Electronic implants

Abstract

The present invention relates to an electronic implant (100) for implantation in the body of a living being and for monitoring bodily functions, in particular a pacemaker for monitoring and controlling bodily functions, the implant (100) comprising: an electrode part (2) attached or placed on a body part according to the intended purpose; 0.5≦V G ≦4cm 3 , preferably ≦2 cm 3 Volume V within the range G and a housing having: (i) an electronics assembly (3) connected to the electrode portion (2), configured to monitor at least a bodily function via the electrode portion (2); (ii) an energy storage device (4) for supplying electrical energy to the electronics assembly (3) for a long period of time, the energy storage device (4) being capable of being recharged with electrical energy after being discharged; and (iii) housing the following components of the electronic implant (100): an energy receiving unit (5) electrically connected to the energy storage (4) and configured to be capable of contactlessly receiving energy and supplying energy to the energy storage (4) for recharging the energy storage (4); (I) the energy receiving unit (5) comprises at least one coil (6) extending along a coil axis (SA) and adapted to receive and supply energy to the energy storage (4) when passed through an external alternating magnetic field generated by an external charging device, the coil being an air-core coil or comprising a magnetically conductive core (7) located within the coil and extending along the coil axis; (II) The coil (6) generates a charging current of up to 2 A rectified by a rectifier, and this charging current is supplied to the energy storage for recharging; (III) The energy receiving unit (5) is A0<=2.5*10 -3 m 2 having a magnetic field collection area A0 perpendicular to the coil axis (SA) which is (IV) The electronics assembly (3) is configured to provide information for spatial adaptation of the alignment of the alternating magnetic field relative to the coil axis.

Description

[Technical Field]

[0001] The present invention relates to electronic implants for implantation in the body of a living being and for monitoring bodily functions, in particular to electronic pacemakers intended to be implanted in the human heart. [Background technology]

[0002] A pacemaker that can be recharged contactlessly is known from publication US 2021 / 0212586 A1. This pacemaker has a coil bonded to a ferrite foil. In this regard, the coil is neither an air-core coil nor a cored coil. Therefore, the coil's ability to collect the magnetic field generated for charging is low. The flat design of the coil also leads to a strong opposing magnetic field, thus limiting the current that can be drawn earlier than usual.

[0003] Pacemakers are designed to assume a certain orientation, namely, parallel to the skin surface of the pacemaker wearer, when secured to the heart. This orientation is necessary so that the charging coil, positioned on the skin surface, can be aligned with the pacemaker coil. Even a slight misalignment between the pacemaker coil and the charging coil results in a rapid drop in charging current. In addition, the charging coil must generate a very strong alternating magnetic field at the skin surface so that a sufficient magnetic field for charging can reach the coil within the pacemaker.

[0004] The fact that pacemakers must be secured in a particular way is an extreme medical burden to the implanting physician: poor securement can lead to the implanted pacemaker being unable to charge at all if the coil alignment deviates significantly from the target alignment.

[0005] Against the above background, it is an object of the present invention to provide an implant that can be implanted in any spatial orientation, allows for a short wearing time and at the same time has a compact design, or at least to create an alternative implant. Summary of the Invention

[0006] This object is solved by an implant according to patent claim 1. Preferred embodiments are the subject of the dependent claims.

[0007] Electronic implants for implantation in the body of a living being and for monitoring bodily functions, in particular pacemakers for monitoring and controlling bodily functions, an electrode portion attached or positioned on a body part according to an intended purpose; 0.5≦V G ≦4cm 3 , preferably ≦2 cm 3 Volume V within the range G and a housing that encases the (i) an electronics assembly connected to the electrode portion and configured to monitor at least a bodily function via the electrode portion; (ii) an energy storage device for supplying electrical energy to the electronics assembly for an extended period of time, the energy storage device being capable of being recharged with electrical energy after being discharged; and (iii) housing a component of the electronic implant: an energy receiver electrically connected to the energy storage device and adapted to contactlessly receive energy and supply energy to the energy storage device to recharge it; (I) the energy receiving unit includes at least one coil extending along a coil axis and adapted to receive and supply energy to the energy storage when passed through an alternating magnetic field generated by an external charging device, the coil being an air-core coil or including one or more portions of a magnetically conductive core located within the coil and extending along the coil axis; a) The core runs along the coil axis and does not protrude beyond the ends of the coil, or b) the core extends along the coil axis and protrudes beyond at least one end, preferably both ends, of the coil without increasing the cross-sectional / longitudinal diameter of the core to form a respective magnetic field collector; (II) the coil generates a charging current of up to 2 A rectified by a rectifier when penetrated by an alternating magnetic field, and this charging current is supplied to an energy storage device for recharging; (III) The energy receiving part is A0=Ф SM Defined by / B0, A0<=2.5*10 -3 m 2 and a magnetic field collection area A0 perpendicular to the coil axis, where Φ SM is the magnetic flux passing through the cross-sectional area at the longitudinal magnetic center and at a position within the coil as a maximum value in the direction of the coil axis, respectively; B is the external average magnetic flux density of the AC magnetic field over the magnetic field collection area A; (IV) The electronics assembly is configured to provide information for automatic spatial adaptation of the orientation of the vector of the external alternating magnetic field relative to the coil axis, so that the implant can be implanted in any spatial orientation.

[0008] In particular, the electronic assembly according to (IV) is configured to transmit information to the charging device for automatic correction of deviations between, for example, the spatial orientation of the vector of the internal alternating magnetic field of the charging coil of the charging device and the coil axis of the implant, so that the implant can be implanted in any spatial orientation.

[0009] The electronic implant is preferably designed so that the location of maximum magnetic flux as the longitudinal center of the magnet and the location of the cross-sectional area are respectively at the longitudinal center of the coil.

[0010] This is the case when the energy receiver has a mirror symmetric structure.

[0011] The implant may be, for example, a cardiac pacemaker, a brain pacemaker, an organ pacemaker, or an analysis unit. The latter analysis unit is designed, for example, to continuously or at regular intervals determine parameters such as blood pressure and / or blood values ​​and / or to continuously or at regular intervals record an electrocardiogram. If the implant is a pacemaker as described above, it is preferably intended to restore the (intrinsic) control impulses supplied to the heart by the body, i.e., to completely form them or to compensate for missing intrinsic control impulses. It is particularly preferred that the implant is located inside or on the human heart and is part of a single-chamber or multi-chamber pacemaker network implanted in these locations, respectively. For example, a pacemaker network may include two or three implants connected via electrical signals, each implanted in a heart chamber and fixed there, communicating with each other.

[0012] Depending on the purpose of the implant, the electrode portion may include a number of electrodes, one of which serves as a ground.

[0013] If the implant performs the function of one of the mentioned pacemakers, the electrodes are intended to be connected to the body part to be stimulated, e.g. the heart or the brain, or to be fitted onto or within the body part.

[0014] Generally, the mentioned electrodes may be, for example, cable electrodes. In particular, the implant in this context preferably comprises one length of cable per cable electrode, which cable may be guided to a desired area of ​​the body part within the body according to the intended purpose. Preferably, a helical segment is formed at the end of the cable, which is used to fix the cable electrode in the area of ​​the body part.

[0015] Alternatively, the electrode portion can function without a cable electrode. In this case, the aforementioned electrodes are formed on the outer surface of the implant, and the implant is implanted, allowing the electrodes to fit and / or be fixed to the body part in or at an area of ​​the body part. This configuration is particularly advantageous when the implant is a pacemaker or part of a pacemaker network, each of the pacemakers being completely implanted in the heart. Thus, a pacemaker network includes multiple implants according to the invention, each with a corresponding electrode portion exposed on the outer surface of the respective unit.

