanted position of use. Optionally, the preferably plastic deformation of the housing alone may be sufficient to fix the device reliably and in a fixed position in its implanted position in the body.Finally, the deformability of the device thus also promotes the operational reliability of the device. A targeted deformation of the device adapted to an anatomy of the patient can prevent the device from leaving its implanted position in the patient's body and possibly losing contact with the target tissue of his application and thus losing its function.In one embodiment of the device, it is provided that the housing has, in its at least one bending zone, at least one bending line along which the housing can be bent, i.e. deformed. The at least one bending line can be predefined, for example, by a corrugated shape of the housing and / or preferably oriented transversely or at right angles to a longitudinal axis of the device.A longitudinal axis of the device may be an axis that runs along a longest dimension of its housing. The housing of the device can have an elongate shape and preferably be of strip-shaped design. The at least one bending line can then preferably be oriented transversely or at right angles to the longitudinal extent of the housing of the device.In one embodiment of the device, it is provided that the housing comprises at least two housing parts which are hermetically connected to one another. Such an at least two-part housing facilitates the assembly of the device and thus its economical production.In order to connect the housing parts hermetically sealed to one another, the housing parts of the device can be welded to one another. For example, the housing parts can be welded to one another by means of ultrasound and / or by means of lasers in order to produce a hermetically sealed connection of the housing parts. This enables the economic production of a particularly reliably hermetically sealed housing which can reliably protect the at least one electronic component of the device arranged in the at least one rigid receiving region from conditions prevailing in the body and possibly harmful to the electronic component.A weld seam for hermetically sealing housing parts of the housing can be arranged in a plane in which a neutral fiber of the device, in particular of the housing, runs. This arrangement of the weld seam or of a plurality of weld seams can minimize a mechanical load of the weld seam / welds when the housing is deformed in its at least one bending zone and thus avoid mechanically induced damage to the device.In one embodiment of the device, it is provided that the housing has on its outer side at least one, preferably hermetically sealed, interface with an electronic component arranged in the housing.The at least one interface thus serves as a feedthrough through which signals, data and / or pulses can pass from the interior of the housing of the device to the outside or in the opposite direction from the outside to the inside.The data, signals and / or pulses can be of different nature-depending on the application and specific design of the device.The aforementioned interface is also referred to as a feed-through. It thus represents a feedthrough which enables an interaction for signals and / or data between the electronics arranged in the interior of the hermetically closed housing and the environment of the device. In one embodiment of the interface, it is designed as an electrical interface and has at least one electrical connection contact. An electromedical electrode can be or can be connected to an interface embodied in this way, for example, via which body signals can be recorded from the patient's body or stimulation pulses can be emitted from the device to a target tissue in the patient's body.In one embodiment of the device, the latter has an optical interface as at least one interface. The optical interface can be accessible for optical signals, for example, through at least one window in the housing of the device. The window may be, for example, a sapphire window. The window can be formed in the housing and allow passage of optical signals from the interior of the housing to the outside or from the outside into the interior of the housing.In one embodiment, the device can have a wireless interface as at least one interface. In this way, it is possible to communicate wirelessly with an electronics in the interior of the housing of the device. For example, data that the device acquires by means of its electronics can thus be read wirelessly or data, for example programming, can be sent from the outside to the implanted medical device.The aforementioned at least one interface of the device can be arranged, for example, in a reinforced region of the housing and / or in a plane in which a neutral fiber of the housing runs.The aforementioned interface can preferably be designed as a hermetically sealed feedthrough. It is particularly preferred if the interface is implemented in LTCC technology. LTCC stands for low temperature co-fired ceramics (German: low temperature fired ceramics) and describes a technology from the field of electronics for producing multilayer circuits based on sintered ceramic carriers. The configuration of the interface in LTCC technology makes it possible to construct the interface in a particularly flat manner, which simplifies the integration of the interface into the device, in particular into the housing of the device, and can promote miniaturization of the device overall.The device may comprise an electromedical electrode. The