Devices, systems, and methods for stimulation therapy

Abstract

This article generally discusses systems, apparatuses, and methods for providing therapeutic (e.g., stimulation) and / or data signals using implantable devices. Systems, apparatuses, and methods for interacting with external devices (e.g., communicating with them, receiving power from them) are also provided.

Description

[0001] This application is a divisional application of the invention patent application filed on October 20, 2016, with application number 202111520232.6, entitled "Apparatus, System and Method for Stimulation Therapy", which in turn is a divisional application of the invention patent application filed on October 20, 2016, with application number 201680074833.X, entitled "Apparatus, System and Method for Stimulation Therapy". This application claims priority to the following U.S. provisional applications: U.S. Provisional Application No. 62 / 244,495, filed October 21, 2015, entitled “COMPACT INTEGRATION OF ELECTRONIC CONTROL HARDWARE WITH ELECTROMAGNETICTRANSMITTING ELEMENT”; U.S. Provisional Application No. 62 / 264,239, filed December 7, 2015, entitled “DISCREET EXTERNAL DEVICE COUPLING TO IMPLANTED DEVICE”; U.S. Provisional Application No. 62 / 291,379, filed February 4, 2016, entitled “IMPLANTABLE STIMULATION DEVICES AND STEERING AND AFFIXING MECHANISMS THEREFORE”; and U.S. Provisional Application No. 62 / 291,379, filed June 15, 2016, entitled “WIRELESS NEURAL THERAPY DELIVERY SYSTEMS AND METHODS USING”. U.S. Provisional Application No. 62 / 350,674, entitled "Assessments of Electromotive Stimulation Systems"; U.S. Provisional Application No. 62 / 350,676, filed June 15, 2016, entitled "Implantable Stimulation Devices and Steering Mechanisms Herefore"; U.S. Provisional Application No. 62 / 350,681, filed June 15, 2016, entitled "Implantable Stimulation Devices, Systems, and Methods"; U.S. Provisional Application No. 62 / 350,684, filed June 15, 2016, entitled "Dual-Frequency Electromotive Stimulation for Neural Therapy"; and U.S. Provisional Application No. 62 / 350,684, filed July 28, 2016, entitled "Implantable Stimulation Devices Inclusing Hall". U.S. Provisional Application No. 62 / 367,995, entitled "LUMEN"; and U.S. Provisional Application No. 62 / 367,995, filed on July 28, 2018, entitled "SURFACE ACOUSTIC WAVE BASED COMMUNICATION DEVICE".U.S. Provisional Application No. 62 / 368,005, filed August 11, 2016, entitled “ACTIVE POWER MANAGEMENT TECHNIQUES FORWIRELESS IMPLANTABLE DEVICES”; U.S. Provisional Application No. 62 / 373,569, filed September 19, 2016, entitled “SYSTEMS AND METHODS FOR EMBEDDING COMMUNICATION SIGNALS WITH ELECTROSTIMULATION THERAPY”; and U.S. Provisional Application No. 62 / 396,478, filed September 21, 2016, entitled “BACKSCATTER COMMUNICATION TECHNIQUES”; and U.S. Provisional Application No. 62 / 397,620, filed September 21, 2016. The entire contents of each of these U.S. Provisional Applications are incorporated herein by reference.

[0002] The technical field discussed herein relates to apparatus, systems, and methods for providing signals (e.g., wireless field-powered signals) to an implantable device (e.g., a stimulation device) using an external device (e.g., an external field coupler or field power source). The technical field discussed herein relates to apparatus, systems, and methods for providing treatment (e.g., stimulation or other modulation) or diagnosis from an implantable device. The technical field discussed herein relates to the configuration of an implantable device and an external device. The technical field discussed herein relates to transmitting data from an implantable device to an external device. The technical field discussed herein relates to apparatus, systems, and methods for positioning an implantable device at or near a specific site and / or shaping the implantable device.

[0003] Background Art Most known wireless power supply methods for implantable electronic devices are based on near-field coupling methods, which, along with other proposed methods, have many drawbacks. The power harvesting structure in the implanted device is typically large (usually on the order of centimeters or larger). In near-field coupling methods, the coil outside the body is also typically bulky and inflexible. This makes it difficult to integrate the external device into daily life. The inherent exponential attenuation of the near field limits the miniaturization of implanted devices beyond surface depth (greater than 1 cm). On the other hand, the radiation properties of the far field severely limit energy transfer efficiency. Summary of the Invention

[0004] Despite significant progress 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.

[0005] According to several embodiments, a system for delivering treatment to a subject includes an external field power source positioned outside the subject's body (e.g., outside the skin) and an internal treatment delivery device positioned inside the subject's body (e.g., below the skin), or essentially constituted by the above. The external source includes at least one subwavelength structure (e.g., one, two, three, four, or more than four) configured to deliver radio frequency (RF) signals to a specific site in the subject's tissue (e.g., a site below the subject's skin where the internal treatment device is permanently or temporarily implanted). The RF signals are selected to manipulate evanescent fields (e.g., oscillating electric and / or magnetic fields that do not propagate as electromagnetic waves) outside the tissue (e.g., outside the skin surface), thereby generating a propagating field within the tissue below the skin surface.

[0006] The internal therapeutic delivery device includes at least a partially implantable device configured to receive RF signals from an external source. Partial implantability may mean that the device is not fully implanted under the patient's skin or that the device is temporarily implanted (e.g., for a trial phase, or inserted and removed in a single procedure), rather than permanently implanted for a long duration (e.g., months or years). The implantable device includes a distal portion and a proximal portion. The implantable device may include circuitry (e.g., receiver circuitry) in a first housing and may include an antenna in a separate second housing located in the proximal portion. The first and / or second housings may also be positioned in the distal portion or any other portion of the implantable device. The antenna may be electrically coupled to the circuitry in the first housing. In some embodiments, the implantable device includes a flexible, biocompatible elongated member comprising the distal and proximal portions and a plurality of energy delivery members (e.g., electrodes, transmitting elements, transducers) positioned along the distal portion of the elongated member. The circuitry may be hermetically sealed or enclosed within the first housing and configured to receive electrical energy from an external source and supply electrical energy to the plurality of energy delivery members (e.g., electrodes). The circuit may include any receiver capable of receiving electrical energy from an external source (e.g., an ultra-high frequency receiver, a very high frequency receiver, a microwave receiver, or other receivers depending on the desired and / or required frequency).

[0007] In some embodiments, the second housing is attached to the first housing at a proximal end opposite to the end of the first housing along the length of the elongated member. In some embodiments, a hollow tubular member extends through the elongated member at least from the proximal end to a distal portion of the elongated member. The second housing may include a dielectric material with a dielectric constant between that of human tissue and that of air.

[0008] In some embodiments, the antenna is a primary antenna, and the system further includes a secondary antenna in the second housing, the secondary antenna being shaped and positioned to provide near-field coupling with the primary antenna. In some embodiments, the implantable device further includes a feedthrough plate located between and connected to the first housing and the separate second housing; and an electrical conductor in a feedthrough aperture of the feedthrough plate, the electrical conductor being electrically connected to the circuitry and the antenna.

[0009] In some embodiments, the circuitry in the first housing includes a surface acoustic wave (SAW) device. The SAW device may be configured to receive a portion of an RF signal received at the antenna along a first signal path, convert the received portion into a mechanical wave to buffer the RF signal, and provide the buffered RF signal along a second signal path to the antenna. The circuitry in the first housing may further include a modulator coupled between the antenna and the SAW device along the second signal path. The modulator may be adapted to adjust the baseband signal to embed the data signal with the baseband signal.

[0010] In various embodiments, the source includes a top cover, a bottom cover, and antenna circuitry disposed between the top cover and the bottom cover. The top cover and bottom cover may include rectangular coverage areas with rounded corners, and the edges of the top cover and bottom cover are rounded. The edges of the bottom cover may be rounded to include a smaller radius of curvature than the edges of the top cover. In some embodiments, the coverage areas of the top cover and bottom cover are square, circular, triangular, or any other shape.

[0011] An external source may include a Faraday cage on the top surface of a first layer of a circuit board (e.g., a printed circuit board), circuitry housed within the Faraday cage and disposed on the top surface, a ground plane disposed in a second layer of the circuit board, and a resonant slot in a third layer of the circuit board. The resonant slot may be electrically connected to the circuitry within the Faraday cage. In some embodiments, the Faraday cage, the ground plane, and the resonant slot form an antenna. The ground plane may include a grounding slot formed therein, and the coverage area of ​​the Faraday cage may be arranged so as not to overlap with the grounding slot in the ground plane.

[0012] In some embodiments, the internal treatment device (e.g., at least partially implantable) includes one or more first electrodes (e.g., a first set of electrodes or an electrode array) coupled to the circuit and disposed along a distal portion of the implantable device, and a second electrode (e.g., a second set of electrodes or an electrode array) coupled to the circuit and disposed along a proximal portion of the implantable device. The distance between the nearest one of the first electrodes and the farthest one of the second electrodes can be sufficiently large to generate a far-field stimulation signal therebetween. The one or more first electrodes may include at least two electrodes, and the circuit may include stimulation circuitry for configuring one of the first electrodes as an anode, another of the first electrodes as a cathode, and one of the second electrodes as either a cathode or an anode.

[0013] In some embodiments, the internal treatment device includes at least three electrodes configured to deliver treatment (e.g., stimulation, denervation, or other types of modulation) to tissue (e.g., one or more sacral nerves, tibial nerves, or other nerves, muscles, or other normal or abnormal body tissues) or to support diagnostic assessment (e.g., sensing) of the tissue and / or parameters of the treatment provided or delivered. The circuitry of the internal treatment device may include treatment delivery circuitry configured to provide a treatment signal via one or more of the electrodes. The treatment signal may include a series of at least two electrical stimulation pulses provided using corresponding carriers corresponding to different combinations of electrodes. In some embodiments, the treatment delivery circuitry is configured to provide the treatment signal in a manner with a specified delay interval between each pulse. The series of pulses is repeated at least twice (e.g., twice, three times, four times, five times, or more).

[0014] The circuitry of the internal treatment device may include treatment delivery circuitry configured to provide a phase-amplitude coupled treatment signal, the phase-amplitude coupled treatment signal comprising a first signal component provided using a first neurostimulation carrier and a second signal component provided using a different second neurostimulation carrier, the second signal component being provided substantially simultaneously with the first signal component. In one embodiment, the at least partially implantable device includes at least four electrodes axially spaced along a lead portion of the device, wherein two of the four electrodes are configured to serve as the first neurostimulation carrier and the other two of the four electrodes are configured to serve as the second neurostimulation carrier. In some embodiments, the treatment delivery circuitry is configured to adjust the amplitude or frequency characteristics of at least one of the first and second signal components of the phase-amplitude coupled treatment signal to overcome a patient’s neuropathophysiology or otherwise improve neurological function (e.g., to overcome symptoms such as those associated with one or more of the following: motor disorders, Parkinson’s disease, dementia, Alzheimer’s disease, Creutzfeldt-Jakob disease, Huntington’s disease, depression (e.g., by stimulating the left cervical vagus nerve or trigeminal nerve), dystonia, or epilepsy, etc.). Improved neurological function may include improved cognitive and / or motor function.

[0015] In some embodiments, the external source further includes an RF signal generator system configured to provide multiple sets of different RF signals to the subwavelength structure, each set comprising two or more individual signals; and transmitter circuitry including an excitation port of a respective subwavelength structure coupled to the subwavelength structure. The transmitter circuitry may be coupled to the RF signal generator system and configured to transmit the multiple sets of different RF signals to the excitation port at respective different times. The excitation port receives a corresponding signal from each set of individual signals. Each set of RF signals transmitted by the transmitter circuitry includes a non-negligible magnetic field (H-field) component substantially parallel to the outer surface of the tissue, and each set of transmitted RF signals is selected to manipulate the evanescent field at or near the outer surface of the tissue in different ways to transmit power or data signals to various target devices implanted in the tissue.

[0016] The circuitry in the implantable device may include a treatment delivery circuit configured to provide signal pulses to an electrostimulation electrode or other energy delivery component using a portion of a mid-field power signal received from an external source. The signal pulses may include treatment pulses (e.g., electrostimulation treatment pulses) and / or data pulses. In some embodiments, the treatment delivery circuit is configured to interweave data pulses between consecutive treatment pulses or to embed multiple data pulses within treatment pulses.

[0017] The source and implantable device may be configured to communicate at least partially using backscattered signals, wherein at least one subwavelength structure of the external source is configured to receive a first backscattered signal from the implantable device, and circuitry in the implantable device is configured to receive a mid-field signal from the external source and provide the first backscattered signal based on the received mid-field signal. In some embodiments, the system further includes a second implantable device similar to the first implantable device, such that each of the implantable devices includes a respective receiver circuitry configured to receive at least one of the plurality of different sets of RF signals emitted by the transmitter circuitry.

[0018] In some embodiments, the system may include one or more mechanisms for implanting / transplanting an implantable device from the body. In such embodiments, the implantable device may include a connection structure in its proximal portion configured to mate with a mating connection structure of a push rod. In some embodiments, the push rod may be a hollow element, such as including a hole extending longitudinally therethrough. The push rod can be used to position the implantable device within the body. The implantable device may include a suture attached thereto, for example, at a location more proximal than the antenna housing and / or deployment fork. The hole in the push rod may be configured such that the push rod can slide along the suture when the suture is placed in the hole. In one or more embodiments, a second push rod may be configured to insert (e.g., adjacent to the suture) into the hole and contact a connection portion of the implantable device to allow the push rod to disengage from the implantable device. In some embodiments, the push rod may be configured to help hold the suture in place, for example, to help prevent the suture from slipping into and / or moving out of the body in which it is placed. In such embodiments, the push rod may include a female Luer thread, and the system may further include a male Luer cap configured to mate with the female Luer thread. The male Lurper cap may include a hole through which it is configured to be positioned around the seam so that when the male Lurper cap mates with the female Lurper thread, the male Lurper cap presses against the seam to help hold the seam in place.

[0019] According to several embodiments, at least partially implantable electrotherapy delivery devices include flexible, biocompatible elongated members comprising distal and proximal portions. The elongated member may have a generally uniform diameter along its length, or may have a varying diameter at different portions along its length. The electrotherapy delivery device may include a plurality of electrodes (e.g., cylindrical, annular, planar electrodes) positioned along the distal portion of the elongated member and a circuit housing (e.g., a cylindrical hermetically sealed housing) attached to the proximal portion of the elongated member. The circuit housing may have a diameter substantially the same as that of the elongated member. In this embodiment, the circuit is hermetically sealed within the circuit housing. The circuit is configured to provide electrical power to the plurality of electrodes. An antenna housing is connected to the circuit housing at a proximal end opposite to the end of the circuit housing attached to the elongated member. An antenna (e.g., a dipole antenna, coil antenna, helical antenna, patch antenna, or other type of antenna) is disposed within the antenna housing.

[0020] In some embodiments, the antenna housing comprises a dielectric material with a dielectric constant between that of human tissue and that of air. For example, the dielectric material may be ceramic, such as aluminum or zirconium. The dielectric material (e.g., ceramic) may at least partially cover the antenna. The elongated member may include a channel extending from a proximal end of the elongated member through the elongated member to a distal portion of the elongated member. A shape memory wire may be disposed in the channel. The shape memory wire may be pre-shaped to a specific orientation to provide curvature for the elongated member. In one embodiment, the shape memory is shaped to conform to the shape of a body structure or tissue (e.g., the S3 foramen) and substantially matches the curve of a nerve (e.g., the sacral nerve). The antenna may be a primary antenna, and the treatment delivery device may further include a secondary antenna within the antenna housing or in a separate housing that may be attached to the antenna housing. The secondary antenna may be shaped and positioned to provide near-field coupling with the primary antenna. The one or more stitches may be attached at one or more of the following locations: (1) the proximal portion of the antenna housing; (2) the proximal portion of the circuit housing; and (3) an attachment structure attached to the proximal end of the antenna housing. Other attachment locations are also possible. In some embodiments, the primary antenna is coupled to a conductive ring of circuitry located in the proximal portion of the circuit housing. Ceramic material may be positioned between the antenna and the conductive ring.

[0021] According to several embodiments, an implantable stimulation device includes, or substantially comprises, the following: an outer housing; a plurality of electrodes exposed on a surface of the outer housing; a circuitry housing attached to the outer housing; a circuitry encapsulated by the circuitry housing, the circuitry being electrically connected to the plurality of electrodes; and a hollow cavity extending from a proximal end of the circuitry housing to a distal portion (distal end) of the outer housing. In some embodiments, the implantable stimulation device further includes an antenna housing attached to the circuitry housing, wherein an antenna is encapsulated or disposed within the antenna housing. The hollow cavity may extend through the antenna housing. In some embodiments, the implantable stimulation device includes an antenna electrically connected to a circuitry proximal to the circuitry housing, wherein the encapsulation hermetically seals the antenna, and the hollow cavity extends through the encapsulation.

[0022] In some embodiments, the implantable stimulation device further includes a distal feedthrough plate including a plurality of through-holes and a first cavity through-hole, wherein a hollow cavity is located in the first cavity, and wherein a circuit housing is attached to the distal feedthrough plate at a distal end of the circuit housing, and an outer casing is attached to the distal feedthrough plate at a proximal end of the outer casing. The implantable stimulation device may further include a proximal feedthrough plate including a plurality of through-holes and a second cavity through-hole, wherein a hollow cavity is located in the second cavity, and wherein the circuit housing is attached to the proximal feedthrough plate at a proximal end of the circuit housing. An antenna housing may be attached to the proximal feedthrough plate at a distal end of the antenna housing. In some embodiments, the antenna is encapsulated in an antenna housing and the hollow cavity extends through the antenna housing.

[0023] In some embodiments, the implantable stimulation device further includes an end plate attached to the antenna housing at a proximal end, the end plate including a third cavity through which a hollow cavity is located. In some embodiments, the antenna is electrically connected to a circuit, wherein the antenna is located at a proximal end of a circuit housing. The package can hermetically seal the antenna and the hollow cavity can extend through the package. The package can seal the proximal feedthrough hole of the proximal feedthrough plate as described above.

[0024] In some embodiments, the hollow cavity of the implantable stimulation device includes a discrete first cavity portion and a discrete second cavity portion. The first cavity portion extends from the distal end of the outer casing to the proximal side of one side of the distal feedthrough plate, and the second cavity portion extends from the proximal side of the distal feedthrough plate to the proximal end of the stimulation device. The first cavity portion may include a flexible material, and the second cavity portion may include a rigid material. The flexible material of the first cavity portion may include a shape memory metal (e.g., a nickel-titanium alloy).

[0025] According to several embodiments, a method of assembling an implantable stimulation device includes placing a circuit housing over a hollow cavity extending to the distal end of an outer casing, positioning a circuit within the circuit housing, electrically connecting electrodes exposed on an outer surface of the outer casing to the circuit, and attaching the circuit housing at the distal end of the circuit housing. The hollow cavity may extend entirely through the circuit housing to the proximal end of the circuit housing. In one embodiment, the method further includes placing a distal feedthrough plate over the hollow cavity such that the hollow cavity extends through a first cavity aperture in the distal feedthrough plate, electrically connecting electrodes to corresponding distal feedthrough apertures in the distal feedthrough plate, and attaching the hollow cavity and the outer casing to the distal feedthrough plate, and then positioning the circuit housing on the hollow cavity. Attaching the outer casing to the distal feedthrough plate may include at least one of welding and brazing.

[0026] In some embodiments, the method further includes positioning a near-side feedthrough plate above the hollow cavity such that the hollow cavity extends through a cavity aperture of the near-side feedthrough plate, electrically connecting a conductor in the near-side feedthrough aperture of the near-side feedthrough plate to the circuit, and attaching the near-side feedthrough plate to a proximal end of the circuit housing. Attaching the near-side feedthrough plate to the circuit housing may include soldering and brazing at least one of the near-side feedthrough plates. In some embodiments, the method further includes electrically connecting an antenna to a conductor in the near-side feedthrough aperture of the near-side feedthrough plate. The method may further include positioning an antenna housing around the antenna and the hollow cavity such that the hollow cavity extends entirely through the antenna housing, and attaching the antenna housing to the circuit housing at a proximal end of the circuit housing. Attaching the antenna housing to the circuit housing includes at least one of soldering and brazing. The method may also include placing an end plate on the antenna housing above the hollow cavity such that the hollow cavity extends through a third cavity aperture of the end plate, and attaching the end plate to the antenna housing at a proximal end of the antenna housing. Attaching the end plate to the antenna housing may include at least one of welding and brazing. In some embodiments, the method includes hermetically sealing the area around the cavity.

[0027] In some embodiments, the assembly method includes distributing a dielectric material around the hollow cavity and the antenna, such that the antenna is encapsulated within the dielectric material and the hollow cavity extends entirely through the dielectric material. Distributing the dielectric material around the hollow cavity and the antenna may further include distributing the dielectric material around a near-side feedthrough hole of the near-side feedthrough plate such that the near-side feedthrough hole is hermetically sealed.

[0028] According to several embodiments, a method performed by an implantable device includes wirelessly receiving electromagnetic waves at an antenna of the implantable device, the electromagnetic waves including alternating active and inactive periods. The method further includes providing at least a portion of the received electromagnetic waves to a surface acoustic wave (SAW) device electrically coupled to the antenna, and buffering the provided electromagnetic waves using the SAW device. The method also includes harvesting energy from the provided electromagnetic waves using circuitry electrically coupled to the SAW device during an active period of the active period, and transmitting the buffered electromagnetic waves using the antenna during an inactive period of the inactive period. In some embodiments, after energy harvesting and before signal transmission, the method includes using a converter electrically coupled to the SAW device to change the electrical path of the buffered electromagnetic waves from a receiving path to a transmitting path. The method may further include using a power divider electrically coupled between a rectifier and the SAW device to split the received electromagnetic waves into a first wave portion and a second wave portion, wherein the buffered electromagnetic waves are the first portion of the received electromagnetic waves, and wherein the harvested energy comes from the second portion.

[0029] According to several embodiments, at least partially implantable devices include, or are substantially composed of, the following: an antenna adapted to wirelessly receive electromagnetic waves and convert the electromagnetic waves into electrical signals comprising alternating active and inactive periods; a surface acoustic wave (SAW) device adapted to receive at least a portion of the electrical signals and buffer the received portion; and an energy harvesting circuit adapted to receive at least a portion of the electrical signals during an active period and convert the received signals into electrical power. The antenna may be configured to transmit the buffered signal during an inactive period. The implantable device may also include a modulator adapted to receive the buffered signal and use the buffered signal as a radio frequency source to modulate a baseband signal. Furthermore, the antenna may be adapted to transmit the modulated baseband signal during the inactive period.

[0030] In some embodiments, the implantable device further includes a converter (e.g., a transmit / receive converter) electrically coupled between the SAW device and the antenna, and a digital controller electrically coupled to the converter. The digital controller is adapted to select an electrical path for the converter. A first electrical path of the converter may be shunt to a reference voltage, and a second electrical path of the converter may be electrically coupled to a buffered signal.

[0031] According to several embodiments, a method for providing wide-area stimulation therapy is provided. The method may include wirelessly receiving a power signal at a radio circuit of at least a partially implantable stimulation device, the power signal being generated by a field power supply device, and using a treatment delivery circuit coupled to the radio circuit and to a plurality of electrodes of the stimulation device, to provide the wide-area stimulation therapy signal to a patient using at least a portion of the wirelessly received power signal. The implantable stimulation device may include at least two first electrodes and at least one second electrode, the at least two first electrodes including at least one anode and at least one cathode on or at least partially in a distal portion of the stimulation device, and the at least one second electrode on or at least partially in a proximal portion of the stimulation device. In such embodiments, providing the far-field stimulation therapy signal includes using the treatment delivery circuit to disconnect one of the first electrodes, such that a far-field electric field is generated between at least one of the first electrodes and the at least one second electrode. The method may further include using the treatment delivery circuit to reconnect the disconnected first electrode and disconnect the at least one second electrode, and providing local stimulation therapy to the patient using at least a portion of the wirelessly received power, the local stimulation therapy being generated between at least two of the first electrodes.