[0016] In a further alternative, the electrode portion may consist of a combination of at least one cable electrode and at least one electrode formed on the outer surface, in which case the implant is preferably placed on the body part such that the electrode formed on the outer surface contacts and / or is fixed to a corresponding area of ​​the body part, and the other electrode, i.e. the cable electrode, is guided to another area of ​​the body part and fixed or attached thereto.

[0017] The electronics assembly of the implant according to the invention is adapted to monitor at least one or more bodily functions, including, for example, the functions of the aforementioned analysis unit, i.e., recording of electrocardiogram data, blood pressure values ​​or blood values. In terms of hardware, the electronics assembly for performing the corresponding functions includes, for example, a computing circuit with a corresponding memory.

[0018] If the implant is part of the aforementioned pacemaker or pacemaker network implanted in the human heart, the electronics assembly is configured to monitor the heart rate and, based on this, recognize whether the heart rate needs to be controlled, in which case the electronics assembly generates and transmits stimulation pulses, in particular voltage pulses or, in extreme cases, voltage surges, to the body part via the electrodes.

[0019] With regard to the structure and function of the pacemaker network, reference is made to the description in patent application EP3756726A2, in particular paragraphs [0011-0028] of EP3756726A2, which are incorporated by reference.

[0020] The energy store for the long-term supply of the implant according to the invention is preferably a rechargeable electrochemical accumulator, in particular a lithium-ion accumulator. The energy store is preferably dimensioned so that it can supply electrical energy to the entire implant for a service life (recharge interval) of 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, or 2.0 years without the energy storage unit having to be recharged. For example, the energy store has a charge capacity of 200 As to 400 As (ampere-seconds, coulombs).

[0021] The energy store may comprise a plurality of energy storage units distributed at different locations within the implant and arranged separately from one another, with at least one or each of the energy storage units preferably being an electrochemical accumulator unit, in particular a lithium-ion accumulator unit.

[0022] The energy receiver preferably comprises at least one rectifier and at least one smoothing capacitor located between the coil and the energy storage device. The coil transfers the received energy to the smoothing capacitor via the rectifier. In this context, the charging (alternating) current (AC) emitted by the coil is rectified by the rectifier and supplied to the energy storage device by the smoothing capacitor.

[0023] The energy receiver is configured to receive energy by induction and, to that end, comprises a coil through which an external alternating magnetic field passes. In response to changes in the magnetic flux passing through the coil, the coil generates a corresponding charging voltage and a corresponding charging current via a rectifier, which charging current is used to recharge the energy store. In other words, the charging voltage depends proportionally on the frequency and amplitude of the magnetic flux of the alternating magnetic field.

[0024] In particular, the core according to (a) and / or the magnetic field collector according to (b) are not elements such as Wiegand wires / pulse wires which exhibit large Barkhausen jumps in the form of Bloch walls running over the wire when the magnetic field varies by a certain amplitude and thus induces a pulse of the same level in the coil regardless of the frequency of the alternating magnetic field. Generally, the material of the core according to (a) and the material of the magnetic field collector according to (b) as magnetic flux conductors have randomly magnetically oriented regions.

[0025] The enclosure preferably contains and hermetically encloses the aforementioned components, i.e., the electronics assembly, the energy storage, and the energy receiver. The enclosed volume V of the enclosure G is up to 1.5cm 3 , 2cm 3 , 3cm 3 , or 4 cm 3 Preferably, 1 cm 3 Preferably, the electrode portion is constructed as described above.

[0026] The implant according to the invention is therefore an autonomously operating implant, which performs its functions independently without the need for interaction with a control unit located outside the body.

[0027] According to the present invention, the implant has an energy receiving section that is SM Defined by / B0, A0<=2.5*10 -3 m 2 is constructed to have a magnetic field collection area A0 perpendicular to the coil axis, where Φ SMis the magnetic flux passing through the longitudinal magnetic center, located in the direction of the coil axis and corresponding to the cross-sectional area of ​​the coil at a position within the coil, as a maximum value, B0 is the external average magnetic flux density over the magnetic field collection area A0, and the coil is configured to generate a charging current, preferably with a magnitude in the range of 20 mA to 2 A, in the presence of an alternating magnetic field.

[0028] Preferably, the range of charging current excludes a value of about 200 mA.

[0029] The external alternating electromagnetic field (B0) is preferably generated so that it is aligned with the coil axis, i.e., the B vector points in the direction of the coil axis.

[0030] The core according to (a) and / or the magnetic field collector according to (b) ensure that the alternating electromagnetic field is increasingly conducted into the core via a larger magnetic field collection area (magnetic field collection area) A0, in other words, the magnetic field collector ensures that the magnetic flux density (n*B0) in the coil is significantly increased.

[0031] The magnetic field collecting area A0 is located at a distance along the coil axis from the end of the core according to (a) or the magnetic field collector according to (b) and runs perpendicular to the coil axis. The magnetic field collecting area A0 is larger than the core according to (a) or the magnetic field collector according to (b). In the case of an air-core coil, the magnetic field collecting area is located at the longitudinal center of the coil.

[0032] The magnetic field lines passing through the magnetic field collection area A0 enter the coil (e.g., via the magnetic field collector according to (b) and / or the core according to (a) or (b)) and pass through the longitudinal center of the coil, which is located in the direction of the coil axis.

[0033] The magnetic field collection area A0 is A0=Ф SM / B0, respectively, the maximum magnetic flux Φ through the cross-sectional area of ​​the coil at the magnetic longitudinal center and at a specific position on the coil axis. SM, and the external magnetic flux density B0 of the external alternating electromagnetic field across A0. The symmetrical structure of the energy receiver, in particular the mirror symmetrical structure, ensures that the longitudinal magnetic center, which corresponds to the position of the cross-sectional area of ​​the coil through which the maximum magnetic flux passes, and the (geometrical) longitudinal center of the coil coincide.

[0034] The following applies to the core and magnetic field collector according to (b):

[0035] The length of the core facing the coil axis is l K and the length of the magnetic field collector pointing in the direction of the coil axis is l FK and the diameter of the magnetic field collector perpendicular to the coil axis is D FK If the circular cross section of the core and magnetic field collector is assumed to be perpendicular to the coil axis, then by approximation (l K +2l FK +D FK ) 2 *PI / 8 <A0<(l K +2l FK +D FK ) 2 *PI / 4 applies.

[0036] The charging device preferably has a magnetic flux density of B0=0.02mT, 0.04mT, 0.1mT, 0.2mT, 0.5mT, 1mT, 2mT, 3mT, 4mT, 5mT, 6mT, 7mT, 8mT, 9mT, 10mT, 11mT, 12mT, 13mT, 14mT, 15mT, 16mT, 17mT, 18mT, 19mT, or 20mT, and a frequency f=0.5kHz, 0.5kHz, 1kHz, Preferably, an external alternating electromagnetic field is generated at frequencies of 2 kHz, 3 kHz, 4 kHz, 5 kHz, 6 kHz, 7 kHz, 8 kHz, 9 kHz, 10 kHz, 11 kHz, 12 kHz, 13 kHz, 14 kHz, 15 kHz, 16 kHz, 17 kHz, 18 kHz, 19 kHz, 20 kHz, or f>20 kHz, or f=21 kHz up to 1.5 MHz in steps of 1 kHz. The magnetic flux density B0 is constant and uniform within a large spatial area of ​​the implanted implant, for example within the area of ​​the human heart where small implants are located for pacemaker function on / inside the heart.

