Electronic implant device

Abstract

The invention relates to an electronic implantation device (100) for implantation in a living body and for monitoring the function of the body, in particular a pacemaker for monitoring and controlling the function of the body, the implantation device (100) comprising: an electrode part (2) attached or arranged to a body part according to intended use; and a housing having a volume VG in the range of 0.5 < = VG < = 4 cm3, preferably < = 2 cm3, the housing housing the following components of the electronic implant device (100): (i) an electronic component (3) connected to the electrode portion, the electronic component (3) being arranged to monitor at least a body function through the electrode portion (2); (ii) an energy storage member (4) which supplies electric energy to the electronic component (3) for a long period of time and which can be charged with electric energy after being discharged; and (iii) an energy collection portion (5) electrically connected to the energy storage member (4), wherein the energy collection portion (5) is configured to collect energy in a non-contact manner and transmit the energy to the energy storage member (4) to charge the energy storage member (4); wherein (I) the energy harvesting portion (5) comprises at least one winding (6) extending along a winding axis and arranged to harvest and deliver energy to the energy storage member (4) when an external alternating magnetic field generated by an external charging device passes through, the winding being a gas core winding or comprising a magnetically conductive core portion (7) positioned within the winding and extending along the winding axis, (II) the winding (6) generates a charging current of maximum 2A rectified by the rectifier, the charging current being fed to the energy storage for charging; (III) the energy harvesting section (5) has a magnetic field harvesting region A0 perpendicular to the winding axis, wherein A0lt; = 2.5 * 10 <-3 > m < 2 >; and (IV) the electronic assembly (3) is arranged to provide information about spatial adjustment of the alternating magnetic field in alignment with the winding axis.

Description

[0001] This invention relates to electronic implantable devices for use in the body to monitor bodily functions. Specifically, this invention relates to electronic pacemakers intended for implantation in or on the human heart.

[0002] A pacemaker capable of contactless charging is disclosed in patent publication US2021 / 0212586A1. This pacemaker has a winding bonded to a ferrite foil. In this respect, the winding is neither an air core winding nor a winding with a core. Therefore, the winding has a weaker ability to collect the generated magnetic field for charging. The flat design of the winding also generates a strong opposing field, thus limiting the current that can be drawn earlier.

[0003] The pacemaker is designed so that when anchored to the heart, the windings maintain a specific orientation, parallel to the pacemaker wearer's skin surface. This orientation is necessary so that the charging windings positioned on the skin surface can align with the pacemaker's windings. Even a slight misalignment between the pacemaker's and charging windings will cause the charging current to drop rapidly. Furthermore, the charging windings must generate a very strong alternating magnetic field on the skin surface to ensure a sufficient charging field reaches the pacemaker's windings.

[0004] Pacemakers must be anchored in a specific way, which is a significant medical burden for implanting physicians. If improper anchoring causes the winding alignment to deviate significantly from the target alignment, the implanted pacemaker may become completely unchargeable.

[0005] Based on the above background, the object of the present invention is to provide an implantation device that can be implanted in any spatial orientation, which can shorten loading times and simultaneously has a compact configuration. At least one object of the present invention is to manufacture an alternative implantation device.

[0006] This objective is achieved by the implantation device according to claim 1. Preferred embodiments are the subject of the dependent claims.

[0007] Electronic implantable devices for use in a living organism to monitor bodily functions, particularly pacemakers for monitoring and controlling said bodily functions, include: Electrode portions, which are attached to or disposed on body parts according to their intended use; and Housing, the housing having a capacity of 0.5 ≤ V G ≤4cm 3 Volume V within the range G The volume V GPreferably ≤2cm 3 The housing also houses the following components of the electronic implant device: (i) An electronic component connected to the electrode portion, the electronic component being configured to monitor at least the bodily functions via the electrode portion; (ii) an energy storage device for continuously supplying electrical energy to the electronic components, the energy storage device being rechargeable by electrical energy after discharge; and (iii) An energy harvesting unit electrically connected to the energy storage device, the energy harvesting unit being configured to harvest energy non-contactly and deliver the energy to the energy storage device for charging the energy storage device; wherein (I) The energy harvesting unit includes at least one winding extending along a winding axis and configured to harvest energy and deliver it to the energy storage device when an alternating magnetic field generated by an external charging device passes through it. The winding is either an air-core winding or includes a magnetic core positioned within the winding and extending along its axis. a) The core extends along the winding axis and does not protrude beyond the end of the winding, or b) The core extends along the winding axis and protrudes beyond at least one end of the winding, preferably beyond both ends of the winding, to form a corresponding field collector without increasing the cross-sectional diameter / longitudinal diameter of the core (7), and (II) When the winding is passed through the alternating magnetic field, it generates a charging current of up to 2A rectified by a rectifier, which is fed to the energy storage device for charging. (III) The energy harvesting unit has a magnetic field collecting region A0 perpendicular to the winding axis, wherein A0 ≤ 2.5 × 10 -3 m 2 And through A0=Ф SM / B0 defines A0, where Ф SM B0 is the maximum magnetic flux through the cross-sectional area at a location passing through the longitudinal magnetic center and at a position within the winding along the winding axis, respectively, and B0 is the external average magnetic flux density of the alternating magnetic field in the magnetic field collection region A0; and (IV) The electronic component is configured to provide information for the automatic spatial adjustment of the orientation of the vector of the external alternating magnetic field relative to the winding axis, so that it can be implanted in the implantation device along any spatial orientation.

[0008] Specifically, the electronic components according to (IV) are configured to transmit information to, for example, the charging device for automatically correcting the spatial orientation of the vector of the internal alternating magnetic field of the charging winding of the charging device and the deviation between the vector and the winding axis of the implantation device, thereby enabling the implantation device to be implanted along any spatial orientation.

[0009] The electronic implantation device is preferably designed such that the position of the maximum magnetic flux, which is the magnetic longitudinal center, and the position of the cross-section are respectively the longitudinal center of the winding.

[0010] This applies to situations where the energy harvesting unit has a mirror-symmetric structure.

[0011] The implanted device is, for example, a cardiac pacemaker, a brain pacemaker, an organ pacemaker, or an analytical unit. For example, the latter analytical unit is designed to continuously or at intervals determine parameters of blood pressure and / or blood values, and / or continuously or at intervals record an electrocardiogram (ECG). If the implanted device is a pacemaker, it is preferably designed to restore the (endogenous) control pulses supplied to the heart by the body, i.e., to fully generate these pulses, or to supplement missing endogenous control pulses. Particularly preferably, the implanted device is part of a single-chamber pacemaker or a multi-chamber pacemaker network located within or on the human heart and implanted at these locations. For example, a pacemaker network has two or three implanted devices connected by electrical signals, each implanted in a heart chamber, anchored therein, and communicating with each other.

[0012] Depending on the intended use of the implanted device, the electrode section contains a number of electrodes, one of which serves as a grounding element.

[0013] If the implanted device performs the function of one of the pacemakers, the electrodes are intended to be attached to the body site to be stimulated, such as the heart or brain, or to be adapted to the body site, either on or within the body site.

[0014] Generally, the electrode can be, for example, a cable electrode. Specifically, in this case, the implantation device preferably includes a cable of a certain length for each cable electrode, which can be inserted into the desired area of ​​the body site according to the intended use. The end of the cable is formed with a preferred helical segment for anchoring the cable electrode in the area of ​​the body site.

