Wireless energy transfer system

Abstract

During charging of the implantable device via inductive coupling, heat may be generated within the implantable device, so control of charging may be desirable to reduce or avoid the risk of unwanted tissue heating. Altering parameters related to charging may prevent unwanted heating, but typically increases the complexity of the device used. An implantable device is provided for wirelessly receiving energy pulses, monitoring energy storage, and transmitting a first energy-sufficient signal when the energy storage exceeds a first maximum value. An associated energy transmission device is provided for wirelessly transmitting multiple consecutive energy pulses transmitted at a first power level, pausing energy transmission immediately after the first energy-sufficient signal is received, and then resuming energy pulse transmission at the first power level if no further energy-sufficient signals are received.

Description

Technical Field

[0001] Copyright Notice Part of the disclosure of this patent document contains content subject to copyright protection. The copyright owner reserves all copyrights in all cases except when it is shown in the patent application documents or records of the Patent and Trademark Office, in which case there is no objection to a complete copy of the patent document or patent disclosure.

[0002] This disclosure relates to an improved method for controlling wireless energy transfer from an energy transmission device to a wirelessly embedded device. The present invention further relates to an improved energy controller for a wirelessly embedded device. In particular, the present invention relates to an improved energy controller for a wirelessly embedded stimulation device for applying electrical stimulation to human or animal tissue, having an electrode array arranged along a substrate.

Background Art

[0003] Implanted devices can be used to monitor diseases. Additionally or alternatively, implanted devices may perform treatments for therapeutic or cosmetic reasons. In many long-term or chronic uses, implanted devices currently include a rechargeable energy source (e.g., including one or more capacitors or batteries) to maintain or extend their operating life. Generally, it is also desirable to optimize the time between recharges so that the device can operate correctly during treatment. In the case of an implanted stimulation device configured and arranged to apply electrical stimulation as a treatment, optimization may be more important to increase the chances of correct treatment.

[0004] In many cases, the charging device is external and provides transdermal charging. In some embodiments, charging may be performed via inductive coupling between a primary coil in the charging device and a secondary coil in the implanted device. When a current is applied to the primary coil and the primary coil is aligned with the secondary coil, the current is induced into the secondary coil for charging. Since heat may be generated within the implanted device during charging, charging is controlled to reduce or avoid the risk of undesirable tissue heating. For example, the energy and / or duration and / or interval of charging may be controlled.

[0005] More recently, implantable devices have emerged that include charging coils for charging the implantable device and for communication in either one-way or two-way. Parameters related to the charging of the implantable device can therefore be provided directly to the charging device, allowing for a more precise reduction and / or avoidance of undesirable overheating.

[0006] This allows for more complex control of charging, but to enable miniaturized and safer designs, it is also necessary to improve charging control, especially for implantable devices that do not have batteries. [Overview of the Initiative]

[0007] Both the above-mentioned summary of the invention and the descriptions of modes for carrying out the invention are illustrative and descriptive, and should be understood as intended to provide a further description of the claimed invention. Neither the summary of the invention nor the description that follows it is intended to define or limit the scope of the invention to any specific features mentioned in the summary or description. Rather, the scope of the invention is defined by the claims.

[0008] In certain embodiments, the disclosed embodiments may include one or more of the features described herein.

[0009] While wireless energy control for implantable devices is described, this disclosure can also be implemented without requiring any potentially surgical steps.

[0010] A method is provided for controlling wireless energy transfer from an energy transmission device to a wireless embedded device, the embedded device comprising: one or more energy receivers configured and positioned to wirelessly receive a plurality of continuous energy pulses transmitted at a first power level; energy storage configured and positioned to store at least a portion of the energy received by the one or more energy receivers; and an energy monitor configured and positioned to monitor the status level of the energy storage, the status level of which is largely influenced by the energy received by and / or used by the embedded device, wherein the energy transmission device wirelessly transmits a plurality of energy pulses at a first power level. A method comprising one or more configured and arranged energy transmitters and one or more signal receivers configured to detect energy sufficiency signals from an embedded device, the method comprising: the energy transmission device initiating energy pulse transmission at a first power level; the energy transmission device and the embedded device generating an energy transmission channel between one or more energy transmitters and one or more energy receivers; the embedded device transmitting a first energy sufficiency signal when the status level of energy storage exceeds a first maximum value; the energy transmission device pausing energy pulse transmission immediately after the first energy sufficiency signal is received, and then resuming energy pulse transmission at the first power level if no further energy sufficiency signals are received.

[0011] This reduces the risk of the embedded device's temperature becoming undesirably high by using relatively simple status signals to primarily transmit energy when needed.

[0012] In particular, corrective measures are triggered by similar, sometimes identical, signals from the implanted device. Generating such feedback signals can utilize only simpler electronic equipment, further reducing the complexity required for the implanted device. Fixed-power transmitters may be used, reducing the complexity of external transmission devices. The corrective measures performed by external power transmitters are similar, and sometimes identical—they suspend the transmission of energy pulses as quickly as possible.

[0013] Furthermore, energy transfer control can be performed with a limited handshake protocol or even without one. Especially in the case of medical implants, it is advantageous for the implanted device to be highly independent from external devices for proper operation. Also, little to no handshake can reduce communication overhead and further accelerate the response speed of external transmitters.

[0014] Optionally, the method includes the energy transmission device pausing energy pulse transmission within 2 milliseconds or less, within 1 millisecond or less, within 100 microseconds or less, or within 10 microseconds or less after a first or further energy suffocation signal is received.

[0015] While additional features and functions can be implemented, relatively simple control of energy transfer allows for relatively quick decision-making. It may be advantageous to pre-determine and / or control downtime to minimize it, as this reduces the risk of the implanted device receiving excessive energy.

[0016] Furthermore, or alternatively, the energy storage is configured and positioned to provide sufficient energy to operate the embedded device, and the duration of the pause in energy pulse transmission is 1000 milliseconds (ms) or less, 500 milliseconds or less, 200 milliseconds or less, 100 milliseconds or less, 50 milliseconds or less, 20 milliseconds or less, or 10 milliseconds or less.

[0017] Minimizing the time an implanted device can operate without receiving external energy can reduce the complexity (and therefore the cost) of the implanted device, decrease the amount of energy stored (and therefore the risk of overheating), and further reduce the "charging time" (and therefore the risk of overheating during "charging") while energy is stored.

[0018] Optionally, the method further includes predetermining and / or controlling an energy transmission device to transmit an energy pulse of a first duration; the energy transmission device initiating the transmission of a first pulse of a first duration; the energy transmission device receiving a first or further energy suffocation signal; and the energy transmission device pausing the transmission of the energy pulse so that the first pulse is truncated such that the first pulse has a truncated duration less than the first duration.

[0019] (Where applicable) By interrupting the current pulse, it may be possible to temporarily suspend energy transmission, further reducing the risk of overheating.

[0020] Optionally, the method includes the embedded device transmitting a first and / or further energy-sufficient signal by modifying one or more parameters of an energy transmission channel, thereby making the modification of one or more parameters detectable by the energy transmission device.

[0021] By using existing energy transmission channels to provide energy sufficiency signals, a dedicated communication channel is not required, thus further reducing complexity.

[0022] For example, an embedded device may modify the tuning of the energy transmission channel to transmit as load shift keying (LSK).

[0023] Optionally, the energy transmission device monitors one or more historical parameters associated with one or more transmitted energy pulses, monitors the one or more historical parameters before a first and / or further energy replenishment signal is received, generates a monitoring data set including the one or more historical parameters, generates a historical database including a plurality of monitoring data sets, derives an expected amount of energy transmitted before an energy replenishment signal is received from the historical database, compares a subsequent monitoring data set with the expected amount of energy transmitted, and identifies a significant difference between the expected amount of energy transmitted and the subsequent monitoring data set.

[0024] This can be advantageous because one or more significant differences may indicate that the status of the embedded device has changed or is predicted to change - for example, that there is a defect in the embedded device, that the risk of malfunction has increased, that the risk of inefficient operation has increased, that an unexpected degree of fluid intrusion has occurred, that the primary and / or secondary energy sources are depleted to an undesirable extent, or any combination thereof.

[0025] Optionally, the embedded device provides a certain degree of detuning of the energy transmission channel when the energy storage status level exceeds a second maximum value.

[0026] This can enable direct control of detuning and the quality of energy transfer.

[0027] Optionally, the embedded device further includes one or more voltage regulators that control at least a portion of the energy stored in the energy storage, and the method further includes the embedded device lowering the output voltage of the voltage regulator when the energy storage status level exceeds a third maximum value.

[0028] This can be advantageous as it provides automatic protection against very high pressures. In practice, the third level may determine the maximum energy storage possible within the embedded device.

[0029] Optionally, the embedded device further includes one or more shunts for reducing at least a portion of the energy stored in the energy storage, and the method further includes the embedded device operating one or more shunts when the status level of the energy storage exceeds a third maximum value.

[0030] This can be advantageous because shunts, such as Zener diodes, can provide relatively reliable and automatic and simple protection against very high voltages.

[0031] Optionally, the embedded device can be configured and arranged to transmit an energy replenishment signal centered on two or more modulation frequencies and to select the center modulation frequencies of the first and / or additional energy replenishment signals.

[0032] A suitable energy transmission device includes one or more signal receivers configured to detect two or more center modulation frequencies of the first and / or additional energy replenishment signals.

[0033] This can be advantageous because an additional communication channel may be less sensitive to the Q factor (i.e., quality factor) of the energy transmission channel.

[0034] The embedded device being configured and arranged to transmit an energy replenishment signal centered on two modulation frequencies can be advantageous because this enables the use of binary encoding. Any frequencies including modulation frequencies centered around approximately 212 kHz and approximately 424 kHz can be used.

[0035] Generally, it may be advantageous to simplify additional data and / or information being transmitted using a modified energy replenishment signal to reduce the risk of distorting or delaying a primary request to suspend transmission.

[0036] Optionally, the energy transmission device may be configured and arranged to modify one or more parameters of the energy pulse transmission based on one or more center modulation frequencies of the first and / or further energy-sufficient signals.

[0037] Optionally, one or more parameters may include at least one of the following: default transmit pulse duration, pause duration before the next transmit pulse is required, default power level levels for multiple energy transmit pulses, feedback on the quality of energy transfer, feedback on the quality of any data transmission from the energy transmission device, energy storage status, indicators of the health of the implanted device, measurement data, or any combination thereof.

[0038] Optionally, the embedded device may further include a modulator that transmits a first energy-sufficient signal.

[0039] Optionally, the embedded device may further include a voltage regulator and a shunt, the voltage regulator and shunt being configured and positioned to reduce the voltage when it exceeds an energy storage protection level.

[0040] Optionally, the embedded device may be configured and positioned to send commands to the energy transmission device such that the intensity of subsequent energy pulse transmissions is reduced compared to energy pulse transmissions at a first power level.

[0041] When configured and positioned as an implantable stimulator, the implantable stimulator may further include a pulse generator configured and positioned to receive electrical energy from energy storage for its operation and further configured to generate at least one stimulation pulse, at least two electrodes, and a plurality of electrical interconnections for electrically coupling the pulse generator to at least two electrodes, the method further includes configuring and positioning the pulse generator to provide electrical stimulation energy to at least two electrodes as one or more electrotherapeutic stimulation pulses.

[0042] When implanted in an implantable stimulator, these features can be particularly advantageous, as they typically require more complex energy control and may consume more power during use.

[0043] Optionally, at least two electrodes may be configurable as either stimulating or return electrodes using one or more parameters of the pulse generator.

[0044] Optionally, the pulse generator may include one or more energy receivers.

[0045] Optionally, an implantable device configured and positioned as an implantable stimulator may further include a substrate having a first surface and a second surface, the thickness of which is defined by the first surface and the second surface, at least two electrodes included in an electrode array positioned along a fitting portion of the substrate, a plurality of electrical interconnections positioned between the first surface and the second surface of the substrate, and the thickness of the substrate along the fitting portion being 0.5 millimeters or less.

[0046] Optionally, the substrate conforming portion may include at least one of polymer, liquid crystal polymer (LCP), or any combination thereof.

[0047] Optionally, the substrate includes a further portion along which a pulse generator is positioned, and the embedded device further includes an encapsulation layer that at least partially covers the further portion of the substrate.

[0048] Generally, an embedded device suitable for performing a method (disclosed herein) for controlling wireless energy transmission from an energy transmission device includes one or more energy receivers configured and arranged to wirelessly receive a plurality of continuous energy pulses transmitted at a first power level; energy storage configured and arranged to store at least a portion of the energy received by the one or more energy receivers; and an energy monitor configured and arranged to monitor the status level of the energy storage, the status level of which is largely influenced by the energy received by and / or used by the embedded device, wherein the embedded device is further configured and arranged to generate an energy transmission channel between the one or more energy receivers included in the energy transmission device and one or more energy transmitters, and to transmit a first energy sufficiency signal when the status level of the energy storage exceeds a first maximum value.

[0049] Generally, an energy transmission device suitable for performing a method (disclosed herein) for controlling wireless energy transfer to a wireless embedded device includes one or more energy transmitters configured and arranged to wirelessly transmit a plurality of energy pulses at a first power level, and one or more signal receivers configured to detect an energy sufficiency signal from the embedded device, wherein the energy transmission device is further configured and arranged to generate an energy transmission channel between one or more energy transmitters contained within the wireless embedded device and one or more energy receivers, to pause energy pulse transmission immediately after a first energy sufficiency signal is received, and thereafter resume energy pulse transmission at the first power level if no further energy sufficiency signals are received.

[0050] Generally, a system suitable for performing a method (disclosed herein) for controlling wireless energy transfer to a wireless embedded device includes an energy transmission device comprising at least one energy transmitter for wirelessly transmitting a plurality of energy pulses at a first power level and at least one signal receiver for detecting an energy sufficiency signal from a wireless embedded device, and a wireless embedded device comprising at least one energy receiver for wirelessly receiving a plurality of continuous energy pulses transmitted at a first power level, energy storage for storing at least a portion of the energy received by the at least one energy receiver, and an energy monitor for monitoring the status level of the energy storage, the status level of which is largely influenced by at least one of the energy received by the embedded device and / or the energy used by the embedded device.

[0051] Specific exemplary embodiments illustrating the organization and method of operation can be best understood by referring to the embodiments for carrying out the invention described below, which should be interpreted in conjunction with the accompanying drawings, which are not necessarily drawn to scale, along with their purposes and advantages.

[0052] The accompanying drawings incorporated herein and forming part of the specification illustrate exemplary embodiments and, together with the description, are further useful in enabling those skilled in the art to create and use these embodiments and other embodiments that will become apparent to those skilled in the art.

[0053] Those skilled in the art will also understand that the descriptions of signals and timing in this disclosure are schematic and intended to highlight relevant aspects of the embodiments. For example, when the embodiments are implemented, moments shown as simultaneous may be separated by delays, the rising edges of signals shown as vertical may have slopes, waveforms shown as square may be deformed and / or rounded, and additional delays may be present. [Brief explanation of the drawing]

[0054] [Figure 1A] This is a longitudinal (or lateral) cross-section of an implantable stimulator. [Figure 1B] This is a top view of an implantable stimulator. [Figure 1C] This is a bottom view of an implantable stimulator. [Figure 1D] This is a further longitudinal (or lateral) cross-section through the implanted stimulator. [Figure 2] This diagram schematically shows the data communication or signal communication and energy transmission signals generated when implementing a method for controlling wireless energy transfer. [Figure 3A] A suitable pulse generator or pulse energy controller is outlined below. [Figure 3B] A schematic representation of the appropriate relevant energy transmission equipment is provided. [Figure 4] The data communications or signal communications and energy transmission signals generated when implementing further methods for controlling wireless energy transfer are schematically shown. [Figure 5] Examples of nerves that can be stimulated to treat headaches are shown. [Figure 6] Examples of nerves that can be stimulated to treat headaches are shown. [Figure 7] Examples of nerves that may be stimulated for other treatments are shown. [Figure 8] The use of up to three levels of protection is outlined below. [Figure 9A] A more detailed schematic diagram of a suitable pulse generator is shown. [Figure 9B] A more detailed schematic diagram of a suitable pulse generator is shown. [Figure 10] Further methods for controlling wireless energy transmission are outlined below. [Modes for carrying out the invention]

[0055] Implantable devices and methods for controlling them are described herein in reference to various exemplary embodiments. This specification discloses one or more embodiments incorporating features of the present invention. The described embodiments and references herein to “one embodiment,” “an embodiment,” and “an example embodiment” indicate that the described embodiments may include certain features, structures, or characteristics. Such wording does not necessarily refer to the same embodiment. When certain features, structures, or characteristics are described in reference to one embodiment, those skilled in the art will know that such features, structures, or characteristics may affect other embodiments, whether or not they are explicitly described.

[0056] In some figures, similar reference numerals may be used for similar elements having similar functions even in different drawings. The embodiments described, and their detailed structures and elements, are provided only to aid in a comprehensive understanding of the invention. Thus, it is clear that the invention can be carried out in a variety of ways and does not require any of the specific features described herein. Furthermore, well-known functions or structures are not described in detail because they would obscure the invention with unnecessary details. Unless otherwise noted, any signal arrows in the drawings / figures should be considered illustrative only, and not restrictive.

[0057] Since the scope of the present invention is best defined by the appended claims, this description should not be interpreted restrictively, but is merely for the purpose of illustrating the general principles of the present invention.

[0058] Furthermore, while terms such as "first," "second," etc., may be used herein to describe various elements, it will be understood that these elements should not be limited by these terms. These terms are used solely to distinguish one element from another. Without departing from the scope of the exemplary embodiments, for example, the first element may be referred to as the second element, and similarly, the second element may be referred to as the first element. As used herein, the term "and / or" includes any and all combinations of one or more of the enumerated items relating to the subject. As used herein, "at least one of A, B, and C" indicates A or B or C or any combination thereof. As used herein, unless the context explicitly indicates otherwise, the singular form includes the plural form, and vice versa. Thus, the references "a," "an," and "the" generally include the plural form of the respective terms.

[0059] Furthermore, please note that in some alternative embodiments, the functions / actions shown may occur in a different order than that shown in the diagrams. For example, two diagrams shown consecutively may actually be executed substantially simultaneously, or they may be executed in reverse order depending on the functions / actions involved.

[0060] Where used herein, the term "range" is used concisely to avoid the need to enumerate and describe every value within the range. Any suitable value within the range can be selected as the upper, lower, or end of the range, as needed.

