Active implantable medical device
A flexible, hermetically sealed metal housing with defined bending zones and rigid receiving areas addresses the challenge of adapting to patient anatomy, ensuring reliable fixation and protection of electronic components in active implantable medical devices.
Patent Information
- Application Number
- PCT/EP2025/051113
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-01-19
- Filing Date
- 2025-01-17
- Publication Date
- 2025-07-24
AI Technical Summary
Existing active implantable medical devices struggle to adapt to the unique anatomical conditions of individual patients, leading to unreliable fixation and potential dislocation from the intended implantation site.
A flexible, hermetically sealed metal housing with defined bending zones and rigid receiving areas allows targeted deformation to fit the patient's anatomy, protecting electronic components from mechanical stress while ensuring reliable fixation and functionality.
The device achieves precise adaptation to patient anatomy, preventing dislocation and ensuring the electronic components remain functional and protected, facilitating efficient treatment and monitoring.
Smart Images

Figure EP2025051113_24072025_PF_FP_ABST
Abstract
Description
[0001] Active implantable medical device
[0002] The invention relates to an active implantable medical device.
[0003] An active implantable medical device within the meaning of the claimed invention can be any active medical device designed to be introduced, in whole or in part, into the human body through a surgical or medical procedure, or into a natural body orifice through a medical procedure, and intended to remain there at least temporarily after the procedure. Such devices are used, for example, for treating and / or monitoring patients.
[0004] The object of the invention is to provide an active implantable medical device which can be particularly easily adapted to the anatomical conditions of a patient in whom the device is implanted and which can be reliably fixed in the patient's body.
[0005] To solve this problem, an active implantable medical device having the features of the independent claim directed to such a device is proposed.
[0006] To achieve the object, an active implantable medical device with a housing made of metal is proposed, which contains at least one electronic component of the device, is hermetically sealed and at least partially flexible.
[0007] Because the device's housing is flexible, at least in sections, it can be deformed in a targeted manner. This allows the device to be adapted to the patient's anatomical characteristics and securely fixed within the patient's body.
[0008] If the active implantable medical device is designed, for example, as an electromedical pulse generator for the treatment of migraines and / or Parkinson's disease, the device can be deformed to fit the shape of the patient's skull and then positioned on the outside of the patient's skull. This enables particularly reliable, space-saving, and unobtrusive implantation of the device in the patient's body.
[0009] In a preferred embodiment of the device, the housing can comprise at least one defined bending zone and at least one receiving area which is rigid compared to the bending zone and in which the at least one electronic component of the device is arranged.
[0010] 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 to fix it reliably in the patient's body.
[0011] The at least one rigid receiving area provided by the housing for an electronic component of the device serves to protect the electronic component from external influences. Because the receiving area is rigid compared to the defined bending zone of the housing, deformation of the housing in the receiving area, which could potentially endanger at least one electronic component of the device arranged in the receiving area, can be specifically avoided.
[0012] Preferably, the deformation of the housing is limited to the at least one defined bending zone, whereas the at least one rigid receiving area for the at least one electronic component of the device remains undeformed even when the housing is deformed. In this way, the at least one electronic component in the rigid receiving area of the housing is reliably protected from mechanical stress and, if necessary, damage.
[0013] The device can thus have a metallic housing that is flexible due to the at least one bending zone for the hermetic encapsulation of at least one electronic component of the device, which allows for defined deformation. This allows for patient-specific adaptation of the housing geometry through permanent plastic deformation of the housing.
[0014] The housing can have different wall thicknesses in the at least one bending zone and in the at least one receiving area. The housing can further have at least one stiffener, in particular a stiffening geometry, and / or a filling for stiffening the housing. This favors the targeted provision of at least one bending zone on the housing that can be deformed, while the at least one receiving area for the at least one electronic component is deliberately designed to be stiffer or more rigid and thus resists deformation compared to the bending zone.
[0015] The housing can, for example, have at least one rib as a stiffener. The rib can, for example, be created by a targeted 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 stiffener. The epoxy resin can be applied to the housing over a large area or, for example, in the form of a rib or along a line or in other forms in order to specifically stiffen a certain section of the housing. 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 thickened portion, in or on its at least one receiving area. This stiffening structure can contribute to making the receiving area of the housing rigid and resistant to deformation.This can improve the protective effect of the housing's receiving area for an electronic component of the device located therein.