[0015] Alternatively, the electrode portion can also be implemented without a filamentous electrode. In this case, the electrode is fabricated on the outer surface of the implantable device, wherein the implantable device is inserted such that the electrode can be adapted to and / or anchored in a portion of the body part or at a portion of the body part. This arrangement is particularly advantageous if the implantable device is part of a pacemaker or pacemaker network, where each pacemaker in the pacemaker network will be fully implanted in / on the heart. Thus, the pacemaker network comprises several implantable devices according to the invention, wherein the respective electrode portions are exposed on the outer surface of the respective unit.

[0016] In another alternative, the electrode portion may consist of a combination of at least one filamentous electrode and at least one electrode formed on the outer surface. In this case, the implantation device is preferably disposed at a body part such that the electrode formed on the outer surface contacts and / or is anchored thereto in a corresponding area of ​​the body part. The other electrode, i.e., the filamentous electrode, is introduced into another area of ​​the body part and anchored or attached thereto.

[0017] The electronic components of the implantable device according to the invention are configured to monitor at least one or more bodily functions. For example, this includes the functions of the aforementioned analysis unit, such as recording data from electrocardiograms, blood pressure values, or blood test results. In terms of hardware, the electronic components for performing the corresponding functions include, for example, a computational circuit with a corresponding memory.

[0018] If the implanted device is part of a pacemaker or pacemaker network to be implanted in / on the human heart, the electronic components are configured to monitor the heartbeat and, accordingly, identify the need to control the heartbeat. If heartbeat control is required, the electronic components generate stimulation pulses, particularly voltage pulses, or in extreme cases, voltage surges, and transmit these stimulation pulses to the body site via electrodes.

[0019] Regarding the structure and function of the pacemaker network, refer to the description in patent application EP3756726A2. Specifically, paragraphs [0011 to 0028] of EP3756726A2 are incorporated herein by reference.

[0020] According to the invention, the energy storage device for long-term power supply of an implantable device is preferably a rechargeable electrochemical accumulator, particularly a lithium-ion accumulator. The energy storage device is preferably sized such that it can supply the entire implantable device with electrical energy for a service life (charging 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 requiring recharging. For example, the energy storage device has a capacity of 200 As to 400 As (ampere-seconds, coulombs).

[0021] The energy storage device may include multiple energy storage units, which are distributed and arranged at different locations in the implantation device, spaced apart from each other, wherein at least one energy storage unit or each energy storage unit is preferably an electrochemical energy storage unit, particularly a lithium-ion energy storage unit.

[0022] Preferably, the energy harvesting unit includes at least one rectifier and at least one smoothing capacitor located between the winding and the energy storage device. The winding transfers the harvested energy to the smoothing capacitor via the rectifier. In this case, the alternating current (AC) output from the winding is rectified by the rectifier and fed to the energy storage device by the smoothing capacitor.

[0023] The energy harvesting unit is configured to harvest energy through induction. For this purpose, the energy harvesting unit includes a winding through which an external alternating magnetic field passes. Based on the change in magnetic flux through the winding, a corresponding charging voltage is generated, and a corresponding charging current is generated through a rectifier. This charging current is used to charge the energy storage device. In other words, the charging voltage is proportional to the frequency and amplitude of the magnetic flux of the alternating magnetic field.

[0024] Specifically, the core according to a) and / or the field collecting element according to b) are not, for example, Wiegandwire / pulse wire elements. When the magnetic field changes by a certain amplitude, the Wiegandwire / pulse wire exhibits a large Barkhausen jump, which takes the form of a Bloch wall extending along the wire, and thus induces a pulse of the same magnitude in the winding, regardless of the frequency of the alternating magnetic field. Generally, the materials of the core according to a) and the field collecting element according to b) as magnetic flux conductors have magnetically oriented domains with irregular magnetic orientations.

[0025] The housing houses the aforementioned components, namely electronic components, energy storage devices, and energy harvesting units, and preferably seals and encapsulates these components. The enclosed volume V of the housing G The maximum size is preferably 1.5cm. 3 2cm 3 3cm 3 Or 4cm 3 Preferably, 1cm is excluded. 3 The electrode section is constructed as described above.

[0026] Therefore, the implantable device according to the present invention is an autonomous implantable device that performs its functions independently without needing to interact with a control unit located outside the body.

[0027] According to the present invention, the implanted device is configured such that the energy harvesting section has a magnetic field collecting region A0 perpendicular to the winding axis, wherein A0 <= 2.5 × 10 -3 m 2 A0 is defined as A0=Ф SM / B0, where Ф SM It is the maximum magnetic flux passing through the longitudinal magnetic center located along the winding axis, and corresponds to the cross-sectional area of ​​the winding at a certain position within the winding, and B0 is the external average magnetic flux density on the magnetic field collection region A0; and

[0028] The winding is configured such that when an alternating magnetic field is present, the winding generates a charging current with an intensity preferably in the range of 20mA to 2A.

[0029] Preferably, a value of approximately 200mA is excluded from the range of charging current.

[0030] The external alternating electromagnetic field (B0) is preferably generated such that the external alternating electromagnetic field is aligned with the direction of the winding axis, that is, the B vector points in the direction of the winding axis.

[0031] According to the core described in a) and / or the field collector described in b), the electromagnetic alternating field is ensured to be conducted more extensively to the core through a larger magnetic field collection region (field collection region) A0. In other words, the field collector ensures a significant increase in the magnetic flux density n×B0 within the winding.

[0032] The magnetic field collecting region A0 is located along the winding axis at a certain distance from the end of the core according to a) or the end of the field collecting element according to b), and extends perpendicular to the winding axis. The magnetic field collecting region A0 is larger than the core according to a) or the magnetic field collecting element according to b). For air-core windings, the magnetic field collecting region is located at the longitudinal center of the winding.

[0033] Magnetic field lines passing through the magnetic field collecting region A0 enter the winding (e.g., via the field collecting element according to b) and / or the core according to a) or b), and pass through the longitudinal center of the winding, located in the direction along the winding axis.

[0034] The magnetic field collecting region A0 draws the maximum magnetic flux Ф from the cross-section of the winding at a specific location at the longitudinal center of the winding and along the winding axis. SM And the external magnetic flux density B0 of the external alternating electromagnetic field on A0, according to the relationship A 0= It is concluded that the longitudinal magnetic center of the energy harvesting section with a symmetrical structure, especially a mirror-symmetrical structure, corresponds to the position of the winding cross-section through which the maximum magnetic flux passes, and coincides with the (geometric) longitudinal center of the winding.

[0035] The following applies to the core and field collection components according to b).

[0036] If the core length pointing in the direction of the winding axis is l K This indicates that the length of the field collector, pointing in the direction of the winding axis, is l. FK It indicates that the diameter of the field collector, perpendicular to the winding axis, is D. FK If we assume that the core and field collector have circular cross-sections perpendicular to the winding axis, then the following formula is approximately applicable. (l K +2l FK +D FK ) 2 ×PI / 8 < A0 < (l K +2l FK +D FK ) 2 ×PI / 4.

[0037] The charging device preferably generates an external alternating electromagnetic field, which 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 f = 0.5kHz. The frequencies are 0.5kHz, 1kHz, 2kHz, 3kHz, 4kHz, 5kHz, 6kHz, 7kHz, 8kHz, 9kHz, 10kHz, 11kHz, 12kHz, 13kHz, 14kHz, 15kHz, 16kHz, 17kHz, 18kHz, 19kHz, and 20kHz, or frequencies with f > 20kHz, or frequencies starting from f = 21kHz in 1kHz increments up to 1.5MHz. The magnetic flux density B0 is constant and uniform within a large spatial region of the implanted device, such as the heart region of the human body, where the small implanted device is located in the functional section of a pacemaker on / inside the heart.