[0037] In addition to the magnetic field collector according to (b), due to the core, an amplification n of the magnetic flux density occurs in the coil, compared to the case where no magnetic field collector is provided, for n≧50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200. As a result, with a spatially uniform magnetic flux density near the coil, for example B0=1 mT, the maximum (amplification 200) core magnetic flux density B of 0.2 T in the core K The resulting voltage / current values ​​are sufficient to provide the energy store with enough energy to recharge it, even if the frequency f of the generated alternating magnetic field is in the low range mentioned, e.g., 20 kHz.

[0038] Electronic implants are the energy receiving portion includes a rectifier; Preferably, the coil is designed such that when penetrated by an alternating magnetic field, it generates a charging current rectified by the rectifier and is configured to supply the energy storage for recharging; The coil is configured to generate a charging current with a magnitude in the range of 20 mA to 2 A when an alternating magnetic field is present.

[0039] The coil (6) has a frequency in the range of 0.5kHz to 1.5MHz and a frequency of 1*10 -9 Vs~5*10 -5 Magnetic flux Ф within the range of Vs SM Preferably, the charger is designed to generate a charging current having an intensity in the range of 20 mA to 2 A in the presence of an AC magnetic field having a magnitude of 1.0 V.

[0040] Value Ф SM =1*10 -9 Vs refers to the smallest possible area of ​​A0 at minimum B0 = 0.02 mT, and the value Ф SM =5*10 -5 Vs is the maximum area A0=2.5*10 at maximum B0=20mT -3 m 2 Refers to...

[0041] The coil has, for example, a number of turns W, preferably W=10, 20, 30, 40, 50, 100, 200, 300, 400, 500, 600, 700, or 800. The maximum value for W is W=1000, with lower values ​​being much more preferred. W≦50 is particularly preferred. The winding formed by the number of turns W can be multi-layered or preferably single-layered. The metal wire forming the number of turns W is made of, for example, copper or preferably the lighter metal aluminum, and has a wire diameter of, for example, 60 μm, 70 μm, 80 μm, 90 μm, 100 μm, 150 μm, 200 μm to 700 μm, and a circular or rectangular cross section. The length of the coil 6 preferably corresponds to the length of the core 7, so that the ends of the coil preferably correspond to the ends of the core.

[0042] The number of turns W, which is the square of the coil's inductance L, gives the coil's AC resistance as ωL, and the length and cross-section of the metal wire forming the coil gives the corresponding ohmic resistance.

[0043] When an alternating magnetic field passes through the magnetic field collection area A0 of the energy receiver, the alternating magnetic field consequently enters the coil and therefore passes through the coil, causing the coil to generate a charging current.

[0044] With a charging current drawn within a specified range, the coil generates an opposing magnetic field within itself through self-induction, which counteracts the external magnetic field passing through the coil. The difference between the external and opposing magnetic fields results in an effective magnetic field that drives the charging current.

[0045] The strength of the opposing magnetic field is the product of the charging current strength and the number of turns, i.e., I GL *W. In this respect, it is desirable to have fewer turns. However, this leads to the opposite effect: the effective magnetic field induces a lower voltage (EMF) in the coil. The induced voltage and EMF each correspond to the frequency-dependent change in magnetic flux Φ multiplied by the number of turns W (EMF=-W*dΦ / dt).

[0046] Against this background, if the implant is to be minimized, the number of turns W of the coil is selected for one of the frequencies of the alternating magnetic field specified above so that the voltage induced in the coil by the intended effective magnetic field is high enough to charge the energy store, but at the same time as low as possible for the opposing magnetic field, for example, so that the charging current is within the specified range of 20 mA to 2 A.

[0047] If this cannot be achieved for a particular cut-off frequency because the voltage induced by the effective magnetic field is too low to charge the energy storage, the strength of the external magnetic field (B magnetic field) can be increased or the magnetic field collection area A0 can be increased by designing an air-core coil or core according to (a) and / or a magnetic field collector according to (b).

[0048] A high field strength over a wide range of external alternating magnetic fields can be generated by a charging device, for example as described in EP 4035728 A1.

[0049] Using a compensation capacitor, the AC resistance of the coil can be compensated for by resonant or partial resonant operation, ensuring that the charging current is within the specified range of 20mA to 2A.

[0050] The capacitance of the compensation capacitor is preferably selected so that the resonant circuit formed by the coil and the compensation capacitor is not resonating and the frequency of the external alternating magnetic field is at most 10% above or below the resonant frequency of the resonant circuit.

[0051] The energy reservoir preferably has a maximum charge of 200 As to 400 As (coulombs) to ensure long-term supply to the implant.

[0052] The energy receiver is arranged to generate a charging current in the range of 20 mA to 2 A, so that the implant can charge the energy reservoir within a charging time of 1 hour or less, preferably 20 or 30 minutes or less.

[0053] Depending on the combined size of the magnetic field collector and the core in the direction of the coil axis, the amplification n of the magnetic flux density in the core varies.

[0054] The magnetic field collector and the magnetic field collectors are each preferably part of the core, in particular monolithic with the core and made from the same material, or alternatively the magnetic field collectors may be separate elements from the core.

[0055] The implant is preferably constructed so that the core according to (a) or (b) is a magnetically conductive solid shaft or a magnetically conductive hollow shaft.

[0056] For example, the core is a magnetically conductive solid shaft, and the energy storage device is located next to the solid shaft and outside the coil in the direction of the coil axis.

[0057] Alternatively, the coil is wound on a solid shaft and the energy store is located radially around the coil relative to the coil axis. For example, the energy store can completely surround the coil or cover an angular range of, for example, 180° or 270°. The remaining space or open area extending radially and parallel to the coil axis can be used for other elements of the implant, such as part of the electronics assembly.

[0058] Furthermore, for example, the core is a magnetically conductive hollow shaft around which the coil is wound, and the magnetically non-conductive energy store is located inside the hollow shaft. Alternatively, the magnetically conductive energy store is located next to the hollow shaft and inside or outside the coil in the direction of the coil axis.

[0059] Furthermore, for example, the core is a magnetically conductive housing of the energy store around which the coil is wound. The energy store may have a magnetically non-conductive housing and further serve as a support for the coil, whereby the coil forms the aforementioned air-core coil.

[0060] In particular, the core and / or the magnetic field collector are preferably made of a material with a high (material-specific) relative permeability and / or the highest possible (material-specific) saturation flux density.

[0061] Examples of materials are ferrites, especially soft magnetic ferrites, or amorphous metals such as SiFe, also available under the brand name ARNON, or mu metals such as NiFe alloys.

[0062] The core and / or magnetic field collector may be, for example, a solid material or a layered structure made up of multiple layers, for example, the core may be partially formed from a solid material and partially formed from a layered structure.

[0063] The layer structure preferably consists of a number of thin layers, such as thin films or plates, between which electrically insulating layers are arranged, which are capable of bonding the thin layers to one another.

[0064] If the core has a layered structure, the individual layers have a thickness of, for example, 0.015 mm, ..., 0.025 mm, ..., 0.035 mm, ..., 0.050 mm. The electrical insulating layers can have the same thickness or be thinner.

