Assembly set for providing an implantable medical device

Abstract

An assembly set for providing an implantable medical device (1) comprising at least one supply module (3A, 3A') having an energy supply device (31), at least one control module (3B) having a control device (32) for controlling operation of the implantable medical device (1), a multiplicity of functional modules (3C-3G) each having a functional device (33) for performing a medical function in an implanted state of the implantable medical device (1), and a collection of interface modules (4). The supply module (3A, 3A'), the control module (3B) and at least one of the multiplicity of functional modules (3C-3G) are connectable to one another using the interface modules (4) such that, in an assembled state, interface modules (4) interconnect pairs of neighboring modules of the supply module (3A, 3A'), the control module (3B) and at least one of the multiplicity of functional modules (3C-3G).

Description

[0001] Applicant: BIOTRONIK SE & Co. KG

[0002] Assembly set for providing an implantable medical device

[0003] The instant invention generally relates to an assembly set of an implantable medical device, an implantable medical device and a method for fabricating an implantable medical device.

[0004] An implantable medical device of the type concerned herein may for example be a pacemaker, an implantable cardioverter defibrillator, a sensor device such as a bio-sensor, or a recording device such as a loop recorder. The implantable medical device herein is configured to sense electrocardiogram signals. For example, the implantable medical device may be a recording device which is configured to record electrocardiogram signals and to communicate recorded electrocardiogram signals or information derived from recorded electrocardiogram signals to an external device in the context of a home monitoring system.

[0005] An implantable medical device as for example described in EP 3 278 836 Bl may for example comprise a housing and an arrangement of electrode poles arranged on the housing. The electrode poles herein are arranged on the housing of the implantable medical device such that the electrode poles are aligned along a longitudinal axis along which the implantable medical device extends. The electrode poles may for example be formed by housing segments which are made from an electrically conductive material such as a metal material and are exposed to the outside such that they may be brought into electrical contact with surrounding tissue in order to establish an electrical coupling to the tissue in an implanted state of the implantable medical device.

[0006] Implantable medical devices, such as pacemaker devices, implantable cardioverter defibrillator devices, sensor devices or recording devices, generally are configured to provide different functions when they are implanted in a patient. Such implantable medical devices hence generally are designed for their specific, dedicated function and purpose, coming with the drawback that it potentially may be cumbersome, if at all possible, to adapt a specific implantable medical device to change or add a function. There hence is a general desire to allow for providing for an implantable medical device adapted to a desired medical function in a versatile manner.

[0007] WO 2017 / 050878 Al describes a system and method for operating a modular pulse oximetry platform with interchangeable modules. A plurality of modules and a pulse oximeter platform may be selected based on a health context and may be connected in a serial manner using connection means for use on a finger of a patient.

[0008] US 2009 / 0118779 Al discloses a modular platform for wireless implantable devices, the platform enabling different functional units, which either measure or affect a parameter of the patient’s body, to be interchanged. The modularity of the platform enables the functional unit to be remote from the remainder of the implantable device.

[0009] It is an object of the instant invention to provide an assembly set for providing an implantable medical device, an implantable medical device and a method for fabricating a medical device which in a versatile manner allow for providing for an implantable medical device which is adapted to a desired medical function.

[0010] In one aspect, an assembly set for providing an implantable medical device comprises: at least one supply module having an energy supply device, at least one control module having a control device for controlling operation of the implantable medical device, at least one functional module or a multiplicity of functional modules each having a functional device for performing a medical function in an implanted state of the implantable medical device, and a collection of interface modules. The (at least one) supply module, the (at least one) control module and the at least one functional module or at least one of the multiplicity of functional modules are connectable to one another using the interface modules such that, in an assembled state, interface modules interconnect pairs of neighboring modules of the (at least one) supply module, the (at least one) control module and the at least one functional module or at least one of the multiplicity of functional modules.

[0011] Within the assembly set, a set of different modules is provided which may be connected to form the implantable medical device. Within the set, at least one supply module comprises an energy supply device, in particular a battery. At least one control module comprises a control device for controlling operation of the implantable medical device, the control device being made up of electronic circuitry, such as an electronic chip on which software is implemented for controlling operation of the implantable medical device. In addition, the set comprises at least one functional module or a multiplicity of functional modules each having a functional device for performing a medical function in an implanted state of the implantable medical device. Different functional modules herein serve to carry out different medical functions, such that by combining the supply module and the control module with one or multiple (of the multiplicity of) functional modules an implantable medical device may be provided having a specific functional configuration according to the functional module or modules used on the implantable medical device.