[0038] Due to the presence of the magnetic field collector (as per b) and the core, the magnetic flux density within the winding is amplified by a factor of n, where n>=50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200 compared to the case without the magnetic field collector. For example, in the case of a magnetic flux density B0=1mT near the winding, this results in a maximum core magnetic flux density B that dominates within the core. K (Amplification factor of 200) is 0.2T. The resulting voltage / current is sufficient to supply enough energy to the energy storage device for charging, even if the frequency f of the generated alternating magnetic field is in the aforementioned low range, such as 20kHz.

[0039] The electronic implant device is preferably configured such that The energy harvesting unit includes a rectifier. The windings are configured to generate a charging current rectified by a rectifier when passed through by an alternating magnetic field. This charging current is supplied to the energy storage device for charging, and The winding is configured such that when an alternating magnetic field is present, the winding generates a charging current with an intensity in the range of 20mA to 2A.

[0040] Preferably, the winding (6) is configured such that when an alternating magnetic field with a frequency in the range of 0.5 kHz to 1.5 MHz and a 1 × 10⁻⁶ ohmmeter is present... -9 Vs to 5×10 -5 Magnetic flux Ф within the range Vs SMAt that time, the winding (6) generates a charging current with an intensity in the range of 20mA to 2A.

[0041] Value Ф SM =1×10 -9 Vs corresponds to the minimum feasible area of ​​A0 when B0 = 0.02mT, and the value Ф SM =5×10 -5 Vs corresponds to the maximum area A0 = 2.5 × 10 when the maximum B0 = 20mT. -3 m 2 .

[0042] The winding has, for example, W turns, wherein preferably W = 10, 20, 30, 40, 50, 100, 200, 300, 400, 500, 600, 700, or 800. The maximum value of W is W = 1000, with lower values ​​being more preferred. Particularly preferred is W ≤ 50. The winding formed by W turns can be multi-layered, or preferably single-layered. The metal wire forming the W turns is made of, for example, copper, or preferably a lighter metal, aluminum, and has a wire diameter of, for example, 60µm, 70µm, 80µm, 90µm, 100µm, 150µm, 200µm to 700µm, and has a circular or rectangular cross-section. The length of the winding 6 preferably corresponds to the length of the core 7, such that the ends of the winding preferably correspond to the ends of the core.

[0043] The inductance L of the winding is proportional to the square of the number of turns W, and the number of turns W gives the AC resistance of the winding as ωL, while the length and cross-section of the metal wires constituting the winding give the corresponding ohmic resistance.

[0044] If the alternating magnetic field passes through the magnetic field collection area A0 of the energy harvesting unit, the alternating magnetic field will enter the winding and thus pass through the winding, causing the winding to generate a charging current.

[0045] Because the drawn charging current is within a specified range, the winding generates a reverse field within the winding through self-induction. This reverse field weakens the external field passing through the winding. The difference between the external field and the reverse field generates the effective field that drives the charging current.

[0046] The intensity of the reverse field is proportional to the product of the charging current intensity and the number of turns, i.e., proportional to I. GLThe number of turns is proportional to W. In this regard, it is desirable to maintain a low number of turns. However, this leads to the opposite effect: the effective field induces a lower voltage (electromotive force, EMF) in the winding. The induced voltage and EMF correspond to the frequency-dependent change in magnetic flux Ф multiplied by the number of turns W, respectively (EMF = -W × dФ / dt).

[0047] In this context, when the implanted device is minimized, for a frequency of the aforementioned alternating magnetic field, the number of turns W of the winding is selected such that the voltage induced in the winding by the expected effective field is high enough to charge the energy storage device, but at the same time, due to the presence of, for example, a reverse field, the induced voltage is as low as possible, and the charging current is within a specified range of 20mA to 2A.

[0048] If the energy storage device cannot be charged due to the voltage of the effective field induction being too low, thus preventing this from being achieved at a certain cut-off frequency, the strength of the external magnetic field (B field) can be increased, or the magnetic field collection area A0 can be increased by means of the air core winding or the core according to a) and / or the field collection device according to b).

[0049] For example, a wide range of high field strengths of an external alternating magnetic field can be generated by a charging device, as described in EP4035728A1.

[0050] Using a compensation capacitor, the AC resistance of the winding can be compensated through resonant or partial resonant operation, so that the charging current is within a specified range of 20mA to 2A.

[0051] The capacitance value of the compensation capacitor is preferably selected such that the resonant circuit composed of the winding and the compensation capacitor does not resonate, but the frequency of the external alternating magnetic field is at most 10% higher or at most 10% lower than the resonant frequency of the resonant circuit.

[0052] The energy storage device preferably has a maximum charge of 200As to 400As (coulombs) to ensure long-term power supply to the implanted device.

[0053] Since the energy harvesting unit is set to generate a charging current in the range of 20mA to 2A, the implanted device can charge the energy storage device in a charging time of one hour or less, preferably ≤20 minutes or 30 minutes.

[0054] The amplification factor n of the magnetic flux density in the core changes depending on the sum of the field collector and the core along the winding axis.

[0055] Preferably, the field collector and the plurality of field collectors are part of the core, particularly integral with the core, and made of the same material. Alternatively, the field collector can be a separate element from the core.

[0056] The implantation device is preferably configured such that the core according to a) or b) is a magnetic solid shaft or a magnetic hollow shaft.

[0057] For example, the core is a solid magnetic shaft, and the energy storage element is positioned outside the winding, adjacent to the solid shaft, along the direction of the winding axis.

[0058] Alternatively, the winding is wound on a solid shaft, and the energy storage element is positioned radially around the winding axis. For example, the energy storage element may completely surround the winding, or cover an angular range of, for example, 180° or 270°. The remaining unused portions or spaces radially and parallel to the winding axis can be used for other components of the implanted device, such as parts of electronic components.

[0059] Alternatively, for example, the core is a magnetically conductive hollow shaft, the winding is wound on the magnetically conductive hollow shaft, and the non-magnetically conductive energy storage element is located inside the hollow shaft. Alternatively, the magnetically conductive energy storage element is positioned along the winding axis, adjacent to the hollow shaft, inside or outside the winding.

[0060] Furthermore, for example, the core is the magnetic housing of the energy storage device, and the winding is wound on the magnetic housing. The energy storage device may have a non-magnetic housing, but it still serves as the carrier of the winding, thereby forming the air-core winding described above.

[0061] Particularly preferred is that the core and / or field collector is made of a material having a high (material-specific) relative magnetic permeability and / or the highest feasible (material-specific) saturation magnetic flux density.

[0062] Examples of materials are ferrites, especially soft magnetic ferrites, or amorphous metals such as SiFe, which is also available under the brand name ARNON, or mu metals such as NiFe alloys.

[0063] For example, the core and / or field collector may be a solid material or a layered structure consisting of a large number of layers. For example, the core may also be partially composed of a solid material and partially composed of a layered structure.

[0064] The layered structure preferably consists of a large number of thin layers, such as films or sheets, with an electrically insulating layer disposed between the thin layers. The electrically insulating layer can bond the thin layers together.

[0065] If the core has a layered structure, each layer has a thickness of, for example, 0.015 mm, ..., 0.025 mm, ..., 0.035 mm, ..., 0.050 mm. The electrical insulation layers can have the same thickness or can be thinner.

[0066] Specifically, when the material is an insulator, the element (core and / or field collector) is preferably made of a solid material, and when the material has poor conductivity but some degree of conductivity, the element (core and / or field collector) preferably has a layered structure.

