Midfield transmitters and injectable midfield receivers

Abstract

Generally discussed herein are systems, devices, and methods for providing therapy (e.g., stimulation) and / or data signals using implantable devices. Also provided are systems, devices, and methods for therapy devices to interact with (e.g., communicate with, receive power from) external devices, which therapy devices provide stimulation or other therapy to target locations within the body.

Description

[0001] This application is a divisional application of Chinese patent application No. 201880021261.8, filed on January 30, 2018, entitled "Midfield transmitter and injectable midfield receiver". Technical Field

[0002] One or more examples discussed herein relate to apparatus, systems, and methods for providing signals (e.g., wireless mid-field signals) to an implantable device (e.g., a stimulation device) using an external device (e.g., an external mid-field coupler or mid-field power supply). One or more examples discussed herein relate to apparatus, systems, and methods for providing treatment (e.g., stimulation or other modulation) or diagnosis from an implantable device. One or more examples discussed herein relate to configurations of an implantable device and an external device. One or more examples discussed herein relate to transmitting data from an implantable device to an external device. One or more examples discussed herein relate to apparatus, systems, and methods for positioning an implantable device at or near a specific location and / or shaping the implantable device. Background Technology

[0003] Various wireless power supply methods for implantable electronics are based on near-field or far-field coupling. These and other methods have several drawbacks. The power signal acquisition structure in the implanted device is typically large (e.g., usually about one centimeter or larger). Similarly, the coil outside the main body in near-field coupling can be bulky and inflexible. These constraints present difficulties in integrating the external device into the patient's daily life. Furthermore, the inherent exponential attenuation of the near-field signal limits the miniaturization of the implanted device beyond shallow depths (e.g., greater than 1 cm). On the other hand, the radiation characteristics of the far-field signal limit the energy transfer efficiency.

[0004] This article primarily discusses systems, apparatus, and methods for providing or delivering patient treatment using implantable devices. In one example, patient treatment includes providing electrical stimulation to one or more neural targets in the patient's body. In one example, an implantable device is used to provide electrical stimulation, which wirelessly receives power and data signals from a mid-field transmitter.

[0005] Wireless mid-field power supply technology can be used to provide power to implanted electrical stimulation devices from an external power source. The external power source or transmitter can be located on or near the tissue surface, such as on the outer surface of the patient's skin. Mid-field based devices can offer several advantages over conventional implantable devices. For example, mid-field power supply technology eliminates the need for a relatively large implantable pulse generator and one or more leads electrically connecting the pulse generator to the stimulation electrodes. Mid-field devices offer a simpler implantation process, which can lead to lower costs and a reduced risk of infection or other implantation complications.

[0006] Another advantage of using mid-field powered technology includes the ability to supply batteries or power to the patient externally, thus relaxing the low-power and high-efficiency circuitry requirements of battery-powered implantable devices. Another advantage of using mid-field powered technology includes the ability to implant devices that are smaller in appearance than battery-powered devices. Therefore, mid-field powered technology can help achieve better patient tolerability and comfort, and can potentially reduce manufacturing and implantation costs.

[0007] There are currently unmet needs, including the use of mid-field transmitters and receivers to transmit power and / or data, such as transmitting power and / or data from an external mid-field transmitter to and from an implanted device (e.g., a neurostimulation device or a sensor device). Summary of the Invention

[0008] Despite significant advancements in the field of medical device therapy, there remains a need for therapeutic devices that deliver stimulation or other treatments to target sites within the body. Effective wireless power and data communication with implanted therapeutic delivery devices and / or implanted diagnostic (e.g., sensor) devices is also required.

[0009] According to several embodiments, an implantable system may include an elongated structure configured for implantation in a patient using a catheter. The system may include an elongated circuit board assembly that, along its length, sequentially includes a proximal portion, a first flexible portion, a central portion, a second flexible portion, and a distal portion, as well as a sealing housing configured to enclose the elongated circuit board assembly. In one example, the sealing housing includes a first end cap and a second end cap, the first end cap having a conductive first feedthrough to a conductor coupled to the proximal portion of the elongated circuit board assembly, and the second end cap having a conductive second feedthrough to a conductor coupled to the distal portion of the elongated circuit board assembly. In one example, the first flexible portion and the second flexible portion have different length characteristics.

[0010] Various elongated field devices are available. In one example, such an elongated device may include: at least one antenna configured to wirelessly receive power signals from an external device; a first circuit housing including a first circuit coupled to the antenna; and a second circuit housing including a second circuit. The elongated device may include an elongated portion between the first and second circuit housings, the elongated portion including one or more conductors extending therethrough and electrically coupling the first and second circuits. The elongated device may also include a body portion coupled to the second circuit housing and one or more electrodes exposed on or at least partially located within the body portion.

[0011] In one example, the electrode system can be deployed within a patient at a neural target using a cannula. Such an electrode system may include or use an elongated component body and an electrode assembly. The elongated component body is configured to house electrical stimulation circuitry or sensing circuitry, and the electrode assembly is coupled to the electrical stimulation circuitry or sensing circuitry and configured to provide electrical stimulation to a neural target within the patient or to sense electrical signal activity from that neural target. In one example, the electrode assembly includes multiple elongated members extending away from the component body in a predominantly longitudinal direction, and the electrode assembly may have a retracted first configuration when inside the cannula and an expanded second configuration when outside the cannula. In one example, the electrode assembly has a further expanded third configuration while receiving the neural target.

[0012] In one example, an electrical stimulation and / or sensor system may be configured for implantation within a patient's blood vessel. Such a system may include or utilize a wireless receiver circuitry and an expandable and retractable support structure. The wireless receiver circuitry is configured to receive wireless power and / or data signals from a source device external to the patient. The expandable and retractable support structure has a first contractile configuration inside the delivery catheter and a second expandable configuration outside the delivery catheter. In one example, the support structure is coupled to the wireless receiver circuitry.

[0013] In one example, the mid-field transmitter may include a layered structure, such as at least a first conductive plane disposed on a first layer of the transmitter, one or more microstrips disposed on a second layer of the transmitter, and a third conductive plane disposed on a third layer of the transmitter, the third conductive plane being electrically coupled to the first conductive plane using one or more vias extending through the second layer. In one example, the mid-field transmitter may include a first dielectric member inserted between the first and second conductive planes and different second dielectric members inserted between the second and third conductive planes.

[0014] The content of this invention is intended to provide an overview of the subject matter of this application. It is not intended to provide an exclusive or exhaustive explanation of the one or more inventions discussed herein. Detailed descriptions are included to provide further information regarding this patent application. Attached Figure Description

[0015] In accompanying drawings that are not necessarily drawn to scale, the same numbers may describe similar parts in different views. The same numbers with different letter suffixes may represent different instances of similar parts. The accompanying drawings illustrate various embodiments discussed in this document by way of example and not as limitations.

[0016] Figure 1A schematic diagram of an embodiment of a system using a wireless communication path is shown in general.

[0017] Figure 2A The diagram mainly shows a block diagram of an embodiment of the field source device.

[0018] Figure 2B The diagram primarily shows a block diagram of an embodiment of the system configured to receive a signal.

[0019] Figure 3 A schematic diagram of an embodiment of a mid-field antenna with multiple subwavelength structures is shown in general.

[0020] Figure 4 A diagram generally illustrates an embodiment of a phase-matching and / or amplitude-matching network for a field source device.

[0021] Figure 5 A diagram generally illustrates an embodiment of the circuitry for an implantable device.

[0022] Figure 6 A diagram generally illustrates an embodiment of the first implantable device.

[0023] Figure 7 A schematic diagram of an embodiment of the circuit housing is shown in general.

[0024] Figure 8 A cross-sectional view of an embodiment of the circuit board is shown in general.

[0025] Figure 9 A top view of an embodiment of the circuit board is shown in general.

[0026] Figure 10 A top view of an embodiment of the circuit board is shown in general.

[0027] Figure 11 The embodiments of the apparatus, which generally include a variety of electrical and / or electronic components connected to a circuit board, are shown in general.

[0028] Figure 12 An embodiment of an apparatus is generally shown, which includes various components coupled to a circuit board and the circuit board coupled to a first end cap.

[0029] Figure 13 An embodiment of a device is generally shown, which includes a circuit board coupled to a first end cap and placed within a housing.

[0030] Figure 14 An embodiment of a device is generally shown, which includes a circuit board coupled to a first end cap and a second end cap and placed in a housing.

[0031] Figure 15An embodiment of a device is generally shown, which includes a circuit board coupled to a first end cap and a second end cap and sealed within a housing.

[0032] Figure 16 An example top view of the end cap is shown in general.

[0033] Figure 17 Generally shown Figure 16 Example of a cross-sectional view of the end cap.

[0034] Figure 18 Broadly showing including Figure 16 Example of a cross-sectional view of the end cap and circuit board assembly.

[0035] Figure 19 An example top view of the two-port cap is shown in general.

[0036] Figure 20 Broadly shown includes Figure 19 Example of a cross-sectional view of a double-port cap.

[0037] Figure 21 An example of a top view of a multi-port cap is shown in general.

[0038] Figure 22 Broadly showing including Figure 21 Example of a cross-sectional view of a multi-port cover.

[0039] Figure 23 Broadly shown includes Figure 21 An example of a side view of a multi-port cap.

[0040] Figure 24 An example side view of an embodiment of the implantable device is shown in general.

[0041] Figure 25 An example of a slender, implantable device is shown in general.

[0042] Figure 26 Generally showing including implants within the tissue Figure 25 Examples of implantable devices.

[0043] Figure 27 A schematic example of a first circuit that can be set in a circuit housing is shown in general.

[0044] Figure 28 A schematic example of a second circuit, which may be disposed in a circuit housing, is shown in general.

[0045] Figure 29 An example of a slender, implantable device is shown in general.

[0046] Figure 30A and Figure 30B Different views of an example of an implantable electrode assembly located inside a cannula are shown in general.

[0047] Figure 30C An example of an implantable electrode assembly partially located outside the cannula is shown in general.

[0048] Figure 30D This illustration generally shows an example of an implantable electrode assembly deployed from a cannula and coupled to a push rod.

[0049] Figure 30E An example of an implantable electrode assembly including a central lead is shown in general.

[0050] Figure 31A The first example of an implantable electrode assembly that is close to a neural target is shown in general.

[0051] Figure 31B A second example of an implantable electrode assembly is shown in general, in which a neurally wrapped electrode is flexed away from a neural target.

[0052] Figure 31C A third example of an implantable electrode assembly is shown in general, in which a neurally wrapped electrode is positioned around a neural target.

[0053] Figure 32A , Figure 32B and Figure 32C This section broadly illustrates an example of using a flexible electrode configuration to receive and retain neural targets.

[0054] Figure 33A and Figure 33B The side view and perspective view of the second implantable electrode assembly are shown in general.

[0055] Figure 34 An example including a nerve-covered electrode and an electrode insulating component is shown in general.

[0056] Figure 35A and Figure 35B The side view and perspective view of the third implantable electrode assembly are shown in general.

[0057] Figure 36 An example of an implantable electrode is shown in general.

[0058] Figure 37 An example of an implantable electrode is shown in general.

[0059] Figure 38 An example of an implantable electrode assembly is shown in general, which is configured to deliver electrical stimulation axially to a neural target.

[0060] Figure 39 An example of an implantable electrode assembly is shown in general, which is configured to deliver electrical stimulation transversely to a neural target.

[0061] Figure 40 An example of an implantable electrode assembly with a flexible body is shown in general.

[0062] Figure 41 The illustration generally shows an example of a method that includes approaching and positioning electrodes around a neural target.

[0063] Figure 42 This diagram shows an example of the implantation location of the vascular system in the torso for use in a midfield device.

[0064] Figure 43 Examples of side views and cross-sectional views of a mid-field device configured for installation and fixation within a blood vessel are shown in general.

[0065] Figure 44 The first example of a midfield device is shown in general, which has multiple passive elements protruding laterally from the housing assembly of the midfield device.

[0066] Figure 45 A second example of a midfield device is shown in general, which has multiple expandable elements protruding laterally from the housing assembly of the midfield device.

[0067] Figure 46 A third example of a midfield device is shown in general, which has multiple active elements protruding laterally from the housing assembly of the midfield device.

[0068] Figure 47 A fourth example of a midfield device is shown, which has a fixing element that protrudes laterally from the housing assembly of the midfield device.

[0069] Figure 48 Generally shown Figure 43 A variation of the exemplary midfield device.

[0070] Figure 49 An example of a support-based system is shown in general, which may include a midfield device that is coupled to an expandable support.

[0071] Figure 50 Examples of support-based or spring-based systems that may include or use a mid-field device are generally shown.

[0072] Figure 51 An example of a spring-based support member connected to the midfield device is shown in general.

[0073] Figure 52 An example of a spring-based support member connected to the midfield device is shown in general.

[0074] Figure 53 An example of a spring-based support is shown in general, which includes an elongated member with a coil shape.

[0075] Figure 54 An example of a system that may include multiple structures, each configured for intravascular placement during a single implantation procedure, is shown in general.

[0076] Figure 55 The diagram generally shows a cross-sectional view of the lumen that can surround the implantable midfield device, deployment structure, and inflatable balloon.

[0077] Figure 56 A perspective view is shown generally of the implantable device and deployment structure located outside the distal end of the lumen.

[0078] Figure 57 This image shows an example of an implantable device that has been implanted in a blood vessel.

[0079] Figure 58 An example of an implantable device is shown in general, which includes a device housing and an antenna that can extend outside the housing.

[0080] Figure 59 A perspective view generally shows an example of a first electrode assembly coupled to an electronic device module for an intravascular implantable device.

[0081] Figure 60 A perspective view generally shows an example of a second electrode assembly coupled to an electronic device module for an intravascular implantable device.

[0082] Figure 61 An example of an implantable device for intravascular use is shown in general.

[0083] Figure 62 A side view of the intravascular implantable device is shown in general.

[0084] Figure 63 A perspective view of the second intravascular implantable device is shown in general.

[0085] Figure 64 A perspective view of the third intravascular implantable device is shown in general.

[0086] Figure 65 An example of a mid-field device is shown in general, which is attached to an implantable device within a blood vessel.

[0087] Figure 66This image shows an example of a mid-field device that is attached to an intravascular implantable device located within a blood vessel.

[0088] Figure 67 A top view of an example of the first layer of a layered first transmitter is shown in general.

[0089] Figure 68A This is a top view of the second layer superimposed on the first layer of the layered first transmitter.

[0090] Figure 68B This is a top view of the second layer, which is superimposed on the different first layers of the layered transmitter.

[0091] Figure 69 Generally shown Figure 67 and Figure 68A A perspective view of an example of a layered first transmitter.

[0092] Figure 70 Generally shown Figure 67 , Figure 68A and Figure 69 A side view cross-sectional view of the layered first transmitter.

[0093] Figure 71 A top view of an example of a layered second transmitter is shown in general.

[0094] Figure 72 Generally shown Figure 71 A perspective view of the layered second transmitter.

[0095] Figure 73 A general example of a cross-sectional schematic diagram of the transmitter used for layering is shown.

[0096] Figure 74 The image shows an example of signal or field penetration within tissue.

[0097] Figure 75 The image shows an example of the surface current generated when the field transmitter is excited.

[0098] Figure 76 An example of a graph is shown in general, which illustrates the relationship between the coupling efficiency from the transmitter port to the implanted receiver and changes in the angle or rotation of the implanted receiver.

[0099] Figure 77A , Figure 77B and Figure 77C Examples of different polarizations of the midfield launcher are shown in general.

[0100] Figure 78This is a general example of a portion of a layered midfield launcher, showing the first layer with slots.

[0101] Figure 79 A perspective view of an example of a layered third transmitter is shown in general.

[0102] Figure 80 Generally shown Figure 79 A side view cross-sectional view of the layered third transmitter.

[0103] Figure 81 A block diagram is shown of an embodiment of a machine on which one or more methods discussed herein may be performed or which may be used in conjunction with one or more systems or apparatuses described herein. Detailed Implementation

[0104] In the following description, which includes examples of different neural electrode interfaces, reference is made to the accompanying drawings, which form part of the detailed description. The drawings illustrate, by way of illustration, specific embodiments in which the invention may be practiced. These embodiments are also referred to herein as “examples.” Such examples may include elements other than those shown or described. However, the inventors also contemplate instances in which only those elements shown or described are provided. The inventors contemplate examples of any combination or arrangement of those elements (or one or more aspects thereof) shown or described with respect to specific examples (or one or more aspects thereof) or with respect to other examples (or one or more aspects thereof) shown or described herein. The primary focus herein is on implantable devices and methods of assembling implantable devices. I. Implantable systems and devices

[0105] The chapter headings in this document (such as the one mentioned above, "Implantable Systems and Devices") are set to primarily guide the reader to the material corresponding to the heading indicated by that heading. However, the discussion under a specific heading should not be interpreted as applicable only to a single type of configuration; rather, the multiple features discussed in the various chapters or subsections of this document may be combined in various ways and sequences. For example, some discussions of the features and benefits of implantable systems and devices can be found in the text and corresponding figures under the current heading "Implantable Systems and Devices".

[0106] Mid-field power supply technology can provide power to a deeply implanted electrical stimulation device from an external power source located on or near the tissue surface (e.g., the outer surface of the user's skin). The user can be a clinical patient or other user. Mid-field power supply technology can have one or more advantages over implantable pulse generators. For example, a pulse generator can have one or more relatively large implantable batteries and / or one or more lead systems. In contrast, a mid-field device can include a relatively small battery cell that can be configured to receive and store a relatively small amount of electricity. A mid-field device can include one or more electrodes integrated into a single implantable package. Therefore, in some examples, a mid-field power supply device can provide a simpler implantation process than other conventional devices, which can result in lower costs and a lower risk of infection or other implantation complications. One or more of the advantages may come from the amount of electricity delivered to the implanted device. The ability to concentrate energy from the mid-field device can allow for an increase in the amount of electricity delivered to the implanted device.

[0107] The advantages of using mid-field powered technology can include an externally supplied main battery or power source to the patient, thus relaxing the low-power and high-efficiency circuitry requirements of conventional battery-powered implantable devices. Another advantage of using mid-field powered technology can be that the implantable device can be smaller in appearance than a battery-powered device. Therefore, mid-field powered technology can help achieve better patient tolerability and comfort, while reducing the cost of manufacturing and / or implantation in patient tissue.

[0108] There are currently unmet needs, including the use of mid-field transmitters and receivers to transmit power and / or data from external mid-field couplers or source devices to one or more implanted neurostimulation devices and / or one or more implanted sensor devices. The unmet needs may further include transmitting data from one or more implanted neurostimulation devices and implanted sensor devices to external mid-field couplers or source devices.

[0109] In one or more examples, multiple devices may be implanted in patient tissue and configured to deliver treatment and / or sense physiological information about the patient and / or about the treatment. The multiple implanted devices may be configured to communicate with one or more external devices. In one or more examples, the one or more external devices are configured to provide power and / or data signals to the multiple implanted devices, for example, simultaneously or in a time-division multiplexing (e.g., “polling scheduling”) manner. The provided power and / or data signals may be manipulated or directed by the external devices to efficiently transmit signals to the implant. While this disclosure may specifically relate to power signals or data signals, these references are generally understood to optionally include one or both of power signals and data signals.

[0110] The embodiments described herein may be advantageous because they include one, several, or all of the following benefits: (i) a system configured to (a) transmit power signals and / or data signals from a field coupler device via a field radio frequency (RF) signal to an implantable device, (b) generate and provide a therapeutic signal via one or more electrodes coupled to the implantable device, the therapeutic signal including an information component, and generate an incoming signal to provide the therapeutic signal, (c) receive the signal based on the therapeutic signal using electrodes coupled to the field coupler device, and (d) decode the received signal and respond to the information component at the field coupler device or another device; (ii) a dynamically configurable active field transceiver configured to provide an RF signal to modulate an evanescent field at a tissue surface, thereby generating a propagating field within the tissue to transmit power signals and / or data signals to an implanted target device (see, for example...). Figure 74 (i) an example, which illustrates signal penetration within tissue); (ii) an implantable device comprising an antenna configured to receive a mid-field power signal from a mid-field transceiver, and comprising therapeutic delivery circuitry configured to provide signal pulses to electrostimulation electrodes using a portion of the received mid-field power signal, wherein the signal pulses comprise therapeutic pulses and data pulses, and the data pulses may be interleaved with or embedded within the therapeutic pulses; (iii) an implantable device configured to encode information about the device itself in a therapeutic signal, such information including, for example, information about the operational status of the device or information about previously provided, concurrent, or planned future treatments provided by the device; (iv) a mid-field transceiver comprising electrodes configured to sense electrical signals at the surface of tissue; and / or (vi) an adjustable wireless signal source and receiver configured together to implement a communication loop or feedback loop.

[0111] In one or more examples, systems for manipulating evanescent fields at or near the surface of external tissue can be used to wirelessly transmit power and / or data to one or more target devices implanted in the tissue to achieve one or more of these benefits and other benefits. In one or more examples, one or more of these benefits can be achieved using one or more devices implanted in or capable of being implanted in the body and as described herein. In one or more examples, one or more of these benefits can be achieved using field power supply and / or communication devices (e.g., transmitter devices and / or receiver devices or transceiver devices).

[0112] The system may include a signal generator system adapted to provide multiple sets of different signals (e.g., RF signals). In some embodiments, each set may include two or more individual signals. The system may also include a mid-field transmitter comprising multiple excitation ports coupled to the RF signal generator system, and the mid-field transmitter is adapted to transmit multiple sets of different RF signals via the excitation ports at corresponding different times. The excitation ports may be adapted to receive some of the corresponding individual signals from each set of RF signals. Each set of RF signals transmitted may include a non-negligible magnetic field (H-field) component substantially parallel to the external tissue surface. In one or more examples, each set of RF signals transmitted is adapted or selected to manipulate the evanescent field at or near the tissue surface in different ways to transmit power and / or data signals via the mid-field signal rather than via inductive near-field coupling or radiative far-field transmission to one or more target devices implanted in the tissue.

[0113] In one or more examples, one or more of the above-described benefits can be achieved, at least in part, using an implantable therapeutic delivery device (e.g., a device configured to provide neurostimulation) including receiver circuitry comprising an antenna (e.g., an electric or magnetic field-based antenna) configured to receive a field power signal from an external source device, for example, when the receiver circuitry is implanted within tissue. The implantable therapeutic delivery device may include therapeutic delivery circuitry. The therapeutic delivery circuitry may be coupled to the receiver circuitry. The therapeutic delivery circuitry may be configured, for example, to provide signal pulses to one or more energy delivery components (e.g., electrostimulation electrodes) by using a portion of a field power signal received from an external source device (e.g., depending on the device's configuration and / or the environment of use, which is sometimes referred to herein as an external device, external source, external field device, field transmitter device, field coupler, field power supply device, power supply device, etc.), which may be integrally coupled to the body of the therapeutic delivery device or positioned separately from the body of the therapeutic delivery device (e.g., not positioned on the body of the therapeutic delivery device). The signal pulses may include one or more electrostimulation therapeutic pulses and / or data pulses. In one or more examples, one or more of the removals described above may be implemented, at least in part, using an external transmitter and / or receiver (e.g., transceiver) device comprising an electrode pair configured to be placed on an external tissue surface and configured to receive an electrical signal via the tissue. This electrical signal may correspond to an electrical stimulation therapy delivered to the tissue via a therapeutic delivery device. A demodulator circuit may be coupled to the electrode pair and configured to demodulate a portion of the received electrical signal to recover the data signal generated by the therapeutic delivery device.

[0114] In one or more examples, including the use of a mid-field wireless coupler, tissue can act as a dielectric to tunnel energy. Coherent interference of the propagation modes can confine the field at the focal plane to a size smaller than the corresponding vacuum wavelength; for example, the spot size is affected by the diffraction limit in high-refractive-index materials. In one or more examples, a receiver positioned in such a high-energy-density region (e.g., implanted in tissue) can be one or more orders of magnitude smaller than a conventional near-field implantable receiver, or can be implanted deeper in the tissue (e.g., deeper than 1 cm). In one or more examples, the transmitter source described herein can be configured to deliver electromagnetic energy to multiple target locations, including, for example, devices implanted at one or more depths. In one example, energy can be delivered to locations with a positioning accuracy greater than about a few millimeters. That is, the transmitted power signal or energy signal can be directed or focused onto a target location within about one wavelength of the signal in the tissue. This energy focusing is generally more precise than focusing achievable via conventional inductive devices and is sufficient to provide adequate power to a millimeter-scale receiver. In other wireless power supply methods using near-field coupling (inductive coupling and its resonant enhancement derivatives), the evanescent component outside the tissue (e.g., near the source) continues to evanescent within the tissue, which does not allow for effective depth penetration. Unlike near-field coupling, energy from a field source is primarily carried in a propagation mode; therefore, the energy transmission depth is limited by environmental losses, but not by the inherent attenuation of the near field. Energy transmission utilizing these characteristics can be at least two to three orders of magnitude more efficient than near-field systems.

[0115] One or more of the systems, devices, and methods discussed herein can be used to help treat fecal or urinary incontinence (e.g., overactive bladder) by stimulating, for example, the tibial nerve (e.g., but not limited to the posterior tibial nerve) or any branch of the tibial nerve, one or more nerves or nerve branches originating from the sacral plexus (including, but not limited to, S1-S4, the tibial nerve, and / or the pudendal nerve). Urinary incontinence can be treated by stimulating one or more muscles of the pelvic floor, the nerves innervating the pelvic floor muscles, the internal urethral sphincter, the external urethral sphincter, and the pudendal nerve or branches of the pudendal nerve.

[0116] One or more of the systems, devices, and methods discussed herein can be used to aid in the treatment of sleep apnea and / or snoring by stimulating one or more of the hypoglossal nerve or its branches, the root of the tongue (muscle), the phrenic nerve, the intercostal nerves, the accessory nerve, and the cervical nerves C3-C6. Treatment of sleep apnea and / or snoring may include providing energy to an implant to sense a reduction, impairment, or cessation of breathing, for example, by measuring oxygen saturation.

[0117] One or more of the systems, devices, and methods discussed herein can be used, for example, to help treat vaginal dryness by stimulating one or more of the vestibular bulb glands, Skene's glands, and the vaginal lining. One or more of the systems, devices, and methods discussed herein can be used, for example, to help treat migraines or other headaches by stimulating one or more of the occipital nerve, supraorbital nerve, C2 cervical nerve or its branches, and frontal nerve or its branches. One or more of the systems, devices, and methods discussed herein can be used, for example, to help treat post-traumatic stress disorder, hot flashes, and / or complex regional pain syndromes by stimulating one or more of the stellate ganglion and C4-C7 sympathetic trunks.