[0032] In some embodiments, wirelessly receiving a power signal at the radio circuitry of at least a partially implantable stimulation device includes generating a current at the wire in response to the power signal being incident on a wire in the stimulation device. In such embodiments, at least one of the first electrodes and the at least one second electrode may be electrically connected to the treatment delivery circuitry via the wire. In some embodiments, the method includes using the treatment delivery circuitry to turn on a disconnected first electrode, providing local stimulation therapy to a patient using at least a portion of the wirelessly received power, the local stimulation therapy being generated between at least two of the first electrodes, and providing wide-area stimulation therapy simultaneously with the local stimulation therapy. The method advantageously provides both local stimulation therapy and wide-area stimulation therapy.

[0033] According to several embodiments, a system includes a mid-field power supply device and a biocompatible stimulation device, or substantially composed of the above, wirelessly coupled to at least part of the mid-field power supply device. In some embodiments, the stimulation device includes a circuitry housing comprising a therapeutic generation circuit; a distal portion comprising a plurality of first electrodes electrically coupled to the therapeutic generation circuit; and a proximal portion opposite the distal portion, the proximal portion comprising at least one second electrode electrically coupled to the therapeutic generation circuit. In one embodiment, the distance between the nearest side of the first electrode of the distal portion and the farthest side of the at least one second electrode of the proximal portion is greater than 1.5 cm (e.g., between 1.5 cm and 3 cm, between 2 cm and 4 cm, between 1.5 cm and 2 cm, between 2 cm and 2.5 cm, their overlapping range, or any value within the listed range). In one embodiment, the distance between directly adjacent electrodes of the first electrode is less than ten millimeters (e.g., between eight and ten millimeters, between six and ten millimeters, between six and eight millimeters, between five and nine millimeters, between five and seven millimeters, between four and eight millimeters, between two and six millimeters, between one and five millimeters, their overlap range, or any value within the listed range). A circuit housing may be located between the first electrode and the at least one second electrode.

[0034] In some embodiments, the treatment generation circuit includes a plurality of transducers, each of which is electrically connected to one of: (1) an electrode of a plurality of first electrodes, and (2) an electrode of at least one second electrode. The treatment generation circuit may be configured to shut down all transducers such that all electrodes are electrically activated, and the stimulation device provides wide-area stimulation therapy simultaneously with local stimulation therapy.

[0035] According to several embodiments, a system includes a field power supply device and two implantable stimulation devices wirelessly coupled to the field power supply device. For example, the first and second stimulation devices each include, or substantially consist of, an antenna housing including an antenna disposed therein for receiving electrical signals from the field power supply device; a circuit housing including treatment generation circuitry; and a plurality of electrodes electrically coupled to the treatment generation circuitry. The first and second stimulation devices can be arranged and configured to generate wide-area stimulation therapy between at least one electrode of the first stimulation device and at least one electrode of the second stimulation device. In some embodiments, the distance between directly adjacent electrodes is less than 10 mm (e.g., between 8 mm and 10 mm, between 6 mm and 10 mm, between 6 mm and 8 mm, between 5 mm and 9 mm, between 5 mm and 7 mm, between 4 mm and 8 mm, between 2 mm and 6 mm, between 1 mm and 5 mm, their overlap range, or any value within the listed range). A wire can be electrically connected between one electrode of the first stimulation device and one electrode of the second stimulation device. In some embodiments, the electrodes of the first stimulation device are configured as anode and cathode, and the electrodes of the second stimulation device are configured as cathode and anode, and the treatment generation circuit provides local stimulation therapy simultaneously with wide-area stimulation therapy. The electrodes in each stimulation device may include a first electrode in a proximal portion of the stimulation device and a second electrode in a distal portion of the stimulation device, the proximal portion being opposite to the distal portion. A circuit housing and an antenna housing may be located between the first and second electrodes or the circuit housing, and the antenna housing may be located in the proximal portion of the stimulation device, while the first and second electrodes may be located in the opposite distal portion of the stimulation device.

[0036] According to several embodiments, a system includes a biocompatible implant device. The implant device comprises, or substantially comprises, a rigid body having opposite surfaces, the width of which is less than its length; a plurality of electrodes coupled to the body and positioned at the periphery of the implant device; and a circuit housing coupled to the body. The circuit housing includes therapeutic delivery circuitry electrically coupled to the plurality of electrodes and configured to wirelessly receive electrical energy and deliver electrical stimulation therapy to a subject's body via one or more of the plurality of electrodes using at least a portion of the received electrical energy. In some embodiments, the two opposite surfaces of the rigid body of the implant device are generally planar and generally elliptical in shape. The circuit housing may be located at least partially between two foci of one of the opposite surfaces. In some embodiments, the circuit housing includes one of a helical antenna and a patch antenna.

[0037] In some embodiments, the plurality of electrodes includes at least four electrodes that are generally uniformly distributed around the outer periphery of the implant device. In some embodiments, the top surface of the rigid body is an ellipse having a major axis and a minor axis, wherein two of the at least four electrodes are located at corresponding intersections of the major axis and the outer periphery of the body, and wherein two of the at least four electrodes are located at corresponding intersections of the minor axis and the outer periphery of the body.

[0038] In some embodiments, a first portion of the rigid body includes a male or female connection feature (e.g., a screw hole, socket, fastener, or other connecting member). An implant structure may be attached to the first portion of the rigid body, and the male or female connection feature or member may be positioned within the implant structure. In one embodiment, the implant structure includes two rods generally parallel to the long axis of the body and coupled to and extending away from the body, and a rod connecting the two rods, said rod being generally parallel to the short axis of the body. The male or female connection feature or member (e.g., a threaded hole or other connecting member) may be in said rod, which is generally parallel to the short axis of the body. In some embodiments, a suture is attached to the first portion of the body. The system may further include a power supply device (e.g., a mid-field power supply device) configured to provide electrical power to the implant device.

[0039] According to several embodiments, an apparatus includes or substantially comprises: a substrate; a first circuit layer on a first surface of the substrate; a second circuit layer in the substrate; a planar electromagnetic emitting element on a second surface of the substrate opposite to the first surface; and a Faraday cage above the first circuit layer. The second circuit layer may include a ground plane, which may be patterned to include slots for energizing the emitting element. In some embodiments, the Faraday cage is patterned such that the cover area of ​​the Faraday cage does not overlap with the slots. The apparatus may include a via electrically connecting the cover of the Faraday cage to the second circuit layer. The via may be located at or near the edge of the slot in the second circuit layer, and / or at or near the edge of the Faraday cage.

[0040] In some embodiments, a thermally conductive material is positioned or disposed between a component of the first circuit layer and the Faraday cage to conduct heat from the component (e.g., discrete high-power electronic components) to the Faraday cage. In some embodiments, the first circuit layer includes control hardware comprising a power amplifier. One or more of the vias may be configured to transfer electromagnetic energy from the control hardware within the Faraday cage to the planar electromagnetic emission element outside the Faraday cage.

[0041] According to several embodiments, a system is provided for manipulating an evanescent field at or near an external tissue surface to wirelessly transmit power and / or data to multiple target devices implanted in the tissue. The system includes or comprises: an RF signal generator system configured to provide multiple sets of different RF signals, each set including two or more individual signals; and a field transmitter including multiple excitation ports. The field transmitter is coupled to the RF signal generator system and configured to transmit the multiple sets of different RF signals at respective different times via the excitation ports, wherein the excitation ports are configured to receive a corresponding signal from the individual signals of each set of RF signals. Each of the transmitted sets of RF signals includes a non-negligible magnetic field (H-field) component substantially parallel to the external tissue surface, and each transmitted set of RF signals is selected to manipulate the evanescent field at or near the tissue surface in different ways to transmit power or data signals to corresponding different target devices implanted in the tissue.

[0042] In some embodiments, the system further includes first and second implantable devices, or substantially comprises first and second implantable devices, each of the first and second devices including corresponding receiver circuitry configured to receive at least one of the plurality of different sets of RF signals emitted by the mid-field transmitter. The RF signal generator system may be configured to provide two or more separate signals with different signal characteristics for each set of RF signals, each of the emitted sets of RF signals manipulating an evanescent field at a tissue surface in a different manner to direct a power or data signal to a selected one of the first and second implantable devices. In some embodiments, the mid-field transmitter is configured to emit a first set of RF signals to the first implantable device during a first duration, and the mid-field transmitter is configured to emit a second set of RF signals to the second implantable device during a subsequent second duration.

[0043] In some embodiments, the first implantable device is configured to provide electrical stimulation therapy in response to receiving the first set of said sets of RF signals for a treatment duration less than or equal to the first duration. In other embodiments, the first implantable device is configured to provide electrical stimulation therapy for a duration less than or equal to the sum of the first duration and the second duration. The first implantable device may include a therapeutic energy storage circuit and may be configured to provide electrical stimulation therapy using energy from said therapeutic energy storage circuit for a duration exceeding the first duration.

[0044] In some embodiments, the system further includes feedback control circuitry configured to update the transmit power of at least one of the sets of RF signals from the mid-field transmitter based on information relating to power signals received at one or more of the first and second implantable devices from the mid-field transmitter. The system may also include a backscatter sensor configured to monitor backscatter signals in response to the emission of each set of RF signals from the mid-field transmitter, wherein the feedback control circuitry is configured to use information about the backscatter signals to identify a portion of the power signal received at the first and / or second implantable device. In some embodiments, the system includes a surface electromyography (EMG) sensor configured to monitor muscle activity at or near the tissue surface, and the feedback control circuitry is configured to use information about muscle activity to update the transmit power of at least one of the sets of RF signals from the mid-field transmitter.

[0045] In some embodiments, the first implantable device is configured to receive a portion of the first RF signal in the RF signal at a first time when the first RF signal has a first signal characteristic, and the second implantable device is configured to receive a portion of the second RF signal in the RF signal at a second time when the second RF signal has a different second signal characteristic. In some embodiments, one of the sets of RF signals is configured to manipulate an evanescent field at or near the tissue surface to simultaneously transmit power or data signals to both the first and second implantable devices.

[0046] At least one of the first and second implantable devices may include a therapeutic delivery circuit (e.g., circuitry adapted to provide neurostimulation therapy) coupled to the receiver circuitry. The therapeutic delivery circuitry may be configured to provide an electrical stimulation signal to the tissue using a received portion of at least one of the sets of RF signals emitted by the mid-field transmitter. In some embodiments, at least one of the first and second implantable devices includes a sensor circuit coupled to the receiver circuitry. The sensor circuitry may be configured to sense physiological parameters and may be powered at least partially by a received portion of at least one of the sets of RF signals emitted by the mid-field transmitter. The sensor circuitry may determine the electrode impedance of one or more electrodes of the implantable device. In one or more embodiments, the implantable device may respond to data received from the sensor, such as by using control circuitry to change stimulation parameters (e.g., frequency, power, burst frequency, duty cycle, phase, etc.). The sensor may be on or communicatively coupled to the implantable device, for example, inside or outside the body.

[0047] In some embodiments, the RF signal generator is configured to generate a first set of RF signals, the first set of RF signals comprising first and second signals phase-shifted relative to each other, and the RF signal generator is configured to generate a second set of RF signals, the second set of RF signals comprising third and fourth signals phase-shifted relative to each other in different ways, wherein, in response to the mid-field transmitter transmitting the first and second sets of RF signals, the evanescent field is manipulated differently to direct the respective wireless power or data signals of the first and second sets of RF signals to the transmission of the respective implantable devices in the first and second implantable devices. In some embodiments, the RF signal generator is configured to generate a first set of RF signals, the first set of RF signals comprising first and second signals having different amplitude characteristics of the first and second signals, and the RF signal generator is configured to generate a second set of RF signals, the second set of RF signals comprising third and fourth signals having amplitude characteristics different from the first and second signals, wherein, in response to the mid-field transmitter transmitting the first and second sets of RF signals, the evanescent field is manipulated differently to direct the respective wireless power or data signals of the first and second sets of RF signals to the transmission of the respective implantable devices in the first and second implantable devices. The mid-field transmitter is configured to provide the multiple sets of different RF signals using duty-cycled pulses, each pulse being provided at the saturation power of the amplifier circuitry of the mid-field transmitter.

[0048] According to several embodiments, a transmitter for manipulating an evanescent field at or near an external tissue surface to wirelessly transmit power and / or data to a plurality of target devices implanted in tissue includes: an RF signal generator configured to provide RF signals to first and second excitation channels. The transmitter further includes a phase shifter contained in the first excitation channel, the phase shifter being configured to receive the RF signal from the RF signal generator and, in response, providing a phase-shifted first signal for a first duration and then providing a phase-shifted second signal for a subsequent second duration. The transmitter may further include a first excitation port and a second excitation port respectively coupled to the RF generator and the phase shifter. The excitation port is configured to simultaneously transmit a reference RF signal from the first or second excitation channel and the phase-shifted first signal during the first duration for directing a wireless power signal to a first device implanted at a first tissue site, and the excitation port is configured to simultaneously transmit the reference RF signal from the first or second excitation channel and the phase-shifted second signal during the subsequent second duration for directing the wireless power signal to a second device implanted at a second tissue site.

[0049] According to several embodiments, a method for manipulating an evanescent field at or near an external tissue surface to wirelessly transmit power and / or data to a plurality of target devices implanted in the tissue includes: generating a plurality of different sets of RF signals, each set comprising two or more separate signals with different signal characteristics. The method further includes transmitting a first set of the plurality of different RF signals from a mid-field transmitter via a plurality of excitation ports during a first duration to manipulate the evanescent field at or near the external tissue surface and thereby direct power to a first implantable device within the implanted tissue. The method also includes transmitting a second set of the plurality of different RF signals from a mid-field transmitter via the same or different plurality of excitation ports during a second duration to manipulate the evanescent field at or near the external tissue surface and thereby direct power to a second implantable device within the implanted tissue. The method may also include receiving an indication of the power transfer efficiency from the mid-field transmitter to the first and / or second implantable device at the mid-field transmitter. The transmission step includes providing a non-negligible magnetic field (H-field) signal component substantially parallel to the external tissue surface.

[0050] In some embodiments, the step of receiving an indication of power transfer efficiency includes receiving data signals from the first and / or second implantable device at a mid-field transmitter. In some embodiments, the step of receiving an indication of power transfer efficiency includes receiving a backscattered signal at a mid-field transmitter in response to transmitting a first or second set of RF signals.

[0051] The method may further include, based on the indication of power transfer efficiency, altering the signal characteristics corresponding to one or more of the discrete signals in the first group of RF signals to provide an updated group of RF signals, and then transmitting the updated group of RF signals to a first or second implantable device. The method may include providing a delay between transmitting the first and second groups of RF signals. The step of transmitting the first group of RF signals may include providing a first pulse at the saturation power of the mid-field transmitter, and the step of transmitting the second group of RF signals includes providing a second pulse at the saturation power of the mid-field transmitter.

[0052] In some embodiments, the method includes receiving at least a portion of a first set of RF signals emitted by the mid-field transmitter at the first implantable device, and, in response, delivering neuro-electrical stimulation therapy to the tissue simultaneously with or asynchronously with receiving the first set of RF signals.

[0053] According to several embodiments, a system for manipulating an evanescent field at or near an external tissue surface to direct the transmission of wireless power and / or data signals into the tissue. The system includes first and second target devices implanted in the tissue. The target devices may include neurostimulation therapy devices and / or diagnostic (e.g., sensor) devices configured to wirelessly receive power and / or data. The system also includes a remote RF field generator configured to generate and transmit a first field, and a mid-field coupler including a plurality of subwavelength structures and at least one tunable device configured to adjust the RF signal transmission characteristics of the mid-field coupler. The mid-field coupler is configured to be positioned at or near the external tissue surface to receive a portion of the first field from the remote RF field generator and, in response, modulate the received portion of the first field to control the evanescent field at the tissue surface and thereby direct the wireless power and / or data signals from the mid-field coupler to the first and second target devices in a time-division multiplexing manner. The mid-field coupler is configured to transmit the power and / or data signals to the first and second target devices implanted in the tissue using corresponding different parameters of the at least one tunable device. In one embodiment, the mid-field coupler is configured to perform a “greedy” parameter search algorithm to determine preferred parameter values ​​for the tunable device, thereby transmitting the power and / or data signals to the first and / or second target device.

[0054] In some embodiments, the at least one tunable device includes one or more capacitors coupled to the subwavelength structure and including adjustable capacitance. The field coupler can be configured to transmit signals to the first and second target devices using a corresponding first capacitance value and different second capacitance values ​​of the capacitor. In some embodiments, the at least one tunable device includes one or more inductors coupled to the subwavelength structure and including adjustable inductance. The field coupler can be configured to transmit signals to the first and second target devices using a corresponding first inductance value and different second inductance values ​​of the inductor. In some embodiments, the at least one tunable device includes one or more resistors coupled to the subwavelength structure and including adjustable resistance. The field coupler can be configured to transmit signals to the first and second target devices using a corresponding first resistance value and different second resistance values ​​of the resistor.

[0055] The at least one tunable device may include an adjustable phase shifter coupled to one or more of the subwavelength structure and configured to provide a corresponding first phase delay and different second phase delays to transmit the signal to the first and second target devices. The field coupler may be configured to perform a "greedy" phase search algorithm to determine a preferred phase delay for transmitting the power and / or data signal to the first and / or second target devices.

[0056] In some embodiments, the system includes a memory (e.g., a non-volatile memory device or other memory circuitry) configured to store parameter information for the at least one tunable device, the stored parameter information including known good parameter information corresponding to previous successful power and / or data exchanges with one or both of the first and second target devices. Upon startup, the field coupler may be configured to transmit the power and / or data signal to the first target device using stored parameter values ​​for the at least one tunable device, and wherein the field coupler may be configured to repeatedly update the stored parameter values ​​to determine preferred parameter values ​​for further transmission of the power and / or data signal.

[0057] In some embodiments, the system includes sensor circuitry configured to receive backscattered signals in response to the mid-field coupler transmitting power and / or data signals to the first and second target devices. The mid-field coupler may be configured to use information about the backscattered signals to update or adjust parameters of the at least one tunable device. In some embodiments, the system includes one or more sensors (e.g., EMG sensors and / or accelerometers) configured to sense tissue responses at or near the external tissue surface to signals transmitted by the mid-field coupler. The mid-field coupler may be configured to use information about the sensed tissue responses to update or adjust parameters of the at least one tunable device.

[0058] The system may include a second field coupler configured to transmit additional power and / or data signals to the same first and second target devices. In one embodiment, the two field couplers are communicatively coupled and configured to simultaneously provide power signals to the first target device. In another embodiment, the two field couplers are communicatively coupled and configured to simultaneously provide different corresponding power and / or data signals to the first and second target devices.

[0059] According to several embodiments, a device is provided for receiving, processing, and transmitting an RF field (the transmitted RF field including a non-negligible H-field component substantially parallel to the surface of the body tissue) outside body tissue to control an evanescent field at the surface of the body tissue and thereby guide wireless power and / or data signals to a target device implanted within the tissue in a time-division multiplexing manner, the transmitted RF field including a non-negligible H-field component substantially parallel to the surface of the body tissue. The device comprises, or substantially comprises, a plurality of subwavelength structures configured to receive and transmit RF signals; and a tunable device configured to modulate the RF signals transmitted by at least one of the subwavelength structures by changing the electrical characteristics of the at least one of the subwavelength structures, wherein different parameter values ​​of the at least one tunable device configure the device to transmit the power and / or data signals to correspondingly different target devices implanted in the tissue.

[0060] According to several embodiments, a method for manipulating an evanescent field at or near an external tissue surface to wirelessly transmit power and / or data to a plurality of target devices implanted in tissue includes: receiving RF energy from a first remote RF field source using a plurality of subwavelength structures of a field coupler. The method further includes modulating the received RF energy using the field coupler to provide a first output signal, the modulation including using a first value of a first tunable device coupled to the subwavelength structures. The method further includes transmitting the first output signal to a first target device implanted in a first tissue site, and modulating the received RF energy using the field coupler to provide a subsequent second output signal, the modulation including using a second value of the first tunable device. The method further includes transmitting the second output signal to second target devices implanted in different second tissue sites.

[0061] In some embodiments, the method includes receiving at least a portion of a first output signal emitted at a first target device, and, in response, providing neuroelectric stimulation therapy at a first tissue site using a portion of the received signal. The method may also include performing a “greedy” parameter value search algorithm to determine preferred values ​​for the first tunable device, thereby transmitting power and / or data from the mid-field coupler to one or both of the first and second target devices.

[0062] In some embodiments, using the first value of the first tunable device includes communicating with a first target device using a first inductance, capacitance, and / or resistance value of the mid-field coupler, and wherein using the second value of the first tunable device includes communicating with a second target device using different second inductance, capacitance, and / or resistance values ​​of the mid-field coupler. In some embodiments, using the first value of the first tunable device includes communicating with the first target device using a first phase shift value of the mid-field coupler, and wherein using the second value of the first tunable device includes communicating with the second target device using different second phase shift values ​​of the mid-field coupler. In some embodiments, using the first value of the first tunable device includes communicating with the first target device using a first amplitude value of the mid-field coupler, and wherein using the second value of the first tunable device includes communicating with the second target device using different second amplitude values ​​of the mid-field coupler.

[0063] According to several embodiments, a system for covering a wearable external device worn by a user includes one of a pocket and a sleeve, comprising one or more top fabric layers and one or more bottom fabric layers. When the pocket or sleeve is worn, the bottom fabric layers are closer to the user's body than the top fabric layers. The bottom fabric layers include: a first fabric layer, which is a soft, supple material; and a second fabric layer, which is one of a thermally insulating material and / or a waterproof material. When the pocket or sleeve is worn, the second fabric layer is farther from the user's body. The top fabric layer includes a third fabric layer of thermally conductive material. The system also includes an external stimulator device (e.g., either the external device described herein or a field coupler) located between the top and bottom fabric layers in the pocket or sleeve. The external stimulator device is adapted to provide electromagnetic energy to an implanted medical device.

[0064] The top layer of fabric may include a fourth fabric layer that, when the pocket or sleeve is worn, is further away from the user's body than the third fabric layer, and the fourth layer includes an elastic band. The elastic band may include a plurality of holes on at least a portion of the band. In some embodiments, advantageously, the plurality of holes are taller than their width. However, in other embodiments, the holes may have substantially the same height and width, or they may be wider than their height.

[0065] In some embodiments, the system includes a clothing item comprising the pocket or sleeve, wherein the pocket or sleeve is positioned on the clothing item at a location above or near a target tissue site of the body (e.g., the S3 orifice). The external stimulator device may include positioning circuitry configured to communicate with the implanted device and provide indication of whether the device is correctly positioned near the implanted device.

[0066] In some embodiments, the external stimulator device includes a first attachment mechanism and the pocket or sleeve includes a corresponding second attachment mechanism. The attachment mechanisms can be positioned such that when these attachment mechanisms engage, the external stimulator device is correctly positioned relative to (e.g., near or close to) the implanted device.

[0067] In some embodiments, the external stimulator device includes a top cover and a bottom cover, both comprising a thermoplastic material, with the top cover positioned further away from the user's body when the device is worn. An external stimulator device (e.g., a mid-field coupler of the external stimulator device) may be located between the top cover and the bottom cover. In some embodiments, the top cover includes fins configured to radiate heat toward the third fabric layer. In some embodiments, one or more of the top cover and the bottom cover include one or more (e.g., one, two, three, four, or more than four) vents configured to deliver air toward the top cover. In some embodiments, the top cover and the bottom cover each include two or four vents.

[0068] The circuitry can be disposed between the top and bottom covers. The circuitry can generate an audible or tactile output, indication, or alarm (e.g., vibration or sound) in response to determining that the external stimulator device is not positioned sufficiently close to the implanted device. The circuitry can be configured to determine that the external stimulator device is not positioned sufficiently close to the implanted device by determining that the received signal strength of a signal from the implanted device is below a threshold. In some embodiments, the circuitry is configured to generate different audible or tactile outputs (e.g., providing different vibrations or emitting different sounds) in response to determining that the external device is correctly positioned.

[0069] In some embodiments, one or more of the top and bottom covers include a plurality of recesses to retain air therein. The top and bottom covers may include rectangular coverage areas with rounded corners, wherein all edges of the top and bottom covers are rounded. In one embodiment, the edges of the bottom cover are rounded to include a smaller radius of curvature than the edges of the top cover.