electromedical electrode can be connected to the interface of the device in the position of use. The electromedical electrode can have, for example, at least one stimulation pole and / or at least one sensing pole and / or at least one sensor. The delivery of stimulation pulses to a target tissue is possible via a stimulation pole of the electromedical electrode. Body signals or other parameters of interest or measured values from the target tissue can be recorded via a sensing pole of the electrode and transmitted to a corresponding electronic component of the device for storage and / or processing. It can be advantageous if the electromedical electrode has at least one sensor which is configured to record parameters of interest and / or measured values. A pH sensor, a temperature sensor, a pressure sensor and / or an oxygen sensor can be provided as the sensor, for example.Other, application-specific sensors are likewise conceivable. An electrode equipped with such a sensor enables the acquisition of body signals, measured values and / or parameters of interest in or on the target tissue.The aforementioned electromedical electrode is preferably flexible. This makes it possible to guide the electrode from the implantation site of the device to a target tissue at which the electrode is to be applied and to take account of the anatomical circumstances of the patient.The electromedical electrode can have at least one flexible wire and / or at least one flexible printed circuit board section. The electromedical electrode can consist at least in part, for example, of polyimide, polyurethane, parylene and / or silicone or can comprise such material, in particular as a carrier material for at least one electrical line, at least one stimulation pole, at least one sensing pole and / or at least one sensor of the electromedical electrode.In one embodiment of the device, the device has at least one sensor. The at least one sensor may be arranged on an outer side of the housing or within the housing. An electrical sensor and / or an electronic sensor and / or a biochemical sensor, for example for detecting oxygen and / or for measuring a pH value, can be provided as a sensor, for example. A temperature sensor and / or a pressure sensor can also be provided as a sensor. Temperature and / or pressure values in the patient's body can thus be detected. An acceleration sensor can also be provided as a sensor, with which a movement of the device and thus at least indirectly a movement of a target tissue to be monitored is possible.In this way, it is possible to record data and / or body signals from the region in which the active implantable medical device is implanted in the patient's body.The good adaptability of the device to the anatomical conditions of the patient also makes it possible to implant the device in the most immediate vicinity possible to and even directly on the target tissue to be monitored and / or treated. Thus, for example, signals of interest can be recorded directly on the target tissue by means of at least one sensor of the device. The same also applies to the delivery of stimulation pulses to a target tissue in a device according to the invention designed as a pulse generator. Implantation of the medical device at a location which is far from the actual field of application of the device can thus be avoided if necessary.The device can have at least one electrical stimulation pole for delivering electromedical stimulation pulses. The stimulation pole can be arranged, for example, on an outer side of the housing of the device. In this way, the device can function as an electromedical pulse generator.The device can have at least one sensing pole for detecting body signals. The sensing pole can be arranged, for example, on an outer side of the housing.It is preferred to produce the housing of the device from titanium. Titanium is sufficiently robust and additionally biocompatible and thus particularly suitable as material for the housing.In a preferred embodiment of the device, the housing, in particular in the region of its at least one bending zone, has a wall thickness of between 10 μm and 100 μm, preferably between 10 μm and 50 μm.A housing formed in this way enables, on the one hand, the most compact possible design of the device and thus its particularly simple implantation. On the other hand, such a small wall thickness, at least in the region of its at least one bending zone, promotes simple deformation of the housing for adapting the device to anatomical circumstances of the patient. Such a small wall thickness of the housing can also enable wireless transmission of energy and / or data through a wall of the housing. In this connection, it may be expedient if the housing has a small and preferably a smaller wall thickness in the region of a wireless interface which the device can have than in other regions of the device. This can facilitate the passage of wireless signals through the wall of the housing and enable the accessibility of the wireless interface through the closed housing. In this way, a wireless communication is thus possible between a transceiver located outside the housing and an electronic component of the device located inside the housing. The interface can be designed as a communication interface.It should be mentioned at this point that the device can have as an electronic component an antenna arranged within the housing and / or a coil arranged within the housing for wirelessly receiving data and / or energy. Via the antenna and / or coil, the device can also