[0067] The implantable device is preferably configured in the following manner, such that To charge the energy storage device, an alternating magnetic field with a magnetic flux density B0 is generated as expected within the region of the implanted device, thereby inducing a corresponding charging voltage in the windings. This causes the windings to output a charging (AC) current, which is supplied directly or indirectly to the energy storage device. The core and / or field collector are made of a material with high saturation magnetic flux density, and Choose the geometry of the core and / or field collector such that the core magnetic flux density B K Within the range of (material-specific) saturation magnetic flux density, particularly within ±1%, ±2%, ±3%, ±4%, ±5%, or ±10% of the saturation magnetic flux density, the multiplied magnetic flux density (n×B0) in the core of the winding, reduced by the reverse field generated by the charging (AC) current, forms the core magnetic flux density B. K .

[0068] The magnetic flux density B0 can have the values ​​described above, particularly 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 within the core, because the field collector (and the core) concentrates the magnetic field relatively strongly. According to the invention, the material is preferably selected such that the field weakened by the reverse field in the core approaches the saturation magnetic flux density or is within the aforementioned range.

[0069] In terms of the size of the core / field collector, this setup makes full use of the externally generated alternating magnetic field.

[0070] The charging current is preferably supplied from the winding to the energy storage device via a charging electronic device having at least one rectifier and at least one smoothing capacitor.

[0071] The saturation magnetic flux density mentioned above refers to a range of magnetic flux density specific to the material, within which the corresponding magnetization characteristic curve (B (magnetic flux density) - H (magnetic field strength) characteristic curve) has a kink region or transition region. Below this region, the magnetization characteristic curve is substantially linear, and above this region, the magnetization characteristic curve has a small gradient (i.e., μ0). Preferably, the saturation magnetic flux density refers to a magnetic flux density at which the material polarization no longer increases when the field strength H of the applied alternating magnetic field further increases.

[0072] As described above, when charging the energy storage device, the orientation of the implanted device should preferably be such that the external alternating electromagnetic field or the corresponding field vector (B vector) preferably points in the direction of the winding axis and passes through the winding. This can generate optimally feasible induced and charging current pulses.

[0073] Preferably, the electronic components of the implanted device further include a communication unit for communicating with the outside (outside the biological body), such as transmitting setting data, setting commands, analysis data, and / or information data related to the electrical state of the energy storage device.

[0074] Preferably, a data storage device is provided for storing data between communications; for example, a data storage device and the aforementioned arithmetic circuitry are provided.

[0075] According to (IV), the electronic components are configured to provide information on the spatial adjustment of the orientation of the alternating magnetic field relative to the winding axis, so that it can be implanted in the implantation device along any spatial orientation.

[0076] For example, the electronic components connected to the electrode section are configured to generate information for the winding axis, preferably automatically aligned and preferably parallel aligned, that is, information for aligning the field vector of the charging device with the winding axis of the implantation device.

[0077] Specifically, the electronic component according to (IV) is configured to generate information for automatically correcting the deviation between the spatial orientation of the vector of the alternating magnetic field generated by the charging device and the winding axis of the implantation device, and preferably sends this information to the charging device so that it can be implanted into the implantation device as needed. For example, the charging winding of the charging device generates an alternating magnetic field, and the patient's body is located within the winding during charging.

[0078] According to (IV), the electronic component is preferably configured as follows: (i) Sending a start signal to or receiving a start signal from the charging device to initiate the alignment adjustment of the alternating magnetic field; and (ii) Then the charging information representing / reflecting the charging current intensity is sent to the charging device as information.

[0079] Electronic components can preferably generate information by measurement or processing, wherein the information includes, for example, values ​​regarding the magnitude and / or gradient of the induced voltage and / or the intensity of the charging current.

[0080] The information generated thus forms the basis for implanting the device into the organism in any orientation, where orientation refers to location and spatial orientation.

[0081] Specifically, the electronic components are preferably configured to detect the gradient and / or amplitude of the induced charging voltage and / or the charging current driven by the induced charging voltage, and to generate a signal containing information about the gradient and / or amplitude.

[0082] The communication unit transmits signals containing information to the outside world at intervals, such as a certain distance, so that the receiving unit, such as a charging device (preferably according to EP4035728A1), can infer the position and orientation of the implanted device from the information. Knowing the position and orientation of the implanted device, the receiving unit, for example, can align the B-field vector of the alternating magnetic field accordingly to optimize / improve the charging process.

[0083] It should be emphasized here that the initial orientation of the B-field vector can be arbitrary in space, because the position and orientation of the implanted device can always be adjusted subsequently. After this, when implanting the device, there is no need to concern oneself with its final position and alignment.

[0084] Preferably, the electronic components are alternatively configured according to the (IV) method. (i) Sending a start signal to or receiving a start signal from the charging device to initiate the orientation of a vector of alternating magnetic field that exists at a certain position and has a certain direction. Then, the charging device changes the orientation of the alternating magnetic field according to a movement function, which is also stored in the electronic component (3). (ii) After the movement function is completed, orientation information is sent to the charging device, which indicates the spatial orientation of the winding axis.

[0085] For example, orientation information is vector data that represents the orientation of the winding axis in space, preferably within a specified tolerance range.

[0086] The movement function includes, for example, a fixed initial orientation of the alternating magnetic field, such as parallel to the longitudinal axis of the stretcher on which the body is placed. Starting from this initial orientation, the charging device changes the orientation of the alternating magnetic field or its B vector according to the defined movement function.

[0087] During this time period, the implanted device can detect changes in the charging DC current and, after processing with a shift function, use this time to determine the moment when the charging DC current reaches its maximum value, as well as the orientation of the alternating field at that time. The implanted device outputs the corresponding orientation as azimuth information.

[0088] The charging device can adjust the alternating field as described above according to the following options: - The charging device can rotate, preferably about three orthogonal axes, and / or cause linear displacement of the body support (e.g., a chair or stretcher) on which the body is placed; and / or - The charging device can rotate, preferably about three orthogonal axes, and / or linearly shift the charging winding that generates the alternating magnetic field; and / or - The charging device can adjust the alternating magnetic field generated by multiple charging windings by changing the operating parameters of the charging windings and superimposing the alternating magnetic fields of each charging winding to form an alternating magnetic field with a specific orientation.

[0089] Particularly preferably, the (V) electronic component is configured as follows: (i) The spatial alignment of the alternating magnetic field is detected as complete, or a signal is emitted by the charging device indicating that the spatial alignment of the alternating magnetic field is complete; and (ii) Subsequently, a field change signal is sent to the charging device based on the instantaneous (generated) charging current, which instructs the charging device to increase or decrease the frequency and / or amplitude of the alternating magnetic field.

[0090] With this setup, given that the alternating field is optimally adapted to the winding axis to a large extent, the charging current can be increased / decreased, or ideally, the charging current can be kept constant, because the decay of different values ​​of the magnetic field in the body no longer plays a role in this case.

[0091] According to the implantation device of the present invention, particularly a preferred variant of the energy harvesting unit, it is especially preferably configured and sized such that, with the B-field vector aligned parallel to the winding axis and the magnetic flux density B0 of the external alternating magnetic field being 0.02 mT to 1 mT, a 5 × 10⁻⁶ m² / m² magnetic field is established in the core at the maximum A0. -8 Vs up to 2.5×10 -6 Vs (Weber) is the average magnetic flux, which refers to the unloaded condition without a reverse field.