[0012] In a preassembly state, the supply module, the control module and the at least one functional module or the at least one of the multiplicity of functional modules beneficially are separate from one another, such that the implantable medical device may be formed by combining a desired combination of modules. Herein, by selecting a desired combination of at least one functional module together with at least one supply module and at least one control module, an implantable medical device may be created which has a specific, desired hardware configuration according to the combination of functional module or modules. In the following, the term ’’multiplicity of functional modules” also includes the term “at least one functional module” and “one functional module”.

[0013] In the assembled state, the supply module, the control module and the at least one of the multiplicity of functional modules are connected to one another by interface modules. Each interface module serves to establish a connection in between a pair of neighboring modules, that is between e.g. the supply module and the control module, between the supply module and a functional module or between the control module and a functional module. Between the modules of each pair of neighboring modules, hence, an interface module is placed, the interface module serving to establish a connection in between the neighboring modules.

[0014] All interface modules may for example have the same structure, such that alike interface modules are used to provide for a connection in between neighboring modules. In one embodiment, interface modules of different structure may be provided within the set, the interface modules for example differing in an arrangement of electrical interconnects or in the mechanical structure for establishing a connection in between neighboring modules.

[0015] In one embodiment, in the assembled state the supply module, the control module and the at least one of the multiplicity of functional modules are connected, in particular fixedly connected to one another by means of intermediate interface modules. The connection of the modules to one another, by means of the interface modules, beneficially is non-reversible.

[0016] In particular, an implantable medical device may be fabricated by a device manufacturer according to a desired hardware configuration, for example as ordered by a customer, such as a physician. For fabricating the implantable medical device, the device manufacturer may select and combine modules according to the desired configuration, and may manufacture the implantable medical device by (fixedly) connecting the modules to one another using the interface modules. In the assembled state, the implantable medical device is delivered to the customer, which hence obtains a ready -to-use implantable medical device according to the desired hardware configuration.

[0017] In one embodiment, in the assembled state the supply module, the control module and the at least one of the multiplicity of functional modules are aligned with respect to one another along a longitudinal axis. By combining the desired modules, hence, an implantable medical device is provided which longitudinally extends along a longitudinal axis, such that the implantable medical device may for example be implanted in a vessel of the patient, such as a blood vessel.

[0018] In the assembled state, the modules are interconnected by means of the interface modules such that a hermetic, fluid-tight, sealed implantable medical device is provided. The modules may be fluid-tight in themselves. In one embodiment, a hermetic sealing of the modules with respect to one another is established (only) upon connecting the modules with each other using the interface modules, such that in the assembled state a hermetic, fluid-tight device is established, which is sealed and biocompatible.

[0019] In one embodiment, at least the supply module and the control module are sealed, biocompatible and biostable by themselves, i.e. already in the preassembly state.

[0020] The supply module generally serves to supply electrical energy during operation of the implantable medical device. The supply module may in particular comprise an electrochemical battery. Within the assembly set, herein, a set of different supply modules may be provided, for example different supply modules having different energy storage capacities, such that within the assembly set it may be chosen between different supply modules. The control module generally serves to control operation of the implantable medical device. The control module in particular may comprise electronic circuitry for electronically controlling operation of the implantable medical device. Within the assembly set, herein, a set of different control modules may be provided, for example different control modules having different electronic circuitries or different programming configurations for performing different control functions.

[0021] In one embodiment, the medical function of the at least one functional module is at least one of a sensing function for sensing a medical signal in the patient and / or an active function for performing a medical stimulation action in the patient.

[0022] For example, the medical function may be a sensing function for sensing a cardiac signal, such as an electrocardiogram signal. In one embodiment, the sensing function may be a photoplethysmogram (PPG) function, configured to optically obtain a plethysmogram that can be used to detect blood volume changes in a microvascular bed of tissue. In one embodiment, the sensing function may be a function for sensing glucose, calcium, potassium, a pH value or the like. In one embodiment, the sensing function may be a pressure sensing function, in particular a blood pressure sensing function. In one embodiment, the sensing function may be an acoustic sensing function for sensing an acoustic signal. The functional module may comprise a suitable transducer, such as a pressure sensor or an acoustic sensor, and may for this comprise a transducer for converting energy from one form to another, such as a pressure signal or an acoustic signal into an electrical signal.

[0023] In another example, the medical function may be an active function for performing a medical stimulation action in the patient. The active function may for example be a cardiac stimulation function for outputting cardiac stimulation signals, such as pacing signals or defibrillation signals. In one embodiment, the active function may be a drug delivery function for delivering a particular drug using a drug delivery unit within the patient.