be configured to wirelessly transmit data to an external receiver.The device may be configured for use with an external coil and / or with an external antenna. The external coil can be connected, for example, via the aforementioned interface in order to establish a connection between the coil and the at least one electronic component in the housing.Data and / or signals can then be transmitted from the device to the outside and / or from the outside to the device via the coil and / or antenna. The transmission of energy via the coil is also possible, for example, in order to supply the device with energy, in particular with current.In one embodiment of the device, a rigid receiving region of the housing is formed on each side of a bending zone, wherein at least one electronic component of the device can be integrated in each receiving region.The housing can have a plurality of defined bending zones, in particular which are arranged between two or more receiving regions for in each case at least one electronic component of the device. This promotes a comprehensive change in shape of the device and thus a particularly targeted adaptation of the device to anatomical circumstances of the respective patient.According to the invention, the device has an electronics carrier arranged in the housing. The electronics carrier can be, for example, a printed circuit board, preferably made of printed circuit board foil.The electronics carrier of the device can be rigid in one embodiment of the device. In this context, it may be advantageous if the electronics carrier is movably mounted in the housing. Due to the movable mounting, the rigidly formed electronics carrier and one or more electronic components arranged thereon can be protected from damage during a deformation of the housing. The electronics carrier can be movably mounted in the housing in the housing by at least one flexible connecting means, for example by a flexible filling compound, in particular made of silicone.In another embodiment of the device, the electronics carrier can be flexible at least in sections. In this way, the electronics carrier is protected from damage when the housing is deformed by its flexibility. When the housing is deformed, the electronics carrier can thus adapt its shape accordingly on account of its flexibility, without suffering damage.The electronics carrier can have at least one defined bending section. The bending section of the electronics carrier can be arranged within the bending zone of the housing. The bending section of the electronics carrier is thus then matched with respect to its position in the housing to the position of the bending zone of the housing. The matching of the at least one bending zone and the at least one bending section to one another then enables a deformation of the housing and of the electronics carrier in the interior of the housing for adapting the external shape of the device, without the electronics carrier and / or the at least one electronic component being damaged when the device is deformed.According to the invention, the electronics carrier has a carrier section on which the at least one electronic component of the device is arranged. In the position of use of the electronics carrier in the interior of the housing, this carrier section is then positioned within the rigid receiving region of the housing. An electronic component of the device, which is arranged on the carrier section of the electronics carrier, is thus then positioned within the rigid and particularly protective receiving region of the housing. Within the receiving region of the housing, the at least one electronic component of the device is then reliably protected from external influences and, in addition, also from deformation of the housing.In one embodiment of the device, the electronics carrier consists of a rigid-flex printed circuit board. A rigid flex circuit board comprises at least one rigid circuit board portion and at least one flexible circuit board portion. The flexible printed circuit board section can have a smaller thickness than the rigid printed circuit board section and / or consist of printed circuit board foil.The electronics carrier, in particular if it consists of a rigid flex circuit board, can comprise at least one bending section which consists of a flexible circuit board material. The flexible printed circuit board material can be printed circuit board foil, for example.The at least one flexible bending section of the electronics carrier can also have a smaller thickness, in particular a smaller layer thickness, than a carrier section of the electronics carrier which is rigid in comparison with the flexible bending section. In the case of an electronics carrier which consists of a rigid flex printed circuit board, the at least one carrier section of the electronics carrier can be formed from a rigid printed circuit board material.The sequence of at least one rigid carrier section and at least one flexible bending section thus provides an electronics carrier which has flexible properties and can adapt itself to a deformation of the housing for adapting the device to anatomical circumstances of a patient without being damaged.The electronics carrier can have in its at least one bending section at least one cutout which makes the electronics carrier flexible. If the electronics carrier is formed from a printed circuit board or a printed circuit board foil, the cutout can be, for example, a cutout or a punching out. In the at least one bending section, the recess then functions as a