[0061] The terms “comprise,” “comprises,” and “comprising” should be interpreted comprehensively, not exclusively. Similarly, the terms “include,” “including,” and “or” should all be interpreted comprehensively unless such interpretation is explicitly prohibited in the context. The terms “comprising” or “including” are intended to include embodiments that are encompassed by the terms “consisting essentially of” and “consisting of.” Similarly, the term “consisting essentially of” is intended to include embodiments that are encompassed by the term “consisting of.” The terms “comprising,” “having,” “containing,” and “consisting of” have distinct meanings, but may be interchangeable throughout this explanation.

[0062] "About" or "approximately" means plus or minus 10% of the referenced numerical value. For example, the term "about 4" would include a range of 3.6 to 4.4. All numbers used herein to represent quantities such as components and reaction conditions should be understood as being modified by the term "about" in all examples. Thus, unless otherwise indicated, the numerical parameters described herein are approximations that may vary depending on the desired properties to be obtained. Each numerical parameter should be interpreted with respect to significant figures and common rounding techniques, at least, not as an attempt to limit the application of the doctrine of equivalents to the scope of any claim.

[0063] Whenever the words “for example,” “etc.,” or “including,” are used herein, they are understood to be followed by the words “and without limitation,” unless otherwise explicitly indicated.

[0064] "Normally" or "optionally" means that the event or situation described thereafter may or may not occur, and that the description includes both the cases in which the event or situation occurs and the cases in which it does not occur.

[0065] Implantable devices or implantable implants can be configured and positioned to provide a variety of functions. For example, - Function to measure one or more environmental parameters, - Function to measure one or more biological parameters, - The function of releasing one or more substances. - The ability to deliver one or more electrical pulses to the tissue. Or a combination of those.

[0066] Because implantable stimulators typically require more complex energy control, embodiments will be described primarily using examples of implantable stimulators. However, those skilled in the art will understand that, since this disclosure relates to energy control, it can be implemented in any suitable implantable device capable of receiving electrical energy wirelessly. Such devices may be particularly advantageous when implanted in an implantable stimulator, as they typically have relatively high power consumption.

[0067] Figures 1A and 1D show longitudinal sections of an implantable device 100 configured and positioned to deliver energy to human or animal tissue as a treatment for cosmetic and / or therapeutic reasons, while Figures 1B and 1C show plan views. The implantable device 100 may also be described as an implantable stimulator 100.

[0068] The stimulator 100 includes an implantable first substrate portion 610 and an implantable second substrate portion 620. The first substrate portion 610 may also be described as the proximal end. The second substrate portion 620 may also be described as the distal end. Figure 1A shows the second substrate portion 620, Figure 1D shows the first substrate portion 610, and Figures 1B and 1C show both the first 610 and the second 620 substrate portions.

[0069] The stimulator 100 further includes the following: - Electrode arrays 200, 400 having at least two electrodes 200, 400, contained within the second substrate portion 620. Optionally, the second substrate portion 620 may be fitted.

[0070] In this embodiment, one or more electrodes of a first type 200a, 200b are provided, and one or more electrodes of a second type 400a, 400b are provided. The electrodes 200, 400 are contained on a first surface 310 or a second surface 320, and each can be configured to deliver energy to and / or from human or animal tissue during use (as a stimulating electrode). In this regard, an array can be considered a systematic arrangement of two or more electrodes 200a, 200b, 400a, 400b. One-dimensional (1D), two-dimensional (2D), or three-dimensional (3D) arrays can be provided. Optionally, one-dimensional (1D), two-dimensional (2D), or three-dimensional (3D) arrays can be arranged in rows and / or columns.

[0071] In this embodiment, the second substrate portion 620 includes a 1D array having two electrodes 200a, 200b of the first type and two electrodes 400a, 400b of the second type. However, any number and type of electrodes may be used, as described below.

[0072] The implantable stimulator 100 further includes the following: - One or more electrical and / or electronic components included in the first substrate portion 610. - An optional pulse generator 500 (shown in Figure 1B) for generating one or more therapeutic electrical stimulation pulses. The pulse generator 500 may also be called a pulse energy controller. In this embodiment, the optional pulse generator 500 is included in the first substrate portion 610. The pulse energy controller 500 may include a well-configured and programmed processor that controls one or more parameters, such as the intensity, duration, waveform shape, frequency, and repetition rate of the stimulation energy pulse, using one or more software or firmware methods. Alternatively, a hardware-based solution may be used, such as a state machine implemented on an ASIC (Application-Specific Integrated Circuit). It may also operate in standalone mode, periodically communicate with an external controller, or a combination of both. - A substrate 300 extending longitudinally along the longitudinal axis 600 from a first substrate portion 610 to a second substrate portion 620. - When the associated energy transmission device 1000 is in proximity, one or more receivers 550r (not shown in Figure 1A) for wirelessly receiving energy from the associated energy transmission device 1000 (shown only in Figure 1D). As described below, the energy receivers 550r are generally configured and positioned to wirelessly receive energy and transmit at least a portion of the energy to one or more electrical and / or electronic components included in the embedded device 100.

[0073] In this embodiment, one or more energy receivers 550r are included in the first substrate portion 610 and are further configured to transmit at least a portion of the energy received to at least two electrodes 200, 400. If a pulse generator 500 is included, one or more energy receivers 550r are configured to transmit at least a portion of the energy to the pulse generator 500 and / or a portion to at least two electrodes 200, 400.

[0074] Optionally, a second substrate portion 620 may be fitted. Furthermore, or instead, a first substrate portion 610 may be fitted.

[0075] Optionally, the substrate 300 may include one or more fitted foil-like substrate portions as described below. Furthermore or alternatively, the substrate 300 may include two or more adjacent polymer substrate layers.

[0076] The substrate 300 includes a first surface 310 and a second surface 320 defining one or more thicknesses. Optionally, the surfaces 310 and 320 may be substantially planar.

[0077] As shown in Figures 1B and 1D, one or more energy receivers 550r are contained within the second surface 320. Alternatively, the energy receivers 550r may be contained within the first surface 310 and / or between the first surface 310 and the second surface 320.

[0078] As shown in Figure 1D, the pulse energy controller 500 is contained between the first surface 310 and the second surface 320. Alternatively, the pulse controller 500 may be contained on either the first surface 310 or the second surface 320. Alternatively, the pulse controller 500 may be divided into multiple electrical and / or electronic components, allowing the pulse controller 500 to be contained between two surfaces 310, 320, and also contained on one or more surfaces 310, 320.

[0079] The implantable stimulator 100 also includes the following: - A first substrate portion 610 for transmitting electrical energy as one or more electrotherapeutic stimulation pulses to first electrodes 200a, 200b and / or second electrodes 400a, 400b, and one or more electrical interconnections 250 between the first electrodes 200a, 200b and the second electrodes 400a, 400b. One or more electrical interconnections 250 are contained between the first surface 310 and the second surface 320. In other words, multiple electrical interconnections 250 are contained between the first surface 310 and the second surface 320.

[0080] If the separation between the first substrate portion 610 and the second substrate portion 620 is relatively large, a further substrate portion of the substrate without stimulating electrodes may be provided. The length of this further substrate portion without stimulating electrodes may be configured and arranged to allow the first substrate portion 610 and the second substrate portion 620 to be placed in different locations on and / or within the body.

[0081] In this disclosure, the compatibility of at least two electrodes 200, 400 is largely determined by one or more of the following: - Compatibility of the substrate 300 adjacent to electrodes 200 and 400, - Arrangement and position of electrodes 200 and 400, - Materials of electrodes 200 and 400, and dimensions (or range) of materials included in electrodes 200 and 400, - The arrangement and position of one or more interconnects 250 adjacent to electrodes 200, 400, and - Materials and dimensions (or range) of materials included in the interconnect 250.

[0082] Through appropriate configuration, arrangement, and optimization, an embedded substrate portion can be provided having at least two electrodes 200, 400 that are foil-like (or film-like) and further configured and arranged to fit very well.

[0083] As shown, preferably the substrate 300 is elongated and tape-shaped along the longitudinal axis 600, allowing the first substrate portion 610 to be positioned further away from the electrodes 200 and 400. This provides a high degree of flexibility when the proximal end 610 and distal end 620 of the stimulator 100 have different cross-sectional shapes.

[0084] If the substrate 300 is positioned substantially planarly (for example, by enabling the substrate 300 to conform to a plane), the first surface 310 and the second surface 320 are positioned along substantially parallel transverse planes 600, 700. As shown in Figures 1A and 1C, the first surface 310 lies in the plane containing the longitudinal axis 600 and the first transverse axis 700 - the first transverse axis 700 is substantially perpendicular to the longitudinal axis 600. As shown in Figures 1A and 1D, the plane of the first surface 310 is substantially perpendicular to the plane of the section drawing (substantially perpendicular to the plane of the paper). As shown in Figures 1A and 1B, the second surface 320 lies in the plane containing the longitudinal axis 600 and the first transverse axis 700. As shown in Figures 1A and 1D, the plane of the first surface 310 is substantially perpendicular to the plane of the section drawing (substantially perpendicular to the plane of the paper).

[0085] If the substrate 300 is suitable and in foil form, the substrate 300 has a maximum thickness of typically 0.5 millimeters or less, adjacent to the first electrodes 200a, 200b and the second electrodes 400a, 400b.

[0086] The substrate thickness can be considered as the perpendicular distance between corresponding points on the first surface 310 and the second surface 320. This is preferably determined when the substrate 300 conforms to a plane.

[0087] As shown in Figure 1A, the thickness of the substrate 300 is a range along the second transverse axis 750—this second transverse axis 750 is substantially perpendicular to both the longitudinal axis 600 and the first transverse axis 700—the second transverse axis 750 lies in the plane of the drawing (along the plane of paper), as shown. The first surface 310 is shown as the top surface, and the second surface 320 is shown as the bottom surface. The range (thickness) along the second transverse axis 750 may also be described as the dimension of the cross section in the transverse planes 700, 750.

[0088] Therefore, the thickness can be determined by the perpendicular distance along the second transverse axis 750 between corresponding points on the first surface 310 and the second surface 320. The maximum thickness of the fitted and / or foil-like substrate 300 along the second substrate portion 620 is preferably 0.5 mm or less, preferably 0.3 mm or less, even more preferably 0.2 mm or less, and still more preferably 0.1 mm or less. In general, the less the maximum thickness (in other words, the thinner the substrate), the greater the degree of fit. Alternatively, the maximum thickness can be determined in proximity to the first electrodes 200a, 200b and the second electrodes 400a, 400b.

[0089] To clarify the differences between the various diagrams shown, the axes are given nominal directions. - The longitudinal axis 600 extends from the first substrate portion 610 on the left (not shown in Figure 1A) to the first substrate portion 620 shown on the right of the page (not shown in Figure 1D). - The first horizontal axis, 700, extends into the page as shown in Figures 1A and 1D. - The second horizontal axis, 750, extends from the bottom to the top, as shown in Figures 1A and 1D.

[0090] The substrate 300 may be configured and arranged as a multilayer including two or more adjacent polymer substrates having a first surface 310 and a second surface 320. One or more electrical interconnects 250 are also included between the first surface 310 and the second surface 320. However, it is not necessary that the two or more polymer layers and / or interconnects have similar extents along the first transverse axis 700. In other words, in the context of this disclosure, there may be regions where the interconnects 250 are sandwiched between regions of polymer substrates (displayed as a multilayer in the longitudinal section) adjacent to regions where the polymer substrates are substantially continuous. Similarly, there may be regions where the interconnects 250 are sandwiched between two polymer substrate layers (displayed as a multilayer in the longitudinal section) adjacent to regions where the substrate includes two adjacent substrate layers. Likewise, a substrate including two or more polymer substrate layers may be modified (physically and / or chemically) to appear as if it were a single layer of polymer substrates.

[0091] These polymer substrate layers are selected for compatibility so as to fit and include one or more electrical interconnections. Preferably, the polymer substrate material is also biocompatible and durable, such as a material selected from the group including silicone rubber, siloxane polymer, polydimethylsiloxane, polyurethane, polyether urethane, polyether urethane urea, polyester urethane, polyamide, polycarbonate, polyester, polypropylene, polyethylene, polystyrene, polyvinyl chloride, polytetrafluoroethylene, polysulfone, cellulose acetate, polymethyl methacrylate, polyethylene, and polyvinyl acetate. Suitable examples of polymers including LCP (liquid crystal polymer) films are described in "Polymers for Neural Implants", Hassler, Boretius, Stieglitz, Journal of Polymer Science: Part B Polymer Physics, 2011, 49, 18-33 (DOI 10.1002 / polb.22169). Table 1, which shows the characteristics of polyimide (UBE U-Varnish-S), parylene C (PCS parylene C), PDMS (NuSil MED-1000), SU-8 (MicroChem SU-8 2000 & 3000 series), and LCP (Vectra MT1300), is included here for reference.

[0092] The conforming foil-like substrate 300 is configured to conform very precisely to the contours of the underlying anatomical features due to its flexibility. Very thin foil-like substrates 300 have the additional advantage of increased flexibility. Generally, thinner elements allow for placement in multiple subcutaneous locations, providing greater comfort to the subject.

[0093] Most preferably, the polymer substrate layer comprises LCP, parylene, and / or polyimide. LCP is a chemically and biologically stable thermoplastic polymer that enables small-sized, sealed sensor modules with low moisture penetration. Advantageously, LCP can be thermoformed, allowing for the provision of complex shapes. Very thin (later very conformable) and very flat (extremely planar) layers of LCP can be provided. For fine-tuning of the shape, a suitable laser may also be used for cutting. For example, a conformed foil-like substrate 300 of LCP may have a thickness in the range of 50 microns (um) to 720 microns (um), preferably 100 microns (um) to 300 microns (um) (range along the second transverse axis 750). For example, values ​​of 150 um, 100 um, 50 um, or 25 um may be provided. The range (thickness) along the second transverse axis 750 may also be described as the dimensions of the cross-section within the transverse planes 700, 750.

[0094] When substantially conformed to a plane, the foil-like surface 300 is substantially contained within a plane having a transverse range substantially perpendicular to the longitudinal axis 600, and the planar width can be determined by the perpendicular distance between corresponding points on the outer edge of the planar foil-like substrate 300 along each transverse range. As shown, this is along the first transverse axis 700. For example, widths of electrodes 200, 400 ranging from 2 mm to 20 mm can be provided using LCP. The range (width) along the first transverse axis 700 may also be described as the dimensions of the cross-section within the transverse planes 700, 750. Typically, such a conformed foil-like substrate has an average transverse range (thickness) along the second transverse axis 750 that is less than or equal to the average transverse range (planar width) along the first transverse axis 700.

[0095] At room temperature, LCP thin films have mechanical properties similar to steel. This is important because the embedded substrate 300 needs to be strong enough to be embedded, strong enough to be removed (explanted), and strong enough to follow any movement of adjacent anatomical features and / or structures without degradation.

[0096] LCPs belong to the polymer materials with the lowest permeability to gases and water. LCPs can be bonded to themselves, enabling multilayer structures with a homogeneous structure. In contrast to LCPs, polyimides are thermosetting polymers that require adhesives to construct multilayer substrate portions with at least two electrodes. Polyimides are thermosetting polymer materials with high temperature and bending durability.

[0097] LCP can be used, for example, to provide a substrate 300 that is adapted as a multilayer—in other words, two or more adjacent polymer substrate layers. For example, these may be layers with a thickness of 25 μm (microns).

[0098] For example, one or more electrical interconnects 250 may be provided between a first surface 310 and a second surface 320 by metallization. These may be conductors embedded in the substrate 300—for example, having a single polymer layer and applying a conductive material using suitable deposition techniques known from the semiconductor industry. For example, the substrate may include a first adapted layer and at least one second adapted layer, and the multiple electrical interconnect layers 250 may be arranged along the first layer using deposition techniques, with at least one second layer fixed to the first layer and covering the multiple electrical interconnects.

[0099] When two or more adjacent polymer substrate layers are provided, interconnection layers may be provided using appropriate techniques, such as those from the semiconductor industry. Polymer substrate layers may also be considered adjacent when one or more adhesive layers are used between them.

[0100] Lamination may also be used to impart desired physical and chemical properties to the substrate 300 and / or to provide a convenient manufacturing method. For example, the substrate 300 may include three laminated polymer layers, namely two high-temperature thermoplastic layers with a low-temperature layer (bond ply) in between, and a high-temperature layer toward the first surface 310 and the second surface 320.

[0101] In another embodiment, two silicone layers may be provided as polymer substrate layers. That is, a first silicone layer is provided and a metal is patterned on one of its outer surfaces, and a second silicone layer is added on top of the metal patterning, for example by spraying, overmolding, or spin coating.

[0102] The electrical interconnection 250 may include one or more conductors, such as metal, formed as needed, within one or more conductive elements, such as wires, strands, foils, layers, plates, and / or sheets. They may be substantially continuous (a single conductor). They may also include multiple conductors configured and arranged to be electrically connected to one another during use—in other words, one or more conductors are configured and arranged to be substantially electrically continuous during use.

[0103] Alternatively, one or more electrical interconnects 250 may be contained within one or more conductive interconnect layers 250, and one or more conductive interconnect layers may be contained between two adjacent polymer substrate layers. As shown in Figures 1A and 1D, multiple interconnects may be provided in different arrangements (or depths) between the first surface 310 and the second surface 320.

[0104] In the context of this disclosure, the interconnects 250 are not configured or positioned to come into contact with human or animal tissue during use. For example, this may be done by embedding one or more interconnects 250 in one or more layers of a low-conductivity or insulating polymer such as LCP. Furthermore or alternatively, one or more encapsulation layers may be used.

[0105] One or more interconnection layers 250 may also be provided by metallization, using techniques from the PCB (printed circuit board) industry, such as metallization using biocompatible metals like gold or platinum. Electroplating may be used. Layers containing LCP films are particularly suitable for metallization. These electrical interconnects 250 and / or interconnection layers 250 are configured to transmit electrical energy from the pulse generator 500 as one or more electrotherapeutic stimulation pulses to the first electrodes 200a, 200b and / or the second electrodes 400a, 400b.