[0118] One or more of the systems, devices, and methods discussed herein can be used to help treat neuralgia (e.g., trigeminal neuralgia), for example, by stimulating the sphenopalatine ganglion nerve block, the trigeminal nerve, or one or more branches of the trigeminal nerve. One or more of the systems, devices, and methods discussed herein can be used to help treat dry mouth (e.g., caused by drugs, chemotherapy or radiation therapy, cancer treatment, Sjögren's syndrome, or other causes of dry mouth), for example, by stimulating the buccal mucosa, labial mucosa and / or lingual mucosa, soft palate, lateral part of the hard palate and / or floor of the mouth, tissues within the oral cavity and / or between the tongue muscle fibers, Ebernal gland, glossopharyngeal nerve (CN IX), branches including CN IX (including the auricular ganglion), facial nerve (CN VII), branches including CN VII (e.g., the submandibular ganglion) and branches of T1-T3 (e.g., the upper cervical ganglion).

[0119] One or more of the systems, devices, and methods discussed herein can be used, for example, to aid in the treatment of a transverse nerve by sensing electrical output from the proximal portion of the transverse nerve and delivering electrical input to the distal portion of the transverse nerve, and / or sensing electrical output from the distal portion of the transverse nerve and delivering electrical input to the proximal portion of the transverse nerve. One or more of the systems, devices, and methods discussed herein can be used, for example, to aid in the treatment of cerebral palsy by stimulating one or more muscles or nerves innervated by one or more affected muscles in a patient with cerebral palsy. One or more of the systems, devices, and methods discussed herein can be used, for example, to aid in the treatment of erectile dysfunction by stimulating the pelvic splanchnic nerves (S2-S4) or any of their branches, the pudendal nerve, the cavernous nerve, and the hypogastric plexus.

[0120] One or more of the systems, devices, and methods discussed herein can be used, for example, to help treat menstrual pain by stimulating one or more of the uterus and vagina. One or more of the systems, devices, and methods discussed herein can be used as intrauterine devices, for example, by sensing one or more of pH and blood flow or by delivering an electric current or a drug to help with contraception, fertility, bleeding, or pain. One or more of the systems, devices, and methods discussed herein can be used, for example, to stimulate human arousal by stimulating female genitalia (both external and internal) (including the clitoris or other sensory activity sites in women) or by stimulating male genitalia.

[0121] One or more of the systems, devices, and methods discussed herein can be used, for example, to aid in the treatment of hypertension by stimulating the carotid sinus, the left or right cervical vagus nerve, or one or more branches of the vagus nerve. One or more of the systems, devices, and methods discussed herein can be used, for example, to aid in the treatment of paroxysmal supraventricular tachycardia by stimulating one or more of the trigeminal nerve or its branches, the anterior ethmoid nerve, and the vagus nerve. One or more of the systems, devices, and methods discussed herein can be used, for example, to aid in the treatment of vocal cord dysfunction by sensing the activity of the vocal cords and the relative vocal cords, or by stimulating only one or more of the vocal cords by stimulating the nerves innervating the vocal cords, the left and / or right recurrent laryngeal nerves, and the vagus nerve.

[0122] One or more of the systems, devices, and methods discussed herein can be used to aid in tissue repair, for example, by stimulating tissue to enhance microcirculation and protein synthesis to heal wounds and restore the integrity of connective tissue and / or dermal tissue. One or more of the systems, devices, and methods discussed herein can also be used to aid in the treatment of asthma or chronic obstructive pulmonary disease, for example, by stimulating the vagus nerve or its branches, blocking the release of norepinephrine and / or acetylcholine, and / or interfering with one or more receptors for norepinephrine and / or acetylcholine.

[0123] One or more of the systems, devices, and methods discussed herein can be used, for example, to aid in the treatment of cancer by stimulating one or more nerves near or within a tumor to reduce sympathetic innervation (e.g., adrenaline / NE release) and / or parasympathetic innervation (e.g., adrenocortical hormones). One or more of the systems, devices, and methods discussed herein can be used, for example, to aid in the treatment of diabetes by powering a sensor in the human body that detects diabetes parameters (e.g., glucose or ketone levels) and using such sensor data to modulate the delivery of exogenous insulin from an insulin pump. One or more of the systems, devices, and methods discussed herein can be used, for example, to aid in the treatment of diabetes by powering a sensor in the human body that detects diabetes parameters (e.g., glucose or ketone levels) and by using a mid-field coupling agent to stimulate the release of insulin from pancreatic β-cells.

[0124] One or more of the systems, devices, and methods discussed herein can be used, for example, to help treat neurological symptoms, conditions, or diseases (e.g., Parkinson's disease (e.g., by stimulating the interior or nuclei of the brain), Alzheimer's disease, Huntington's disease, dementia, Cujjac syndrome, epilepsy (e.g., by stimulating the left cervical vagus nerve or trigeminal nerve), post-traumatic stress disorder (PTSD) (e.g., by stimulating the left cervical vagus nerve), or essential tremor (e.g., by stimulating the thalamus), neuralgia, depression, dystonia (e.g., by stimulating the interior or nuclei of the brain), phantom limbs (e.g., by stimulating amputation nerves, such as the distal ends of amputation nerves), dry eye (e.g., by stimulating the lacrimal glands), arrhythmias (e.g., by stimulating the heart), and gastrointestinal disorders (e.g., obesity, gastroesophageal reflux, and / or gastroparesis) by stimulating the C1-C2 occipital nerves or deep brain stimulation (DBS) and / or stroke (e.g., by stimulating the subdural muscles of the motor cortex), such as by stimulating the C1-C2 occipital nerves or deep brain stimulation (DBS) and / or stroke by stimulating the C1-C2 occipital nerves or / or deep brain stimulation (DBS) of the hypothalamus, esophagus, or the muscles of the sphincter leading to the stomach and / or the lower stomach). Using one or more examples discussed in this article, stimulation can be provided continuously, as needed (e.g., as requested by a doctor, patient, or other user), or periodically.

[0125] When stimulation is delivered, the implantable device can be positioned up to five centimeters or more below the skin surface. The mid-field power supply device is capable of delivering power to those depths within the tissue. In one or more examples, the implantable device can be positioned at a distance of approximately 2 to 4 centimeters, approximately 3 centimeters, between approximately 1 and 5 centimeters, less than 1 centimeter, approximately 2 centimeters, or other distances below the skin surface. The implantation depth may depend on the intended use of the implantable device. For example, to treat depression, hypertension, epilepsy, and / or post-traumatic stress disorder (PTSD), the implantable device may be positioned between approximately 2 and approximately 4 centimeters below the skin surface. In another example, to treat sleep apnea, arrhythmias (e.g., bradycardia), obesity, gastroesophageal reflux, and / or gastroparesis, the implantable device may be positioned more than approximately 3 centimeters below the skin surface. In yet another example, to treat Parkinson's disease, essential tremor, and / or dystonia, the implantable device may be positioned between approximately 1 and approximately 5 centimeters below the skin surface. Other examples include placing an implantable device between about 1 cm and about 2 cm below the skin surface to treat fibromyalgia, stroke and / or migraine, placing it about 2 cm below the skin surface to treat asthma, and placing it about 1 cm or less below the skin surface to treat dry eye.

[0126] While many of the embodiments included herein describe apparatus or methods for providing stimulation (e.g., electrical stimulation), embodiments may be adapted to provide other forms of modulation besides or in lieu of stimulation (e.g., denervation). Additionally, although many of the embodiments included herein relate to the use of electrodes for therapeutic delivery, other embodiments may use or deliver other energy delivery components (e.g., ultrasonic transducers or other ultrasonic energy delivery components) or other therapeutic components or substances (e.g., fluid delivery devices or components for delivering chemicals, drugs, cryogenic fluids, thermal fluids, or steam or other fluids).

[0127] Figure 1 A schematic diagram of an embodiment of system 100 using a wireless communication path is generally shown. System 100 includes an example of an external source 102 positioned at or above an interface 105 between air 104 and a high-refractive-index material 106 (e.g., body tissue). This external source 102 is, for example, a field transmitter source, sometimes referred to as a field coupler. The external source 102 may generate source currents (e.g., in-plane source currents). The source currents (e.g., in-plane source currents) may generate electric and magnetic fields. The magnetic field may include a non-negligible component parallel to the surface of source 102 and / or the surface of high-refractive-index material 106 (e.g., the surface of high-refractive-index material 106 facing the external source 102). According to several embodiments, external source 102 may include the structural features and functions of the mid-field coupler and external source described in International Publication No. WO2015 / 179225 entitled “MIDFIELD COUPLER”, published on November 26, 2015, which is incorporated herein by reference in its entirety.

[0128] External source 102 may include at least one pair of outward-facing electrodes 121 and 122. Electrodes 121 and 122 may be configured to contact a tissue surface, for example, at interface 105. In one or more examples, external source 102 is configured for use with a sleeve, pocket, or other garment or accessory that holds external source 102 adjacent to a high-refractive-index material 106 and optionally maintains electrodes 121 and 122 in physical contact with a tissue surface. In one or more examples, the cannula, pocket, or other garment or accessory may include or use conductive fibers or fabric, and electrodes 121 and 122 may be in physical contact with a tissue surface via conductive fibers or fabric.

[0129] In one or more examples, more than two outward-facing electrodes may be used, and the processor circuitry carried by or assisted by source 102 may be configured to select the optimal electrode pair or group for sensing far-field signal information (e.g., signal information corresponding to delivered therapeutic or near-field signals). In this embodiment, the electrodes may operate as antennas. In one or more examples, source 102 includes three outward-facing electrodes arranged in a triangle or four outward-facing electrodes arranged in a rectangle, and any two or more of the electrodes may be selected for sensing and / or may be electrically grouped or coupled together for sensing or diagnostic purposes. In one or more examples, the processor circuitry may be configured to sense multiple different electrode combination selections to identify the optimal configuration for sensing far-field signals (examples of the processor circuitry are provided in...). Figure 2A (as presented in the text, etc.).

[0130] Figure 1 Embodiments of the implantable device 110 are shown, which may include, for example, a multipolar therapeutic delivery device configured to be implanted in a high-refractive-index material 106 or in a blood vessel. In one or more examples, the implantable device 110 includes [missing information - likely related to a specific component or component]. Figure 5 All or part of the circuitry 500 will be discussed in further detail below. In one or more examples, the implantable device 110 is implanted in tissue below the tissue-air interface 105. Figure 1 In the implantable device 110, an elongated body and a plurality of electrodes E0, E1, E2, and E3 spaced axially along a portion of the elongated body are included. The implantable device 110 includes receiver and / or transmitter circuitry. Figure 1 Not shown in the figure, see example Figure 2A , Figure 2B and Figure 4 (etc.), which enables communication between the implantable device 110 and the external source 102.

[0131] Multiple electrodes E0-E3 can be configured to deliver electrical stimulation therapy to or near a nerve or muscle target, for example. In one or more examples, at least one electrode may be selected as the anode, and at least one other electrode may be selected as the cathode to define the electrical stimulation vector. In one or more examples, electrode E1 is selected as the anode, and electrode E2 is selected as the cathode. Commonly, the combination of E1-E2 defines the electrical stimulation vector V12. Multiple vectors can be configured independently to deliver neurostimulation therapy to the same or different tissue targets, for example, simultaneously or at different times.

[0132] In one or more examples, source 102 includes an antenna (see example...) Figure 3The implantable device 110 includes an antenna 108 (e.g., an electric field-based or magnetic field-based antenna). The antenna (e.g., in terms of length, width, shape, material, etc.) can be configured to transmit and receive signals at substantially the same frequency. The implantable device 110 can be configured to transmit power signals and / or data signals through the antenna 108 to an external source 102, and to receive power signals and / or data signals transmitted by the external source 102. The external source 102 and the implantable device 110 can be used to transmit and / or receive RF signals. A transmit / receive (T / R) switch can be used to switch each RF port of the external source 102 from transmit (transmit data or power) mode to receive (receive data) mode. The T / R switch can also be used to switch the implantable device 110 between transmit and receive modes. In particular, see... Figure 4 An example of a T / R switch.

[0133] In one or more examples, a receiving terminal on external source 102 may be connected to one or more components that detect the phase and / or amplitude of a signal received from implantable device 110. Phase and amplitude information may be used to program the phase of the transmitted signal to, for example, have substantially the same relative phase as the signal received from implantable device 110. To aid in this, external source 102 may include or use phase-matching and / or amplitude-matching networks, such as… Figure 4 The network shown in the embodiment. The phase-matching and / or amplitude-matching network can be configured for use with a mid-field antenna (e.g., including multiple ports). Figure 3 (As shown in the embodiments) used together.

[0134] Refer again Figure 1In one or more examples, the implantable device 110 may be configured to receive a mid-field signal 131 from an external source 102. The mid-field signal 131 may include power and / or data signal components. In some embodiments, the power signal component may include one or more data components embedded therein. In one or more examples, the mid-field signal 131 includes configuration data for use by the implantable device 110. The configuration data may in particular define therapeutic signal parameters, such as therapeutic signal frequency, pulse width, amplitude, or other signal waveform parameters. In one or more examples, the implantable device 110 may be configured to deliver electrical stimulation therapy to a therapeutic target 190, which may include, for example, a neural target (e.g., a nerve or other tissue such as a vein, connective tissue, or other tissue including one or more neurons in or near the nerve), a muscle target, or other tissue target. A portion of the power signal received from the external source 102 may be used to provide electrical stimulation therapy delivered to the therapeutic target 190. Examples of therapeutic targets 190 may include neural tissue or neural targets, such as those in the cervical, thoracic, lumbar, or sacral regions, brain tissue, muscle tissue, abnormal tissue (e.g., tumors or cancerous tissue), targets corresponding to the sympathetic or parasympathetic nervous system, targets at or near peripheral nerve bundles or fibers, neural tissue or neural targets selected to treat urinary incontinence, urinary urgency, overactive bladder, fecal incontinence, constipation, pain, neuralgia, pelvic pain, movement disorders or other diseases or conditions, deep brain stimulation (DBS) therapeutic targets, or other targets at or near any other condition, disease or condition (such as those identified herein).

[0135] The delivery of electrical stimulation therapy may include using a portion of a power signal received via a mid-field signal 131 and supplying a current signal to electrodes or electrode pairs (e.g., two or more in E0-E3) coupled to the implantable device 110 to stimulate the treatment target 190. The supply of a current signal to the electrodes results in the generation of a near-field signal 132. The potential difference caused by the near-field signal 132 can be detected remotely relative to the treatment delivery location. Several factors influence where and whether the potential difference can be detected, including in particular the characteristics of the treatment signal, the type or arrangement of the treatment delivery electrodes, and the characteristics of any surrounding biological tissue. This remotely detected potential difference can be considered as a far-field signal 133. The far-field signal 133 may represent an attenuated portion of the near-field signal 132. That is, the near-field signal 132 and the far-field signal 133 may originate from the same signal or field. For example, the near-field signal 132 is considered to be associated with an area at or near the implantable device 110 and the treatment target 190, and the far-field signal 133 is considered to be associated with other areas further away from the implantable device 110 and the treatment target 190. In one or more examples, information about the implantable device 110 or about prior or future planned treatments provided by the implantable device 110 may be encoded in the treatment signal and detected and decoded by the external source 102 by means of the far-field signal 133.

[0136] In one or more examples, device 110 may be configured to deliver a series of electrical stimulation pulses to a tissue target (e.g., a neural target). For example, device 110 may provide multiple electrical stimulation pulses that are separated in time, thereby providing treatment, for example, using the same or different electrical stimulation vectors. In one or more examples, treatment comprising multiple signals may be provided in parallel to multiple different vectors, or may be provided sequentially to provide many or a series of electrical stimulation pulses to the same neural target. Thus, even if one vector is more optimized for eliciting a patient response than others, the treatment as a whole may be more effective than stimulating only the known optimized vector, because (1) the target may experience a rest period during non-stimulation, and / or (2) stimulating the area near and / or adjacent to the optimal target may cause some patient benefit.

[0137] System 100 may include a sensor 107 at or near an interface 105 between air 104 and a high-refractive-index material 106. Sensor 107 may include, in particular, one or more electrodes, optical sensors, accelerometers, temperature sensors, force sensors, pressure sensors, or surface electromyography (EMG) devices. Sensor 107 may include multiple sensors (e.g., two, three, four, or more than four sensors). Depending on the type of sensor used, sensor 107 may be configured to monitor electrical, muscle, or other activity in the vicinity of device 110 and / or source 102. For example, sensor 107 may be configured to monitor muscle activity at a tissue surface. If muscle activity exceeding a specified threshold level is detected, the power level of source 102 and / or device 110 may be adjusted. In one or more examples, sensor 107 may be coupled to or integrated with source 102, and in other examples, sensor 107 may be decoupled from and (e.g., using wired or radio coupling or connection) communicate with source 102.

[0138] System 100 may include a far-field sensor device 130, which may be decoupled or communicatively coupled to one or more of source 102 and sensor 107. Far-field sensor device 130 may include two or more electrodes and may be configured to sense far-field signals, such as far-field signals 133 corresponding to treatment delivered by device 110. Far-field sensor device 130 may include at least a pair of outward-facing electrodes 123 and 124 configured to contact a tissue surface (e.g., a tissue surface at interface 105). For example, in one or more examples, three or more electrodes may be used, and processor circuitry carried by or assisted by far-field sensor device 130 may select various combinations of two or more electrodes for sensing far-field signal 133. In one or more examples, far-field sensor device 130 may be configured for use with a sleeve, pocket, or other garment or accessory that holds far-field sensor device 130 in proximity to a high-refractive-index material 106 and optionally maintains electrodes 123 and 124 in physical contact with the tissue surface. In one or more examples, sleeves, pockets, or other clothing or accessories may include or use conductive fibers or fabrics, and electrodes 123 and 124 may physically contact the tissue surface via the conductive fibers or fabrics. (This is in conjunction with...) Figure 2B Examples of at least a portion of the far-field sensor device 130 are further described.

[0139] In one or more examples, an external source 102 provides an implantable device 110 with a field signal 131 comprising power signals and / or data signals. The field signal 131 includes signals (e.g., RF signals) having various or adjustable amplitude, frequency, phase, and / or other signal characteristics. The implantable device 110 may include an antenna, such as the one described below, capable of receiving the field signal 131, and can modulate the received signal at the antenna based on characteristics of the receiver circuitry in the implantable device 110 to generate a backscattered signal. In one or more examples, the implantable device 110 may encode information in the backscattered signal 112, such as information about the characteristics of the implantable device 110 itself, information about the receiving portion of the field signal 131, information about treatment provided by the implantable device 110, and / or other information. The backscattered signal 112 may be received by an antenna at the external source 102 and / or the far-field sensor device 130, or may be received by other devices. In one or more examples, the biosignal can be sensed by a sensor of the implantable device 110, such as a glucose sensor, an electrode potential (e.g., an electromyography sensor, an electrocardiogram (ECG) sensor, a resistor, or other electrical sensor), a light sensor, a temperature sensor, a pressure sensor, an oxygen sensor, a motion sensor, etc. The signal representing the detected biosignal can be modulated onto the backscattered signal 112. Other sensors are discussed elsewhere in this document, such as in conjunction with... Figure 81 The following will be discussed. In this embodiment, sensor 107 may include appropriate monitoring devices, such as glucose, temperature, ECG, EMG, oxygen, or other monitors, to receive, decode, interpret, and / or store data modulated onto the backscattered signal.

[0140] In one or more examples, the external source 102 and / or implantable device 110 may include an optical transceiver configured to facilitate communication between the external source 102 and the implantable device 110. The external source 102 may include a light source, such as a photodiode or LED, or may include a photodetector, or may include both a light source and a photodetector. The implantable device 110 may include a light source, such as a photodiode or LED, or may include a photodetector, or may include both a light source and a photodetector. In one example, the external source 102 and / or implantable device 110 may include a window adjacent to its light source or photodetector, such as a window made of quartz, glass, or other translucent material.

[0141] In one example, optical communication may be decoupled from or supplemented by electromagnetic coupling between external source 102 and implantable device 110. Optical communication may be provided using optical pulses modulated according to various protocols, such as pulse position modulation (PPM). In one example, the light source and / or photodetector carried by implantable device 110 may be powered by a power signal received at least partially via a field coupling with external source 102.

[0142] In one example, a light source at external source 102 can transmit a communication signal through the skin into the subcutaneous tissue and through an optical window (e.g., a quartz window) in the implantable device 110. This communication signal can be received at a photodetector carried on the implantable device 110. Various measurement, treatment, or other information from or relating to the implantable device can be encoded and emitted from the implantable device 110 using a light source located at the implantable device 110. The light signal emitted from the implantable device 110 can travel through the same optical window, subcutaneous tissue, and skin tissue, and can be received at a photodetector carried on external source 102. In one example, the light source and / or photodetector may be configured to emit and / or receive electromagnetic waves in the visible or infrared regions, for example, in the wavelength range of about 670-910 nm (e.g., 670 nm - 800 nm, 700 nm - 760 nm, 670 nm - 870 nm, 740 nm - 850 nm, 800 nm - 910 nm, their overlapping ranges, or any value within the range).

[0143] As an example, Figure 2A A block diagram illustrating an embodiment of a field source device, such as an external source 102, is shown. The external source 102 may include various components, circuits, or functional elements in data communication with each other. Figure 2A In the example, external source 102 includes components such as processor circuitry 210, one or more sensing electrodes 220 (e.g., including electrodes 121 and 122), demodulator circuitry 230, phase-matching or amplitude-matching network 400, mid-field antenna 300, and / or one or more feedback devices, which may include or use, for example, an audio speaker 251, a display interface 252, and / or a haptic feedback device 253. The following... Figure 3 The mid-field antenna 300 is further described in the embodiments, and below... Figure 4 The network 400 is further described in the embodiments. The processor circuit 210 may be configured to coordinate various functions and activities of components, circuits and / or functional elements of the external source 102.

[0144] The mid-field antenna 300 can be configured to provide a mid-field excitation signal, such as an RF signal having a non-negligible H-field component substantially parallel to the external tissue surface. In one or more examples, the RF signal can be adjusted or selected to manipulate the evanescent field at or near the tissue surface to transmit power and / or data signals to corresponding different target devices implanted in the tissue (e.g., implantable device 110 or any one or more other implantable devices described herein). The mid-field antenna 300 can also be configured to receive backscattered or other wireless signal information that can be demodulated by demodulator circuitry 230. The demodulated signal can be interpreted by processor circuitry 210. The mid-field antenna 300 can include a dipole antenna, loop antenna, coil antenna, slot or strip antenna, or other antenna. Antenna 300 may be shaped and sized to receive signals ranging between approximately 400 MHz and approximately 4 GHz (e.g., between 400 MHz and 1 GHz, between 400 MHz and 3 GHz, between 500 MHz and 2 GHz, between 1 GHz and 3 GHz, between 500 MHz and 1.5 GHz, between 1 GHz and 2 GHz, between 2 GHz and 3 GHz, their overlapping ranges, or any value within said ranges). In embodiments incorporating a dipole antenna, the mid-field antenna 300 may include a straight dipole, a folded dipole, a short dipole, a cage dipole, a bowtie dipole, or a bat-shaped dipole having two substantially straight conductors.

[0145] Demodulator circuitry 230 may be coupled to sensing electrode 220. In one or more examples, sensing electrode 220 may be configured to receive far-field signal 133, for example, based on treatment provided by implantable device 110, which may be delivered to treatment target 190. The treatment may include embedded or intermittent data signal components that may be extracted from far-field signal 133 by demodulator circuitry 230. For example, data signal components may include amplitude-modulated or phase-modulated signal components that may be distinguished from background noise or other signals and processed by demodulator circuitry 230 to generate information signals that can be interpreted by processor circuitry 210. Based on the content of the information signal, processor circuitry 210 may instruct a feedback device to alert a patient, caregiver, or other system or individual. For example, in response to an information signal indicating successful delivery of a specified treatment, processor circuitry 210 may instruct audio speaker 251 to provide auditory feedback to the patient, may instruct display interface 252 to provide visual or graphical information to the patient, and / or may instruct haptic feedback device 253 to provide tactile stimulation to the patient. In one or more examples, the haptic feedback device 253 includes a transducer configured to vibrate or provide another mechanical signal.

[0146] Figure 2BA block diagram is generally illustrated as part of a system configured to receive far-field signals. This system may include sensing electrodes 220, such as electrodes 121 and 122 of source 102, or electrodes 123 and 124 of far-field sensor device 130. Figure 2B In the example, at least four sensing electrodes are present, collectively referred to as sensing electrodes 220 and individually as SE0, SE1, SE2, and SE3; however, other numbers of sensing electrodes 220 may also be used. The sensing electrodes may be communicatively coupled to a multiplexer circuit (MUX) 261. The multiplexer circuit 261 may select electrode pairs or groups for sensing far-field signal information. In one or more examples, the multiplexer circuit 261 selects electrode pairs or groups based on the highest signal-to-noise ratio of the detected received signal or based on another relative indicator of signal quality (e.g., amplitude, frequency content, and / or other signal characteristics).

[0147] The sensed electrical signal from multiplexer circuit 261 can undergo various processing steps to extract information from the signal. For example, the analog signal from multiplexer circuit 261 can be filtered by bandpass filter 262. Bandpass filter 262 can be centered on the known or expected modulation frequency of the sensed signal of interest. The bandpass-filtered signal can then be amplified by low-noise amplifier 263. The amplified signal can be converted into a digital signal by analog-to-digital converter circuit (ADC) 264. This digital signal can be further processed by various digital signal processors 265 (as further described herein) for retrieving or extracting information signals transmitted by implantable device 110.

[0148] Figure 3 A schematic diagram of an embodiment of a mid-field antenna 300 having multiple subwavelength structures 301, 302, 303, and 304 is generally shown. The mid-field antenna 300 may include a mid-field plate structure having a flat surface. One or more subwavelength structures 301-304 may be formed in this plate structure. Figure 3In the example, antenna 300 includes a first subwavelength structure 301, a second subwavelength structure 302, a third subwavelength structure 303, and a fourth subwavelength structure 304. Fewer or more subwavelength structures may be used. Subwavelength structures may be individually or selectively excited by one or more RF ports (e.g., first to fourth RF ports 311, 312, 313, and 314) respectively coupled thereto. A “subwavelength structure” may include a hardware structure having dimensions defined relative to the wavelength of the field manifested and / or received by external source 102. For example, for a given λ0 corresponding to a signal wavelength in air, a source structure including one or more dimensions smaller than λ0 may be considered a subwavelength structure. Various designs or configurations of subwavelength structures may be used. Some examples of subwavelength structures may include slots in a planar structure, or strips or patches of conductive sheets of generally planar material.