[0092] When the AC resistance (ωL) of the winding significantly exceeds the ohmic resistance R of the winding, as mentioned above, the electronic components preferably include additional compensation capacitors, and the alternating magnetic field is generated at a frequency derived from the values ​​of the winding, compensation capacitor, ohmic resistance, and load, thus the ohmic resistance R substantially limits the level / intensity of the charging current.

[0093] Finally, regarding the implantation device, given the predetermined dimensions of the housing volume (e.g., a cylindrical shell), the structure of the implantation device having a winding with W turns and a cross-sectional area A per turn, is preferably optimized according to the charging current under a given external magnetic field B0. In the case of (ωL>>R), under resonant conditions (Ф / R), a first approximation is that the charging current is proportional to the ratio (Ф / L) of the magnetic flux through the winding to the winding inductance. Therefore, the sum of the size of the field collector and the length of the core along the winding axis, as well as the diameter of the field collector, are important measures of the intensity of the charging current that can be drawn. These parameters affect both the magnetic flux in the core and the inductance of the winding.

[0094] In the implantable device according to the invention, the structural arrangement is preferably implemented such that the charging current reaches its maximum value or is at most 10% lower. Regarding the obtained charging current, it should be emphasized that while having a high electric field strength in the core, the ohmic resistance R of the windings can be kept at a very low level due to the small number of turns. Lower ohmic resistance results in lower losses and therefore significantly reduces heat generation. This is a very important factor given the intended location of the implantable device in the human body, such as the heart, brain, tissue, blood vessel, or organ.

[0095] The following can be derived from the description of the implantation device according to the invention and its preferred features: The structural configuration of the implantable device, particularly the energy harvesting section, offers a wide range of possibilities for achieving optimal solutions for various applications of the implantable device, such as cardiac pacemakers, brain pacemakers, organ pacemakers, or analysis units, through multiple variable parameters. This optimal solution can be achieved by maximizing the magnetic field generated in the windings (effective magnetic field), minimizing the weight and losses of the windings, particularly the number of turns W, and specifying the dimensions of the magnetic components as a first approximation of the implantable device's volume.

[0096] When the implantable device has the required small size and weight, and, for example, one year of autonomous operation time and, for example, less than 30 minutes of charging time, when assuming the implantable device has the aforementioned structural configuration, especially when assuming the energy harvesting unit has the aforementioned structural configuration, the volume and weight are explicitly optimized according to the first approximation by the maximum feasible, medically limited external magnetic field (<1mT), and according to the second approximation by the losses or heating that occur during charging and the field concentration in the windings or core.

[0097] The implantable device according to the invention, particularly in its embodiment as an energy storage-driven autonomous pacemaker, can be widely used and is minimized in terms of volume and weight. Therefore, this implantable device meets high requirements and overcomes technical limitations. For example, the structural configuration of the implantable device allows it to address or meet the following high requirements: External alternating magnetic field (B field) ≤ 1mT; Capacitance: 400As; Charging interval > 1 year Charging time < 1 hour Volume <2cm³ The maximum power loss here is <60mW.

[0098] Generally speaking, the larger the external magnetic field B field is, the shorter the charging time is.

[0099] The maximum external field (possibly ≤1mT) is determined by the duration of exposure related to human binding and compatibility (in the medical sense).

[0100] In the boundary case, 400As briefly (10 3 (seconds) leads to charging current I Gl =0.4A. Although the external alternating magnetic field B0 is low, or even if the external alternating magnetic field B0 is low, the relatively large charging current produces a considerable amount of I. Gl The reverse field, which is proportional to W, remains controllable because the number of turns is small, for example, W≤50, and the magnetic field collection area is large enough relative to the small spatial size of the implanted device so that the effective field (the difference between the magnetic field concentrated in the core and the reverse field) can drive the charging current.

[0101] Additionally, given the small volume of the implanted device, the core structure according to a), the field collection element according to b), and the core diameter d k The winding thickness is ≤2mm, resulting in lower winding losses (copper or aluminum losses) and a lighter implantation device. Because the magnetic field concentrated in the core in the implantation device according to the invention passes through the core sufficiently uniformly, and the number of turns W is relatively small, the winding can preferably employ a single-layer structure, which helps to improve efficiency and reduce weight.

[0102] The above requirements and / or effects can be achieved even when the external alternating magnetic field is generated at a higher frequency. Due to the fewer turns, the already low AC resistance can be further reduced through compensation capacitors and partial or resonant operation, thereby optimizing the current drawable.

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

[0104] Preferred embodiments are described below with reference to the accompanying drawings.

[0105] Figure 1A A preferred embodiment of the implantation device according to the present invention is shown, wherein the illustration is merely schematic;

[0106] Figure 1B A schematic cross-sectional view of the energy harvesting section of the implantable device according to the present invention is shown;

[0107] Figure 1C Showing according to Figure 1B The core and the corresponding field characteristics of the alternating magnetic field generated when charging the implantation device with the key area A0 set.

[0108] Figures 2A to 2C Further embodiments of the implantation device according to the present invention are shown.

[0109] Figure 1A The arrangement of the implantation device 100 according to the present invention is shown schematically.

[0110] The implantable device 100 is preferably fully implanted into the human body, wherein the final spatial orientation of the implantable device 100 can be arbitrary due to the function of the electronic component 3, as will be explained below. In other words, a physician can implant the device without considering the final orientation.

[0111] The implantable device 100 may be, for example, a cardiac pacemaker, a brain pacemaker, an organ pacemaker, or an analytical unit. For example, the latter analytical unit is configured to continuously or at intervals measure parameters such as blood pressure and / or blood test values. Particularly preferred is a pacemaker or pacemaker network located within or on the human heart, and the implantable device will be implanted at these locations respectively.

[0112] The implantable device 100 preferably has a housing 1 that houses all the components of the implantable device 100 and preferably seals all the components of the implantable device 100. The housing 1 is made of, for example, titanium or glass. Alternatively, the housing 1 may also be made of a biocompatible plastic. The advantage of this plastic is that the housing 1 can be made by using this plastic to encapsulate the components internally.

[0113] The implantable device 100 has an electrode section, which includes electrodes 2. The number of electrodes 2 depends on the intended use of the implantable device and the body function it is intended to monitor / stimulate. Depending on the intended use, the electrodes 2 are connected to or in contact with the body part to be monitored and / or stimulated, such as the heart or brain.

[0114] Electrode 2 may include, for example, a helical segment at its end, which is twisted and positioned within the body part, and thus anchored therein. If one of the electrodes and / or the housing is conductive, it may serve as a grounding electrode.

[0115] Generally speaking, the electronic pacemaker or pacemaker network according to the present invention can be a cardiac pacemaker according to any North American Society for Pacing and Electrophysiology (NASPE) / British Pacing and Electrophysiology Group (BPEG) code (NBG code).

[0116] Generally, the electrode can be, for example, a filamentary electrode or an electrode surface exposed on an outer surface.

[0117] The housing 1 also houses the electronic component 3 and an energy storage device having two preferred energy storage units 4a and 4b, as well as a charging electronic device 9. The electronic component 3 is configured to monitor and / or stimulate bodily functions through electrodes 2, and the energy storage device provides electrical energy to the electronic component 3 for a long period of time.

[0118] Preferably, the charging electronic device 9 includes a rectifier 9a and a capacitor 9b, the rectifier 9a and the capacitor 9b supplying a charging (alternating current) I to the winding 6. L Rectify it and use it as I LG The power supply is provided to energy storage units 4a and 4b, wherein the rectifier 9a outputs a charging (AC) current (I) to winding 6. L The current is rectified and supplied to capacitor 9b, which then supplies the current I. LG It is transferred to energy storage units 4a and 4b.