[0106] By using a suitable polymer substrate material such as an LCP film, a fitted foil-like (or film-like) substrate 300 and at least two electrodes 200, 400 can have a high width-to-height ratio, providing a biocompatible electronic foil (or film) or bioelectronic foil (or film). For example, when the substrate 300 is positioned to conform substantially to a plane, the ratio of the maximum planar width 700 to the maximum thickness 750 adjacent to the first electrodes 200a, 200b and the second electrodes 400a, 400b may be 7:1 or greater, preferably 10:1 or greater, more preferably 15:1 or greater, even more preferably 30:1 or greater, and still more preferably 50:1 or greater. Ratios of 100:1 or greater may also be advantageous and can be provided using one or more mechanically strong substrate layers of an LCP film with a width of about 20 mm and a thickness of about 0.2 mm. This also provides high flexibility and therefore high conformability. To improve the degree of conformity in the first transverse direction 700, additional measures may be taken, such as changing the width of the substrate, adding one or more ridges, and / or providing inflection points.

[0107] Using a single row of electrodes 200, 400 and / or narrower electrodes 200, 400, for example, the width may be 4 mm and the thickness approximately 0.2 mm—this is a ratio of approximately 20:1. Closer to the pulse generator 500, a larger range may be required, which further depends to a greater extent on the dimensions of the electronic components used, for example, 20 mm in width and 3 mm in thickness. This is a ratio of approximately 6.67:1.

[0108] As shown in the embodiment of Figure 1A, the second substrate portion 620 of the substrate 300 includes the following: -Two electrodes of the first type 200a, 200b, included in the first surface 310, -Also included in the first surface 310 are two electrodes of the second type, 400a and 400b. From the proximal end 610 to the distal end 620, the order drawn is 200a, 400a, 200b, and 400b - in other words, each electrode of the first type 200a and 200b is adjacent to the electrodes of the second type 400a and 400b and is included in the same surface 310.

[0109] The substrate 300 includes electrical interconnects 250 between each electrode 200a, 400a, 200b, 400b and the pulse generator 500. In this embodiment, each electrical interconnect 250 is configured and arranged such that each electrode 200a, 400a, 200b, 400b is electrically connected substantially independently—consequently, one of the operating modes available by appropriately configuring the pulse generator 500 is substantially independent operation. The pulse generator 500 may be configured using one or more hardware, firmware, and / or software parameters.

[0110] In Figure 1A (and Figure 1D), the connections 250 are schematically shown as individual connections at different distances between the first surface 310 and the second surface 320, but those skilled in the art will also understand that the same interconnection can be provided by a well-configured interconnection 250 (or interconnection layer 250) at approximately the same distance between the first surface 310 and the second surface 320.

[0111] "Included in" the first surface 310 and the second surface 320 means that electrodes 200a, 400a, 200b, and 400b are mounted (or at least partially embedded) to the surface. Preferably, they are relatively thin (for example, if the substrate is positioned to conform substantially to a plane, the substrate may have an extent of 20 to 50 microns or less along the second transverse axis 750; thinner electrodes may also be used to further improve the degree of conformity, such as 1 micron or less) and mounted (or at least partially embedded) to the surface.

[0112] Electrodes 200, 400 may contain conductive materials such as gold, platinum, platinum black, TiN, IrO2, iridium, and / or platinum / iridium alloys and / or oxides. Conductive polymers such as Pedot may also be used. Preferably, biocompatible conductive materials are used. PCB / metallization techniques may be used to manufacture them on or within the first surface 310 and / or second surface 330 of one or more polymer substrate layers. Since electrodes 200a, 200b, 400a, 400b may be exposed to bodily fluids that can decompose the metal, thicker metal layers are generally preferred over thinner metal layers. However, thicker metal layers usually increase the rigidity (reducing compatibility) of adjacent thicker layers.

[0113] As shown in Figure 1, there is no substantial hardware difference between the first type electrodes 200a, 200b and the second type electrodes 400a, 400b—any functional differences in this embodiment are determined primarily by the following configurations (one or more hardware, firmware, and / or software parameters). - Pulse generator 500, -One or more energy receivers 550r, - One or more electrical components included in the embedded device, - 250 interconnections, placement and routing, Or a combination of those.

[0114] One or more electrodes 200a, 200b, or 400a, 400b of the same type can be operated substantially identically by a suitable configuration of the implantable device 100—in other words, the stimulating energy applied to electrodes 200, 400 is substantially the same at substantially the same moment (usually measured as voltage, current, power, energy, electrification, or any combination thereof). This can also be used to predict and / or correct for misalignment and / or lead movement—which is advantageous as it allows the configuration to be performed at least partially using software.

[0115] Furthermore, or alternatively, two or more electrodes 200, 400 may be configured and positioned as stimulating or returning electrodes using one or more parameters of the implantable device 100. This may provide greater configurability, as it only requires embedding the substrate 300 so that at least two of the electrodes are close to the desired stimulation locations.

[0116] In this embodiment 100, the first type electrodes 200a and 200b are configured and arranged to be nominally operated as stimulating electrodes.

[0117] The second type of electrodes 400a, 400b are nominally configured to operate as return electrodes—each configured to provide electrical return to one or more stimulating electrodes 200a, 200b during use. In other words, the electrical returns 400a, 400b close the electrical circuit. The electrical returns 400a, 400b may also be similarly configured to provide electrical grounding to the corresponding electrical energy source.

[0118] Therefore, three configurations are provided based on this nominal configuration. - A pair of stimulating / returning electrodes 200a / 400a adjacent to the first surface 310 at the stimulating / returning position, or - A pair of stimulating / returning electrodes 200b / 400b adjacent to the first surface 310 at the stimulating / returning position, or A combination of those.

[0119] Generally, one or more stimulating electrodes 200a, 200b may be provided in such a stimulator 100. The number, dimensions, and / or spacing of the stimulating electrodes 200a, 200b may be selected and optimized depending on the treatment—for example, if multiple stimulating electrodes 200a, 200b are provided, each stimulating electrode 200a, 200b may provide different stimulating effects, similar stimulating effects, or the same stimulating effect.

[0120] To avoid misalignment, selection may be made from one or two electrodes 200a, 200b that are close to the tissue where the effect should occur. Two or more stimulating electrodes 200a, 200b may be activated substantially simultaneously at positions between the active stimulating electrodes 200a, 200b if stimulation over a larger area is required and / or

[0121] The stimulating electrodes 200a and 200b may have dimensions of approximately 6-8 mm along the longitudinal axis 600 and 3-5 mm along the first transverse axis 700, and thus approximately 18-40 square mm (mm²).

[0122] A suitable substrate 300 for an implantable stimulator may include, for example, up to 12 stimulating electrodes 200a, 200b and return electrodes 400a, 400b over a length of 15 cm, to allow for displacement correction or simply to allow a specialist to select the most effective stimulation position.

[0123] Figure 1B shows a diagram of the second surface 320 of the first embeddable substrate portion 610 of the substrate 300 shown in Figure 1A. In other words, the second surface 320 is shown on the paper and lies within the first transverse axis 700 (drawn from left to right) along the longitudinal axis 600 (drawn from bottom to top). The second transverse axis 750 extends into the page. The first surface 310, not shown in Figure 1B, is located higher along the second transverse axis 750 (into the page) and is substantially parallel to the plane of the drawing. The substrate 300 is positioned to conform substantially to the plane.

[0124] in general, - The second substrate portion 620 comprises substantially only one or more electrodes 200, 400 and one or more interconnections 250. - The first substrate portion 610 includes one or more electrical components disposed between the second surface 320 and the first surface 310. Alternatively, one or more electrical components may be disposed at least partially on the first surface 310 or the second surface 320. Alternatively, one or more components may be disposed at least partially within the first surface 310 or the second surface 320.

[0125] For example, the maximum thickness and / or planar width may be optimized depending on the degree of embedding and the one or more electrical components used. Components may be made thinner to minimize thickness. Components may include one or more energy receivers 550r and / or one or more pulse generators 500 to provide stimulating pulses to electrodes 200, 400 during use. Additional optional electrical components, such as antennas (e.g., coil antennas, dipole antennas, or fractal antennas), may also affect the thickness and / or width depending on the degree to which they are embedded in the substrate.

[0126] Advantageously, the first substrate portion 610 includes a pulse generator 500. Optionally, as shown in Figure 1D, it may be positioned between the second surface 320 and the first surface 310. In Figures 1B and 1C, the pulse generator 500 is not directly visible, and its position is indicated by a dotted line. Alternatively, the pulse generator 500 may be at least partially positioned on the first surface 310 or on the second surface 320. Alternatively, the pulse generator 500 may be at least partially embedded within the first surface 310 or within the second surface 320.

[0127] For example, the maximum thickness (maximum transverse spread along the second transverse axis 750) may be optimized depending on the degree of embedding and one or more electrical components used in the pulse generator 500. Alternatively, the maximum planar width (maximum transverse spread along the first transverse axis 700) may be optimized.

[0128] When the substrate 300 is configured and arranged to be fitted and / or foil-like, the maximum thickness (extension along the second transverse axis 750) of the implantable stimulator 100 adjacent to the pulse generator 500 may be 5 millimeters or less, preferably 4 millimeters or less, and more preferably 3 millimeters or less, and the thickness is determined by the vertical distance between corresponding points on the outer plane when the implantable stimulator 100 is substantially fitted to the plane.

[0129] The stimulator 100 and substrate 300 extend along a first transverse axis 700 (considered to be the planar width of the stimulator 100 / substrate 300 when fitted to a substantial plane). The planar width adjacent to the energy receiver and / or pulse generator 500 depends, for example, on the hardware and components used—typically, it is the width of at least the largest integrated circuit used. Additional optional electrical components, such as antennas (e.g., coil antennas, dipole antennas, or fractal antennas), may also affect the maximum planar width. The planar width adjacent to electrodes 200a, 200b, 400a, 400b depends, for example, on the conductors used in electrodes 200a, 200b, 400a, 400b and one or more interconnects 250—typically, it is the width of at least the first electrodes 200a, 200b or the second electrodes 400a, 400b.

[0130] Figure 1C shows a diagram of the first surface 310 of the embeddable second substrate portion 620 of the substrate 300 shown in Figures 1A and 1B. In other words, the first surface 310 is shown on the paper and along the longitudinal axis 600 (drawn from bottom to top) and within the first transverse axis 700 (drawn from right to left). The second transverse axis 750 extends out of the page. This is the diagram facing the animal or human tissue to be stimulated (in use). The second surface 320 is not shown in Figure 1C but is located lower along the second transverse axis 750 (into the page) and is substantially parallel to the plane of the drawing. The substrate 300 is positioned to conform substantially to the plane.

[0131] One or more interconnects 250 are located between the first surface 310 and the second surface 320, as shown in Figures 1A and 1D. In Figure 1C, the interconnects 250 are shown by dotted lines and represent the interconnects 250 (or one or more appropriately configured interconnect layers 250) provided for each of the electrodes 200a, 200b, 400a, and 400b in this embodiment. A single dotted line 250 is shown between the pulse generator 500 and the electrodes 200, 400, indicating that in this embodiment 100, the interconnects 250 are in substantially the same arrangement along the first transverse axis 700.

[0132] As shown in Figure 1C, electrodes 200a, 200b, 400a, and 400b each have a longitudinal extension (length) along the longitudinal axis 600 and a transverse extension (width) along the first transverse axis 700. Although shown as similar, in practice each electrode 200a, 200b, 400a, and 400b may differ in shape, transverse cross-section, orientation, and / or size (or extension) depending on the intended use and / or the desired degree of configurability.

[0133] Following the implantation of the stimulator 100, or at least the implantation of a fitted second substrate portion 620 including at least two electrodes 200, 400, the electrical components may be configured and positioned to provide electrical energy to one or more electrodes 200a, 200b of the first type in response to electrical return applied to one or more electrodes 400a, 400b of the second type during use.

[0134] If a configurable pulse generator 500 is included, the configurability of the stimulator 100 allows for the determination and / or adaptation of the operation of one or more electrodes 200a, 200b, 400a, 400b before, during, and / or after implantation of at least two electrodes 200, 400, on the second substrate portion 620. The operation may also be reconfigured once or more during the period the stimulator 100 is implanted to optimize and / or extend the treatment. For example, the pulse generator 500 may be initially configured to nominally operate 200a and 400a as stimulating electrode / return electrode pairs, respectively. After implantation of at least the second substrate portion 620, insufficient stimulation may be observed and / or measured. If the insufficient stimulation is assumed to be primarily due to longitudinal misalignment, the pulse generator 500 may instead be configured to nominally operate 200b and 400b as stimulating electrode / return electrode pairs, respectively, using one or more parameters.

[0135] The stimulator 100 may be further configured and arranged to switch the pulse generator 500 between these configurations under predetermined and / or controlled conditions. Furthermore, it may be convenient to consider these configurations as a first electrode mode and a second electrode mode, and to allow the user to select a mode as a preference and / or switch between modes. Further or alternatively, the pulse generator 500 may switch modes under predetermined and / or controlled conditions.

[0136] Furthermore, or alternatively, other modes may be provided, such as configuring the pulse generator 500 to operate as follows: - Electrical stimulation energy is supplied to one or more electrodes 200a, 200b of a first type as one or more electrotherapy stimulation pulses, and one or more electrodes 400a, 400b of a second type are configured to provide electrical return corresponding to one or more first electrodes 200a, 200b during use, or - A second electrode mode in which, for one or more electrodes 400a, 400b of the second type, one or more electrodes 200a, 200b of the first type are configured to provide electrical return corresponding to one or more second electrodes 400a, 400b as one or more electrotherapeutic stimulation pulses.

[0137] Again, the stimulator 100 may be further configured and arranged to switch the pulse generator 500 between these configurations or modes under predetermined and / or controlled conditions. Furthermore, or alternatively, the user may be allowed to select a mode as a preference and / or switch between modes.

[0138] Those skilled in the art will understand that electrodes 200a, 200b, 400a, and 400b can be configured to operate in more complex configurations, such as the following: -400a and 200a can be operated as a stimulating electrode / returning electrode pair, respectively (reversing the original intended operation). -400b and 200b can be operated as a stimulating electrode / returning electrode pair, respectively. - If intermediate stimulation is preferred, two or more electrodes 200a, 200b, 400a, and 400b can be operated substantially simultaneously as one or more stimulating electrodes. -One or more electrodes 200a, 200b, 400a, 400b may be operated as one or more return electrodes. - Electrode 400a can be used as a stimulating electrode in combination with electrodes 200a and 200b as a return electrode. -Electrodes 400a and 200b can be used as stimulating electrodes in combination with electrodes 200a and 400b as return electrodes.

[0139] Alternatively, or furthermore, the shape, orientation, transverse cross-section, and / or size (or length) of one or more stimulating electrodes may be configured to differ from that of one or more return electrodes.

[0140] When configuring and positioning the substrate 300 in close proximity to at least two electrodes 200, 400, several parameters and characteristics can be considered regarding the following compatibility. - A transverse spread of 700 and / or longitudinal spread of 600 of one or more electrodes 200a, 200b, 400a, 400b. - The thickness of the substrate 300, or the vertical distance between the first surface 310 and the second surface 320. - Materials contained in substrate 300, and their physical properties. - The number and extent of interconnections 250 and / or interconnection layers 250 between the first surface 310 and the second surface 320.

[0141] Attempts have been made to make conventional lead wires, such as cylindrical lead wires, much thinner to enable subcutaneous implantation and / or to improve comfort through flattening. However, the surface area of ​​flattened electrodes can unfortunately be smaller.

[0142] For example, a conventional 0.2 mm round lead wire with an electrode of 1 cm in length has an electrode surface of approximately 6 mm. 2 It is presumed that this will generate electrodes.

[0143] However, using the fitted second substrate portion 620 having at least two electrodes as described herein, a relatively thin substrate 300 having dimensions of 0.2 mm thickness and 4 mm width can be made approximately 35 mm in length. 2 It can be configured and arranged to provide an electrode surface. This is estimated to reduce impedance by approximately 35 / 6 and energy consumption by approximately 35 / 6.

[0144] Figure 1D shows details of one or more energy receivers 550r - in this embodiment, one or more energy receivers 550r are included in the second surface 320.

[0145] The embedded device 100 is further configured and positioned to transmit signals to the energy transmission device 1000. For example, a signal carrying one or more parameters and / or one or more values ​​may be transmitted to the energy transmission device 1000 to provide feedback on the status of the embedded device 100.

[0146] In this embodiment, one or more energy receivers 550r may be further configured and / or arranged to receive pulse energy and / or transmit signals. Thus, energy and data may be transmitted over the same channel. The data may be transmitted substantially simultaneously with, or not substantially simultaneously with, or temporally overlapping with, the reception of an energy pulse.

[0147] The related energy transmission device 1000 shown in Figure 1D includes the following: - One or more energy transmitters 1550t configured and arranged to transmit energy wirelessly. One or more energy transmitters 1550t include one or more conductors, such as coils having one or more windings. One or more energy transmitters 1550t are configured to wirelessly transmit pulsed energy to one or more energy receivers 550r when the energy transmission device 1000 is in close proximity to the embedded device 100. Preferably, one or more energy transmitters 1550t are configured and arranged to cooperate with one or more energy receivers 550r to provide a high degree of efficiency during wireless energy transmission.

[0148] For example, a coil may be configured and arranged to convert an energy pulse into an electromagnetic pulse for transmission. Generally, electromagnetic signals such as RF (radio frequency) or microwaves are advantageous because they are usually not very sensitive to bandwidth and / or data rate issues. However, there may be some limitations, such as the available frequency band. In an implanted device, the coil included in the implanted device 100 is configured and arranged to convert magnetic energy into electrical energy.

[0149] Preferably, an authorized operating frequency, such as the ISM band, is used (in-band communication). The ISM radio band is internationally reserved for industrial, scientific, and medical (ISM) purposes, in addition to telecommunications.

[0150] The ISM frequencies include center frequencies of 6.78MHz, 13.56MHz, 27.12MHz, and 40.68MHz, providing 30kHz, 14kHz, 326kHz, and 40kHz, respectively.

[0151] The related energy transmission device 1000 further includes the following: - An energy transmission controller 1500 configured and positioned to control one or more parameters of one or more energy transmitters 1550t, and -Optionally, one or more mechanical accessories, such as studs, hooks, or magnets 1555, configured and positioned to work in conjunction with the implanted device 100 to reduce the risk of displacement of one or more energy transmitters 1550t and one or more energy receivers 550r. For example, the implanted device 100 may also include magnets 555 at appropriate positions on the implanted device 100 to enable docking by magnetic attraction.

[0152] The energy transmission device 1000 is further configured and positioned to detect signals transmitted from the embedded device 100. For example, a signal carrying one or more parameters and / or one or more values ​​may be transmitted to the energy transmission device 1000 to provide feedback on the status of the embedded device 100.