[0065] In particular, said elements (core and / or magnetic field collector) are preferably formed from a solid material if the material is an insulator, and said elements (core and / or magnetic field collector) preferably have a layered structure if the material is poorly conductive but has some electrical conductivity.

[0066] The implant is preferably designed as follows: To recharge the energy store, an alternating magnetic field having a magnetic flux density B0 is generated as intended in the area of ​​the implanted implant, resulting in a corresponding charging voltage being induced in the coil and emitted by the coil, leading to a charging (alternating) current being supplied directly or indirectly to the energy store; the core and / or the magnetic field collector are formed of a material having a high saturation magnetic flux density; The geometry of the core and / or magnetic field collector determines the resulting core flux density B in the coil from the multiplied flux density (n*B) reduced by the opposing magnetic field generated by the charging (AC) current. K is specifically chosen to be within plus / minus 1%, 2%, 3%, 4%, 5%, or 10% of the saturation flux density (which is material specific).

[0067] The magnetic flux density B0 can have the values ​​already mentioned, in particular in the range of 20 μT to 20 mT. This magnetic flux density B0 results in a relatively strong magnetic flux of the alternating magnetic field in the core, since the magnetic field collector (and the core) accordingly binds the magnetic field strongly. According to the invention, the material is preferably selected so that the magnetic field in the core, weakened by the opposing magnetic field, is close to the saturation magnetic flux density or is within the mentioned range.

[0068] This design makes optimal use of the externally generated AC magnetic field in terms of core / field collector size.

[0069] The charging current is preferably supplied from the coil to the energy store via charging electronics having at least one rectifier and at least one smoothing capacitor.

[0070] The saturation flux density referred to in various points above refers to a range of magnetic flux densities specific to a material, below which the corresponding magnetization characteristic curve (BH characteristic curve) has a kink or transition region, below which the magnetization characteristic curve is essentially linear and above which the magnetization characteristic curve runs with a lower slope (i.e., μ0). Preferably, the saturation flux density refers to the magnetic flux density at which further increases in the field strength H of the applied alternating magnetic field no longer increase the polarization of the material.

[0071] As already mentioned above, the orientation of the implant when charging the energy store should preferably be realized in such a way that the external alternating electromagnetic field or the corresponding magnetic field vector (B-vector) passes through the coil, preferably pointing in the direction of the coil axis, thereby obtaining the best possible induction and charging current pulses.

[0072] Preferably, the implant electronics assembly further comprises a communication unit for communicating with the outside (outside the body of the living organism), e.g., for transmitting setting data, setting commands, analysis data and / or information data relating to the charge state of the energy store.

[0073] A data memory is preferably provided for storing data during communication, for example in conjunction with the aforementioned arithmetic circuitry.

[0074] According to (IV), the electronics assembly is configured to provide information for spatial adaptation of the orientation of the alternating magnetic field relative to the coil axis, so that the implant can be implanted in any spatial orientation.

[0075] For example, an electronics assembly connected to the electrode portion is configured to generate information for preferably automatic (preferably parallel) alignment of the coil axis, i.e., magnetic field vector, of the charging device with respect to the coil axis of the implant.

[0076] In particular, the IV electronics assembly is configured to generate, and preferably transmit to, the charging device information for automatic correction of deviations between the spatial orientation of the vector of the AC magnetic field generated by the charging device and the coil axis of the implant, so that the implant can be implanted as desired. For example, the charging coil of the charging device generates an AC magnetic field within which the coil of the patient's body is positioned during charging.

[0077] The electronic device assembly is, in accordance with (IV), (i) transmitting or receiving an initiation signal to or from a charging device to initiate alignment of an alternating current magnetic field; (ii) then transmitting charging information indicating / reflecting the strength of the charging current as information to the charging device.

[0078] The electronics assembly is preferably capable of generating information by measurement or processing, this information including, for example, values ​​relating to the amplitude and / or gradient of the induced voltage and / or charging current intensity.

[0079] The generated information therefore forms the basis for implanting an implant in the body of a living being at any location, ie position and spatial orientation.

[0080] In particular, the electronics assembly is preferably configured to detect the slope and / or amplitude of the inductive charging voltage and / or the charging current driven by the inductive charging voltage, and to generate a signal containing information regarding the slope and / or amplitude.

[0081] The communication unit transmits this signal containing the information to the outside, for example at certain intervals, so that a higher level unit receiving the signal, such as a charging device (preferably according to EP 4035728 A1), can infer the position and orientation of the implant from the information. By knowing the position and orientation of the implant, the higher level unit, such as the charging unit, can align the B-field vector of the AC magnetic field accordingly and optimize / improve charging.

[0082] It should be emphasized herein that the initial orientation of the B-field vector can be any direction in space, since it can always accommodate the subsequent position and orientation of the implant, and it follows that no attention needs to be paid to the resulting position and alignment of the implant when it is implanted.

[0083] The electronics assembly may alternatively comprise, in accordance with (IV): (i) sending or receiving an initiation signal to or from a charging device to initiate the adjustment of the orientation (of a vector at a certain location and having a certain direction) of an alternating magnetic field, which charging device then sends or receives to or changes the orientation of the alternating magnetic field according to a movement function (also) stored in the electronics assembly (3); (ii) transmitting position information to the charging device indicating how the coil axis is oriented in space after passing through the movement feature.

[0084] The position information is, for example, vector data indicating the orientation of the coil axis in space, preferably within a specified tolerance range.

[0085] The movement function includes, for example, a fixed starting orientation of the AC magnetic field, for example parallel to the longitudinal axis of the litter the body is located in. Starting from this initial orientation, the charging device changes the orientation of the AC magnetic field or its B-vector according to the defined movement function.

[0086] During this time, the implant detects changes in the charging DC current and, after going through the movement function, uses this time to determine when the charging DC current was at its maximum and what orientation the AC magnetic field had at that time. The implant outputs the corresponding orientation as position information.

[0087] The charging device can perform the aforementioned adjustment of the alternating magnetic field according to the following options: - the charging device is preferably capable of rotating about three orthogonal axes and / or of linearly moving the body support (e.g., chair or stretcher) on which the body is positioned; and / or - the charging device is preferably capable of rotating around three orthogonal axes and / or linearly moving a charging coil that generates an alternating magnetic field; and / or The charging device can adjust the AC magnetic field preferably generated by multiple charging coils by changing the operating parameters of the charging coils and superimposing the individual AC magnetic fields of the individual charging coils to form an AC magnetic field with a specific orientation.

[0088] (V) Electronic equipment assemblies (i) detecting or signaling by the charging device that the spatial alignment of the AC magnetic field is complete; (ii) thereafter, based on the instantaneous (resulting) charging current, sending a magnetic field modification signal to the charging device, signaling the charging device to increase or decrease the frequency and / or amplitude of the alternating magnetic field, is particularly preferred.

[0089] With this design, the AC magnetic field is almost optimally adapted to the coil axis, and the charging current can be increased / decreased, e.g. kept optimally constant, since different values ​​of magnetic field attenuation in the body no longer play a role here.

[0090] A preferred variant of the implant according to the invention, in particular the energy receiving part, is achieved by parallel alignment of the B field vector and the coil axis and by a magnetic flux density B0 of 0.02 mT to 1 mT of the external alternating magnetic field. -8 ~2.5*10 -6 It is particularly preferred that the core is designed and dimensioned so that an average magnetic flux of Vs (Weber) is established in the core at the aforementioned maximum A0, this flux referring to the no-load case in the absence of an opposing magnetic field.