[0119] The energy storage units, namely one energy storage unit 4a and preferably another energy storage unit 4b, are preferably rechargeable electrochemical energy storage devices, such as lithium-ion energy storage devices, which supply the entire implantable device 100 with electrical energy for, for example, 0.5 to 1.5 years before needing to be recharged. Therefore, the energy storage units 4a and 4b are used for the long-term power supply of the implantable device 100.

[0120] Energy storage units 4a and 4b can be charged non-contactly via induction. Therefore, the implantable device 100 includes an energy harvesting unit 5.

[0121] Energy storage unit 4a is located in the surrounding area (see Figure 1B or Figure 2A ) or within the core 7 (see Figure 2B This will be described below. For this reason, in Figure 1A In the diagram, energy storage unit 4a is schematically shown inside energy harvesting unit 5.

[0122] Figure 1BA longitudinal cross-section of the energy harvesting section 5 of the implantation device according to the first variant of the present invention is shown.

[0123] It includes a winding 6 having, for example, 1000 turns (W=1000). W is preferably much less than 1000, and W<50, 40, 30, 20, 10.

[0124] The winding 6 is wound on and around the core 7, which extends along the winding axis SA. In this variant, the core 7 is a solid shaft. The winding axis SA also corresponds to the longitudinal axis of the implantation device 100, i.e., the longitudinal axis of the housing 1.

[0125] At the corresponding ends of winding 6 and core 7, field collectors 18a and 18b are preferably provided, respectively. These field collectors 18a and 18b are formed by portions of solid shafts protruding beyond the winding ends to homogenize the field in winding 6. Field collectors 18a and / or 18b are preferably sized such that their transverse dimension to the winding axis SA is the same as the dimension of core 7. In this variation, field collectors 18a and 18b extend core 7 only beyond its end positioned along the winding axis SA. The end of the core corresponds to the end of winding 6 along the winding axis SA.

[0126] exist Figure 1B In this case, the diameter of the core 7 (and the field collection components 18a, 18b), measured perpendicular to the winding axis SA, is 1 mm to 3 mm. Therefore, the winding 6 wound on it also has a corresponding inner diameter of 1 mm to 3 mm.

[0127] In this alternative, the length of the field collection elements 18a and 18b along the winding axis SA is preferably at least 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 100% of the total length of the core 7 located within the winding 6. Figure 1B Specifically, the length is between 83% and 65% of the total length of the core 7, and particularly preferably 70% of the total length of the core 7.

[0128] The core 6 and the two field collectors 18a, 18b preferably have a circular cross-section perpendicular to the winding axis SA. Alternatively, the cross-section may also be rectangular, and in particular square.

[0129] See also Figure 1A and Figure 1B It can be understood that an energy storage unit 4a of the energy storage component 4 can be arranged at least partially around the core 7 radially to the winding axis SA.

[0130] Preferably, the energy storage unit 4a completely surrounds the core 7, such as Figure 2A As shown.

[0131] according to Figure 2A The energy storage device and the energy storage unit 4a each have a housing, preferably each have a single housing, which is adapted to the outer contour or outer surface of the winding 6.

[0132] The core 7 and the winding 6 have a circular cross-section perpendicular to the winding axis SA. Therefore, the cross-section of the energy storage element 4a facing the inner surface of the winding 6 or the surface of the housing is annular (transverse to the winding axis SA).

[0133] according to Figure 2A The energy storage element 4a is housed in a single housing that completely surrounds the core 7. For example, in this configuration, the housing of the energy storage element 4 can be enclosed or bent around the core 7 or the winding 6.

[0134] Alternatively, the energy storage unit 4a may consist of multiple energy storage cells, each having a housing corresponding to a portion of the circumference surrounding the core 7. When assembled flush, the energy storage cells completely or partially surround the core 7.

[0135] and Figure 1B compared to, Figure 2A Not only is the energy harvesting unit 5 shown, but also the longitudinal cross-section and perspective view of the entire implantation device 100 are shown.

[0136] The arrangement of the energy storage device and the energy storage unit 4a respectively makes the entire implantation device have a very compact configuration.

[0137] Another preferred energy storage unit 4b can be disposed along the direction of the winding axis SA, on the winding 6, adjacent to the energy storage unit 4a, or according to... Figure 1B It is installed on one of the field collection components 18a and 18b, adjacent to the winding 6.

[0138] according to Figure 1B or Figure 1C The core 7 with field collection components 8a and 8b has a length l K The diameter can be from 15mm to 40mm, particularly from 15mm to 25mm, wherein the dimensions of field collector 18a and another field collector 18b along the winding axis are preferably within 0. <l K Within the range of ≤6.0mm, this is because at the outer end of the field collector, the effective field may become negative.

[0139] The invention is not limited to the dimensions described. These are merely examples.

[0140] Field collection components 18a and 18b can be components separate from the core 7, or they can be integral parts of the core 7.

[0141] Figure 1B Two field collectors 18a and 18b are shown integrated with the core 7, which is made of a homogeneous magnetically conductive material. This material is, for example, ferrite. If the material is an insulator or at least a poorly conductive material such as ferrite, the integrated structure is particularly preferred because it does not generate any or almost no eddy currents.

[0142] Generally, the core and / or field collecting elements 18a, 18b are made of materials with high relative permeability µ. r The material is made of a material (particularly preferably in the range of 1000) having the highest possible saturation magnetic flux density (e.g., 0.4 Tesla to 0.7 Tesla for ferrites; 1 Tesla to 1.5 Tesla for amorphous metals, such as SiFe, as described further below) and the lowest possible electrical conductivity, and the material is preferably an insulator.

[0143] The arrangement of field collection elements 18a and 18b is merely a preferred but important reason why the energy storage units 4a and 4b of the implanted device 100 can also be charged with a smaller structural size by sensing frequencies from 200 kHz to 1.5 MHz.

[0144] When the energy storage units 4a and 4b of the implanted device 100 require charging, an alternating magnetic field with a magnetic flux density (B field) B0 of approximately 0.1 mT to 1 mT (millitales) is generated by a charging device (not shown). This alternating magnetic field is uniformly distributed over a large area including the implanted device 100. Specifically, the field is preferably aligned along the direction of the winding axis SA (B vector) and passes through the winding 6.

[0145] Strictly speaking, an alternating magnetic field is an alternating electromagnetic field. However, the electric component of this field is secondary, which is why this application only mentions alternating magnetic fields. However, this invention also covers pure alternating magnetic fields.

[0146] The frequency f of the alternating magnetic field is within the range specified above, for example, 500 kHz.

[0147] Since the energy harvesting unit 5 has the aforementioned core 7 with field collection elements 18a and 18b, the core 7 receives a sufficient magnetic field to generate a sufficiently high charging (alternating) current I in the winding 6. L This charges energy storage units 4a and 4b, and the charging electronic device 9 rectifies this current into a rectified charging current I. GL .

[0148] Figure 1C The magnetic properties of the core 7 with field collecting elements 18a and 18b are shown.

[0149] Figure 1C The magnetic field collection area A0 is schematically shown.

[0150] The magnetic field collection region A0 is defined by the dimensions of the field collection components 18a and 18b and the core 7. The magnetic field collection region A0 shown is the magnetic field collection region corresponding to the structure shown, in which the parallel field lines of the external alternating magnetic field begin to change direction after passing through the energy collection unit.