weakening of the material of the electronics carrier and promotes a simple deformation of the electronics carrier when the housing is deformed in order to adapt the device to anatomical circumstances of the patient.The at least one electronic component of the device and also the electronics carrier itself can be protected particularly reliably from mechanical loads, since the electronics carrier is arranged according to the invention in a plane in which a neutral fiber of the housing runs. If the housing is deformed, in particular in the region of its at least one bending zone, the mechanical loads which can act on the electronics carrier in this case are minimized by the arrangement of the electronics carrier in the plane in which a neutral fiber of the housing runs.The device can be designed as an active implantable electromedical device. The device can be designed in particular as an electromedical pulse generator, for example as a neurostimulator, cardiac pacemaker, cardioverter and / or as a brain pacemaker.It goes without saying that the at least one electronic component of the device is then selected to be matched to the specific application and the specific configuration of the device.In one embodiment, the device is designed as a medical recording device that is set up for recording, in particular electromedical and / or physiological, body signals and / or other parameters and / or measured values of interest.Such a device can record ECG signals, for example, or else other parameters which are of interest for the diagnosis and / or treatment of patients.In this context, it is expedient if the device has as electronic components a data memory and a data interface via which the data memory can be read out. The data interface can be, for example, one of the interfaces already explained above.Here, too, it is self-evident that the correspondingly designed device then has the electronic components necessary for its specific application.As an electronic component, the device can have, for example, a control unit and / or a pulse delivery unit, which enable delivery of electromedical control pulses.In one embodiment, the device has a transmitter as an electronic module, which is configured for wireless transmission, in particular for wireless reception and / or for wireless transmission, of data, in particular with a transmission frequency of 125 kHz. In one embodiment, the device has as an electronic module a receiver which is configured for wirelessly receiving energy, in particular with a transmission frequency of 125 kHz.Such a transmitter and / or receiver is suitable for wirelessly receiving and / or wirelessly transmitting data and / or energy through a closed wall of the housing. The housing thus then does not require an opening through which the transmission of data and / or energy would have to take place. This promotes the permanent tightness of the housing and thus contributes to the reliability of the operation of the device.The housing may include a silicone jacket. The silicone sheathing can serve for protection against mechanical influences and for fixing the device in its implanted position of use.The invention is described in more detail below with reference to an exemplary embodiment, but is not limited to this exemplary embodiment. Further exemplary embodiments result from a combination of the features of individual claims or of a plurality of claims with one another and / or by a combination of individual features or of a plurality of features of the exemplary embodiment. The following are shown: FIG. 1 : shows a perspective illustration of an active implantable medical device having a housing made of metal, which is hermetically sealed and comprises two defined bending zones and three receiving regions, which are rigid in comparison with the bending zones and in which electronic components of the device are arranged, FIG. 2 is a plan view of the apparatus shown in FIG. 1, FIG. 3 : a sectional side view of the device shown in FIGS. 1 and 2, FIG. 4 : shows an exploded perspective view of a further active implantable medical device according to the invention, which corresponds with respect to its structure to that shown in the preceding figures.The figures each show an active implantable medical device denoted overall by 1. The apparatus 1 comprises a housing 2 made of metal. The housing 2 is hermetically sealed, contains a plurality of electronic components 5 of the device 1 and is flexible at least in sections. This enables the shape of the housing 2 to be adapted to anatomical circumstances of a patient.The flexibility of the housing 2 at least in sections is achieved in the devices 1 shown in the figures in that the respective housing 2 has at least one defined bending zone 3 and at least one receiving region 4, which is rigid in comparison with the bending zone 3 and in which at least one electronic component 5 of the device 1 is arranged.The at least one defined bending zone 3 of the device 1 enables a targeted plastic deformation of the housing 2 of the device 1 for adapting the device 1 to anatomical circumstances of a patient.The figures show that the respective housing 2 has a plurality of bending lines 6 in its bending zones 3. In particular, FIG. 3 illustrates that a wall of the housing 2 along the bending lines 6 is at a shorter distance from the neutral fiber 15 and from the longitudinal axis 16 of the housing 2, which can be a longitudinal central axis of the housing 2, than in portions of the housing 2 adjoining the bending line 6. Walls of the housing 