[0091] If the AC resistance of the coil (ωL) significantly exceeds the ohmic resistance R of the coil, then as already mentioned, it is preferable that the electronics assembly comprises an additional compensation capacitor and that the AC magnetic field is generated at a frequency resulting from the values ​​of the coil, compensation capacitor, ohmic resistance, and load; therefore, the ohmic resistance R essentially limits the height / strength of the charging current.

[0092] Finally, for a given size of the implant given by the volume of the housing, e.g., a cylindrical housing, the structure of the implant, comprising a coil with a number of turns W and a winding cross-section A, is preferably optimized with respect to the charging current at a specific external magnetic field B. If (ωL >> R), a first approximation is that in the case of resonance (Φ / R), the charging current is proportional to the ratio of the magnetic flux through the coil (Φ / L) to the inductance of the coil. Therefore, the dimensions of the magnetic field collector in the direction of the coil axis and the sum of the length of the core, together with the diameter of the magnetic field collector, are important measures of the strength of the charging current that can be drawn. The mentioned parameters affect both the magnetic flux in the core and the inductance of the coil.

[0093] In the implant according to the invention, the structural design is preferably realized in such a way that the charging current reaches a maximum or is at most 10% lower. In relation to the charging current achieved, it should be emphasized that due to the small number of turns, the ohmic resistance R of the coil can be kept very low, with a simultaneously high magnetic field strength in the core. The lower the ohmic resistance, the fewer losses occur and therefore the heat generation is significantly reduced. This becomes a very important factor due to the intended location of the implant in the human body, for example in the heart, brain, tissue, blood vessels or organs.

[0094] From the description of the implant according to the present invention and its preferred features, the following can be inferred.

[0095] The described structural design of the implant, in particular of the energy receiving part, opens up important possibilities to find the optimum for the respective application of the implant, for example as a cardiac pacemaker, cerebral pacemaker, organ pacemaker or analysis unit, with many variable parameters. This optimum can be found by maximizing the magnetic field generated in the coil (effective magnetic field), minimizing the weight, losses and especially the number of turns W of the coil, with the volume of the implant being specified, as a first approximation, by the dimensions of the magnetic components.

[0096] With a desired small size and weight, as well as an autonomous operating time of the implant, for example 1 year, and a charging time of, for example, less than 30 minutes, the optimization is dictated in a first approximation by the maximum possibilities limited by medical reasons, external magnetic fields (<1 mT), in terms of volume and weight, given the described structural design of the implant, in particular of the energy receiving part, and in a second approximation by losses or heating occurring during charging and magnetic field concentration in the coil or core.

[0097] The implant according to the invention, in particular in its embodiment as an autonomous pacemaker powered by a battery, can be used universally and is minimized in terms of volume and weight. As a result, the implant meets high requirements and overcomes technical limitations. For example, the structural design of the implant allows it to address or meet high requirements such as: External AC magnetic field (B magnetic field) ≦1mT, Charging capacity: 400As, Charge interval>1 year, Charging time <1 hour, Volume <2cm 3 , Herein, maximum power dissipation <60mW.

[0098] Generally, the stronger the external B-field, the shorter the charging time.

[0099] The maximum external magnetic field (probably ≦1 mT) is determined by the human body (medically) together with the duration of exposure according to the compatibility.

[0100] In borderline cases, 400As is 3 seconds) Gl This leads to a charging current of 0.4 A. This relatively large charging current results in a significant opposing magnetic field (the opposing magnetic field is I Gl *Proportional to W) remains controllable despite or even at low external alternating magnetic fields B0 due to the small number of turns, e.g., W≦50, and the fact that the magnetic field collection area is large enough relative to the small spatial size of the implant, so that the effective magnetic field (the difference between the magnetic field concentrated in the core and the opposing magnetic field) can drive the charging current.

[0101] In addition, the small volume of the implant and kThe structure of the core according to (a) and the magnetic field collector according to (b) with a core diameter of ≦2 mm results in low winding losses (copper losses or aluminum losses) and low weight of the implant. Due to the fact that in the implant according to the invention the magnetic field concentrated in the core passes through the core sufficiently uniformly and the number of turns W is low, the coil can preferably be made single layer, which leads to high efficiency and reduced weight.

[0102] The mentioned requirements and / or the described effects can be achieved even if the external AC magnetic field is generated at a high frequency. Due to the small number of turns, the already low AC resistance can be further reduced by compensation capacitors and sub-resonant or resonant operation in order to optimize the current that can be drawn.

[0103] The above description applies equally to the following embodiments.

[0104] In the following, preferred embodiments will be described with reference to the accompanying drawings. [Brief explanation of the drawings]

[0105] [Figure 1A] 1 shows a preferred embodiment of an implant according to the present invention, the figure being merely schematic. [Figure 1B] FIG. 2 shows a schematic cross-sectional view of an energy receiving portion of an implant according to the present invention. [Figure 1C] FIG. 1C shows the corresponding field behavior of an alternating magnetic field generated to charge an implant with a core according to FIG. 1B and a required area A0 of the design. [Figure 2A] 10A-10C show further embodiments of implants according to the present invention. [Figure 2B] 10A-10C show further embodiments of implants according to the present invention. [Figure 2C] 10A-10C show further embodiments of implants according to the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0106] FIG. 1A shows a schematic configuration of an implant 100 according to the present invention.

[0107] The implant 100 is preferably fully implanted in the human body, and the resulting spatial orientation of the implant 100 can be arbitrary due to the functionality of the below-described electronics assembly 3. In other words, a physician can implant the implant without having to consider the resulting orientation.

[0108] The implant 100 may be, for example, a cardiac pacemaker, a brain pacemaker, an organ pacemaker, or an analysis unit, the latter being configured to determine parameters such as, for example, blood pressure and / or blood values ​​continuously or at intervals. It is particularly preferred that the implant is a pacemaker or pacemaker network located in or on the human heart and implanted at these locations, respectively.

[0109] The implant 100 preferably has a housing 1 that houses all elements of the implant 100 and preferably hermetically encapsulates them. The housing 1 is made of, for example, titanium or glass. Alternatively, the housing 1 can be made of a plastic that is compatible with the human body. An advantage of plastic is that the housing 1 can be formed by overmolding the internal components using the plastic.

[0110] The implant 100 has an electrode section with electrodes 2, each of which may comprise a number of electrodes 2 depending on the purpose of the implant and which bodily functions it is intended to monitor / stimulate. The electrodes 2 are connected to or in contact with the body parts to be monitored and / or stimulated, e.g., the heart or the brain, according to the intended use.

[0111] The electrodes 2 may, for example, be provided at their ends with helical segments that are twisted into the body part and thus fixed therein. One of the electrodes and / or the housing, if conductive, can function as a ground electrode.

[0112] In general, an electronic pacemaker or pacemaker network according to the present invention may be any NBG coded cardiac pacemaker.

[0113] In general, the electrodes referred to may be, for example, cable electrodes or electrode surfaces exposed to the outside.

[0114] The housing 1 also houses charging electronics 9 as well as an electronics assembly 3 configured to monitor and / or stimulate bodily functions via electrodes 2, and an energy reservoir comprising multiple, preferably two, energy storage units 4a, 4b that supply electrical energy to the electronics assembly 3 over an extended period of time.

[0115] The charging electronics 9 detects the charging (alternating) current (AL) I emitted by the coil 6. L Rectify and I LG The rectifier 9a preferably comprises a rectifier 9a and a capacitor 9b which supply the energy storage units 4a, 4b with the charging (alternating) current IL(AC)I emitted by the coil 6. L is rectified and fed to capacitor 9b, which then supplies the current I LG is passed to the energy storage units 4a and 4b.