[0151] use Figure 1B The naming convention, for a shell size of 1cm 3 ≤V G ≤4cm 3 and µ r =10 3 (µ of the structure consisting of a core, a field collector, and a mirror-symmetric structure) r The size of the magnetic field collecting region A0 can be approximately calculated from the following formula. (l K +2l FK +D FK ) 2 ×PI / 8 < A0 < (l K +2l FK +D FK ) 2 ×PI / 4,

[0152] Furthermore, the size of the magnetic field collection region A0 is from A0=Ф SM / B0 is calculated accurately. This indicates that A0 is a fundamental parameter for setting up implanted devices or pacemakers.

[0153] The magnetic field collecting region A0 is located along the winding axis SA at a certain distance from the corresponding field collecting elements 18a and 18b, and each magnetic field collecting region A0 extends perpendicular to the winding axis SA. Each magnetic field collecting region A0 is significantly larger than the corresponding field collecting elements 18a and 18b. The largest A0 is <= 2.5 × 10⁻⁶. -3 m 2 .

[0154] Due to the setup of the charging device, the external alternating magnetic field (B0) is almost uniform.

[0155] Magnetic field lines passing through the magnetic field collecting region A0 enter via the corresponding field collecting element and core 7, and pass through the longitudinal center LM of winding 6, which is arranged along the winding axis SA. If the magnetic field collecting region A0 shifts along the direction of the corresponding magnetic field collecting element due to structural reasons, the magnetic field collecting region A0 will become smaller. On the other hand, if the magnetic field collecting region A0 moves substantially in the opposite direction, the magnetic field collecting region A0 remains unchanged, and according to µ... r The magnetic field collection region A0 remains at its maximum value.

[0156] If the charging device reverses the polarity of the alternating magnetic field, the situation is the same, except that the field lines passing through the magnetic field collection area enter another field collector and core 7, and exit from the opposite field collector.

[0157] As described above, the maximum magnetic flux Ф passing through the longitudinal magnetic center is respectively SM The cross-sectional area of ​​the winding at a specific location within winding 6 and the average external magnetic flux density B0 of the external alternating electromagnetic field on A0 are determined by the relationship A0 = The magnetic field collection region A0 is accurately determined. In the case of the mirror-symmetric structure of the energy collection unit shown, this position is the longitudinal center SM of the winding.

[0158] In the previous section, we assumed an alternating magnetic field with a frequency of <1mT and 500kHz to illustrate the charging process of the energy storage device.

[0159] This invention is not limited thereto. The accompanying drawings describe the charging current I. GL Number of turns W, magnetic flux Ф SM The same considerations apply to this embodiment, including the frequency of the alternating magnetic field, the ohmic resistance of the windings, and optional compensation capacitors.

[0160] Due to the dimensions of field collector 18a and another field collector 18b, the core magnetic flux density B within the core 7 K Increase. For example, the core magnetic flux density B K Exceeding the magnetic flux density B0 by up to 200 times (B K =200B0).

[0161] If the magnetic flux density B0 of the alternating magnetic field generated by the charging device and existing in the region of the implanted device is 0.1 mT, then the core magnetic flux density B under no-load conditions is... K It is approximately 20 mT. However, the aforementioned core magnetic flux density B K The voltage is reduced due to the reverse field generated within winding 6, which is caused by the charging (AC) current I. L This is caused by the charging current being 400mA.

[0162] These values ​​allow energy storage units 4a and 4b, which preferably have a total capacity of 400As, to be fully charged in about 15 to 20 minutes.

[0163] Preferably, the dimensions of the core 7 and the field collection components 18a and 18b, as well as the parameters of the winding 6 and the remaining components, are selected respectively, so that the weight of the entire implantation device 100 is low and in the range of 4g, preferably less than 3g.

[0164] The charging current is preferably supplied from the winding 6 to the energy storage device through the charging electronic device 9 shown, that is, to the energy storage units 4a and 4b respectively.

[0165] Particularly preferred, an amorphous metal such as SiFe can be used as an alternative material to ferrite for the core 7 and / or field collectors 18a, 18b. This metal is commercially available under brand names such as ARNON.

[0166] The core 7 and / or field collectors 18a, 18b may preferably have a layered structure, wherein each layer is made of the material (e.g., ferrite or SiFe), and is preferably square rather than circular.

[0167] exist Figure 2A In the variant shown, the electronic component 3 and the charging electronics are mounted on a circuit board or flexible circuit board with through holes. The circuit board is pressed onto or bent around a solid shaft, as shown, and eventually contacts the connector 41a of the energy storage component and the energy storage unit 4a, respectively.

[0168] Figure 2B Another variation of the implantation device 100 according to the invention is shown, which is consistent with... Figure 2A The difference in the variant shown is that the core 7a and the field collection components 28a, 28b are set as continuous hollow shafts. Figure 2C The core 7a and the hollow shaft without a shell are shown, as well as the corresponding magnetic properties of the core 7a with field collecting elements 28a and 28b. Figure 1C The same applies to Figure 2C .

[0169] On the other hand, the energy storage component 4, the energy storage unit 4a, and the circuit board having the electronic component 3 and the charging electronics are respectively inserted into the hollow shaft. The electronic component 3 preferably employs three-dimensional wiring and is inserted into the hollow shaft in an integral molding manner.

[0170] Preferably, the hollow shaft 7a is made of a reference material. Figure 1A , Figure 1B , Figure 2AThe magnetically conductive material described is used. Winding 6 is wound on the outer surface of a hollow shaft. Two energy storage units are particularly preferably housed within the hollow shaft 7a, with electronic components 3 positioned between these two energy storage units, and each energy storage unit is positioned at its outer end within the hollow shaft 7a, thereby homogenizing and increasing the magnetic flux in winding 6, and reducing the field density on the surface of the magnetically conductive hollow shaft 7a.

[0171] Alternatively, the hollow shaft may serve solely as the carrier of winding 6, and this hollow shaft may be made of a non-magnetic material. In this case, winding 6 is an air-core winding.

[0172] The following description applies to all variations of the implantable device shown in the figure.

[0173] The electronic component 3 is preferably configured to output information to the charging device for spatial adjustment / correction of the vector (B vector) of the alternating magnetic field of the charging winding of the charging device relative to the winding axis, so that the implantation device 100 can be implanted in any spatial orientation.

[0174] For example, the electronic component 2 connected to the electrode section 3 is configured to generate information for automatically aligning and preferably parallel aligning the winding axis of the charging device with the winding axis of the implantation device.

[0175] Therefore, electronic component 3 is preferably configured as follows: (i) Sending a start signal to or receiving a start signal from the charging device to initiate the alignment adjustment of the alternating magnetic field; and (ii) Then the charging information representing / reflecting the charging current intensity is sent to the charging device as information.

[0176] The electronic components may preferably generate information by measuring or processing, wherein the information includes, for example, values ​​regarding the magnitude and / or gradient of the induced voltage, and / or preferably includes values ​​regarding the intensity of the charging current.

[0177] Therefore, the generated information forms the basis for implanting the device into the organism in any orientation, i.e., position and spatial orientation.

[0178] Specifically, the electronic components are preferably configured to detect the gradient and / or amplitude of the induced charging voltage and / or the charging current driven by the induced charging voltage, and to generate a signal containing information about the gradient and / or amplitude.

[0179] The communication unit transmits a signal containing information to the outside world at short time intervals (e.g., 100Hz), where an upper-level unit receiving the signal, such as a charging device (preferably according to EP4035728A1), can infer the position and orientation of the implanted device from the information. Knowing the position and orientation of the implanted device, the upper-level unit, for example, can accordingly align the B-field vector of the alternating magnetic field to optimize / improve the charging process.