[0016] 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 created by a targeted shaping of the housing. For example, it is possible for the housing to have a wall which, along the at least one bending line, has a distance, in particular a mean distance, to a neutral fiber and / or to a longitudinal axis, preferably to a longitudinal center axis, of the housing, which is smaller than the distance of the wall in a section of the housing adjacent to 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.
[0017] The housing of the device can, for example, comprise at least two bending zones. This facilitates 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 have the same bending direction or different bending directions. In one embodiment of the device, its housing is provided to comprise several bending zones which specify at least two different bending directions and thus enable 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.
[0018] Bending lines assigned to different bending zones can be aligned parallel to each other or point in different directions. If two bending zones specify the same bending direction, their bending lines are aligned parallel to each other. If the bending lines of two bending zones point in different directions, the bending zones specify different bending directions.
[0019] In one embodiment of the device, the housing is corrugated in at least one of its bending zones. Due to the corrugated shape of the bending zone, the housing is flexible in the bending zone and can be deformed particularly easily and precisely there to adapt the device to the anatomical characteristics of a patient.
[0020] The deformability of the housing, at least in the area of its at least one bending zone, makes it possible, for example, to adapt the device to the shape of a bony structure in the patient's body and, for example, to at least partially wrap the device around the bony structure. This promotes reliable positioning and fixation of the device in its implanted position of use. In some cases, the deformation of the housing alone, preferably plastic, may be sufficient to reliably and firmly fix the device in its implanted position in the body.
[0021] Ultimately, the device's deformability also enhances its operational reliability. Targeted deformation of the device, adapted to the patient's anatomy, can prevent the device from leaving its implanted position in the patient's body and potentially losing contact with the target tissue, thus compromising its function.
[0022] In one embodiment of the device, the housing has at least one bending line in its at least one bending zone, along which the housing can be bent, i.e., deformed. The at least one bending line can be predetermined, for example, by a corrugated shape of the housing and / or preferably be oriented transversely or at right angles to a longitudinal axis of the device.
[0023] A longitudinal axis of the device can be an axis that runs along a longest dimension of its housing. The housing of the device can have an elongated shape and can preferably be strip-shaped. 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.
[0024] In one embodiment of the device, the housing comprises at least two housing parts that are hermetically sealed to one another. Such a housing with at least two parts facilitates assembly of the device and thus its economical production.
[0025] To hermetically connect the housing parts, the housing parts of the device can be welded together. For example, the housing parts can be welded together using ultrasound and / or a laser to create a hermetically sealed connection between the housing parts. This enables the economical production of a particularly reliable, hermetically sealed housing that can reliably protect the at least one electronic component of the device arranged in the at least one rigid receiving area from conditions prevailing in the body that may be harmful to the electronic component.
[0026] A weld seam for the hermetically sealed connection of 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 several weld seams can minimize mechanical stress on the weld seam(s) when the housing is deformed in at least one of its bending zones and thus prevent mechanically caused damage to the device.
[0027] In one embodiment of the device, it is provided that the housing has on its outer side at least one, preferably hermetically sealed, interface to an electronic component arranged in the housing.
[0028] The at least one interface thus serves as a passage through which signals, data and / or impulses 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.
[0029] The data, signals and / or impulses can be of different nature - depending on the application and the specific design of the device.
[0030] The previously mentioned interface is also referred to as a feedthrough. It therefore represents a feedthrough that enables interaction for signals and / or data between the electronics arranged inside the hermetically sealed 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, for example, can be connected to an interface designed in this way, via which body signals from the patient's body can be picked up or stimulation pulses can be delivered from the device to a target tissue in the patient's body.
[0031] In one embodiment of the device, it 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 can be a sapphire window, for example. The window can be formed in the housing and allow the passage of optical signals from the interior of the housing to the outside or from the outside into the interior of the housing.
[0032] In one embodiment, the device can have a wireless interface as at least one interface. This makes it possible to communicate wirelessly with electronics inside the device's housing.
[0033] For example, data that the device records using its electronics can be read out wirelessly, or data, such as programming, can be sent from outside to the implanted medical device.