[0153] Using one or more signal receivers 1520 separate from one or more energy transmitters 1550t can be advantageous because it allows for the separate optimization of each distinct energy and signal (data) channel. This is illustrated in Figure 3.

[0154] Alternatively, one or more energy transmitters 1550t may be further configured and arranged to transmit pulsed energy and / or receive signals. This is shown in Figure 1. Thus, energy and data may be transmitted over the same channel. The data may be received substantially simultaneously with, or not substantially simultaneously with, or temporally overlapping with, the transmission of the energy pulse.

[0155] Optionally, the energy transmission controller 1500 may be further configured and positioned to transmit signals to the implanted device 100. For example, a signal carrying one or more parameters and / or one or more instructions may be transmitted to the implanted device 100 to instruct how, where, and when the implanted device 100 should operate. In this case, one or more parameters and / or one or more instructions may indicate how, where, and when the implanted device 100 should stimulate tissue.

[0156] Using one or more signal transmitters separate from one or more energy transmitters 1550t can be advantageous because it allows for the separate optimization of each distinct energy and signal (data) channel.

[0157] Alternatively, one or more energy transmitters 1550t may be further configured and arranged to transmit pulsed energy and / or signals. Thus, energy and data may be transmitted over the same channel. Data may be transmitted substantially simultaneously, substantially not simultaneously, or temporally overlapping, as any energy pulses.

[0158] One or more energy receivers 550r include one or more conductors, such as coils having one or more windings. One or more energy receivers 550r are configured to wirelessly receive pulsed energy from associated energy transmission devices 1000 when the energy transmission devices 1000 are in proximity. Coils having one or more windings may also be described as inductive antennas.

[0159] It may be advantageous to embed one or more energy receivers 550r into the substrate 300 to resist fluid ingress, and / or a coating may be applied to the top of one or more energy receivers 550r.

[0160] The capsule material may also be applied to the top. Preferably, the material and properties of the capsule material are selected to avoid a significant reduction in energy transmission to one or more energy receivers 550r.

[0161] Figure 3A schematically shows an embodiment of a suitable pulse generator 500 or pulse energy controller. It is suitable for the embodiment described above with respect to Figure 1. It includes the following non-limiting embodiments of five main functional units.

[0162] (i) A single functional unit may include one or more interfaces configured and arranged to receive electrical energy from one or more energy receivers 550r through one or more electrical interconnects 250 and transfer the electrical energy to an energy supply regulator 501.

[0163] For example, one or more energy receivers 550r may be positioned in a convenient location for receiving energy from one or more energy transmitters 1550t (shown in Figure 3B).

[0164] Furthermore, or alternatively, one or more energy receivers 550r may be positioned at different locations within the implanted device 100.

[0165] Furthermore, or alternatively, one or more energy receivers 550r may be included within the pulse energy controller 500.

[0166] The energy transmitted from the energy transmission device 1000 may be provided as pulses. When received by one or more energy receivers 500, they may have a width of, for example, 100 microseconds to 1 millisecond and be repeated at 40 to 1000 Hz.

[0167] (ii) One functional unit may include an energy supply regulator 501 configured and arranged to provide an appropriate voltage and / or current to excite electronic and electrical components included in one or more functional units of the pulse energy controller 500. Furthermore, one functional unit may be further configured and arranged to provide energy suitable for tissue stimulation to at least two electrodes 200a, 200b, 400a, and 400b.

[0168] (iii) One functional unit may include an energy storage module 510 which includes one or more electrical and / or electronic components configured and arranged to provide some energy storage. In this embodiment, one functional unit is included in the pulse generator 500. As shown in Figure 3A, in this embodiment, one functional unit may be included in the energy supply regulator 501, along with a measurement connection to the control module 503.

[0169] Alternatively, the energy storage module 510 may include multiple electrical and / or electronic components located at different positions within the pulse generator 500.

[0170] Furthermore, or alternatively, the embedded device 100 may include multiple energy storage modules.

[0171] Furthermore, or alternatively, the energy storage module may be external to the pulse generator 500 but included in the embedded device. Additional interconnections may be required for proper electrical connection to the pulse generator 500.

[0172] (iv) A functional unit may include a stimulation module 502 configured and arranged to deliver energy from an energy supply regulator 501 to at least two electrodes 200ab, 400ab, preferably as pulses. This may also be described as generating one or more stimulation pulses. In the shown embodiment, connections to four electrodes 200ab, 400ab are shown.

[0173] Energy can be supplied to the electrode pair 200a / 400a and / or 200b / 400b as differential potential and / or current.

[0174] Optionally, one or more blocking capacitors 401abcd may be connected between the stimulation module 502 and one or more electrodes 200ab, 400ab to block some unwanted DC components in the electrode connection. Preferably, electrodes 200ab, 400ab are connected through blocking capacitors to provide a high degree of safety. For example, one or more 4.7 μF (microfarad) blocking capacitors 401abcd may be used - such capacitors are available in medical grade.

[0175] Two or more interconnections 250 are provided between the stimulation module 502 and at least two electrodes 200ab, 400ab.

[0176] (v) One functional unit may include a control module 503 configured and arranged to control the transfer of energy from one or more energy receivers 550r to at least two electrodes 200ab, 400ab. One functional unit may be further configured and arranged to measure parameters and / or values ​​related to the execution of the method.

[0177] The interface is further configured and arranged to transmit signals to the energy transmission device 1000, as described above in relation to Figure 1.

[0178] In this embodiment, one or more pulse energy receivers 550r may be further configured and arranged to receive pulse energy and / or transmit signals.

[0179] An example of the related energy transmission device 1000 is shown in Figure 3B. The energy transmission device 1000 includes the following: - As described above with respect to Figure 1, one or more energy transmitters 1550t are configured and arranged to transmit energy wirelessly. - An energy transmission controller 1500 configured and positioned to control one or more parameters of one or more energy transmitters 1550t. - An energy supply regulator 1501 is configured and positioned to provide appropriate voltage and / or current to excite electronic and electrical components included in one or more functional units of the energy transmission controller 1500. - An energy storage module 1510 comprising one or more electrical and / or electronic components configured and arranged to provide a certain amount of energy storage. In this embodiment, it is included in the energy transmission controller 500. In this embodiment, as shown in Figure 3B, it may be included in the energy supply regulator 1501, along with a measuring connection to the control module 1503. - A radio energy transmitter module 1504 configured and arranged to radio-transmit energy through one or more energy transmitters 1550t. Preferably, the radio energy transmitter module 1504 includes one or more tuning components to provide a high degree of efficiency (or a high Q value, i.e., a high quality factor) during radio energy transfer to one or more energy receivers 550r. -Communication module 1505, and - A control module 1503 is configured and positioned to control the transfer of energy from one or more energy transmitters 1550t to the embedded device 100. The control module 1503 is further configured and positioned to measure parameters and / or values ​​related to the execution of the method.

[0180] The energy transmission device 1000 is further configured and positioned to detect signals transmitted from the embedded device 100, as described above in relation to Figure 1.

[0181] In this embodiment, one or more energy transmitters 1550t may be further configured and arranged to transmit energy and / or receive signals.

[0182] Optionally, the energy transmission controller 1500 may be further configured and arranged to transmit signals to the embedded device 100, as described above in relation to Figure 1.

[0183] The implantable device 100 includes an energy storage monitor 530 configured and positioned to monitor the state of energy storage, the state being largely influenced by the energy received by the implantable device 100 and / or the energy used by the implantable device 100. As shown in Figure 3, in this embodiment, it may be included in a control module 503 along with a measurement connection to an energy storage module 510. It may also be advantageous to provide measurement connections to an energy supply regulator 501 and / or a stimulation module 502.

[0184] Figures 9A and 9B show two more detailed schematic diagrams of an embodiment of the pulse generator 500. It includes the same functional blocks as in Figure 3A—however, further details of the embodiments of components and interconnections that may be used to perform those functions are shown here. The right-hand portion of Figure 9A and the left-hand portion of Figure 9B show the connected functional blocks, some features of which are repeated in the figures for the sake of brevity in the following explanation. The pulse generator 500 includes: - One or more energy receivers 550r as described above. In this embodiment, a coil having one or more windings configured and arranged to wirelessly receive energy from one or more corresponding energy transmitters (not shown) included in an external energy transmission device (not shown). - One or more tuning components 540, such as inductors and / or capacitors, to optimize the efficiency of radio energy transfer from one or more energy transmitters to one or more energy receivers 550r. For example, energy may be transferred as RF with a center frequency of 13.56 MHz. As shown in this embodiment, one or more tuning components 540 may be included in the radio energy receiver module 504. One or more tuning components 540 may be connected in parallel with the coil as energy receivers 550r. - One or more detuning components 545. As shown in this embodiment, one or more detuning components 545 are included in the radio energy receiver module 504. One or more detuning components 545 may be connected in parallel with the coil as an energy receiver 550r. One or more detuning components 545 are configured and arranged to provide a predetermined and / or controlled degree of "detuning" protection against "overcharging". -Optionally, a clock recovery module 563m is connected directly or indirectly to the electrical contacts of the coil (as energy receiver 550r). The recovered clock signal 563s, e.g., 13.56 MHz, may be supplied to one or more other electronic components included in the embedded device 100, such as a microcontroller 506. The recovered clock signal 563s may be used to synchronize one or more actions between the embedded device 100 and the external energy transmission device 1000. Optionally, the clock signal 563s may be divided using, for example, a 1 / 32 frequency divider.

[0185] Furthermore, or alternatively, this could be used to determine whether energy is being transmitted—some actions within the embedded device may be blocked when energy is not being transmitted, or blocked when energy is being transmitted. For example, since the transmission of data-out 566o uses some interruption of the energy transmission channel by modulator 565, reliable transmission of data-out 566o requires that some energy be present in the energy transmission channel.

[0186] As described below, the embedded device 100 may be configured and arranged to provide three or more functions for protection against “overcharging.” This may also be described as a situation in which a higher level of energy than necessary is present in the embedded device 100. The protective functions may be as follows: 1) An embedded device 100 that transmits an energy sufficiency signal to an external energy transmission device 1000. The external energy transmission device 1000 can receive the energy sufficiency signal (as shown in Figures 4, 8, and 10) and immediately suspend energy transmission. The transmission of the energy sufficiency signal may be triggered when a first energy storage protection level is exceeded. 2) The degree of detuning of the energy transfer link between one or more energy transmitters 1550t and one or more energy receivers 550r. This may be triggered when it exceeds a second energy storage protection level. 3) If the third energy storage protection level is exceeded, one or more voltage regulators and / or shunts, such as Zener diodes, will operate to reduce the voltage. Or any combination thereof.

[0187] One, two, or three of these protective features may also be combined with one or more additional protective features, such as the following: 4) An embedded device 100 that transmits a command to an external energy transmission device 1000 to reduce the intensity of subsequent energy transmission (as shown in Figure 2).

[0188] The embedded device 100 may be configured and arranged to provide two or more protective functions in any convenient order, and may allow the protective functions to be triggered in series, in parallel, or in any combination thereof. Furthermore, or alternatively, the protective functions may be triggered based on one or more different parameters.

[0189] The protective function may be configured and arranged to perform, for example, the following: - To reduce and / or avoid undesirable heating, and / or - To increase or decrease the time during which the embedded device 100 can operate without receiving external energy.

[0190] Minimizing the time an implanted device can operate without receiving external energy can reduce the complexity (and therefore the cost) of the implanted device, decrease the amount of energy stored (and therefore the risk of overheating), and further reduce the "charging time" (and therefore the risk of overheating during "charging") while energy is stored.

[0191] Preferably, since a status level is selected for monitoring, the status level is largely influenced by the energy received by the embedded device 100 and / or the energy used by the embedded device 100. The status level may be based on a single value or parameter, or two or more values ​​or parameters, such as voltage, current, or power, which may be measured directly. They may also be derived or estimated from other direct estimates.

[0192] The acceptable degree of heating can be determined by considering, for example, one or more of the following parameters: - The geometric shape of the implantable device 100, the material of the implantable device 100, the implantation depth (some devices 100 may be limited to a maximum implantation depth), the implantation location, the tissue into which the implantable device 100 is implanted, the proximity of blood vessels that may provide a means of transporting heat away from the device 100, the proximity of tissues that may reduce the ability of surrounding tissues to transport heat away from the device 100, the preference for human or animal subjects, or any combination thereof. Generally, the implantable device 100 is configured and positioned to operate in an expected location and depth, or within a range of location and / or depth.

[0193] Furthermore, or alternatively, the acceptable degree of heating may be determined by local regulations and / or standards. For example, ISO 14708-3:2017 Surgical implants - Active implantable medical devices - Part 3: Implantable nerve stimulators stipulates that the surrounding tissue heating must be less than 2 degrees Celsius. Available from https: / / www.iso.org / standard / 60539.html.

[0194] Furthermore, or alternatively, the maximum SAR rate (specific absorption rate) may also be specified, and therefore an appropriate degree of compliance is required.

[0195] As shown in Figure 9A, one or more detuning components 545 may be connected in parallel with the coil as an energy receiver 550r. This may allow for direct control of the quality of detuning and energy transfer—a predetermined and / or controlled degree of detuning may be applied when the voltage across the coil exceeds a predetermined and / or controlled safety voltage. For example, a smaller degree of detuning may be preferred by modifying the impedance and / or the resistance connected in parallel with the coil. For example, a higher degree of detuning may be preferred by substantially "short-circuiting" the coil.

[0196] This "detuning" safety voltage is selected to correspond to a second energy storage protection level. Detuning may occur over a predetermined and / or controlled period, or until certain conditions are met, or a combination thereof. Typically, detuning is performed for up to 2 or 3 ms (milliseconds).

[0197] By detuning the energy transfer link between one or more energy transmitters 1550t and one or more energy receivers 550r, the energy received by one or more energy receivers 550r may be reduced. Generally, a higher degree of detuning results in less energy received. A lower degree of detuning may be preferred if a second energy storage protection level is more frequently available and / or if additional protection is available. A higher degree of detuning may be preferred if the risk of overheating must be reduced and / or if additional protection is not available. The degree of detuning may also depend on the Q-factor (i.e., quality factor) of the energy transfer channel.

[0198] As shown in Figure 9A, the pulse generator 500 optionally further includes a demodulator 560 configured and positioned to recover information content added to the energy transmitted by the external energy transmission device 1000. This information content may be extracted and passed to a suitable data decoder 561d to provide a “data input” channel 561i to the embedded device 100. As shown in this embodiment, the demodulator 560 may be connected in parallel with the coil as an energy receiver 550r, the demodulator 560 may be included in the communication module 505, and / or the data decoder 561d may be included in the control module 503. - A modulator 565 configured and positioned to add information content to the energy transmission channel by changing one or more parameters. The external energy transmission device 1000 may be appropriately configured and positioned to detect changes in the parameters of the energy transmission channel and retrieve the added information using an appropriate modulator. This information may be passed from an appropriate data encoder 566e to the modulator 565. This provides the embedded device 100 with a "data out" channel 566o (i.e., data out). As shown in this embodiment, the modulator 565 may be connected in parallel with the coil as an energy receiver 550r, the modulator 565 may be included in the communication module 505, and / or the data encoder 566e may be included in the control module 503. This may use a principle similar to detuning, but the modulator 565 is preferably configured and positioned to use relatively small parameter fluctuations and / or to change the parameter for a relatively short period, such as 2-3 microseconds (us), so as not to significantly affect energy transmission. By using existing energy transmission channels to provide energy sufficiency signals, a dedicated communication channel is not required, thus further reducing complexity.

[0199] As shown in Figures 9A and 9B, the pulse generator 500 further includes the following: - A rectifier 570 is configured and positioned to convert an input alternating current (AC) 569 received by the coil as an energy receiver 550r into a direct current (DC) output 571. As shown in this embodiment, the rectifier 570 may be connected in parallel with the coil as an energy receiver 550r and / or may be included in an energy supply regulator 501. - An energy storage module 510 configured and positioned to provide some energy storage within the implanted device 100. As shown in this embodiment, one or more buffer capacitors 510 may be provided and connected in parallel with the DC output 571 of the regulator 510. As shown in this embodiment, the energy storage module 510 may be included in the energy supply regulator 501. For example, one or more 4.7 μF (microfarad) buffer capacitors 510 may be connected in series and / or in parallel - such capacitors are available in medical grade. For example, voltages between 6V and 11V may be connected across one or more buffer capacitors 510. For example, up to 100 4.7 μF (microfarad) buffer capacitors 510 may be used to provide up to 470 μF (microfarad) of storage.

[0200] Furthermore, or alternatively, one or more supercapacitors may be used as buffer capacitors 510 and / or included in the energy storage 510.

[0201] Furthermore, the energy storage 510 may further include one or more rechargeable batteries. This is less desirable because the presence of batteries may, for example, shorten the lifespan of the embedded device 100, increase the dimensions of one or more embedded devices 100, increase the risk of overheating during charging, require undesirable chemicals and / or materials, and / or increase the complexity of the electronic device. Therefore, preferably, the energy storage 510 includes one or more capacitors, one or more supercapacitors, or any combination thereof.

[0202] One or more supercapacitors (or ultracapacitors) may be used at will. The term supercapacitor is used for any capacitor that uses any technology to provide significantly higher energy storage in a package that is significantly smaller in size than conventional capacitors.

[0203] In some embedded devices 100, significant energy storage in the energy storage 510 using electrochemistry, such as batteries and some supercapacitors, may be preferable to avoid because it may require the use of undesirable chemicals and / or substances.

[0204] For example, one or more buffer capacitors 510 may be configured and positioned to provide sufficient energy for correct operation for periods of 1000ms or less, 500ms or less, 200ms or less, 100ms or less, or 50ms or less, or 20ms or less, or 10ms or less.

[0205] This can be predetermined and / or controlled to provide at least enough energy for the duration of the pause in energy pulse transmission. In other words, the energy storage 510 may be configured and positioned to provide enough energy to operate the embedded device 100, thereby the duration of the pause in energy pulse transmission being 1000 ms (microseconds) or less, 500 ms or less, 200 ms or less, 100 ms or less, 50 ms or less, 20 ms or less, or 10 ms or less.