[0116] The energy storage units, i.e. one energy storage unit 4a and the preferred further energy storage unit 4b, are each preferably rechargeable electrochemical accumulators, for example lithium ion accumulators, and supply electrical energy to the entire implant 100 for, for example, 0.5 to 1.5 years before needing to be recharged. Thus, the energy storage units 4a, 4b are used for long-term supply of the implant 100.

[0117] The energy storage units 4a, 4b may be recharged contactlessly using induction, for which purpose the implant 100 comprises an energy receiver 5.

[0118] The energy storage unit 4a is located in the peripheral area (see Figure 1B or Figure 2A) or in the core 7 (see Figure 2B), as will be explained below. For this reason, the energy storage unit 4a is shown schematically in the energy receiver 5 in Figure 1A.

[0119] FIG. 1B shows a longitudinal section through an energy receiving part 5 of an implant according to the invention according to a first variant.

[0120] This figure includes, for example, a coil 6 with 1000 turns (W=1000). W is well below 1000, with W<50, 40, 30, 20, 10 being particularly preferred.

[0121] The coil 6 is wound on and around the aforementioned core 7, which extends along a coil axis SA. In this variant, the core 7 is a solid shaft. The coil axis SA also corresponds to the longitudinal axis of the implant 100, the housing 1, respectively.

[0122] At each end of the coil 6 and the core 7 there is preferably a magnetic field collector 18a and preferably a further magnetic field collector 18b, respectively, formed from a section of a solid shaft protruding beyond the coil end in order to homogenize the magnetic field in the coil 6. The magnetic field collector 18a and / or the further magnetic field collector 18b are preferably dimensioned such that their dimension transverse to the coil axis SA is identical to that of the core 7. In this respect, the magnetic field collectors 18a, 18b in this variant simply extend the core 7 beyond the end of the core 7 located in the direction of the coil axis SA. The end of the core corresponds to the end of the coil 6 in the direction of the coil axis SA.

[0123] 1B, the diameter of core 7 (and magnetic field collectors 18a, 18b) measured perpendicular to coil axis SA is 1 mm to 3 mm (millimeters). Accordingly, coil 6 wound around core 7 also has a corresponding inner diameter of 1 mm to 3 mm.

[0124] In this alternative, the length of the magnetic field collectors 18a, 18b in the direction of the coil axis SA is preferably at least 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100% of the total length of the core 7 located within the coil 6. In Fig. 1B, this length is in particular 83% to 65%, particularly preferably 70%, of the total length of the core 7.

[0125] The core 6 and both magnetic field collectors 18a, 18b preferably have a circular cross section perpendicular to the coil axis SA. Alternatively, this cross section may also be rectangular, in particular square.

[0126] 1A and 1B together, it can be seen that one energy storage unit 4a of the energy store 4 may be arranged radially relative to the coil axis SA, at least in a section around the core 7.

[0127] The energy storage unit 4a preferably completely surrounds the core 7, as shown in Figure 2A.

[0128] The energy store and the energy storage unit 4a each have a housing, preferably a single housing, adapted to the outer contour or surface of the coil 6 according to FIG. 2A.

[0129] The core 7 and the coil 6 have a circular cross section perpendicular to the coil axis SA, so that the inner surface or surface of the housing of the energy store 4a facing the coil 6 is annular in cross section (transverse to the coil axis SA).

[0130] 2A, the energy store 4a is housed in a single housing that completely surrounds the core 7. For example, the housing of the energy store 4 can be wrapped or bent around the core 7 or the coil 6 for this arrangement.

[0131] Alternatively, the energy store 4a can be made up of multiple energy storage units, each having a housing corresponding to a circular segment around the core 7. When assembled in the same plane, the energy storage units completely or partially surround the core 7.

[0132] In comparison with FIG. 1B, FIG. 2A shows not only the energy receiving portion 5 but also the entire implant 100 in longitudinal section and perspective view.

[0133] This arrangement of the energy store and the energy storage unit 4a, respectively, gives the entire implant a very compact design.

[0134] Preferably, the further energy storage unit 4b may be arranged in the direction of the coil axis SA next to the energy storage unit 4a on the coil 6 or next to the coil 6 on one of the magnetic field collectors 18a, 18b according to FIG. 1B.

[0135] The length l of the core 7 with the magnetic field collectors 8a, 8b according to FIG. 1B or 1C K can be between 15 mm and 40 mm, in particular between 15 mm and 25 mm, and the dimensions of the magnetic field collector 18a and the further magnetic field collector 18b in the direction of the coil axis should be between 0 and 10 mm, since at the outer ends of the magnetic field collectors there is a risk that the effective magnetic field will become negative. <l K It is preferable that the thickness is in the range of ≦6.0 mm.

[0136] The invention is not limited to the dimensions mentioned, these are examples only.

[0137] The magnetic field collectors 18 a , 18 b may be separate elements from the core 7 or may be integral components of the core 7 .

[0138] 1B shows both magnetic field collectors 18a, 18b monolithically with the core 7 made of a homogeneous magnetically conductive material, for example, ferrite. A monolithic structure is particularly preferred if the material is an insulator or at least a material with low electrical conductivity, such as ferrite, since no or very little eddy currents will occur.

[0139] Generally, the core and / or magnetic field collectors 18a, 18b have a high relative permeability μ (particularly preferably in the range of 1000). r and is formed from a material, preferably an insulator, having the highest possible saturation flux density (e.g., 0.4 to 0.7 Tesla for ferrite, or 1 to 1.5 Tesla for amorphous metals, such as SiFe, which are further mentioned below), and the lowest possible electrical conductivity.

[0140] The placement of the magnetic field collectors 18a, 18b is the only preferred, but essential, reason that the energy storage units 4a, 4b of the implant 100 can also be charged by induction at frequencies between 200 kHz and 1.5 MHz with a small structural size.

[0141] When the energy storage units 4a, 4b of the implant 100 need to be charged, an alternating magnetic field having a uniform magnetic flux density (B field) B0 of approximately 0.1 mT to 1 mT (millitesla) over a wide area including the implant 100 is generated by a charging device (not shown). In particular, the magnetic field is preferably aligned in the direction of the coil axis SA (B vector) and passes through the coil 6.

[0142] Strictly speaking, an alternating magnetic field is an alternating electromagnetic field, but since the electric component of this field is of secondary importance, only alternating magnetic fields will be referred to in this application, although pure alternating magnetic fields are also within the scope of the present invention.

[0143] The frequency f of the alternating magnetic field is within the range specified above, for example 500 kHz.

[0144] The energy receiving part 5 has the aforementioned core 7 with magnetic field collectors 18a, 18b, so that the core 7 can receive a high (AC) charging current I sufficient for the coil 6 to charge the energy storage units 4a, 4b. L , the charging electronics 9 converts this current into a rectified charging current I GL Rectify to

[0145] FIG. 1C shows the magnetic properties of the core 7 with the magnetic field collectors 18a and 18b.

[0146] FIG. 1C shows a schematic representation of the magnetic field collection area A0.

[0147] The magnetic field collection area A0 results from the dimensions of the magnetic field collectors 18a, 18b and the core 7. The magnetic field collection area A0 shown in the figure is the corresponding magnetic field collection area for the structure shown in the figure where the parallel magnetic field lines of the external alternating magnetic field begin to change direction through the energy receiver.