[0034] The above-mentioned at least one interface of the device can be arranged, for example, in a reinforced area of the housing and / or in a plane in which a neutral fiber of the housing runs.
[0035] The aforementioned interface can preferably be designed as a hermetically sealed feedthrough. It is particularly preferred if the interface is designed using LTCC technology. LTCC stands for Low Temperature Cofired Ceramics and describes a technology from the field of electronics for producing multilayer circuits based on sintered ceramic carriers. Designing the interface using LTCC technology makes it possible to build the interface particularly flat, which simplifies integration of the interface into the device, particularly into the device housing, and can overall promote miniaturization of the device.
[0036] The device can 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, for example, have at least one stimulation pole and / or at least one sensing pole and / or at least one sensor. Stimulation pulses can be delivered to a target tissue via a stimulation pole of the electromedical electrode. Body signals or other parameters or measured values of interest 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 that is set up to record parameters and / or measured values of interest.The sensor can be, for example, a pH sensor, a temperature sensor, a pressure sensor, and / or an oxygen sensor. Other, application-specific sensors are also conceivable. An electrode equipped with such a sensor enables the recording of body signals, measured values, and / or parameters of interest in or on the target tissue.
[0037] The aforementioned electromedical electrode is preferably designed to be flexible. This allows the electrode to be guided from the device implantation site to the target tissue where the electrode is to be applied, while taking the patient's anatomical characteristics into account.
[0038] The electromedical electrode may comprise at least one flexible wire and / or at least one flexible circuit board section. The electromedical electrode may consist at least in part of, for example, polyimide, polyurethane, parylene, and / or silicone, or may 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.
[0039] In one embodiment of the device, it has at least one sensor. The at least one sensor can be arranged on an outside of the housing or inside the housing. For example, an electrical sensor and / or an electronic sensor and / or a biochemical sensor, e.g. for detecting oxygen and / or for measuring a pH value, can be provided as a sensor. A temperature sensor and / or a pressure sensor can also be provided as a sensor. In this way, temperature and / or pressure values in the patient's body can be recorded. 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.
[0040] In this way, it is possible to record data and / or body signals from the area in which the active implantable medical device is implanted in the patient's body.
[0041] The device's excellent adaptability to the patient's anatomical characteristics also makes it possible to implant the device as close as possible to, and even directly on, the target tissue to be monitored and / or treated. For example, signals of interest can be recorded directly on the target tissue using at least one sensor of the device. The same applies to the delivery of stimulation pulses to a target tissue using a device according to the invention designed as a pulse generator. This may make it possible to avoid implanting the medical device at a location far removed from the device's actual area of application.
[0042] The device may have at least one electrical stimulation pole for delivering electromedical stimulation pulses. The stimulation pole may, for example, be located on an outer side of the device's housing. In this way, the device can function as an electromedical pulse generator.
[0043] The device may have at least one sensing pole for detecting body signals. The sensing pole may, for example, be located on an outer side of the housing.
[0044] It is preferred to manufacture the device's housing from titanium. Titanium is sufficiently robust and also biocompatible, making it a particularly suitable material for the housing.
[0045] 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 pm and 100 pm, preferably between 10 pm and 50 pm.
[0046] A housing designed in this way firstly enables the device to be designed as compactly as possible, thus making it particularly easy to implant. Secondly, such a low wall thickness, at least in the region of its at least one bending zone, facilitates easy deformation of the housing to adapt the device to the patient’s anatomical characteristics. Such a low wall thickness of the housing can also enable wireless transmission of energy and / or data through a wall of the housing. In this context, it can be expedient if the housing has a low wall thickness in the region of a wireless interface, which the device can have, and preferably a lower wall thickness than in other areas of the device. This can make it easier for wireless signals to pass through the wall of the housing and enable the wireless interface to be accessible through the closed housing.In this way, wireless communication is possible between a transmitter / receiver located outside the housing and an electronic component of the device located inside the housing. The interface can be designed as a communications interface.
[0047] It should be noted here that the device, as an electronic component, may have an antenna and / or a coil arranged within the housing for wirelessly receiving data and / or energy. The device may also be configured to wirelessly transmit data to an external receiver via the antenna and / or coil.