[0024] In one embodiment, the multiplicity of functional modules includes at least a first functional module for performing a first medical function and a second functional module for performing a second medical function different than the first medical function. The assembly set hence includes different functional modules for performing different medical functions, wherein by combining one or multiple functional modules with at least one supply module and at least one control module an implantable medical device may be provided according to a desired hardware configuration.

[0025] In one embodiment, the (at least one) supply module comprises a first housing segment enclosing the energy supply device therein. The (at least one) control module comprises a second housing segment enclosing the control device therein. At least one of the multiplicity of functional modules comprises a third housing segment enclosing the functional device therein. In one embodiment, the housing segments by themselves may already be sealed, such that the modules already in the preassembly state are fluid-tight. In another embodiment, the housing segments are sealed only once they are connected to one another by the interface modules in the assembled state. The housing segments enclose the particular associated device therein, such that the housing segments, at least in the assembled state in connection with the interface modules, provide for an encapsulation of the particular units enclosed therein.

[0026] Generally, the functional modules may be of different configurations. For example, one or multiple of the functional modules may comprise a housing segment for encapsulating a functional device therein. Other functional modules for example do not comprise a housing segment, such that for example a transducer may be brought immediately into contact with tissue in an implanted state of the implantable medical device.

[0027] In one embodiment, at least one of the first housing segment, the second housing segment and the third housing segment is electrically conductive to form an electrode pole for at least one of sensing an electrical sense signal in the patient and outputting an electrical stimulation signal in the patent. For example, two or more housing segments of modules combined to form the implantable medical device may be electrically conductive and, in the assembled state and when implanted in the patient, may be configured to form electrode poles for sensing electrical sense signals or outputting electrical stimulation signals. The poles formed by the housing segments may be aligned along the longitudinal axis along which the implantable medical device extends, such that by means of the electrode poles different sensing vectors or excitation electrodes may be spanned for sensing e.g. electrocardiogram signals or for outputting e.g. cardiac stimulation signals.

[0028] In one embodiment, in the assembled state one of the interface modules interconnects neighboring housing segments of a pair of the first housing segment of the supply module, the second housing segment of the control module and the third housing segment of the at least one of the multiplicity of functional modules. An interface module hence establishes a connection in between housing segments of neighboring modules. The connection in particular may be such that at least in the assembled state a sealed, biocompatible and biostable assembly is established.

[0029] In particular, the interface module may be configured for establishing a positive-fit connection or a material bond connection in between housing segments of neighboring modules. The connection in particular may be non-reversible, such that a disassembly of the implantable medical device is not possible without further ado. A positive-fit connection in particular may be established by means of a mechanical locking in between the housing segments of the neighboring modules and the interface module placed in between, for example using a snap-fit connection. A material bond connection may in particular be established by using a welding technique, such as laser welding, a soldering technique or a gluing technique.

[0030] In one embodiment, the interface modules each comprise an electrically insulating carrier element having a first side and a second side opposite to the first side. In the assembled state, one of the modules of the pair of neighboring modules is connected to the first side of the interface module, and the other of the modules of the pair of neighboring modules is connected to the second side of the interface module. The insulating carrier element may for example be made up of a circuit board having a planar extension along a plane oriented perpendicularly with respect to the longitudinal axis along which the implantable medical device extends in the assembled state. On either side of the carrier element one of the neighboring modules is placed, such that the neighboring modules are connected to one another via the carrier element of the interface module.

[0031] In one embodiment, the carrier element comprises a connection device such as a connection flange, for example having a ring shape, the connection device for example being configured for establishing a positive-fit connection or a material bond connection. A connection device of this kind may be placed on either side of the carrier element, such that on either side a connection with one of the neighboring modules may be established. For example, using the connection device a housing segment of a module may be welded to the interface module, such that a weld connection may be established in between the interface module and the module using the connection device.

[0032] In one embodiment, the housing segment comprises or consists of translucent and / or electromagnetic permeable materials, e.g. ceramic and / or glass and / or polymers. In one embodiment, each module and / or each functional module has its own housing, which may be a housing segment. Alternatively, at least one of the modules has its own housing or housing segment.

[0033] In one embodiment, the carrier element comprises an arrangement of electrical interconnects for establishing an electrical interconnection between the pair of neighboring modules. The electrical interconnects may be formed by feedthroughs reaching through the carrier element, wherein connection pads may be placed on either side of the carrier element allowing for an electrical connection of a unit of the particular module to the electrical interconnects and hence an electrical interconnection of functional units of the neighboring modules across the interface module.

[0034] An implantable medical device may be fabricated from an assembly set of the type described above using a desired combination of modules, such as at least one supply module, at least one control module and one or multiple functional modules interconnected by an arrangement of interface modules.