[0070] According to several embodiments, an external stimulator device (e.g., any of the external devices or field couplers described herein) comprises, or substantially comprises, the following: a top cover; a bottom cover mechanically coupled to the top cover; a positioning circuit disposed between the top and bottom covers to communicate with an implanted device and provide an indication of whether the device is correctly positioned in the vicinity of the implanted device; and a field coupler disposed between the top and bottom covers, the field coupler being adapted to provide electromagnetic energy to the implanted device. The top cover may include fins configured to dissipate heat away from the external stimulator device. One or both of the top and bottom covers may include one or more (e.g., one, two, three, four, or more than four) vents configured to deliver air toward the top cover.

[0071] According to several embodiments, a method is provided for wirelessly transmitting data from an implantable device to an external source device. The method includes transmitting a field signal from the external source device using a first antenna including at least first and second excitation ports; receiving the field signal using a second antenna coupled to the implantable device; generating a backscattered signal by modulating a signal path between the second antenna and a load circuit of the implantable device according to a communication control signal; and transmitting the backscattered signal using the second antenna. The backscattered signal includes information about the implantable device. The method further includes receiving the backscattered signal using the first excitation port of the first antenna of the external source device; and generating a predicted self-interference signal based on the field signal using the external source device. The method may further include extracting information about the implantable device from the received backscattered signal using the external source device and the predicted self-interference signal.

[0072] In some embodiments, generating the predicted self-interference signal includes using information related to frequency-dependent signal leakage between the first and second excitation ports and information related to the magnitude of the excitation signal driving the second excitation port. The method may include using the external source device to combine the predicted self-interference signal, the actual (e.g., real) self-interference signal received from the first excitation port of the first antenna, and the received backscattered signal to provide a time-varying information signal and a DC signal component. Extracting information about the implantable device may include extracting information about the implantable device from the information signal.

[0073] In some embodiments, generating a predicted self-interference signal based on a mid-field signal includes generating a signal offset by 180 degrees from an actual self-interference signal received from a first excitation port of a first antenna. The method may include measuring the magnitude of a DC signal component and adjusting the predicted self-interference signal when the magnitude exceeds a specified threshold. Adjusting the predicted self-interference signal may include adjusting the amplitude or phase characteristics of the predicted self-interference signal. The method may also include adjusting the magnitude or phase of the predicted self-interference signal based on the magnitude of the DC signal component.

[0074] In some embodiments, the backscattered signal includes information about characteristics of the implantable device itself or about treatments provided or to be provided by the implantable device. In some embodiments, the backscattered signal includes information about physiological characteristics sensed or measured by the implantable device.

[0075] The method may further include providing an RF carrier signal using the external source device; and generating the field signal using at least one phase-shifted form of the RF carrier signal to excite one of the first and second excitation ports. In some embodiments, the step of generating a predicted self-interference signal based on the field signal includes using different phase-shifted forms of the RF carrier signal. Extracting information about the implantable device from the received backscattered signal using the predicted self-interference signal may include summing the predicted self-interference signal with the received backscattered signal and the actual (e.g., real) self-interference signal received from the first excitation port of the first antenna. The field signal may include a power signal, a data signal, or a power signal in which data is encoded.

[0076] According to several embodiments, a wireless communication system for transmitting information from an implantable device to an external field source device using a backscattered signal includes: an external field source device configured to provide a field signal by simultaneously exciting multiple ports of an integral RF antenna using corresponding multiple excitation signals, wherein at least one of the ports is configured to receive a first backscattered signal. The system also includes a first implantable device configured to receive the field signal from the external field source device and provide the first backscattered signal based on the received field signal. The external field source may be configured to encode instructions into the field signal for use by the first implantable device, for introducing a specified phase perturbation into the first backscattered signal.

[0077] In some embodiments, the first implantable device includes modulator circuitry coupled to an antenna. The modulator circuitry may be configured to provide a specific phase perturbation in a first backscattered signal by modulating the tuning characteristics of the antenna in the first implantable device. Modulating the tuning characteristics of the antenna in the first implantable device may involve using amplitude shift keying (ASK) modulation.

[0078] The external field source device may include control circuitry configured to update a specified phase perturbation based on the quality characteristics of the first backscattered signal when it is received from the first implantable device. The system may also include a second implantable device configured to receive the field signal from the external field source device and provide a second backscattered signal, wherein the external field source device is configured to encode first and second instructions into the field signal for use by the first and second implantable devices, respectively, to introduce different specified phase perturbations into the first and second backscattered signals.

[0079] In some embodiments, the system further includes processor circuitry configured to generate a correction signal based on expected self-interference between the plurality of ports of the monolithic RF antenna, wherein the external field source device is configured to extract information about the first implantable device from the first backscattered signal using the correction signal. The processor circuitry may be a component of the external field source device.

[0080] In some embodiments, the external field source device includes an RF source signal generator configured to provide an RF carrier signal to (1) a first signal processor circuit configured to provide a corresponding RF drive signal to the plurality of ports of the integral RF antenna based on the RF carrier signal, and to (2) a second signal processor circuit configured to provide a self-interference cancellation signal based on the RF carrier signal, wherein the external field source device is configured to apply the self-interference cancellation signal to the first backscattered signal to extract information about the first implantable device encoded in the first backscattered signal.

[0081] According to several embodiments, a method is provided for extracting information from a backscattered signal received using a first port of a plurality of RF ports, the plurality of RF ports including portions of an integral antenna in a field transceiver device. The method includes generating a self-interference suppression signal based on prior information relating to signal leakage characteristics between the plurality of RF ports of the field transceiver device; receiving a backscattered signal from an implantable device using the first port of the plurality of RF ports in response to a field power and / or data signal, the backscattered signal including an information signal encoded by the implantable device in the backscattered signal; and extracting the information signal from the backscattered signal using the self-interference suppression signal.

[0082] In some embodiments, generating a self-interference suppression signal includes information based on calculated or measured signal leakage between corresponding pairs of the plurality of RF ports of the mid-field transceiver device. The method may further include providing the power and / or data signals from the mid-field transceiver device to the implantable device using the plurality of RF ports, wherein the power and / or data signals are based on an RF carrier signal, and wherein generating the self-interference suppression signal includes providing an amplitude modulation and / or phase modulation form of the RF carrier signal. The method may further include determining quality characteristics of the information signal extracted from the backscattered signal and selectively updating the self-interference suppression signal based on the quality characteristics to improve quality.

[0083] According to several embodiments, a method for wirelessly transmitting information from an implantable device to an external mid-field transceiver includes: modulating a wirelessly received mid-field signal at the implantable device to transmit a backscattered signal encoded with implantable device information according to the modulation; receiving the backscattered signal at the external mid-field transceiver; and decoding the backscattered signal using a self-interference suppression signal based on measured or predicted interference characteristics associated with multiple simultaneously excited ports of an integral RF antenna of the external mid-field transceiver. In some embodiments, the implantable device information includes one or more of the following: information about treatment provided by the implantable device, information about treatment to be provided by the implantable device, information about the power conversion efficiency of the implantable device, or information about electrode impedance characteristics, wherein the electrodes are coupled to the implantable device. Modulation of the wirelessly received mid-field signal may be performed according to a modulation scheme specified by the external mid-field transceiver.

[0084] According to several embodiments, a method of providing neurostimulation therapy includes wirelessly receiving a power signal at or using a receiver circuit in an implantable neurostimulation device. The power signal is generated and transmitted by a field coupler device and includes a non-negligible magnetic field (H-field) component substantially parallel to the surface of the field coupler device. The method further includes providing neurostimulation therapy using a portion of the wirelessly received power signal, using a treatment delivery circuit coupled to the receiver circuit and to a plurality of electrodes configured to deliver electrical stimulation signals to one or more neural targets. This includes sequentially providing stimulation signals to correspondingly different electrical stimulation carriers, wherein the carriers correspond to different combinations of the plurality of electrodes, and providing a non-stimulation interval between each stimulation signal provided to a different carrier. In some embodiments, providing the neurostimulation therapy includes providing the neurostimulation therapy multiple times in a manner that provides the same non-stimulation interval between each treatment.

[0085] In some embodiments, the method includes generating and transmitting a power signal (which may be a microwave signal) using a field coupler device, including focusing the power signal onto a site within body tissue, the site being within the wavelength range of the power signal when measured in air. The step of wirelessly receiving the power signal may include using an antenna based on an E-field or magnetic field (e.g., an H-field) coupled to an implantable neurostimulation device.

[0086] In some embodiments, sequentially providing stimulation signals includes providing at least first and second neural stimulation signals at or near the same neural target using distinct electrical stimulation carriers, wherein one of the first and second neural stimulation signals is less desirable than the other in evoking a patient response to treatment. Providing the at least first and second neural stimulation signals may include providing signals having substantially the same pulse width, amplitude, or frequency characteristics. In some embodiments, providing the at least first and second neural stimulation signals includes providing signals with different pulse width, amplitude, or frequency characteristics.

[0087] In some embodiments, sequentially providing stimulation signals includes providing at least four discrete neural stimulation signals to a neural target using distinct electrical stimulation carriers, wherein at least one of the discrete neural stimulation signals is more desirable than the others for eliciting a patient response to treatment. Providing the at least four discrete neural stimulation signals may include providing signals having substantially the same pulse width, amplitude, or frequency characteristics, or providing signals having at least two different pulse width, amplitude, or frequency characteristics.

[0088] The method may further include, using processor circuitry communicatively coupled to the implantable neurostimulation device, identifying a plurality of available neurostimulation carriers corresponding to the plurality of electrodes configured to deliver the neurostimulation therapy; and using the same or different processor circuitry to select at least two of the identified neurostimulation carriers for use by the treatment delivery loop to deliver the neurostimulation therapy to the one or more neural targets. The selection step includes selecting first and second neurostimulation carriers, wherein one of the selected carriers is previously known to be more effective than the other in evoking a patient response to treatment. In some embodiments, the selection step is performed without prior knowledge of the effectiveness of one or more of the selected carriers in evoking a patient response to treatment. In some embodiments, the selection step includes selecting a first carrier comprising a first electrode as an anode and comprising a plurality of other electrodes co-coupled as cathodes; and selecting a second carrier comprising a second electrode as an anode and comprising the first electrode co-coupled with at least one other electrode as a cathode.

[0089] The selection step may include selecting at least three different neural stimulation carriers for the treatment delivery circuit to deliver the neural stimulation therapy, wherein providing the neural stimulation therapy includes providing a corresponding stimulation signal to each of the at least three selected carriers in a manner that provides a non-stimulation interval between each stimulation signal; and wherein the order in which the corresponding stimulation signals are provided is randomly selected. In some embodiments, sequentially providing stimulation signals to the corresponding different electrical stimulation carriers in a manner that has a non-stimulation interval between each stimulation signal includes: providing a first stimulation signal comprising a portion of the neural stimulation therapy using a first electrical stimulation carrier among the electrical stimulation carriers; prohibiting the delivery of neural stimulation therapy from all electrical stimulation carriers during the non-stimulation interval after the first stimulation signal; and providing a subsequent second stimulation signal comprising a portion of the neural stimulation therapy using a different second electrical stimulation carrier among the electrical stimulation carriers after the non-stimulation interval.

[0090] In some embodiments, the neurostimulation therapy is administered to the patient multiple times at the same or different non-stimulation intervals between each neurostimulation therapy signal provided. In some embodiments, the neurostimulation therapy is administered to the patient multiple times, each time using a different order for providing neurostimulation therapy signals to different electrical stimulation carriers.

[0091] In some embodiments, the step of wirelessly receiving power signals includes a portion of receiving the same or different power signals at two different implantable neurostimulation devices, each device including two or more electrodes configured to deliver neurostimulation signals, and wherein using therapeutic delivery circuitry includes a portion of using two different therapeutic delivery circuitry to provide neurostimulation therapy, each therapeutic delivery circuitry associated with a different implantable neurostimulation device.

[0092] In some embodiments, sequentially delivering stimulation signals in a manner that provides a non-stimulation interval between each stimulation signal includes prohibiting the delivery of stimulation signals by the implantable neurostimulation device during the non-stimulation interval. In one embodiment, the interval is at least about 50 milliseconds (e.g., at least 40 milliseconds, at least 50 milliseconds, at least 60 milliseconds, at least 70 milliseconds, at least 80 milliseconds, at least 90 milliseconds, at least 100 milliseconds, between 50 and 100 milliseconds, between 80 and 120 milliseconds, between 100 and 150 milliseconds, their overlapping range, or any value within the listed range). Other smaller or larger intervals may also be used.

[0093] According to several embodiments, an implantable therapeutic delivery device (e.g., adapted to provide neuroelectric stimulation) comprises, or substantially comprises, the following: a receiver circuit including an antenna based on an electric or magnetic field, configured to receive a wireless microwave power signal from a mid-field transmitter circuit when the receiver circuit is implanted within tissue; and a therapeutic delivery circuit coupled to the receiver circuit, the therapeutic delivery circuit being configured to provide a series of electrical stimulation signals using a portion of the wireless microwave power signal received from the mid-field transmitter circuit. The therapeutic delivery circuit includes an output stage configured to provide a sequential sequence of electrical stimulation signals to various electrical stimulation carriers corresponding to different electrode pairs implanted in the tissue.

[0094] The implantable therapeutic delivery device may further include at least three electrodes (e.g., three, four, five, six, seven, eight, or more than eight electrodes) configured to be implanted in tissue at or near a neurostimulation target. The at least three electrodes may be arranged along the axial direction of the implantable lead. In some embodiments, the therapeutic delivery circuitry is configured to randomly select different pairs or groups of the at least three electrodes to deliver the series of electrical stimulation signals.

[0095] The therapeutic delivery circuit can be configured to repeatedly provide the series of electrical stimulation signals for a specified number of repetitions or a specified duration. In some embodiments, the output stage includes: a first output configured to provide a first signal from the series of electrical stimulation signals to a first pair or group of electrodes corresponding to a first electrical stimulation carrier; and a second output configured to provide a subsequent second signal from the series of electrical stimulation signals to different second pairs or groups of electrodes corresponding to different second electrical stimulation carriers; wherein at least one electrode is shared by the first pair or group and the second pair or group of electrodes.

[0096] In some embodiments, the treatment circuit output stage is configured to disable the delivery of electrical stimulation signals from both the first output and the second output during a delay interval between the first signal and a subsequent second signal. The first output may be configured to provide the first signal having a first amplitude, pulse width, or frequency characteristic, and the second output may be configured to provide the second signal having the same first amplitude, pulse width, or frequency characteristic. In some embodiments, the first output is configured to provide the first signal having a first amplitude, pulse width, or frequency characteristic, and the second output is configured to provide the second signal having a different second amplitude, pulse width, or frequency characteristic.

[0097] In some embodiments, the output stage of the treatment circuit is configured to provide a sequential series of electrical stimulation signals to various different electrical stimulation carriers, including at least one carrier that is suboptimal in evoking a patient response. In some embodiments, the output stage is configured to provide a sequential series of the electrical stimulation signals to corresponding different electrical stimulation carriers selected from a set of available electrical stimulation carriers, wherein one of the selected carriers is superior to at least one other selected carrier in evoking a patient response.

[0098] The implantable neurostimulation device may also include a memory (e.g., non-volatile memory or memory circuitry) coupled to receiver circuitry. The memory is configured to store instructions received from the mid-field transmitter circuitry relating to which of a plurality of available electrical stimulation carriers to provide the sequence of electrical stimulation signals.

[0099] According to several embodiments, a system includes, or substantially comprises, a mid-field transmitter configured to transmit a wireless signal at a first frequency, and at least partially implantable biocompatible device including receiver circuitry and therapeutic delivery circuitry coupled to the receiver circuitry. The receiver circuitry includes an antenna for receiving the wireless signal from the mid-field transmitter. The therapeutic delivery circuitry is configured to provide a therapeutic signal comprising a series of at least two electrical stimulation pulses provided using corresponding carriers corresponding to different combinations of the at least three electrodes, wherein a specified delay interval is present between each pulse, and the series of pulses is repeated at least twice. The wireless signal includes a non-negligible magnetic field (H-field) component substantially parallel to the surface of the mid-field transmitter. The mid-field transmitter is adapted to focus the wireless signal onto a site within tissue within approximately one wavelength of the wireless signal when measured in air.

[0100] According to several embodiments, a method of providing neuro-electrical stimulation therapy includes delivering neuro-electrical stimulation therapy to a neural target using a first pair of electrodes implanted in patient tissue. The method includes delivering a first electrical stimulation signal at a first frequency, and delivering a second electrical stimulation signal substantially simultaneously with the first electrical stimulation signal and using a second pair of electrodes implanted in the patient tissue at a different second frequency than the first frequency. The amplitude characteristics of the first electrical stimulation signal can be modulated by the phase characteristics of the second electrical stimulation signal, or vice versa.

[0101] In some embodiments, modulation (e.g., amplification) of the amplitude characteristics of the first electrical stimulation signal is performed using a specified phase characteristic of the second electrical stimulation signal. The method may further include receiving a power signal wirelessly at or using receiver circuitry in an implantable neurostimulation device. This power signal may be a power signal generated and emitted by a field coupler device, comprising a non-negligible magnetic field (H-field) component substantially parallel to the surface of the field coupler device. In some embodiments, the implantable neurostimulation device includes first and second pairs of electrodes, and the first and second electrical stimulation signals include portions of the received power signal. The method may further include generating the power signal using signal generator circuitry in the field coupler device and emitting the power signal from the field coupler device using an electromagnetic structure configured to generate an evanescent field outside body tissue. Emitting the power signal may include focusing the power signal onto a site within body tissue within a wavelength range that the power signal would be measured in air. The power signal may be a microwave signal.

[0102] In some embodiments, the method includes selecting at least two neurostimulation carriers to provide neurostimulation therapy, for therapeutic delivery, and utilizing processor circuitry within an implantable neurostimulation device, a mid-range power transmitter device, or an intermediate coupler device. The selected stimulation carriers correspond to first and second electrode pairs, respectively, and the first and second electrode pairs can be coupled to the implantable neurostimulation device.

[0103] In some embodiments, providing the first electrical stimulation signal includes providing a signal having a smaller peak amplitude characteristic than that of the second electrical stimulation signal. In some embodiments, providing the first electrical stimulation signal is performed using a first electrode and a second electrode, which are axially spaced apart along a lead portion of the implantable neurostimulation device, and providing the second electrical stimulation signal is performed using a third electrode and a fourth electrode, which are axially spaced apart along the lead portion and axially spaced apart from the first and second electrodes along the lead portion.

[0104] While continuously providing a first electrical stimulation signal at a first frequency, a second electrical stimulation signal can be suppressed after a first duration, and a third electrical stimulation signal at a third frequency can be provided substantially simultaneously with the first electrical stimulation signal. In one embodiment, the amplitude characteristics of the first electrical stimulation signal are modulated differently by the respective phase characteristics of the first and second electrical stimulation signals. Providing the third electrical stimulation signal can be performed using a different third pair of electrodes implanted in the patient tissue or using a second pair of electrodes implanted in the patient tissue.

[0105] In some embodiments, providing a first electrical stimulation signal using a first pair of electrodes is performed using electrodes disposed on a first implantable lead, and providing a second electrical stimulation signal using a second pair of electrodes includes using electrodes disposed on a different second implantable lead.

[0106] The method may further include using a sensor disposed at or near the second neural target to sense an intrinsic neural signal, and using processor circuitry to determine the frequency or phase characteristics of the sensed intrinsic neural signal. The method may also include using processor circuitry to select one of a first and a second frequency based on the determined frequency or phase characteristics of the sensed intrinsic neural signal.

[0107] In some embodiments, the method includes periodically blocking the delivery of a second electrical stimulation signal while continuously delivering a first electrical stimulation signal. In some embodiments, a first frequency of the first electrical stimulation signal is about 120 Hz, and a second frequency of the second electrical stimulation signal is about 20 Hz. The first frequency can be between 100 Hz and 500 Hz (e.g., between 100 Hz and 150 Hz, between 110 Hz and 140 Hz, between 120 Hz and 160 Hz, between 200 Hz and 400 Hz, between 300 Hz and 500 Hz, their overlapping ranges, or any value within the listed ranges), and the second frequency can be between 1 Hz and 80 Hz (e.g., between 1 Hz and 10 Hz, between 5 Hz and 30 Hz, between 10 Hz and 30 Hz, between 15 Hz and 50 Hz, between 20 Hz and 60 Hz, between 30 Hz and 80 Hz, between 30 Hz and 60 Hz, their overlapping ranges, or any value within the listed ranges).

[0108] In some embodiments, the method includes identifying neuropathology in a patient based on physiological signals sensed from the patient, and in response, selecting amplitude characteristics of first and second electrical stimulation signals to overdrive the physiological signals sensed from the patient. The method may include timing the delivery of the first or second electrical stimulation signal to correspond with intrinsic neural impulse events in the patient to enhance, improve, or amplify one or more features of the intrinsic neural impulse events.

[0109] According to several embodiments, a system includes a mid-field transmitter configured to transmit wireless signals at a first frequency, and at least partially implantable biocompatible devices, the at least partially implantable biocompatible devices including receiver circuitry and therapeutic delivery circuitry coupled to the receiver circuitry, the receiver circuitry including an antenna for receiving wireless signals from the mid-field transmitter. The wireless signals may include a non-negligible H-field component, and the mid-field transmitter may be particularly suitable for focusing the wireless signals onto a site within tissue that is within approximately one wavelength of the wireless signal when measured in air. In some embodiments, the therapeutic delivery circuitry is configured to provide a phase-amplitude coupled therapeutic signal comprising a first signal component provided using a first neurostimulation carrier and a second signal component provided using a different second neurostimulation carrier, wherein the second signal component is provided substantially simultaneously with the first signal component.

[0110] A biocompatible device may include at least four electrodes spaced axially along a lead portion of the biocompatible device, wherein two of the four electrodes are configured as first neural electrical stimulation carriers, and the other two of the four electrodes are configured as second neural electrical stimulation carriers. Each of the at least four electrodes may be a ring electrode or a cylindrical electrode. Electrodes of other shapes or configurations may also be used.

[0111] In some embodiments, the treatment delivery circuit includes a first oscillator circuit configured to provide a first signal component having a first frequency characteristic and a first amplitude characteristic, and a second oscillator circuit configured to provide a second signal component having a different second frequency characteristic and a different second amplitude characteristic. In one embodiment, the first frequency characteristic is greater than the second frequency characteristic, and the second amplitude characteristic is greater than the first amplitude characteristic. In another embodiment, the second frequency characteristic is greater than the first frequency characteristic, and the first amplitude characteristic is greater than the second amplitude characteristic. In some embodiments, the treatment delivery circuit is configured to adjust the amplitude or frequency characteristic of at least one of the first and second signal components of a phase-amplitude coupled treatment signal to overcome a patient's neuropathophysiology or otherwise improve neurological function (e.g., to overcome symptoms such as those associated with one or more of the following: motor disorders, Parkinson's disease, dementia, Alzheimer's disease, Creutzfeldt-Jakob disease, Huntington's disease, depression, dystonia, or epilepsy, etc.).

[0112] According to several embodiments, systems and methods are provided for embedding communication signals with electrical stimulation therapy. For example, a method for wirelessly transmitting data between an external source device and an implantable device may include generating and transmitting a mid-field power signal using the external source device, receiving the mid-field power signal at an implantable device located beneath the surface of implanted tissue, and providing near-field electrical stimulation therapy using the implantable device and a portion of the received mid-field power signal. The method may also include receiving a far-field signal corresponding to the near-field electrical stimulation therapy at the external source device. In some embodiments, receiving the far-field signal is achieved using electrodes coupled to the tissue surface and coupled to the external source device. The method may further include using the external source device and, based on the received far-field signal, reporting information about the near-field electrical stimulation therapy to a user and / or to a remote device and / or reporting information about the implantable device to a user and / or to a remote device. The method may also include updating the characteristics of the mid-field power signal and generating an updated mid-field power signal and transmitting it to the same or different implantable devices.