[0048] The device may be configured for use with an external coil and / or an external antenna. The external coil may, for example, be connected via the aforementioned interface to establish a connection between the coil and the at least one electronic component in the housing.
[0049] 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. Energy can also be transmitted via the coil, for example, to supply the device with energy, especially electricity.
[0050] In one embodiment of the device, a rigid receiving area 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 area.
[0051] The housing can have several defined bending zones, in particular those arranged between two or more receiving areas, each for at least one electronic component of the device. This facilitates extensive shape changes of the device and thus a particularly targeted adaptation of the device to the anatomical characteristics of the respective patient.
[0052] The device may have an electronics carrier arranged in the housing. The electronics carrier may, for example, be a printed circuit board, preferably made of printed circuit board foil.
[0053] In one embodiment of the device, the electronics carrier of the device can be rigid. In this context, it can be advantageous if the electronics carrier is movably mounted in the housing. Due to the movable mounting, the rigid electronics carrier and one or more electronic components arranged thereon can be protected from damage in the event of deformation of the housing. The electronics carrier can be movably mounted in the housing by at least one flexible connecting means, for example by a flexible filling compound, in particular made of silicone.
[0054] In another embodiment of the device, the electronics carrier can be designed to be flexible, at least in sections. This way, the electronics carrier is protected from damage by its flexibility if the housing is deformed. If the housing is deformed, the electronics carrier can adapt its shape accordingly thanks to its flexibility without sustaining damage.
[0055] 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 position of the bending section of the electronics carrier in the housing is thus coordinated with the position of the bending zone of the housing. The coordination of the at least one bending zone and the at least one bending section with one another then enables deformation of the housing and the electronics carrier inside the housing to adapt 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.
[0056] The electronics carrier can have a carrier section on which the at least one electronic component of the device is arranged. When the electronics carrier is in the use position inside the housing, this carrier section can then be positioned within the rigid receiving area of the housing. An electronic component of the device that is arranged on the carrier section of the electronics carrier is thus then positioned within the rigid and particularly protective receiving area of the housing. Within the receiving area of the housing, the at least one electronic component of the device is then reliably protected from external influences and also from deformation of the housing.
[0057] In one version of the device, the
[0058] An electronics carrier made from a rigid-flex printed circuit board. A rigid-flex printed circuit board comprises at least one rigid printed circuit board section and at least one flexible printed circuit board section. The flexible printed circuit board section can be thinner than the rigid printed circuit board section and / or made of printed circuit board foil.
[0059] The electronics carrier, particularly if it consists of a rigid-flex circuit board, can comprise at least one bending section made of a flexible circuit board material. The flexible circuit board material can be, for example, circuit board foil.
[0060] 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 that is rigid compared to the flexible bending section. In an electronics carrier consisting 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.
[0061] The sequence of at least one rigid support section and at least one flexible bending section thus provides an electronics support which has flexible properties and can adapt to a deformation of the housing in order to adapt the device to the anatomical conditions of a patient without being damaged.
[0062] The electronics carrier can have at least one recess in its at least one bending section that makes it more flexible. If the electronics carrier is formed from a printed circuit board or a printed circuit board foil, the recess can be, for example, a cutout or a punched-out portion. In at least one bending section, the recess then acts as a material weakening of the electronics carrier and facilitates easy deformation of the electronics carrier when the housing is deformed to adapt the device to the patient's anatomical characteristics.
[0063] The at least one electronic component of the device and also the electronics carrier itself can be particularly reliably protected from mechanical stress if the electronics carrier is arranged 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 stresses that can act on the electronics carrier are minimized by arranging the electronics carrier in the plane in which a neutral fiber of the housing runs.
[0064] 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 cerebral pacemaker.
[0065] It goes without saying that at least one electronic component of the device is then selected to suit the specific application and the specific design of the device.
[0066] In one embodiment, the device is designed as a medical recording device configured to record, in particular, electromedical and / or physiological, body signals and / or other parameters and / or measured values of interest. Such a device can, for example, record ECG signals or other parameters of interest for the diagnosis and / or treatment of patients.
[0067] In this context, it is useful for the device to have, as electronic components, a data memory and a data interface through which the data memory can be read. The data interface can, for example, be one of the interfaces already explained.