[0148] Using the nomenclature of Figure 1B, the dimensions of the magnetic field collection area A0 are approximately the size of the enclosure, 1 cm. 3 ≦V G ≦4cm 3 and μ r =10 3 (The structure consisting of a core and a magnetic field collector and the μ of a mirror symmetric structure r ) (l K +2l FK +D FK ) 2 *PI / 8 <A0<(l K +2l FK +D FK ) 2 *PI / 4 and precisely A0=Φ SM / B0, which shows that A0 is a fundamental parameter in the design of an implant or pacemaker.

[0149] The magnetic field collection areas A0 are located a distance from each magnetic field collector 18a, 18b along the coil axis SA and each run perpendicular to the coil axis SA. Each magnetic field collection area A0 is significantly larger than the corresponding magnetic field collector 18a, 18b. The maximum A0 is 2.5*10 -3 m 2 The following is the result.

[0150] The external alternating magnetic field (B0) is nearly uniform due to the design of the charging device.

[0151] The magnetic field lines penetrating the magnetic field collection area A0 enter through the respective magnetic field collectors and the core 7 and pass through the longitudinal center LM of the coil 6 in the direction of the coil axis SA. If, by construction, the magnetic field collection area A0 is shifted towards the respective magnetic field collectors, the magnetic field collection area A0 becomes smaller. On the other hand, if the magnetic field collection area A0 is moved in virtually the opposite direction, the magnetic field collection area A0 remains constant and μ r Depending on the input, the maximum A0 remains.

[0152] If the charging device reverses the polarity of the AC magnetic field, the situation is the same, with the difference that the magnetic field lines passing through the magnetic field collection area enter the other magnetic field collector and core 7 and exit at the opposite magnetic field collector.

[0153] As mentioned before, the magnetic field collection area A0 is A0=Φ SM / B0, the maximum magnetic flux Φ passing through the longitudinal center of the magnetic field and the cross-sectional area of ​​the coil at a specific position within the coil 6, respectively. SM , as well as the average external magnetic flux density B0 of the external alternating electromagnetic field across A0. In the case of the mirror-symmetrical structure of the energy receiver shown in the figure, this position is the longitudinal center SM of the coil.

[0154] In the previous section, an alternating magnetic field with a frequency of less than 1 mT and 500 kHz was assumed to describe the charging of the energy reservoir.

[0155] The present invention is not limited to this. GL, number of turns W, magnetic flux Φ of AC magnetic field SM The previous considerations in the description of the figures regarding frequency, ohmic resistance of the coil, and optional compensation capacitors apply to the embodiment as well.

[0156] Due to the dimensions of the magnetic field collector 18a and the further magnetic field collector 18b, an increased core magnetic flux density B K For example, the core magnetic flux density B K exceeds the magnetic flux density B0 by up to 200 times (B K =200B0).

[0157] If the magnetic flux density B0 of the alternating magnetic field generated by the charging device in the area of ​​the implant is 0.1 mT, then the core magnetic flux density B K is therefore about 20 mT. However, the core flux density B K Charging (alternating current) (AC) L The charging current is 400 mA.

[0158] These values ​​allow the energy storage units 4a, 4b, which together preferably have a charge capacity of 400 As, to be charged in about 15 to 20 minutes.

[0159] The parameters of the core 7 and magnetic field collectors 18a, 18b, respectively, the coil 6, and the dimensions of the remaining elements are preferably selected so that the weight of the entire implant 100 is light, in the range of 4 g (grams), preferably less than 3 g.

[0160] Charging current is supplied from the coil 6, preferably via charging electronics 9 shown in the figure, to the energy storage units 4a, 4b of the energy store, respectively.

[0161] Particularly preferably, amorphous metals, for example SiFe, can be used as an alternative material to ferrite for the core 7 and / or the magnetic field collectors 18a, 18b. Metals of this type are available on the market, for example, under the brand name ARNON.

[0162] The core 7 and / or the magnetic field collectors 18a, 18b may preferably have a layered structure comprising individual layers of the mentioned materials (e.g. ferrite or SiFe), in which case they are preferably no longer circular but square.

[0163] In the variant shown in Figure 2A, the electronics assembly 3 and the charging electronics are placed on a circuit board or flexible circuit board with through holes, which is pressed onto the solid shaft as shown or bent around the solid shaft, and which ultimately contacts the energy storage and connections 41a of the energy storage unit 4a, respectively.

[0164] Figure 2B shows a further variant of the implant 100 according to the invention, which differs from the implant shown in Figure 2A in that the core 7a and the magnetic field collectors 28a, 28b are designed as a continuous hollow shaft. Figure 2C shows the core 7a and hollow shaft without a housing and the corresponding magnetic characteristics of the core 7a with the magnetic field collectors 28a and 28b. The explanation for Figure 1C applies analogously to Figure 2C.

[0165] Meanwhile, the energy storage device 4 and the energy storage unit 4a, respectively, as well as the electronics assembly 3 and the circuit board with the charging electronics, are inserted into the hollow shaft. The electronics assembly 3 is preferably three-dimensionally wired, integrally molded, and inserted into the hollow shaft.

[0166] The hollow shaft 7a is preferably formed from a magnetically conductive material as already described with reference to Figures 1A, 1B, and 2A. The coil 6 is wound around the outer surface of the hollow shaft. Two energy storage units are particularly preferably housed within the hollow shaft 7a, with the electronics 3 assembly located between them, and each located at an outer end within the hollow shaft 7a to homogenize and increase the magnetic flux within the coil 6 and to reduce the magnetic field density on the surface of the magnetically conductive hollow shaft 7a.

[0167] Alternatively, the hollow shaft simply forms a support for the coil 6, the hollow shaft being made of a magnetically non-conductive material, in which case the coil 6 is an air-core coil.

[0168] The following explanation applies to all implant variations shown in the figures.

[0169] The electronics assembly 3 is preferably configured to output information to the charging device for spatial adaptation / modification of the vector (B vector) of the alternating magnetic field of the charging coil of the charging device relative to the coil axis, thereby allowing the implant 100 to be implanted in any spatial orientation.

[0170] For example, the electronics assembly 3 connected to the electrode portion 2 is configured to generate information for preferably automatic (preferably parallel) alignment of the coil axis of the charging device with respect to the coil axis of the implant.

[0171] For this purpose, the electronics assembly 3 is (i) transmitting or receiving an initiation signal to or from a charging device to initiate alignment of an alternating current magnetic field; (ii) then transmitting charging information indicating / reflecting the strength of the charging current as information to the charging device.

[0172] The electronics assembly is preferably capable of generating information by measurement or processing, this information comprising for example values ​​relating to the amplitude and / or slope of the induced voltage and / or preferably values ​​relating to the strength of the charging current.

[0173] The generated information therefore forms the basis for implanting an implant in the body of a living being at any location, ie position and spatial orientation.

[0174] In particular, the electronics assembly is preferably configured to detect the slope and / or amplitude of the inductive charging voltage and / or the charging current driven by the inductive charging voltage, and to generate a signal containing information regarding the slope and / or amplitude.

[0175] The communication unit transmits this signal containing the information to the outside, for example at short intervals (for example 100 Hz), and a higher level unit receiving the signal, such as a charging device (preferably according to EP 4035728 A1), can infer the position and orientation of the implant from the information. By knowing the position and orientation of the implant, the higher level unit, such as the charging unit, can align the B-field vector of the AC magnetic field accordingly to optimize / improve charging.