[0113] In some embodiments, providing near-field electrical stimulation therapy includes providing a plurality of treatment pulses interleaved with one or more data communication intervals, wherein each data communication interval includes a plurality of data signal pulses. In some embodiments, providing near-field electrical stimulation therapy includes providing the treatment pulses at a first frequency and providing the data signal pulses at a higher second frequency within each data communication interval. In some embodiments, providing near-field electrical stimulation therapy includes providing a plurality of treatment pulses, wherein at least one of the treatment pulses includes an amplitude modulation portion, and wherein the amplitude modulation portion encodes information about the near-field electrical stimulation therapy and / or about an implantable device.

[0114] The method may further include reporting information about near-field electrical stimulation therapy to the user and / or to a remote device. This reporting step may include, for example, providing audible, vibratory, or visual indications of whether the near-field electrical stimulation therapy was successfully provided by the implantable device. In some embodiments, the reporting step includes providing information about the quantity or quality of the field power signal received by the implantable device.

[0115] The method may include updating the characteristics of the mid-field power signal and generating and transmitting the updated mid-field power signal, including adjusting the amplitude, phase, or frequency characteristics of the updated signal. In some embodiments, the method includes using a pocket, sleeve, or clothing item (such as those described herein) configured to maintain electrical contact between the electrodes of the external source device and the tissue surface.

[0116] In response to receiving the mid-field power signal at the implantable device, the method may include using generator circuitry in the implantable device to generate the near-field electrical stimulation therapy. This generation step may include generating a signal pulse train, wherein the signal pulse train has a pulse width modulation or pulse amplitude modulation portion, the pulse width modulation or pulse amplitude modulation portion encoding information about the therapy and / or information about the implantable device itself for an external source device.

[0117] In some embodiments, the method includes measuring characteristics of a mid-field power signal received by the implantable device using the implantable device; encoding information about the measured characteristics in near-field electrical stimulation therapy using the implantable device; decoding the information about the measured characteristics in near-field electrical stimulation therapy using an external source device; and reporting information about the implantable device, including information about the characteristics of the measured mid-field power signal received by the implantable device, to a user and / or a remote device. In some embodiments, generating and transmitting the mid-field power signal using the external source device includes encoding specified information about pulse pattern, frequency, frequency range, signal burst, amplitude, pulse width, or waveform morphology for use by the implantable device to provide near-field electrical stimulation therapy.

[0118] The step of receiving a far-field signal corresponding to near-field electrical stimulation therapy may include determining whether the received signal corresponds to specified information regarding: pulse pattern, frequency, frequency range, signal burst, amplitude, pulse width, or waveform morphology. In some embodiments, providing near-field electrical stimulation therapy using an implantable device includes providing pulse-based therapy, wherein the pulse pattern of the pulse-based therapy encodes information about near-field electrical stimulation or information about the implantable device. Providing pulse-based therapy with encoded information may include introducing a phase bias in the pulse pattern corresponding to the encoded information.

[0119] According to several embodiments, an implantable neurostimulation therapy delivery device comprises, or substantially comprises, the following: a receiver circuit including an antenna based on an E-field or magnetic field, the antenna being configured to receive a field power signal from an external source device when the receiver circuit is implanted within tissue; and a therapy delivery circuit coupled to the receiver circuit, configured to provide signal pulses to an electrostimulation electrode using a portion of the field power signal received from the external source device. The signal pulses may advantageously include electrostimulation therapy pulses and data pulses.

[0120] In some embodiments, the treatment delivery circuitry is configured to interleave a series of discrete data pulses between consecutive treatment pulses. The series of discrete data pulses may encode information about the implantable device itself or about treatment provided by the implantable device. In some embodiments, the treatment delivery circuitry is configured to embed a plurality of data pulses within a treatment pulse. In some embodiments, the treatment delivery circuitry is configured to perform amplitude modulation or pulse width modulation on a portion of the treatment pulses based on the plurality of data pulses.

[0121] The treatment delivery circuit may be configured to provide the data pulses during blanking periods between consecutive treatment pulses. In some embodiments, the treatment delivery circuit is configured to provide the data pulses at a frequency at least twice the frequency of the treatment pulses. The treatment delivery circuit may be configured to encode information about the status of the implantable device and / or about the treatment provided by the implantable device in the data pulses.

[0122] The implantable neurostimulation therapy delivery device may further include a power detector circuit configured to measure the amount of power received via the mid-field power signal. In some embodiments, the therapy delivery circuit is configured to encode information about the measured amount of power in the data pulse.

[0123] The data pulse may include a pulse with a peak amplitude of less than about 2 volts and / or a frequency of about 100 kHz or more. In some embodiments, the treatment pulse includes a pulse having a pulse frequency about an order of magnitude smaller than that of the data pulse.

[0124] According to several embodiments, an external transmitter / receiver (transceiver) device includes a mid-field transmitter comprising a plurality of subwavelength structures configured to simultaneously transmit corresponding plurality of RF signals to a target device implanted in tissue; an electrode pair configured to be disposed on the outer surface of the tissue, the electrode pair being configured to receive electrical signals via the tissue, the electrical signals corresponding to electrical stimulation therapy delivered to the tissue by the target device; and a demodulator circuit coupled to the electrode pair and configured to demodulate a portion of the received electrical signals to recover a data signal originating from the target device. In some embodiments, the external transceiver device includes a demodulator circuit configured to distinguish data pulses from therapeutic pulses in the electrical signals. The demodulator circuit may be configured to identify modulated portions of the therapeutic pulses in the electrical signals and demodulate the identified portions to recover the data signal. In some embodiments, the external transceiver device includes user feedback circuitry including audible, vibrational, or visual alarms capable of being provided to a user based on the recovered data signal.

[0125] Figure Description The accompanying drawings are not necessarily drawn to scale. In the drawings, the same numbers in different views may describe the same parts. The same numbers with different letter suffixes may indicate different instances of similar parts. By way of example, but not limitation, the drawings generally illustrate the various embodiments discussed herein.

[0126] Figure 1 A schematic diagram illustrating an embodiment of a system using a wireless communication path is provided.

[0127] Figure 2A A block diagram illustrating an embodiment of a field source device is provided.

[0128] Figure 2B A block diagram illustrating an embodiment of a system configured to receive signals is provided.

[0129] Figure 3 A schematic diagram illustrating an embodiment of a mid-field antenna with multiple subwavelength structures is provided.

[0130] Figure 4 An illustration of an embodiment of a phase-matching and / or amplitude-matching network for a field source device is provided.

[0131] Figure 5An illustration of an embodiment of the circuitry for an implantable device is provided.

[0132] Figure 6 A perspective view illustrating an embodiment of an implantable device is provided.

[0133] Figure 7 A perspective view illustrating another embodiment of the implantable device is provided, showing the internal circuitry and the antenna within the device.

[0134] Figure 8A A perspective view illustrating an embodiment of the circuit housing is provided.

[0135] Figure 8B A perspective view of another embodiment of the circuit housing is illustrated by example.

[0136] Figure 9 An example perspective view illustrating an embodiment of the circuit housing shows... Figure 8A The circuitry inside the circuit housing.

[0137] Figure 10 An example is given, illustrating a graph of the signal power of a stimulation pulse from an implantable device versus time.

[0138] Figure 11A An example is illustrated by a perspective view of the proximal portion of an embodiment of an implantable device.

[0139] Figure 11B An example is illustrated by a perspective view of the proximal portion of another embodiment of the implantable device.

[0140] Figure 11C A perspective view of the proximal portion of another embodiment of the implantable device is illustrated.

[0141] Figure 12A An example perspective view of an embodiment of an implantable device is provided, wherein the outer housing is not visible to show the internal circuitry of the implantable device.

[0142] Figure 12B Examples illustrate in Figure 12A An exploded view of the implantable device portion within the dashed box marked "12B".

[0143] Figure 13A A perspective view illustrating an embodiment of an implantable device with a proximal portion and an attachable fork tooth portion is provided.

[0144] Figure 13B A perspective view illustrating an embodiment of an implantable device with a proximal portion and an attachable fork tooth portion is provided.

[0145] Figure 13CA perspective view illustrating an embodiment of an implantable device having attached fork teeth is provided.

[0146] Figure 14A A perspective view illustrating an embodiment of a system for attaching fork teeth to an implantable device is provided.

[0147] Figure 14B Examples Figure 14A A perspective view of an embodiment of the system, in which the fork teeth are being pushed closer to the implantable device.

[0148] Figure 14C Examples Figure 14B A perspective view of an embodiment of the system, wherein the fork teeth are attached to an implantable device.

[0149] Figure 15A A perspective view illustrating an embodiment of a system for securing fork teeth to an implantable device is provided.

[0150] Figure 15B Examples are given as follows: Figure 15A The dashed box marked "15B" shows a perspective view of an embodiment of a system for securing the fork teeth to an implantable device.

[0151] Figure 15C A perspective view illustrating an embodiment of a system for manipulating an implantable device is provided.

[0152] Figure 15D Examples illustrate as Figure 15C An exploded diagram of an embodiment of a part of the system.

[0153] Figure 15E An exploded diagram illustrating an embodiment of a system that includes push rods in the seam is provided.

[0154] Figure 15F An example perspective view of a system for removing push rods from implantable devices is provided.

[0155] Figure 16A A perspective view illustrating an embodiment of a suture fixation system is provided.

[0156] Figure 16B Examples Figure 16A A perspective view of an embodiment of a suture fixing system, wherein the suture is fixed to a push rod.

[0157] Figure 17A 17B and 17C illustrate perspective views of embodiments of a system for configuring the teeth of an implantable device.

[0158] Figure 18A perspective view illustrating an embodiment of a suture and fork-tooth configuration mechanism attached to the proximal portion of an implantable device.

[0159] Figure 19 Examples Figure 18 A perspective view of an embodiment of the stitching and fork tooth configuration mechanism, wherein the fork tooth configuration mechanism has translucent markings.

[0160] Figure 20 A perspective view illustrating an embodiment of a suture attached to the proximal portion of an implantable device.

[0161] Figure 21 A perspective view showing an embodiment of multiple sutures attached to the proximal portion of an implantable device.

[0162] Figure 22A A perspective view illustrating an embodiment of the suture and the proximal portion of the implantable device is shown.

[0163] Figure 22B Examples illustrate being attached to Figure 22A A perspective view of an embodiment of an implantable device suture.

[0164] Figure 22C A perspective view illustrating an embodiment of a suture and a proximal portion of an implantable device is shown, wherein the suture is attached to a circuit housing.

[0165] Figure 22D A perspective view illustrating an embodiment of a stitching and fork tooth configuration mechanism is shown, with the fork teeth unfolded.

[0166] Figure 23A A perspective view illustrating an embodiment of a stitch attached to a gripping mechanism.

[0167] Figure 23B A perspective view illustrating an embodiment of the gripping mechanism in the open position is shown.

[0168] Figure 23C A perspective view illustrating an embodiment of a gripping mechanism in a closed position is shown.

[0169] Figure 24A Perspective views illustrating embodiments of implantable devices and shape memory metals are provided.

[0170] Figure 24B A perspective view illustrating an embodiment of shape memory metal in a catheter of an implantable device.

[0171] Figure 25A A perspective view illustrating an embodiment of a probe in a catheter of an implantable device.

[0172] Figure 25BA perspective view illustrating another embodiment of a probe in a catheter of an implantable device is shown.

[0173] Figure 26A A perspective view illustrating an embodiment of a system for guiding an implantable device is provided.

[0174] Figure 26B Examples Figure 26A A perspective view of an embodiment, with some portions removed to show probes within the implantable device.

[0175] Figure 26C Examples Figure 26A and 26B An exploded view of an embodiment of the system's operating mechanism.

[0176] Figure 27A An exploded view illustrating an embodiment of an implantable device's distal portion and a guiding mechanism for providing curvature to the implantable device is provided.

[0177] Figure 27B An exploded view illustrating an embodiment of the distal portion of the sleeve is shown, wherein Figure 27A The guiding mechanism is housed inside the casing.

[0178] Figure 28 A perspective view illustrating an embodiment of a system for placing an implantable device within the body is shown.

[0179] Figure 29 Perspective views illustrating embodiments of cannulas and dilators used to create pathways for or to implantable devices within the body are provided.

[0180] Figure 30 A perspective view illustrating an embodiment of another system for housing a push rod and a sheath within a body is provided.

[0181] Figure 31A A perspective view illustrating an embodiment of a push rod and a suture attached to the proximal end of the implant.

[0182] Figure 31B A perspective view illustrating an embodiment of a push rod and a cannula attached to an attachment structure on a suture and attached to the proximal end of an implantable device.

[0183] Figure 31C A perspective view illustrating an embodiment of an implantable device within a cannula is provided.

[0184] Figure 31D A perspective view illustrating an embodiment of an implantable device partially detached from the cannula.

[0185] Figure 32AExamples include those located at the target anatomical structure (e.g., the S3 orifice in this example). Figure 31A A perspective view of an embodiment of the system.

[0186] Figure 32B Examples include those located at the target anatomical structure. Figure 32A A perspective view of an embodiment of the system, in which the sleeve and push rod are removed.

[0187] Figure 32C An exploded view of an embodiment is shown as an example of the portion near the dashed box labeled "32C" in Figure 32B.

[0188] Figure 33A A perspective view illustrating an embodiment of an implantable device removal system is provided.

[0189] Figure 33B An exploded view illustrates an embodiment of interwoven sutures used to assist in the removal of an implantable device.

[0190] Figure 33C Examples Figure 33B An exploded view of an embodiment of the system, wherein probes are placed on interwoven sutures.

[0191] Figure 34A Perspective views of embodiments of the implantable device removal system are illustrated in 34B, 34C, and 34D.

[0192] Figure 35A and 35B An exploded view of another embodiment of an implantable device removal system is illustrated.

[0193] Figure 36 A perspective view illustrating an embodiment of an implantable device is provided.

[0194] Figure 37 A perspective view illustrating another embodiment of the implantable device is shown.

[0195] Figure 38 A perspective view illustrating an embodiment of the far-side feedthrough plate is provided.

[0196] Figure 39 A perspective view illustrating an embodiment of the near-side feedthrough plate is provided.

[0197] Figure 40 A perspective view illustrating an embodiment of the endplate is provided.

[0198] Figure 41A and 41B The illustrations illustrate an example of a technique for assembling an implantable stimulating device.

[0199] Figure 42 A perspective view illustrating an embodiment of an implantable stimulating device is provided.

[0200] Figure 43 A perspective view illustrating another embodiment of an implantable stimulating device is shown.

[0201] Figure 44 Examples illustrate from Figure 43 When viewed from the angle of the arrow marked "44" Figure 43 A perspective view of one embodiment of the device.

[0202] Figure 45 Perspective views illustrating examples of implant / explant systems are provided.

[0203] Figure 46 Perspective views illustrating examples of implant / explant systems are provided.

[0204] Figure 47 A perspective view illustrating an embodiment of another implant / explant system.

[0205] Figure 48 Perspective views illustrating embodiments of communication and / or stimulation systems are provided.

[0206] Figure 49 Waveform diagrams illustrating embodiments of signals in communication and / or stimulation systems are provided.

[0207] Figure 50 A schematic diagram illustrating an embodiment of the circuitry of an implantable device is provided.

[0208] Figure 51 A schematic diagram illustrating another embodiment of the circuitry for an implantable device is provided.

[0209] Figure 52 A schematic diagram illustrating yet another embodiment of the circuitry for an implantable device is provided.

[0210] Figure 53 A schematic diagram illustrating yet another embodiment of the circuitry for an implantable device is provided.

[0211] Figure 54 A perspective view illustrating an embodiment of an implantable stimulating device is provided.

[0212] Figure 55A An example illustrates the direction of the arrows marked "55A / 55B". Figure 54 A cross-sectional view of an embodiment of an implantable stimulation device.

[0213] Figure 55B An example illustrates the direction of the arrows marked "55A / 55B". Figure 54Another cross-sectional view of an embodiment of an implantable stimulation device.

[0214] Figure 56 Examples illustrate implanted in the body Figure 54 A perspective view of an embodiment of a stimulation device, wherein an external field power supply device is externally located.

[0215] Figure 57 A perspective view illustrating another embodiment of an implantable stimulating device is shown.

[0216] Figure 58A Examples illustrate implanted in the body Figure 57 A perspective view of an embodiment of multiple stimulation devices, wherein an external field power supply device is externally located.

[0217] Figure 58B Examples illustrate implanted in the body Figure 57 A perspective view of another embodiment of multiple stimulation devices, wherein an external field power supply device is externally located.

[0218] Figure 59 A perspective view illustrating another embodiment of an implantable stimulating device is shown.

[0219] Figure 60 Examples illustrate implanted in the body Figure 59 A perspective view of embodiments of multiple stimulation devices, wherein an external field power supply device is externally located. Figure 61 Examples illustrate in Figure 59 A logic circuit diagram of an embodiment of the plurality of stimulation devices within the corresponding electric field range generated between the plurality of stimulation devices.

[0220] Figure 62 The illustrations illustrate an embodiment of a system that includes control hardware and electromagnetic emission elements (such as an antenna).

[0221] Figure 63 The illustration shows a perspective view of an embodiment of a system including control hardware and electromagnetic emission elements located on a separate board.

[0222] Figure 64 The illustrations illustrate embodiments of systems including control hardware and electromagnetic emission elements located on a single board (e.g., a substrate).

[0223] Figure 65 An example perspective view illustrates an embodiment of a system including control hardware and electromagnetic emission elements located on a single board.

[0224] Figure 66 A perspective view illustrating an embodiment of a system including a Faraday cage located above components of a control circuit is provided.

[0225] Figure 67A A perspective view illustrating an embodiment of a Faraday cage is provided.

[0226] Figure 67B Examples Figure 67A A perspective view of an embodiment of the lid of a Faraday cage.

[0227] Figure 67C Examples Figure 67A A perspective view of an embodiment of the Faraday cage seat.

[0228] Figure 68 An example illustrates the view from the back of the board. Figure 66 A perspective view of an embodiment of the system.

[0229] Figure 69 Examples Figure 66 A perspective view of an embodiment of the top layer of the plate.

[0230] Figure 70 A perspective view illustrating an embodiment of a top layer of a plate on which a Faraday cage is disposed.

[0231] Figure 71 Examples Figure 66 A perspective view of an embodiment of the system, which includes a Faraday cage cover to illustrate that discrete components below the Faraday cage have been removed.

[0232] Figure 72 A block diagram illustrating an embodiment of a system for providing power to or stimulating an implanted device is provided.

[0233] Figure 73 An example of a perspective view of a part of the human body is given from the perspective of the lumbar and back sections of the skeletal system.

[0234] Figure 74 Examples illustrate similar Figure 73 A perspective view showing an embodiment of clothing including a pocket located above the potential implantation site of a neurostimulator.

[0235] Figure 75 A block diagram illustrating an embodiment of each layer of the pocket is provided, for example. Figure 74 The pocket shown.

[0236] Figure 76 An example perspective view of an embodiment of the bottom layer of a pocket is provided.

[0237] Figure 77 A perspective view illustrating another embodiment of the bottom layer of the pocket is shown.

[0238] Figure 78 Examples Figure 77A perspective view of the underlying embodiment, in which external devices are arranged through layers.

[0239] Figure 79 Examples Figure 77 A perspective view of the underlying embodiment, which includes an external device and a top layer.

[0240] Figure 80 Examples Figure 77 A perspective view of the underlying embodiment, which includes an external device, a top layer, and an elastic band on the top layer.

[0241] Figure 81 Examples Figure 80 A perspective view of an embodiment of each layer, wherein an external device is provided, and attachment mechanisms are included on both the external device and the top layer of the pocket.

[0242] Figure 82 Examples Figure 81 A perspective view of an embodiment of the system, wherein the pocket and the attachment mechanism of the external device cooperate to secure the external device in the pocket.

[0243] Figure 83 The illustration shows a perspective view of an embodiment of an external device located in a sleeve, which includes a top layer, a bottom layer, and an attachment mechanism on the top layer of the sleeve.

[0244] Figure 84A The illustration shows a perspective view of an embodiment of an external device located in a sleeve, which includes padding material on the underside of the sleeve.

[0245] Figure 84B The illustration shows a perspective view of an embodiment of an external device located in a sleeve, including padding material located on the external device and in the sleeve. Figure 85 A perspective view illustrating an embodiment of an external device located in a sleeve or pocket between layers of clothing.

[0246] Figure 86 An example perspective view of an implementation of an underwear is shown, which includes a securing mechanism at the bottom of the underwear that allows the user to open the underwear while wearing it.

[0247] Figure 87 A perspective view illustrating an embodiment of an external device in the closed position is provided.

[0248] Figure 88 An example perspective view is provided, showing an embodiment of the external device in the open position to illustrate the internal circuitry, top cover, and bottom cover.

[0249] Figure 89 A perspective view illustrating an embodiment of an external device in the closed position is provided.

[0250] Figure 90 An example perspective view is provided, showing an embodiment of the external device in the open position to illustrate the internal circuitry, top cover, and bottom cover.

[0251] Figure 91 A perspective view illustrating an embodiment of a cover (e.g., a top cover or a bottom cover) of an external device including two vents is shown.

[0252] Figure 92 A perspective view illustrating an embodiment of a cover (e.g., a top cover or a bottom cover) for an external device including four vents is shown.

[0253] Figure 93 A perspective view illustrating an embodiment of a cover (e.g., a top cover or a bottom cover) that includes an external device for heat conduction.

[0254] Figure 94 Another perspective view illustrates an embodiment of a cover (e.g., a top cover or a bottom cover) that includes an external device for heat conduction.

[0255] Figure 95 An example perspective view is provided, showing an external device in the open position to reveal the internal circuitry, top cover, and bottom cover.

[0256] Figure 96 An example perspective view is provided for another embodiment of the external device in the open position to show the internal circuitry, top cover, and bottom cover.

[0257] Figure 97 An example perspective view of an embodiment of an external device in a closed position is shown, wherein a fastening mechanism is attached to the cover of the external device.

[0258] Figure 98 A block diagram illustrating an embodiment of a system for communicating with an implanted device is provided.

[0259] Figure 99 A block diagram illustrating an embodiment of another system for communicating with an implanted device is provided.

[0260] Figure 100 A block diagram illustrating an embodiment of another system for communicating with an implanted device is provided.

[0261] Figure 101A The illustrations illustrate an embodiment of the leakage paths of the various cross structures of the mid-field antenna.

[0262] Figure 101B The illustration provides an example of a frequency-dependent leakage path between various subwavelength structures in an antenna.

[0263] Figure 102 A schematic diagram illustrating an embodiment of a backscatter communication system is provided.

[0264] Figure 103 The illustrations illustrate an embodiment of a method for updating broadcast signals based on information about an implanted device.

[0265] Figure 104 The illustrations illustrate an embodiment of a method for receiving antenna signals, including modulated wireless signals.

[0266] Figure 105 A schematic diagram illustrating an embodiment of a system configured to excite a mid-field antenna and receive backscattered signals is provided.

[0267] Figure 106A-106D Examples illustrate the corresponding Figure 105 An illustration of an embodiment of the signal frequencies of different parts of the system.

[0268] Figure 107 The illustrations illustrate embodiments of methods including adjusting the amplitude and / or phase characteristics of the cancellation signal.

[0269] Figure 108 The illustrations illustrate an embodiment of a system for selectively providing power and / or data communication to multiple target devices.

[0270] Figure 109 The illustrations illustrate embodiments of methods that include transmitting power and / or data signals to different target devices at different times using different signal characteristics.

[0271] Figure 110 The illustrations illustrate an embodiment of a method for receiving power transmission efficiency information from multiple target devices.

[0272] Figure 111 The illustration illustrates an embodiment of a method for updating the characteristics of at least one signal in a set of RF signals based on data signals received from a target device.

[0273] Figure 112 The illustrations illustrate an embodiment of a method that includes updating the characteristics of at least one signal in a set of RF signals based on a backscattered signal.

[0274] Figure 113 The illustration illustrates an embodiment of a method for updating the characteristics of at least one signal in a set of RF signals based on data signals received from a target device.

[0275] Figure 114The illustrations illustrate an embodiment of a system for selectively supplying power and / or data to multiple target devices using a remote RF source and a mid-field coupler.

[0276] Figure 115 An illustration is provided illustrating an embodiment of a field coupler having multiple tunable devices.