[0068] Here too, it goes without saying that the appropriately designed device then has the electronic components necessary for its specific application.
[0069] As an electronic component, the device can, for example, have a control unit and / or a pulse delivery unit that enables the delivery of electromedical control pulses.
[0070] 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 wireless transmission, of data, in particular with a transmission frequency of 125 kHz. In one embodiment, the device has a receiver as an electronic module, which is configured for wireless reception of energy, in particular with a transmission frequency of 125 kHz.
[0071] Such a transmitter and / or receiver is suitable for wireless reception and / or transmission of data and / or energy through a closed housing wall. The housing thus requires no opening through which the data and / or energy would have to be transmitted. This promotes the permanent tightness of the housing and thus contributes to the reliability of the device's operation.
[0072] The housing may have a silicone coating. The silicone coating may serve to protect against mechanical influences and to fix the device in its implanted position for use.
[0073] The invention is described in more detail below using an exemplary embodiment, but is not limited to this embodiment. Further exemplary embodiments result from combining the features of individual or multiple claims with one another and / or by combining individual or multiple features of the exemplary embodiment. They show:
[0074] Fig. 1: a perspective view of an active implantable medical device with a metal housing that is hermetically sealed and comprises two defined bending zones and three receiving areas that are rigid compared to the bending zones and in which electronic components of the device are arranged,
[0075] Fig. 2: a plan view of the device shown in Figure 1,
[0076] Fig. 3: a sectional side view of the device shown in Figures 1 and 2,
[0077] Fig. 4: a perspective exploded view of another active implantable medical device according to the invention, which corresponds in terms of its structure to that shown in the previous figures.
[0078] The figures each show an active implantable medical device, designated as a whole by 1. The device 1 has a metal housing 2. The housing 2 is hermetically sealed, contains several electronic components 5 of the device 1, and is flexible at least in sections. This allows the shape of the housing 2 to be adapted to the anatomical characteristics of a patient.
[0079] 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 area 4 which is rigid compared to the bending zone 3 and in which at least one electronic component 5 of the device 1 is arranged.
[0080] 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 in order to adapt the device 1 to the anatomical conditions of a patient.
[0081] The figures show that the respective housing 2 has a plurality of bending lines 6 in its bending zones 3. Figure 3 in particular illustrates that a wall of the housing 2 along the bending lines 6 has a smaller distance to the neutral fiber 15 and to the longitudinal axis 16 of the housing 2, which can be a longitudinal center axis of the housing 2, than in sections of the housing 2 adjacent to the bending line 6. Because a plurality of such bending lines 6 are provided in the bending zones 3, the housing 2 takes on a corrugated shape in the respective bending zone 3. Walls of the housing 2 on both sides of the neutral fiber 15 thus alternately approach the neutral fiber 15 of the housing 2 in the bending zones 3.
[0082] In the device 1 shown in the figures, the two bending zones 3 specify the same bending direction due to the respective course of the bending lines 6. The bending lines 6 are aligned parallel to each other. With an appropriate design of the bending zones 3, it is also possible for the bending zones 3 to specify different bending directions.
[0083] The device 1 shown specifically in each of the figures has a housing 2 comprising two defined bending zones 3 and three receiving areas 4 that are rigid compared to the bending zones 3. At least one electronic component 5 of the device 1 is arranged in each of the receiving areas 4.
[0084] The figures show that the housing 2 is corrugated in the two bending zones 3 and has bending lines 6 in the bending zones 3 defined by the corrugated shape of the housing 2. The housing 2 of the device 1 can be bent and thus plastically deformed along the bending lines 6.
[0085] The bending lines 6 are aligned transversely, namely at right angles to a longitudinal axis 16 of the device 1.
[0086] Figure 3 illustrates that the housing 2 comprises two housing parts 7 and 8, which are hermetically sealed to one another, namely welded. The housing parts 7 and 8 can consist of sheet metal strips and can be deep-drawn into the desired shape. The housing 2 of the device 1 has an elongated shape and is strip-shaped. The bending lines 6 are aligned at right angles to the longitudinal extent of the housing 2 of the device 1.