[0176] It should be emphasized herein that the initial orientation of the B-field vector can be any direction in space, since it can always accommodate the subsequent position and orientation of the implant, and it follows that no attention needs to be paid to the resulting position and alignment of the implant when it is implanted.

[0177] The electronics assembly may alternatively include: (i) sending or receiving an initiation signal to or from a charging device to initiate the orientation of the alternating magnetic field, which charging device then sends or receives a change in the orientation of the alternating magnetic field according to a translation function (also) stored in the electronics assembly (3) of the implant (100); (ii) transmitting position information to the charging device indicating how the coil axis SA is oriented in space after passing through the translation feature.

[0178] The position information is, for example, vector data indicating the orientation of the coil axis SA in space, preferably within a specified tolerance range.

[0179] The movement function includes, for example, a fixed starting orientation of the AC magnetic field, for example parallel to the longitudinal axis of the litter the body is located in. Starting from this initial orientation, the charging device changes the orientation of the AC magnetic field or its B-vector according to the defined movement function.

[0180] During this time, the implant 100 detects changes in the charging DC current and, after passing through the movement function, determines when the charging DC current was at its maximum and what orientation the AC magnetic field had at that time. The implant 100 outputs the corresponding orientation as position information.

[0181] Preferably, the charging device may have the same information if the implant 100 transmits, for example continuously, the changes in charging current to the charging device as in the first variant.

[0182] Electronic equipment assembly (i) detecting or signaling by the charging device that the spatial alignment of the AC magnetic field is complete; (ii) then, based on the current charging current, sending a magnetic field modification signal to the charging device to increase or decrease the frequency and / or amplitude of the alternating magnetic field and signal the charging device to begin the charging process, which is particularly preferred.

[0183] This design allows a nearly optimal charging current to be achieved for all positions of the implant within the body.

[0184] The preceding description of the figures applies accordingly to the embodiments and the variations and modifications described, and vice versa.

Claims

1. An electronic implant (100) for implantation in the body of a living being and for monitoring bodily functions, in particular a pacemaker for monitoring and controlling said bodily functions, said implant (100) comprising: an electrode part (2) attached or placed on a body part according to the intended purpose; 0.5≦V Ｇ ≦4cm ３ , preferably ≦2 cm ３ Volume V within the range Ｇ and a housing that encases the (i) an electronics assembly (3) connected to the electrode unit (2), configured to monitor at least the bodily function via the electrode unit (2); (ii) an energy storage (4) for long-term supply of electrical energy to said electronics assembly (3), which can be recharged with electrical energy after being discharged; and (iii) housing a component of the electronic implant (100): an energy receiving unit (5) electrically connected to the energy storage (4) and configured to receive energy in a contactless manner and to supply the energy to the energy storage (4) for recharging the energy storage (4); (I) the energy receiving unit (5) comprises at least one coil (6) extending along a coil axis (SA) and adapted to receive and supply the energy to the energy storage (4) when passed through an alternating magnetic field generated by an external charging device, the coil being an air-core coil or comprising a magnetically conductive core (7) located within the coil and extending along the coil axis; a) the core (7) runs along the coil axis and does not protrude beyond the ends of the coil (6), or b) the core (7) extends along the coil axis (SA) and protrudes beyond at least one end of the coil (6) without increasing the cross-sectional area of ​​the core (7) to form magnetic field collectors (18a, 18b); (II) the coil (6) generates a charging current of up to 2 A rectified by a rectifier when penetrated by the AC magnetic field, and the charging current is supplied to the energy storage (4) for recharging; (III) The energy receiving unit is A ０ =Ф ＳＭ / B ０ A is defined by ０ <= 2.5 * 10 －３ m ２ a magnetic field collection area A perpendicular to the coil axis, ０ and Φ ＳＭ is the magnetic flux passing through the longitudinal magnetic center of the coil in the direction of the coil axis at its maximum value, and B ０ However, the magnetic field collecting area A ０ is the external average magnetic flux density of the alternating magnetic field over a (IV) An electronic implant (100) wherein the electronics assembly (3) is configured to transmit information to the charging device for automatic correction of deviations, for example, between the spatial orientation of the vector of the internal alternating magnetic field of the charging coil of the charging device and the coil axis of the implant (100), thereby allowing the implant (100) to be implanted in any spatial orientation.

2. 2. The electronic implant (100) of claim 1, wherein the electronics assembly (3) is configured to: (i) send or receive an initiation signal to the charging device to initiate adjustment of the alignment of the alternating current magnetic field, the charging device then sending or receiving the signal to change the alignment of the alternating current magnetic field according to a movement function stored in the electronics assembly (3); and (ii) send position information to the charging device after the movement function has been passed, the information indicating how the coil axes are spatially aligned, according to (IV).

3. 2. The electronic implant (100) of claim 1, wherein the electronics assembly (3) is configured to (i) send or receive an initiation signal to the charging device to initiate the adjustment of the orientation of the alternating magnetic field, and (ii) thereafter send charging information to the charging device indicating / reflecting the strength of the charging current, in accordance with (IV).

4. 4. The electronic implant (100) of claim 1, 2, or 3, wherein (V) the electronics assembly (3) is configured to: (i) detect completion of the spatial adjustment of the orientation of the alternating magnetic field or be signaled the completion by the charging device; and (ii) thereafter send a magnetic field modification signal to the charging device, signaling the charging device to increase or decrease the frequency and / or amplitude of the alternating magnetic field based on the current charging current.

5. The electronic implant (100) of any one of claims 1 to 4, wherein the coil is an air-core coil and is wound around a magnetically non-conductive housing of the energy store.

6. 5. The electronic implant (100) according to any one of claims 1 to 4, wherein the core (7) is a magnetically conductive housing of the energy store around which the coil (6) is wound.

7. 5. The electronic implant (100) according to any one of claims 1 to 4, wherein the core (7) is a magnetically conductive solid shaft or a magnetically conductive hollow shaft.

8. 8. The electronic implant (100) of claim 7, wherein the core (7) is the magnetically conductive solid shaft, and a magnetically conductive energy store is located next to the solid shaft and inside or outside the coil in the direction of the coil axis.

9. 8. The electronic implant (100) of claim 7, wherein the core (7) is the magnetically conductive solid shaft around which the coil is wound, and the magnetically non-conductive energy store extends radially around the coil relative to the coil axis.

10. 8. The electronic implant (100) of claim 7, wherein the core (7) is the magnetically conductive hollow shaft around which the coil is wound, and the energy stores are located within the hollow shaft, preferably one of the energy stores at each end of the hollow shaft.

11. 8. The electronic implant (100) of claim 7, wherein the core (7) is the magnetically conductive hollow shaft around which the coil is wound, and the magnetically non-conductive energy store is located next to the hollow shaft and inside or outside the coil in the direction of the coil axis.

12. 12. The electronic implant (100) of any one of claims 1 to 11, wherein the coil has a number of turns W, W being less than or equal to 1000, preferably W≦50, 40, 30, 20, 10.

13. 13. The electronic implant (100) of any one of claims 1 to 12, wherein the implant generates the charging current as intended at a frequency f of the external alternating magnetic field, f≦2 MHz, preferably f≦500 kHz, 400 kHz, 300 kHz, 200 kHz, 100 kHz, 50 kHz.

14. 14. The electronic implant (100) of any one of claims 1 to 13, wherein the energy receiver is constructed such that the longitudinal magnetic center coincides with the longitudinal center of the coil.

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