[0277] Figure 116 The illustrations illustrate embodiments of methods that include using different signal characteristics to transmit power and / or data signals to different target devices at different times.

[0278] Figure 117 The illustrations illustrate an embodiment of a method that includes updating modulation features using an external device.

[0279] Figure 118 The illustrations illustrate an embodiment of a method that conditionally updates modulation features using an external device.

[0280] Figure 119 The illustrations illustrate an embodiment of a system that includes multiple external mid-field transceivers.

[0281] Figure 120 An illustration of an embodiment of a communication system is provided.

[0282] Figure 121 An illustration shows an example of a receiver device implanted in tissue.

[0283] Figure 122 An illustration of an embodiment of a multipolar therapeutic delivery device is provided.

[0284] Figure 123 An illustration of an embodiment of a usable electrical stimulation carrier in a quadrupole electrical stimulation system is provided.

[0285] Figure 124A An illustration of an example of a nerve stimulation therapy delivery sequence is provided.

[0286] Figure 124B An illustration is provided illustrating an embodiment of receiving a treatment delivery command at a stimulation device.

[0287] Figure 125 The illustrations illustrate embodiments including methods for providing nerve stimulation therapy.

[0288] Figure 126 The illustrations illustrate embodiments including methods for identifying or selecting electrical stimulation carriers for providing neurostimulation therapy.

[0289] Figure 127The illustrations illustrate an embodiment of a method that includes randomly selecting the order in which neural stimulation therapy is delivered via multiple carriers.

[0290] Figure 128 An illustration is provided illustrating an example of a phase-amplitude coupled signal.

[0291] Figure 129 An illustration is provided illustrating an embodiment of a method for simultaneously providing neuroelectric stimulation therapy.

[0292] Figure 130 The illustrations illustrate an embodiment of a method that includes providing multiple phase-amplitude coupled therapeutic signals.

[0293] Figure 131 The illustrations illustrate an embodiment of a method for selecting features of one or more signal components in a PAC signal.

[0294] Figure 132 An illustration illustrating an embodiment of a therapeutic signal having data signal components. Figure 133 Illustrations illustrating embodiments of methods for retrieving information signals from far-field signals. Figure 134 Illustrations illustrating embodiments including methods for encoding information in therapeutic signals. Figure 135 Illustrations illustrating embodiments including methods for determining whether treatment has been correctly delivered. Figure 136 Examples are given of systems that can perform one or more of the methods discussed in this article. Detailed Implementation

[0295] Mid-field power supply technology can power a deeply implanted electrical stimulation device from an external power source located on or near the tissue surface (e.g., on 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 may have one or more relatively large implantable batteries and / or one or more lead systems. In contrast, a mid-field device may include a relatively small battery cell that can be configured to receive and store a relatively small amount of power. A mid-field device may include one or more electrodes integrated into a monolithic implantable package. Thus, in some examples, a mid-field 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 these advantages may come from the amount of power delivered to the implanted device. The ability to focus energy from a mid-field device can allow for an increase in the amount of power delivered to the implanted device.

[0296] The advantages of using mid-field powered technology can include having the main battery or power source located outside the patient's body, resulting in lower power consumption, and reducing the need for efficient circuitry required in traditional battery-powered implantable devices. Another advantage of using mid-field powered technology can be the ability to create implantable devices with a smaller physical size compared to battery-powered devices. Therefore, mid-field powered technology can help achieve better patient tolerance and comfort, while potentially reducing manufacturing costs and / or the cost of implantation in patient tissue.

[0297] There are currently unmet needs, including the use of mid-field transmitters and receivers to transmit power and / or data, such as for transmitting power and / or data from an external mid-field coupler or source to one or more implanted neurostimulation devices and / or one or more implanted sensor devices. The unmet needs may further include transmitting data from said one or more implanted neurostimulation devices and implanted sensor devices to an external mid-field coupler or source device.

[0298] In one or more embodiments, a plurality of 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 plurality of implanted devices may be configured to communicate with one or more external devices. In one or more embodiments, the one or more external devices are configured to provide power and / or data signals to the plurality of implanted devices, for example, simultaneously or in a time-division multiplexing (e.g., “cyclic”) manner. The provided power and / or data signals may be manipulated or directed by the external devices to efficiently transmit signals to the implant. Although this disclosure may specifically refer to power signals or data signals, such references should generally be understood to optionally include one or both power and data signals.

[0299] 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 and / or data signals from a field coupler device to an implantable device via a field radio frequency (RF) signal, (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 a signal accompanying the provision of the therapeutic signal, (c) receive a signal based on the therapeutic signal using electrodes coupled to the field coupler device, and (d) decode and react to the information component from the received signal 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 and thereby generate a propagating field within the tissue, for example for use with an implantable target. (iii) A device for transmitting power and / or data signals; (iv) an implantable device including an antenna configured to receive a mid-field power signal from a mid-field transceiver and including a treatment delivery circuit configured to provide signal pulses to electrical stimulation electrodes using a portion of the received mid-field power signal, wherein the signal pulses include treatment pulses and data pulses, and the data pulses may be interleaved with or embedded in the treatment pulses; (v) an implantable device configured to encode information about the device itself in the treatment signal, such as information about the operating status of the device or information about treatments previously provided by the device, concurrently or planned to be provided in the future; (vi) a mid-field transceiver including electrodes configured to sense electrical signals at the surface of tissue; and / or (vi) an adjustable wireless signal source and receiver configured together to enable a communication loop or feedback loop.

[0300] In one or more embodiments, one or more of these and other benefits may be achieved using a system for manipulating an evanescent field at or near an external tissue surface to wirelessly transmit power and / or data to one or more target devices implanted in the tissue. In one or more embodiments, one or more of these benefits may be achieved using devices implanted or capable of being implanted in the body and as described herein. In one or more embodiments, one or more of these benefits may be achieved using field power supply and / or communication devices (e.g., transmitter and / or receiver or transceiver devices).

[0301] A 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 separate 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 the multiple sets of different RF signals at respective different times via the excitation ports. The excitation ports may be adapted to receive a corresponding separate signal from each set of RF signals. Each of the transmitted sets of RF signals may include a non-negligible magnetic field (H-field) component substantially parallel to the external tissue surface. In one or more embodiments, each transmitted set of RF signals is adapted or selected to differently manipulate the evanescent field at or near the tissue surface to transmit power and / or data signals to one or more target devices implanted in the tissue via the mid-field signal, rather than via inductive near-field coupling or radiative far-field transmission.

[0302] In one or more embodiments, one or more of the benefits described above may be achieved at least in part using an implantable therapeutic delivery device (e.g., a delivery device adapted to provide neural stimulation), the implantable therapeutic delivery device including receiver circuitry comprising an antenna (e.g., an electric or magnetic field-based antenna) configured to receive a mid-field power signal from an external source device, such as 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 to provide signal pulses to one or more energy delivery components (e.g., electrostimulation electrodes), which may be integrally coupled to the body of the therapeutic delivery device or positioned independently of the body of the therapeutic delivery device (e.g., not disposed on the body), for example by using a portion of a mid-field power signal received from an external source device (e.g., as sometimes referred to herein as an external device, external source, external mid-field device, mid-field transmitter device, mid-field coupler, mid-field power supply device, power supply device, etc., depending on the configuration and / or usage context of the device). The signal pulses may include one or more electrostimulation therapeutic pulses and / or data pulses. In one or more embodiments, one or more of the aforementioned beneficial effects may be achieved at least in part using an external transmitter and / or receiver (e.g., a transceiver) device comprising an electrode pair configured to be disposed on an external tissue surface and configured to receive electrical signals via the tissue. The electrical signals may correspond to electrical stimulation therapy delivered to the tissue by a treatment delivery device. A demodulator circuit may be coupled to the electrode pair and configured to demodulate a portion of the received electrical signals to recover the data signals generated by the treatment delivery device.

[0303] In one or more embodiments, including the use of a near-field wireless coupler, tissue can act as a dielectric to allow energy tunneling. Coherent interference of 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 embodiments, the receiver positioned in this 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 embodiments, the transmitter source described herein can be configured to provide electromagnetic energy to various target sites, including, for example, to one or more deeply implanted devices. In one example, energy can be provided to a site with a positioning accuracy greater than about a few millimeters. That is, the transmitted power or energy signal can be directed or focused to a target site within about one wavelength of the signal in the tissue. This energy focusing is much more precise than focusing achievable with 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) remains evanescent within the tissue, which does not allow for effective depth penetration. Unlike near-field coupling, energy from a field source primarily occurs in a propagation mode. Therefore, the energy transfer depth is limited by environmental losses, rather than by the inherent attenuation of the near field. Energy transfer achieved using these characteristics can be at least two to three orders of magnitude more efficient than near-field systems.

[0304] One or more of the systems, devices, and methods discussed in this article can be used to help treat fecal or urinary incontinence (e.g., overactive bladder), for example by stimulating the tibial nerve or any branch of the tibial nerve, such as, but not limited to, the posterior 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 of the following: the muscles of the pelvic floor, the nerves innervating the pelvic muscles, the internal urethral sphincter, the external urethral sphincter, and the pudendal nerve or its branches.

[0305] One or more of the systems, devices, and methods discussed herein can be used to help treat sleep apnea and / or snoring by stimulating one or more of the following: nerves or branches of the hypoglossal nerve, the base 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 (e.g., by measuring oxygen saturation).

[0306] One or more of the systems, devices, and methods discussed herein can be used to help treat vaginal dryness, for example by stimulating one or more of the Bartholin glands, Skene glands, and the vaginal lining. One or more of the systems, devices, and methods discussed herein can be used to help treat migraines or other headaches, for example by stimulating one or more of the following: the occipital nerve, the supraorbital nerve, the C2 cervical nerve or its branches, and the frontal nerve or its branches. One or more of the systems, devices, and methods discussed herein can be used to help treat post-traumatic stress disorder, hot flashes, and / or complex regional pain syndromes, for example by stimulating one or more of the stellate ganglion and the C4-C7 sympathetic chain.

[0307] 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 side effects of medications, chemotherapy or radiation therapy for cancer, Sjogren's disease, or other dry mouth conditions), for example by stimulating one or more of the following: the parotid gland, submandibular gland, sublingual gland, submucosal layer of the oral mucosa within the buccal mucosa, labial mucosa, and / or lingual mucosa, soft palate, lateral portion of the hard palate, and / or floor of the mouth and / or between the muscle fibers of the tongue, Von Ebner gland, glossopharyngeal nerve (CN IX), including CN IX branches, including the auricular ganglion, facial nerve (CN VII), including CN VII branches such as the submandibular ganglion, and T1-T3 branches such as the superior cervical ganglion.

[0308] One or more of the systems, devices, and methods discussed herein can be used to aid in the treatment of transverse nerves, for example 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 to aid in the treatment of cerebral palsy, for example by stimulating one or more muscles or one or more nerves innervating one or more muscles in a patient with cerebral palsy. One or more of the systems, devices, and methods discussed herein can be used to aid in the treatment of erectile dysfunction, for example by stimulating one or more of the pelvic splanchnic nerves (S2-S4) or any branches thereof, the pudendal nerve, the cavernous nerve, and malignant or hypogastric nerve plexuses.

[0309] One or more of the systems, devices, and methods discussed herein can be used to help treat menstrual pain, for example 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, such as by sensing one or more pH levels and blood flow or by delivering an electric current or medication to aid in contraception, fertility, bleeding, or pain. One or more of the systems, devices, and methods discussed herein can be used to arouse human arousal, for example by stimulating female genitalia, including external and internal female genitalia, including the clitoris or other sensory-active parts of the female genitalia, or by stimulating the female genitalia.

[0310] One or more of the systems, devices, and methods discussed in this article can be used to help treat hypertension, for example by stimulating the carotid sinus, the left or right vagus nerve, or one or more branches of the vagus nerve. One or more of the systems, devices, and methods discussed in this article can be used to help treat paroxysmal supraventricular tachycardia, for example by stimulating the trigeminal nerve or its branches, the anterior ethmoidal nerve, and one or more of the vagus nerve. One or more of the systems, devices, and methods discussed in this article can be used to help treat vocal cord dysfunction, for example by sensing the activity of the vocal cords and the opposite 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.

[0311] 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 and / or dermal tissues. One or more of the systems, devices, and methods discussed herein can 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 receptors for norepinephrine and / or acetylcholine.

[0312] One or more of the systems, devices, and methods discussed in this paper can be used to aid in the treatment of cancer, for example by stimulating one or more nerves near or within a tumor, such as to reduce sympathetic innervation, such as adrenaline / NE release, and / or parasympathetic innervation, such as acetylcholine (ACh). One or more of the systems, devices, and methods discussed in this paper can be used to aid in the treatment of diabetes, for example by powering sensors in a person that detect diabetes parameters, such as glucose or ketone levels, and using this sensor data to adjust the delivery of exogenous insulin from an insulin pump. One or more of the systems, devices, and methods discussed in this paper can be used to aid in the treatment of diabetes, for example by powering sensors in a person that detect diabetes parameters, such as glucose or ketone levels, and using a mid-field coupler to stimulate the release of insulin from pancreatic β-cells.

[0313] One or more of the systems, devices, and methods discussed in this article can be used to help treat neurological disorders, disorders, or diseases (e.g., Parkinson's disease (e.g., by stimulating the interior or core of the brain), Alzheimer's disease, Huntington's disease, dementia, Creutzfeldt-Jakob disease, 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 core of the brain), phantom limbs (e.g., by stimulating the amputation). This includes nerve stimulation, such as the nerve endings of an amputated limb; dry eye (e.g., by stimulating the lacrimal gland); cardiac arrhythmias (e.g., by stimulating the heart); gastrointestinal disorders such as obesity, gastroesophageal reflux, and / or gastroparesis, such as by deep brain stimulation (DBS) of the C1-C2 occipital nerves or the hypothalamus; the esophagus; muscles near the sphincter leading to the stomach; and / or the lower part of the stomach; and / or stroke (e.g., by subdural stimulation of the motor cortex). Using one or more embodiments discussed herein, stimulation can be provided continuously or periodically as needed (e.g., as required by a physician, patient, or other user).

[0314] When stimulation is provided, the implantable device can be positioned up to five centimeters or more below the skin surface. A mid-field power supply device is capable of delivering power to these depths within the tissue. In one or more embodiments, the implantable device may be located between approximately 2 and 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. This implantation depth may depend on the intended use of the implanted device. For example, to treat depression, hypertension, epilepsy, and / or PTSD, the implantable device may be located 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 located more than approximately 3 centimeters below the skin surface. In yet another example, to treat Parkinson's disease, basic tremor, and / or dystonia, the implantable device may be located between approximately 1 and approximately 5 centimeters below the skin surface. Other examples include placing implantable devices between about 1 cm and about 2 cm below the skin surface, for example, to treat fibromyalgia, stroke, and / or migraines; placing them at about 2 cm to treat asthma; and placing them at about 1 cm or less to treat dry eye.

[0315] While many of the embodiments included herein describe apparatus or methods for providing stimulation (e.g., electrical stimulation), these embodiments may be adapted to provide other forms of modulation (e.g., denervation) in addition to or in lieu of stimulation. Furthermore, although many of the embodiments included herein relate to the use of electrodes for delivering therapy, in other embodiments 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, hot fluids or steam, or other fluids) may be used or delivered.

[0316] Figure 1 A schematic diagram illustrating an embodiment of system 100 using a wireless communication path is provided. System 100 includes an example of an external source 102, such as a mid-field transmitter source, sometimes referred to as a mid-field coupler, positioned at or above an interface 105 between air 104 and a higher refractive index material 106, such as body tissue. The external source 102 can generate source currents (e.g., in-plane source currents). The source currents (e.g., in-plane source currents) can generate electric and magnetic fields. The magnetic field can include a non-negligible component parallel to the surface of source 102 and / or parallel to the surface of the higher refractive index material 106 (e.g., the surface of the higher refractive index material 106 facing the external source 102). According to several embodiments, the external source 102 can include the structural features and functions described with respect to the mid-field coupler and external source, which are included in WIPO publication WO / 2015 / 179225 entitled “MIDFIELD COUPLER”, published November 26, 2015, which is incorporated herein by reference in its entirety.

[0317] 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 embodiments, external source 102 is configured for use with a sleeve, pocket, or other garment or accessory that holds external source 102 in proximity to a higher refractive index material 106 (e.g., see the section entitled “Discrete External Devices Coupled to Implanted Devices” herein) and optionally maintains electrodes 121 and 122 in physical contact with the tissue surface. In one or more embodiments, the sleeve, pocket, or other garment or accessory may include or use conductive fibers or fabrics, through which electrodes 121 and 122 may physically contact the tissue surface. Sleeves, pockets, or other garments or accessories suitable for use with external source 102 are described in detail, for example, in the section entitled “Discrete External Devices Coupled to Implanted Devices” herein.

[0318] In one or more embodiments, two or more outward-facing electrodes may be used, and on-board or auxiliary processor circuitry to 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 signals or near-field signals). In such embodiments, the electrodes may operate as antennas. In one or more embodiments, 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 aforementioned electrodes may be selected for sensing and / or may be electrically grouped or coupled together for sensing or diagnosis. In one or more embodiments, processor circuitry may be configured to test multiple different electrode combination selections to determine the optimal configuration for sensing far-field signals (examples of processor circuitry are provided in...). Figure 2A (It was presented in the middle).

[0319] Figure 1 Embodiments of the implantable device 110 are illustrated, and may include, for example, a multipolar therapeutic delivery device configured for implantation in a higher refractive index material 106. In one or more embodiments, the implantable device 110 includes... Figure 5 All or part of the circuitry 500, which will be discussed in further detail below. In one or more embodiments, the implantable device 110 is implanted in tissue below the tissue-air interface 105. Figure 1 In the embodiment, the implantable device 110 includes an elongated body and a plurality of electrodes E0, E1, E2, and E3 spaced axially along a portion of the elongated body. The implantable device 110 includes receiver and / or transmitter circuitry (not shown in the original text) enabling communication between the implantable device 110 and an external source 102. Figure 1 As shown, see, for example Figure 2A (e.g., 2B and 4).

[0320] Electrodes E0-E3 can be configured to deliver electrical stimulation therapy to patient tissue, such as at or near a nerve or muscle target. In one or more embodiments, at least one electrode can be selected as the anode and at least one other electrode can be selected as the cathode to define the electrical stimulation carrier. In one or more embodiments, electrode E1 is selected as the anode and electrode E2 is selected as the cathode. E1-E2 together define the electrical stimulation carrier V12. The carriers can be configured independently to provide neurostimulation therapy to the same or different tissue targets, for example, simultaneously or at different times.

[0321] In one or more embodiments, source 102 includes an antenna (see, for example, see...). Figure 3The implantable device 110 includes an antenna 108 (e.g., an electric field-based or magnetic field-based antenna). The antenna can be configured (e.g., in terms of length, width, shape, material, etc.) to transmit and receive signals at substantially the same frequency. The implantable device 10 can be configured to transmit power and / or data signals to an external source 102 via the antenna 108 and can receive power and / or data signals transmitted by the external source 102. The external source 102 and the implantable device 110 can be used for transmitting and / or receiving RF signals. A transmit / receive (T / R) converter 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. Similarly, a T / R converter can be used to switch the implantable device 110 between transmit and receive modes. See [link to T / R converter example] for an example of a T / R converter. Figure 4 .

[0322] In one or more embodiments, the receiving terminal on the external source 102 may be connected to one or more components that detect the phase and / or amplitude of the signal received from the implantable device 110. The phase and amplitude information can be used to program the phase of the transmitted signal, for example, to a relative phase substantially the same as the signal received from the implantable device 110. To help achieve this, the external source 102 may include or use a phase-matching and / or amplitude-matching network, such as... Figure 4 As shown in the embodiments. The phase-matching and / or amplitude-matching network can be configured for use with a mid-field antenna including multiple ports, such as... Figure 3 As shown in the embodiments.

[0323] See again Figure 1In one or more embodiments, the implantable device 110 may be configured to receive a field signal 131 from an external source 102. The 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 embodiments, the field signal 131 includes configuration data for use by the implantable device 110. The configuration data may define treatment signal parameters, such as treatment signal frequency, pulse width, amplitude, or other signal waveform parameters. In one or more embodiments, the implantable device 110 may be configured to deliver electrical stimulation therapy to a treatment target 190, which may include a neural target (e.g., a nerve), a muscle target, or other tissue target. The electrical stimulation therapy delivered to the treatment target 190 may be provided using a portion of the power signal received from the external source 102. Examples of treatment targets 190 may include neural tissue or neural targets, such as those in or near the sacral region of the cervix, thoracic vertebrae, lumbar vertebrae or spine, brain tissue, muscle tissue, abnormal tissue (e.g., tumor or cancerous tissue), targets corresponding to the sympathetic or parasympathetic nervous system, targets in or near peripheral nerve bundles or fibers, targets in or near other targets selected to treat incontinence, urinary urgency, overactive bladder, fecal incontinence, constipation, pain, neuralgia, pelvic pain, movement disorders or other diseases or disorders, deep brain stimulation (DBS) treatment targets or any other condition, disease or disorder (e.g., those other conditions, diseases or disorders identified herein).

[0324] Electrical stimulation therapy may include using a portion of a power signal received via a mid-field signal 131 and providing a current signal to electrodes or electrode pairs (e.g., two or more of E0-E3) coupled to the implantable device 110 to stimulate the treatment target 190. As a result of the current signal being provided to the electrodes, a near-field signal 132 may be generated. The potential difference induced by the near-field signal 132 can be detected remotely from the treatment delivery location. Various factors can influence the location where the potential difference can be detected and whether it can be detected, including 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 may be considered 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 may be associated with an area at or near the implantable device 110 and the treatment target 190, while the far-field signal 133 may be associated with other areas further away from the implantable device 110 and the treatment target 190. In one or more embodiments, information relating to the implantable device 110, or information relating to planned treatment previously provided or to be provided in the future by the implantable device 110, may be encoded into a treatment signal and detected and decoded by an external source 102 via a far-field signal 133.

[0325] In one or more embodiments, the device 110 may be configured to deliver a series of electrical stimulation pulses to a tissue target (e.g., a neural target). For example, the device 110 may deliver multiple electrical stimulation pulses that are spaced out in time to provide treatment, for example, using the same or different electrical stimulation carriers. In one or more embodiments, treatment comprising multiple signals may be delivered in parallel to multiple different carriers, or may be delivered sequentially to deliver a series or sequence of electrical stimulation pulses to the same neural target. Thus, even if one carrier is better than another for eliciting a patient response, the treatment as a whole may be more effective than simply stimulating the carrier known to be optimal because (1) the target can be rested during non-stimulation periods, and / or (2) stimulating areas near and / or adjacent to the optimal target may elicit a patient benefit.

[0326] System 100 may include a sensor 107 at or near the interface 105 between air 104 and a higher refractive index material 106. Sensor 107 may include 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 is detected to be greater than a specific threshold activity level, the power level of source 102 and / or device 110 may be adjusted. In one or more embodiments, sensor 107 may be coupled to or integrated with source 102, and in other examples, sensor 107 may be separate from source 102 and / or device 110 and communicate data with source 102 and / or device 110 (e.g., using wired or radio coupling or connection).

[0327] System 100 may include a far-field sensor device 130, which may be separate from 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 signal 133 corresponding to a 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, for example, at interface 105. In one or more embodiments, three or more electrodes may be used, and processor circuitry carried by or assisting far-field sensor device 130 may select various combinations of two or more of the electrodes to sense far-field signal 133. In one or more embodiments, far-field sensor device 130 may be configured for use with sleeves, pockets, or other clothing or accessories that hold far-field sensor device 130 adjacent to a higher refractive index material 106 and optionally maintain physical contact between electrodes 123 and 124 and the tissue surface. In one or more embodiments, 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 through said conductive fibers or fabrics. Sleeves, pockets, or other clothing or accessories suitable for use with the far-field sensor device 130 are described herein in the section entitled “Discrete External Devices Coupled to Implantable Devices”. Figure 2B Examples of at least a portion of the far-field sensor device 130 are further described.