[0149] Figure 4 A phase-matched or amplitude-matched network 400 is generally shown. In one example, network 400 may include antenna 300, and antenna 300 may be transmitted via, for example, through... Figure 3 The first through fourth RF ports 311, 312, 313, and 314 shown are electrically coupled to a plurality of switches 404A, 404B, and 404C. Switches 404A-D are each electrically coupled to a corresponding phase and / or amplitude detector 406A, 406B, 406C, and 406D and a corresponding variable gain amplifier 408A, 408B, 408C, and 408D. Each amplifier 408A-D is electrically coupled to a corresponding phase shifter 410A, 410B, 410C, and 410D, and each phase shifter 410A-D is electrically coupled to a common power divider 412, which receives the RF input signal 414 to be transmitted using an external source 102.

[0150] In one or more examples, switches 404A-D can be configured to select either the receive line (“R”) or the transmit line (“T”). The number of switches 404A-D in network 400 can be equal to the number of ports of the field source 402. In an example of network 400, the field source 402 includes four ports (e.g., corresponding to...). Figure 3 (Example antenna 300 has four subwavelength structures). However, any number of ports (and switches) can be used, such as one, two, three, four, five, six, seven, eight or more.

[0151] Phase and / or amplitude detectors 406A-D are configured to detect the phase (Φ1, Φ2, Φ3, Φ4) ​​and / or power (P1, P2, P3, P4) of the signal received at each corresponding port of the field source 402. In one or more examples, the phase and / or amplitude detectors 406A-D may be implemented in one or more modules (hardware modules, which may include electrical or electronic components arranged to perform operations such as determining the phase or amplitude of a signal), such as phase detector modules and / or amplitude detector modules. Detectors 406A-D may include analog and / or digital components arranged to generate one or more signals representing the phase and / or amplitude of the signal received at the external source 102.

[0152] Amplifiers 408A-D can receive corresponding inputs from phase shifters 410A-D (e.g., phase shift of Pk by Φk, Φ1+Φk, Φ2+Φk, Φ3+Φk, or Φ4+Φk). When the amplitude of RF signal 414 is 4... M (in) Figure 4 In the embodiment (where), the amplifier output O is typically the power divider output M multiplied by the amplifier gain Pi. Pk. Pk can be dynamically set as the values ​​of P1, P2, P3 and / or P4 change. Φk can be a constant. In one or more examples, the phase shifter 410A-D can dynamically or responsively configure the relative phase of the ports based on phase information received from the detector 406A-D.

[0153] In one or more examples, the transmit power requirement from the mid-field source 402 is Ptt. The RF signal supplied to the power divider 412 has 4 The power of M. The output of amplifier 408A is approximately M. P1 Pk. Therefore, the power emitted from the mid-field coupler is M. (P1 Pk + P2 Pk + P3 Pk + P4 Pk) = Ptt. Solving for Pk, we get Pk = Ptt / (M) (P1 + P2 + P3 + P4)).

[0154] The amplitude of the signal at each RF port can be transmitted with the same relative (scaled) amplitude as the signal received at the corresponding port coupled to that RF port at the mid-field coupler. The gain of amplifiers 408A-D can be further improved to account for any losses between the transmission and reception of the signal from the mid-field coupler. Considering the reception efficiency η = Pir / Ptt, where Pir is the power received at the implanted receiver, the efficiency (e.g., maximum efficiency) can be estimated based on the amplitude received from the implantable source at an external mid-field source, given a specified phase and amplitude tuning. This estimate can be given as η ≈ (P1+P2+P3+P4) / Pit, where Pit is the original power of the signal from the implanted source. Information about the magnitude of the power transmitted from the implantable device 110 can be transmitted as a data signal to the external source 102. In one or more examples, the amplitude of the signal received at amplifiers 408A-D can be scaled according to the determined efficiency to ensure that the implantable device receives power to perform one or more programming operations. Given an estimated link efficiency η and an implant power (e.g., amplitude) requirement Pir', Pk can be scaled to Pk = Pir' / [η(P1 + P2 + P3 + P4)] to help ensure that the implant receives enough power to perform the programmed function.

[0155] The control signals (e.g., phase input and gain input) used for the phase shifters 410A-D and amplifiers 408A-D respectively can be obtained from... Figure 4 The processing circuitry, not shown, is provided. This circuitry is omitted to make... Figure 4 The views provided are neither overly complex nor obscure. The same or different processing circuitry can be used to update the state of one or more of the switches 404A-D between the receive and transmit configurations. See also Figure 2A The processor circuit 210 and examples of the processing circuit are described in connection with it.

[0156] Figure 5A diagram generally illustrates an embodiment of circuitry 500 for an implantable device 110 or target device, which, according to one or more embodiments discussed herein, may include, for example, an elongated device and may optionally be deployed within a blood vessel. Circuitry 500 includes one or more pads 536, for example, that may be electrically connected to antenna 108. Circuitry 500 may include a tunable matching network 538 to set the impedance of antenna 108 based on the input impedance of circuitry 500. For example, the impedance of antenna 108 may change due to environmental variations. Tunable matching network 538 may adjust the input impedance of circuitry 500 based on the changing impedance of antenna 108. In one or more examples, the impedance of tunable matching network 538 may be matched to the impedance of antenna 108. In one or more examples, the impedance of tunable matching network 538 may be set such that a portion of a signal incident on antenna 108 is reflected back from antenna 108, thereby generating a backscattered signal.

[0157] A transmit-receive (T / R) switch 541 can be used to switch circuit 500 from a receive mode (e.g., where power and / or data signals can be received) to a transmit mode (e.g., where signals can be transmitted to another implanted or external device). An active transmitter can operate in the 2.45 GHz or 915 MHz Industrial, Scientific, and Medical (ISM) band or the 402 MHz Medical Implant Communications Service (MICS) band for transmitting data from the implant. Alternatively, a surface acoustic wave (SAW) device can be used to transmit data, which backscatters incident radio frequency (RF) energy to an external device.

[0158] Circuit 500 may include a power meter 542 for detecting the amount of power received at the implanted device. A signal indicating the power from power meter 542 may be used by digital controller 548 to determine whether the received power is sufficient (e.g., above a specified threshold) for the circuit to perform certain specified functions. The relative value of the signal generated by power meter 542 may be used to indicate to a user or machine whether an external device (e.g., source 102) for powering circuit 500 is in a suitable position for transmitting power and / or data to the target device.

[0159] In one or more examples, circuit 500 may include demodulator 544 for demodulating the received data signal. Demodulation may include extracting the original information-bearing signal from the modulated carrier signal. In one or more examples, circuit 500 may include rectifier 546 for rectifying the received AC power signal.

[0160] Circuitry (e.g., state logic, Boolean logic, etc.) may be integrated into digital controller 548. Digital controller 548 may be configured to control various functions of the receiver device, for example, based on one or more of the power meter 542, demodulator 544, and / or clock 550. In one or more examples, digital controller 548 may control which electrodes(e.g., E0-E3) are configured as current absorbers (anodes) and which electrodes(e.g., E0-E3) are configured as current sources (cathodes). In one or more examples, digital controller 548 may control the amplitude of the stimulation pulses generated through the electrodes.

[0161] The charge pump 552 can be used to boost the rectified voltage to higher voltage levels, for example, it may be suitable for stimulating the nervous system. The charge pump 552 may use one or more discrete components to store charge to boost the rectified voltage. In one or more examples, the discrete components include one or more capacitors, for example, which may be coupled to pad 554. In one or more examples, these capacitors may be used for charge balancing during stimulation, for example, to help avoid tissue damage.

[0162] The stimulation driver circuit 556 can provide programmable stimulation to an electrode array, for example, through multiple outputs 534. The stimulation driver circuit 556 may include impedance measurement circuitry, which can be used, for example, to test the correct positioning of the electrodes in the array. The stimulation driver circuit 556 can be programmed by a digital controller to make the electrodes a current source, a current absorber, or a short-circuited signal path. The stimulation driver circuit 556 can be a voltage or current driver. The stimulation driver circuit 556 may include or use therapeutic delivery circuitry configured to provide electrical stimulation signal pulses to one or more electrodes, for example, using at least a portion of a mid-field power signal received from an external source 102. In one or more examples, the stimulation driver circuit 556 can provide pulses with frequencies up to about 100 kHz. Pulses with a frequency of about 100 kHz can be used for nerve blocks.

[0163] Circuit 500 may also include memory circuitry 558, such as non-volatile memory circuitry. Memory circuitry 558 may include storage of device identification, neural recordings and / or programming parameters, and other implant-related data.

[0164] Circuit 500 may include an amplifier 555 and an analog-to-digital converter (ADC) 557 to receive signals from electrodes. The electrodes may sense electrical signals from nerve signals within the body. The nerve signals may be amplified by amplifier 555. These amplified signals may be converted into digital signals by ADC 557. These digital signals may be transmitted to an external device. In one or more examples, amplifier 555 may be a transimpedance amplifier.

[0165] The digital controller 548 provides data to the modulator / power amplifier 562. The modulator / power amplifier 562 modulates the data onto a carrier wave. The power amplifier 562 increases the amplitude of the modulated waveform to be transmitted.

[0166] Modulator / power amplifier 562 can be driven by oscillator / phase-locked loop (PLL) 560. The PLL trains the oscillator discipline to maintain its accuracy. The oscillator can optionally use a different clock than clock 550. The oscillator can be configured to generate an RF signal for transmitting data to an external device. Typical frequency ranges for the oscillator are approximately 10 kHz to approximately 2600 MHz (e.g., from 10 kHz to 1000 MHz, from 500 kHz to 1500 kHz, from 10 kHz to 100 kHz, from 50 kHz to 200 kHz, from 100 kHz to 500 kHz, from 100 kHz to 1000 kHz, from 500 kHz to 2 MHz, from 1 MHz to 2 MHz, from 1 MHz to 10 MHz, from 100 MHz to 1000 MHz, from 500 MHz to 2500 MHz, their overlapping ranges, or any value within said range). Other frequencies may be used, depending on the application. Clock 550 is used for timing the digital controller 548. Typical frequencies of clock 550 are between approximately one kilohertz (kHz) and approximately one megahertz (GHz) (e.g., between 1 kHz and 100 kHz, between 10 kHz and 150 kHz, between 100 kHz and 500 kHz, between 400 kHz and 800 kHz, between 500 kHz and 1 MHz, between 750 kHz and 1 MHz, or any value within these overlapping ranges). Other frequencies may be used depending on the application. Faster clocks generally use more power than slower clocks.

[0167] The return path for the signal sensed from the nerve is selectable. This path may include amplifier 555, ADC 557, oscillator / PLL 560, and modulator / power amplifier 562. Each of these items and its connections can be selectively removed.

[0168] In one or more examples, the digital controller 548, amplifier 555, and / or stimulation driver circuitry 556, as well as other components of circuitry 500, may include multiple portions of a state machine device. The state machine device may be configured to wirelessly receive power and data signals via pad 536 and, in response, release or provide electrical stimulation signals via one or more of outputs 534. In one or more examples, such a state machine device does not need to retain information about available electrical stimulation settings or vectors, and instead, the state machine device may execute or provide electrical stimulation events upon receiving and / or in response to instructions from source 102.

[0169] For example, a state machine device can be configured to receive instructions to deliver a neurostimulation therapy signal, for example, at a specified time or under conditions having certain specified signal characteristics (e.g., amplitude, duration, etc.), and the state machine device can respond by initiating or delivering the therapy signal at the specified time and / or under conditions having the specified signal characteristics. At subsequent times, the device can receive further instructions to terminate the therapy, change the signal characteristics, or perform some other task. Therefore, the device can be optionally configured to be substantially passive, or it can be configured to respond to received instructions (e.g., instructions received simultaneously). A. Circuit housing assembly

[0170] This section describes embodiments and / or features of therapeutic devices, guiding mechanisms for positioning implantable devices (e.g., therapeutic devices) within tissue, and / or fixation mechanisms for helping to ensure that the implantable device does not move significantly when positioned within the tissue. One or more examples relate to therapeutic devices for treating incontinence (e.g., urinary incontinence, fecal incontinence), overactive bladder, pain, or other conditions or symptoms such as those described elsewhere herein.

[0171] The advantages of implantable devices discussed in this section (and other sections) may include one or more of the following: (i) configurable implantable devices that can be modified in shape and / or electrode configuration to aid in targeting sites for electrical stimulation in vivo; (ii) implantable devices that can be implanted and then secured to a target location (e.g., the S3 intervertebral foramen); (iii) implantable devices with improved signal reception efficiency (e.g., (1) the use of a dielectric material around the antenna, the dielectric material comprising a dielectric constant between that of human tissue and that of air, or (2) the use of multiple antennas in the implantable device, such as including a primary antenna inductively coupled to a secondary antenna); (iv) thin, discrete implantable devices that can be implanted in, for example, a narrow area or thin tissue between skin and bone; (v) implantable devices that can provide electrical stimulation patterns that elongated tubular implantable devices (e.g., due to the location of the electrodes and the shape of the implantable device) cannot provide; and / or (vi) networks of implantable devices that can provide local or wide-area stimulation individually or in combination, etc.

[0172] According to several embodiments, a system includes an implantable device comprising an elongated member having a distal portion and a proximal portion. The device includes a plurality of electrodes, a circuit housing, circuitry within the circuit housing adapted to supply power to the plurality of electrodes, an antenna housing, and an antenna (e.g., a helical antenna) within the antenna housing. The plurality of electrodes are disposed or positioned along the distal portion of the elongated member. The circuit housing is attached to the proximal portion of the elongated member. The circuitry is hermetically sealed or encapsulated within the circuit housing. The antenna housing is attached to the circuit housing at its proximal end, opposite the end of the circuit housing attached to the elongated member.

[0173] The system may optionally include an external field power source adapted to provide power or electrical signals or energy to the implantable device. The implantable device may be adapted to transmit information (e.g., data signals) to an external source via an antenna. One, more than one, or all electrodes may optionally be positioned on the proximal or central portion of the elongated member, rather than the distal portion. A circuit housing may optionally be attached to the distal or central portion of the elongated member. An antenna housing may not be attached to the circuit housing, or may not be attached to the proximal end of the circuit housing. The antenna housing may optionally include a dielectric material, such as ceramic, having a dielectric constant between that of human tissue and that of air. The ceramic material may optionally cover the antenna. The elongated member may optionally be flexible and / or cylindrical. The electrodes may optionally be cylindrical and positioned around the circumference of the elongated member.

[0174] The elongated member may optionally include a channel extending from the proximal end of the elongated member through the elongated member to a distal portion of the elongated member, and a shape memory metal wire positioned within the channel, the shape memory metal wire being pre-formed in one orientation to provide curvature for the elongated member. The shape memory metal may optionally be shaped to conform to the shape of the S3 intervertebral foramen and generally match the curve of the sacral nerve. The antenna may be a primary antenna, and the device may also include a secondary antenna in a housing attached to the antenna housing, the secondary antenna being shaped and positioned to provide a near field coupled to the primary antenna. The device may optionally include one or more sutures attached to one or more of the following: (1) a proximal portion of the antenna housing; (2) a proximal portion of the circuit housing; (3) an attachment structure attached to the proximal end of the antenna housing. The antenna may optionally be coupled to a conductive loop of circuitry located in the proximal portion of the circuit housing. A ceramic material may be present between the antenna and the conductive loop.

[0175] There has been a persistent desire to reduce the displacement volume of implantable sensor and / or stimulator devices, such as neurostimulation devices. Further miniaturization allows for easier, minimally invasive implantation procedures, reduces the surface area of ​​the implantable device, which in turn lowers the likelihood of post-implantation infection, and enhances patient comfort in chronically bedridden settings. In some examples, miniaturized devices can be injected via catheters or cannulas, further reducing the invasiveness of the implantation procedure.

[0176] In one example, the implantable neurostimulation device has a configuration different from conventional leads with implanted pulse generators. The implantable stimulation device may include a leadless design and may be powered from a remote source, such as a mid-field source located distal to the implantable device.

[0177] In one example, a method of manufacturing an implantable stimulating device may include forming an electrical connection at both ends of a circuit housing (e.g., a hermetically sealed circuit housing). The method may include forming an electrical connection between a feedthrough assembly and pads on a circuit board. In one example, the feedthrough assembly includes a cap-like structure within which electrical and / or electronic components may be disposed. The surfaces of the pads on the circuit board may typically be perpendicular to the surface of one end of the feedthrough element of the feedthrough assembly.

[0178] This method can be used, for example, to form a sealed circuit housing, which may be part of other devices, such as implantable stimulating devices or devices that may be exposed to liquids or other environmental factors that may negatively affect electrical and / or electronic components.

[0179] Many traditional assembly techniques can be difficult to apply to microdevices (e.g., implantable or injectable stimulator devices). For example, wire bonding can be challenging because the connection to the substrate may be on a surface that is typically perpendicular to the feedthrough. In some examples, the bonding wires can be compressed when the circuit housing is sealed. However, using thin wires that can be compressed to connect between the substrate and the circuit board increases the parasitic capacitance and / or inductance of the RF feedthrough and can cause the RF receiver structure to detune. Furthermore, such compression and / or thinning of the wires limits manufacturing yield. Compression can cause the bond between the conductor and the pad to break or can cause the conductor itself to break. The thickness of the conductor affects the likelihood of breakage, for example, because thinner wires are more likely to break when compressed than thicker wires.

[0180] Figure 6 A diagram generally illustrates an embodiment of a first implantable device 600. Device 600 includes a body portion 602, a plurality of electrodes 604, a circuit housing 606, and an antenna housing 608. The antenna housing 608 encapsulates an antenna 610. The implantable device 600 can be configured to sense electrical (or other) activity information from a patient, or, for example, to deliver electrical stimulation therapy to a patient using one or more of the electrodes 604.

[0181] The body portion 602 may be made of flexible or rigid materials. In one or more examples, the body portion 602 may include a biocompatible material. Among other materials, the body portion 602 may include platinum, iridium, titanium, ceramics, zirconium oxide, alumina, glass, polyurethane, silicone, epoxy resin, and / or combinations thereof.

[0182] The main body portion 602 has or at least partially includes one or more electrodes 604. Figure 6 As shown in the example, electrode 604 is a ring electrode. Figure 6 In the example, electrodes 604 are distributed substantially uniformly along the main body, i.e., substantially equal spaces are provided between adjacent electrodes. Other electrode configurations may be used alternatively or as an option. This document, for example... Figure 30A-40 Examples of other electrode configurations are shown in the figure.

[0183] The main body portion 602 may include or be coupled to the circuit housing 606. In one example, the circuit housing 606 is coupled to the main body portion 602 at a first end 601. Figure 6 In the example, the first end 601 of the main body 602 is opposite to the second end 603 of the main body 602.

[0184] Circuit housing 606 may house electrical and / or electronic components 712 therein (see example...) Figure 7The electrode 604 may be electrically connected to the circuitry in the circuitry housing 606 using one or more feedthroughs and one or more conductors, as shown and described herein. In other words, the circuitry housing 606 may provide a hermetically sealed enclosure for electronic components 712 (e.g., electrical and / or electronic components disposed within or encapsulated by the circuitry housing 606).

[0185] In one example, the antenna housing 608 is located at the first side end 711 of the circuit housing 606 (see example). Figure 7 The antenna 610 is attached to the circuit housing 606 at a location 608. The antenna 610 may be disposed within the antenna housing 608. In one example, the antenna 610 is used to receive and / or transmit power signals and / or data signals at and / or from the device 1200. The first end 711 is opposite to the second end 713 of the circuit housing 606. In one example, the second end 713 is an end to which an electrode assembly (e.g., including electrode 604) or other components may be electrically connected.

[0186] The antenna housing 608 can be attached to the circuit housing 606 in various ways or using various connection devices. For example, the antenna housing 608 can be soldered to the circuit housing 606 (e.g., using gold or other conductive or non-conductive materials). The antenna housing 608 may include epoxy resin, thermoplastic polyurethane, or other protective materials that are substantially radio frequency (RF) transparent (e.g., at frequencies used for communicating with device 1200).

[0187] In one or more examples, the antenna housing 608 may comprise a ceramic material, such as zirconium oxide or alumina. Zirconia has a dielectric constant similar to that of typical body muscle tissue. Using a material with a dielectric constant similar to that of muscle tissue helps stabilize the circuit impedance of the antenna 610 and reduces impedance variations when the antenna 610 is surrounded by different tissue types.

[0188] For example, the power transfer efficiency from the external transmitter to device 1200 can be affected by the choice of antenna or housing material. For instance, when antenna 610 is surrounded or encapsulated by a material with low permeability, such as when antenna housing 608 comprises a ceramic material, the power transfer efficiency of device 1200 increases. In one example, antenna 610 may consist of a single ceramic structure with a feedthrough.

[0189] Figure 7A schematic diagram of an embodiment of circuit housing 606 is shown in general. The circuit housing 606 shown includes various electrical and / or electronic components 712A, 712B, 712C, 712D, 712E, 712F, and 712G, such as circuit board 714, which may be electrically connected to the circuit housing 714. Components 712A-G and circuit board 714 are located within a housing 722. In one example, housing 722 includes a portion of circuit housing 606.

[0190] One or more of components 712A-G may include one or more transistors, resistors, capacitors, inductors, diodes, central processing units (CPUs), field-programmable gate arrays (FPGAs), Boolean logic gates, multiplexers, switches, regulators, amplifiers, power supplies, charge pumps, oscillators, phase-locked loops (PLLs), modulators, demodulators, radios (receiving and / or transmitting radios), and / or antennas (e.g., helical antennas, coil antennas, loop antennas, or patch antennas, etc.). Components 712A-G in circuit housing 606 may be arranged or configured to, in particular, form: a stimulation therapy generation circuit configured to provide a stimulation therapy signal, which may be delivered to the body, for example, using electrodes 604; a receiver circuit configured to receive power and / or data from a remote device; a transmitter circuit configured to provide data to a remote device; and / or an electrode selection circuit configured, for example, to select which electrode 604 is configured as one or more anodes or cathodes.

[0191] The housing 722 may comprise a platinum-iridium alloy (e.g., 90 / 10, 80 / 20, 95 / 15, etc.), pure platinum, titanium (e.g., commercially pure, 6Al / 4V, or other alloys), stainless steel, or ceramic materials (e.g., zirconium oxide or alumina), or other hermetically sealed biocompatible materials. The circuit housing 606 and / or the housing 722 may provide a hermetically sealed space for the circuitry therein. The thickness of the sidewalls of the housing 722 may be approximately tens of micrometers, for example, approximately ten, twenty, thirty, forty, fifty, sixty, seventy, eighty, ninety, one hundred, one hundred and ten micrometers, or some thickness between these values. The outer diameter of the housing 722 may be approximately less than ten millimeters, for example, approximately one, one and a half, two, two and a half, three, three and a half millimeters, or some outer diameter between these values. The length of the housing may be approximately several millimeters, for example, it may comprise two, three, four, five, six, seven, eight, nine, ten, eleven, twelve, thirteen millimeters, or some length between these values. If a metallic material is used for the housing 722, the housing 722 can be used as part of an electrode array, thereby effectively increasing the number of selectable electrodes 604 for stimulation.

[0192] The housing 722 may be filled rather than sealed to prevent moisture from entering. The filling material may include a non-conductive, waterproof material, such as epoxy resin, parylene, thermoplastic polyurethane, or other materials or combinations thereof.

[0193] exist Figure 7 In one example, the circuit housing 606 may include a first end cap 716A and a second end cap 716B. In one example, caps 716A and 716B are located on or at least partially within housing 722. Caps 716A and 716B may be configured to cover openings on substantially opposite sides of, for example, housing 722. Cap 716A forms part of a first side end 711 of the circuit housing 606, and cap 716B forms part of a second side end 713 of the circuit housing 606. Each cap 716A-B includes one or more conductive feedthroughs. Figure 7 In the example, the first end cap 716A includes a first feedthrough 718A, and the second end cap 716B includes a second feedthrough 718B and a third feedthrough 718C. The conductive feedthroughs 718A-C provide an electrical path to the conductors connected thereto.

[0194] Figure 8 A cross-sectional view of an embodiment of circuit board 714 is shown in general. Figure 9 and Figure 10 A top view of a corresponding embodiment of circuit board 714 is shown in general. The circuit board 714 shown comprises materials stacked to form a layered circuit board, wherein the layered circuit board has one or more flexible portions or materials. (Refer again) Figure 8 The multiple portions or structures shown by dashed lines 801 and 803 of circuit board 714 may include flexible material. The multiple portions or structures shown outside of dashed lines 801 and 803 may be flexible or rigid.

[0195] exist Figure 8 In the example, circuit board 714 includes dielectric materials 802 and 812 (e.g., including one or more materials having the same or different dielectric or permeability characteristics) disposed in dielectric material regions 802A, 802B, 812A, and 812B, and conductive materials 804 and 806 (e.g., including one or more materials having the same or different conductivity characteristics) disposed in conductive material regions 804A-804F and 806A-806H. The dielectric regions may include the same or different dielectric materials, and the conductive material regions may include the same or different conductive materials.

[0196] In one example, dielectric material regions 802A and 802B include polyimide, nylon, polyetheretherketone (PEEK), combinations thereof, or other flexible dielectric materials. The dielectric material may include a solder mask and / or reinforcements such as polymers, epoxy resins, or other dielectric solder masks and / or reinforcing materials. In one example, dielectric regions 812A and 812B include reinforcing material. In one example, the solder mask is used to enhance the stiffness or rigidity of selected portions of the circuit assembly.

[0197] In one example, conductive material regions 804A, 804B, 804C, 804D, 804E, and 804F comprise a first conductive material, and conductive material regions 806A, 806B, 806C, 806D, 806E, 806F, 806G, and 806H comprise a second conductive material. In one or more examples, the first conductive material may be rolled and / or annealed. The first conductive material may include copper, silver, nickel, gold, titanium, platinum, aluminum, steel, combinations thereof, or other conductive materials. The second conductive material may include a solderable material (e.g., a material capable of forming a bond with molten solder), for example, it may include one or more of the materials discussed with respect to the first conductive material. In one example, the second conductive material may include a plating comprising a material with a relatively low oxidation rate, for example, it may include silver, gold, nickel, and / or tin. In other examples, conductive material regions 804A-804F and 806A-806H comprise the same type of material. Multiple conductive material regions can be used to provide multiple portions of mating conductors, for example, to connect circuit board 714 to one or more other devices or components.

[0198] In one example, a first dielectric material 802A forms a base layer or bottom layer, on which additional materials may be stacked or deposited to form a circuit board 714. Different materials may be stacked or deposited on different areas of the circuit board 714. For example, a first material may be stacked on a first surface 809 of the first dielectric material 802A, and a second material may be stacked on the opposite second surface 811 of the first dielectric material 802A.