[0206] The pulse generator 500 further includes the following: - An energy storage monitor 530 is configured and positioned to monitor the state of energy storage within the energy storage module 510. Preferably, the state is selected, and therefore the state is largely influenced by the energy received by the embedded device 100 and / or the energy used by the embedded device 100. - A voltage regulator (or shunt) 575 configured and positioned to reduce the voltage when a third energy storage protection level is exceeded. As shown in this embodiment, one or more Zener diodes 575 may be provided and connected in parallel with the DC output 571 of the regulator 510. As shown in this embodiment, the voltage regulator (or shunt) 575 may be included in the energy supply regulator 501. -Optionally, a voltage converter 577 configured and positioned to provide a DC power source 578 suitable for supplying power to electronic components included in the embedded device 100. In this embodiment, the DC / DC voltage converter 577 is provided connected in parallel to the DC output 571 of the regulator 510 to provide a logic voltage 578. As shown in this embodiment, a voltage regulator (or shunt) 575 may be included in the energy supply regulator 501. For example, a logic voltage of 1.9V 578 may be supplied to one or more ICs, such as a microcontroller 506. In this embodiment, the microcontroller 506 is included in the control module 503 and controls several functions within the embedded device 100, such as communication and electrode switching.

[0207] As shown in Figure 9B, the pulse generator 500 further includes the following: -One or more electrode switching units 585abcd. Each electrode 200ab, 400ab is connected to the electrode switching unit 585abcd through one or more interconnects 250. Each switching unit 585abcd is configured and arranged to connect or disconnect the associated stimulating electrode 200ab to / from the output voltage 571 of a rectifier 570, or to / from the associated return electrode 400ab to / from an electrical return (not shown). In other words, the rectifier 570 is configured and arranged to provide the relatively high voltage 571 required at the stimulating electrode 200ab. One or more blocking capacitors 401abcd are provided to block unwanted DC currents from each stimulating electrode / return electrode pair 200 / 400.

[0208] Furthermore, or alternatively, each switching unit 585abcd is further configured and arranged to connect the associated electrodes 200ab, 400ab as either stimulating or return electrodes, for example by using an H-bridge configuration. This provides a high degree of flexibility in determining the location and direction of stimulatory energy delivery to the surrounding tissue. Optionally, each electrode 200ab, 400ab may be connected through a blocking capacitor 401abcd to provide a high degree of flexibility in determining the function of each electrode 200ab, 400ab.

[0209] As shown in Figure 9B, the pulse generator 500 further includes the following: - A current source 507 configured and arranged to be connected to one or more electrodes 200ab, 400ab by one or more switches. For example, a 3mA current source. Preferably, the current source 507 is configured and arranged to monitor the current flowing, for example by including a appropriately configured transistor, and to pass the value to the energy storage monitor 530. - A switch controller 580 configured and positioned to control the position of one or more switches included in the stimulation module 501. The switch controller 580 may be included in the control module 503. The switch controller 580 may be controlled by a microcontroller 506 (not shown).

[0210] For example, therapeutic pulses delivered to at least two electrodes 200ab, 400ab for cosmetic or therapeutic reasons may have a width of 100 microseconds to 1 millisecond and be repeated at 40–1000 Hz. For pain treatment using peripheral nerve stimulation (PNS), appropriate pulse parameters are 0–10 volts, particularly 0.5–4.0 volts, amplitude 0–10 mA, pulse width 90–200 microseconds, and repetition rate 50–400 Hz.

[0211] The energy storage monitor 530 is configured and positioned to detect and / or monitor one or more parameters related to the energy received by the implanted device 100 and / or the energy use of the implanted device pulse energy controller 500. For example, energy use may be an average, maximum, or minimum value over a specific time or over a specific period. Appropriate values ​​may include the energy received by the energy receiver 550r, the voltage received from the energy receiver 550r at the input 569 of the rectifier 570, the stimulation energy delivered through electrodes 200ab, 400ab, the stimulation voltage delivered at the output 571 of the rectifier 570, or the stimulation current delivered (measured by the current source 507). Combinations of one or more values ​​may also be considered. Optionally, the energy storage module may also indirectly measure the tissue impedance Z(Ex-Ey) using measurements within the implanted device 100.

[0212] As shown in Figures 9A and 9B, in this embodiment, the energy storage monitor 530 may be included in the control module 503, along with a measurement connection to the energy storage module 510. It may also be advantageous to provide measurement connections to the energy supply regulator 501 and / or the stimulation module 502.

[0213] As shown in this embodiment, the output DC voltage 571 of the rectifier 570 is selected as the primary parameter for monitoring the state of the energy storage 510. This provides a relatively direct measurement of the voltage across the coil at the input 560 to the rectifier 570, and the voltage across the buffer capacitor 510, which is influenced by the energy transferred from the output of the rectifier 571 through electrodes 200ab, 400ab.

[0214] For example, if a stimulus voltage of 200ab and 400ab requires 10-15 volts at the output 571 of the rectifier 570 and approximately 2 volts at the logic 578, the following embodiment of the energy storage protection level can be used by monitoring the rectifier output voltage 571. 1) A first energy storage protection level corresponding to a rectifier output voltage of 10.5V. When the voltage exceeds this predetermined and / or controlled value, the embedded device 100 transmits an energy sufficiency signal to the external energy transmission device 1000 using the data output 566o and modulator 565. 2) A second energy storage protection level corresponding to a rectifier output voltage of 11.5V. If the voltage exceeds a predetermined and / or controlled value, the energy transfer link between one or more energy transmitters 1550t and one or more energy receivers 550r is detuned to a predetermined and / or controlled extent 545. 3) A third energy storage protection level corresponding to a rectifier output voltage of 12.5V. If the voltage exceeds a predetermined and / or controlled value, the voltage is reduced using a voltage regulator (shunt) 575. Preferably, this is implemented using one or more Zener diodes. Or any combination thereof.

[0215] This example of the use of the three main levels of protection is schematically shown in Figure 8, which is described in detail below.

[0216] Using the first level (energy-sufficient signal) is particularly advantageous because it means that the second level (detuning) is less likely to be triggered. Detuning can be disadvantageous because, in a highly detuned state, information (data) can no longer be received. If the first and second protection levels do not function quickly enough, or become excessive, the third level (Zener diode) provides relatively reliable automatic protection against very high voltages. In practice, the third level may determine the maximum possible energy storage within the embedded device.

[0217] Furthermore, it may be advantageous to predetermine and / or control the minimum energy storage level at which the implanted device will function properly. For example, below 2 volts, the logic functions will not operate correctly. In another embodiment, if the voltage is greater than 2 volts but less than 9 volts, one or more electrical stimulation pulses supplied to electrodes 200ab, 400ab may be distorted. In this embodiment, a minimum voltage of 9 volts at the output 571 of the rectifier 570 may be used.

[0218] Figure 2 schematically shows an example of a data (signal) communication signal and an energy transmission signal generated when performing a first method for controlling wireless energy transfer from the energy transmission device 1000 to the wireless embedded device 100.

[0219] A series of waveforms, namely the energy 1550e transmitted by the energy transmission device 1000, the energy 550e received by the embedded device 100, the energy level 510e stored in the energy storage module 510m, and the data out 566o transmitted by the embedded device 100, are shown from top to bottom. The data out 566o may be used to provide feedback. Signals and / or pulses in the same horizontal position occur substantially simultaneously. Time progresses from left to right, from t0 to t9. The amplitude of each pulse represents the power value, and the area under each pulse represents the energy.

[0220] The energy is transmitted as multiple continuous energy pulses with varying amplitude or power levels in 1550e. In this context, "multiple" means two or more.

[0221] On the left side (time = 0 or t0), the transmitted energy of 1550e starts at almost zero.

[0222] In this embodiment, the energy storage monitor 530 is configured and positioned to monitor the energy level 510e of the energy storage module 510m and take action when it exceeds the energy storage upper limit 515 and / or when the energy level falls below the energy storage lower limit 514.

[0223] In this case, energy 1550e is transmitted periodically over the entire indicated period to charge the energy storage module 510m and keep it charged within the energy storage upper limit 515 and energy storage lower limit 514. The duration of the transmitted pulse 1550e is from t1 to t3, this period is approximately equal to t3 to t5, and approximately equal to t5 to t7. The duty cycle is approximately 50%.

[0224] As shown in this embodiment, the energy transmission device 1000 is configured and arranged to deliver energy in pulses, in particular to provide a better degree of control during the initial startup phase of the embedded device 100. Energy can then be supplied continuously until the embedded device signals that the transmission should be adapted or until the maximum energy storage condition is reached.

[0225] A pulse [a] with a transmitted energy of 1550e is the first pulse to occur, on the left, starting from t1 to t2, and having an initial amplitude or power level of 1552e. Substantially simultaneously, a pulse [b] with energy 550e is received by the implant from t1 to t2.

[0226] In this embodiment, it is assumed that the energy storage level 510e at t=0 is equal to the lower energy storage limit 514. Since the energy storage level is below the upper energy storage limit 515, the embedded device 100 allows at least a portion of the received energy 550e to charge the energy storage module 510m. As shown, between t1 and t2, the energy storage level 510e rises above the lower energy storage limit 514 in section [c].

[0227] Between pulses [a] and [b] with a transmitted energy of 1550e, the transmitted energy is nearly zero from t2 to t3. It is assumed that the embedded device 100 uses / loses some of the stored energy 510e, so the curve in section [d] drops.

[0228] The pulse [e] with a transmitted energy of 1550e is the second pulse that occurs from 3 to t4. Since no feedback was transmitted by the implanted device 100 during the last cycle, the energy transmission device 1000 continues—and the energy transmission device 1000 transmits a pulse [e] with approximately the same amplitude or power level 1552 as the first pulse [a] (in other words, with the initial amplitude or power level 1552) and approximately the same duration. Almost simultaneously, the pulse of energy [f] is received by the implant from t3 to t4 with an energy of 550e.

[0229] Since the energy level of the energy storage 510e is below the energy storage upper limit 515, the embedded device 100 allows at least a portion of the received energy 550e to further charge the energy storage 510e. As shown, between t3 and t4, the energy storage level 510e rises upward in section [g].

[0230] At time tx, between t3 and t4, the energy storage level 510e becomes equal to the energy storage upper limit 515. At that moment, the energy storage monitor 530 generates a signal [h] which is transmitted from the embedded device 100 to the external energy transmission device 1000 as data out 566o. This signal is preferably transmitted when there is sufficient energy in the energy transmission channel. This signal [h] preferably provides additional information, such as an increase rate, to enable the energy transmission device 1000 to determine the most appropriate corrective action.

[0231] Furthermore, or alternatively, the embedded device 100 may determine the most appropriate corrective action and instruct the external energy transmission device 1000 to implement the corrective action.

[0232] Since energy 1550e was still being transmitted between tx and t4, the energy storage level 510e exceeded the energy storage limit of 515e in t4.

[0233] Between pulses [a] and [b] with a transmitted energy of 1550e, the transmitted energy is nearly zero from t4 to t5. It is assumed that the embedded device 100 uses / loses some of the stored energy 510e, so the curve in section [j] drops.

[0234] The pulse [k] with a transmitted energy of 1550e is the third pulse that occurs from t5 to t6. Since the feedback was transmitted by pulse [h] during the last cycle, the energy transmission device 1000 transmits pulse [k] with a significantly reduced amplitude or power level 1553 compared to the second pulse [e]. Almost simultaneously, the pulse [l] of energy 550e is received by the implant from t5 to t6.

[0235] The energy 550e received by the implanted device 100 is used to further charge the energy storage of the implanted device 100—however, the implanted device 100 uses / loses a portion of the stored energy 510e, so the rate is reduced for the energy 550e received in pulse (l), but the curve drops in section [j].

[0236] Between pulses [k] and [p] with a transmitted energy of 1550e, the transmitted energy is nearly zero from t6 to t7. It is assumed that the embedded device 100 uses / loses a portion of the stored energy 510e, so the curve in section [n] drops.

[0237] From here The pulse [p] with a transmitted energy of 1550e is the fourth pulse that occurs from t7 to t8. Since the feedback has been transmitted for two cycles by pulse [h], the energy transmission device 1000 transmits pulse [p] with approximately the same amplitude or power level 1553 (in other words, with a significantly reduced amplitude or power level 1553) for the duration of the third pulse [k]. Almost simultaneously, the pulse [q] of energy 550e is received by the implant from t7 to t8.

[0238] The energy 550e received by the implanted device 100 is used to further charge the energy storage of the implanted device 100—however, the implanted device 100 uses / loses a portion of the stored energy 510e, so the rate is reduced for the energy 550e received in pulse (q), but the curve drops in section [r].

[0239] After a pulse [p] with a transmitted energy of 1550e, the transmitted energy is nearly zero from t8 to t9. It is assumed that the embedded device 100 uses / loses some of the stored energy 510e, so the curve in section [s] drops further.

[0240] The energy level 510e of the energy storage module 510m eventually falls below the lower energy storage limit 514 (not shown). At that moment, the energy storage monitor 530 generates a signal (not shown) that is transmitted from the embedded device 100 to the external energy transmission device 1000 as data out 566o. This signal preferably provides additional information, such as the rate of decrease, to enable the energy transmission device 1000 to determine the most appropriate corrective action. This signal is preferably transmitted when there is sufficient energy in the energy transmission channel.

[0241] Furthermore, or alternatively, the embedded device 100 may determine the most appropriate corrective action and instruct the external energy transmission device 1000 to implement the corrective action.

[0242] From that point onward, the cycle restarts from t0.

[0243] When the energy storage upper limit 515 and the energy storage lower limit 514 are close to each other, it may be advantageous to apply hysteresis.

[0244] This first method of controlling energy transfer may be advantageous for certain embodiments, but may be less advantageous for other embodiments. For example, - Corrective measures such as reducing amplitude (power) may take a relatively long time to become effective, and the temperature of the embedded device may become undesirably high. -Generating the feedback signal [h] as data output 566o may require relatively complex electronic equipment. This may increase the cost and size of the embedded device 100. - A variable amplitude / power transmitter is required, increasing the complexity of the energy transmission device 1000. - Determining appropriate corrective measures may also require relatively complex electronic equipment within the implanted device 100 and / or energy transmission device 1000. Particularly in the case of medical implants, it may not be desirable for the implanted device 100 to rely solely on external devices 1000 for proper operation. -Frequently, more energy is transmitted than is needed, increasing the risk of undesirable overheating.

[0245] Figure 4 schematically shows an example of a data (signal) communication signal and an energy transmission signal generated when a second method is implemented to control wireless energy transfer from the energy transmission device 1000 to the wireless embedded device 100.

[0246] A series of waveforms, namely the energy 1550e transmitted by the energy transmission device 1000, the energy 550e received by the embedded device 100, the energy level 510e stored in the energy storage module 510m, and the energy sufficiency signal transmitted as data out 566o by the embedded device 100, are shown from top to bottom. Signals and / or pulses in the same horizontal position occur substantially simultaneously. Time progresses from left to right, from t0 to t9. The amplitude of each pulse represents the power value, and the area below each pulse represents the energy.

[0247] The energy is transmitted as multiple consecutive energy pulses 1550e, having substantially the same amplitude (or power)—in other words, with a first amplitude (or power level) 1551. In this context, multiple means two or more. The duration of the transmitted pulses 1550e is from t1 to t3 (in this embodiment, approximately equal to t3 to t5 and approximately equal to t5 to t7). The duty cycle for the period t1-t3 is initially about 50%.

[0248] On the left side (time = 0 or t0), the transmitted energy of 1550e starts at almost zero.

[0249] In this embodiment, the energy storage monitor 530 is configured and positioned to monitor the energy storage level 510e and take action when the level 510e exceeds the first energy storage protection level 511.

[0250] In this case, energy 1550e is transmitted periodically throughout the indicated period to charge the energy storage 510e, keeping the energy storage 510e charged as close as possible to the first protection level 511. As shown in Figure 2, the energy is transmitted in pulses. However, in this second method shown in Figure 4, the amplitude (power) of the transmitted energy pulse 1550e remains substantially the same—although the pulse duration (duty cycle) may change.

[0251] A pulse [a] with a transmitted energy of 1550e is the first pulse to occur, on the left, starting from t1 to t2. Almost simultaneously, a pulse [b] with an energy of 550e is received by the implant from t1 to t2.

[0252] In this embodiment, it is assumed that the energy storage level 510e at t=0 is lower than the first energy storage protection level 511. Since the energy storage level 510e is less than the first protection level 511, the embedded device 100 allows at least a portion of the received energy 550e to charge the energy storage module 510m. As shown, between t1 and t2, the energy storage level 510e rises in section [c].

[0253] Between pulses [a] and [b] with a transmitted energy of 1550e, the transmitted energy is nearly zero from t2 to t3. It is assumed that the embedded device 100 uses / loses some of the stored energy 510e, so the curve in section [d] drops.

[0254] The pulse [e] of the transmission energy 1550e is the second pulse that occurs from t3 to t4. Since no feedback was transmitted by the implantable device 100 during the last cycle, the energy transmission device 1000 continues - the energy transmission device 1000 transmits a pulse [e] with approximately the same duration as the first pulse [a]. Substantially simultaneously, a pulse [f] of energy is 550e received by the implant from t3 to t4.

[0255] Since the energy storage 510e level is below the first energy storage protection level 511, the implantable device 100 enables at least a portion of the received energy 550e to further charge the energy storage 510e. As shown, between t3 and t4, the energy storage 510e rises upward in section [g].

[0256] At time tx, between t3 and t4, the energy storage level 510e becomes the same as the first energy storage protection level 511. At that moment, the energy storage monitor 530 generates an energy full signal [h] that is transmitted as data out 566o from the implantable device 100 to the external energy transmission device 1000. This energy full signal [h] is a signal intended as a request to temporarily stop transmission to the energy transmission device. This may be for a predetermined and / or controlled duration, which may be advantageous when reducing power consumption, especially when the implantable device includes additional protection features.

[0257] Alternatively, the energy full signal may be transmitted until the received energy 550e falls below a predetermined and / or controlled level.

[0258] Upon receiving the energy full signal, the energy transmitter 1550t immediately stops pulse transmission 1550e with the intention of resuming transmission after a pause.

[0259] In this context, "immediately" means "as soon as possible". For example, - less than 2 ms (milliseconds) after receiving the energy supply signal [h], or - less than 1 ms (milliseconds) after receiving the energy supply signal [h], or - less than 100 us (microseconds) after receiving the energy supply signal [h], or - less than 10 us (microseconds) after receiving the energy supply signal [h].

[0260] This may also be described as the stop time. It may be advantageous to pre-determine and / or control the stop time to be as short as possible. This is because it reduces the risk that the embedded device 100 receives excessive energy. Preferably, the energy transmission device 1000 can be configured and arranged to keep the waiting time (e.g., delay) relatively low when stopping the transmission of the pulse after receiving the energy supply signal. For example, this can be achieved by including one or more dedicated components and / or one dedicated circuit.