[0328] In one or more embodiments, the external source 102 provides a field signal 131, including power and / or data signals, to the implantable device 110. The field signal 131 includes signals (e.g., RF signals) having various or tunable amplitude, frequency, phase, and / or other signal characteristics. The implantable device 110 may include an antenna capable of receiving the field signal 131 and modulating the received signal at the antenna based on characteristics of the receiver circuitry in the implantable device 110, thereby generating a backscattered signal. In one or more embodiments, the implantable device 110 may encode information in the backscattered signal 112, such as information about 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 it may be received by another device. In one or more embodiments, the biological signal 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 biological signal can be modulated onto the backscattered signal 112. Other sensors are discussed elsewhere herein, such as in [reference 112]. Figure 136 In such embodiments, sensor 107 may include appropriate monitoring devices, such as glucose, temperature, ECG, EMG, oxygen, or other monitoring devices, to receive, demodulate, interpret, and / or store data modulated onto the backscattered signal.

[0329] In one or more embodiments, 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 embodiment, the external source 102 and / or implantable device 10 may include a window adjacent to its light source or photodetector, said window being made of, for example, quartz, glass, or other translucent material.

[0330] In one embodiment, optical communication may be separate from or supplementary to the electromagnetic coupling between the external source 102 and the implantable device 110. Optical communication may be provided using light pulses modulated according to various protocols, such as pulse position modulation (PPM). In one embodiment, the light source and / or photodetector carried on the implantable device 110 may be powered by a power signal received at least partially via a field coupling with the external source 102.

[0331] In one embodiment, the light source at external source 102 can transmit communication signals 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 information, treatment information, or other information from or related to the implantable device can be encoded and emitted from the implantable device 110 using the light source located at the implantable device 110. The light signal emitted from the implantable device 110 can pass 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 range, for example, in the range of wavelengths 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 listed ranges).

[0332] Figure 2A Block diagrams and embodiments of field source devices (e.g., external source 102) are illustrated. External source 102 may include components, circuits, or functional elements that communicate data with each other. Figure 2A In this example, the 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, components of the mid-field antenna 300, and / or one or more feedback devices, such as including or using an audio speaker 251, a display interface 252, and / or a haptic feedback device 253. The following... Figure 3 The embodiment further describes the mid-field antenna 300, and below... Figure 4 The embodiment further describes network 400. Processor circuitry 210 may be configured to coordinate the various functions and activities of the components, circuits, and / or functional elements of the external source 102.

[0333] 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 that is substantially parallel to the external tissue surface. In one or more embodiments, the RF signal can be adapted or selected to control the evanescent field at or near the tissue surface, such as for transmitting power and / or data signals to corresponding different target devices (e.g., implantable device 110) implanted in the tissue. The mid-field antenna 300 can be further 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 antennas. The shape and size of antenna 300 can be configured to receive signals in the range of approximately 400 MHz and approximately 4 GHz (e.g., between 400 MHz and 1 GHz, 400 MHz and 3 GHz, 500 MHz and 2 GHz, 1 GHz and 3 GHz, 500 MHz and 1.5 GHz, 1 GHz and 2 GHz, 2 GHz and 3 GHz, their overlapping ranges, or any value within the listed ranges). For embodiments incorporating dipole antennas, the mid-field antenna 300 may include a straight dipole, folded dipole, short dipole, cage dipole, bowtie dipole, or bat-shaped dipole having two substantially straight conductors.

[0334] Demodulator circuitry 230 may be coupled to sensing electrode 220. In one or more embodiments, sensing electrode 220 may be configured to receive far-field signal 133, such as based on treatment provided by implantable device 110, for example, which may be delivered to treatment target 190. Treatment may include embedded or intermittent data signal components that can be extracted from far-field signal 133 by demodulator circuitry 230. For example, the data signal components may include amplitude-modulated or phase-modulated signal components that can be identified 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 particular 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 graphic information to the patient, and / or may instruct haptic feedback device 253 to provide tactile stimulation to the patient. In one or more embodiments, the haptic feedback device 253 includes a transducer configured to vibrate or provide another mechanical signal.

[0335] Figure 2BThis diagram illustrates a portion of a system configured to receive far-field signals. The 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 collectively referred to as sensing electrodes 220, and are designated SE0, SE1, SE2, and SE3, respectively; however, other numbers of sensing electrodes 220 may also be used. The sensing electrodes may be communicatively coupled to multiplexer circuitry 261. Multiplexer circuitry 261 may select electrode pairs or groups for sensing far-field signal information. In one or more embodiments, multiplexer circuitry 261 selects electrode pairs or groups based on the highest signal-to-noise ratio of the detected received signal or based on another relative indication of signal quality (e.g., amplitude, frequency content, and / or other signal characteristics).

[0336] 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 set to a 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. As further described herein, the digital signal can be further processed by various digital signal processors 265, such as for retrieving or extracting information signals transmitted by implantable device 110.

[0337] Figure 3 A schematic diagram illustrating an embodiment of a mid-field antenna 300 having multiple subwavelength structures 301, 302, 303, and 304 is provided. The mid-field antenna 300 may include a mid-field plate structure having a planar 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 other subwavelength structures may be used. These subwavelength structures can be excited individually or selectively 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 transmitted and / or received by the external source 102. For example, for a given λ0 corresponding to the wavelength of a signal in air, a source structure including one or more dimensions less than λ0 may be considered a subwavelength structure. Subwavelength structures of various designs or configurations may be used. Some examples of subwavelength structures may include slots in a planar structure, or strips or sheets of generally planar conductive sheets of material. Examples of subwavelength structures are provided at least in the section entitled “Compact Integration of Electronic Control Hardware with Electromagnetic Emission Elements” herein.

[0338] Figure 4 The phase-matching or amplitude-matching network 400 is schematically illustrated. In one embodiment, the network 400 may include an antenna 300, and the antenna 300 may be, for example, via... Figure 3 The first through fourth RF ports 311, 312, 313, and 314 shown are electrically coupled to a plurality of converters 404A, 404B, 404C, and 404D. Converters 404A-D are electrically coupled to corresponding phase and / or amplitude detectors 406A, 406B, 406C, and 406D, and corresponding variable gain amplifiers 408A, 408B, 408C, and 408D, respectively. 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.

[0339] In one or more embodiments, converters 404A-D can be configured to select a receive line (“R”) or a transmit line (“T”). The number of converters 404A-D in network 400 can be equal to the number of ports of field source 402. In an example of network 400, field source 402 includes four ports (e.g., corresponding to...). Figure 3 The example antenna 300 has four subwavelength structures, but any number of ports (and converters) can be used, such as one, two, three, four, five, six, seven, eight or more.

[0340] 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 embodiments, 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 configured to generate one or more signals representing the phase and / or amplitude of the signal received at the external source 102.

[0341] Amplifier 408A-D can receive corresponding inputs from phase shifter 410A-D (e.g., phase Pk is shifted by Φk, Φ1+Φk, Φ2+Φk, Φ3+Φk, or Φ4+Φk). The amplifier's output O is typically the output of a power divider (in... Figure 4 In one embodiment, when the RF signal 414 has an amplitude of 4*M, this output is 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 embodiments, the phase shifters 410A-D can dynamically or responsively configure the relative phase of each port based on phase information received from the detectors 406A-D.

[0342] In one or more embodiments, the transmit power requirement from the field source 402 is Ptt. The RF signal supplied to the power divider 412 has a power of 4*M. The output of amplifier 408A is approximately M*P1*Pk. Therefore, the power transmitted from the 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)).

[0343] The signal amplitude at each RF port can be transmitted with the same relative (proportional) amplitude as the signal received at the corresponding port of the mid-field coupler to which it is coupled. The gain of amplifiers 408A-D can be further improved to account for any loss of signal between transmission and reception at the mid-field coupler. Consider the reception efficiency η = Pir / Ptt, where Pir is the power received at the implanted receiver. Given a specific phase and amplitude tuning, the efficiency (e.g., maximum efficiency) can be estimated based on the amplitude received from the implantable source at an external mid-field source. This estimate can be given by η ≈ (P1 + P2 + P3 + P4) / Pit, where Pit is the original power of the signal from the implantable 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 embodiments, the amplitude of the signal received at amplifiers 408A-D can be scaled according to the determined efficiency, for example, to ensure that the implantable device receives power to perform one or more programmed operations. Assuming the estimated link efficiency is η and the implanted power (e.g., amplitude) requirement is Pir', Pk can be scaled by Pk = Pir'[η(P1+P2+P3+P4)], for example, to help ensure that the implant receives sufficient power to perform the programmed function.

[0344] 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 through... Figure 4 The processing circuitry, not shown, is provided. This circuitry is omitted to prevent... Figure 4 The views provided are overly complex or obscure. The same or different processing circuitry can be used to update the state of one or more converters in the converter 404A-D between receive and transmit configurations. See [link to example processing circuitry] for details. Figure 2A The processor circuit 210 and its related description.

[0345] Figure 5 The illustration illustrates an embodiment of circuitry 500 for an implantable device 110 or target device. Circuitry 500 includes one or more pads 536, which may be electrically connected to antenna 108, for example. 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 can adjust the input impedance of circuitry 500 based on the changing impedance of antenna 108. In one or more embodiments, the impedance of tunable matching network 538 may be matched to the impedance of antenna 108. In one or more embodiments, 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.

[0346] A transmit-receive (T / R) converter 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 device, an implanted device, or an external device). The active transmitter can operate in the 2.45 GHz or 915 MHz Industrial, Scientific, and Medical (ISM) band or the 402 MHz Medical Implantable Communication Service (MICS) band for transmitting data from the implant. Alternatively, a surface acoustic wave (SAW) device that backscatters incident radio frequency (RF) energy to an external device can be used to transmit data. Further discussion of SAW-based backscattering methods can be found at least in the section entitled “Surface Acoustic Wave-Based Communication Devices”.

[0347] Circuit 500 may include a power meter 542 for detecting the magnitude of power received at the implanted device. Digital controller 548 may use a signal representing the power from power meter 542 to determine whether the power received for the circuit is sufficient (e.g., above a specified threshold) to perform a specified function. 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) supplying power to circuit 500 is in a suitable position to deliver power and / or data to the target device.

[0348] In one or more embodiments, circuit 500 may include a demodulator 544 for demodulating the received data signal. Demodulation may include extracting a signal carrying the original information from a modulated carrier signal. In one or more embodiments, circuit 500 may include a rectifier 546 for rectifying the received AC power signal.

[0349] 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 inputs from one or more of power meter 542, demodulator 544, and / or clock 550. In one or more embodiments, digital controller 548 may control which electrodes (e.g., E0-E3) are configured as a current sink (anode) and which electrodes (e.g., current source) are configured as a current source (cathode). In one or more embodiments, digital controller 548 may control the magnitude of stimulation pulses generated through the electrodes.

[0350] The charge pump 552 can be used to increase the rectified voltage to a higher voltage level, for example, it can be suitable for stimulation of the nervous system. The charge pump 552 can use one or more discrete components to store the charge used to increase the rectified voltage. In one or more embodiments, the discrete components include one or more capacitors, for example, which can be coupled to pad 554. In one or more embodiments, these capacitors can be used for charge balancing during stimulation, for example, to help avoid tissue damage.

[0351] The stimulation driver circuit 556 can provide programmable stimulation, such as to an electrode array, through each output 534. The stimulation driver circuit 556 may include impedance measurement circuitry, for example, for testing 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, current sink, or shortened 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, such as using at least a portion of a mid-power signal received from an external source 102. In one or more embodiments, the stimulation driver circuit 556 can provide pulses with frequencies up to about 100 kHz. Pulses with frequencies of about 100 kHz can be used for nerve blocks.

[0352] Circuit 500 may further 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.

[0353] 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 the amplifier 555. These amplified signals may be converted into digital signals by the ADC 557. These digital signals may be transmitted to an external device. In one or more embodiments, the amplifier 555 may be a transimpedance amplifier.

[0354] The digital controller 548 can provide 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.

[0355] The modulator / power amplifier 562 can be driven by an oscillator / phase-locked loop (PLL) 560. The PLL disciplines the oscillator to maintain greater 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 from about 10 kHz to about 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 can be used, depending on the application. Clock 550 is used for timing the digital controller 548. Typical frequencies for clock 550 are between approximately 1 kHz and approximately 1 MHz (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, their overlapping ranges, or any value within the listed ranges). Other frequencies can be used depending on the application. Generally, faster clocks use more power than slower clocks.

[0356] The return path from the sensored signal is optional. This path may include amplifier 555, ADC 557, oscillator / PLL 560, and modulator / power amplifier 562. Each of these items and the connections to them may be optionally removed.

[0357] In one or more embodiments, the digital controller 548, amplifier 555, and / or stimulation driver circuitry 556 of circuitry 500 may include 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 embodiments, this state machine device does not need to retain information about available electrical stimulation settings or carriers; instead, the state machine device performs or provides electrical stimulation events after receiving a command from source 102 and / or in response to receiving a command from source 102.

[0358] For example, a state machine device can be configured to receive commands to transmit neural electrical stimulation therapy signals, such as at a specified time or with certain specified signal characteristics (e.g., amplitude, duration, etc.), and the state machine device can respond by initiating or transmitting the therapy signal at the specified time and / or with the specified signal characteristics. At subsequent times, the device can receive further instructions to terminate the therapy, change the signal characteristics, or perform another task. Therefore, the device can optionally be configured to be substantially passive, or it can be configured to respond to received commands (e.g., commands received simultaneously).

[0359] I. Implantable device configuration The chapter headings here, as described above (“Implantable Device Configurations”), are provided to guide the reader to the subject matter substantially corresponding to the heading. However, the discussion under a particular heading should not be interpreted as applicable only to a single type of configuration; rather, the various features discussed in the chapters or sub-sections here can be combined in various ways and arrangements. For example, some discussion of the features and advantages of external devices can be found in the text and corresponding figures under the heading “Implantable Device Configurations”.

[0360] A. Implantable stimulatory devices and the manipulation and attachment mechanisms for them. This section describes embodiments and / or features of therapeutic devices, guiding mechanisms for placing implantable devices (e.g., therapeutic devices) within tissue, and / or attachment mechanisms for helping to ensure that the implantable device does not move significantly when placed within tissue. One or more embodiments 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.

[0361] The advantages of implantable devices discussed in this section (and others) may include one or more of the following: (i) configurable implantable devices that can be modified in shape and / or electrode configuration to help target sites for electrical stimulation in the body; (ii) implantable devices that can be implanted and then attached to a target location (e.g., an S3 hole); (iii) implantable devices with improved signal reception efficiency (e.g., using (1) a dielectric material surrounding the antenna, the dielectric material comprising a dielectric constant between that of human tissue and that of air, or (2) multiple antennas in an implantable device, such as a primary antenna including an inductively coupled secondary antenna); (iv) thinner and more discrete implantable devices that can be implanted into thinner tissue regions, such as between skin and bone; (v) implantable devices that can provide electrical stimulation patterns that elongated tubular implantable devices cannot provide (due to the location of the electrodes and the shape of the implantable device); and (vi) networks of implantable devices that, individually or in combination, can provide local or wide-area stimulation.

[0362] 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 provide electrical 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 arranged 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 enclosed within the circuit housing. The antenna housing is attached to the circuit housing at a proximal end opposite to the end of the circuit housing attached to the elongated member.

[0363] 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 an antenna adapted to transmit information (e.g., data signals) to the external source via an antenna. One, more, or all of the electrodes described above may optionally be disposed at the proximal or central portion of the elongated member rather than at the distal portion. The circuit housing may optionally be attached to the distal or central portion of the elongated member. The 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 comprise a dielectric material with a dielectric constant between that of human tissue and that of air, such as a ceramic material. 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.

[0364] 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 wire disposed within the channel, the shape memory wire being pre-shaped to provide bending to the elongated member. The shape memory may optionally be shaped to conform to the shape of the S3 aperture and generally match the curve of the sacral nerve. The antenna may be a primary antenna, and the device may further include a secondary antenna attached to an antenna housing, the secondary antenna being shaped and positioned to provide a near field for coupling with 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; and (3) an attachment structure attached to the proximal end of the antenna housing. The antenna may optionally be coupled to a conductive ring of circuitry disposed in the proximal portion of the circuit housing. Ceramic material may be present between the antenna and the conductive ring.

[0365] Figure 6A perspective view illustrating an embodiment of implantable device 600 is provided. Implantable device 110 may include one or more features of implantable devices discussed in this section. As shown, implantable device 600 includes an elongated distal body portion 602. Body portion 602 includes a plurality of electrodes 604 at least partially embedded therein and / or attached thereto. Body portion 602 includes a distal end 606 and a proximal end 608. Proximal end 608 is attached to a circuit housing 610. Circuit housing 610 is attached to an antenna housing 612. As shown, antenna housing 612 includes a plurality of forked portions 614 attached thereto.

[0366] The body portion 602, electrode 604, circuit housing 610, and antenna housing 612 are shown as generally cylindrical. The implantable device 600 is configured to be wirelessly powered (e.g., by electromagnetic waves incident on and outside the body onto which the implantable device 600 is implanted). The implantable device 600 is configured to deliver stimulation (e.g., nerve stimulation, muscle stimulation, other electrical stimulation) or other forms of modulation (e.g., denervation) to a treatment site within a patient (e.g., a human or other animal patient). The implantable device 600 may utilize a cannula (regarding...). Figure 26A-35B (And as discussed elsewhere in this article) placed inside the patient.

[0367] Body portion 602 may include a flexible material. In one or more embodiments, this flexible material may include polyurethane, silicone, epoxy, and / or any other flexible material. In one or more embodiments, body portion 602 may include a shape memory polymer. This flexible material can provide the ability to shape body portion 602, for example, when body portion 602 is inside a patient.

[0368] The illustrated electrode 604 comprises an electrode array of four stimulating electrodes 604 along the body portion 602. In one or more embodiments, the electrode 604 comprises platinum, iridium, stainless steel, titanium, titanium nitride, or other conductive materials. In one or more embodiments, the electrode comprises a platinum and iridium alloy, such as a combination of 90% platinum and 10% iridium. Other combinations are possible (e.g., 85% platinum and 15% iridium, 95% platinum and 5% iridium, 80% platinum and 20% iridium). In one or more embodiments, the electrode may include a coating, such as a material that can improve electrical properties in a particular medium (e.g., the body). In one or more embodiments, the electrodes 604 are electrically separated from each other, for example, by one or more electrical transducers. In one or more embodiments, the width of the electrode 604 (an elongated dimension along the body portion 602) is approximately 1 to 10 millimeters (e.g., 1 to 3, 2 to 5, 2 to 8, 3 to 6, 4 to 9, 5 to 7, 6 to 10, 2 to 4, their overlapping ranges, or any value within the listed range, such as 3 millimeters). In one or more embodiments, electrodes 604 are separated by approximately 1 to 10 millimeters (e.g., 1 to 3, 2 to 5, 2 to 8, 3 to 6, 4 to 9, 5 to 7, 6 to 10, 2 to 4, their overlapping range, or any value within the listed range, such as 3 millimeters). In one or more embodiments, the diameter of the electrodes is approximately 1 to 5 millimeters (e.g., 1 to 2, 1 to 3, 2 to 4, 3 to 5, their overlapping range, or any value within the listed range, such as 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm). Electrodes 604 are electrically connected to circuit 716 (see...). Figure 7 It is airtightly sealed in the circuit housing 610.

[0369] The circuit housing 610 can provide a hermetically sealed enclosure for the circuit 716. The circuit housing 610 may comprise titanium (e.g., commercially pure 6Al / 4V or another alloy), platinum, stainless steel, or ceramic materials (e.g., zirconium oxide or alumina), or other hermetically sealed biocompatible materials. The circuit housing 610 provides a hermetically sealed space for the circuit 716. If a metallic material is used in the circuit housing 610, the circuit housing 610 can be used as part of an electrode array, for example, effectively increasing the number of selectable electrodes 604 for stimulation or other modulation.

[0370] Antenna housing 612 may be disposed near end 611 of circuit housing 610. Antenna 718 (see, for example) is located within antenna housing 612. Figure 12A-1 2C) can be used for power supply and communication to and / or from the implantable device 600, such as from a device outside the patient or subject.

[0371] Not airtight, the circuit housing 610 can be backfilled to prevent moisture intrusion. Backfill materials may include non-conductive, waterproof materials such as epoxy resin, parylene, Tecothane® material, its copy, or other materials.

[0372] In one or more embodiments, the fork tooth 614 may be attached to the proximal portion of the antenna housing 612 (see view for a view of the proximal portion of the antenna housing 612). Figure 14A (e.g., 14B, 14C, 15A, 15B, 15C, 16A, and 16B). The fork 614 can provide the ability to attach (e.g., attach or couple) the implantable device 600 to a specific location within a patient's body. The fork 614 can be configured to attach the implantable device 600 to a specific anatomical structure. The fork 614 can be made of a polymer or other flexible or semi-flexible material, such as silicone, polyurethane, epoxy, or similar materials. The fork 614 can open away from the central axis of the antenna housing 612, such that the distal portion of a given fork 614 is closer to the central axis than the proximal portion of the given fork 614, for example, in... Figure 6 As shown in the image.

[0373] Figure 7 A perspective view illustrating another embodiment of the implantable device 700 is shown, illustrating internal circuitry 716 and antenna 718. The circuitry housing 610 and antenna housing 612 are shown as transparent so as not to obstruct the view of the contents therein.

[0374] Circuit 716 is configured to provide programmable control for each electrode 604 in the electrode array. Any electrode along the array can be used or programmed as a current source or sink based on a signal received at circuit 716 from source 102. Each electrode 604 can independently adjust the current or voltage amplitude in substantially the same manner. For example, an electrode marked "0" can be programmed as a current source to reach further into the patient's body. In this example, any one or more other electrodes can be programmed as a current sink.

[0375] Circuit 716 is shown housed within circuit housing 610. Circuit 716 is electrically connected to an electrode array, for example, via a corresponding electrical connection 720 at a distal portion of circuit housing 610. Circuit 716 is electrically coupled to antenna 718, for example, via inductive coupling or a wired connection. Antenna 718 and / or electrode 604 can be encapsulated in a non-hermetic material and connected to circuit 716, for example, by using one or more feedthrough connections, as shown in reference to… Figure 8A and 8B The subject of discussion.

[0376] Figure 8A A perspective view illustrating an embodiment of the circuit housing 610A is shown. As shown, the circuit housing 610A includes a wall 820 (e.g., a cover), a near-side feedthrough 822, and a far-side feedthrough 824. In one embodiment, the wall thickness 821 can be between about 25 micrometers and about 400 micrometers (e.g., less than 400 micrometers, less than 350 micrometers, less than 300 micrometers, less than 250 micrometers, less than 200 micrometers, less than 150 micrometers, less than 130 micrometers, less than 125 micrometers, less than 120 micrometers, less than 115 micrometers, less than 110 micrometers, less than 100 micrometers, less than 50 micrometers, between 25 micrometers and 100 micrometers, between 40 micrometers and 60 micrometers, between 50 micrometers and 100 micrometers, between 100 micrometers and 200 micrometers, between 150 micrometers and 400 micrometers, between 200 micrometers and 350 micrometers, their overlapping ranges, or any value within the listed ranges, such as 50 micrometers), and can depend on the material used to form the circuit housing 610A. In one embodiment, the outer diameter 823 of the circuit housing 610A can be approximately 1 mm to 3 mm (e.g., 1 mm to 2 mm, 1.5 mm to 2.5 mm, 1.50 mm to 1.75 mm, 2 mm to 3 mm, their overlapping ranges, or any value within the listed ranges, such as 1.66 mm, 1.70 mm, 1.60 mm, 1.55 mm, 1.72 mm). The circuit housing 610A can be manufactured using machining processes, or it can be provided by stretching, casting, molding, or other methods. The circuit housing 610A can be made of metal, metal alloy, ceramic, or similar materials, for example, it can include a combination of platinum and iridium. The circuit housing 610A can include a dielectric film, such as polyimide, to line the inner surface of the electrode housing 610 to provide additional electrical insulation for the circuit housed within the circuit housing 610A.