[0035] In one aspect, an implantable medical device comprises: at least one supply module having an energy supply device, at least one control module having a control device for controlling operation of the implantable medical device, at least one functional module out of a multiplicity of functional modules each having a functional device for performing a medical function in an implanted state of the implantable medical device, and a collection of interface modules. The (at least one) supply module, the (at least one) control module and the at least one functional module out of the multiplicity of functional modules are connected to one another using the interface modules such that interface modules interconnect pairs of neighboring modules of the supply (at least one) module, the (at least one) control module and the at least one functional module out of at least one of the multiplicity of functional modules.

[0036] A method for fabricating an implantable medical device may use an assembly set of the type described above.

[0037] In one aspect, a method for fabricating an implantable medical device using an assembly set comprises: providing at least one supply module having an energy supply device; providing at least one control module having a control device for controlling operation of the implantable medical device; providing a multiplicity of functional modules each having a functional device for performing a medical function in an implanted state of the implantable medical device; providing a collection of interface modules; fabricating the implantable medical device by connecting the supply module, the control module and at least one of the multiplicity of functional modules to one another using the interface modules such that, in an assembled state, interface modules interconnect pairs of neighboring modules of the supply module, the control module and at least one of the multiplicity of functional modules. The design of the assembly offers freedoms in the manufacturing (e.g. exchanging modules late in the manufacturing process).

[0038] The advantages and advantageous embodiments described above for the assembly set equally apply to the implantable medical device and the method for fabrication, such that it shall be referred to the above in this respect.

[0039] The various features and advantages of the present invention may be more readily under-stood with reference to the following detailed description and the embodiments shown in the drawings. Herein,

[0040] Fig. 1 shows a schematic drawing of an implantable medical device implanted in a patient;

[0041] Fig. 2 shows a schematic drawing of an implantable medical device comprising different modules, in an assembled state;

[0042] Fig. 3 shows another example of an implantable medical device comprising different modules, in an assembled state;

[0043] Fig. 4 shows a schematic drawing of an interface module for connecting modules to one another;

[0044] Fig. 5A shows an assembly set for fabricating an implantable medical device in a preassembly state;

[0045] Fig. 5B shows the arrangement of Fig. 5A during fabrication of the implantable medical device;

[0046] Fig. 6 shows a schematic drawing of an implantable medical device comprising different modules, in an assembled state; Fig. 7 shows a schematic drawing of another example of an implantable medical device comprising different modules, in an assembled state; and

[0047] Fig. 8 shows a schematic drawing of yet another example of an implantable medical device comprising different modules, in an assembled state.

[0048] Subsequently, embodiments of the invention shall be described in detail with reference to the drawings. In the drawings, like reference numerals designate like structural elements.

[0049] It is to be noted that the embodiments are not limiting for the invention, but merely represent illustrative examples.

[0050] Referring to Fig. 1, in one embodiment an implantable medical device 1 is implanted (for example subcutaneously) into a patient for serving a therapeutic and / or diagnostic function. The implantable medical device 1 may for example be implanted subcutaneously into a patient P for monitoring cardiac activity of the patient’s heart H. The implantable medical device 1, for this, may comprise an arrangement of electrode poles which are used to couple to surrounding tissue and to sense electrocardiogram signals originating from the heart H.

[0051] The implantable medical device 1 may comprise communication circuitry for establishing a communication with an external device 2 which rests outside of the patient P. During operation, data may be communicated between the implantable medical device 1 and the external device 2, for example within the context of a home monitoring system.

[0052] Generally, the implantable medical device 1 shall provide for a specific function within a patient P. Such function may include a sensing function for sensing medical signals, such as cardiac signals. In addition, such function may include a stimulation function for outputting stimulation signals for performing a stimulation action, such as a pacing action or a defibrillation action.

[0053] It shall be noted that an implantable medical device 1, in the context as concerned herein, may provide for a cardiac sensing or stimulation function, or for another function remote from the patient’s heart H, such as a neuro-stimulation function or the like. Typically, an implantable medical device 1 is designed for performing a specific function, the implantable medical device 1 comprising a hardware configuration which enables the implantable medical device 1 to carry out its prescribed function.

[0054] As there may be a desire to be able to provide an implantable medical device 1 in a versatile fashion for a variety of different medical functions, it herein is proposed to use an assembly set for fabricating an implantable medical device 1 , the assembly set providing for a modular platform made up of a variety of different modules which are combinable in order to fabricate an implantable medical device 1 of a desired functional configuration.