[0180] It should be emphasized here that the initial orientation of the B-field vector can be arbitrary in space because the position and orientation of the implanted device can always be adjusted subsequently. Therefore, there is no need to concern oneself with the final position and alignment of the implanted device during implantation.

[0181] Preferably, the electronic components are alternatively configured as follows: (i) Sending or receiving a start signal to or from a charging device to initiate the adjustment of the orientation of the alternating magnetic field, the charging device subsequently changing the orientation of the alternating magnetic field according to a shift function, which is also stored in the electronic components (3) of the implanted device (100), and (ii) After the movement function is completed, orientation information is sent to the charging device, which indicates the spatial orientation of the winding axis SA.

[0182] Orientation information is, for example, vector data representing the orientation of the winding axis SA in space, which is preferably within a specified tolerance range.

[0183] The movement function includes, for example, a fixed initial orientation of the alternating magnetic field, such as parallel to the longitudinal axis of the stretcher on which the body is placed. Starting from this initial orientation, the charging device changes the orientation of the alternating magnetic field or its B vector according to the defined movement function.

[0184] During this time, the implantation device 100 can detect changes in the charging DC current, and after processing with a shift function, determine the moment when the charging DC current reaches its maximum value, and determine the orientation of the alternating field at that time. The implantation device 100 outputs the corresponding orientation as orientation information.

[0185] Preferably, when the implantation device 100 sends changes in the charging current to the charging device, for example, continuously, the charging device may have the same information as described in the first variant.

[0186] Particularly preferably, the electronic components are configured as follows: (i) The spatial alignment of the alternating magnetic field is detected as complete, or a signal is emitted by the charging device indicating that the spatial alignment of the alternating magnetic field is complete; and (ii) Then, based on the current charging current, a field change signal is sent to the charging device, which instructs the charging device to increase or decrease the frequency and / or amplitude of the alternating magnetic field and initiate the charging process.

[0187] This configuration allows for virtually optimal charging current in every position of the implanted device within the body.

[0188] The preceding descriptions in the accompanying drawings apply accordingly to this embodiment and the variations and modifications described, and vice versa.

Claims

1. An electronic implantable device (100) for implantation in a living organism and for monitoring bodily functions, particularly a pacemaker for monitoring and controlling bodily functions, said implantable device (100) comprising: Electrode part (2), said electrode part (2) is attached to or disposed on a body part according to its intended use; as well as Housing, the housing having a capacity of 0.5 ≤ V G ≤4cm 3 Volume V within the range G The volume V G Preferably ≤2cm 3 The housing also houses the following components of the electronic implant device (100): (i) An electronic component (3) connected to the electrode portion, the electronic component (3) being configured to monitor at least the bodily functions via the electrode portion (2); (ii) an energy storage device (4) that supplies electrical energy to the electronic component (3) for a long period of time, and that can be charged with electrical energy after being discharged; as well as (iii) An energy harvesting unit (5) electrically connected to the energy storage device (4), the energy harvesting unit (5) being configured to harvest energy non-contactly and deliver the energy to the energy storage device (4) for charging the energy storage device (4); in (I) The energy harvesting unit (5) includes at least one winding (6) extending along the winding axis and configured to harvest the energy when an alternating magnetic field generated by an external charging device passes through it, and to deliver the energy to the energy storage unit (4). The winding is an air-core winding or includes a magnetic core (7) positioned within the winding and extending along the winding axis. a) The core (7) extends along the winding axis and does not protrude beyond the end of the winding (6), or b) The core (7) extends along the winding axis and protrudes beyond at least one end of the winding (6) to form a field collector (18a, 18b) without increasing the cross-sectional area of ​​the core (7), and (II) When the winding (6) is passed through by the alternating magnetic field, it generates a charging current of up to 2A rectified by the rectifier, which is fed to the energy storage device (4) for charging. (III) The energy harvesting unit has a magnetic field collecting region A0 perpendicular to the winding axis, wherein A0 ≤ 2.5 × 10 - 3 m 2 And through A0=Ф SM / B0 defines A0, where Ф SM B0 is the maximum magnetic flux passing through the longitudinal magnetic center within the winding along the direction of the winding axis, and B0 is the external average magnetic flux density of the alternating magnetic field in the magnetic field collection region A0; and (IV) The electronic component (3) is configured to transmit information to, for example, the charging device for automatically correcting the spatial orientation of the vector of the internal alternating magnetic field of the charging winding of the charging device and the winding axis of the implantation device (100), thereby enabling the implantation device (100) to be implanted in any spatial orientation.

2. The implantation device (100) according to claim 1, wherein According to (IV), the electronic component (3) is configured to: (i) send or receive a start signal to initiate an adjustment of the alignment of the alternating magnetic field of the charging device, and then the charging device changes the alignment of the alternating magnetic field according to a movement function stored in the electronic component (3), and (ii) after the movement function has run, send orientation information to the charging device, the information indicating the spatial alignment of the winding axis.

3. The implantation device (100) according to claim 1, wherein According to (IV), the electronic component (3) is configured to (i) send or receive a start signal to the charging device for initiating the adjustment of the orientation of the alternating magnetic field, and (ii) subsequently send charging information to the charging device representing / reflecting the intensity of the charging current.

4. The implantable device (100) according to claim 1, 2 or 3, wherein (V) The electronic component (3) is configured to (i) detect the completion of spatial adjustment of the orientation of the alternating magnetic field, or to receive a signal from the charging device indicating the completion, and (ii) subsequently send a field change signal to the charging device based on the current charging current, the field change signal instructing the charging device to increase or decrease the frequency and / or amplitude of the alternating magnetic field.

5. The implantable device (100) according to any one of claims 1 to 4, wherein The winding is an air-core winding and is wound on the non-magnetic shell of the energy storage device.

6. The implantation device (100) according to any one of claims 1 to 4, wherein the core (7) is the magnetic housing of the energy storage element, and the winding (6) is wound on the magnetic housing.

7. The implantation device (100) according to any one of claims 1 to 4, wherein the core (7) is a magnetic solid shaft or a magnetic hollow shaft.

8. The implantation device (100) according to claim 7, wherein the core (7) is the magnetic solid shaft, and the magnetic energy storage element is positioned along the direction of the winding axis, adjacent to the solid shaft and inside or outside the winding.

9. The implantation device (100) according to claim 7, wherein the core (7) is the magnetic solid shaft, the winding is wound on the magnetic solid shaft, and the non-magnetic energy storage element extends radially to the axis of the winding and around the winding.

10. The implantation device (100) according to claim 7, wherein the core (7) is the magnetic hollow shaft, the winding is wound on the magnetic hollow shaft, and the energy storage element is positioned inside the hollow shaft, preferably, one of the energy storage elements is positioned at each end of the hollow shaft.

11. The implantation device (100) according to claim 7, wherein the core (7) is the magnetic hollow shaft, the winding is wound on the magnetic hollow shaft, and the non-magnetic energy storage element is positioned along the direction of the winding axis, adjacent to the hollow shaft and inside or outside the winding.

12. The implantation device (100) according to any one of claims 1 to 11, wherein the winding has W turns, and W≤1000, preferably W≤50, 40, 30, 20, 10.

13. The implantation device (100) according to any one of claims 1 to 12, wherein the implantation device generates a preset charging current at a frequency f of the external alternating magnetic field, wherein f ≤ 2 MHz, preferably f ≤ 500 kHz, 400 kHz, 300 kHz, 200 kHz, 100 kHz, or 50 kHz.

14. The implantation device (100) according to any one of claims 1 to 13, wherein the energy harvesting unit is configured such that the longitudinal magnetic center coincides with the longitudinal center of the winding.

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