[0377] The proximal feedthrough 822 and the distal feedthrough 824 provide space through which a wire (conductive or non-conductive) can extend from inside the circuit housing 610A to outside the circuit housing 610A. The feedthrough 822 passes through the proximal portion 825 of the circuit housing 610A, for example, to provide a wire to the antenna 718 in the antenna housing 612 or other proximal destinations, such as outside the patient's body. The feedthrough 824 passes through the distal portion 827 of the circuit housing 610A to provide a wire to the distal portion of the corresponding electrode 604 or body portion 602, such as the distal end 606. Figure 8AThe circuit housing 610A is shown to include two near-side feedthroughs 822 (e.g., two feedthroughs through the near-side portion 825) and four far-side feedthroughs 824 (e.g., four feedthroughs through the far-side portion 827). The circuit housing 610A can be used in embodiments that include a wired connection between the antenna 718 and the circuit 716.

[0378] Figure 8B A perspective view illustrating another embodiment of the circuit housing 610B is shown. The circuit housing 610B includes a distal feedthrough 824 but no proximal feedthrough 822. Note that although the number of distal feedthroughs 824 is shown as four, in different embodiments the number of distal feedthroughs 824 can be any number, two or more. The number of distal feedthroughs 824 and proximal feedthroughs 822 can be limited by the outer diameter 823 of the circuit housing 610B and the diameter of the feedthroughs 824 / 822.

[0379] The circuit housing 610B can be used in embodiments where there is inductive (e.g., near-field) coupling between the circuit 716 and the antenna 718. The feedthrough 824 can be used for an electrical connection to the electrode 604, or a mechanical connection to a distal portion of the body portion 602, such as the distal end 606.

[0380] Figure 9A perspective view illustrating an embodiment of circuit housing 610A is provided, showing the internal circuitry 716. As shown, circuitry 716 includes an application-specific integrated circuit (ASIC) 928, a board 930, and discrete components (e.g., one or more inductors, capacitors, resistors, diodes, transistors, converters, oscillators, etc.). ASIC 928 may be designed as a system-on-a-chip (SoC) package. In one or more embodiments, the substrate for the SoC may be thinned to 625 micrometers or less (e.g., between about 50 micrometers and 250 micrometers, about 100 micrometers, between about 75 micrometers and about 125 micrometers, between about 100 micrometers and 300 micrometers, between about 50 micrometers and 625 micrometers, or other thicknesses within the provided range). ASIC 928 may be attached to board 930 (e.g., a printed circuit board (PCB)) for example, using flip-chip attachment. The material used for plate 930 may be a glass-reinforced epoxy laminate (e.g., FR4 material) comprising a composite material of woven fiberglass cloth and a flame-retardant epoxy resin adhesive, a composite material of aluminum nitride, polyimide, etc. The thickness of plate 930 may be less than 125 micrometers (e.g., between 50 and 100 micrometers, greater than 75 and less than 125 micrometers, greater than 100 and less than 125 micrometers, between 75 and 100 micrometers, between 100 and 120 micrometers, their overlapping range, or any value within said range), in one or more embodiments. Discrete component 932 may be a surface mount or other component.

[0381] Pad 934 can be used for electrical connection to a line fed through via via 824. Pad 936 can be used for electrical connection to a line fed through via 822. Connections to pads 934 / 936 can include wire bonding, electromagnetic wires, extensions of feed lines, flat striplines, and / or solder connections to a flexible substrate, etc.

[0382] Figure 5 The illustration illustrates an embodiment of a circuit 500 that can be housed in a circuit housing 610, which may include, for example, an ASIC 928, a board 930, or... Figure 9 Other components. The ASIC 928 can be a SoC integrating functions for wireless RF power harvesting, RF communication, digital control, and therapeutic delivery. The ASIC 928 can be manufactured using (complementary metal-oxide-semiconductor) CMOS technology, such as 0.18 micrometers or other processes.

[0383] Figure 10Example 1100 illustrates a graph of signal power versus time for a stimulation pulse from an implantable device 600, such as one created by circuitry 1000, which may include one or more components of circuitry 716. The stimulation waveform can be controlled using stimulation driver circuitry 556. The stimulation can be wirelessly programmed from an external power supply unit to vary the amplitude at discrete levels (e.g., 0-10 V in voltage-controlled cases, or 0-10 mA in current-controlled cases). Control of the stimulation waveform may include using a digital-to-analog converter (DAC) with stimulation driver circuitry 556.

[0384] The stimulation can be digitally programmed to change the pulse frequency (e.g., between approximately 0.1 Hz and 100,000 Hz, between 1 Hz and 1 kHz, between 0.1 Hz and 100 Hz, between 100 Hz and 1 kHz, between 500 Hz and 2 kHz, between 1 kHz and 10 kHz, between 5 kHz and 15 kHz, between 10 kHz and 20 kHz, between 1 kHz and 10 kHz, between 1 kHz and 15 kHz, between 50 kHz and 100 kHz). The stimulation can be monophasic or biphasic. Monophasic means that the stimulation current flows in only one direction. Biphasic signals flow in two directions (e.g., positive and negative pulses, which may be provided in a non-overlapping, partially overlapping, or substantially simultaneous manner). In one embodiment, the biphasic signals may be “charge-balanced” such that the net charge shift is practically zero (i.e., the magnitude of the positive signal is approximately the same as the amplitude of the negative signal). The stimulus shape can typically be rectangular, exponential, or other shapes. The stimulus waveform can be programmed to emit pulse trains (e.g., between 1 and 1000 pulses, between 1 and 100 pulses, between 50 and 200 pulses, between 10 and 500 pulses, between 100 and 400 pulses, between 250 and 750 pulses, between 500 and 1000 pulses, between 300 and 800 pulses, between 750 and 1000 pulses, their overlapping ranges, or any values ​​within said ranges). A pulse train can be followed by a period without pulses, another pulse train, etc. Figure 10As shown. In some embodiments, the time period between pulses varies between 1 ms and 1000 ms (e.g., between 1 ms and 100 ms, between 10 ms and 150 ms, between 50 ms and 500 ms, between 100 ms and 800 ms, between 150 ms and 450 ms, between 200 ms and 600 ms, between 250 ms and 1000 ms, between 400 ms and 800 ms, between 500 ms and 1000 ms, between 750 ms and 1000 ms, their overlapping ranges, or any value within said range). Of course, values ​​outside these ranges can also be used. In some embodiments, each pulse train may have a duration between 0.1 ms and 100 ms (e.g., between 0.1 ms and 1 ms, between 0.2 ms and 20 ms, between 0.1 ms and 10 ms, between 1 ms and 10 ms, between 5 ms and 50 ms, between 10 ms and 100 ms, between 10 ms and 50 ms, between 20 ms and 80 ms, between 30 ms and 60 ms, between 60 ms and 100 ms, their overlapping ranges, or any value within said ranges). Values ​​outside these ranges may also be used. In some embodiments, each pulse has a duration between 20 microseconds and 2000 microseconds (e.g., between 20 and 50 microseconds, between 20 and 200 microseconds, between 50 and 500 microseconds, between 100 and 1000 microseconds, between 500 and 2000 microseconds, between 1000 and 2000 microseconds, between 100 and 500 microseconds, their overlapping ranges, or any value within said range). Of course, values ​​outside these ranges can also be used. The stimulation driver circuit 556 can be programmed to cause the stimulation pulses to slope upwards (e.g., the pulses have an increased amplitude), such as in response to activation to a programmed amplitude. Upon deactivation of the stimulation, the amplitude of the stimulation driver circuit 556 can be programmed to cause the stimulation pulses to slope downwards (e.g., using pulses with a decreased amplitude) to zero. The stimulation pulses can be synchronized over time with various parameters, such as characteristics of stimulation waveforms from other wireless implants at other anatomical locations.

[0385] The stimulation driver circuit 556 can be programmed to cause the stimulation pulse to slope upward (e.g., the pulse has an increased amplitude), such as in response to activation to a programmed amplitude. Upon deactivation of the stimulation, the amplitude of the stimulation driver circuit 556 can be programmed to cause the stimulation pulse to slope downward (e.g., using a pulse with a decreased amplitude) to zero. The stimulation pulse can be synchronized over time with various parameters, such as the characteristics of stimulation waveforms from other wireless implants at other anatomical locations.

[0386] Figure 11A A perspective view illustrating the proximal portion of an embodiment of implantable device 1200A is shown. Device 1200A can be powered by signals received at antenna 718A housed within antenna housing 612. Antenna housing 612 may be located in the proximal portion of device 1200A. Antenna 718A may be connected to circuitry 716 via one or more feedthroughs 822. In one or more embodiments, antenna 718A may be a dielectric rod antenna, helically shaped, coiled, or otherwise shaped. Device 1200A includes circuitry housing 610A. In one or more embodiments, antenna 718A may be an asymmetric dipole antenna, such that circuitry housing 610A acts as part of the dipole. In one or more embodiments, the antenna may be a dielectric rod antenna.

[0387] Figure 11B A perspective view of the proximal portion of another embodiment of the implantable device 1200B is illustrated. Device 1200B is similar to device 1200A, wherein device 1200B includes a helical antenna 718B and a circuit housing 610B. The normal vector of antenna 718B may be substantially parallel to the magnetic field induced by antenna 718B. Antenna 718B may include a helically extending wave antenna whose normal vector is substantially parallel to the pointing vector of the incident wave. The antenna may also be an asymmetric dipole antenna, with the hermetically sealed enclosure as part of the dipole. As discussed above, the antenna may be a dielectric rod antenna.

[0388] In one or more embodiments, the antenna housing 612 may be soldered to the circuit housings 610A-B. In one or more embodiments, the antenna housing 612 may include epoxy resin, tecothane, or other RF transparent and protective materials. The antenna 718B may be coupled to the circuit housing 610B in the near field, for example, to help increase the amount of electromagnetic energy captured by the antenna 718C.

[0389] In one or more embodiments, the antenna housing 612 may comprise a ceramic material, such as zirconium oxide or alumina. Because the dielectric constant of zirconium oxide is closer to that of muscle, embodiments comprising zirconium oxide or other ceramic materials can help stabilize the impedance of the antenna 718 and reduce variations in that impedance when the antenna 718 is surrounded by different types of tissue. Using a ceramic housing increases power transmission efficiency when the antenna 718 is surrounded by tissue with a lower permittivity. In this case, the antenna 718 may form a single ceramic structure together with the feed element.

[0390] Without using a feedthrough to connect antenna 718, power can be transferred from an antenna outside circuit housing 610 to a structure inside circuit housing 610 (e.g., another antenna). Energy transfer can occur or be achieved inductively via a ceramic cap 1264. The ceramic cap 1264 can be used to seal one end of circuit housing 610B. In one or more embodiments, a ring-shaped or spiral structure can encapsulate the antenna housing 612 outside circuit housing 610B. Electromagnetic energy from outside the housing is transferred to antenna 718B, which in turn transfers energy to antenna 718C inside circuit housing 610B. In effect, antenna 718B acts as a relay for antenna 718C within circuit housing 610B. Antenna 718C within the package can be connected to circuit 716 (e.g., via pad 936).

[0391] Figure 11C A perspective view of the proximal portion of yet another embodiment of the implantable device 1200C is illustrated. Alternative antenna structures include the use of multiple antennas that are not physically connected to conductors. For example, a loop 718E can be used as a primary antenna. Loop 718E can be connected to circuit 716 (through feedthrough 832). One or more surrounding loops 718D can trap energy and transfer it to the primary antenna (loop 718E) via near-field coupling. Each smaller loop can operate below its self-resonant frequency when within tissue, compared to a single larger loop having the same total cross-sectional area as the sum of the smaller loops.

[0392] Figure 12A A perspective view illustrating an embodiment of the implantable device 1300A is shown, with its outer housing not visible to reveal the internal circuitry of the implantable device. Figure 12B Examples illustrate in Figure 12A An exploded view of the portion of the implantable device 1300A within the dashed box labeled "12B". In one or more embodiments, the antenna 718F may be housed within the circuit housing 610C. In such embodiments, the circuit housing 610C is made of an RF-transparent material such as zirconium oxide, alumina, or glass, or other ceramic materials instead of metal. The antenna 718F may be a helical antenna wound around the circuit 716. This configuration provides a more compact package compared to other embodiments.

[0393] exist Figure 12A and 12B In the illustrated embodiment, the quad feedthrough is located on both sides of the circuit housing 610C. Compared to other embodiments discussed previously, this configuration helps to allow for an increased number of electrodes (eight in this example, but other numbers of electrodes are also possible, such as 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, or more).

[0394] Figure 13A A perspective view illustrating an embodiment of an implantable device and an attachable fork tooth system 1400A. Figure 13B Examples Figure 13A A perspective view of an embodiment of the implantable device and the proximal portion of the attachable fork tooth system 1400B. Figure 13C A perspective view illustrating an embodiment of an implantable device 1400C with forked teeth attached is provided. The forked teeth 614 can be used for fixation of the implantable device, for example, by grasping tissue. The growth of fibrous tissue adjuncts can provide additional long-term fixation, for example, to help prevent implant movement. However, in some cases, fixation with the forked teeth 614 is not useful, for example, for temporary implants used in a trial phase. The trial phase can determine whether the patient has an appropriate treatment response. In one or more embodiments, the forked teeth 614 cannot be attached to the implant during the trial phase, for example, to allow the device to be more easily removed from the patient. After the trial phase, which has demonstrated an appropriate treatment response, is completed, the forked teeth 614 can be added to the device, for example, in… Figures 13A-13C As shown in the image.

[0395] System 1400A-B may include an attachment structure 1468 attached to or integrally formed with antenna housing 612. The attachment structure 1468 may be located at the proximal end of antenna housing 612. A fork-tooth portion 614 may be part of a structure including a cap 1470, which is adapted to the attachment structure 1468 and / or antenna housing 612. The cap 1470 may be mounted on structure 1468, and the fork-tooth structure may be slidable onto an implantable device, such as... Figure 13B and 13C As shown in the image.

[0396] A non-circular structure 1466 at the proximal end of the fork tooth structure helps lock the fork tooth 614 in place on the implantable device. Structure 1468 allows the fork tooth to be attached to the implantable device, for example, when the device is placed over a target anatomical structure. The engagement of structure 1468 and cap 1470 helps make the fork tooth 614 more difficult to rotate (e.g., about the longitudinal axis of the implantable device 600). According to several embodiments, advantageously, this restricted movement helps to hold the fork tooth 614 in place.

[0397] Figure 14A A perspective view illustrating an embodiment of a system 1500A for attaching the fork tooth 614 to an implantable device is provided. Figure 14B Examples Figure 14A A perspective view of the system, in which the fork 614 is pushed closer to the circuit housing 610. Figure 14C Examples Figure 14BA perspective view of the system, in which the fork 614 is attached to the circuit housing 610.

[0398] For example, by using a suture 1476 that extends at least to the surface of an anatomical structure (e.g., may extend outside the patient's body), the fork portion 614 can be guided to the proximal portion of the implantable device 600. The cap 1470 may have an opening therethrough, allowing the fork portion 614 to be fitted around the suture 1476. Using a hollow pusher 1472 with a suture 1476 passing through it, the fork portion 614 can be pushed into place by tissue and attached to an implant, such as... Figures 14A-14C As shown. The suture 1476 can be kept taut. The fork 614 and push rod 1472 can be inserted while the suture 1476 is kept taut. The suture 1476 provides guidance to the implantable device 600 and also provides tension on which the fork 614 can attach.

[0399] Figure 15A A perspective view illustrating an embodiment of a system 1600B for securing the fork tooth 614 to an implantable device. Figure 15B Examples illustrate the relationship with Figure 15A An exploded view of an embodiment corresponding to the area marked "15B" in the dashed box. The attachment structure 1466 may include a non-circular symmetrical shape (cube or hexagon, or other polygon) or an asymmetrical shape. The attachment structure 1466 may be molded at the proximal end of the implantable device 600. A push rod 1478 (e.g., may include a mating socket-type device) may be used to rotate the structure including the fork tooth portion 614. Rotating the push rod 1478 while attached to the structure 1466 may lock the fork tooth portion 614 into place, for example, to help ensure that the implantable device 600 does not move after implantation. The push rod 1478 may include a hole 1484 passing through it. A suture 1476 (e.g., a suture attached to the implanted device) may pass through the hole 1484 to guide the push rod 1478 to the attachment structure 1466. Such embodiments may facilitate control of the depth, angle, rotation, and / or bending direction of the electrode array of the implant during placement.

[0400] Figure 15C A perspective view illustrating an embodiment of a system 1600C for manipulating an implantable device 600 is provided. The implantable device 600 includes a suture 1476 attached thereto. The suture 1476 can pass through a hole 1484. The suture 1476 can guide a push rod 1478 to the implantable device 600, for example, by using an attachment structure 1466 to accommodate a polygonal attachment mechanism disposed at the end of the push rod.

[0401] Figure 15DAn exploded view illustrating an embodiment of system 1600D, which is part of system 1600C. Attachment structure 1485 is configured to mate with attachment structure 1466. (Figure) Figure 15E An exploded view of system 1600E, which includes push rod 1478 on suture 1476, is shown as an example.

[0402] The push rod 1478 provides the ability to manipulate an implant (e.g., implantable device 600) by applying torque in a desired direction. For example, if the implant or cannula is not in the correct position, this allows a person to pull the implant away from the body and out of the cannula (e.g., away from the cannula or the patient). When the implant is in the correct position, a mechanism can be used to release the implant, such as a button coupled to a support that, when pressed, releases the support and allows the push rod 1478 to be released from the implant, similar to a connector driver. In one or more embodiments, the push rod 1478 can be used as a microwave waveguide to transfer energy to the implant, for example, it can be used to test the implant's positioning by activating it.

[0403] The implantable device can be located within a cannula. A push rod 1478 can be attached to an attachment structure 1466. The push rod 1478 may include a drill hole 1482 extending laterally through its distal portion. The push rod 1478 can then be pressed into the cannula (into the patient's body), and when the implantable device has been driven to the desired depth, an insertion handle 1480 can be positioned through the laterally extending drill hole 1482, and the push rod 1478 can be rotated to orient the implantable device in the desired direction.

[0404] Figure 15F A perspective view illustrating an embodiment of a system 1600F for disengaging push rod 1478 from implantable device 600 is shown. A second push rod 1467 is insertable into a hole 1484 (e.g., along suture 1476). The second push rod 1467 may contact implantable device 600, for example, at attachment structure 1466. In one or more embodiments, the second push rod 1467 may be held in place when the first push rod 1478 is retracted to disengage push rod 1478 from implantable device 600. In one or more embodiments, the second push rod 1467 may be made of metal, such as a shape memory metal material (e.g., nitinol) or other metals or metal alloys.

[0405] Figure 16AAn illustration of an embodiment of a suture fastening system 1000A is provided. As shown, system 1000A includes a push rod comprising a hollow rod portion 1479, a handle 1481, a brake portion 1483, a female mating structure 1485, a male mating structure 1487, and a suture 1476. The push rod can be used as described with respect to push rod 1478. In one or more embodiments, the male mating structure 1487 may be a male Luer cap. In one or more embodiments, the female mating structure 1485 may include a female Luer thread. When structure 1487 is coupled to structure 1485 (e.g., screwed onto structure 1485), the tapered opening 1493 of structure 1487 applies pressure to the mating tapered structure 1495, for example, to compress the tapered structure 1495 and apply mechanical pressure to the suture, thereby mechanically fastening the suture 1476 to the push rod, for example, to fix the push rod in a specific position.

[0406] Figure 16B A schematic diagram illustrating an embodiment of system 1000B is provided, the system including a male mating structure 1487 (in) attached to a female mating structure 1485. Figure 16B In the middle, most of the mating structure 1485 is blocked. Figure 16B The center seam 1476 is fixed to the push rod.

[0407] Figure 17A Figures 17B and 17C illustrate perspective views of embodiments of systems 1700A, 1700B, and 1700C for deploying the fork portion 614 of an implantable device. During the trial phase, a cap 1486 may surround the fork portion 614 to hold them in the undeployed position. The cap 1486 may include an RF-transparent material, for example, to help prevent interference with other signals supplying power to the implant or to the antenna of the implantable device. The cap 1486 may be attached to a suture 1476, for example, to allow the fork portion 614 to be easily deployed by pulling the suture 1476. The cap 1486 can be retrieved through tissue, for example, by using the suture 1476 as a guide. Alternatively, the cap 1486 may be made of a bioabsorbable material, such that the cap 1486 can remain in the body and will degrade over time, eventually exposing the fork portion 614.

[0408] Figure 18A perspective view illustrating an embodiment of a fork-tooth unfolding system 1800 attached to the proximal portion of an implantable device is provided. The implantable device may be connected to multiple sutures 1488 and 1490. One suture 1490 may be used to remove the implantable device, and one suture 1488 may be used to unfold the fork-tooth portion 614. Sutures 1488 and 1490 may be arranged concentrically or side-by-side. In one or more embodiments, only one suture 1488 or 1490 is used. If the patient is known not to require removal of the device, the embodiment may include only suture 1488. If the fork-tooth portion does not need to be unfolded or has already been unfolded, the embodiment may include only suture 1490. Suture 1490 may be pulled to remove the implantable device 600 from the body.

[0409] Figure 19 Examples Figure 18 A perspective view of an embodiment of the suture and forked tooth unfolding system 1800, wherein the suture 1488 has a radiopaque marker 1492. The suture 1488 may also include the radiopaque marker 1492. This allows the suture 1488 to be visible during fluorescence examination, enabling the suture 1488 to be located below the skin surface after implantation. Tools can be used to hook onto the subcutaneous suture 1488, for example, this can be done using imaging guidance. In the event that the suture 1488 has broken, the radiopaque marker 1492 can help guide the physician to grasp the proximal end of the implant and / or indicate to the physician the location of the broken suture and that the suture 1488 has been broken.

[0410] Figure 20 A perspective view illustrating an embodiment of a system 2000 including sutures attached to the proximal portion of an implantable device is provided. The suture 1490 may be attached to the implant at one or more locations, such as the proximal end of the implantable device 600, the circuit housing 610, the antenna housing 612, or another location of the implantable device 600. Multiple connection points can help reinforce this connection. Multiple connection points can also help manipulate the proximal portion of the implant during removal of the implantable device.

[0411] Figure 21 A perspective view illustrating an embodiment of multiple sutures 1490 attached to the proximal portion of an implantable device is shown. The multiple sutures 1490 can be attached, for example, around the periphery of the proximal end of the implantable device. These multiple sutures can be used to assist in manipulating the implantable device during removal.

[0412] Figure 22A A perspective view illustrating an embodiment of a system 2200A including a suture 2292 and a proximal portion of an implantable device is provided. Figure 22B An example illustrates that suture 2292 is attached to Figure 22A A perspective view of an embodiment of an implantable device. Figure 22CAn example perspective view of an embodiment of system 2200C is shown, which includes suture 2292 and a proximal portion of an implantable device, wherein the suture is attached to the implantable device. Figure 22D A perspective view illustrating an embodiment of the suture 2292 and the fork-tooth unfolding mechanism is shown, with the fork-tooth portion 614 unfolded. The suture 2292 can be attached to the implantable device at multiple locations, for example, to reinforce the aforementioned connection and to facilitate manipulation of the proximal end of the implantable device during removal. For removal, the suture 2292 can be attached to a lever, for example, at or near the skin surface, which can be pulled out through the distal end of the dilator. By pulling the lever while pushing the dilator, a channel to the implantable device can be created. This channel can be used for removal of the implantable device.

[0413] Figure 23A A perspective view illustrating an embodiment of system 2300A is provided, which includes a lever 2396 attached to a gripping mechanism. Figure 23B A perspective view illustrating an embodiment of the gripping mechanism 2394 in the open position is shown. Figure 23C A perspective view illustrating an embodiment of the gripping mechanism 2394 in the closed position is shown. If the proximal end of suture 1488 is subcutaneous, the grasping mechanism 2394 can be used to grasp the proximal end of suture 1488, effectively elongating suture 1488 percutaneously. This extension can then be fed through an expander, for example, to position the expander relative to the implantable device. In cases where pulling the suture is insufficient to remove the implantable device, or in cases of chronic implantation where the suture may no longer be feasible, a mechanical instrument can be used to remove the implantable device. The mechanical rod 2396 is shaped as a grasping instrument (see...). Figure 23A The device can be inserted into a cannula. At the distal end of the instrument, a gripping mechanism 2394 extends from the rod 2396 and clamps the proximal end of the implantable device or suture 1488. The gripping mechanism 2394 may be spring-loaded, for example, having a high leverage ratio to provide sufficient friction between the claws 2398 of the gripping mechanism 2394 and the implantable device or suture, allowing the physician to apply sufficient pulling force to remove the implantable device. Alternatively, the gripping mechanism 2394 may include a ratchet-based retention mechanism, such as a mechanism similar to that of a mechanical pencil.