[0199] In one example, a first conductive material 804A is coupled to a first surface 809 of a first dielectric material 802A. The first conductive material 804A may be coupled to one or more of the first dielectric materials at 802B and / or to a second conductive material at 806A, 806C, and / or 806D. The first conductive material 804A may be disposed between the first dielectric material (e.g., at 802A and 802B) and the second conductive material (e.g., at 806A, 806C, and 806D). In one example, the first conductive material 802B extends, for example, into and through one or more flexible portions of the circuit board 714 in one or both regions within dashed lines 801 and 803.

[0200] In one example, the flexibility or rigidity of one or more portions of the circuit board 714 can be altered by selectively cutting or etching it. For example, the multiple flexible portions circled by dashed lines 801 and 803 can be made more flexible by cutting various features into the board structure (e.g., into the first dielectric material 802A, the first conductive material 804A, etc.). For example, laser cutting can be used to remove a portion of the material or substrate forming the circuit board 714. In one example, cutting may include forming through-holes in the circuit board 714 to completely remove material. In one example, the laser cutting features include one or more narrow openings or grooves that extend transversely to the length of the circuit board 714, partially across the board (the length direction is in...). Figure 8 (represented by 833). This cutting feature controls the stiffness and curvature of the circuit board 714.

[0201] Now for joint reference Figure 8 and Figure 9 For example, the second conductive material at 806A, 806C, 806D, 806I, 806J, and 806K can be connected to the first conductive material at 804A. The second conductive material at 806A, 806C, 806D, 806I, 806J, and 806K can be disposed at or around the corresponding opening or through-hole, for example... Figure 9 The openings 920A-920B, 920C, 920D, 920E, and 920F are shown in the diagram. Openings 920A-F extend from the surfaces of the second conductive materials 806A, 806C, 806D, 806I, 806J, and 806K to the corresponding opposite surfaces of the second conductive materials 806H, 806F, and 8056E (some of which are obscured in the shown view). In one example, openings 920A-F extend through the second conductive materials 806A, 806C, 806D, 806I, 806J, and 806K, the first conductive materials 804A, 804C, 804D, and 804F, and the first dielectric material 802A.

[0202] In one example, a first dielectric material 802B is coupled to first conductive materials 804A and 804B. The first dielectric material 802B may be disposed on the first conductive material 804A. The first dielectric material 802B may be disposed between the first conductive materials at 804A and 804B. The first dielectric material 802B may be disposed between the second conductive materials at 806A and 806C, and the unoccupied portion of this layer corresponds to a flexible portion of the circuit board 714 (e.g., corresponding to...). Figure 8 The area circled by dashed lines 801 and 803.

[0203] The first conductive material 804B can be connected to the first dielectric material 802B and the second conductive material 806B. The first conductive material 804B can be disposed on the first dielectric material 802B. The first conductive material 804B can be disposed between the first dielectric material 802B and the second conductive material 806B. The first conductive material 804B can be disposed between the second conductive material 806A and the second conductive material 806C, for example, the open space corresponds to multiple flexible portions of the circuit board 714 (e.g., corresponding to...). Figure 8 (Multiple areas circled by dashed lines 801 and 803). (For example...) Figure 8 Various connections and / or interfaces are provided between the dielectric material regions 802A, 802B, 812A and 812B and the conductive material regions 804A-804F and 806A-806H, as shown or otherwise configured.

[0204] The multiple flexible portions of the circuit board 714 may have different dimensions. For example, the first flexible portion of the circuit board 714, indicated by the dashed line 801, may have a first length 805, and the second flexible portion of the circuit board 714, indicated by the dashed line 803, may have a different second length 807. Figure 8 In the example, the second length 807 is less than the first length 805.

[0205] In one example, second conductive materials 806A, 806H, and 806K may be connected to antenna 610. The length of the flexible portion near the first end 817 of circuit board 714 affects the parasitic inductance and / or capacitance of antenna 610. Therefore, a second length 807 may be selected to reduce such parasitic capacitance and / or inductance. In one example, the first length 805 may be greater than distance 723 (see [reference]). Figure 7 Distance 723 is shown as the distance from end 625 of dielectric material 802B (see [reference]). Figure 7 ) extends to one end of the housing 722. A first length 805 can be selected such that when openings 920A-B correspond to the respective feedthroughs 718A (other feedthroughs are in...) Figure 7 When the cover 716A is hidden in the view and is located on or at least partially within the housing 722, the opening 920C-F (see Figure 9 It is located outside the housing 722.

[0206] The circuit board 714 may have a board length extending from its first end 817 to its opposite second end 819. In one example, the length of the circuit board 714 from its first end 817 to the distal end of the flexible portion indicated by the dashed line 801 (represented by 833) may be greater than the length of the housing 722 (e.g., by 833). Figure 7 727 in the figure). This length or distance relationship allows for an opening 920C-F in the circuit board 714 (see [reference]). Figure 9) or pad 1102 (see Figure 10 The portion containing the opening 920C-F or pad 1102 is turned or flexed away from the central portion of the circuit board 714, such that the opening 920C-F or pad 1102 can be attached to the cover 716A. A portion of the circuit board 714 between the first flexible portion and the second flexible portion (e.g., indicated by dashed line 835) may be flexible or rigid. As explained herein, among other dielectric materials or techniques, the rigidity of one or more portions of the circuit board 714 may be provided by solder, solder mask, electrical and / or electronic components, one or more of conductive materials 804 and 806 and / or one or more of dielectric materials 802A, 802B and 812A, 812B.

[0207] In one example, an embodiment of the circuit board may have two rigid portions connected by a flexible portion. For example, an elongated circuit board assembly may sequentially include a proximal portion (e.g., corresponding to) along its length. Figure 8 In the example, one or more of 802A, 804A, 804F, 806A and / or 806H near the proximal first end 817 of the plate, and flexible portions (e.g., corresponding to...). Figure 8 (one of regions 801 and 803 in the example) and the distal portion (e.g., corresponding to Figure 8 (One or more of 804C, 804D, 806C, 806D, 806E, and / or 806F near the distal second end 819 of the board in the example). The hermetic enclosure can be configured to enclose the elongated board assembly. In one example, the proximal and distal portions can be asymmetrical and can have different length characteristics.

[0208] Figure 9 and Figure 10 Corresponding embodiments of circuit boards 714A and 714B are shown, for example, an embodiment of circuit board 714. Circuit board 714A is similar to circuit board 714B, but circuit board 714B includes pads 1102, which may optionally include solder bumps instead of vias or through-holes, which may be formed, for example, using a second conductive material 806A-K and openings 920A-F. In one example, circuit board 714A may be coupled or soldered to pins of feedthrough components 718A-C. In one example, circuit board 714B may be coupled to other components using solder reflow technology, for example, to couple circuit board 714B to one or more pins (e.g., see...). Figure 16-18(e.g., pin 1110 in the example). While the example of circuit board 714A includes through-holes but not pads, and the example of circuit board 714B includes pads but not through-holes, other examples may include a combination of pads and / or through-holes, and covers 716A-B may be configured to accommodate such pads and / or through-holes. For example, the first end cover 716A may include one or more feedthroughs 718A, while the second end cover 716B may include pads, or a cover may include feedthroughs 718A and pad 1102.

[0209] Figure 11-15 and Figure 7 Operation of an embodiment of a method including electrically connecting and encapsulating a circuit board 714 in a circuit housing 606 is shown. Figure 11 An embodiment of a device 1100 is shown, comprising electrical and / or electronic components 712A-G connected to a circuit board 714. The circuit board 714 and components 712A-G have been generally discussed above.

[0210] Figure 12 An embodiment of device 1200 including device 1100 and first end cap 716A is shown. In one example, device 1200 includes a second conductive material 806A, 806K and / or 806H electrically connected to a corresponding feedthrough (e.g., feedthrough 718A) of the first end cap 716A.

[0211] Figure 13 An embodiment of the device 1300, including a device 1200 and a housing 722, is shown. Figure 13 In the example, circuit board 714 and its components are disposed inside housing 722. A first end cap 716A is alignable with a first opening in housing 722, and the cap may include one or more portions extending at least partially inside housing 722. Figure 13 In the example, the flexible distal portion of the circuit board 714 extends beyond end 1331 of the housing 722, which is opposite to the first opening in the housing 722. Electrical connections (e.g., including the flexible distal portion) disposed on the extension of the circuit board 714 can be used to electrically couple the circuit board 714 (or one or more components thereon) to the second end cap 716B. That is, having the extension of the circuit board 714 helps facilitate electrical connection because the connection task can be performed at least partially outside the housing or housing 722.

[0212] Figure 14 An embodiment of the device 1400, including the device 1300 and the second end cap 716B, is shown. Figure 14In one example, one or more of the circuit board 714 or components connected to the circuit board 714 are electrically coupled to one or more of the feedthroughs 718B and 718C, and the feedthroughs 718B and 718C are coupled to the second end cap 716B. In one example, the second conductive material at 806C-D and / or 806I-J may be soldered or otherwise electrically coupled to the corresponding locations on the feedthroughs 718B and 718C.

[0213] Figure 15 An embodiment of device 1500 including device 1400 is shown, wherein a second end cap 716B is mounted on an end 1331 of housing 722. A first end cap 716A and a second end cap 716B are disposed or mounted on opposite ends of housing 722. The second end cap 716B may include one or more portions extending at least partially inside housing 722.

[0214] Refer again Figure 7 The diagram illustrates a device 1500 in which a first end cap 716A and a second end cap 716B are attached to a housing 722. These caps can be attached to the housing 722 using various attachment processes, including, for example, brazing, welding, or other processes. Figure 7 The example shows fusion welding / brazing markings 720A-720D, indicating that the first end cap 716A and the second end cap 716B are secured to the housing 722. The same applies to… Figure 7 and Figure 11-15 Variations of the exemplary method shown. For example, the first end cap 716A may be welded, brazed, glued, or otherwise attached to the housing 722 before the circuit board 714 is attached to the second end cap 716B.

[0215] Figure 16 An example top view of end cap 1600 is generally shown. In one example, end cap 1600 corresponds to embodiments of first end cap 716A and / or second end cap 716B. Exemplary end cap 1600 includes a first dielectric material 1606, a connecting material 1608, a flange material 1601, and a plurality of leads 1110. Dielectric material 1606 may include alumina, zirconium oxide, sapphire, ruby, combinations thereof, etc. Dielectric material 1606 may be substantially non-conductive and may be fixed to flange material 1601. Flange material 1601 may include metallic materials, such as platinum-iridium alloys (e.g., 90 / 10, 95 / 15, 80 / 20, etc.), pure platinum, 6Al / 4V titanium, 3Al / 2.5V titanium, pure titanium, niobium, combinations thereof, etc. In one example, flange material 1601 may surround dielectric material 1606. Figure 16In the example including the circular outline, the dielectric material 1606 and the flange material 1601 are concentric. In one example, the pin 1610 is hollow and conductive and may include the same or similar material as discussed above for the first and second conductive materials (e.g., at 804A-F and / or 806A-K).

[0216] Figure 16 The top view shows the first surface 1103 of the dielectric material 1606. Leads 1610 may extend from the first surface 1603 to the opposite second surface 1605 of the dielectric material 1606. In one example, each lead 1610 may be soldered or otherwise hermetically sealed within the dielectric material 1606.

[0217] Figure 17 An example cross-sectional view of end cap 1600 is shown in general. This cross-sectional view shows a first surface 1603 and an opposite second surface 1605 of end cap 1600. The cross-sectional view also shows a plurality of pins 1610 extending from the first surface 1603, for example, through a dielectric material 1606, to the second surface 1605. Figure 17 In one example, the end of each pin 1610 includes a conductive adhesive 1612 disposed on a second surface 1605. The conductive adhesive 1612 may include solder, conductive glue, or other conductive material that can be used to electrically couple the pins 1610 of the end cap 1600 to another component. In one example, the conductive adhesive 1612 includes solder bumps.

[0218] Now for reference Figure 6 and Figure 17 The body portion 602 can be coupled to the circuit housing 606 using the end cap 1600. In one example, the coupling can use a conductive material coupled to the pin 1610 and may additionally or alternatively include fusion soldering or brazing the body portion 602 to the end cap 1600. In one example, the pin 1610 includes a hollow portion or socket configured to receive a conductive member from the body portion 602.

[0219] Figure 18 An example cross-sectional view of component 1800 is shown, which includes an end cap 1600 and a circuit board 714C. Circuit board 714C may have the same or similar structure as one of the circuit boards 714, 174A, and / or 714B discussed herein. In one example, circuit board 714C is similar to... Figure 10 The circuit board 714B shown is an example of a circuit board 714C, however, the circuit board 714C includes additional pads 1102 compared to the pads shown in the example of circuit board 714B. Figure 18In the example, component 1800 includes an end cap 1600 electrically coupled to circuit board 714C. For example, conductive adhesive 1612 can be reflowed to adhere to pad 1102.

[0220] In one example, an epoxy resin or other underfill material 1604 may be provided between the dielectric material 1606 and the circuit board 714C to provide additional mechanical support and connectivity between the circuit board 714C and the dielectric material 1106, for example, in addition to any such connectivity provided by the electrical connection formed between the pads 1102 and the conductive adhesive 1612 and / or as insulation for short circuits between electrical connections.

[0221] Circuit housings for implantable devices (e.g., circuit housing 606 as previously discussed) may include electrical or electronic components for providing stimulation to a patient to whom the implantable device is implanted. Furthermore, as previously discussed, the circuit housing may include one or more plates and / or feedthroughs (e.g., portions of one or more end caps) to seal the circuit housing and / or provide electrical signals from within the circuit housing to the outside. The plates and / or feedthroughs may be made very small to help reduce or minimize the volume of the implantable device assembly. The inventors have particularly recognized that the problem to be solved includes miniaturizing the plates and / or feedthroughs. The inventors have recognized that the problem includes forming feedthroughs or plates with a diameter of less than about 3 mm. Solutions to this problem may include selecting appropriate materials and assembly processes, as described herein.

[0222] By reducing the diameter of the end cap of the circuit housing, this implantable device may require a smaller opening in the patient compared to previous implantable devices. The sheath (through which the implantable device passes and into the patient's body) can also be made with a smaller diameter. The implantable device can be small enough to allow for implantation without the sheath. In one or more examples, the body portion of the implantable device, including the electrode (e.g., a ring electrode) on which the electrode is disposed, can be replaced or reinforced using one or more electrodes on the cap. This configuration can further reduce the overall length of the implantable device, decrease the displacement volume of the implantable device, reduce the risk of infection, and / or reduce the costs associated with manufacturing and / or installing the implantable device.

[0223] Figure 19 An example top view of the double-port cover 1900 is shown in general. Figure 20A cross-sectional view of a two-port cover 1900 is shown in general. The two-port cover 1900 is similar to the end cover 1600, wherein the cover 1900 includes feedthroughs 718D and 718E, rather than pins 1610. The cover 1900 is considered a "two-port" cover because it includes a pair of feedthroughs or electrical ports. Feedthroughs 718D and 718E may extend or protrude from opposite sides of the two-port cover 1900 toward a surface, such as... Figure 20 As shown in the diagram. That is, multiple portions of the feed elements 718D and 718E may include extensions extending away from the first side 1903 and / or the opposite second side 1905 of the cover.

[0224] In this example, the dual-port cover 1900 includes a flange material 1601, a dielectric material 1606, a welded or brazed connecting material 1608, and another connecting material 1906, which may be, for example, the welded or brazed material surrounding feedthroughs 718D and 718E. The connecting material 1906 may include gold, ruthenium, platinum, rhodium, palladium, silver, osmium, iridium, platinum, combinations thereof, or other precious or similar materials. The connecting material 1906 may form a bond and / or seal the gap between feedthroughs 718D and 718E and the dielectric material 1606. Feedthroughs 718D and 718E may include conductive materials, such as those previously discussed with respect to feedthroughs 718A-C, and / or may include platinum, iridium, or combinations thereof, for example, approximately 80% to approximately 100% platinum with the remainder being iridium. As previously discussed, the dielectric material 1606 may include ceramics, such as alumina and / or zirconium oxide. In one or more examples, flange material 1601 may include the same or similar material as that used for feedthroughs 718D and 718E.

[0225] The diameter 1902 of the feed elements 718D and 718E can be less than 1 mm to, for example, a few millimeters, such as approximately one-tenth of a millimeter, half a millimeter, one millimeter, one and a half millimeters, two millimeters, or some diameter therebetween. The diameter 1904 of the double-port cover 1900 can be between approximately 5 and approximately 9 Fr (e.g., approximately 1.67 mm to approximately 3 mm), such as approximately 7 Fr or less than approximately 3 mm and greater than approximately 1.5 mm.

[0226] Figure 20An example cross-sectional view of a dual-port cover 1900 is generally shown. In this example, flange material 1601 may extend or protrude beyond a second surface 1605 of dielectric material 1606. Flange material 1601 may generally be flush with dielectric material 1606 at a first surface 1603. Feedthroughs 718D and 718E extend or protrude beyond the second surface 1605 and the first surface 1603. Welded or brazed connecting materials 1608 and 1906 may be used to mechanically connect flange material 1601 to dielectric material 1606 and feedthroughs 718D and 718E to dielectric material 1606, respectively. In one example, the welded or brazed materials discussed herein (e.g., welded or brazed material connectors 1608 or 1906) may provide an hermetically sealed environment such that substantially no foreign matter can penetrate the cover 1900 into housing 722. Feedthroughs 718D and 718E are electrically connected to the antenna at or near one end and to the circuit board 714 at or near the other opposite end.

[0227] Figure 21 An example top view of a multi-port cap 2100 is shown in general. Cap 2100 can be used in place of one or more of the other caps discussed herein. Figure 21 In the example, the multi-port cover 2100 has a rectangular outline. Cover 2100 includes components similar to other covers discussed herein, wherein some components have shapes different from those previously shown or discussed herein. In one example, cover 2100 includes an electrode cover 2102 and a push rod assembly 2104.

[0228] Electrode cap 2102 may include one or more conductive materials (e.g., those also used in feedthroughs 718A-G), connecting materials 1608 and / or 1906, pins 1610, or other conductive materials. Push rod assembly 2104 provides a location for attaching a push rod, which can be used, for example, during implantation surgery, to attach cap 2100 (and the circuitry attached thereto, see...). Figure 23 It is placed inside the patient's body. The push rod assembly 2104 may include an attachment mechanism (not shown) to which the push rod can be attached, such as a threaded hole, a pawl, etc.

[0229] Figure 22 An example cross-sectional view of a multi-port cover 2100 is generally shown. The flange material 1601 of the cover 2100 is shown as comprising a stepped profile. The dielectric material 1606 may comprise a matching (e.g., mirrored) stepped profile such that the steps of the dielectric material 1606 mate with the steps of the flange material 1601. Similar to other embodiments shown, connecting materials 1608 and 1906 can mechanically connect the flange material 1601 to the dielectric material 1606, and can respectively mechanically connect feedthroughs to the dielectric material 1606.

[0230] In one example, electrode cap 2102 may be pressed onto feedthroughs 718F and / or 718G or cast as part of feedthroughs 718F and / or 718G. For different feedthroughs, the distance from the end of each electrode cap 2102 to the first surface 1603 may be different or the same. As shown, cap 2100 includes six feedthroughs and corresponding electrode caps 2102. Cap 2100 may include fewer or more feedthroughs and electrode caps, for example, it may include one, two, three, four, five or more electrode caps and corresponding feedthroughs.

[0231] In one example, cover 2100 may include an optional dielectric coating 2106, for example Figure 22 As shown in the diagram. The dielectric coating 2106 helps prevent shunting of the magnetic and / or electric fields provided through the electrode cap 2102. The dielectric coating 2106 may include parylene, other conformal coatings, or other dielectric materials that may be disposed on the surface 1603.

[0232] Figure 23 An example side view of an embodiment of device 2300 including a multi-port cover 2100 is shown in general. Device 2300 includes a housing 722A, wherein the cover 2100 is disposed on and attached to the housing 722A to seal the housing 722A from moisture or other materials. A circuit board 714 (and associated electrical and / or electronic components attached thereto) and an antenna 610 (indicated by dashed lines) are shown as being located inside the housing 722A. Feedthroughs 718F, 718H, and 718I are electrically connected to the circuit board 714, for example, via a wire bond 2108.

[0233] Figure 24 An example side view of an embodiment of the implantable device 2400 is shown in general. The implantable device 2400 may include a dielectric end cap 2406, an electrode 604, a dielectric portion 2404, an electrode end cap 2402, a fusion-bonded or brazed material connection 1608, a circuit board 714, an antenna 610, and an electrical connector 2108. The dielectric end cap 2406 may be made of alumina, zirconium oxide, other ceramic materials, etc. The dielectric portion 2404 may be made of the same or different material as the dielectric end cap 2406.

[0234] In one example, the electrode end cap 2402 may be made of a conductive material, such as the same or similar material as the feedthrough discussed herein. The dielectric portion 2404 may be fused or brazed to the electrode 604, for example, at opposite sides of the dielectric portion 2404. A fused or brazed bonding material 1608 may be disposed around or around the electrode 604 to hermetically seal the circuit 714 against substances located outside the device 2400. In one or more examples, the antenna 610 is disposed inside the end cap 2406, and a cover such as cap 716 or 2100 may be used to electrically connect the antenna 610 to the circuit 714. One or more embodiments discussed herein may include a hermetically sealed housing to include less than 10 -9 The measured helium leakage rate is expressed in cubic centimeters (cc) - atmospheres (atm) / seconds (s). B. Slender implantable components

[0235] As discussed elsewhere in this document, powering an implantable device using an external wireless power transmitter can be challenging, especially when the device is deeply implanted. The embodiments discussed herein may, for example, use implantable devices with elongation features to help overcome this difficulty. In some embodiments, the distance between the wireless power transmitter (e.g., external to the patient's body) and the antenna of the implantable device is less than the implantation depth of the electrodes on the implantable device. Some embodiments may, for example, include elongated portions between circuit housings that extend the length of the implantable device.

[0236] The inventors have recognized the need to increase the depth of operation of devices for delivering neural stimulation pulses to tissues. Embodiments may allow implantable devices (e.g., implantable neurostimulation devices) to: (a) deliver therapeutic pulses to deep nerves (e.g., nerves in the center of the trunk or deep within the head, for example, at a depth greater than ten centimeters); and / or (b) deliver therapeutic pulses deep within vascular structures, thus requiring stimulation originating from locations deeper than currently achievable using other wireless technologies. In one example, some structures within the body may be within approximately 10 cm of the skin surface, but may be unreachable using earlier techniques. This could be because the implantation path may not be linear, or due to bends or other obstacles in the implantation path, preventing the device's electrodes from reaching the structure.

[0237] The inventors have recognized that, among other issues, a solution to the implantation depth problem may include an implantable device configured to function at various depths by dividing a proximal circuit (e.g., a circuit located within a proximal circuit housing and typically including communication and / or power transceiver circuitry) into at least two portions and providing an elongated (e.g., flexible, rigid, or semi-rigid) portion between these two circuit portions. The more proximal portion of the circuit (e.g., relative to the other circuit portion) may include power receiving and / or signal conditioning circuitry. The more distal portion of the circuit (e.g., more distal to the other circuit portion) may include stimulation wave generation circuitry. In the following discussion, the more proximal housing is designated as the first circuit housing, and the more distal housing is designated as the second circuit housing.

[0238] Electrosensitive radio frequency (RF) receiving and / or backscattering transmitting circuitry components can be disposed or encapsulated in the proximal first circuit housing. In one example, the received RF power signal can be rectified into direct current (DC) in the first circuit housing, for example, for use by circuitry disposed in the same or other parts of the component. The backscattering transmitting circuitry can optionally be disposed. In one example, the first circuit housing can be maintained at a sufficiently minimal distance to be powered by an external power transmitter (e.g., a field power supply, near-field communication, etc.), the external power transmitter including, for example, the field power supply described above.

[0239] Figure 25 An example of an elongated implantable device 2500 is generally shown. The implantable device 2500 may include an elongated portion 2502, a first circuit housing 606A, a second circuit housing 606B, and a connector 2504. Figure 25 In the example, connector 2504 is truncated conical; however, other shapes or configurations can also be used. The second circuit housing 606B is optional, and the elongated portion 2502 can be directly connected to the truncated conical connector 2504. In one example, the first circuit housing 606A includes communication circuitry, for example, for receiving wireless power signals and / or transmitting data to and from external devices. Various circuits in the second circuit housing 606B may include application-specific integrated circuits (ASICs), footprint capacitors, resistors, and / or other components configured to generate therapeutic signals or pulses, and may be electrically connected to the electrodes 604.

[0240] An elongated portion 2502 separates a first circuit housing 606A and a second circuit housing 606B. The elongated portion 2502 may optionally include conductive materials 2512A and 2512B (e.g., one or more conductors) extending therethrough or on it. In one example, conductive materials 2512A and 2512B may electrically connect a conductive feedthrough of the first circuit housing 606A to a conductive feedthrough of the circuit housing 606B. In one example, conductive materials 2512A and 2512B are configured to carry output + and / or output - signals, respectively (see example...). Figure 27 and Figure 28 ).

[0241] Conductive materials 2512A and 2512B may include copper, gold, platinum, iridium, nickel, aluminum, silver, combinations thereof, or alloys thereof. A coating on the elongated portion 2502 and / or conductive materials 2512A and 2512B may electrically insulate the conductive materials 2512A and 2512B from their surrounding environment, for example, when the device is implanted in a patient's body, it may include body tissue. The coating may include a dielectric, such as epoxy resin and / or other dielectric materials. The elongated portion 2502 may include a dielectric material, such as a biocompatible material. The dielectric material may include thermoplastic polyurethane, Med 4719, etc.

[0242] In one example, the elongated portion 2502 may be formed of or coated with a material that enhances or increases friction relative to a desired material (e.g., body tissue), within which the device is configured for implantation. In one example, the material includes silicone. Alternatively, a rough surface polish may be applied to the surface of the elongated portion 2502 or a portion thereof. The friction-enhancing material and / or surface polish can increase the friction of the implant relative to biological tissue, in which the implantable device may be implanted. Increased friction can help the implantable device maintain its position within the tissue. In one or more examples, additional small-sized features, such as protrusions (e.g., bumps, fins, barbs, etc.), may be added to increase friction in one direction. Increased friction can help improve chronic bonding, making the implantable device less likely to move during implantation (e.g., axially or in other directions).

[0243] The dimension 2506A (e.g., width, cross-sectional area, or diameter) of the first circuit housing 606A may be substantially the same as the corresponding dimension 2506B (e.g., width) of the circuit housing 606B. The elongated portion 2502 may include a first dimension 2508 (e.g., width) that is substantially the same as the dimension 2506A of the first circuit housing 606A and the dimension 2506B of the second circuit housing 606B. The second dimension 2510 (e.g., width) of the distal portion of the implantable device 2500 may be smaller than dimensions 2506A, 2506B, and 2508.