[0261] The energy transmitter 1550t does not necessarily continue until the scheduled end of the pulse 1550e being transmitted. If the remaining duration of the pulse 1550e being transmitted is less than or equal to the stop time, the pulse 1550e being transmitted appears to end as scheduled. In other words, the duty cycle during such a period is initially scheduled to be about 50% and about 50% remains.

[0262] If the remaining duration of the pulse 1550e being transmitted is longer than the stop time, the pulse 1550e being transmitted is interrupted. For example, the interrupted duration may be less than the scheduled duration. As shown, the energy transmission pulse [e] is interrupted, and thus the time from t4 to ty is shorter than that of the pulse [a]. In other words, in this case, the duty cycle from period t3 to t5 was initially scheduled to be about 50%, but due to the interruption, it becomes about 44.5%.

[0263] This energy sufficiency signal [h] is preferably transmitted when there is sufficient energy in the energy transmission channel.

[0264] Since energy 1550e was still being transmitted between tx and t4, the energy storage level 510e continued to rise, exceeding the first energy storage protection level 511 at t4.

[0265] Between pulses [e] and [k] with a transmitted energy of 1550e, the transmitted energy is nearly zero from t4 to t5. It is assumed that the embedded device 100 uses / loses a portion of the stored energy 510e, so the curve in section [j] drops.

[0266] Pulse [k] with a transmitted energy of 1550e is the third pulse to occur, intended to occur from t5 to t6. Since the energy transmission device 1000 is configured and positioned to continue transmitting energy unless an energy sufficiency signal is received, pulse [k] is transmitted with substantially the same amplitude (power) as the previous pulses [a] and [e]—in other words, at the first amplitude (or power) level 1551. Substantially simultaneously, pulse [l] of energy is received by the implant at 550e.

[0267] During these pulses [k] and [l], the energy storage 510e level exceeds the first energy storage protection level 511. At that moment, the energy storage monitor 530 generates a signal [n] which is transmitted from the embedded device 100 to the external energy transmission device 1000 as data out 566o. This energy sufficiency signal [n] is a signal that signifies a request for pause.

[0268] Upon receiving an energy sufficiency signal, the energy transmitter 1550t "immediately" pauses transmission, as described above. This energy sufficiency signal [n] is preferably transmitted when there is sufficient energy in the energy transmission channel. Therefore, the energy transmission pulse [k] has a shorter t6-tz time than pulse [a]. In other words, in this case, the duty cycle for period t5 to t7 was initially planned to be about 50%, but becomes about 10.5% due to the termination.

[0269] Since energy 1554 was still being transmitted between t5 and tz, the energy storage level 510e continued to rise slightly, further exceeding the first energy storage protection level 511.

[0270] Between pulses [k] and [q] with a transmitted energy of 1550e, the transmitted energy is nearly zero from tz to t7. It is assumed that the embedded device 100 uses / loses a portion of the stored energy 510e, causing the curves in sections [m] and [p] to drop.

[0271] Pulse [q] with a transmitted energy of 1550e is the fourth pulse to occur, intended to occur from t7 to t8. Since the energy transmission device 1000 is configured and positioned to continue transmitting energy unless an energy sufficiency signal is received, pulse [k] is transmitted with substantially the same amplitude (power) 1551 as the previous pulses [a], [e], and [k]—in other words, at the first amplitude (or power) level 1551. Substantially simultaneously, pulse [r] of energy is received by the implant at 550e.

[0272] During these pulses [q] and [r], the energy storage 510e level exceeds the first energy storage protection level 511. At that moment, the energy storage monitor 530 generates a signal [s] which is transmitted from the embedded device 100 to the external energy transmission device 1000 as data out 566o. This energy sufficiency signal [s] is a signal that signifies a request for pause.

[0273] Upon receiving an energy sufficiency signal, the energy transmitter 1550t "immediately" pauses transmission, as described above. This energy sufficiency signal [s] is preferably transmitted when there is sufficient energy in the energy transmission channel. Therefore, the energy transmission pulse [q] has a shorter t8-tw time than pulse [a]. In other words, in this case, the duty cycle for the period starting at t7 was initially planned to be about 50%, but becomes about 25% due to the termination.

[0274] Since energy 1550e was still being transmitted between t7 and t8, the energy storage level 510e continued to rise slightly, further exceeding the first energy storage protection level 511.

[0275] After pulse [q] with a transmitted energy of 1550e, after tw, the transmitted energy is almost zero. It is assumed that the embedded device 100 uses / loses a portion of the stored energy 510e, so the curves in sections [t] and [u] drop.

[0276] This second method of controlling energy transfer may be advantageous for certain embodiments compared to the first method shown in Figure 2. This reduces the risk of the temperature of the embedded device becoming undesirably high. In particular, - The corrective action is triggered by a similar, sometimes identical, signal from the embedded device 100. -Such feedback signals [h], [n], and [s] require only simpler electronic equipment, further reducing the complexity required for the embedded device 100. - A fixed-power transmitter may be used to reduce the complexity of the energy transmission device 1000. The corrective action performed by the external power transmitter 1000 is similar, sometimes identical - to suspend the transmission of energy pulses 1550e as soon as possible. - Energy transfer control can be performed with limited handshake protocols or without handshake protocols. Especially in the case of medical implants, for correct operation, it is advantageous for the implanted device 100 to be highly independent from the external device 1000. Also, with little or no handshake, communication overhead can be reduced, and the response speed by the energy transmitting device 1000 can be further accelerated. - The transmitted energy is optimized to reduce the risk of unwanted heating by transmitting energy mainly when needed.

[0277] (If applicable) By further stopping the current pulse 1550e, it is possible to temporarily stop the energy transmission, and thus the risk of overheating can be further reduced. This may be advantageous compared to a device where the amplitude or power level continuously changes following a comparison with the desired settings required by the patient. The method of the present disclosure is different from known devices that provide feedback on the status - conventionally, reporting the ready state may sometimes be regarded as a request to start and / or continue energy transmission. This is not the same as a request for a temporary stop.

[0278] FIG. 8 schematically shows the use of one, two, or three main protection levels. Examples of the generated data (e.g., signals) communication signals, and energy transmission signals are shown when performing a further method of controlling wireless energy transfer from the energy transmission device 1000 to the wireless implanted device 100.

[0279] A series of waveforms, namely the energy 1550e transmitted by the energy transmission device 1000, the energy sufficiency signal transmitted as data output 566o by the embedded device 100, and the energy level 510e stored in the energy storage module 510m, are shown from top to bottom. Signals and / or pulses in the same horizontal position occur substantially simultaneously. Time progresses from left to right, from t0 to t9, and three different possible protection steps a, b, and c are shown from left to right. The amplitude of each pulse represents the power value, and the area below each pulse represents the energy.

[0280] Protection step a is the same as the protection described above with respect to the period between t3 and t4 in Figure 4.

[0281] The energy is transmitted as multiple consecutive energy pulses having substantially the same amplitude or power level 1551 - in other words, at a first amplitude (or power) level 1551e. In this context, multiple means two or more. In this case, the duration is nearly constant, and the planned duty cycle is approximately 74%.

[0282] In this embodiment, an energy storage monitor (not shown) is configured and positioned to monitor the energy storage level 510e and take action if the level 510e is below a certain level. - Exceeding the first energy storage protection level 511. For example, a rectifier output voltage of 10.5V, as described above with respect to Figures 9A and 9B. - Exceeds the second energy storage protection level 512. For example, a rectifier output voltage of 11.5V, as described above with respect to Figures 9A and 9B. - The third energy storage protection level exceeds 513. For example, a rectifier output voltage of 12.5V, as described above with respect to Figures 9A and 9B.

[0283] In this case, energy 1550e is transmitted periodically throughout the indicated period to charge the energy storage 510e, keeping the energy storage 510e charged as close as possible to the first protection level 511. As shown in Figure 4, the energy is transmitted in pulses, and the amplitude of the transmitted energy pulse 1550e at power level 1551 remains substantially the same—in other words, at the first amplitude (or power) level 1551. However, the duration of the pulse (e.g., duty cycle) may vary. The energy transmission device 1000 is configured and arranged to take appropriate measures to immediately pause the transmission of energy 1550e through one or more energy transmitters 1550t when the energy transmission device 100 receives an energy sufficiency signal from the embedded device 100. In this embodiment, the time (or period) between the start of transmitted pulses 1550e remains substantially the same throughout the period of operation.

[0284] The pulse with a transmission energy of 1550e is the first pulse to occur, and the pulse begins on the left side. Almost simultaneously, the energy pulse is received by an implant (not shown) and passed to the energy storage module 510m.

[0285] In this embodiment, it is assumed that the energy storage level 510e is lower than the first protection level 511. Since the energy storage level 510e is less than the first energy storage protection level 511, the embedded device 100 allows at least a portion of the received energy to charge the energy storage 510e, causing the energy storage level 510e to rise.

[0286] At time t0, the energy storage level 510e becomes the same as the first energy storage protection level 511. At that moment, the energy storage monitor (not shown) generates an energy sufficiency signal which is transmitted from the embedded device 100 to the external energy transmission device 1000 as data out 566o. This energy sufficiency signal [h] is a signal that signifies a request for a pause.

[0287] In this embodiment, the embedded device 100 is configured and positioned to transmit an energy sufficiency signal as data out 566o until the received energy falls below a predetermined and / or controlled level. This may also be advantageous when the embedded device 100 is preferred because it does not include additional protection features or because additional protection would not be used due to serious disruption of normal operation.

[0288] Alternatively, the energy sufficiency signal may be a predetermined and / or controlled duration.

[0289] At time t1, the energy-sufficient signal as data out 566o is detected by the energy transmission device 1000. This may be nearly simultaneous. Alternatively, there may be a delay, as shown in the embodiment. The delay may be affected by one or more parameters, which may include the distance between the implanted device 100 and the energy transmission device 1000, the type of tissue between the implanted device and the energy transmission device, one or more alignment angles, the power of the energy-sufficient signal, the transmit power of the data out channel 566o, the sensitivity of detection by the energy transmission device 1000, the time to decode or read the energy-sufficient signal, the distortion of the energy-sufficient signal, or any combination thereof.

[0290] Upon receiving an energy sufficiency signal as data out 566o, the energy transmission device 1000 takes appropriate measures to immediately suspend the transmission of energy through one or more energy transmitters 1550t. As shown, the energy transmission 1550e terminates at t2.

[0291] As shown in the example, the remaining planned duration of the transmitted pulse 1550e (until t3) is longer than the stop time, so the transmitted pulse 1550e is terminated, and the terminated duration is less than the planned duration. For example, as shown, the energy transmission pulse is terminated only for t3-t2. In other words, in this case, the duty cycle for the first period was initially planned to be about 74%, but becomes about 54.5% due to the termination.

[0292] Since energy 1550e was still being transmitted between t0 and t2, the energy storage level 510e continued to rise, further exceeding the first energy storage protection level 511. However, if the transmitted energy 1550e is low or near zero (from t2), the embedded device 100 will use / lose some of the stored energy 510e, causing the energy storage level 510e to fall below the first energy storage protection level 511. When the embedded device 100 determines that the energy storage level 510e is below the first energy storage protection level 511, the embedded device 100 stops transmitting an energy sufficiency signal as data out 566o.

[0293] Since the energy transmission device 1000 is configured and positioned to continue transmitting energy unless an energy sufficiency signal is received, the second pulse 1550e is transmitted with substantially the same amplitude or power 1551 as the previous first pulse—in other words, at the first amplitude (or power) level 1551. Because the energy storage level 510e is below the first protection level 511, the embedded device 100 allows at least a portion of the received energy to charge the energy storage 510e, causing the energy storage level 510e to rise.

[0294] At time t4, the energy storage level 510e becomes the same as the first energy storage protection level 511 again. At that moment, the embedded device 100 generates an energy sufficiency signal which is transmitted as data out 566o. In this embodiment, the embedded device 100 is still configured and positioned to transmit the energy sufficiency signal until the received energy falls below a predetermined and / or controlled level.

[0295] As shown in the embodiment, the embedded device 100 is configured and positioned to implement a further protection step b. In this protection step, unlike the situation described above for step a, it is assumed that the energy transmission device 1000 does not receive and / or recognize an energy sufficiency signal from the embedded device 100.

[0296] This may be due to changes in one or more parameters, which may include an increase in the distance between the embedded device 100 and the energy transmission device 1000 due to migration or physical movement, an increase in one or more alignment angles due to migration or physical movement, defects in the embedded device 100 and / or the energy transmission device 1000, distortion or disturbance of the energy sufficiency signal, distortion or disturbance of the data out channel 566o, or any combination thereof.

[0297] Therefore, the embedded device 100 expected the energy transmission device 1000 to receive an energy sufficiency signal at t5, but the transmission device 1000 did not take appropriate measures to immediately suspend the transmission of energy 1550e through one or more energy transmitters 1550t. As shown, the energy transmission in the second pulse 1550e is not terminated and ends as planned by the transmission device 1000. In other words, in this case, the duty cycle for the second period was initially planned to be about 74%, and remains about 74% due to the lack of appropriate measures.

[0298] Since the stored energy exceeds the first energy storage protection level 511, the embedded device 100 continues to transmit an energy sufficiency signal as data out 566o.

[0299] Since energy 1550e continues to be transmitted after t4 and t5, the energy storage level 510e continues to rise and further exceeds the second energy storage protection level 512 at t6. The embedded device 100 is configured and positioned to provide the degree of detuning of the energy transfer link between one or more energy transmitters 1550t and one or more energy receivers.

[0300] As described above, detuning may occur over a predetermined and / or controlled period until certain conditions are met, or a combination thereof. The greater the degree of detuning, the less energy is received by the embedded device 100 and the less energy is supplied to the energy storage level 510e.

[0301] Since the energy transfer link may also be used for communication, the degree of detuning may be kept small and / or short. If a lower risk of overheating is preferred, a higher degree of detuning may be predetermined and / or controlled. In the embodiment shown in Figure 8, since some energy is still being received, the energy storage level 510e continues to rise and further exceeds the second energy storage protection level 512. In this embodiment, a further protection step c is available so that a lower degree of detuning is predetermined and / or controlled.

[0302] However, if the transmission energy 1550e is low or near zero (after the last scheduled transmission), the embedded device 100 will use / lose some of the stored energy 510e, causing the energy storage level 510e to drop. In the embodiment shown in Figure 8, the energy storage level 510e remains above the second energy protection level 512.

[0303] Because the stored energy exceeds the first energy storage protection level 511, the embedded device 100 continues to transmit an energy sufficiency signal as data out 566o. Because the stored energy exceeds the second energy storage protection level 512, the embedded device 100 continues to provide further detuning of the energy transfer link.

[0304] The energy transmission device 1000 is configured and positioned to continue transmitting energy unless an energy sufficiency signal is received, and since no energy sufficiency signal is received and / or recognized, the third pulse 1550e is transmitted with substantially the same amplitude (power) 1551 as the previous first pulse and second pulse 1550e that started at t7 - in other words, at the first amplitude (or power) level 1551.

[0305] As shown in the embodiment, the embedded device 100 is configured and positioned to implement a further protection step c. In this protection step, the situation is different from that described above for step b. In this case, it is further assumed that the degree of detuning applied by the embedded device 100 is insufficient to prevent a further increase in the energy storage level 510e.

[0306] This may be due to changes in one or more parameters, which may include higher-than-expected transmission power levels, simultaneous exposure to additional energy transmission devices, increased ambient or background energy, defects in embedded device 100 and / or energy transmission device 1000, or any combination thereof.

[0307] In the embodiment shown in Figure 8, it is assumed that the source of the received energy is an energy transmission device 1000 that does not take appropriate measures to immediately suspend the transmission of energy. Since energy 1550e is still being transmitted after t7, the energy storage level 510e continues to rise.

[0308] Since the stored energy exceeds the first energy storage protection level 511, the embedded device 100 continues to transmit an energy sufficiency signal as data out 566o. Since the stored energy exceeds the second energy storage protection level 512, the embedded device 100 continues to provide further detuning of the energy transfer link.

[0309] As the energy storage level 510e continues to rise, it exceeds the third energy storage protection level 513 at t8. The embedded device 100 is configured and positioned to lower the energy storage level 510e from further increases by modifying one or more voltage regulators and / or operating one or more shunts. For example, one or more Zener diodes may be used as described above.

[0310] After t8, the energy storage level 510e remains at a level determined by the voltage regulator and / or shunt. In the illustrated embodiment, the energy storage level 510e does not exceed the third energy storage level 513.

[0311] The energy transmission device 100 continues to transmit the third pulse 1550e as planned, with substantially the same amplitude (power) 1551 as the previous first and second pulses 1550e (in other words, at the first amplitude or power level 1551), and terminates the pulse that was scheduled for t9. However, the energy storage level 510e remains at the third energy storage level 513. In other words, in this case, the duty cycle for the third period was initially scheduled to be about 74%, and remains about 74% due to the lack of appropriate measures.

[0312] If the transmission energy 1550e is low or near zero (after the end of the scheduled transmission t9), the embedded device 100 will use / lose some of the stored energy 510e, causing the energy storage level 510e to drop.

[0313] In the embodiment shown in Figure 8, the embedded device 100 is configured and arranged to provide one, two, or three protective steps a, b, and / or c. In some configurations, it may be sufficient to have only a, a and b, or a and c. This may also be determined at least in part by local regulations or standards. As mentioned above, the protective steps may also be configured to operate in different sequences, such as bac, bca, cba, cab, or acb.

[0314] One or more additional protection steps may also be implemented, such as sending a command to the external energy transmission device 1000 to reduce the intensity of subsequent energy transmission (as shown in Figure 2).

[0315] For example, in some configurations, the energy transmission channel can be highly detuned for longer periods. However, this effectively reduces the energy received by the embedded device 100 into shorter energy bursts, thereby reducing the heating of the embedded device 100.

[0316] Figure 10 schematically illustrates a further method for controlling wireless energy transfer from the energy transmission device 1000 to the wireless embedded device 100, using at least one protection function.

[0317] A series of waveforms, namely the energy 1550e transmitted by the energy transmission device 1000, the modified energy sufficiency signal as the modified data out 2566o transmitted by the embedded device 100, and the energy level 510e stored in the energy storage module 510m, are shown from top to bottom. Signals and / or pulses in the same horizontal position occur substantially simultaneously. Time progresses from left to right, from t0 to t10. The amplitude of each pulse represents the power value, and the area below each pulse represents the energy.