[0087] On its outer side, the housing 2 further has a hermetically sealed interface 9, which can also be referred to as a feedthrough, to the electronic components 5 arranged in the housing 2. The interface 9 is also arranged in a region of the housing 2 that is reinforced compared to 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 inside the hermetically sealed housing 2 is possible, for example to an electromedical electrode not shown in the figures.
[0088] The device 1 shown in the figures has an electrical interface with at least one electrical connection contact 10 as interface 9.
[0089] Interface 9 is designed as a hermetically sealed feedthrough using LTCC technology. This makes interface 9 particularly flat, which facilitates its integration into the housing 2 of device 1.
[0090] In another embodiment of the device 1 according to the invention, this 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.
[0091] 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 flexible and can comprise at least one flexible wire and / or at least one flexible circuit board section and / or be made at least partially from or comprise polyimide, polyurethane, parylene and / or silicone. 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 inside the housing 2.The sensor can, for example, be an electrical sensor and / or an electronic sensor and / or a biochemical sensor with which certain parameters of a patient to be monitored and / or of interest can be recorded.
[0092] In one embodiment of the device 1, which is designed 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.
[0093] The housing 2 of the device 1 shown in the figures is made of titanium. The housing 2 has a wall thickness of between 10 pm and 100 pm, particularly in the region of its two bending zones 3. Preferably, the wall thickness is between 10 pm and 50 pm, particularly in the region of the two bending zones 3.
[0094] A rigid receiving area 4 of the housing 2 is formed on each side of each bending zone 3. Thus, both bending zones 3 are located between two rigid receiving areas 4.
[0095] One bending zone 3 is flanked by a rigid receiving area 4 and the previously mentioned interface 9, which is also arranged on a receiving area 4 of the housing 2 that is rigid in comparison to the bending zones 3.
[0096] Figure 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 Figure 3, are arranged within the bending zones 3 of the housing 2.
[0097] 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 areas 4 of the housing 2.
[0098] The electronics carrier 11 has at least one recess 14 in each of its bending sections 12, which makes the electronics carrier 11 more 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.
[0099] The electronics carrier 11 of the devices 1 shown in the figures can be referred to as a rigid-flex printed circuit board due to its flexibility in certain areas.
[0100] The bending sections 12 of the respective electronics carrier 11 can consist of a flexible circuit board material, for example of circuit board foil, while the carrier sections 13 of the electronics carrier 11 are formed of a rigid circuit board material.
[0101] In an embodiment of the device 1 not shown in the figures, it is provided that the electronics carrier 11 itself is rigid, but is movably mounted in the housing 2 of the device 1 to avoid mechanical damage in the event of deformation of the housing 2. The movable mounting of the electronics carrier 11 can be realized by a flexible connecting means, for example by a flexible filling compound, via which the electronics carrier 11 is then connected to the housing 2. The flexible connecting means can be made of silicone.
[0102] Such a rigid electronics carrier 11 can, for example, be formed as a whole from a rigid printed circuit board or from several printed circuit board foil sections layered one above the other.
[0103] 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.
[0104] In another embodiment of the device 1, it is designed as a medical recording device which is set up to record in particular electromedical and / or physiological body signals and / or other parameters of interest.
[0105] Optionally, the housing 2 can be provided with a silicone coating to additionally protect the device 1 from external influences.
[0106] In particular, Figure 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 out through the opening 17 and is accessible from the outside.
[0107] Figure 4 also shows, by way of example, various electronic components 5 on the electronics carrier 11 arranged inside the housing 2. The electronic components 5 are clearly arranged on the carrier regions 13 of the electronics carrier 11. Sensors can also be provided as electronic components 5 and arranged on the electronics carrier 11. Between the carrier regions 13, the electronics carrier 11 has its bent sections 12 with the recesses 14, which serve to make the electronics carrier 11 more flexible. The devices 1 shown in the figures are set up for the wireless transmission of data and for the wireless reception of energy. The transmission can take place at a transmission frequency of 125 kHz. For this purpose, the devices 1 have a transmitter and a receiver as electronic modules 5, which are set up for wireless transmission, namely for the wireless reception and wireless transmission of data and energy.The transmitter and the receiver may comprise an antenna and / or a coil, which are not shown separately in the figures.