[0055] Referring now to Fig. 2, in one embodiment an implantable medical device 1 may be produced from a number of different modules 3 A, 3B, 3C, which in an assembled state are connected to one another using interface modules 4. A first module herein is a supply module 3A having an energy supply device 31 received in a housing segment 30 A. A second module is a control module 3 OB having a control device 32 received in a housing segment 3 OB. A third module is a functional module 3C having a functional device 33 received in a housing segment 30. The functional device 33 may for example include a transducer for sensing signals and converting sensed signals, such as a pressure signal or an acoustic signal, into electrical signals to be processed by the control device 32. Of course, there are always electrical connections between the interface modules 4 and the devices 31, 32, 33 in the modules. Thus, at least one of the modules 3A, 3B, 3C may have its own housing or housing segment. Furthermore, at least one of the housings or housing segments 30A, 3 OB, 30 may comprise or consist of ceramic and / or glass and / or polymers.

[0056] In the embodiment of Fig. 2 and in all of the following embodiments, the implantable medical device 1 may have more than one supply module and / or more than one control module.

[0057] In another example, shown in Fig. 3, an implantable medical device 1 is produced from a combination of modules 3A, 3B, 3D. As in the example of Fig. 2, a first module is a supply module 3 A having an energy supply device 31 received in a housing segment 30A and a second module is a control module 30B having a control device 32 received in a housing segment 30B. Herein, in the example of Fig. 3, a third module is a functional module 3D having a functional device 33, for example including a transducer for sensing signals and converting sensed signals, such as a pressure signal or an acoustic signal, into electrical signals to be processed by the control device 32. In contrast to the example of Fig. 2, the functional device 33 of the functional module 3D is not enclosed in a housing segment, such that the functional device 33, for example a transducer, may be placed in direct contact with surrounding tissue in an implanted state of the implantable medical device 1.

[0058] Within the modular platform for fabricating an implantable medical device 1, an assembly set may be provided which comprises one or multiple supply modules 3 A, one or multiple control modules 3B, and a multiplicity of different functional modules 3C, 3D. The different modules 3A-3D of the assembly set are combinable in order to make up an implantable medical device 1, such that the implantable medical device 1 may be fabricated by selecting a desired combination of modules 3A-3D in order to enable the implantable medical device 1 to perform desired medical functions.

[0059] The modules 3A-3D of the assembly set herein, for fabricating the implantable medical device 1, are selected and are connected to one another by means of interface modules 4, one interface module 4 being placed in between an associated pair of modules 3A-3D, as this is visible from Figs. 2 and 3, such that by means of the interface modules 4 the modules 3 A-3D of the implantable medical device 1 are aligned along a longitudinal axis L to form the implantable medical device 1.

[0060] Referring now to Fig. 4, each interface module 4 for example is structurally identical. For example, each interface module 4 may comprise a carrier element 40, for example being made from an electrically insulating material, for example a circuit board material. The carrier element 40 carries, on either side of the planar carrier element 40, a connection device 42A, 42B formed by a flange ring circumferentially extending about the longitudinal axis L and axially protruding from the carrier element 40. The connection device 42A, 42B is connected to the carrier element 40 by means of a soldering layer 43 such that each connection device 42A, 42B is fixedly connected to the carrier element 40.

[0061] Each connection device 42A, 42B, for example having the shape of a flange ring, may for example be made from a metal material, such as titanium. The connection device 42A, 42B allows for a connection to a housing segment 30A, 30B, 30 of a module 3A-3D, for example a material bond connection, such as a weld connection or the like.

[0062] The carrier element 40 furthermore carries an arrangement of electrical interconnects 41 having connection pads 410, 411 and electrical feedthroughs 412 for allowing for an electrical interconnection of neighboring modules 3A-3D across the carrier element 40. In a preassembly state, the modules 3A-3D as well as the interface modules 4 are separate from one another.

[0063] As illustrated in Fig. 5A, for manufacturing an implantable medical device 1 of a desired functional configuration, a combination of modules 3A, 3B, 3C is selected, the selection including a supply module 3A, a control module 3B and a desired functional module 3C. Between each pair of modules 3A-3C an interface module 4 is placed, such that the modules 3A-3C may be connected to one another by means of the interface modules 4 in between.

[0064] During manufacturing, neighboring modules 3A-3C are connected to one another by establishing a connection to the respective interface module 4 in between, as this is illustrated in Fig. 5B. In particular, the housing segments 30A, 30B of the modules 3A, 3B may each be welded to the corresponding connection device 42A, 42B on either side of the carrier element 40 of the interface module 4, such that the modules 3 A, 3B are fixedly and non-reversibly connected to one another. In Figs. 5A and 5B (and optionally for all other figures) the devices 31, 32, 33 of the modules 3A, 3 OB, 30 are only examples and each of them may be replaced by other devices.