[0318] The energy is transmitted as multiple consecutive energy pulses 1550e having substantially the same amplitude (or power) 1551—in other words, at a first amplitude or power level 1551. In this context, multiple means two or more. In this case, the duration and / or planned duty cycle may be varied.

[0319] In this embodiment, an energy storage monitor (not shown) is configured and positioned to monitor energy storage level 510e and take action if level 510e exceeds the first energy storage protection level 511. For example, as described above with respect to Figures 9A and 9B, the rectifier output voltage may be 10.5V. This is the same protection described above with respect to the period between t3 and t4 in Figure 4 and protection step a in Figure 8.

[0320] Optionally, one or more energy storage protection levels are monitored, but these are not shown.

[0321] In this case, energy 1550e is transmitted periodically throughout the indicated period to charge the energy storage 510e and maintain the energy storage 510e in a charge state as close as possible to the first protection level 511. As shown in Figures 4 and 8, the energy is transmitted in pulses, and the amplitude (power) 1551 of the transmitted energy pulse 1550e remains substantially the same (in other words, at the first amplitude or power level 1551)—however, the duration (i.e., duty cycle) of the pulse may vary.

[0322] The energy transmission device 1000 is configured and arranged to take appropriate measures to immediately pause the transmission of energy 1550e through one or more energy transmitters 1550t when it receives an energy sufficiency signal modified as a modified data out 2566o from the embedded device 100. In this embodiment, the time (or period) between the start of a transmitted pulse 1550e during the operation period may be variable.

[0323] In this embodiment, when the stored energy exceeds the first energy storage protection level 511, the embedded device 100 is configured and positioned to transmit an energy sufficiency signal as a modified data out 2566o. The modified energy sufficiency signal and modified data out 2566o are the same as the energy sufficiency signal and data out 566o described above, except as follows: -It has a predetermined and / or controlled duration. In the embodiment shown in Figure 10, each modified energy-sufficient signal has substantially the same duration. -The embedded device 100 is further configured and arranged to transmit a modified energy-sufficient signal as a modified data out 2566o, modulated around two or more different frequencies. For example, as shown in the embodiment of Figure 10, two types of modified energy-sufficient signals are shown: a "type a" modified energy-sufficient signal modulated around a first frequency such as approximately 212 kHz, and a "type b" modified energy-sufficient signal modulated around a second frequency such as approximately 424 kHz. Any combination of frequencies distinguishable by the energy transmission device 1000, and any number of separate frequencies may be used.

[0324] Using the modified energy sufficiency signal as the modified data out 2566o allows the embedded device 100 to provide an additional communication channel to the energy transmission device 1000. This can be advantageous because the additional communication channel may be less sensitive to the Q factor (i.e., quality factor) of the energy transmission channel.

[0325] For example, in simple encoding, a “type a” signal as modified data out 2566o might be considered a “0” bit, and a “type b” signal as modified data out 2566o might be considered a “1” bit, allowing the transmission of encoded data using one or more modified energy-sufficient signals. This communication may be used to control one or more parameters of energy transmission, or to provide feedback to one or more parameters of energy transmission, including: - The duration of the default transmit pulse 1550e, the duration of the pause until the next transmit pulse 1550e needs to be transmitted, the default amplitude or power level used for multiple energy transmit pulses 1550e, feedback on the quality of energy transmission, feedback on the quality of any data transmission from the energy transmission device 1000, energy storage status, an indicator of the health of the embedded device 100, or any combination thereof.

[0326] In general, it may be advantageous to simplify additional data and / or information transmitted using a modified energy-sufficient signal as a modified data-out 2566o. In many configurations, the primary function of the modified energy-sufficient signal is to pause energy transmission, and adding the extra complexity to transmit additional information and / or data is undesirable as it may thereby reduce the reliability of the primary function. In other configurations, this trade-off may be more acceptable.

[0327] Communication can be further simplified by providing relative instructions, such as "longer," "shorter," 10% longer, and 10% shorter.

[0328] It may also be advantageous that the embedded device 100 includes one or more sensors for measuring one or more values ​​within the embedded device 100 and / or one or more values ​​in the environment adjacent to the embedded device 100 and / or one or more values ​​related to the intended operation of the embedded device 100. A modified energy sufficiency signal as modified data out 2566o may be used to provide at least a portion of this measurement data to the energy transmission device 1000.

[0329] In the embodiment shown in Figure 10, the embedded device 100 is configured and arranged such that a “type a” energy sufficiency signal as a modified data out 2566o is transmitted as a request to pause energy transmission for a standard duration “c”, and a “type b” energy sufficiency signal as a modified data out 2566o is transmitted as a request to pause energy transmission for a longer duration than standard “d”.

[0330] The pulse with a transmitted energy of 1550e is the first pulse to occur, and the transmitted pulse may begin on the left. Almost simultaneously, the energy pulse is received by an implant (not shown) and passed to the energy storage module 510m.

[0331] In this embodiment, it is assumed that the energy storage level 510e is lower than the first protection level 511. Since the energy storage level 510e is less than the first protection level 511, the embedded device 100 allows at least a portion of the received energy to charge the energy storage 510e, causing the energy storage level 510e to rise.

[0332] At time t0, the energy storage level 510e becomes the same as the first energy storage protection level 511. At that moment, the energy storage monitor (not shown) generates a modified energy sufficiency signal of type A, which is transmitted from the embedded device 100 to the external energy transmission device 1000 as a modified data out 2566o. This modified energy sufficiency signal of type A is a signal that signifies a request for pause.

[0333] In this embodiment, the embedded device 100 is configured and positioned to transmit a modified energy sufficiency signal as a modified data out 2566o for a predetermined and / or controlled duration. This may be advantageous for reducing power consumption, particularly when the embedded device includes additional protection features.

[0334] Alternatively, the embedded device 100 may be configured and positioned to transmit a modified energy sufficiency signal using the modified data out 2566o until the received energy falls below a predetermined and / or controlled level.

[0335] The corrected energy sufficiency signal, as corrected data out 2566o, is detected by the energy transmission device 1000, which takes appropriate measures to immediately suspend the transmission of energy 1550e through one or more energy transmitters 1550t. As shown, the energy transmission 1550e terminates at t1.

[0336] Furthermore, the energy transmission device 1000 recognizes the energy sufficiency signal 2566 modified as "type a" - the energy transmission device 1000 is configured and arranged to transmit the next pulse after a pause duration "c".

[0337] In this embodiment, the remaining planned duration (not shown) of the transmitted pulse 1550e is longer than the pause time, so the transmitted pulse 1550e is terminated at t1, and the terminated duration is less than the planned duration. The energy transmission device 1000 schedules the next pulse to be transmitted at t1+"c", which is labeled as t2.

[0338] In this case, the duty cycle for the first period becomes approximately 43.7% due to censorship. The period (from the start of the first pulse to the start of the second pulse at t2) is also modified (not shown).

[0339] If the transmitted energy 1550e is low or nearly zero (from t1), the embedded device 100 will use / lose some of the stored energy 510e, so the energy storage level 510e will fall below the first energy storage protection level 511.

[0340] Since the energy transmission device 1000 is configured and positioned to continue transmitting energy unless a modified energy sufficiency signal 2566 is received, the second pulse 1550e is transmitted at t2 with substantially the same amplitude (power) 1551 as the previous first pulse—in other words, at the first amplitude (or power) level 1551. Because the energy storage level 510e is below the first protection level 511, the embedded device 100 allows at least a portion of the received energy to charge the energy storage 510e, causing the energy storage level 510e to rise.

[0341] At time t3, the energy storage level 510e becomes the same as the first energy storage protection level 511 again. At that moment, the energy storage monitor (not shown) generates a further modified “Type A” energy sufficiency signal 2566, which is transmitted from the embedded device 100 to the energy transmission device 1000 as a modified data out 2566. This modified “Type A” energy sufficiency signal is a signal that signifies a request for pause.

[0342] The corrected energy sufficiency signal, as corrected data out 2566o, is detected by the energy transmission device 1000, which takes appropriate measures to immediately suspend the transmission of energy 1550e through one or more energy transmitters 1550t. As shown, the energy transmission 1550e terminates at t4.

[0343] Furthermore, the energy transmission device 1000 recognizes the energy sufficiency signal 2566 modified as an additional "type A" - the energy transmission device 1000 is configured and arranged to transmit the next pulse after a pause duration "c".

[0344] In this embodiment, the remaining planned duration (not shown) of the transmitted pulse 1550e is longer than the pause time, so the transmitted pulse 1550e is terminated at t4, and the terminated duration is less than the planned duration. The energy transmission device 1000 schedules the next pulse to be transmitted at t4+"c", which is labeled as t5.

[0345] In this case, the duty cycle for the second period will be approximately 22.4% due to censorship. The period (from the start of the second pulse at t2 to the start of the third pulse at t5) has also been modified (not shown) - it is about 10% less than the first period.

[0346] If the transmitted energy 1550e is low or nearly zero (from t4), the embedded device 100 will use / lose some of the stored energy 510e, so the energy storage level 510e will fall below the first energy storage protection level 511.

[0347] Since the energy transmission device 1000 is configured and positioned to continue transmitting energy unless a modified energy sufficiency signal 2566 is received, the third pulse 1550e is transmitted at t5 with substantially the same amplitude (power) 1551 as the previous first and second pulses—in other words, with the first amplitude or power level 1551. Because the energy storage level 510e is below the first protection level 511, the embedded device 100 allows at least a portion of the received energy to charge the energy storage module 510m, and the energy storage level 510e rises.

[0348] At time t6, the energy storage level 510e becomes the same as the first energy storage protection level 511. At that moment, the energy storage monitor (not shown) generates a modified energy sufficiency signal 2566 of type B, which is transmitted from the embedded device 100 to the external energy transmission device 1000 as a modified data out 2566o. This modified energy sufficiency signal of type B is a signal that signifies a request for pause.

[0349] The corrected energy sufficiency signal, as corrected data out 2566o, is detected by the energy transmission device 1000, which takes appropriate measures to immediately suspend the transmission of energy 1550e through one or more energy transmitters 1550t. As shown, the energy transmission 1550e terminates at t7.

[0350] Furthermore, the energy transmission device 1000 recognizes the energy sufficiency signal 2566 modified as "type b" - the energy transmission device 1000 is configured and positioned to transmit the next pulse after a longer-than-standard pause duration "d".

[0351] In this embodiment, the remaining planned duration (not shown) of the transmitted pulse 1550e is longer than the pause time, so the transmitted pulse 1550e is terminated at t7, and the terminated duration is less than the planned duration. The energy transmission device 1000 schedules the next pulse to be transmitted at t7+"d", which is labeled as t8.

[0352] In this case, the duty cycle for the third period will be approximately 20.6% due to censorship. The period (from the start of the third pulse at t5 to the start of the fourth pulse at t8) has also been modified (not shown) - it is approximately 17% longer than the second period and approximately 6% longer than the first period.

[0353] If the transmitted energy 1550e is low or nearly zero (from t7), the embedded device 100 will use / lose some of the stored energy 510e, so the energy storage level 510e will fall below the first energy storage protection level 511.

[0354] Since the energy transmission device 1000 is configured and positioned to continue transmitting energy unless a modified energy sufficiency signal 2566 is received, the fourth pulse 1550e is transmitted at t8 with substantially the same amplitude (power) 1551 as the previous first, second, and third pulses—in other words, with the first amplitude or power level 1551. Because the energy storage level 510e is below the first protection level 511, the embedded device 100 allows at least a portion of the received energy to charge the energy storage module 510m, and the energy storage level 510e rises.

[0355] At time t9, the energy storage level 510e becomes the same as the first energy storage protection level 511. At that moment, the energy storage monitor (not shown) generates a further modified “Type B” energy sufficiency signal 2566, which is transmitted from the embedded device 100 to the external energy transmission device 1000 as a modified data out 2566o. This modified “Type B” energy sufficiency signal is a signal that signifies a request for pause.

[0356] The corrected energy sufficiency signal, as corrected data out 2566o, is detected by the energy transmission device 1000, which takes appropriate measures to immediately suspend the transmission of energy 1550e through one or more energy transmitters 1550t. As shown, the energy transmission 1550e terminates at t10.

[0357] Furthermore, the energy transmission device 1000 recognizes the energy sufficiency signal 2566 modified as "type b" - the energy transmission device 1000 is configured and positioned to transmit the next pulse after a longer-than-standard pause duration "d".

[0358] In this embodiment, the remaining planned duration (not shown) of the transmitted pulse 1550e is longer than the stop time, so the transmitted pulse 1550e is terminated at t10, and the terminated duration is less than the planned duration. The energy transmission device 1000 schedules the next pulse to be transmitted at t10+"d" (not shown).

[0359] In this case, the duty cycle for the fourth period is approximately 23.3% due to censorship. The period (from the start of the fourth pulse at t8 to the start of the next pulse (not shown)) is also modified (not shown) - it is approximately 7% longer than the third period, approximately 26% longer than the second period, and approximately 14% longer than the first period.

[0360] Furthermore, or alternatively, an additional communication channel may be provided between the energy transmission device 1000 and the embedded device 100. The embedded device 100 may be further configured and arranged to distinguish variations in the parameters of one or more transmitted pulses 1550e, such as duty cycle, duration, duration between received energy pulses (pause duration), and any combination thereof. Furthermore, or alternatively, the embedded device 100 may be further configured and arranged to measure the parameters of one or more transmitted pulses 1550e, such as duty cycle, duration, duration between received energy pulses (pause duration), and any combination thereof.

[0361] For example, if the energy transmission device 1000 is configured and positioned to modify one or more transmitted pulse 1550e parameters, such as pause duration, communication can be provided from the energy transmission device 1000 to the embedded device 100 without significantly affecting normal operation.

[0362] For example, as shown in the embodiment of Figure 10, two types of pause durations are shown: a standard "type C" pause duration between t1 and t2 and between t4 and t5, e.g., approximately 150 us (microseconds); and a longer-than-standard "type D" pause duration between t7 and t8 and from t10, e.g., 200 us (microseconds). Any number of variations in pause duration that can be distinguished by the embedded device 100 may be used.

[0363] Optionally, the embedded device 100 may be further configured and arranged to determine whether the modified energy sufficiency signal 2566 was transmitted immediately before the pause duration under consideration. In other words, it may also distinguish between agreement with and / or deviation from expected behavior.

[0364] Optionally, the embedded device 100 may further store one or more parameters from one or more previous operating cycles in the history database to allow comparison with one or more parameters determined and / or measured during the current operating cycle. Optionally, the history database may store one or more parameters from multiple energy transmission devices 1000.

[0365] While it may be configured and arranged to provide simulation and treatment parameters, as mentioned above, simple coding may be preferred in many configurations.

[0366] For example, in simple encoding, the pause duration for "type c" may be considered as "0" bits, and the pause duration for "type d" may be considered as "1" bit. This communication may be used to control one or more parameters of energy transmission, or to provide feedback to one or more parameters of energy transmission, one or more of which include: - Feedback regarding the quality of communication, feedback regarding one or more parameters related to the received energy-sufficient signal, additional data regarding one or more parameters related to the transmitted energy pulse, additional data regarding past / present / future transmissions, or any combination thereof.

[0367] Optionally, the energy transmission device 1000 may further store one or more parameters from one or more previous operating cycles in its history database to allow comparison with one or more parameters determined and / or measured during the current operating cycle. Optionally, the history database may store one or more parameters from multiple embedded devices 100.

[0368] For example, the energy transmission device 1000 is - Monitor one or more historical parameters associated with one or more transmitted energy pulses 1550e, - Monitor one or more historical parameters before the first and / or further energy sufficiency signals 566, 2566 are received, -Generate a monitoring dataset containing one or more historical parameters, -Generate a historical database containing multiple monitoring datasets, -From the historical database, derive the expected amount of energy transmitted before energy sufficiency signals 566 and 2566 are received. - Compare the subsequent monitoring dataset with the expected amount of energy being transmitted. - It can be further configured and arranged to identify significant differences between the expected amount of energy transmitted and subsequent monitoring datasets.

[0369] This may be advantageous because one or more significant differences may indicate that the status of the embedded device 100 has changed or is expected to change—for example, that the embedded device 100 is defective, has a higher risk of malfunction, has a higher risk of inefficient operation, has experienced an unexpected amount of fluid ingress, has the primary and / or secondary energy sources depleted to an undesirable degree, or any combination thereof.

[0370] Figures 5 and 6 show examples of nerves that can be stimulated using a appropriately configured implantable second substrate portion of the stimulator 100 to provide nerve stimulation and treat headache or primary headache, for example.

[0371] Figure 5 shows the left supraorbital nerve 910 and the right supraorbital nerve 920, which can be electrically stimulated using a properly configured device. Figure 6 shows the left greater occipital nerve 930 and the right and left greater occipital nerves 940, which can be electrically stimulated using a properly configured device.

[0372] Depending on the size of the area to be stimulated and the dimensions of the part of the implanted device, an appropriate position can be determined to provide the electrical stimulation required for treatment. Appropriate implantation locations for the distal end of the stimulator 100 are shown in Figures 5 and 6 as follows. - Position 810 for left supraorbital stimulation and position 820 for right supraorbital stimulation to treat chronic headaches such as migraines and cluster headaches. - Position 830a or position 830b for left occipital stimulation and position 840a or position 840b for right occipital stimulation to treat chronic headaches such as migraines, cluster headaches, and occipital neuralgia.

[0373] In many cases, these are positions 810, 820, 830a / b, and 840a / b suitable for the implantable stimulator 100.

[0374] A separate stimulation system may be used for each implantation site 810, 820, 830a / b, and 840a / b. If the implantation sites 810, 820, 830a / b, and 840a / b are close to each other or overlap, a single stimulation system may be configured to stimulate multiple implantation sites 810, 820, 830a / b, and 840a / b by extending the length of the substrate 300 and / or the length of the portion having at least two electrodes 200, 400.

[0375] Multiple stimulators 100, 103, 104, and 105 can be operated separately, simultaneously, sequentially, or in combination thereof to provide the requested treatment.

[0376] Figure 7 shows further examples of nerves that can be stimulated using a properly configured improved implantable stimulator 100 to provide nerve stimulation and treat other diseases. The locations shown in Figures 5 and 6 (810, 820, 830, 840) are also shown in Figure 7.