[0244] In one example, the distal portion of the implantable device 2500 includes a body portion 602, one or more electrodes 604, and other components coupled distally to a truncated conical connector 2504. The proximal portion of the implantable device 2500 includes a first circuit housing 606A and a second circuit housing 606B, an elongated portion 2502, an antenna 610, and other components proximal to the truncated conical connector 2504. Dimensions 2506A and 2506B, 2508 and 2510, as shown, are generally perpendicular to the length dimension 2514 of the components of the device 2500.

[0245] The truncated conical connector 2504 includes a proximal side 2516 that is coupled to the proximal portion of the implantable device 2500. The truncated conical connector 2504 also includes a distal side 2518 that is coupled to the distal portion of the implantable device 2500. The distal side 2518 is opposite to the proximal side 2516. The width or diameter dimension of the distal side 2518 may be substantially the same as the corresponding dimension 2510 of the body portion 602. The width or diameter dimension of the proximal side 2516 may be substantially the same as the corresponding dimensions 2506A and / or 2506B.

[0246] In one or more examples, the length 2514 of device 2500 may be between about 50 mm and about several hundred mm. In one or more examples, the elongated portion 2502 may be between about ten mm and about several hundred mm. For example, the elongated portion 2502 may be between about 10 mm and about 100 mm. In one or more examples, dimension 2510 may be between about one millimeter (mm) and about one and a third mm. In one or more examples, dimensions 2506A and 2506B may be between about 1.5 mm and about 2.5 mm. In one or more examples, dimensions 2506A and 2506B may be between about one and two-thirds mm and about two and a third mm. In one or more examples, dimension 2508 may be between about 1 mm and about 2.5 mm. In one or more examples, dimension 2508 may be between about 1 mm and about two and a third mm.

[0247] Figure 26 An example of system 2600 is generally shown, which includes an implantable device 2500 implanted within tissue 2604. As shown, system 2600 includes the implantable device 2500, tissue 2604, external power unit 2602, and lead wire 2606 (e.g., push rod, suture, or other components for implanting or removing the implantable device 2500). In one example, external power unit 2602 includes an external source 102.

[0248] The elongated portion 2502 of the device 2500 allows the electrode 604 implantable in the device 2500 to reach deep within the tissue 2604 and allows the antenna to be sufficiently close to the tissue surface and the external power unit 2602. The device 2500 is shown as having a bent elongated portion, for example to show that the elongated portion is stretchable (e.g., a portion is stretchable and / or elongated) and / or flexural (e.g., rotatable about one or more axes along the length of the device).

[0249] In one or more examples, the external power unit 2602 may include a field power device, such as the external source 102 described herein. Although Figure 27 and Figure 28 The circuitry shown is typically configured for a field-powered embodiment, but a two-piece near-side component package (e.g., a device including a first circuit housing 606A and a second circuit housing 606B and an elongated portion 2502 therebetween) can be applied to other wireless embodiments, including implantable devices powered by inductive near-field, far-field, capacitive coupling, and / or ultrasound.

[0250] Figure 27 A schematic example of a first circuit is shown, which may be disposed, for example, in a first circuit housing 606A. The first circuit housing 606A may be electrically connected to differential radio frequency (RF) lines 2704A and 2704B. The differential RF lines 2704A and 2704B may be electrically connected to corresponding connectors from antenna 610. In one example, the differential RF lines 2704A and 2704B may be electrically connected to corresponding feed conductors 718 of the first circuit housing 606A.

[0251] Circuit 2702 within the first circuit housing 606A can operate on differential RF lines 2704A and 2704B to generate differential RF outputs on positive line 2706A and negative line 2706B. The output waveform can be a sine wave or a square wave. The positive output line 2706A and negative output line 2706B can be electrically coupled to an electrical conductor on another feedthrough of the first circuit housing 606A. The positive RF line 2704A and negative RF line 2704B can be connected to a feedthrough located on a first side of the first circuit housing 606A, for example, opposite to the feedthrough on the opposite side of the first circuit housing 606A, with the positive output line 2706A and negative output line 2706B connected to this opposite side. The positive output line 2706A and negative output line 2706B can provide, for example, a peak-to-peak signal between approximately one volt and ten volts. The signals provided on the positive input line 2706A and the negative output line 2706B can be charge-balanced, for example, through one or more components of the circuit 2702.

[0252] At least a portion of the circuitry of the implantable device 2500 may be housed within the first circuit housing 606A. The portion shown is circuitry 2702. Circuitry 2702 may include, in particular, a pulse width modulator 2708, a clock generator 2710, a controller 2712, a differential rectifier 2714, a backscattered switching load circuitry 2716, a load detector 2718, and an encoder / decoder circuitry 2720. Circuitry 2702 may include other electrical and / or electronic components, such as resistors, transistors, inductors, capacitors, diodes, multiplexers, amplifiers, etc. These other components may help regulate electrical signals, for example, by helping to ensure that the signal includes sufficiently large voltage, current, or power, such as by helping to ensure that the current, voltage, or power is maintained within a specified operating range of circuitry 2702.

[0253] The pulse width modulator 2708 (sometimes called a pulse duration modulator) encodes the message into a pulse signal. The pulse width modulator 2708 controls the power supplied to other components of circuit 2702 or 2802. The average power (voltage and current) fed to the load can be controlled by changing the amount of time the pulse is high, low, and / or at ground potential or reference potential, i.e., by adjusting the duty cycle of the signal.

[0254] Clock generator 2710 is a circuit that generates a clock signal. In one example, controller 2712 and other clock-controlled components can use the clock signal to time their operation. The clock signal generated by clock generator 2710 may include a square wave or other waves with rising and / or falling edges. The basic circuitry included in the clock generator typically includes a resonator and an amplifier. The clock signal generated by clock generator 2710 may be in the megahertz range, but other ranges may also be used or provided by the circuitry.

[0255] The controller 2712 provides control signals that configure other circuits to perform operations according to the control signals. For example, the controller 2712 can configure the duty cycle provided by the pulse width modulator 2708, or configure whether the backscatter switch load provides a signal to the antenna 610 for transmission to the external power unit 2602, etc.

[0256] Differential rectifier 2714 receives an alternating current (AC) signal and generates a DC signal. A capacitor may be connected to the output of differential rectifier 2714 to help smooth the output. The connection and / or circuitry between the first circuit housing 606A and the second circuit housing 606B can help transfer energy from one housing to the other, for example, without exposing any non-hermetic signal processing circuitry to unbalanced signals.

[0257] The backscattering switch load circuit 2716 can switch between receive and transmit modes. The backscattering switch load circuit 2716 can receive power from the external power unit 2602 (in receive mode). The backscattering switch load circuit 2716 can transmit reflected power from the external power unit 2602 back to the antenna 610, for example, transmitting reflected power to the external power unit 2602. The reflected power can be used to encode data communication from the implantable device 2500 to the external power unit 2602. In one example, the encoded data includes information about the power transfer efficiency between the device 2500 and the external power unit 2602.

[0258] Load detector 2718 detection circuit 2702, circuit 2802 (see) Figure 28 The controller 2712 can use the output of the load detector 2718 to adjust the PWM duty cycle or other parameters of the circuit 2702.

[0259] The encoder / decoder circuit 2720 can be configured to convert data from one format to another. The encoder / decoder circuit 2720 receives a rectified waveform and determines whether configuration data or other data is embedded within the rectified waveform. The encoder / decoder circuit 2720 can, for example, receive a backscattered signal from a backscattered switch load circuit 2716 and encode the signal using the data to be transmitted to the external power unit 2602.

[0260] Figure 28 A schematic example of a second circuit is shown, which may be disposed, for example, in circuit housing 606B. Although a particular example or type of circuit is discussed as being located in one of the first circuit housing 606A and the second circuit housing 606B, various circuits may be optionally disposed in either location according to various design constraints and optimizations.

[0261] exist Figure 28 In the example, the second circuit housing 606B is electrically connected to the positive output line 2706A and the negative output line 2706B from the first circuit housing 606A (see example). Figure 27 The positive output line 2706A and the negative output line 2706B may be electrically connected to corresponding connectors within the first circuit housing 606A. In one example, the positive output line 2706A and the negative output line 2706B may be electrically connected to corresponding feed conductors 718 on the proximal side of the second circuit housing 606B.

[0262] A portion of the circuitry of the implantable device 2500 can be housed within the second circuit housing 606B. For example... Figure 28The portion shown includes various circuits 2802. Circuit 2802 includes a full-wave rectifier 2808, a voltage multiplier 2810, a DC-DC converter 2812, a stimulus driver 2814, a multiplexer 2816, a load modulator 2818, and a decoder 2820. Circuit 2802 may include other electrical and / or electronic components, such as resistors, transistors, inductors, capacitors, diodes, multiplexers, amplifiers, etc. These other components can help regulate various electrical signals, for example, to help ensure that the signal includes sufficiently large voltage, current, or power, such as to ensure that the current, voltage, or power is maintained within the specified operating range of circuit 2802. The second circuit housing 606B may also include or provide housings for capacitors 2822A, 2822B, 2822C, 2822D, 2822E, 2822F, 2822G, and 2822H. In one example, capacitors 2822A-2822H can help remove unwanted high-frequency components from the stimulus signal, for example, they can be present on electrode conductor lines 2804A, 2804B, 2804C, 2804D, 2804E, 2804F, 2804G and / or 2804H respectively. In one example, capacitors 2822A-2822H can block the DC voltage on the corresponding electrode lines 2804A-2804H respectively.

[0263] A full-wave rectifier can convert a wave signal, such as a sine wave signal, into a signal that includes either a positive component or a negative component (and ground). In one example, the full-wave rectifier 2808 converts a positive wave, a negative wave, or a positive and negative wave into a wave that includes only one of the positive or negative components.

[0264] The voltage multiplier 2810 includes circuitry that converts an AC power signal from a low voltage to a higher DC voltage. The DC-DC converter 2812 includes circuitry that converts a DC voltage signal to different voltages.

[0265] Stimulation driver 2814 includes circuitry that configures other circuitry 2802 to provide stimulation to tissue 2604. Stimulation driver 2814 may provide a signal to multiplexer 2816, and multiplexer 2816 may select which of lines 2804A, 2804B, 2804C, 2804D, 2804E, 2804F, 2804G, and 2804H is used to provide stimulation and / or for electrical signal sensing. In one example, a control signal input to multiplexer 2816 indicates which electrode 604 provides the cathode for the signal provided by stimulation driver 2814 and which electrode 604 provides the anode for it.

[0266] The load modulator 2818 can change the frequency of the signal provided as a stimulus. In one example, the load modulator 2818 can adjust the duty cycle of the signal provided as a stimulus.

[0267] Decoder 2820 can be configured to convert data signals. In one example, decoder 2820 is configured to change the format of data provided from circuit 2702 on output positive line 2706A and output negative line 2706B to a format compatible with another component (e.g., a component provided in the first circuit housing 606A and / or the second circuit housing 606B and / or the external power unit 2602).

[0268] Figure 29 An example of an elongated implantable device 2900 is generally shown. Device 2900 is similar to the one described above. Figure 25 The example describes device 2500; however, device 2900 includes a single circuit housing 606C. That is, device 2900 does not include components from… Figure 25 The example is the elongated portion 2502. Conversely, device 2900 includes multiple implantable device circuits within a single circuit housing 606C (see, for example...). Figure 27 Circuit 2702 and Figure 28 Circuit 2802).

[0269] exist Figure 29 In one example, device 2900 includes a truncated conical connector 2504, which is connected, for example, between the body portion 602 and a single circuit housing 606C. Embodiments of different sizes of the truncated conical connector 2504 can be used to provide different sizes of the device, for example, relative to the circuit housing and / or the distal lead portion of the device (e.g., the body portion 602 and the electrode 604). In one example, the truncated conical connector 2504 is configured to assist in implantation surgery, for example, by helping to gradually widen the incision during insertion of the device (which in turn helps to reduce patient discomfort). C. Injectable and / or neuro-coated implantable components

[0270] The various embodiments described herein include electrode systems that can be deployed within a patient, such as at a neural target for delivery of electrical stimulation therapy. In one example, an implantable electrode system may include: an elongated component body configured to house electrical stimulation circuitry or sensing circuitry; and an electrode assembly coupled to the electrical stimulation circuitry or sensing circuitry and configured to provide electrical stimulation to a neural target within the patient or to sense electrical signaling activity from the neural target. In one example, the electrode assembly includes a plurality of elongated members extending away from the component body in a predominant longitudinal direction. The electrode assembly may have a retracted first configuration when inside a deployment sheath or cannula, and an expanded second configuration when outside the cannula. In one example, the electrode assembly may include a further expanded third configuration in which the electrode assembly receives or surrounds the neural target. The neural target may include nerves or other tissues, such as veins, connective tissue, or other tissues, which may include one or more neurons within or near the tissue.

[0271] In one example, an electrode with a cuff configuration can be used to encircle all or part of a nerve, for example, to provide electrical stimulation to the nerve. This cuff electrode can be positioned near or attached to the nerve using various techniques. For example, sutures can be used to secure the cuff electrode around the nerve. This binding may require two hands and can be cumbersome and difficult for clinicians.

[0272] In one example, the capsulo electrode may have a spiral shape. This spiral capsulo electrode can be wrapped around the nerve for installation. Compared to a tightly secured capsulo electrode, the way the nerve is wrapped by the spiral structure results in a relatively long length or portion of the nerve segment being used with the spiral capsulo electrode. Therefore, a relatively long length of the nerve must be cut to provide access for the electrode, which could lead to nerve damage if improperly installed.

[0273] The implantation of tethered or spiral skin electrodes is typically performed using a double-handed installation technique and open surgery. Although some suturing can be done laparoscopically, the procedure can be cumbersome, difficult, and invasive. Furthermore, the skin electrode may be too large to be inserted via injection or laparoscopic instruments, thus requiring additional surgical incisions.

[0274] Skin electrodes can be manufactured in different sizes, and clinicians or installers can select an electrode of an appropriately sized size during implantation, for example, based on intraoperative measurements of the target nerve. This increases the time and complexity of the installation procedure.

[0275] In addition to addressing the aforementioned issues, there remains a persistent desire to reduce the displacement volume of implantable neurostimulation devices. Miniaturization of such devices would allow for easier and less invasive implantation procedures, reduce the surface area of ​​the implantable device, which in turn lowers the likelihood of post-implantation infection and helps ensure long-term patient comfort.

[0276] In one example, injectable neurally coated electrodes can be used to provide solutions to a variety of problems associated with traditional capsulo electrodes. In one example, such a neurally coated electrode can be leadless and can be wirelessly coupled to one or more other devices using field-to-field wireless communication technology, for example, to transmit power or data. Figure 1-5 The paper broadly discusses field power technology, including transmitters, transceivers, implantable devices, circuitry, and other details.

[0277] In one example, the aforementioned problems can be addressed, particularly by including or using one or more of improved attachment mechanisms that respond to forces applied in at least one direction. This neural covering electrode includes a stretchable and retractable electrode and can be implanted in the patient at a target location using an injectable sheath or cannula. In one example, multiple portions of the neural covering electrode can be elastic or flexible to conform to various body structures or the physiological functions of the target location.

[0278] In one example, a foldable, deformable, or conformal electrode assembly can be pushed through a sheath and subsequently deployed at or near a target site, nerve location, or within the body. The electrode assembly or the electrode itself may have an elastic or spring-like mass that causes the electrode assembly, or another portion of the assembly attached to one or more electrodes, to expand when the electrode assembly is deployed outside the mounting sheath. In other examples, such as when the target is narrow enough or the electrode is open enough to receive the neural target, the electrode assembly and / or the electrode itself does not need to unfold or bend to accommodate the target.

[0279] In one example, the undeployed electrode may have a length characteristic related to the diameter at which the electrode is deployed. For example, a longer electrode may have a deployment diameter that is significantly larger than that of a short electrode. In this way, the deployed electrode structure may, in some respects, have a diameter that is relatively larger than the diameter of the sheath used to deploy the electrode structure.

[0280] In one example, the nerve may be positioned at or around an artery or tendon. In this case, a large-diameter clasp electrode can be used to adequately encircle the nerve and surrounding tissue. Using deployable nerve-encasing electrodes, large diameters can be achieved without the need for open surgery to install large conventional clasp or spiral electrodes.

[0281] In one example, such as after installation, the nerve-covered electrode remains flexible or expandable and stretchable. Therefore, the nerve-covered electrode may not constrict the pulsating artery. However, in some examples, if the nerve-covered electrode is too loose or too easily expanded, the electrode may not provide optimal surface area contact with the target tissue, and therefore it may use more or variable power to elicit the same response from the target.

[0282] In one example, according to the various embodiments described herein, two or more electrodes can be delivered simultaneously using the same sheath. For example, the two or more electrodes can be arranged in parallel, such that they are positioned side-by-side around the target nerve. The electrodes can be positioned in various configurations to stimulate laterally or axially across the target. In one example, multiple electrodes can be used for electrical blocking or electrical activity sensing and recording. In one example, multiple electrodes or multiple portions of the same electrode can be aligned such that the distal portions of the electrodes are in contact or can be made to be in contact. In other examples, the electrodes can be offset from each other such that their distal portions are not in contact in either a compressed or uncompressed configuration.

[0283] In one example, the neural-covered electrode can be integrated with a power delivery system (e.g., a wireless power delivery system) and electronics, or it can be lead-based.

[0284] In one example, the neural-covered electrode may be part of an electrode deployment system that includes a connector configured to drive the electrode's actuation components parallel to the neural arrangement.

[0285] This document discusses these and other features of various implantable devices and electrode configurations with reference to several accompanying drawings. The inventors have also considered various combinations of the illustrated embodiments.

[0286] In one example, circuit housing 606 (see example) Figure 6 (Or other embodiments of the circuit housing discussed herein) may include electrical or electronic components for providing stimulation to a patient with an implantable device implanted in the body. Furthermore, as previously described, the circuit housing may include one or more feedthroughs to seal the circuit housing 606 and / or provide electrical signals from within the circuit housing 606 to other circuitry outside the housing. Feedthroughs may have a minimal surface area to help reduce the volume of the implantable device. However, miniaturizing feedthroughs can be very challenging. For example, problems may arise when forming feedthroughs on plates where the plate diameter is less than 3 mm. The materials and processes used to form the feedthroughs and / or housing assemblies will be important for manufacturing such small caps (as described herein).

[0287] By reducing the diameter of the feedthrough and housing end caps, the implantable device can be made to have a relatively smaller opening in the patient's body than was used for previous implantable devices. The cannula or sheath (e.g., a lumen through which the implantable device is inserted into the patient's body) can also be made to have a smaller diameter. In some examples, the implantable device can be small enough to allow implantation without a cannula. In one or more examples, the body portion 602, including the electrodes (e.g., ring electrodes) located thereon, can be replaced with corresponding electrodes on or in the circuit housing 606 and / or on one or more end caps used for that housing. This configuration reduces the overall length of the implantable device, reduces the displacement volume of the implantable device, lowers the risk of implantation infection, and / or reduces the manufacturing cost of the implantable device.

[0288] In one example, one or more electrodes may extend from the circuit housing 606 and / or from the body portion 602 of the implantable device 600. Although reference has been made to the implantable device 600 in this discussion and elsewhere herein, other embodiments of the implantable device (such as those discussed elsewhere herein) are equally applicable. The electrodes may extend substantially away from the body portion 602 in a direction substantially along the longitudinal axis of the body portion 602 (e.g., rather than laterally to the body portion 602). Thus, longitudinally extending electrodes can be used without impeding the device's movement or sliding through a cannula for delivery to a neural target.

[0289] Figure 30A and Figure 30B A different view of an example 3000 of an implantable electrode assembly 3001 inside a cannula 3010 is shown in general. The implantable electrode assembly 3001 includes a body portion 3002 and an electrode portion 3003. The electrode portion 3003 includes one or more discrete electrodes that extend away from the body portion 3002 of the implantable electrode assembly 3001 in a direction along the longitudinal axis of the cannula 3010.

[0290] In one example, electrode portion 3003 includes a plurality of electrodes. At least one of the electrodes may be flexible. In one example, electrode portion 3003 is configured to receive and retain a neural target (e.g., a nerve or nerve bundle) or other biological tissue target. Figure 30B A perspective view of Example 3000 is shown in general, including the electrode portion 3003 inside the cannula 3010.

[0291] In one example, electrode portion 3003 is compressed inside the cannula. When electrode portion 3003 is compressed, the extension member of electrode portion 3003 is elongated and can be held in the compressed configuration, for example, by the inner wall of cannula 3010.

[0292] Figure 30CAn example of an implantable electrode assembly 3001, partially located outside the cannula 3010, is generally shown. Figure 30C In the example, electrode portion 3003 is uncompressed or extended. When electrode portion 3003 exits the cannula, the retaining force acting on the extension members of electrode portion 3003 (e.g., provided by the sidewalls of cannula 3010) is removed, and the extension members can expand or spring back away from each other. That is, when electrode portion 3003 is not obstructed by the walls of cannula 3010, the extension members can extend laterally away from the longitudinal axis of cannula 3010.

[0293] Figure 30D An example of an implantable electrode assembly 3001 deployed from cannula 3010 and coupled to push rod 3020 is generally shown. In one example, the proximal end of the implantable electrode assembly 3001 is configured to receive push rod 3020, and push rod 3020 pushes implantable electrode assembly 3001 along the lumen of cannula 3010.

[0294] Figure 30E An example of an implantable electrode assembly 3001, including a central lead 3050, is generally shown. Figure 30E In one example, electrode portion 3003 may be connected to body portion 3002 via intermediate lead 3050, which includes an electrical conductor connecting drive circuitry in body portion 3002 to one or more discrete electrodes in electrode portion 3003. In one example, body portion 3002 may include or use circuit housing 606 (e.g., one or more of a first circuit housing 606A, a second circuit housing 606B, a single circuit housing 606C, etc.) or be configured in a similar manner to circuit housing 606.

[0295] Figure 31A A first example 3110 of an implantable electrode assembly 3001 adjacent to a first neural target 3115 is generally shown. Figure 31A In the example, electrode portion 3003 is shown in a first extension configuration (e.g., outside the delivery cannula), wherein at least some portions of the extension members of electrode portion 3003 are spaced further apart relative to the compression configuration. Figure 31A In the example, the first force is applied to the implantable electrode assembly 3001, for example, via push rod 3020 in a first direction 3101.

[0296] Figure 31B A second example 3120 of the implantable electrode assembly 3001 is generally shown, wherein the neural-covered electrode is flexed away from the first neural target 3115. Figure 31BIn this embodiment, the implantable electrode assembly 3001 is adjacent to the first neural target 3115, and the outer distal edge of the electrode portion 3003 impacts the first neural target 3115. In response to the first force continuing to act in the first direction 3101, the extension members of the electrode portion 3003 can be driven or pushed apart, such that the first neural target 3115 can be engaged, received, or accepted between the extension members. That is, when the electrode portion 3003 is driven against the first neural target 3115, a second force can act in the second direction 3102.

[0297] Figure 31C A third example 3130 of an implantable electrode assembly 3001 is generally shown, wherein a neurally wrapped electrode is disposed around a first neural target 3115. Figure 31C In the example, electrode portion 3003 grasps and holds the first neural target 3115. A spring force or holding force acts on a third direction 3103 (e.g., substantially opposite to the second direction 3102) to push or retract the extension members of electrode portion 3003 together, or toward each other (e.g., toward each other). Figure 31A The first extended configuration shown in the figure is pushed back or retracted.

[0298] Figure 32A , Figure 32B and Figure 32C Examples of using different flexible electrode configurations to receive and retain the second neural target 3215 are generally shown. The second neural target 3215 may be the same as or different from the first neural target 3115. Figure 32A The example generally shows an example 3210 of an implantable electrode assembly having a hook-shaped nerve-covered electrode assembly 3253 adjacent to a second neural target 3215.

[0299] Figure 32B An example 3220 of an implantable electrode assembly is shown, wherein a hook-shaped nerve-covered electrode assembly 3253 is flexed away from the nerve target 3215 to provide access to a nerve target holding region 3260 at least partially surrounded or enclosed by the electrode assembly 3253. That is, the distal portion or end of the hook-shaped nerve-covered electrode assembly 3253 may be flexed, stretched, or otherwise extended to expose the holding region 3260, thereby receiving a second nerve target 3215 therein. Figure 32C An example of an electrode assembly 3230 is shown in general, wherein a hook-shaped nerve-covered electrode assembly 3253 is disposed around a second nerve target 3215, that is, the second nerve target 3215 is disposed in a nerve retention region 3260.

[0300] Figure 33A and Figure 33BSide and perspective views of a second implantable electrode assembly 3301 are shown, respectively. The second implantable electrode assembly 3301 includes a distal portion having a second neural-covered electrode 3303 and an electrode insulating member 3305. For example, the second neural-covered electrode 3303 includes one or more discrete electrodes extending in a direction along the longitudinal axis of the second implantable electrode assembly 3301. At least one electrode may be flexible, and these electrodes may be configured to receive and retain neural targets (e.g., nerves or nerve bundles) or other biological tissue targets.

[0301] Electrode insulating member 3305 is configured to electrically insulate the electrode from surrounding non-target tissue at or near the implantation site. In one example, electrode insulating member 3305 is at least partially made of silicone or at least partially made of another non-conductive and biocompatible material. In one example, electrode insulating member 3305 is flexible and can conform to the shape or extended configuration of the electrode it surrounds. In one example, electrode insulating member 3305 includes a slit through which a neural target is configured to pass when a second implantable electrode assembly 3301 is mounted around the target. Electrode insulating member 3305 may be used with any of the electrode embodiments discussed herein, or the member may be unused. In one example, electrode insulating member 3305 may help prevent damage to nearby tissue or prevent signal interference from nearby tissue.

[0302] Figure 34 An example of another embodiment of the nerve-covered electrode 3413 and the electrode insulating member 3305 is generally shown. Figure 34 In one example, the nerve-covered electrode 3413 includes an inwardly facing hook-shaped distal portion that helps retain target tissue when the component is implanted in a patient. Figure 33A and Figure 33B Examples include a nerve-covered electrode 3303, which may include an outwardly facing hook-shaped distal portion that may include gaps or slits to help facilitate coupling with tissue targets, such as large-diameter neural targets.