[0065] Likewise, the modules 3B, 3C may be connected to each other by means of an intermediate interface module 4, such that the modules 3A, 3B, 3C are aligned with respect to one another along the longitudinal axis L and are fixedly connected to form the implantable medical device 1.

[0066] As illustrated in Fig. 5A, each module 3A-3C, in one embodiment, comprises a connection interface 300 which is configured to electrically couple to the electrical interconnects 41 of the associated interface module 4, such that by means of the connection interface 300 an electrical coupling of neighboring modules 3A-3C is established.

[0067] In the assembled state, the modules 3A-3C are fixedly connected to one another, such that a sealed, biocompatible and biostable device is provided.

[0068] In one embodiment, the modules 3A-3C may already in the preassembly state be sealed, biocompatible and biostable.

[0069] In another embodiment, the sealing only is established once the modules 3A-3C are connected to one another by means of the interface modules 4. Modules of the assembly set may provide for entirely different medical functions. Also, modules of the assembly set may be combinable in an arbitrary order and arbitrary combination, wherein each implantable medical device 1 shall comprise a supply module 3 A, a control module 3B and one or multiple additional functional modules for providing one or more medical functions, such as sensing and stimulation functions.

[0070] Referring now to Fig. 6, in one example an implantable medical device 1 is made up of four modules, wherein a supply module 3A’ and a control module 3B are arranged in between functional modules 3C, 3E each comprising a functional device 33, 34 having a transducer for sensing signals or outputting signals.

[0071] In another example, shown in Fig. 7, a supply module 3A and a control module 3B are connected to one another, wherein two functional modules 3C, 3F each comprising a functional device 33, 35 including a transducer adjoin the control module 3B on a side opposite the supply module 3 A.

[0072] In yet another example, shown in Fig. 8, a supply module 3A and a control module 3B are connected to one another, wherein two functional modules 3F, 3G adjoin the control module 3B on a side opposite the supply module 3 A, a first functional module 3F having a transducer 35 and a second functional module 3G having a functional device 36 being a drug delivery unit for delivering a drug in an implanted state in a patient.

[0073] Functional modules 3C-3G may be configured for providing for a variety of different medical functions.

[0074] For example, a medical function may be a sensing function for sensing a cardiac signal, such as an electrocardiogram signal. In one embodiment, the sensing function may be a photoplethysmogram (PPG) function, configured to optically obtain a plethysmogram that can be used to detect blood volume changes in a microvascular bed of tissue. In one embodiment, the sensing function may be a function for sensing glucose, calcium, potassium, a pH value or the like. In one embodiment, the sensing function may be a pressure sensing function, in particular a blood pressure sensing function. In one embodiment, the sensing function may be an acoustic sensing function for sensing an acoustic signal. The functional module may comprise a suitable sensor, such as a pressure sensor or an acoustic sensor, and may for this comprise a transducer for converting energy from one form to another, such as a pressure signal or an acoustic signal into an electrical signal. In another example, a medical function may be an active function for performing a medical stimulation action in the patient. The active function may for example be a cardiac stimulation function for outputting cardiac stimulation signals, such as pacing signals or defibrillation signals. In one embodiment, the active function may be a drug delivery function for delivering a particular drug using a drug delivery unit within the patient. Different functional modules 3C-3G may be configured for carrying out different medical functions, wherein within an implantable medical device 1 also functional modules may be combined which provide the same medical function, but at different locations.

[0075] Some or all of the housing segments 30A, 30B, 30 of the modules 3A, 3B, 3C may be electrically conductive and may for example be formed by a metal, such as titanium. Housing sections 30A,

[0076] 3 OB, 30 of neighboring modules herein are electrically insulated from one another by means of the interface module 4 in between. By forming the housing segments 30A, 3 OB, 30 from an electrically conductive material, the housing segments 30A, 3 OB, 30 may function as an electrode pole for sensing and / or outputting electrical signals, for example for sensing electrocardiogram signals and / or for outputting cardiac stimulation signals.

[0077] Referring back to Fig. 2, electrode poles formed by the housing segments 30A, 3 OB, 30 may span different signal vectors A, B, C for sensing and / or outputting electrical signals. In the embodiment of Fig. 2, a first electrode pole is formed by the housing segment 30A of the supply module 3A enclosing the energy supply device 31, a second electrode pole is formed by the housing segment 30B of the control module 3B enclosing the control device 32, and a third electrode pole is formed by the housing segment 30 of the functional module 3C enclosing the functional transducer unit 33. The implantable medical device 1 generally extends along a longitudinal axis L, the electrode poles being aligned along the longitudinal axis L and being axially displaced with respect to one another along the longitudinal axis L. The electrode poles formed by the different housing segments 30A, 30B, 30 herein are electrically separated from one another by the interface modules

[0078] 4 arranged in between the different modules 3A, 3B, 3C.