[0377] The appropriate location for providing the electrical stimulation required for treatment is determined based on the size of the area to be stimulated and the dimensions of the part of the implanted device. The approximate implantation locations of the part of the stimulator, including the stimulating electrodes, are shown as follows: -Position 810 for cortical stimulation to treat epilepsy. -Position 850 for deep brain stimulation for the treatment of tremor control in Parkinson's disease patients, dystonia, obesity, essential tremor, depression, epilepsy, obsessive-compulsive disorder, Alzheimer's disease, anxiety disorders, bulimia, tinnitus, traumatic brain injury, Tourette's disease, sleep disorders, autism, bipolar disorder, and recovery from stroke. - Position 860 for vagus nerve stimulation to treat epilepsy, depression, anxiety disorders, bulimia, obesity, tinnitus, obsessive-compulsive disorder, heart failure, Crohn's disease, and rheumatoid arthritis. - Position 860 for stimulating the carotid artery or carotid sinus to treat hypertension. - Position 860 for stimulating the hypoglossal and phrenic nerves to treat sleep apnea. - Position 865 for cerebrospinal stimulation to treat chronic neck pain. - Position 870 for peripheral nerve stimulation to treat hand and foot pain, migraines, and limb pain. - Position 875 for spinal stimulation to treat chronic lower back pain, angina, asthma, and general pain. - Position 880 for gastric stimulation to treat obesity, bulimia, and interstitial cystitis. - Position 885 for sacral and pudendal nerve stimulation for the treatment of interstitial cystitis. - Position 885 for sacral nerve stimulation for the treatment of urinary and fecal incontinence. - Position 890 for sacral nerve modulation for bladder control therapy. - Position 895 for peroneal nerve stimulation to treat gait or foot drop.

[0378] Other treatable conditions include, among others, gastroesophageal reflux disease, autoimmune diseases, inflammatory bowel disease, and inflammatory diseases.

[0379] Depending on the size of the area to be stimulated and the dimensions of the part of the implanted device, an appropriate position can be determined to provide the electrical stimulation required for treatment.

[0380] In some treatments, stimulation of other tissues and / or indirect stimulation of nerves may be advantageous. For example, the implantable device 100 may be configured and positioned to stimulate one or more muscles, one or more organs, spinal cord tissue, brain tissue, one or more cortical surface areas, one or more grooves, or any combination thereof during use.

[0381] For example, such additional or alternative stimulation may be performed in a body position including the appropriate positions shown above and / or in Figures 5, 6, and / or 7.

[0382] The descriptions herein should not be understood as prescribing a fixed order for performing the method steps described therein. Rather, the method steps may be performed in any practical order. Similarly, the examples used to illustrate the methods are presented as non-limiting examples and are not intended to represent only embodiments of these methods. Those skilled in the art can conceive of many different methods to achieve the same functions provided by the embodiments described herein.

[0383] For example, it may be advantageous for the embedded device 100 to include one or more signal transmitters, separate from one or more energy receivers 550r, and configured and positioned to transmit signals (data) 520 to an external energy transmission device 1000. This is advantageous because it allows for the separate optimization of the energy channels and signal (data) channels separately. The one or more signal transmitters may be connected to the control module 503 using, for example, one or more interconnects 250.

[0384] Furthermore, or alternatively, one or more signal transmitters may be included within the pulse energy controller 500.

[0385] For example, it may be advantageous for the energy transmission device 1000 to be separate from one or more energy transmitters 1550t and to include one or more signal receivers configured and positioned to receive signals (data) 520 from the embedded device 100. This is advantageous because it allows each separate energy channel and signal (data) channel to be optimized separately. One or more signal receivers 1520 may be connected to the energy transmission controller 1500.

[0386] Although the present invention has been described in relation to certain exemplary embodiments, it should be understood that various changes, substitutions, and modifications will be made to the disclosed embodiments without departing from the spirit and scope of the invention as described in the appended claims, and will be apparent to those skilled in the art.

[0387] for example, -One or more electrodes of the first type 200a, 200b are included in the first surface 310, and one or more electrodes of the second type 400a, 400b are included in the second surface 320, or -One or more electrodes of the first type 200a, 200b are included in the first surface 310, and one or more electrodes of the second type 400a, 400b are also included in the first surface 310, or -One or more electrodes of the first type 200a, 200b are included in the second surface 320, and one or more electrodes of the second type 400a, 400b are included in the first surface 310, or -One or more electrodes of the first type 200a, 200b are included in the second surface 320, and one or more electrodes of the second type 400a, 400b are included in the second surface 320, or Any combination of those.

[0388] Furthermore, or alternatively, the substrate 300 and electrical components may be embedded in one or more flexible biocompatible encapsulation layers. These layers may include liquid crystal polymers (LCP), polydimethylsiloxanes (PDMS), silicone polyurethanes, polyimides, parylenes, biocompatible polymers, biocompatible elastomers, and any combination thereof.

[0389] By providing relatively large and tall electrode surfaces 200, 400, the stimulator 100 can be operated with lower energy / lower power consumption. This may be advantageous in applications where high-frequency and / or burst stimulation is used.

[0390] High-frequency operation may require more energy than that provided by the pulse generator 500. In applications where energy / power is critical (e.g., where extending the operating life from the energy source of an electrical component is desired, any reduction in the required power may be beneficial). High-frequency operation may be considered to involve generating electrical stimulation pulses with frequencies of 1000 Hz or higher, 1500 Hz or higher, 2000 Hz or higher, and 2500 Hz or higher.

[0391] For example, experiments using burst stimulation have been conducted, such as Burst Occipital Nerve Stimulation for Chronic Migraine and Chronic Cluster Headache by Garcia-Ortega et al, Neuromodulation 2019, 22:638-644, DOI:10.1111 / ner.12977.

[0392] In burst operation, the electrical components are further configured and arranged to generate electrical stimulation pulses in groups of stimulation pulses.

[0393] For example, a group (burst) of stimulation pulses may contain 2 to 10 pulses, more preferably 2 to 5 stimulation pulses. The stimulation pulses within a group may have a repetition frequency greater than 500 Hz, typically 1000 Hz or more. The group may repeat at a frequency greater than 5 Hz, typically 40 Hz or more.

[0394] Similar to high-frequency operation, burst operation may require more energy to be supplied by electrical components, and any reduction in the energy required may be advantageous.

[0395] Furthermore, the rate of charge balance restoration may also increase as impedance decreases. By using stimulation between a first type 200 electrode contained in one surface 310, 320 of a relatively thin foil substrate 300 and a second type 400 electrode contained in the other surface 310, 320, the current path within the tissue becomes relatively short and impedance decreases.

[0396] Similarly, stimulation between a first type 200 electrode contained in the substrate 300 and one of its surfaces 310, 320, and an adjacent second type 400 electrode contained in the same surface 310, 320, provides a relatively short pathway through the tissue.

[0397] Generally, an embedded device 100 suitable for performing the method disclosed herein for controlling wireless energy transmission from an energy transmission device 1000 includes the following: -One or more energy receivers 550r configured and positioned to wirelessly receive multiple continuous energy pulses 1550e transmitted at a first power level 1551, - An energy storage 510e configured and positioned to store at least a portion of the energy received by one or more energy receivers 550r, - An energy monitor 530 configured and positioned to monitor the status level of the energy storage 510e, wherein the status level is largely influenced by the energy received by the embedded device 100 and / or the energy used by the embedded device 100, and the embedded device 100 is further configured and positioned to do the following: - To generate an energy transmission channel between one or more energy receivers 550r and one or more energy transmitters 1550t included in the energy transmission device 1000. - When the status level of the energy storage 510e exceeds a first maximum value 511, transmit the first energy sufficiency signals 566, 2566.

[0398] Generally, an energy transmission device 1000 suitable for performing the method disclosed herein for controlling wireless energy transfer to a wireless embedded device 100 is as follows: -One or more energy transmitters 1550t configured and arranged to wirelessly transmit multiple energy pulses 1550e at a first power level 1551, -Includes one or more signal receivers 550r configured to detect energy sufficiency signals 566, 2566 from the embedded device 100, The energy transmission device 1000 is further configured and arranged to perform the following: - To generate an energy transmission channel between one or more energy transmitters 1550t and one or more energy receivers 550r included in the wireless embedded device 100. Immediately after receiving the first energy sufficiency signals 566 and 2566, pause the energy pulse transmission 1550e. -If no further energy sufficiency signals 566,2566 are received thereafter, resume energy pulse transmission 1550e at the first power level 1551.

[0399] Furthermore, or alternatively, the embedded device 100 may be configured to cooperate with multiple different energy transmission devices 1000. The cooperation may be coordinated by the standardization and / or customization of one or more components.

[0400] Enabling two or more cooperating energy transmission devices 1000 allows medical or cosmetic professionals to operate the implantable device 100 therapeutically, cosmetically, and / or experimentally, and a human or animal may have its own energy transmission device 1000 with more limited (routine) functions.

[0401] Furthermore, or alternatively, the energy transmission device 1000 may be included in a mobile device such as a mobile phone.

[0402] The implantable device 100 may optionally further include the following: - Further energy storage (not shown) configured and positioned to provide a substantial amount of energy to one or more components during periods when the energy 550e received by the energy receiver 550r decreases.

[0403] This can be advantageous because it allows for the application of small voltages to the logic, for example, thereby preserving the stored and / or programmed data.

[0404] For example, further energy storage may include one or more capacitors, one or more supercapacitors, one or more rechargeable batteries, one or more disposable batteries (non-rechargeable), or any combination thereof.

[0405] The present invention encompasses all possible combinations of the various features of each disclosed embodiment. One or more of the elements described herein with respect to various embodiments can be implemented in a more separated or integrated manner than expressly described, or in particular, can be omitted or even disabled, to be useful according to a particular application. [Explanation of Symbols]

[0406] 100 Implantable device configured as an implantable stimulator 200ab One or more stimulating electrodes 250 One or more stimulating electrical interconnection layers 300 circuit boards 310 First surface of the substrate 320 Second surface of the substrate 400ab One or more return electrodes 401abcd One or more blocking capacitors 500 pulse generator or pulse energy controller 501 Energy Supply Coordination Module 502 Stimulation Module 503 Control Module 504 Wireless Energy Receiver Module 505 Communication Module 506 Microcontroller 507 Current source 510m Energy Storage Module 510e Energy Storage 511 First Energy Storage Protection Level 512 Second energy storage protection level 513 Third Energy Storage Protection Level 514 Energy Storage - Lower Limit 515 Energy storage - upper limit 520 One or more signal transmitters 530 Energy Storage Monitor 540 One or more tuning components, i.e., tuners 545 One or more detuning components, i.e., detuners 550r One or more energy receivers 550e Received Energy 555 Magnets for mounting one or more receivers 560 Demodulator 561d Data Decoder 561i Data In Channel 563m Clock Recovery Module 563s clock recovery signal 565 Modulator 566e Data Encoder 566o Data Out 569 Coil Voltage 570 rectifier 571 High Voltage 575 One or more Zener diodes or other voltage regulators or shunts 577 DC / DC voltage converters and other voltage converters 578 Logic Voltage 580 Switch Controller 585abcd One or more switching units 600 Longitudinal axis 610 First substrate portion or proximal end 620 Second substrate portion or distal end 700 First horizontal axis 750 Second horizontal axis Midline plane of 800 subjects 810 Location of left supraorbital nerve or cortical stimulation 820 Location of right supraorbital nerve or cortical stimulation 830a First position for left occipital nerve stimulation 830b Second position for left occipital nerve stimulation 840a First position for right occipital nerve stimulation 840b Second position for right occipital nerve stimulation 850 Position for deep brain stimulation 860 Positions for stimulating the vagus nerve, carotid artery, carotid sinus, phrenic nerve, or sublingual nerve. 865 Position for brain and spinal cord stimulation 870 Position for peripheral nerve stimulation 875 Position for spinal cord stimulation 880 Position for gastric stimulation 885 Position for sacral and pudendal nerve stimulation 890 Position for regulating the sacral nerve 895 Position for peroneal nerve stimulation 910 Left supraorbital nerve 920 Right supraorbital nerve 930 Left greater occipital nerve 940 Right greater occipital nerve 1000 External energy transmission device 1500 Energy Transmission Controller 1501 Energy Supply Regulator 1503 Control Module 1504 Wireless Energy Transmitter Module 1505 Communication Module 1510 Energy Storage Module 1520 One or more signal receivers 1550t 1 or more energy transmitters 1550e transmission energy 1551 First amplitude or power level 1552 Initial amplitude or power level 1553 Significantly reduced amplitude or power level 1555 Magnet for mounting one or more transmitters 2566o Corrected data output

Claims

1. A wireless energy transmission system comprising an energy transmission device (1000) and a wireless embedded device (100), The aforementioned embedded device (100) One or more energy receivers (550) configured and arranged to wirelessly receive a plurality of continuous energy pulses (1550) transmitted at a first power level (1551), One or more energy storage modules (510) configured and arranged to store at least a portion of the energy received by the one or more energy receivers (550), An energy monitor (530) configured and positioned to monitor the status level of one or more energy storage modules (510), wherein the status level is significantly influenced by the energy received by the embedded device (100) and / or the energy used by the embedded device (100). Equipped with, The energy transmission device (1000) One or more energy transmitters (1550) configured and arranged to wirelessly transmit multiple energy pulses (1550) at the first power level (1551), One or more signal receivers (1550) configured to detect energy sufficiency signals (566, 2566) from the embedded device (100), wherein the energy transmission device (1000) is configured and arranged to temporarily suspend energy pulse transmission (1550) immediately after the energy sufficiency signals (566, 2566) are received, and Equipped with, The energy transmission device (1000) starts transmitting an energy pulse (1550) at the first power level (1551), The energy transmission device (1000) and the embedded device (100) generate an energy transmission channel between the one or more energy transmitters (1550) and the one or more energy receivers (550), The embedded device (100) transmits a first energy sufficiency signal (566, 2566) when the status level of one or more energy storage modules (510) exceeds a first maximum value (511), Immediately after the first energy sufficiency signal (566, 2566) is received, the energy transmission device (1000) temporarily suspends the energy pulse transmission (1550) with the intention of resuming the energy pulse transmission (1550) after the duration of the suspension, If no further energy sufficiency signals (566, 2566) are received after the duration of the pause, energy pulse transmission (1550) is then resumed at the first power level (1551). A wireless energy transmission system that performs this function.

2. The energy transmission device (1000) pauses the energy pulse transmission (1550) within 2 milliseconds or less, within 1 millisecond or less, or within 100 microseconds or less, or within 10 microseconds or less, after the first or further energy sufficiency signals (566, 2566) are received. The wireless energy transmission system according to claim 1, further performing the above.

3. The wireless energy transmission system according to claim 1 or 2, wherein one or more energy storage modules (510) are configured and positioned to provide sufficient energy to operate the embedded device (100), and the duration of the pause of energy pulse transmission is 1,000 milliseconds or less, 500 milliseconds or less, 200 milliseconds or less, 100 milliseconds or less, 50 milliseconds or less, 20 milliseconds or less, or 10 milliseconds or less.

4. The wireless energy transfer system according to any one of claims 1 to 3, wherein the one or more energy storage modules (510) comprises at least one of one or more capacitors, one or more supercapacitors, or any combination thereof, and the one or more energy storage modules (510) provide a storage capacity of up to 470 microfarads.

5. Predetermining and / or controlling the energy transmission device (1000) to transmit an energy pulse (1550) of a first duration, The energy transmission device (1000) starts transmitting (1550) the first pulse (1550) of the first duration, The energy transmission device (1000) receives the first or further energy sufficiency signals (566, 2566), The energy transmission device (1000) temporarily suspends the energy pulse transmission (1550), thereby causing the first pulse to be terminated such that it has a truncated duration less than the first duration. A wireless energy transmission system according to any one of claims 1 to 4, further performing the above.

6. The embedded device (100) transmits the first and / or further energy sufficiency signals (566, 2566) by modifying one or more parameters of the energy transmission channel, thereby making the modification of the one or more parameters detectable by the energy transmission device (1000). A wireless energy transmission system according to any one of claims 1 to 5, further performing the above.

7. The aforementioned embedded device (100) A wireless energy transmission system according to any one of claims 1 to 6, wherein when the status level of one or more energy storage modules (510) exceeds a second maximum value (512), the system provides a certain degree of detuning of the energy transmission channel.

8. The embedded device (100) further comprises one or more voltage regulators (570) that control at least a portion of the energy stored in one or more energy storage modules (510), When the status level of one or more of the energy storage modules (510) exceeds a third maximum value (513), the embedded device (100) lowers the output voltage of the voltage regulator. A wireless energy transmission system according to any one of claims 1 to 7, further performing the above.

9. The embedded device (100) further comprises one or more shunts (575) for reducing at least a portion of the energy stored in one or more energy storage modules (510), When the status level of one or more of the energy storage modules (510) exceeds the third maximum value (513), the implanted device (100) operates one or more of the shunts. A wireless energy transmission system according to any one of claims 1 to 8, further performing the above.

10. The wireless energy transmission system according to any one of claims 1 to 9, wherein one or more energy storage modules (510) are not equipped with a battery.

11. The embedded device (100) is configured and arranged to transmit energy-sufficient signals (2566) centered around two or more modulation frequencies, and to select the center modulation frequency of the first and / or further energy-sufficient signals (2566), The wireless energy transmission system according to any one of claims 1 to 10, wherein one or more signal receivers (1550) included in the energy transmission device (1000) are configured to detect two or more center modulation frequencies of the first and / or further energy-sufficient signals (2566).

12. The wireless energy transmission system according to claim 11, wherein the energy transmission device (1000) is configured and arranged to modify one or more parameters of the energy pulse transmission (1550) based on one or more center modulation frequencies of the first and / or further energy-sufficient signals (2566).

13. The wireless energy transmission system according to any one of claims 1 to 12, wherein the embedded device (1000) further comprises a voltage regulator (570) and a shunt (575), and the voltage regulator (570) and the shunt (575) are configured and arranged to reduce the voltage when the protection level (511, 512, 513) of one or more energy storage modules is exceeded.

14. The aforementioned embedded device (100) A pulse generator (500) is configured and positioned to receive electrical energy from one or more energy storage modules (510) for that operation and is further configured to generate at least one stimulation pulse, At least two electrodes (200, 400) and Multiple electrical interconnections (250) electrically coupling the pulse generator (500) to at least two electrodes (200, 400) and Furthermore, The pulse generator (500) is configured and arranged to provide electrical stimulation energy as one or more electrotherapy stimulation pulses to at least two electrodes (200a, 200b). A wireless energy transmission system according to any one of claims 1 to 13, further performing the above.

15. The wireless energy transmission system according to claim 14, wherein the pulse generator (500) comprises one or more energy receivers (550).

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