2 on both sides of the neutral fiber 15 thus approach the neutral fiber 15 of the housing 2 alternately in the bending zones 3.In the device 1 shown in the figures, the two bending zones 3 specify the same bending direction on the basis of the respective course of the bending lines 6. The bending lines 6 are aligned parallel to one another. In the case of a corresponding configuration of the bending zones 3, it is also possible, however, for the bending zones 3 to each specify different bending directions.The device 1 shown in concrete terms in the figures has a housing 2 which comprises two defined bending zones 3 and three receiving regions 4 which are rigid in comparison with the bending zones 3. At least one electronic component 5 of the device 1 is arranged in each of the receiving regions 4.The figures show that the housing 2 is designed to be corrugated in the two bending zones 3 and has bending lines 6 predetermined in the bending zones 3 by the corrugated shape of the housing 2. Along the bending lines 6, the housing 2 of the device 1 can be bent and thus plastically deformed.The bending lines 6 are oriented transversely, namely at right angles to a longitudinal axis 16 of the device 1.FIG. 3 illustrates that the housing 2 comprises two housing parts 7 and 8, which are hermetically connected to one another, namely welded, in a sealed manner. The housing parts 7 and 8 can consist of sheet metal strips and be deep-drawn into their desired shape. The housing 2 of the device 1 has an elongate shape and is of strip-shaped configuration. The bending lines 6 are oriented at right angles to the longitudinal extent of the housing 2 of the device 1.On its outer side, the housing 2 furthermore has a hermetically sealed interface 9, which can also be referred to as a feed-through, with the electronic components 5 arranged in the housing 2. The interface 9 is likewise arranged in a region of the housing 2 reinforced in comparison with the bending zones 3 and can also be referred to as an electronic component 5 of the device 1.The interface 9 functions as a connection interface at which a connection of the electronic components 5 arranged in the interior of the hermetically closed housing 2 is possible, for example, with an electromedical electrode not shown in the figures.The device 1 shown in the figures has an electrical interface with at least one electrical connection contact 10 as interface 9.The interface 9 is designed as a hermetically sealed feedthrough and in this case in LTCC technology. As a result, the interface 9 is particularly flat, which facilitates its integration into the housing 2 of the device 1.In another embodiment of the device 1 according to the invention, it can have as at least one interface 9 an optical interface with at least one window in the housing 2 and / or a wireless interface which enables wireless communication through a wall of the housing 2.The device 1 can comprise an electromedical electrode, as already mentioned above. The electromedical electrode can be connected to the interface 9. Depending on the embodiment, the electromedical electrode has, for example, at least one stimulation pole and / or at least one sensing pole. The electromedical electrode is of flexible design and can comprise at least one flexible wire and / or at least one flexible printed circuit board section and / or can be produced at least partially from polyimide, polyurethane, parylene and / or silicone or comprise such. The device 1 can have at least one sensor, which is not shown in the figures. The sensor is then arranged on an outer side of the housing 2 or else inside the housing 2. The sensor can be, for example, an electrical sensor and / or an electronic sensor and / or a biochemical sensor, with which particular parameters of a patient to be monitored and / or of interest can be detected.In one embodiment of the device 1, which is configured as an electromedical pulse generator, the device 1 has at least one electrical stimulation pole for delivering electromedical stimulation pulses. The stimulation pole is preferably arranged on an outer side of the housing 2.The housing 2 of the device 1 shown in the figures is made of titanium. The housing 2 has a wall thickness between 10 μm and 100 μm, in particular in the region of its two bending zones 3. The wall thickness is preferably between 10 μm and 50 μm, in particular in the region of the two bending zones 3.On both sides of both bending zones 3, a rigid receiving region 4 of the housing 2 is formed. Thus, both bending zones 3 are located between two rigid receiving regions 4.The one bending zone 3 is flanked by a rigid receiving region 4 and the aforementioned interface 9, which is likewise arranged on a receiving region 4 of the housing 2, which receiving region is formed rigidly in comparison to the bending zones 3.FIG. 3 illustrates that the device 1 has an electronics carrier 11 arranged in the housing 2. The electronics carrier 11 consists of a printed circuit board made of printed circuit board foil. The electronics carrier 11 has two defined bending sections 12 which, according to FIG. 3, are arranged within the bending zones 3 of the housing 2.In addition to the defined bending sections 12, the electronics carrier 11 has three carrier sections 13, on which the electronic components 5 of the device 1 are arranged. The carrier sections 13 are positioned within the respective rigid receiving regions 4 of the housing 2.The electronics carrier 11 has in each case in its bending sections 12 at least one cutout 14 which makes