[0079] Using the arrangement of electrode poles, electrocardiogram signals may be received and processed by the control device 32. Based on the processing, a communication with an external device 2 may be established, for example to transmit alert messages to the external device 2 for example within the context of a home monitoring system for monitoring a physiological state of the patient P. The different electrode poles formed by the different housing segments 30A, 3 OB, 30 define signal reception and / or excitation vectors A, B, C by means of which signals may be received and / or output using pairs of associated electrode poles. In particular, a first signal reception vector A is formed between the first electrode pole formed by the housing segment 30A of the supply module 3A and the third electrode pole formed by the housing segment 30 of the functional module 3C, a second signal reception vector B is formed between the first electrode pole formed by the housing segment 30A of the supply module 3 A and the second electrode pole formed by the housing segment 3 OB of the control module 3B, and a third signal reception vector C is formed between the second electrode pole formed by the housing segment 3 OB of the control module 3B and the third electrode pole formed by the housing segment 30 of the functional module 3C. As the first electrode pole and the third electrode pole are arranged at opposite ends of the implantable medical device 1, the associated signal reception vector A is longer than the other two signal reception vectors B, C.

[0080] Referring now again to Fig. 2, e.g. for a regular signal reception for example a pair of electrode poles formed by the housing segment 30A of the supply module 3 A and the formed by the housing segment 30 of the functional module 3C may be used, defining a signal reception vector A as illustrated in Fig. 2. Using the signal reception vector A, e.g. electrocardiogram signals may be recorded and may be processed within the control device 32 (being or including a processor), which is functionally connected to the different housing segments 30A, 30B, 30 of the modules 3 A, 3B, 3C. Using the signal reception vector A for regular signal reception may come with the benefit of a strong signal reception even from remote regions, as the electrode poles define a comparatively long signal reception vector A for receiving signals from surrounding tissue.

[0081] Generally, the control device 32 may e.g. process a received signal in order to monitor an electrocardiogram signal. In the example of Fig. 2, the signal received via the signal reception vector A e.g. may be assessed by comparison e.g. to a signal received via the signal reception vector C defined in between the electrode pole formed by the housing 30B of the control module 3B and the electrode pole formed by the housing 30 of the functional module 3C. Hence, when using a particular pair of electrode poles, for example the pair associated with the first electrode pole formed by the housing segment 30A of the supply module 3A and the third electrode pole formed by the housing segment 30 of the functional module 3C, for regular signal reception, the other two pairs of electrode poles can be used for assessing the consistency of the signal reception using the first pair of electrode poles. Based on a comparison of the signals received by the different signal reception vectors A, B, C it can be assessed e.g. whether an abnormality in one signal reception vector is due to a physiological condition or due to another factor, such as a mechanical or electrical failure of the implantable medical device 1 or a loss of coupling.

[0082] Generally, the signals may be processed in different signal channels, the signals being received synchronously using the different signal reception vectors A, B, C, such that a synchronous assessment of one signal received via one pair of electrode poles with respect to a signal received via another pair of electrode poles is enabled.

[0083] Within the processing, a comparison may take place, for example by comparing signal levels with respect to one another. In another embodiment, waveforms may be compared, for example a timing or level of a QRS waveform, a P wave or a T wave.

[0084] Generally, a processing may take place in one or multiple channels. If for example only one processing channel involving a single signal amplification is used, a signal multiplexing may be employed. The processing may include the use of one or multiple comparators.

[0085] In another embodiment, cardiac events may be compared. For example, if an asystole is identified in the first signal reception vector A being defined between the first electrode pole formed by the housing segment 30A of the supply module 3 A and the third electrode pole formed by the housing segment 30 of the functional module 3C, cardiac events such as ventricular contraction events (Vs) and / or atrial contraction events (As) may be identified in another signal, for example obtained via the signal reception vector C between the second electrode pole formed by the housing segment 3 OB of the control module 3B and the third electrode pole formed by the housing segment 30 of the functional module 3C, wherein based on cardiac events in the other signal for example a heart rate may be identified. Based on detected cardiac events of the second signal an asystole in the first signal may be found to be inconsistent, such that any alarm based on the asystole detected in the first signal is raised or suppressed. List of reference numerals