[0108] / List of reference symbols
[0109] List of reference symbols active implantable medical device housing bending zone receiving area electronic component bending line housing part housing part interface electrical connection contact electronics carrier bending section carrier section recess neutral fiber longitudinal axis of 2 opening for 9 in 7
[0110] / Claims
Claims
Claims 1. Active implantable medical device (1) with a metal housing (2) which contains at least one electronic component (5) of the device (1), is hermetically sealed and at least partially flexible.
2. Device (1) according to claim 1, wherein the housing (2) comprises at least one defined bending zone (3) and at least one receiving area (4) which is rigid compared to the bending zone (3) and in which the at least one electronic component (5) of the device (1) is arranged.
3. Device (1) according to claim 2, wherein the housing (2) has at least one bending line (6) in the at least one bending zone (3), in particular along which a wall of the housing (2) has a smaller, in particular average, distance to a neutral fiber (15) and / or a longitudinal axis (16) of the housing (2) than in sections of the housing (2) adjacent to the bending line (6).
4. Device (1) according to one of the preceding claims, wherein the housing (2) is corrugated in its at least one bending zone (3) and / or has at least one bending line (6), in particular predetermined by a corrugated shape of the housing (2), preferably which is aligned transversely or at right angles to a longitudinal axis (16) of the housing (2).
5. Device (1) according to 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 aligned parallel to each other or point in different directions.
6. Device (1) according to one of the preceding claims, wherein the housing (2) comprises at least two housing parts (7, 8) which are hermetically sealed to one another, in particular welded to one another.
7. 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) to an electronic component (5) arranged in the housing (2).
8. 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.
9. 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.
10. 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.
11. Device (1) according to the preceding claim, wherein the electromedical electrode is flexible.
12. Device (1) according to one of the preceding claims, wherein the electromedical electrode has at least one flexible wire and / or at least one flexible circuit board section and / or consists at least partly 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.
13. 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 inside the housing (2).
14. 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 of interest and / or measured values, preferably wherein the sensing pole is arranged on an outer side of the housing (2).
15. Device (1) according to one of the preceding claims, wherein the housing (2) is made of titanium.
16. 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 between 10pm and 100pm, preferably between 10pm and 50pm.
17. Device (1) according to one of the preceding claims, wherein a rigid receiving area (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 areas (4) for at least one electronic component (5) in each case.
18. Device (1) according to one of the preceding claims, wherein the device (1) has an electronics carrier (11) arranged in the housing (2), in particular a printed circuit board.
19. Device (1) according to the preceding claim, 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 partially flexibly and / or movably in the housing (2).
20. Device (1) according to one of the two preceding claims, wherein the electronics carrier (11) has at least one defined bending section (12) which is 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 area (4) of the housing (2).
21. Device (1) according to one of the three preceding claims, wherein the electronics carrier (11) consists of a rigid-flex Printed circuit board, wherein the at least one bending section (12) of the electronics carrier (11) is formed from a flexible printed circuit board material, in particular from printed circuit board foil, and the at least one carrier section (13) of the electronics carrier (11) is formed from a rigid printed circuit board material.
22. 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 recess (14) which makes the electronics carrier (11) more flexible.
23. Device (1) according to one of the preceding claims, wherein the electronics carrier (11) is arranged in a plane in which a neutral fiber (15) of the housing (2) runs.
24. 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, cardiac pacemaker, cardioverter and / or as a brain pacemaker, and / or wherein the device (1) is designed as a medical recording device which is set up to record, in particular electromedical and / or physiological, body signals and / or parameters and / or measured values.
25. Device (1) according to one of the preceding claims, wherein the device (1) has as electronic module (5) a transmitter which is configured for the wireless transmission of data and / or a receiver which is configured for the wireless reception of energy, in particular with a transmission frequency of 125 kHz.
26. Device (1) according to one of the preceding claims, wherein the housing (2) has a silicone coating. / Summary
Citation Information
Patent Citations
Implantable medical device with electrodes on multiple housing surfaces
US20070073353A1
Flexible hermetic enclosure for implantable medical devices
US20080154327A1
Methods and Apparatus for Selectively Shunting Energy in an Implantable Extra-Cardiac Defibrillation Device
US20080183230A1
Wireless recharging system and method for flexible implantable subcutaneous medical device
US20160175600A1
Conforming implantable defibrillator
US5645586A