[0303] Figure 35A and Figure 35BSide and perspective views of a third implantable electrode assembly 3501 are shown. The third implantable electrode assembly includes a third embodiment of a nerve-covered electrode 3503. The third embodiment of the nerve-covered electrode 3503 may include a pair of flexible, elongated conductors, each conductor extending remotely from the body portion of the assembly 3501 along the longitudinal direction of the body portion. In one example, each conductor terminates at its distal end with a bulbous tip. The conductors may be flexible and may include rotating or bending portions. In one example, each conductor rotates or bends toward the longitudinal axis of the body and / or toward the other conductor. In one example, the conductors rotate or extend substantially along a helical path, and the third implantable electrode assembly 3501 is configured for placement of a nerve target between the conductors by rotating or twisting the assembly about a nerve target.

[0304] It can also use or apply a variety of other implantable electrode assembly configurations, such as those described above. Figures 30A-35B The same or similar cannula-based delivery system described in the example, and for example using cannula 3010. For example. Figure 36 A fourth implantable electrode 3600 is shown in general. The fourth implantable electrode 3600 can be used with a body portion of an implantable component (e.g., body portion 3002). Examples of the fourth implantable electrode 3600 include a pair of hook-shaped electrode members. These members may be adjacent to or offset from each other, and in some examples, one or more of these members may be flexible or configured to move relative to each other to receive a neural target between these members.

[0305] Figure 37 A fifth implantable electrode 3700 is shown in general. The fifth implantable electrode 3700 can be used with a body portion of an implantable component (e.g., body portion 3002). Examples of the fifth implantable electrode 3700 include a pair of hook-shaped electrode members with bulbous end features. These members may be adjacent to or offset from each other, and in some examples, one or more of these members may be flexible or configured to move relative to each other to receive a neural target between these members.

[0306] Figure 38An example 3800 of an implantable electrode assembly 3801 is generally shown, configured to deliver electrical stimulation axially to a neural target 3815. In example 3800, the implantable electrode assembly 3801 includes a first electrode 3600A and a second electrode 3600B axially spaced along the longitudinal axis of the neural target 3815. In one example, the first electrode 3600A and the second electrode 3600B include corresponding instances of the fourth implantable electrode 3600 discussed above, for example, which is coupled to the cannula delivery body portion 3002 of the implantable device. The first electrode 3600A and the second electrode 3600B can be driven by a drive circuit in the housing of the implantable electrode assembly 3801 (see, for example...). Figure 28 The stimulation driver 2814 in the example is addressed individually or separately. In one example, one of the first electrode 3600A and the second electrode 3600B is configured as an anode and the other as a cathode for providing electrical stimulation therapy to the neural target 3815.

[0307] Figure 39 An example 3900 of an implantable electrode assembly 3901 is generally shown, configured to deliver electrical stimulation transversely to a neural target 3915. In example 3900, the implantable electrode assembly 3901 includes a first electrode 3911 and a second electrode 3912 spaced apart from each other. In the illustrated mounting configuration, the first electrode 3911 and the second electrode 3912 are positioned adjacent to opposite sides of the neural target 3915. The first electrode 3911 and the second electrode 3912 can be driven by a drive circuit in the housing of the implantable electrode assembly 3901 (see, for example...). Figure 28 The stimulation driver 2814 in the example is addressed individually or separately. In one example, one of the first electrode 3911 and the second electrode 3912 is configured as an anode and the other electrode is configured as a cathode for providing electrical stimulation therapy to the neural target 3915.

[0308] Figure 40 An example 4000 of an implantable electrode assembly 4001 with a flexible body is generally shown. That is, one or more portions of the electrode assembly 4001 may include a portion capable of flexing, bending, folding, rotating, stretching, or otherwise conforming to different positions. Thus, at least the body portion 4002 may be arranged or positioned substantially parallel to the neural target 4015. In example 4000, the implantable electrode assembly 4001 includes a distal electrode portion 4003 (e.g., including one or more electrodes) which may be wound around the neural target 4015. In one example, the body portion 4002 of the implantable electrode assembly 4001 includes a can electrode or shell electrode configurable as an anode or cathode, and the distal electrode portion 4003 includes at least one electrode configurable as the other of the anode or cathode.

[0309] In one example, the electrode assembly 4001 includes a flexible connector in its body portion 4002, such that after the distal electrode portion 4003 is deployed at or around the neural target 4015, at least a portion of the elongated body portion 4002 can be positioned or arranged substantially parallel to the longitudinal axis of the neural target. Figure 40 In this example, electrode portion 4003 includes two pairs of elongated members having corresponding conductive portions, and a first pair of these pairs may be configured as an anode, and a second pair of these pairs may be configured as a cathode. In this example, electrode assembly 4001 may be configured to transmit an electrical stimulation therapeutic signal to nerve target 4015 when these pairs are coupled to nerve target 4015 and spaced apart along the axial direction of nerve target 4015.

[0310] Figure 41 An example of method 4100 is generally shown, which includes approaching a neural target and positioning electrodes around the neural target. At operation 4110, this example includes approaching the neural target in the patient's body using a surgical device, such as a nerve-covered electrode assembly that includes a cannula and a lumen within the cannula that can slide proximally to distally. Operation 4110 may include using, for example... Figure 30A-40 The electrode assembly shown in the example or one or more of the embodiments.

[0311] At operation 4120, the nerve-covered electrode assembly can be deployed from the cannula. In one example, a pusher can be used to deploy the electrode assembly, allowing the nerve-covered electrode assembly to slide or be pushed outside the cannula. For example, Figure 30A An example is shown in general, including an implantable electrode assembly 3001 located inside the cannula 3010. Figure 30C and Figure 30D Implantable electrode assemblies 3001 are shown, partially and fully deployed from cannula 3010, respectively. At operation 4130, this example includes expanding the electrode members of the nerve-covered electrode assembly into an expanded second configuration. For example, as... Figure 30E As shown, when electrode portion 3003 is deployed and not obstructed by the sidewalls of cannula 3010, electrode portion 3003 may include one or more components that can be extended or deployed remotely from each other to provide a holding area for neural targets between components.

[0312] At operation 4140, this example includes positioning the distal end of the electrode member of the nerve-covered electrode assembly adjacent to the neural target. In one example, the assembly may be positioned substantially transversely to the longitudinal axis of the neural target (see, for example...). Figure 31AIn one example, such as for embodiments that require or use torsional or rotational movements to position a neural target between different portions of one or more conductors, the component may be positioned substantially parallel to the longitudinal axis of the neural target.

[0313] At operation 4150, this example includes pushing the neurally coated electrode assembly toward a neural target, thereby further expanding the electrode components of the neurally coated electrode assembly and receiving the neural target between the electrode components. Figure 31B The illustration for operation 4150 is found there. At operation 4160, method 4100 may include holding the neural target between electrode components (see, for example...). Figure 31C , Figure 32C and Figures 38-40 At operation 4170, electrode components can be used to perform electrical activity sensing or electrical stimulation therapy delivery. D. Vascular deployment

[0314] Miniature or injectable electrodes and electrode assemblies can be used to address a variety of problems discussed herein and associated with conventional electrodes and implantation procedures. In one example, such an electrode assembly may be leadless and can be wirelessly coupled to one or more other devices, such as to transmit power or data, using field wireless communication technology. Figure 1-5 The section broadly discusses field power technology, including transmitters, transceivers, implantable devices, circuitry, and other details.

[0315] Several advantages accompany the field-powered device. For example, wireless power devices do not require the implantation of a relatively large battery-powered pulse generator and leads to electrically connect the pulse generator to the stimulating electrodes. This allows for a simpler implantation procedure at a lower cost and with a much lower risk of chronic infection and other complications. Second advantages include the battery power source being located outside the patient's body, thus traditional design constraints (e.g., ultra-low power and ultra-high circuit efficiency requirements) may be less significant. Third, field electrode devices can be significantly smaller than traditional devices. Smaller devices are better tolerated by patients and are more comfortable. In some cases, the cost of manufacturing and implanting or mounting the field electrode device within the patient is also lower.

[0316] In one example, a mid-field device may be implanted or mounted and configured to deliver electrical stimulation to a renal nerve target. In another example, the mid-field device may be at least partially implanted or mounted in the patient's vascular system. For example, the mid-field device may be implanted or mounted in an artery, vein, or other blood vessel. In one example, the mid-field device may be implanted or mounted in the jugular vein and configured to deliver electrical stimulation to a vagus nerve target. Examples of various implantable device configurations are discussed below.

[0317] In one example, a mid-field-based implantable device could be used to deliver electrical stimulation therapy to a renal target. In recent years, numerous preclinical and clinical studies have been conducted on renal denervation to regulate blood pressure in the treatment of hypertension. The hypertensive patient population is significant, and there exists a portion of this population that is refractory or unresponsive to conventional medical management, which includes medications such as diuretics, angiotensin-converting enzyme inhibitors, and other more potent agents designed to lower blood pressure.

[0318] Although acute surgery, known as renal denervation, has shown promise in early clinical studies of lowering systolic and diastolic blood pressure in these refractory, uncontrolled patients, the inventors recognize that a clinical need remains for a medical device that can treat hypertension. In one example, an alternative to denervation could include, for example, delivering electrical stimulation to a renal nerve target using neuromodulation techniques. In one example, such electrical stimulation could be delivered via a large renal artery with an implantable electrical stimulator. Other non-renal tissue regions could also be targeted.

[0319] The renal nerve is part of the sympathetic nervous system. In one example, neural modulation at the renal nerve (e.g., delivery of electrical stimulation therapy) can lead to similar effects achieved in acute renal denervation. In one example, such renal electrical stimulation could be used to treat uncontrolled hypertension. Other potential therapeutic benefits include modulating the sympathetic-parasympathetic balance and modulating the inflammatory response, which is crucial in several serious conditions, including heart failure and inflammatory bowel disease.

[0320] In one example, the systems and methods according to this disclosure may include or use a mid-field power supply device implanted, mounted, secured, coupled, or otherwise placed in a renal (or other) artery or other part of a patient's vascular system. The device may be powered by an external power supply unit located at or near the renal region where the stimulation device is implanted (see, for example, regarding power transfer from an external unit to the implanted device). Figure 1-5 (Discussion).

[0321] In one example, the therapeutic signal delivered by the implanted mid-field device generates an electric field that originates from the artery and travels through the arterial wall to a nearby renal nerve (or other neural target). In one example, the implanted mid-field device can be implanted using a tool substantially the same or similar to that used in balloon catheter angioplasty, as discussed above. In one example, the proximal end of the device includes a fixation mechanism deployed at the implant and configured to minimize obstruction and not impede blood flow through the artery. The fixation mechanism can have a variety of different configurations, some of which are described herein.

[0322] Figure 42 An example 4200 of the implantation location of the midfield device 4210 relative to the vascular system in the trunk is generally shown. In one example, the implantation procedure may begin by introducing a delivery catheter or cannula through the right femoral artery into the right external iliac artery 4221. Figure 42 The dashed lines in the diagram illustrate the path through which the mid-field device 4210 can be introduced and positioned in or near the renal artery 4222. Similarly, the mid-field device can reach other paths or destinations.

[0323] Figure 43 Examples including a side view and cross-sectional view of a mid-field device 4310 configured for installation and fixation within a blood vessel are shown in general. Fixation of the device may be important to ensure its chronic positioning for optimal neural stimulation (e.g., at a renal target or other site) and to allow substantially unrestricted blood flow through the vessel. In one example, the mid-field device 4310 has a maximum diameter of 7 Fr (2.33 mm) or less at its proximal end. Devices of other sizes may also be used.

[0324] In one example, the implantable device does not obstruct blood flow through the blood vessel when deployed because the vessel's inner diameter is larger than the cross-sectional area of ​​the mid-field device 4310 itself. The measured mean diameter of the artery can vary depending on the imaging method used. In one example, ultrasound revealed a representative diameter of 5.04 ± 0.74 mm, while angiography showed 5.68 ± 1.19 mm.

[0325] exist Figure 43 On the right side of the example, the mid-field device 4310 is deployed and secured within a first blood vessel having a vessel wall 4301. The mid-field device 4310 may be located near or adjacent to the renal nerve 4302 or other neural targets. In one example, the mid-field device 4310 includes a proximal housing assembly 4306 and a distal electrode assembly 4304. For example, drive circuitry within the proximal housing assembly 4306 (e.g., see...) Figure 28 The stimulation driver 2814 in the example can be used to provide an electrical signal for the driving electrode assembly 4304 to provide an electrical stimulation field 4303, and this field can be configured to alter or influence activity at a neural target.

[0326] exist Figure 43In the example, the midfield device 4310 includes various fixation features 4316. For example, the midfield device 4310, as shown, may include a plurality of sharp teeth extending away from the main body portion of the device, and the sharp teeth impact the inner surface of the blood vessel wall 4301 to position and fix the device relative to the blood vessel (e.g., in a coaxial manner with the blood vessel). At least a portion of the midfield device 4310 is spaced from the blood vessel wall 4301 by the sharp teeth or fixation features 4316, such that one or more unrestricted blood flow regions 4307 exist around the midfield device 4310. Although Figure 43 The example shows four discrete fangs as fixing feature 4316, but additional or fewer fangs may be used, as long as the number of fangs is sufficient to fix the mid-field device 4310 in the designated position relative to the blood vessel.

[0327] Figure 44-47 A partial view is shown, generally illustrating examples of different embodiments of the fixing feature 4316 applied to the midfield device 4310. Figure 44 A first example 4400 of a field device with a plurality of passive elements 4416 extending laterally away from the housing assembly 4306 of the field device is generally shown. The passive elements 4416 may comprise silicone or other non-reactive materials and may be configured to hold an implantable field device 4310 in place relative to a vessel wall 4301. In one example, the passive elements 4416 provide a frictional fit with the vessel wall 4301 at locations where the inner diameter of the vessel becomes sufficiently small or tapers to form an interference fit. In other words, the external dimensions of the passive elements 4416 may be approximately the same as the internal cross-sectional dimensions of the vessel (e.g., at locations where the vessel tapers), while the body of the field device 4310 (e.g., including one or more electrodes) has smaller external dimensions so as not to restrict blood flow around the device.

[0328] Figure 45 A second example 4500 of a midfield device with a plurality of expandable elements 4516 extending laterally away from the housing assembly 4306 of the midfield device is generally shown. The expandable elements 4516 may include one or more expandable balloons (e.g., using gas or liquid) configured to hold the implantable midfield device 4310 in place relative to the vessel wall 4301, for example, when inflated to the inner diameter of the vessel wall 4301 and thus providing an interference fit. In one example, complete occlusion of the vessel by, for example, the expandable elements 4516 is acceptable in certain circumstances. For example, occlusion of some small veins may be tolerated, or temporary occlusion may be permitted during placement surgery, for example, for intraoperative testing.

[0329] Figure 46A third example 4600 of a mid-field device is generally shown, comprising a plurality of active elements 4616 extending laterally away from the housing assembly 4306 of the mid-field device. In one example, the active elements 4616 include one or more spring-loaded elements that can be deployed by the implantation clinician during the implantation procedure. In one example, the active elements 4616 can be retracted or constrained to a minimum diameter when the device is inserted or implanted. Once positioned in place, the clinician can deploy the active elements 4616 (e.g., using mechanisms on a cannula or push rod) and cause the active elements 4616 to expand to the inner diameter of the vessel wall 4301, thereby providing an interference fit and securing the mid-field device 4310 in the designated position.

[0330] Figure 47 A fourth example 4700 of a midfield device with a fixation element 4716 is generally shown, the fixation element 4716 extending laterally away from the housing assembly 4306 of the midfield device. The fixation element 4716 can be configured to hold the implantable midfield device 4310 in a position against the vessel wall 4310. That is, although Figures 43-46 The examples generally show a fixing element configured to position the mid-field device 4310 centrally or coaxially relative to the blood vessel, but the fourth example 4700 is configured to be offset relative to the center or axis of the blood vessel. That is, the fourth example 4700 includes a fixing element 4716 that biases the housing assembly 4306 of the mid-field device toward one side of the blood vessel. However, similar to other embodiments, the fourth example 4700 has an external dimension smaller than the blood vessel wall 4301 so as not to restrict blood flow around the device.

[0331] Figure 48 Broadly showing from Figure 43 A variation of the exemplary device 4310. In Figure 48 In Example 4800, at least one of the fixation features 4316 includes an electrode 4801 configured to penetrate the vessel wall 4301. That is, in one example, the electrode 4801 is integrated with one or more of the fixation features 4316. In another example, the electrode 4801 is a discrete electrode separate from the fixation feature 4316. The electrode 4801 may be deployable after the device has been positioned in a suitable location in the arterial system. In one example, the electrode 4801 includes part of an electrode array (e.g., a radially extending array) disposed along a portion of the mid-field device 4310.

[0332] In one example, various other embodiments may include stent-based and / or spring-based systems for positioning a mid-field device within a blood vessel. These embodiments may have a low profile, may be constructed using biocompatible materials, and may be compatible with existing catheter-based tools and techniques.

[0333] Figure 49 An example of a stent-based system 4900 is generally shown, which may include a mid-field device 4910 coupled to an expandable stent 4902. Although schematically shown as a rectangle in the figure, the mid-field device 4910 may have any suitable size and shape for deployment within a blood vessel. Typically, the outer airtight housing of the mid-field device 4910 has a minimal or low profile to minimize obstruction of fluid flow around or above the device, as described elsewhere herein.

[0334] The mid-field device 4910 includes or is coupled to an antenna to receive a mid-field signal, for example, from another implant or from a device disposed outside the patient's body. The mid-field device 4910 may also include an energy storage element and one or more sensors (e.g., to sense physiological features within the vascular system) or electrodes (e.g., to provide electrical stimulation therapy from within or at least partially within the vascular system).

[0335] System 4900 can be configured to be delivered to an intravascular location using a cannula. That is, the expandable stent 4902 and the mid-field device 4910 can be configured to be pushed through the lumen of the cannula toward the distal open end of the cannula for placement within the blood vessel. After exiting the lumen, system 4900 can be expanded using the expandable stent 4902 to retain the mid-field device 4910 within the blood vessel, and preferably toward a sidewall of the vessel, to reduce obstruction to flow through the vessel. In one example, the delivery system includes or uses a balloon 4903 to expand the stent 4902 after deployment from the cannula.

[0336] In one example, the expandable stent 4902 includes a spring material or spring structure. In this example, the stent 4902 is contracted or compressed within the delivery lumen of the cannula, but the stent 4902 automatically springs back or expands upon deployment from the lumen, for example, due to the shape memory of the material.

[0337] Figures 50-52 Examples of bracket-based or spring-based systems that may include or use the mid-field device 5010 are generally shown. Figure 50 In the example, the midfield device 5010 is coupled to a first spring support 5002. The first spring support 5002 may include at least one elongated member having a curved or wavy shape. The midfield device 5010 may be coupled at multiple locations along the elongated member. Figure 50 In the example, the mid-field device 5010 is attached to the approximate center of the elongated member, for example, near one of the maximum (or minimum) degrees of the member.

[0338] exist Figure 50On the left side, the first spring support 5002 is shown as being inside the cannula 5020, and on the right side, Figure 50 A first spring support 5002 is shown deployed outside the cannula 5020. The first spring support 5002 is compressed or contracted before deployment when it is inside the cannula 5020. After deployment from the distal end of the cannula 5020 into the blood vessel, for example by a clinician using a pusher to slide the first spring support 5002 through the lumen of the cannula 5020, the first spring support 5002 can expand within the blood vessel, thereby pushing the mid-range device 5010 towards or forcing it against the sidewall of the blood vessel. Positioning the mid-range device 5010 towards one sidewall of the blood vessel helps minimize restriction on blood flow through the vessel and helps reduce blood flow turbulence around the device.

[0339] Figure 51 and Figure 52 Other examples of spring-based support members generally shown are connected to the same or different midfield devices 5010. Similar to... Figure 50 For example, when each component is arranged within the cannula 5020 Figure 51 The second spring-based support 5102 and Figure 52 The third spring-based support 5202 can be compressed during the deployment process and can be expanded after deployment from the delivery cannula.

[0340] exist Figure 51 In the example, the second spring-based support 5102 includes at least one elongated member having a coil shape. The field device 5010 can be coupled to multiple locations along the elongated member. Figure 51 In the example, the midfield device 5010 is attached to approximately the center of the elongated member.

[0341] exist Figure 52 In the example, the third spring-based support 5202 includes a pair of wire members arranged to form an elongated, compressible elliptical assembly. The field device 5010 can be coupled to multiple locations along this assembly. Figure 52 In the example, the mid-field device 5010 is attached to the approximate center of the component such that when the third spring-based support 5202 expands within the blood vessel, the device is pushed toward one sidewall of the blood vessel.

[0342] Figure 53 An example of a fourth spring-based support 5302 is generally shown, which includes an elongated member having a coil shape. Figure 53In one example, the field device 5310 is coupled to a support member 5302. In another example, the field device 5310 includes or is coupled to a portion of the support member 5302, which includes a portion of an antenna 5312 for the field device 5310. That is, the antenna 5312 for the field device 5310 may be integrated with the support member 5302, or at least partially formed of the same material as the support member 5302. In one example, the field device 5310 includes integrated electrodes or sensors, and in other examples, one or more electrodes or sensors are coupled to and positioned away from the main housing of the field device 5310. Figure 53 In one example, the field device 5310 includes a first electrode 5321 and a second electrode 5322 that are coupled to a support 5302 and spaced apart from the main housing of the field device 5310. The electrodes may be positioned in a fixed location along the support 5302, or in some examples, their position may be adjusted by a clinician, for example, before or during implantation into a blood vessel.

[0343] In one example, the method of using the field device 5310 includes receiving energy at the field device 5310 using an antenna 5312. At least a portion of the received energy can be used in electrical stimulation therapy provided using a first electrode 5321 and a second electrode 5322. In one example, one or more physiological sensors can be coupled to the field device 5310, and at least a portion of the received energy can be used to power the sensors and / or process information from the sensors and / or transmit information from the sensors to a remote device, such as to another implant or external device.

[0344] At least Figures 50-53 In the example, at least some portions of the corresponding support member may have a helical shape, which is configured to encourage the support member to reside near or rest against the vessel wall when the device is deployed. Positioning the support member against the vessel wall can help promote endothelialization and minimize blood flow obstruction.

[0345] Figure 54 An example of system 5400 is generally shown. System 5400 may include multiple structures, each configured for intravascular placement during a single implantation procedure. System 5400 includes a distal structure 5401 and a proximal structure 5402, and each of the distal structure 5401 and proximal structure 5402 can be deployed using a common cannula 5410. In one example, the distal structure 5401 and proximal structure 5402 are coupled to a common pusher. Figure 54In one example, distal structure 5401 and proximal structure 5402 are coupled to corresponding first push rod 5411 and second push rod 5412. In another example, each of distal structure 5401 and proximal structure 5402 includes a corresponding deployment device, such as a balloon.

[0346] In one example, the distal structure 5401 and the proximal structure 5402 are communicatively coupled to provide a transmission path for one or both of power and data between the structures. Figure 54 In the example, these structures are connected using conductive leads 5430. In one example, the distal structure 5401 and the proximal structure 5402 are additionally or optionally coupled using a wireless communication link.

[0347] In one example, at least one of the distal structure 5401 and the proximal structure 5402 includes or uses a support member that is coupled to a bracket-based or spring-based support (e.g., the one described above). Figures 49-53 The mid-field device (as described in the example). In one example, one of the distal structure 5401 and the proximal structure 5402 includes a mid-field receiver, and the other of these structures includes at least one sensor or electrode configured to deliver electrical stimulation therapy.

[0348] In one example, distal structure 5401 and proximal structure 5402 may expand externally to cannula 5410. Distal structure 5401 may have a dedicated first balloon 5441 configured to inflate and expand when the structure is deployed from cannula 5410. Proximal structure 5402 may similarly have a corresponding dedicated second balloon 5442. In one example, system 5400 includes a cannula 5450 disposed between distal structure 5401 and proximal structure 5402. Cannula 5450 may be configured to support or accommodate a blood vessel between these structures. In one example, one or more active or passive elements (e.g., sensors and / or electrodes) may be disposed on cannula 5450 and coupled to one or both of distal structure 5401 and proximal structure 5402.

[0349] In one example, the diameter of the cannula 5450 is chosen such that the assembly including the distal structure 5401 advanced by the first pusher 5411 and the cannula 5450 can be securely held against the cannula 5410. In one example, the cannula 5410 also carries the cannula 5450 and the distal structure 5410 as it is advanced through a vascular system (e.g., across a line, such as for coronary stent placement). The cannula 5450 and the distal structure 5410 can be deployed from the cannula 5410 using, for example, the first pusher 5411 and the first balloon 5441. In one example, after the distal structure 5401 is deployed and the first balloon 5441 is deflated, the first pusher 5411 can be further advanced (e.g., up to several additional inches) to release the proximal structure 5402 from the cannula of the main cannula 5410. Following this deployment, the first pusher 5411 can be completely retracted from the main body, and one or more cannula portions 5410 of the main cannula 5410 can be retracted using it. Next, the proximal balloon 5442 can be inflated to deploy the proximal structure 5402. In another example, the first balloon 5441 and the second balloon 5442 can be positioned on, for example, a single catheter and pusher assembly with a separate lumen, to independently inflate these balloons.

[0350] In examples that include spring-based or stent-based supports or components, these components can be configured to expand automatically after cannulation. In other examples, balloons or other expansion or dilation devices can be used with a variety of components to expand them into a configuration that allows them to remain permanently in a designated vascular location.

[0351] In one example, the implantable device is configured for deployment using a cannula extending through the vascular system. In some examples, the same or similar endovascular delivery systems (e.g., those used for vascular stent deployment) can be used to deploy implantable neurostimulators as described herein.

[0352] Figure 55 A cross-sectional view of a lumen 5510 is generally shown, which may encircle an implantable device 5506 (e.g., may include or use a mid-field device), a deployment structure 5520, and an inflatable balloon 5525. The implantable device 5506 may be configured for intravascular deployment using the lumen 5510. In one example, the implantable device 5506 may be coupled to or disposed adjacent to the deployment structure 5520 within the lumen 5510. The implantable device 5506 may be configured to ride on an external portion of the deployment structure 5520 as it slides within the lumen 5510. In other examples, the implantable device 5506 may be configured to ride within the deployment structure 5520 (e.g., at least partially surrounded or encircled by the deployment structure 5520), for example, displacing a portion of the balloon 5525.

[0353] Figure 56 A perspective view is generally shown of an implantable device 5506 and a deployment structure 5520 positioned distally outside a lumen 5510. In one example, a clinician-operable plunger 5630 can be used to adjust the position of the implantable device 5506 and the deployment structure 5520 within the vascular system upon implantation. Although in Figure 56 The device is shown in the form of a coil or spring, but the deployment structure 5520 can be any biocompatible structure configured to hold the implantable device 5506 in a generally long-term position within a blood vessel.