[0086] 1 Implantable medical device

[0087] 2 External device

[0088] 3 A, 3A’ Supply module

[0089] 3B Control module

[0090] 3C-3G Functional module

[0091] 30, 30A, 30B Housing segment

[0092] 300 Connection interface

[0093] 31 Energy supply device

[0094] 32 Control device

[0095] 33-36 Functional device

[0096] 4 Interface module

[0097] 40 Carrier element (electrically insulating element)

[0098] 41 Electrical interconnects

[0099] 410, 411 Connection pad

[0100] 412 Eelectrical feedthrough

[0101] 42A, 42B Connection device (flange)

[0102] 43 Soldering layer

[0103] A-E Signal reception vector

[0104] H Heart

[0105] L Longitudinal axis

[0106] P Patient

Claims

Claims1. An assembly set for providing an implantable medical device (1), comprising:- at least one supply module (3 A, 3 A’) having an energy supply device (31),- at least one control module (3B) having a control device (32) for controlling operation of the implantable medical device (1),- a multiplicity of functional modules (3C-3G) each having a functional device (33) for performing a medical function in an implanted state of the implantable medical device (1), and- a collection of interface modules (4), wherein the supply module (3A, 3A’), the control module (3B) and at least one of the multiplicity of functional modules (3C-3G) are connectable to one another using the interface modules (4) such that, in an assembled state, interface modules (4) interconnect pairs of neighboring modules of the supply module (3 A, 3A’), the control module (3B) and at least one of the multiplicity of functional modules (3C-3G).

2. The assembly set according to claim 1, wherein in a preassembly state the supply module (3 A, 3A’), the control module (3B) and the at least one of the multiplicity of functional modules (3C-3G) are separate from one another.

3. The assembly set according to claim 1 or 2, wherein in the assembled state the supply module (3A, 3A’), the control module (3B) and the at least one of the multiplicity of functional modules (3C-3G) are connected, in particular fixedly connected, to one another for providing the implantable medical device (1).

4. The assembly set according to one of claims 1 to 3, wherein in the assembled state the supply module (3 A, 3A’), the control module (3B) and the at least one of the multiplicity of functional modules (3C-3G) are aligned with respect to one another along a longitudinal axis (L).

5. The assembly set according to one of the preceding claims, wherein the medical function is at least one of a sensing function for sensing a medical signal in the patient (P) and / or an active function for performing a medical stimulation action in the patient (P).

6. The assembly set according to one of the preceding claims, wherein the multiplicity of functional modules (3C-3G) includes at least a first functional module for performing a first medical function and a second functional module for performing a second medical function different than the first medical function.

7. The assembly set according to one of the preceding claims, wherein the supply module (3 A, 3 A’) comprises a first housing segment (30A) enclosing the energy supply device (31) therein, the control module (3B) comprises a second housing segment (3 OB) enclosing the control device (32) therein, and at least one of the multiplicity of functional modules (3C- 3G) comprises a third housing segment (30) enclosing the functional device (33) therein.

8. The assembly set according to claim 7, wherein at least one of the first housing segment (30A), the second housing segment (3 OB) and the third housing segment (30) is electrically conductive to form an electrode pole for at least one of sensing an electrical sense signal in the patient (P) and outputting an electrical stimulation signal in the patient (P).

9. The assembly set according to claim 7 or 8, wherein, in the assembled state, one of the interface modules (4) interconnects neighboring housing segments of a pair of the first housing segment (30A) of the supply module (3 A, 3A’), the second housing segment (30B) of the control module (3B) and the third housing segment (30) of the at least one of the multiplicity of functional modules (3C-3G).

10. The assembly set according to claim 9, wherein in the assembled state the neighboring housing segments are connected to the one of the interface modules (4) by a positive-fit connection or by a material bond.

11. The assembly set according to one of the preceding claims, wherein the interface modules (4) each comprise an electrically insulating carrier element (40) having a first side and a second side opposite the first side, wherein, in the assembled state, one of the modules of each pair of neighboring modules is connected to the first side of the interface module (4) and the other of the modules of said pair of neighboring modules is connected to the second side of the interface module (4).

12. The assembly set according to claim 11, wherein the carrier element (40) comprises a first connection device (42A) on said first side for establishing a connection to the one of themodules of said pair of neighboring modules and a second connection device (42B) on said second side for establishing a connection to the other of the modules of said pair of neighboring modules.

13. The assembly set according to claim 11 or 12, wherein the carrier element (40) comprises an arrangement of electrical interconnects (41) for establishing an electrical interconnection between said pair of neighboring modules.

14. An implantable medical device (1) fabricated from an assembly set according to one of the preceding claims.

15. A method for fabricating an implantable medical device (1) using an assembly set according to one of the preceding claims.

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