the electronics carrier 11 flexible. Furthermore, the electronics carrier 11 is arranged in a plane of the housing 2 in which a neutral fiber 15 of the housing 2 runs.The electronics carrier 11 of the devices 1 shown in the figures can be referred to as a rigid-flex circuit board because of its flexibility in regions.The bending sections 12 of the respective electronics carrier 11 can consist of a flexible printed circuit board material, for example printed circuit board foil, while the carrier sections 13 of the electronics carrier 11 are formed from a rigid printed circuit board material.In an exemplary embodiment of the device 1, not shown in the figures, it is provided that the electronics carrier 11 itself is of rigid design, but is mounted movably in the housing 2 of the device 1 in order to avoid mechanical damage when the housing 2 is deformed. The movable mounting of the electronics carrier 11 can be realized by a flexible connecting means, for example by a flexible filling compound, by means of which the electronics carrier 11 is then connected to the housing 2. The flexible connecting means may be made of silicone.Such a rigid electronics carrier 11 can be formed, for example, as a whole from a rigid printed circuit board or from a plurality of printed circuit board film sections layered one above the other.The device 1 shown in the figures is designed as an active implantable electromedical device and can be configured, for example, as an electromedical pulse generator, for example as a neurostimulator, cardiac pacemaker, cardioverter and / or as a brain pacemaker.In another embodiment of the device 1, the latter is designed as a medical recording device which is configured to record, in particular, electromedical and / or physiological body signals and / or other parameters of interest.Optionally, the housing 2 can be provided with a silicone casing in order to additionally protect the device 1 from external influences.In particular, FIG. 4 clearly shows that an opening 17 is formed in the upper housing part 7 of the two housing parts 7 and 8. The interface 9 as one of the electronic components 5 of the device 1 is led through the opening 17 to the outside and is accessible from the outside.FIG. 4 additionally shows various electronic components 5 on the electronics carrier 11 arranged within the housing 2 by way of example. The electronic components 5 are arranged in a recognizable manner on the carrier regions 13 of the electronics carrier 11. As electronic components 5, sensors can also be provided and arranged on the electronics carrier 11. Between the carrier regions 13, the electronics carrier 11 has its bending sections 12 with the recesses 14, which serve for the flexibility of the electronics carrier 11.The devices 1 shown in the figures are configured for wirelessly transmitting data and wirelessly receiving energy. The transmission can be effected with a transmission frequency of 125 kHz. For this purpose, the devices 1 have, as electronic modules 5, a transmitter and a receiver which are configured for wireless transmission, namely for wireless reception and for wireless transmission of data and energy. The transmitter and the receiver may comprise an antenna and / or a coil, which are not separately shown in the figures.List of reference characters1 Active implantable medical device 2 Housing 3 Bending zone 4 Receiving region 5 Electronic component 6 Bending line 7 Housing part 8 Housing part 9 Interface 10 Electrical connection contact 11 Electronics carrier 12 Bending section 13 Carrier section 14 Recess 15 Neutral fiber 16 Longitudinal axis of 2 17 Opening for 9 in 7

Claims

Active implantable medical device (1) with a housing (2) made of metal, which contains at least one electronic component (5) of the device (1), is hermetically sealed and flexible at least in sections, wherein the housing (2) comprises at least one defined bending zone (3) and at least one receiving region (4) which is rigid in comparison to the bending zone (3) and in which the at least one electronic component (5) of the device (1) is arranged, characterized in that the housing (2) is designed to be corrugated in its at least one bending zone (3), and in that the device (1) has an electronics carrier (11) arranged in the housing (2), which is arranged in a plane in which a neutral fiber (15) of the housing (2) runs, wherein the electronics carrier (11) has at least one defined bending section (12) arranged within the bending zone (3) of the housing (2), and at least one carrier section (13), on which the at least one electronic component (5) of the device (1) is arranged and which is positioned within the rigid receiving region (4) of the housing (2).Device (1) according to claim 1, wherein the housing (2) has at least one bending line (6) in the at least one bending zone (3), in particular along which one wall of the housing (2) has a smaller, in particular average, distance from a neutral fiber (15) and / or a longitudinal axis (16) of the housing (2) than in sections of the housing (2) adjoining the bending line (6).Device (1) according to one of the preceding claims, wherein the housing (2) has at least one bending line (6), in particular predetermined by a corrugated shape of the housing (2), preferably which is oriented transversely or at right angles to a longitudinal axis (16) of the housing (2).The device (1) according to any one of the preceding claims, wherein the housing (2) comprises at least two bending zones (3), wherein at least two bending zones (3) specify the same