[0354] Figure 57 An example of an implantable device 5706 installed in a blood vessel having a vessel wall 5701 is generally shown. The deployment structure 5520 is schematically represented and may have any suitable structure or configuration to facilitate the long-term placement of the implantable device 5706 against the vessel wall 5701.

[0355] In one example, the implantable device 5706 is a field device configured to receive and utilize energy wirelessly received using a field signal. For example, the field device may include an antenna configured to receive energy from a propagating field within body tissue. The implantable device 5706 may include a device housing 5760 (e.g., a hermetically sealed or otherwise sealed housing structure) and various circuits or hermetically sealed electronic modules 5770 disposed within the device housing 5760. In one example, the electronic module 5770 includes power storage circuitry, processor circuitry, memory circuitry, or (e.g.,...) Figure 27 Exemplary first circuit and Figure 28 (As also described in the exemplary second circuit) one or more other circuits. In one example, electronic module 5770 includes a hermetically sealed cylindrical electronic housing to minimize its cross-sectional area. The cylindrical housing may be mounted or suspended in a biocompatible resin or epoxy resin with smooth outer edges, for example, to make the implantable package more streamlined and reduce irritation to adjacent blood vessel walls. Other hermetically sealed and non-cylindrical housing shapes may also be used.

[0356] In one example, the implantable device 5706 includes an antenna 5780 disposed inside the device housing 5760 but outside a hermetically sealed electronic module 5770. In one example, the implantable device 5706 includes at least one, and preferably at least two, electrodes 5791 and 5792, disposed on or near the outward-facing surface of the device housing 5760. That is, electrodes 5791 and 5792 may be configured to face outward toward the blood vessel wall 5701 when the implantable device 5706 is mounted using the deployment structure 5520. When properly mounted, electrodes 5791 and 5792 may contact the blood vessel wall 5701 to minimize signal transmission or short circuits that may occur through blood flowing through the vessel. Various features may be combined with the implantable device 5706 and / or electrodes 5791 and 5792 to help ensure that the electrodes remain in contact with the blood vessel wall. Some examples are shown in... Figure 59 and Figure 60 The following is shown and discussed.

[0357] exist Figure 57 In the example, the implantable device 5706 and the deployment structure 5520 are configured to expand at least a portion of the vessel wall 5701 (e.g., on one side of the vessel), thereby causing the vessel wall to slightly expand or bulge. By placing the implantable device 5706 in the bulging portion of the vessel, the central open area of ​​the vessel can be configured to maintain blood flow therethrough.

[0358] Figure 58 An example of a second implantable device 5801 is generally shown, which is configured in a manner similar to implantable devices 5506 and / or 5706, but includes an antenna 5880 that can extend to the exterior of the device housing 5760. For example, the antenna 5880 can be a rigid or flexible structure that can remain within a blood vessel after implantation. Since the antenna 5880 is not limited to being inside or contained within the device housing 5760, the antenna 5880 can be generally longer or larger than the housing portion of the implant.

[0359] Figure 59 A perspective view of an example of a first electrode assembly is shown, generally coupled to a hermetically sealed electronic module 5970 for an intravascular implantable device. The electrode assembly is configured to facilitate contact between the vessel wall and one or more electrodes. In one example, the electrode assembly includes a curved surface having one or more discrete conductive regions or electrodes. In one example, the curved surface may be selected to match the curvature of the internal vessel wall, or the surface may be flexible and conform to the wall curvature. In examples with two or more electrodes, non-conductive portions of the curved surface may be disposed between the electrodes. Figure 59In the example, the first electrode 5991 and the second electrode 5992 may be positioned on opposite sides of a non-conductive membrane 5901 that separates the electrodes. The membrane 5901 may comprise a variety of biocompatible materials and may be solid, barbed, or perforated. In one example, the membrane 5901 has a regular or irregular honeycomb configuration, which helps to maintain the implant in place in a blood vessel for an extended period, and in some examples, it may integrate itself with the blood vessel wall. The membrane 5901 may help reduce or minimize current shunting between the first electrode 5991 and the second electrode 5992, for example, by redirecting current through the adjacent blood vessel wall toward a neural target.

[0360] Figure 60 The diagram generally shows a perspective view of an example of a second electrode assembly coupled to an hermetically sealed electronic module 6070 for an intravascular implantable device. The electronic module 6070 is coupled to a first electrode 6091 and a second electrode 6092, which have arcuate shapes and extend laterally relative to the main body of the electronic module 6070. Figure 60 Examples are similar to Figure 59 An example, but there is no membrane 5901 between electrodes 6091 and 6092.

[0361] Figure 61 An example of an intravascular implantable device 6106 is shown in general. Figure 61 Examples include a hermetically sealed device housing encapsulating a hermetically sealed electronic module 6170. An implantable device 6106 may include a first electrode 6191 coupled to the electronic module 6170 and disposed on an outward-facing surface of the housing. In one example, the implantable device 6106 includes a second electrode 6192 disposed on a deployment mechanism configured to puncture a blood vessel wall. In one example, the second electrode 6192 is positioned outside the blood vessel and can therefore be positioned closer to the therapeutic target, and can thus be used to deliver treatment (or sense physiological parameters), for example without side effects, such as those caused by the blood vessel wall being located between the electrode and the target.

[0362] Figure 62 A side view of an endovascular implantable device 6200 is shown in general. In one example, the device may be implanted or mounted and configured to deliver electrical stimulation to a neural target using one or more portions of the device 6200. In one example, the device 6200 may be at least partially implanted or mounted in a patient's vascular system. For example, the device 6200 may be implanted or mounted in an artery. The device 6200 may include one or more discrete electrodes and / or support portions. Figure 62In the example, device 6200 includes a first portion 6201, a second portion 6202, a third portion 6203, and a fourth portion 6204. Each of the first portions 6201 to the fourth portions 6204 may include or use electrodes and / or supports for a portion of the field device.

[0363] exist Figure 62 In the example, the third part 6203 includes a coiled support. The coiled support may include an elongated, substantially flat, and optionally continuous material wound or coiled to a specified diameter. One or more portions of the coiled support may be conductive and may be coupled to a field device for physiological parameter sensing or electrical stimulation. That is, one or more portions of the coiled support may include or use electrodes. The coil diameter may be adjusted, for example, during implantation or transplantation. The coil stiffness or material may be selected based on the specific application of the device 6200. For example, different materials may be used for kidney applications and cardiac applications. The third part 6203 may include a first electrode 6223, which may be coupled to or supported by the coiled support. The first electrode 6223 may be coupled to the field device and may be used in conjunction with driving or sensing electronics included in the field device for electrical stimulation or physiological parameter sensing.

[0364] As shown Figure 62 Examples include four discrete parts; more or fewer parts may be used, for example, to provide multipolar electrical stimulation or sensing devices. Connecting wires 6213 may be used to connect multiple adjacent parts of the implantable device 6200. In one example, connecting wires 6213 are serial connections between multiple adjacent parts of the device, and in other examples, different connecting wires may extend in parallel from each of the first part 6201 to the fourth part 6204 to another part of the mid-field device.

[0365] Figure 63 A perspective view of a second intravascular implantable device 6300 is shown in general. The second intravascular implantable device 6300 may include a coiled portion and one or more discrete support and / or electrode portions, as shown above. Figure 62 As described in the example.

[0366] The second intravascular implantable device 6300 includes a first portion 6301 having a coiled support, and one or more portions of the support may be conductive and / or configured to serve as electrodes. In one example, the first portion 6301 includes discrete electrode extensions 6302. Electrode extensions 6302 may be curved to conform to the shape of the inner wall of the blood vessel in which the device 6300 is mounted. In one example, the first portion 6301 includes one or more fangs, such as a first fang 6303. The first fang 6303 may extend orthogonally to the longitudinal axis of the coiled support. In one example, the first fang 6303 is configured to impinge on or pierce the inner wall of the blood vessel. Thus, the first fang 6303 may be used to anchor or secure the implantable device 6300 to a specific designated location within a patient's vascular system. In one example, the first fang 6303 includes one or more conductive portions and may serve as electrodes when coupled to a mid-field device.

[0367] Figure 64 A perspective view of a third intravascular implantable device 6400 is shown in general. The third intravascular implantable device 6400 may include a coiled portion and one or more discrete support and / or electrode portions, as described above. Figure 62 and / or Figure 63 As described in the example. Figure 64 In one example, the first portion 6401 of device 6400 includes an extension member 6403. In one example, the extension member 6403 extends substantially parallel to the axis of the coiled support of the third device. The extension member 6403 can be configured to be deployed outside the blood vessel wall, for example, adjacent to the first portion 6401 of device 6400. The extension member 6403 can help anchor or secure the implantable device 6400 to a specific designated location within the patient's vascular system. In one example, the extension member 6403 includes one or more conductive portions and can be used as an electrode when coupled to a field device.

[0368] Figure 65 An example of a field device 6501 coupled to an intravascular implantable device 6300 is generally shown. The field device 6501 may include an antenna 6511 configured to receive wireless field power and / or data signals, and the body portion 6512 enclosing telemetry circuitry, processing circuitry, and drive circuitry, as described elsewhere herein with respect to implantable field devices.

[0369] The mid-field device 6501 may also include an interconnect portion 6513 configured to be coupled to one or more electrodes deployed in a blood vessel. In one example, the mid-field device 6501 may receive a wireless power signal and, in response, use one or more electrodes on the implantable device 6300 to provide electrical stimulation therapy or sense physiological parameters from the patient. Figure 65 In the example, the field device 6501 is connected to each part of the implantable device 6300 using a serial connection. That is, a common conductor connects each electrode portion of the four illustrated parts of the device 6300 to the field device 6501. In other examples, parallel connections may be used, for example, to provide separate signals from the field device 6501 to different discrete parts of the device 6300.

[0370] Figure 66 An example 6600 of an intermediate device 6501 is generally shown, which is coupled to an intravascular implantable device 6300 within a blood vessel. The vessel wall 6601 is indicated by dashed lines. The coiled portion of the device 6300 abuts or contacts the vessel wall 6601. Figure 66 In the example, the fangs from device 6300 pierce the vessel wall 6601 at each different discrete coiled portion of device 6300. As illustrated above, the fangs can be used to secure device 6300 within the blood vessel, and / or the fangs may include one or more conductive portions or electrodes for sensing physiological parameters or providing electrical stimulation to the patient. Multiple electrodes may be individually or collectively addressed by drive circuitry within the mid-field device 6501. Figure 66 In the example, the mid-field device 6501 is coupled to the central portion of the intravascular implantable device 6300, wherein a conductor extends from the central portion of the device 6300 to the distal portion of the device 6300 to either side of the mid-field device 6501.

[0371] Any one or more of the fixation features described herein may include unforeseen circumstances (devices, features, mechanisms, etc.) to pull the device back, retract, or shrink it to a smaller diameter to allow retrieval, transplantation (e.g., through the same vascular implantation path), and / or adjustment of the placement of the various intravascular devices described herein.

[0372] While the foregoing discussion has largely concerned mid-wave powered electrical stimulation devices configured for renal nerve stimulation, the mid-wave powered electrical stimulation devices and features discussed herein can be deployed in other vascular or body locations. That is, the systems and methods discussed herein can be used, for example, to deliver electrical stimulation to targets throughout the body by positioning a long-term implantable device at or near a specific therapeutic target within the vascular system. In addition to renal system targets, other targets accessible from the vascular system may include various receptors or targets in the patient's phrenic nerve, visceral nerves, genital nerves, vagus nerve, or gastrointestinal tract.

[0373] In one example, a mid-field device may be deployed in or near a blood vessel in the patient's brain. This device may be configured to deliver electrical stimulation to a neural target or to sense brain activity. In one example, the mid-field sensor device may record or archive measured neural activity information and, for example, report this information in real time or otherwise to an external device using mid-field or other communication technologies. II. Layered midfield launcher system and apparatus

[0374] In one example, for example, corresponding to Figure 1 The example external source 102's mid-field transmitter device may include a layered structure with multiple tuning elements. The mid-field transmitter may be a dynamically configurable active transceiver configured to provide RF signals to modulate an evanescent field at a tissue surface, thereby generating a propagating field within the tissue, for example, to transmit power and / or data signals to an implanted therapeutic target device.

[0375] In one example, the mid-field transmitter device includes a combination of transmitter and antenna features. The device may include a cutout or patch antenna with a backplane or ground plane, and may include one or more microstrip or other device excitation features. In one example, the device includes one or more conductive plates that can be excited, thereby causing these conductive plates to generate signals, for example, in response to the excitation of one or more corresponding microstrips.

[0376] Figure 67 A top view of an example of a first layer 6701A of a layered first emitter 6700 is shown in general. The first emitter 6700 is shown as circular; however, emitters of other shapes and profiles, as well as various emitter elements or layers, can be used similarly. The first layer 6701A includes a conductive plate that can be etched or cut to provide various layered features. Figure 67In this example, the first layer 6701A includes a copper substrate etched with a circular notch 6710 to separate the conductive outer region 6705 from the conductive inner region 6715. In this example, the outer region 6705 includes annular or circular features separated from the disk-shaped features including the inner region 6715 by the circular notch 6710. That is, the conductive inner region 6715 is electrically isolated from the conductive ring including the outer region 6705. When the first transmitter 6700 is excited using one or more microstrip features, for example, it may be set... Figure 67 When on a non-device layer (such as those discussed below), the conductive inner region 6715 generates a tuning field, and the outer ring or outer region 6705 can be connected to a reference voltage or ground potential.

[0377] Figure 67 Examples include multiple tuning features with respect to the physical dimensions and location of the first layer 6701A to influence the field emitted by the first transmitter 6700. In addition to the etched circular notch 6710, this example includes four radial notches or arms 6721A, 6721B, 6721C, and 6721D extending from the circular notch 6710 toward the center of the first layer 6701A. Fewer or additional tuning features, for example, with the same shape as shown or otherwise, could similarly be used to influence the resonant frequency of the device. That is, although a linear radial notch is shown, one or more notches shaped differently could also be used.

[0378] The diameter of the first layer 6701A and the size of the cutout 6710 are adjustable to tune or select the resonant frequency of the device. Figure 67 In the example, as the length of arms 6721A-6721D increases, the resonant or center operating frequency decreases. The dielectric properties of one or more layers adjacent to or close to the first layer 6701A can also be used to tune or influence the resonant or transmission characteristics. Figure 67 In the example, arms 6721A-6721D are substantially the same length. In another example, the arms may have different lengths. Multiple orthogonal pairs of arms may have substantially the same or different length characteristics. In one example, the first arm 6721A and the third arm 6721C have a first length characteristic, while the second arm 6721B and the fourth arm 6721D may have different second length characteristics. The designer can adjust the arm lengths to tune the device's resonance and current distribution modes.

[0379] In one example, capacitor elements may be configured to bridge the cutout 6710 at one or more locations to further tune the transmitter's operating frequency. That is, the individual plates of the capacitor may be electrically coupled to the outer region 6705 and the inner region 6715 to tune the device.

[0380] The dimensions of the first layer 6701A can vary. In one example, the optimal radius is determined by the expected operating frequency, the characteristics of the nearby or adjacent dielectric material, and the characteristics of the excitation signal. In one example, the nominal radius of the first layer 6701A is about 25 mm to 45 mm, and the nominal radius of the notch 6710 is about 20 mm to 40 mm. In one example, the transmitter device including the first layer 6701A can be manufactured smaller, for example, by reducing the notch radius and / or increasing the length of the arm, at the expense of device efficiency.

[0381] Figure 68A A top view is generally shown of a second layer 6801 stacked on a first layer 6701A of a layered first transmitter 6700. The second layer 6801 is spaced apart from the first layer 6701A, for example, by using a dielectric material interposed therebetween. In one example, the second layer 6801 includes a plurality of microstrips configured to excite the first transmitter 6700. Figure 68A Examples include the first to fourth microstripes 6831A, 6831B, 6831C, and 6831D, which correspond to the four regions of the conductive internal region 6715 of the first layer 6701A, respectively. Figure 68A In the example, microstrips 6831A-6831D are oriented at approximately 45 degrees to the corresponding arms in arms 6721A-6721D. Different azimuths or offset angles can be used. Although Figure 68A Examples show microstrips 6831A-6831D spaced at equal intervals around a circular device, but other unequal intervals may be used. In one example, the device may include additional microstrips or only one microstrip.

[0382] The first to fourth microstrips 6831A-6831D disposed on the second layer 6801 are electrically isolated from the first layer 6701A, which includes a conductive annular outer region 6705 and a disk-shaped conductive inner region 6715. That is, dielectric material can be inserted between the first layer 6701A and the second layer 6801 of the first transmitter 6700.

[0383] exist Figure 68A In the example, the first to fourth microstrips 6831A-6831D are coupled to the corresponding first to fourth vias 6832A-6832D. The first to fourth vias 6832A-6832D may be electrically isolated from the first layer 6701A; however, in some examples, the first to fourth vias 6832A-6832D may extend through the first layer 6701A.

[0384] In one example, one or more of the first to fourth microstrips 6831A-6831D can be used, for example, in... Figure 68AOther corresponding vias, not shown in the example, are electrically coupled to the conductive internal region 6715 of the first layer 6701A. Such electrical connections are unnecessary for generating a field signal using the device; however, they may be useful for tuning the device's performance.

[0385] Several benefits are provided by providing an excitation microstrip (e.g., first to fourth microstrips 6831A-6831D) on a layer extending across the conductive internal region 6715 of the first layer 6701A. For example, the overall size of the first transmitter 6700 can be reduced. A variety of different dielectric materials can be used between the first layer 6701A and the second layer 6801 to reduce the size or thickness of the first transmitter 6700.

[0386] Figure 68B A top view is generally shown of a second layer 6801 stacked on top of a different first layer 6701B of a layered transmitter. Relative to... Figure 68A , Figure 68B The example includes a different first layer 6701B, rather than a first layer 6701A including arms 6721A-6721D. The different first layer 6701B includes a copper substrate etched with circular cutouts 6810 to separate the conductive outer region from the conductive inner region. In addition to the etched circular cutouts 6810, this example includes a pair of linear cutouts 6811 arranged in an "X" shape and configured to intersect at the central axis of the device. Therefore, this example includes eight electrically decoupled regions on the different first layer 6701B, including four equal-sized sectors or fan-shaped regions and four equal-sized portions of a ring.

[0387] exist Figure 68B In the example, the pair of linear notches 6811 extend to opposite lateral edges of the substrate or layer. When the device is excited (e.g., using a microstrip on a second layer 6801), the current density obtained on or above the different first layers 6701B is denser at the outer ring portion of that layer than at the inner sector portion. This density can be based on the area of ​​the outer ring (e.g., rather than on the area from...). Figure 68A The operating frequency or resonance of the device is determined by the length of the arms (examples 6721A-6721D). Figure 68B The overall signal transmission efficiency from the transmitter to the implanted mid-field receiver in the embodiment is similar to that from using Figure 68A The efficiency of the transmitter in the embodiment, however. Figure 68B The higher current density at the outer ring portion of the embodiment allows for greater maneuverability (i.e., transmitter field steering) when the receiver is off-axis relative to the transmitter, and thus allows for potentially better access and transmission characteristics for communication with the implanted mid-field receiver. Furthermore, when using... Figure 68BIn this embodiment, the specific absorption rate (SAR) can be reduced, and unwanted connections between ports can be reduced.

[0388] Figure 69 A perspective view of an example of a layered first transmitter 6700 is shown in general. Figure 70 A side cross-sectional view of the layered first transmitter 6700 is generally shown. This example is in Figure 69 and Figure 70 The bottom side of each figure includes a first layer 6701A of the first transmitter 6700. At the top of the figure, the first transmitter 6700 includes a third layer 6901. The third layer 6901 may be a conductive layer providing shielding or a backplane for the first transmitter 6700. A second layer 6801 (e.g., including one or more microstrips) may be interposed between the first layer 6701A and the third layer 6901. One or more dielectric layers (not shown) may be interposed between the first layer 6701A and the second layer 6801, and one or more other dielectric layers may be interposed between the second layer 6801 and the third layer 6901.

[0389] Figure 69 and Figure 70 Examples include vias that electrically couple an external region 6705 on the first layer 6701A to the third layer 6901. Specifically, ground vias 6941A-6941H can be provided to connect a ground plane (e.g., the third layer 6901) to one or more features or regions on the first layer 6701A. In this example, and as described above, each of the first to fourth microstrips 6831A-6831D is coupled to a corresponding signal excitation via 6832A-6832D. The signal excitation vias 6832A-6832D are electrically isolated from the first layer 6701A and the third layer 6901.

[0390] exist Figure 69 and Figure 70 In the example shown, the emitting side of the device is downward. That is, when the first emitter 6700 is used and positioned against or adjacent to a tissue surface, the tissue-facing side of the device is downward as shown in the figure.

[0391] Setting the third layer 6901 as a ground plane has several advantages. For example, other electronic devices or circuits can be placed on top of the third layer 6901 and can operate without excessively interfering with the transmitter. In one example, other radio circuits (e.g., operating outside the range of the mid-field transmitter) can be placed on the third layer 6901, for example, for radio communication with implanted devices or other devices (e.g., implantable device 110 or other implantable devices as described herein). In one example, a second transmitter can be placed, for example, back-to-back with the first transmitter 6700, and can be separated from the first transmitter 6700 using the ground plane of the third layer 6901.

[0392] Figure 71 A top view of an example of a layered second transmitter 7100 is shown. The second transmitter 7100 is similar to the first transmitter 6700 in outline and its layered structure. The second transmitter 7100 includes microstrip excitation elements 7131A-7131D on a second layer, which is offset relative to a first layer 7101 that includes first to fourth patch-like features 7151A-7151D. Figure 72 A perspective view of the layered second transmitter 7100 is shown in general.

[0393] exist Figure 71 In the example, the first layer 7101 includes a conductive plate that can be etched or cut to provide multiple layer features. The first layer 7101 includes a copper substrate that is etched to form several discrete regions. Figure 71 In the example, the etching partially divides the layer into multiple quadrants. However, compared to... Figures 67-69 Unlike the example, the etched portion does not form a physically isolated internal region. Instead, Figure 71 Examples include a pattern of vias 7160 used for partially electrically isolated discrete regions. The vias 7160 are connected to another layer serving as a ground plane. In the example shown, the vias 7160 are arranged in an "X" pattern corresponding to and defining quadrants. In one example, the vias 7160 extend between a first layer 7101 and a second layer 7103, and the vias 7160 are electrically isolated from another layer comprising one or more microstrips. The arrangement of the vias 7160 divides the first layer 7101 into quadrants that can be excited substantially individually.

[0394] The etched portion of the first layer 7101 includes various linear cuts or arms that extend from the outside of the first layer toward the center of the device. Similar to... Figures 67-69 For example, the diameter and cutout or arm size of the second transmitter device can be adjusted to tune or select the resonant frequency of the device. The dielectric properties of one or more layers adjacent to or close to the first layer 7101 can also be used to tune or influence the transmission characteristics of the second transmitter 7100.

[0395] exist Figure 71 In the example, the vias 7160 and via walls arranged in an "X" pattern can be used to isolate different excitation regions and can facilitate the redirection of the propagation field, for example, to target an implantable device that is imprecisely aligned with the transmitter. Signal redirection can be provided by adjusting various characteristics of the excitation signals supplied to the microstrips (e.g., the first to fourth microstrip excitation elements 7131A-7131D). For example, the amplitude and phase characteristics of the excitation signals can be selected to achieve specific transmission positioning.

[0396] The inventors have recognized that vias, such as the via 7160, offer additional benefits. For example, the via walls can cause some signal reflections to and from the excitation, which in turn provides more surface current and thereby improves the efficiency of signals transmitted to the tissue.

[0397] Figure 73 This is a general example of a cross-sectional schematic diagram of a layered transmitter. This schematic diagram roughly corresponds to... Figures 67-72 Any one or more of the examples. Figure 73 In the example, the bottom layer 7301 is the first conductive layer (e.g., copper), and may correspond to, for example... Figure 67 The first layer of the example is 6701A. That is, Figure 73 The underlying 7301 can be Figure 67 The example shows the etched first layer 6701A.

[0398] Move upwards from the bottom layer 7301. Figure 73 It includes a first dielectric layer 7302. The first dielectric layer 7302 may include a low-loss dielectric material, preferably having a Dk of 3-13. Above the first dielectric layer 7302 may be a conductive second layer 7303. The conductive second layer 7303 may include one or more microstrip excitation features discussed herein.

[0399] A second dielectric layer 7304 may be disposed above the conductive second layer 7303. The first dielectric layer 7302 and the second dielectric layer 7304 may comprise the same or different materials and may have the same or different dielectric properties or characteristics. In one example, the first dielectric layer 7302 and the second dielectric layer 7304 may have different dielectric properties, and this characteristic is selected to achieve a specific device resonance.

[0400] exist Figure 73In the example, the second dielectric layer 7304 comprises multiple layers of dielectric material. As the second dielectric layer thickens, the distance between the conductive second layer 7303 and the conductive third layer 7305 increases. The conductive third layer 7305 may include a backplane or ground. As the distance between the conductive second layer 7303 and the conductive third layer 7305 increases, the transmitter bandwidth can be increased accordingly. Greater bandwidth allows for greater data throughput, a wider frequency hopping range, and also improves manufacturability by increasing acceptable tolerances.

[0401] One or more through-holes can extend vertically through the layered assembly, such as Figure 73 As shown in the diagram. For example, a first through-hole 7311 may extend entirely through the vertical height of the device, while a second through-hole 7312 may extend partially through the device. The through-holes may terminate at multiple conductive layers, for example, to provide electrical communication between different layers and drive circuitry or ground.

[0402] Multiple other layers may be disposed above the conductive third layer 7305. For example, multiple layers of copper and / or dielectric may be disposed, for instance, to integrate various electronic devices with the transmitter. Such devices may include one or more of signal amplifiers, sensors, transceivers, radios, or other devices or components of such devices, such as resistors, capacitors, transistors, etc.

[0403] Figure 74 This is a general example showing signal or field penetration within tissue 7406. The transmitter (e.g., corresponding to...) Figures 67-73 (one or more of the examples) or other transmitters (e.g. Figure 1 An external source 102 (designated as 7402 in this example) is positioned at the top of the illustration. When the transmitter 7402 is activated to manipulate the evanescent field at the air gap 7404 between the transmitter 7402 and the tissue 7406, a propagating field (shown in the figure as asymptotic lobes) is generated, which extends away from the transmitter 7402 toward the bottom of the illustration into the tissue 7406.

[0404] Figure 75 Generally, it shows the display when, for example, according to Figures 67-73 An example of surface current generated when a mid-field emitter is excited. The surface current pattern closely simulates the optimal distribution of oscillations to generate an evanescent field that will produce a propagating field within the tissue (see example...). Figure 74 (Example of a propagation field in a document).

[0405] In one example, the excitation signal that provides the optimal current mode (e.g., to the microstrip) includes the microstrip being oriented in the opposite direction (e.g., Figure 68AThe second microstrip 6831B and the fourth microstrip 6831D in the example provide oscillation signals. In one example, the excitation signal also includes signals to the quadrature port (e.g., Figure 68A The signals provided by the first microstrip 6831A and the third microstrip 6831C in the example. This type or pattern of excitation can be used to efficiently transmit signals to deeply implanted receivers (e.g., ring receivers) within tissue. In one example, the ring receiver can be oriented parallel to the current direction as shown at the center of the transmitter.

[0406] Figure 76 An example of Figure 7600 is shown in general, illustrating the relationship between the coupling efficiency of the orthogonal transmitter port and the implanted receiver and changes in the angle or rotation of the implanted receiver. This example demonstrates that weighting the input or excitation signal supplied to the orthogonal port (e.g., to a microstrip) can be used to compensate for rotation of the implanted receiver. When the transmitter can compensate for such changes in the target device's position, consistent power can be delivered to the target device.

[0407] exist Figure 76 In the example, the first curve 7601 shows the S-parameters or voltage ratio of the signals at the transmitter and receiver when the first pair of reverse-oriented (e.g., top / bottom or left / right) microstrips are excited by an oscillating signal. The second curve 7602 shows the S-parameters when the second pair of reverse-oriented microstrips is excited by an oscillating signal. The first and second pairs of microstrips are orthogonal pairs. This example illustrates that signals supplied to the orthogonal pairs can be optimally weighted to achieve consistent power supply with different implantation angles, for example, through constructive interference.

[0408] Figure 76 The examples also illustrate how the transmitters and their equivalents discussed herein can be used to effectively manipulate or orient propagating fields, for example, without moving the transmitter or external source device itself. For instance, rotational changes in the position of an implanted receiver can be compensated for by weighting signals supplied to multiple microstrips with different phases, for example, to ensure consistent signal delivery to the implant. In one example, the weighting can be adjusted based on sensed or measured signal transmission efficiency, for example, using feedback from the implant itself. Adjusting the excitation signal weighting can alter the direction of the transmitter current distribution, which in turn can alter the characteristics of the evanescent field outside body tissue.

[0409] Figure 77A , Figure 77B and Figure 77CExamples of different polarizations of a mid-field transmitter are generally illustrated. In one example, the polarization direction of the transmitter can be altered by adjusting the phase and / or amplitude of the excitation signal supplied to one or more of the microstrips or other excitation features of the transmitter. Adjusting the excitation signal changes the current distribution on the conductive portion of the transmitter and can be used to polarize the transmitter in alignment with or towards the receiver to optimize signal transmission efficiency. Closed-loop feedback from the implant can be used to determine the optimal excitation signal configuration. For example, an external device can make small changes to the signal phase and transmission weighting. The implant can then use an integrated power meter to measure the strength of the received signal and transmit the information about the strength to the external device to determine the effect of the signal phase change. The system can converge over time using adjustments in the positive and negative directions of the phase and port weighting between quadrature ports.

[0410] Figure 77A The example illustrates an approximate optimal current distribution in the left and right quadrants of the transmitter. In this example, the top and bottom microstrips receive the first pair of excitation signals, and the orthogonal microstrips on the left and right sides can be omitted.

[0411] Figure 77B The example shows relative to Figure 77A The example shows an approximate optimal current distribution rotated approximately 45 degrees. In this example, all four microstrips can be excited by, for example, different excitation signals with phase shifts.

[0412] Figure 77C The example shows relative to Figure 77A The example shows an approximate optimal current distribution rotated approximately 90 degrees. In this example, the left and right microstrips receive a second pair of excitation signals, and the orthogonal microstrips at the top and bottom are not used.

[0413] Figure 78 An example of a portion of a layered mid-field transmitter 7800 is shown, illustrating a first layer with a cutout 7810. In one example, this cutout separates the outer conductive region 7805 of the first layer from the inner conductive region 7815 of the first layer. In addition to adding arms or radial cutouts to tune the operating frequency of the transmitter 7800, or alternatively, capacitive elements may be connected across the two opposite conductive sides of the cutout 7810 to bridge the outer conductive region 7805 and the inner conductive region 7815. Figure 78 In the example, the first capacitor element 7801 and the second capacitor element 7802 bridge the outer conductive region 7805 and the inner conductive region 7815 at different locations along the cut 7810. The capacitor elements used for this bridging and tuning can be in the picofarad range. Other emitter configurations and geometries can also be used to achieve the same current distribution and manipulable field.

[0414] Figure 79 A perspective view of an example of a layered third emitter 7900 is shown in general. These examples include a first layer 7901 of the third emitter 7900 at the bottom of the figure. At the top of the figure, the third emitter 7900 includes a second layer 7902. The first layer 7901 and the second layer 7902 can be separated using a dielectric layer. Similar to... Figure 67 For example, the first layer 7901 may include a cutout 7910 that separates or electrically isolates the outer region 7905 of the first layer 7901 from the inner region 7915 of the first layer 7901. The cutout 7910 separates the annular outer region 7905 (e.g., an outer annular region) from the disk-shaped inner region 7915 (e.g., an inner disk-shaped region). In one example, the second layer 7902 may be a conductive layer providing shielding or a backplane for the third transmitter 7900.

[0415] Figure 79 Examples include vias 7930A-7930D, which electrically couple an internal region 7915 on the first layer 7901 to a drive circuit (e.g., which may be located on the second layer 7902). A ground via (not shown) can be used to electrically couple an external region 7905 to the second layer 7902. That is, Figure 79 Examples may include an emitter having an internal region 7915 of a first layer 7901, which can be excited without the use of additional layers and microstrips. In one example, the first layer 7901 may be tuned or modified, for example, by adding one or more arms extending from a notch 7910 toward the center of the device. However, the circular notch 7910 may be fabricated to be generally large enough to achieve a suitable operating resonance or frequency without using such additional etched or deposited features as the notch.

[0416] Figure 80 A side cross-sectional view of the layered third transmitter 7900 is shown in general. Figure 80The example generally illustrates a dielectric layer 7903 disposed between a first layer 7901 and a second layer 7902 of a third transmitter 7900. In one example, a circuit assembly 7950 may be disposed adjacent to the third transmitter 7900 and may be coupled to the third transmitter 7900, for example, using solder bumps 7941, 7942. Using solder bumps can facilitate assembly using an established solder reflow process. Other electrical connections may also be used. For example, the top and bottom layers may include edge plating and / or pads to facilitate interconnection of these layers. In this example, the top layer may optionally be smaller than the bottom layer (e.g., the top layer may have a smaller diameter than the bottom layer), and optical verification of the assembly may be performed more easily. In one example, the third transmitter 7900 may include one or more capacitive tuning elements 8001 coupled to the first layer 7901, for example, at or near a notch 7910. III. Implementations of related computer hardware and / or architecture

[0417] As an example, Figure 81 A block diagram of an embodiment of machine 8100 is shown, on which one or more methods discussed herein may be used or in combination with one or more systems or apparatuses described herein. Figure 81 References include to the structural components discussed and described in conjunction with the foregoing embodiments and figures. In one or more examples, the implantable device 110, source 102, sensor 107, processor circuitry 210, digital controller 548, circuitry in circuit housings 606-606C, system control circuitry, power management circuitry, controller, stimulation circuitry, energy harvesting circuitry, synchronization circuitry, external device, control circuitry, feedback control circuitry, implantable device, positioning circuitry, control circuitry, other circuitry of the implantable device, and / or circuitry that is part of or connected to an external source may include one or more items of machine 8100. According to some exemplary embodiments, machine 8100 is capable of reading instructions from a machine-readable medium (e.g., a machine-readable storage medium) and performing any one or more methods, one or more operations of methods, or one or more circuit functions discussed herein (e.g., methods described herein). For example, Figure 81A graphical representation of machine 8100 in an example form of a computer system is shown, within which instructions 8116 (e.g., software, programs, applications, applets, or other executable code) are executable to cause machine 8100 to perform any one or more of the methods described herein. These instructions translate a general, unprogrammed machine into a specific machine programmed to perform the described and illustrated functions in the manner described. In alternative embodiments, machine 8100 operates as a standalone device or can be coupled (e.g., networked) to other machines. In a networked deployment, machine 8100 may operate as a server machine or client machine in a server-client network environment, or as a peer machine in a peer-to-peer (or distributed) network environment. Multiple portions of machine 8100 may be included in or used with one or more of external source 102 and implantable device 110. In one or more examples, different instances or different physical hardware portions of machine 8100 are individually implanted in external source 102 and implantable device 110.

[0418] In one or more examples, machine 8100 may include, but is not limited to, server computers, client computers, personal computers (PCs), tablet computers, laptop computers, cellular phones, smartphones, mobile devices, wearable devices (e.g., smartwatches), smart home devices (e.g., smart appliances), other smart devices, network devices, network routers, network switches, bridges, or any machine capable of sequentially or otherwise executing instructions 8116 that specify the actions to be taken by machine 8100. Furthermore, although only a single machine 8100 is shown, the term "machine" should also be considered as including a collection of machines 8100 that individually or collectively execute instructions 8116 to perform any or more of the methods discussed herein.

[0419] Machine 8100 may include processor 8110, memory 8130, or I / O components 8150, which may be configured to communicate with each other, for example, via bus 8102. In one or more exemplary embodiments, processor 8110 (e.g., a central processing unit (CPU), a reduced instruction set computing (RISC) processor, a complex instruction set computing (CISC) processor, a graphics processing unit (GPU), a digital signal processor (DSP), an application-specific integrated circuit (ASIC), a radio frequency integrated circuit (RFIC), another processor, or any suitable combination thereof) may include, for example, processors 8112 and 8114 that execute instructions 8116. The term "processor" is intended to include multi-core processors, which may include two or more independent processors (sometimes referred to as "cores") capable of executing instructions simultaneously. Although Figure 81Multiple processors are shown, but machine 8100 may include a single processor with a single core, a single processor with multiple cores (e.g., multi-core processing), multiple processors with a single core, multiple processors with multiple cores, or any combination thereof.

[0420] Memory / storage 8130 may include memory 8132 (e.g., main memory or other memory storage) and storage unit 8136, both of which may be accessed by processor 8110, for example, via bus 8102. Storage unit 8136 and memory 8132 store instructions 8116 that embody one or more of the methods or functions described herein. During execution of instructions 8116 by machine 8100, instructions 8116 may also reside wholly or partially within memory 8132, storage unit 8136, at least one of processor 8110 (e.g., within the processor's cache memory), or any suitable combination thereof. Thus, memory 8132, storage unit 8136, and the memory of processor 8110 are examples of machine-readable media.

[0421] As used herein, "machine-readable medium" means a device capable of temporarily or permanently storing instructions and data, and may include, but is not limited to, random access memory (RAM), read-only memory (ROM), buffer memory, flash memory, optical media, magnetic media, cache memory, other types of memory (e.g., erasable programmable read-only memory (EEPROM)) and / or any suitable combination thereof. The term "machine-readable medium" should be considered to include a single medium or multiple media capable of storing instructions 8116 (e.g., a centralized or distributed database or associated cache and server). The term "machine-readable medium" should also be considered to include any medium or combination of media capable of storing instructions (e.g., instructions 8116) for execution by a machine (e.g., machine 8100), such that when executed by one or more processors of machine 8100 (e.g., processor 8110), the instructions cause machine 8100 to perform any or more of the methods described herein. Therefore, "machine-readable medium" refers to a single storage device or apparatus as well as a "cloud-based" storage system or storage network comprising multiple storage devices or apparatuses. The term "machine-readable medium" does not include the signal itself.

[0422] I / O component 8150 may include a variety of components to receive input, provide output, generate output, transmit information, exchange information, capture measurement values, etc. The specific I / O component 8150 included in a particular machine will depend on the type of machine. For example, a portable machine such as a mobile phone may include a touch input device or other such input mechanism, while a headless server may not include such a touch input device. It will be understood that I / O component 8150 may include... Figure 81Many other components are not shown. For the sake of simplicity in the following discussion, I / O components 8150 are grouped according to function, and the grouping is by no means limiting. In various exemplary embodiments, I / O components 8150 may include output components 8152 and input components 8154. Output components 8152 may include visual components (e.g., displays such as plasma display panels (PDPs), light-emitting diode (LED) displays, liquid crystal displays (LCDs), projectors, or cathode ray tube (CRTs), acoustic components (e.g., speakers), haptic components (e.g., vibration motors, resistive mechanisms), other signal generators, etc. Input components 8154 may include alphanumeric input components (e.g., keyboards, touchscreens configured to receive alphanumeric input, optical photographic keyboards, or other alphanumeric input components), point-based input components (e.g., mice, touchpads, trackballs, joysticks, motion sensors, or other pointing devices), haptic input components (e.g., physical buttons, touchscreens or other haptic input components that provide position and / or force for touch or touch gestures), audio input components (e.g., microphones), etc.

[0423] In other exemplary embodiments, I / O component 8150 may include a series of other components such as biometric component 8156, motion component 8158, environmental component 8160, or position component 8162. For example, biometric component 8156 may include components for detecting expressions (e.g., hand gestures, facial expressions, vocal expressions, body posture, or eye tracking), measuring physiological signals (e.g., blood pressure, heart rate, body temperature, sweating or brain waves, neural activity, or muscle activity), and identifying a person (e.g., voice recognition, retinal recognition, facial recognition, fingerprint recognition, or EEG-based recognition).

[0424] The motion component 8158 may include an acceleration sensor component (e.g., an accelerometer), a gravity sensor component, a rotation sensor component (e.g., a gyroscope), etc. In one or more examples, one or more of the motion components 8158 may be combined with an external source 102 or an implantable device 110 and may be configured to detect the patient's motion or level of physical activity. For example, information about the patient's motion may be used in various ways to adjust signal transmission characteristics (e.g., amplitude, frequency, etc.) when the physical relationship between the external source 102 and the implantable device 110 changes or shifts.

[0425] Environmental component 8160 may include, for example, a lighting sensor component (e.g., a photometer), a temperature sensor component (e.g., one or more thermometers that detect ambient temperature), a humidity sensor component, a pressure sensor component (e.g., a barometer), an acoustic sensor component (e.g., one or more microphones that detect background noise), a proximity sensor component (e.g., an infrared sensor that detects nearby objects), a gas sensor (e.g., a gas detection sensor that detects the concentration of hazardous gases for safety or measures pollutants in the atmosphere), or other components that provide indications, measurements, or signals corresponding to the surrounding physical environment. Location component 8162 may include a location sensor component (e.g., a Global Positioning System (GPS) receiver component), an altitude sensor component (e.g., an altimeter or barometer that detects air pressure from which altitude can be derived), an orientation sensor component (e.g., a magnetometer), etc. In one or more examples, I / O component 8150 may be part of implantable device 110 and / or external source 102.

[0426] Various technologies can be used to implement communication. I / O component 8150 may include communication component 8164, operable to connect machine 8100 to network 8180 or device 8170 via connection 8182 and connection 8172, respectively. For example, communication component 8164 may include network interface component or other suitable means for interface connection with network 8180. In other examples, communication component 8164 may include wired communication component, wireless communication component, cellular communication component, near-field communication (NFC) component, mid-field communication component, far-field communication component, and other communication components to provide communication via other modalities. Device 8170 may be another machine or any of a variety of peripheral devices.

[0427] Furthermore, the communication component 8164 may detect identifiers or include components operable to detect identifiers. For example, the communication component 8164 may include a radio frequency identification (RFID) tag reader component, an NFC smart tag detection component, an optical reader component (e.g., an optical sensor for detecting one-dimensional barcodes such as Universal Product Code (UPC) barcodes, multi-dimensional barcodes such as Quick Response (QR) codes, Aztec codes, data matrices, data symbols, bullseye codes, PDF417, super codes, UCC RSS-2D barcodes, and other optical codes), or an acoustic detection component (e.g., a microphone for identifying tagged audio signals). Additionally, various information can be derived from the communication component 8164, such as location via Internet Protocol (IP) geolocation, location via Wi-Fi® signal triangulation, location via detection of NFC beacon signals indicating a specific location, etc.

[0428] In some embodiments, the system includes multiple features that exist as a single feature (in contrast to multiple features). For example, in one embodiment, the system includes a single external source and a single implantable device or stimulation device with a single antenna. In alternative embodiments, multiple features or components are provided.

[0429] In some embodiments, the system includes one or more of the following: a device for tissue stimulation (e.g., an implantable stimulation device), a device for power supply (e.g., a mid-field power supply device or a mid-field coupler), a device for receiving (e.g., a receiver), a device for transmitting (e.g., a transmitter), a device for control (e.g., a processor or a control unit), etc.

[0430] Although various general and specific embodiments are described herein, it will be understood that various modifications and changes can be made to these embodiments without departing from the broader spirit and scope of this disclosure. Therefore, the specification and drawings are to be considered in an illustrative rather than restrictive sense. The drawings, which form a part of this application, illustrate, by way of illustration and not limitation, specific embodiments in which the subject matter can be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the teachings disclosed herein. Other embodiments may be used or derived therefrom, such that structural and logical substitutions and changes can be made without departing from the scope of this disclosure. Therefore, this detailed description should not be considered in a restrictive sense, and the scope of the various embodiments is defined only by the full scope of the appended claims and their equivalents. Specific embodiments or examples are shown and described herein; however, it should be understood that any arrangement or structure calculated to achieve the same purpose may replace the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of the various embodiments. After reading the above description, combinations of the above embodiments and other embodiments not specifically described herein will be apparent to those skilled in the art.

[0431] In this document, as is commonly used in patent literature, the terms "a" or "an" are used to include one or more items, unrelated to any other instances or uses of "at least one" or "one or more." In this document, the term "or" is used to indicate non-exclusivity, such that "A or B" includes "A but not B," "B but not A," and "A and B," unless otherwise stated. In this document, the terms "comprising" and "wherein" are used as their common English equivalents. Furthermore, in the following claims, the terms "comprising" and "including" are open-ended, meaning that a system, apparatus, article, composition, formulation, or process including elements other than those listed after this term in a claim is still considered to fall within the scope of that claim. Additionally, in the following claims, the terms "first," "second," and "third," etc., are used merely as designations and are not intended to impose numerical requirements on their objects.

[0432] The scope disclosed herein also covers any and all overlapping, sub-scopes, and combinations thereof. Language such as “at most,” “at least,” “greater than,” “less than,” “between,” etc., includes the stated numbers. Numbers preceded by terms such as “about” or “approximately” include the stated numbers. For example, “about 10 kHz” includes “10 kHz.” Terms or phrases preceded by terms such as “substantially” or “approximately” include the stated terms or phrases. For example, “substantially parallel” includes “parallel,” and “approximately cylindrical” includes “cylindrical.”

[0433] The above description is intended to be illustrative and not restrictive. For example, the above examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments may be used by those skilled in the art, for example, after reading the above description. An abstract is provided to allow the reader to quickly determine the nature of this technical disclosure. It is understood that it will not be used to interpret or limit the scope or meaning of the claims. Moreover, in the above detailed description, various features may be combined together to simplify this disclosure. This should not be construed as meaning that any disclosed feature not claimed is essential to any claim. Rather, the subject matter of the invention may lie in fewer than all features of the specific embodiments disclosed. Therefore, the following claims are incorporated into the detailed description as examples or embodiments, wherein each claim is itself a separate embodiment, and it is contemplated that such embodiments may be combined with each other in various combinations or substitutions. The scope and embodiments of the invention should be determined with reference to the appended claims and the full scope of their equivalents.

Claims

1. A midfield launcher, comprising: A first conductive portion is disposed on the first layer of the transmitter; One or more microstrips are disposed on the second layer of the transmitter; A third conductive portion is disposed on the third layer of the transmitter, and the third conductive plane is electrically coupled to the first conductive plane using one or more through-holes extending through the second layer; A first dielectric component is inserted between the first layer and the second layer; and A second dielectric component is inserted between the second layer and the third layer.

2. The midfield launcher as claimed in claim 1, wherein, The first dielectric component and the second dielectric component have different dielectric constant characteristics.

3. The midfield launcher as described in claim 2, wherein, The thickness of the second dielectric component is greater than the thickness of the first dielectric component.

4. The midfield launcher as described in any one of claims 1-3, wherein, The first conductive portion includes an annular outer region electrically coupled to the third conductive portion, and the first conductive portion also includes an inner region spaced apart from the annular outer region by a first cut.

5. The midfield launcher as claimed in claim 4, wherein, The mid-field transmitter includes a cutout extension arm that extends from the first cutout toward the central axis of the first conductive portion.

6. The midfield launcher as claimed in claim 5, wherein, The mid-field transmitter also includes four cut-out extension arms spaced approximately 90 degrees apart and extending from at least half of the first cut to the central axis of the first conductive portion.

7. The midfield launcher as claimed in claim 5, wherein, The cut extension arm has a cut width that is substantially the same as the width of the first cut.

8. The midfield launcher as claimed in claim 4, wherein, The mid-field transmitter also includes a capacitor having an anode connected to the inner region of the first conductive portion and a cathode connected to the annular region of the first conductive portion.

9. The midfield launcher as claimed in any one of claims 1-4, wherein, The first conductive portion includes an etched copper layer, the etched copper layer including a grounded first region and a separate second region electrically isolated from the grounded first region.

10. The midfield launcher as claimed in claim 9, wherein, The one or more microstrips extend from the peripheral portion of the transmitter toward the central portion of the transmitter, and the one or more microstrips are disposed above at least a portion of the second region of the first conductive region.

11. The midfield launcher as claimed in claim 9, wherein, The separated second region also includes etched features or vias that divide the second region into quadrants.

12. The midfield launcher as claimed in any one of claims 1-11, wherein, The mid-field transmitter also includes a signal generator circuit configured to provide a corresponding excitation signal to each of the one or more microstrips.

13. The midfield launcher as claimed in claim 12, wherein, The signal generator circuit is configured to adjust the phase or amplitude characteristics of at least one of the excitation signals to adjust the current distribution around the first conductive portion.

14. The midfield launcher as claimed in claim 13, wherein, The signal generator is disposed on a first side of the third conductive plane, and the opposite second side of the third conductive plane is opposite the first conductive portion.

15. The midfield launcher as claimed in any one of claims 1-14, wherein, The surface area of ​​the third conductive portion is equal to or greater than the surface area of ​​the first conductive plane.

16. The midfield launcher as claimed in any one of claims 1-14, wherein, The first conductive portion and the third conductive portion include conductive members that are substantially circular and coaxial.

17. The midfield launcher as claimed in any one of claims 1-16, wherein, The first conductive portion or the third conductive portion is connected to a reference voltage or ground potential.

18. The midfield launcher as claimed in any one of claims 1-17, wherein, The first dielectric member or the second dielectric member has a dielectric constant Dk of about 3-13.

19. The midfield launcher as claimed in any one of claims 1-18, wherein, The first dielectric member or the second dielectric member has a dielectric constant Dk of about 6-10.

20. The midfield launcher as claimed in any one of claims 1-19, wherein, The mid-field transmitter also includes a plurality of through-holes extending between the first conductive portion and the third conductive portion and isolated from the second layer, the arrangement of the plurality of through-holes dividing the first conductive portion into quadrants that can be excited substantially individually.

21. The midfield launcher as claimed in claim 20, wherein, Each of the individually excitationable quadrants includes a grounded peripheral region and an internal conductive region, and the first conductive portion is etched with one or more features to isolate at least a portion of the peripheral region from the internal conductive region.

22. A midfield launcher, comprising: A substantially planar circular first conductive member and a substantially planar circular second conductive member, the first and second conductive members being substantially coaxial and parallel to each other and spaced apart by a first dielectric member, wherein the second conductive member serves as an electrical reference plane for the transmitter; and A first pair of excitation components, the first pair of excitation components being inserted in an intermediate layer between the conductive components; and A passive excitation patch, wherein the passive excitation patch is coplanar with the first conductive member in the same direction or offset relative to the first conductive member.

23. The midfield launcher as claimed in claim 22, wherein, The excitation components electrically isolate the first conductive component and the second conductive component from each other, and the first pair of excitation components are disposed on opposite sides of the transmitter.

24. The midfield launcher as claimed in claim 22, wherein, The excitation component is electrically coupled to the excitation patch using a corresponding through-hole.

25. The midfield launcher as claimed in any one of claims 22-24, wherein, The passive excitation patch includes a portion of the first conductive component.

26. The midfield launcher as claimed in any one of claims 22-25, wherein, The passive excitation patch is electrically isolated from the first conductive component and the second conductive component.

27. The midfield launcher as claimed in any one of claims 22-26, wherein, The excitation component includes a microstrip.

28. The midfield launcher as claimed in claim 27, wherein, The mid-field transmitter also includes corresponding through-holes that connect the microstrip to a corresponding portion of the passive excitation patch.

29. A midfield launcher, comprising: A first conductive plane is disposed on the first layer of the transmitter, the first conductive plane including an outer annular region spaced apart from the inner disk-shaped region; A second conductive plane is disposed on the second layer of the transmitter, and the second conductive plane is electrically coupled to the outer annular region of the first conductive plane using one or more vias; A first dielectric component is located between the first conductive plane and the second conductive plane; and Multiple signal input ports are connected to the inner disk-shaped region of the first conductive plane and to the through-hole, which extends through the second conductive plane and the first dielectric member and electrically isolates the second conductive plane from the first dielectric member.

30. The midfield launcher as claimed in claim 29, wherein, The midfield transmitter also includes a transmitter excitation circuit disposed on a first side of the second layer opposite to the first layer, and the transmitter excitation circuit is configured to provide drive signals to the internal disk-shaped region using the plurality of signal input ports.

31. The midfield launcher as claimed in claim 30, wherein, The transmitter excitation circuit is configured to be connected to the first side of the second conductive plane using solder bumps.

32. The midfield launcher as claimed in any one of claims 29-31, wherein, The mid-field transmitter also includes a capacitor having an anode connected to the annular region of the first conductive plane and a cathode connected to the disk-shaped region of the first conductive plane.

33. The midfield launcher as claimed in any one of claims 29-32, wherein, The first conductive plane also includes a plurality of linear cuts that extend at least partially from the periphery of the disk-shaped region to the center of the disk-shaped region.

34. The midfield launcher as claimed in claim 33, wherein, The selected length of the plurality of linear cuts tunes the resonance of the transmitter.

35. The midfield launcher as claimed in any one of claims 29-34, wherein, The mid-field transmitter also includes a signal generator circuit configured to provide corresponding excitation signals to the plurality of signal input ports.

36. The midfield launcher as claimed in claim 35, wherein, The signal generator circuit is configured to adjust the phase or amplitude characteristics of at least one of the excitation signals to adjust the current distribution on the first conductive plane.

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