bending direction or different bending directions, in particular wherein bending lines (6) of the different bending zones (3) are oriented parallel to one another or point in different directions.Device (1) according to one of the preceding claims, wherein the housing (2) comprises at least two housing parts (7, 8) which are hermetically connected to one another, in particular welded to one another, in a hermetically sealed manner.Device (1) according to one of the preceding claims, wherein the housing (2) has on its outer side at least one, preferably hermetically sealed, interface (9) with an electronic component (5) arranged in the housing (2).Device (1) according to the preceding claim, wherein the device (1) has an electrical interface with at least one electrical connection contact (10) as at least one interface (9), and / or wherein the device has an optical interface as at least one interface, in particular which is accessible for optical signals through at least one window, for example a sapphire window, in the housing (1), and / or wherein the device (1) has a wireless interface as at least one interface.Device (1) according to one of the two preceding claims, wherein the interface (9) is designed as a hermetically sealed feedthrough and / or in LTCC technology.Device (1) according to one of the three preceding claims, wherein the device (1) comprises an electromedical electrode which is connected to the interface (9), in particular wherein the electromedical electrode has at least one stimulation pole and / or at least one sensing pole and / or at least one sensor.The device (1) according to the preceding claim, wherein the electromedical electrode is flexible.Device (1) according to one of the two preceding claims, wherein the electromedical electrode has at least one flexible wire and / or at least one flexible printed circuit board section and / or consists at least in part of polyimide, polyurethane, parylene and / or silicone, in particular as a carrier material for at least one electrical line, at least one stimulation pole, at least one sensing pole and / or at least one sensor of the electromedical electrode.Device (1) according to one of the preceding claims, wherein the device (1) has at least one sensor, in particular which is arranged on an outer side of the housing (2) or within the housing (2).Device (1) according to one of the preceding claims, wherein the device (1) has at least one electrical stimulation pole for delivering electromedical stimulation pulses, preferably wherein the stimulation pole is arranged on an outer side of the housing (2), and / or wherein the device (1) has at least one sensing pole for detecting body signals and / or parameters and / or measurement values of interest, preferably wherein the sensing pole is arranged on an outer side of the housing (2).The apparatus (1) according to any one of the preceding claims, wherein the housing (2) is made of titanium.Device (1) according to one of the preceding claims, wherein the housing (2), in particular in the region of its at least one bending zone (3), has a wall thickness of between 10 μm and 100 μm inclusive, preferably between 10 μm and 50 μm inclusive.Device (1) according to one of the preceding claims, wherein a rigid receiving region (4) of the housing (2) is formed on both sides of a bending zone (3) and / or wherein the housing (2) has a plurality of defined bending zones (3), in particular which are arranged between two or more receiving regions (4) for in each case at least one electronic component (5).The device (1) according to any one of the preceding claims, wherein the electronics carrier (11) is a printed circuit board.Device (1) according to one of the preceding claims, wherein the electronics carrier (11) is mounted rigidly and / or movably in the housing (2), or wherein the electronics carrier (11) is mounted at least in sections flexibly and / or movably in the housing (2).Device (1) according to one of the preceding claims, wherein the electronics carrier (11) consists of a rigid flex circuit board, wherein the at least one bending section (12) of the electronics carrier (11) is formed from a flexible circuit board material, in particular from circuit board foil, and the at least one carrier section (13) of the electronics carrier (11) is formed from a rigid circuit board material.Device (1) according to one of the preceding claims, wherein the electronics carrier (11) has in its at least one bending section (12) at least one cutout (14) which makes the electronics carrier (11) flexible.Device (1) according to one of the preceding claims, wherein the device (1) is designed as an active implantable electromedical device, in particular as an electromedical pulse generator, for example as a neurostimulator, pacemaker, cardioverter and / or as a brain pacemaker, and / or wherein the device (1) is designed as a medical recording device which is designed for recording, in particular electromedical and / or physiological, body signals and / or parameters and / or measured values.Device (1) according to one of the preceding claims, wherein the device (1) has as an electronic module (5) a transmitter which is configured for wirelessly transmitting data and / or a receiver which is configured for wirelessly receiving energy, in particular with a transmission frequency of 125 kHz.The apparatus (1) according to any one of the preceding claims, wherein the housing (2) comprises a silicone jacket.

Citation Information

Patent Citations

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