[0414] Figure 24A A perspective view illustrating an embodiment of a molding system 2400A for molding an implantable device 2402 is provided. Figure 24BA perspective view illustrating an embodiment of system 2400B, including system 2400A in operation, is shown. Considering implantable device 600, electrodes 604 can be bent relative to each other to extend along a target nerve or other anatomical structure. In one or more embodiments, such bending of implantable device 600 can be achieved using a bent probe that passes through a lead in the body of implantable device 600. The bent probe can allow a physician to orient the ends of the electrode array to the correct location and / or orientation.

[0415] For the wireless, leadless implantable device 2402, an alternative technology is shown here. A pre-formed, flexible memory filament 2404 (e.g., nitinol or other memory metals) can be integrated into the implantable device 2402, such as... Figure 24B As shown. The curvature of the wire 2404 can be predetermined to be ideal relative to a specific anatomical target. Although the implantable device 2402 is curved, it can be easily straightened to fit for implantation through a straight cannula. When the implantable device exits the cannula or other delivery device at the target anatomical site, the natural bias of the implantable device 2402 provided by the memory wire 2404 causes the implantable device to bend. A push rod (e.g., push rod 1478) temporarily attached to the implantable device can help allow the physician to guide the implantable device 2402 to the correct position with the correct curvature orientation. In one or more embodiments, the bend or kink in the implantable device can be created by molding (e.g., reflowing) the implantable device into a specific shape.

[0416] Figure 25A This is a perspective view illustrating an embodiment of a probe 2506 in an internal catheter of an implantable device or implant 2500A. It is not, for example, about... Figures 24A-24B The discussed use of memory wire 2404 within a channel inside the implantable device to provide appropriate bending for the target anatomical structure, allows probe 2506 to be inserted into a continuous channel extending through the implantable device to the distal end 606. Alternatively, probe 2506 can be bent around the circuit housing 610, as... Figure 25BAs shown, a channel may be included in the implantable device 600, allowing the probe 2506 to bend around the circuitry 716 in the circuitry housing 610. Alternatively, the hermetic package may include a channel that allows the probe 2506 to pass through or around the channel of the circuitry 716. The physician can then control the electrode array in a manner similar to a lead-type electrode array. The probe 2506 can be positioned using push rods and cannulas or by placing the probe 2506 in the implantable device prior to implantation. In addition to using the memory wire 2404, the implantable device 600 can be shaped by molding (e.g., reflowing), for example by using a mold.

[0417] Figure 26A A perspective view illustrating an embodiment of a system 2600A for guiding an implantable device is provided. Figure 26B Examples include Figure 26A A perspective view of an embodiment of System 2600A and System 2600B, some portions of which are transparent to show the probes within the implantable device. Figure 26C Examples Figure 26A and 26B An exploded view of an embodiment of the system's operating mechanism 2600C. Figure 26A A manipulable electrode 604 on a wireless implantable device is shown, comprising two probes 2508 and 2510 on opposite sides of the electrode 604. Probes 2508 and 2510 can be at least partially inserted into corresponding channels 2514. Channels 2514 can partially or completely surround probes 2510 and 2508 therein, for example, to at least partially surround probes 2510 and 2508 within the structure of electrode 604. Channels 2514 can extend approximately to the distal end (distal end 606) of the implantable device. Applying a force to one of probes 2508 and 2510 and a smaller force to the other probe 2508 and 2510 manipulates the distal end 606 of the implantable device. For example, due to the increased length of probe 2508 in the associated channel 2514, applying a force toward the distal end to the left probe 2508 causes the end of the electrode array to bend to the right.

[0418] Probes 2508 and 2510 can be temporarily attached to the distal end 2512. By applying sufficient force to probes 2508 / 2510, probes 2508 / 2510 can be removed from the temporary attachment and from the body. In another embodiment, the manipulator 2600C can be used as a test electrode or a test electrode array. If this electrode array remains in the patient's body, the length of the dual probes not in contact with electrode 604 can be cut using a trimmer. In one or more embodiments, the manipulator 2600C can be made of a biodegradable material such that the patient's body decomposes the manipulator when it is in place. In one or more embodiments, electrode 604 and dual probes 2508 and 2510 are inserted into the patient's body through a cannula. In this case, the cannula can be made of two concentric materials. The inner concentric materials can be twisted or manipulated to cut off the extensions of the dual probes without the need for inserting another tool.

[0419] Figure 27A An exploded view of an embodiment of the distal portion of system 2700A is illustrated, the system including an implantable device 600 and a guide mechanism 2716 that provides bending to the implantable device 600. Figure 27B An exploded view illustrating an embodiment of the distal portion of system 2700B is provided, the system including sleeve 2718, within which is disposed... Figure 27A The guide mechanism 2716, including a steering wedge, can be used to guide the orientation of the implantable device 600. The guide mechanism 2716 may include a bend that matches the profile of the implantable device 600. A push rod can be used to advance the implantable device along the guide mechanism 2716. When the implantable device 600 is pushed to the end of the guide mechanism, the bend (e.g., wedge) of the guide mechanism 2716 steers the implantable device 600 toward the bend's orientation. The bend of the guide mechanism 2716 can be configured such that when the implantable device 600 is pushed past the bend, the resulting bend of the implantable device matches the bend of the target anatomical structure.

[0420] As the implantable device 600 advances along its curved end, the curvature at the end of the guide mechanism 2716 forces the implantable device 600 to bend at the same curvature as the guide mechanism 2716. For example, the guide mechanism 2716 can be positioned near a target anatomical structure using a cannula 2718, which may benefit from better stimulation or improved electrode impedance to the target anatomical structure. The guide mechanism 2716 can be configured to be fitted together with the implantable device 600 within the cannula 2718. The guide mechanism 2716 may include markings (e.g., radiopaque markings or other markings) to indicate the location of the curved end of the guide mechanism 2716. This marking can be used to determine whether the curved end is positioned outside the end of the cannula 2718 and / or whether the guide mechanism 2716 is correctly positioned within the cannula 2718 or the target anatomical structure.

[0421] Figure 28 A perspective view illustrating an embodiment of a system 2800 for placing an implantable device 110 within a target anatomical structure. Figure 28 The target anatomical structure shown is the S3 port 2820. An implantable device 600 can be injected into the target anatomical structure 2820 using a cannula 2718. The size of the implantable device 600 can be configured for delivery via the cannula 2718. In one or more embodiments, the size range of the cannula 2718 can be from 4F to 10F (e.g., from 4F to 7F, from 5F to 9F, from 6F to 10F, 4F to 6F, from 8F to 10F, their overlapping ranges, or any value within the listed range). Figure 28 In this example, the implantable device 600 can be injected through the third sacral foramen (i.e., the S3 foramen) into a location near the sacral nerve, for example, to help treat incontinence, urinary urgency, fecal incontinence, constipation, and / or pelvic pain. Alternatively, for example, the implantable device 600 can be injected through the soft tissue surrounding the spinal cord into the dorsal root ganglion or peripheral nerves to treat pain, or it can be injected through a foramen in the skull for deep brain stimulation.

[0422] Figure 29A perspective view illustrating an embodiment of system 2900 is provided, including a cannula 2718 and a dilator 2922 for placement of the implantable device 600 within the body. In one or more embodiments, initial access to the target nerve may be made using a hollow needle (not shown in the figure), for example, under imaging guidance (e.g., fluoroscopy, ultrasound, etc.). The needle may include radiopaque markers to aid in localization. A physician can transmit an electrical current through the needle to test for appropriate physiological responses and help ensure the needle is in the correct position. After proper needle placement is established, a guidewire can be inserted through the needle to the distal end of the needle. The needle can then be retracted while the guidewire is held in place. Next, the hollow dilator 2922 is placed inside the cannula 2718. The cannula 2718 and dilator 2922 can then be combined and placed on the guidewire to form an expanded channel to the target anatomical structure. The dilator 2922 and guidewire can then be removed. The remaining cannula 2718 forms a channel for accessing the target anatomical structure through which the implantable device 600 can be placed, oriented, or otherwise positioned.

[0423] Figure 30 A perspective view illustrating an embodiment of another system 3000 for placing an implantable device 600 within the body is provided. A pusher 3024 can be used to push the implantable device 600 through a cannula 2718 to a target anatomical structure. The pusher 3024 may be hollow, for example, to allow sutures attached to the implantable device to pass through it. The proximal end of the suture may be held above the patient's skin surface. The implantable device 600 is placed in the cannula 2718 and its proximal end may be connected to the pusher 3024. In one or more embodiments, the pusher 3024 includes a socket-type actuation mechanism as described above. Force is applied to the proximal end of the pusher 3024 to guide the implantable device 600 to an anatomical position. The pusher 3024 can then be used to hold the implantable device 600 in the set position while the physician pulls the cannula 2718 to remove it. In one or more embodiments, this action deploys a fork 614, which unfolds upon exposure. The push rod 3024 can be removed, leaving the implantable device 600 in place. The resistance to movement provided by the fork 614 is sufficient to separate the implantable device from the push rod, or a release mechanism, such as a button and support or a button and connector device, can be used to release the push rod 3024 from the implantable device 600. In some embodiments, a second push rod can be inserted into the push rod 3024, for example, to separate the implantable device 600 from the push rod 3024 (see, for example, see...). Figure 15F ).

[0424] exist Figure 31A The various parts of this process are illustrated in 31B, 31C, and 31D. Figure 31A In System 3100A, Figure 31AThe push rod 1478 and the suture 1488 attached to the proximal end of the implantable device 600 are shown. Figure 31B System 3100B shows a pusher 1478 on a suture 1488 and attached to an attachment structure 1466 on the proximal end of an implantable device 600, and a cannula 2718. Figure 31C System 3100C shows an implantable device within cannula 2718. Figure 31D System 3100D illustrates an implantable device 600 distal to a cannula 2718. The distal end of the cannula 2718 can be pressed toward the center of the implantable device 600, and the forked portion can be released to a fully extended position after exiting the cannula 2718. The suture 1488 may include translucent markings 1492 thereon. The implantable device 600 is shown in a pre-bent position, and may include, for example, the use of memory wire.

[0425] Figure 32A A perspective view illustrating an embodiment of system 3200A is provided, wherein system 3200A is positioned at a target anatomical structure (e.g., S3 port 2820 in this example). System 3200A includes an implantable device 600 partially located outside cannula 2718 and partially passing through S3 port 2820. Push rod 1478 is at least partially located within cannula 2718 and suture 1488 extends out of the patient's body. System 3200A includes an implantable device 600 partially located outside cannula 2718 and partially passing through S3 port 2820. Push rod 1478 is at least partially located within cannula 2718 and suture 1488 extends out of the patient's body. Figure 32B A perspective view illustrating an embodiment of system 3200B is provided. System 3200B includes system 3200A positioned at a target anatomical structure, with cannula 2718 and push rod 1478 removed. Suture 1488 is shown extending beyond the surface of the patient's skin 3226.

[0426] Figure 32C An exploded view of the proximal portion of the item within the dashed box labeled "32C" in Figure 32 is illustrated. The proximal portion 3200C includes a retaining device 3228 that passes through a loop on the suture 1488. The retaining device 3228 helps ensure that the suture 1488 is at least partially held outside the patient's body. This configuration helps ensure easy access to the suture 1488 when removing the implantable device 600 from the patient.

[0427] The implantable devices discussed herein can be powered using mid-field power supply techniques, such as those discussed regarding source 102 and elsewhere herein. The mid-field power supply techniques discussed herein can provide efficient power delivery to the implantable device, for example, if the implantable device is located at visceral depth. Mid-field power supply techniques can provide the ability to manipulate or focus power signals.

[0428] Figure 33A A perspective view illustrating an embodiment of the implantable device removal system 3300A is provided. As shown, the system 3300A includes a needle 3332 through which an extension suture 3330 passes. The extension suture 3330 may extend at the distal end of the needle 3332 and may connect to a suture 1488 attached to the implantable device 600.

[0429] The extension suture 3330 can be tied to or otherwise connected to the suture 1488 attached to the implantable device 600. This system can help remove the implantable device 600 from the patient's body if the retaining device 3228 is missing or the suture 1488 is completely inside the patient's body. Figure 33B An exploded view illustrating an embodiment of interlaced sutures used to assist in the removal of an implantable device is shown. The figure illustrates interlaced or otherwise connected sutures 3330 and 1488. Figure 33C Examples Figure 33B An exploded view of an embodiment of the system, wherein needle 3332 is located on interlaced sutures. Needle 3332 can be guided by suture 1488 to implantable device 600.

[0430] Figure 34A Perspective views 34B, 34C, and 34D illustrate embodiments of implantable device removal systems 3400A, 3400B, 3400C, and 3400D, respectively. System 3400A is similar to system 3300C, wherein a needle 3332 is inserted through the skin into the implantable device 600. The proximal end of suture 1488 is connected to an extension suture 3330. Figures 33A-33C In one embodiment, the extension suture 3330 is pre-passed through the needle 3332. However, after the extension suture 3330 is coupled to the suture 1488, the needle 3332 can extend over the extension suture 3330.

[0431] After sutures 3330 and 1488 are securely connected, the doctor (or other operator) can pull on the connected sutures until they are taut. The needle 3332 can then be inserted while suture 1488 remains taut. Suture 1488 serves as a guide to the implantable device 600. Figure 34A An example is shown after the process is completed.

[0432] Needle 3332 can be removed and replaced with expander 3334, for example. Figure 34B As shown. The expander 3334 can be placed on the needle 3332, then the needle 3332 can be removed and the expander 3334 can be placed through the skin, for example while keeping the suture 1488 taut (e.g., using...). Figures 16A-16B(One or more structures under discussion, manual pressure, etc.). Needle 3332 includes an outer diameter smaller than the inner diameter of expander 3334.

[0433] A larger expander can be used to expand the tissue until the cannula 2718, with an inner diameter greater than the maximum diameter of the implantable device 600, can be inserted into the patient. In some embodiments that include a fork-tooth portion 614, the fork-tooth portion 614 is the portion of the implantable device 600 with the maximum diameter. In such embodiments, the inner diameter of the cannula 2718 and / or the expander 3334 should be greater than the effective diameter of the fork-tooth portion 614. Figure 34C A cannula 2718 and / or dilator 3334 are shown on a portion of the implantable device 600 and suture 1488.

[0434] The cannula 2718 can be held in place, for example, to help ensure that the cannula 2718 does not retract. Tension can be applied to sutures 3330 and / or 1488 to allow the implantable device 600 to be removed from the body through the cannula 2718. Figure 34D The implantable device 600 is shown located within the cannula 2718 when it is removed from the body. The cannula 2718 can then be removed from the body.

[0435] Figure 35A and 35B Exploded views of embodiments of other implantable device removal systems 3500A and 3500B are illustrated respectively. Similarly, if the retaining device 3228 has been removed and / or the suture has been retracted into the body, fluorescein guidance can be used to locate the suture 1488 (using radiopaque markings on the suture 1488). These radiopaque markings can help personnel locate the suture 1488 within the body. Figure 35A As shown, a needle 3332 (e.g., under fluorescein guidance) can be used to create an opening leading to suture 1488. This opening is... Figure 35B The dotted line 3538 indicates the thread 1488. A mechanical gripper 3536 can be configured into the hole formed by the needle 3332. The gripper 3536 can mechanically grip the thread 1488 and is used to pull the thread 1488 out of the body. A process, for example, similar to... Figures 33A-33C and Figures 34A-34D The discussion process can be used to remove the implantable device 600 (with or without the extension suture 3330).

[0436] B. Implantable stimulation device including a hollow cavity According to several embodiments, the implantable stimulation device includes a cavity (e.g., a hollow tubular element, such as including a channel therethrough) into which a probe or other guiding device can be inserted. In one or more embodiments, the cavity may be used to help position the device at a designated or desired site and / or to help assemble a portion of the device.

[0437] One or more embodiments may include a hollow cavity that extends substantially along the entire length of the implantable device, for example, from the proximal end of the device to or near the distal end of the device. The hollow cavity can aid in the fabrication of the implantable device. Alternatively or additionally, the hollow cavity can aid in positioning the implantable device at a specific site near tissue or otherwise within a patient. The hollow cavity may include an opening therein that is large enough to allow a probe to be placed therein.

[0438] Implantable devices may be difficult to place correctly. It may be difficult to maneuver an implantable device to the desired location within the body.

[0439] Adding a central cavity that extends almost entirely or completely through the inner surface of the device, for example, reaching the distal end of the outer casing, can help solve the problem of pushing the device into place and can also provide a device without any leads. This implantable device configuration allows probes to be inserted into the device to the distal end and allows for accurate placement of the implantable device without guides. With this central cavity, a sheath and / or push rod used to help guide the device may not be necessary.

[0440] Furthermore, the hollow cavity can assist in the manufacture of the device. Using the hollow cavity, the far-end feed conductor can be connected to the circuit components once the cavity is brazed in place. Using the hollow cavity, the circuit housing and / or antenna housing can be positioned above the far-side feed flange and / or near-side flange of the hollow cavity. The near-side feed conductor can be attached to the device's circuitry with excess conductor length. This excess conductor length can be used as a service loop within the device components. The hollow cavity can also serve as a fixing device that helps position the circuit housing and / or antenna housing in their final positions for brazing and / or soldering.

[0441] Figure 36 An example of an embodiment of at least partially implantable biocompatible device 3600 is illustrated. The illustrated device 3600 includes an outer housing 3602, electrodes 3604A, 3604B, 3604C, and 3604D, and cavity portions 3606A and 3606B (in some embodiments, also including a cavity aperture 3832A (see [link to relevant documentation]). Figure 38 The hollow cavity of the antenna, circuit 3608, circuit housing 3616, far-side feed holes 3612A and 3612B, near-side feed holes 3614A and 3614B, antenna housing 3618, antenna 3610, feed plates 3620 and 3624, and end plate 3622.

[0442] The far-side feedthroughs 3612A-B can be similar to feedthrough 824. The near-side feedthroughs 3614A-B can be similar to feedthrough 822. Circuit 3608 may include, for example, in... Figure 5 One or more of the components shown. Circuit 3608 may be similar to the components in circuit housing 610A, such as... Figure 9 As shown. Antenna 3610 may be similar to antennas 718A-E or other antennas discussed with respect to implantable device 110, such as antenna 108. Outer housing 3602 may be similar to body portion 602. Electrodes 3604A-D may be similar to electrodes E0-E3. Circuit housing 3616 may be similar to circuit housings 610A-B. Antenna housing 3630 may be similar to antenna housing 612.

[0443] The plurality of electrodes 3604A, 3604B, 3604C, and 3604D (e.g., ring electrodes) are exposed on the outer casing 3602. Conductors connecting electrodes 3604A-D to circuit 3608 and some distal feedthroughs are located in... Figure 36 The outer casing 3602 may include a dielectric material, such as silicone or thermoplastic elastomer. (Not shown in the image so as not to obstruct the view.)

[0444] Hollow cavity portion 3606B extends from the proximal end 3626 of device 3600 to the proximal side of feedthrough plate 3624. Hollow cavity portion 3606A extends from the distal side of feedthrough plate 3624 to the distal end 3628 of device 3600. In one or more embodiments, hollow cavity portions 3606A-B are combined to form a hollow cavity extending from the proximal end of device 3600 to the distal end 3628 of device 3600.

[0445] In one or more embodiments, the hollow cavity portion 3606A may be attached to the electrode components of the device (e.g., the outer housing 3602, electrodes 3604A-D thereon, and conductors attached to the electrodes). In one or more other embodiments, the hollow cavity portion 3606A may be disposed within the outer housing 3602 but not attached to it. In such embodiments, the hollow cavity portion 3606A may be attached to the feedthrough plate 3624. In one or more embodiments, the hollow cavity portion 3606A may be made of a flexible material, such as shape memory metal, such as MP35N, nitinol, or other shape memory metals. In one or more other embodiments, the hollow cavity portion 3606A may be made of a thermoplastic, such as Tecothane® material. In embodiments where the outer housing 3602 is made of a flexible material, using a flexible material to form the hollow cavity portion 3606A allows the outer housing 3602 to remain flexible. This flexibility helps provide flexibility in the positioning and shaping of the implantable device 3600. The hollow cavity portion 3606B may be attached to one or more of the feedthrough plates 3620 and / or 3624 and / or end plates 3622. In one or more embodiments, the hollow cavity portion 3606B may be made of an airtight material, such as metallized ceramic, glass, quartz, sapphire, platinum, platinum-iridium, shape memory metals, combinations thereof, etc. In one or more embodiments, the hollow cavity portion 3606B may be made of a rigid (non-flexible) material.

[0446] The circuit 3608 shown in the figure includes a flexible circuit; however, the circuit 3608 may also include a rigid circuit, for example, similar to... Figure 9 As shown in the diagram, circuit 3608 provides energy harvesting, power management, and / or stimulation signaling capabilities, such as providing stimulation to tissue via electrodes 3604A-D. Circuit 3608 is electrically connected to antenna 3610, for example, via conductors in proximal feedthroughs 3614A-B. Antenna 3610 may include a dipole antenna, loop antenna, coil antenna, slot or strip antenna, or other antennas. The shape and size of antenna 3610 may be configured to receive signals in the range of approximately 400 MHz and approximately 3 GHz (e.g., between 400 MHz and 1 GHz, 500 MHz and 2 GHz, 1 GHz and 3 GHz, 500 MHz and 1.5 GHz, 1 GHz and 2 GHz, 2 GHz and 3 GHz, their overlapping ranges, or any value within the listed ranges).

[0447] Circuit 3608 is electrically connected to electrodes 3604A-D via conductors in distal feedthroughs 3612A-B. Circuit 3608 is encapsulated in circuit housing 3616. In one or more embodiments, circuit housing 3616 is separate from outer housing 3602. In such embodiments, circuit housing 3616 and outer housing 3602 may be attached to feedthrough plate 3624 respectively. In one or more embodiments, circuit housing 3616 may be directly attached to outer housing 3602, for example, without feedthrough plate 3624. In such embodiments, distal feedthroughs 3612A-B may be part of outer housing 3602 and / or circuit housing 3616, such as in embodiments where outer housing 3602 or circuit housing 3616 includes feedthrough plate 3624 as an integral part thereof. Circuit housing 3616 may be made of titanium, ceramic, or other biocompatible and / or hermetic materials.

[0448] Antenna 3610 is housed within antenna housing 3618. In one or more embodiments, antenna housing 3618 is separate from circuit housing 3616 and outer casing 3602. In such embodiments, antenna housing 3618 can be attached to circuit housing 3616 by attaching antenna housing 3618 and circuit housing 3616 to feedpass plate 3620, for example by soldering and / or brazing antenna housing 3618 and / or circuit housing 3616 to feedpass plate 3620. The antenna housing 3618 is positioned closer to the proximal side than circuit housing 3616, for example, antenna 3610 is positioned closer to the proximal side than circuit 3608. Plate 3622 provides an hermetically sealed seal between antenna housing 3618 and the external environment.

[0449] Figure 37 A perspective view illustrating another embodiment of the implantable device 3700 is provided. The implantable device 3700 is similar to device 3600, wherein device 3700 includes an antenna 3610 package 3630, but does not include an antenna housing 3618 or a plate 3622. Figure 37 The hollow cavity portion 3606B shown extends beyond the proximal end 3626 of the device 3700. For example... Figure 36 As shown, the hollow cavity portion 3606B extends to the proximal end 3626 of the device 3600. In one or more other embodiments, the hollow cavity portion 3606B may extend from or near the distal end 3628 (inside the outer casing 3602) to the vicinity of the proximal end 3626, but not to the proximal end 3626. In such embodiments, the end plate 3622 or the package 3630 may include an opening that provides access to the hollow cavity.

[0450] Figure 38A perspective view illustrating an embodiment of a feedthrough plate 3620 is provided. The feedthrough plate 3620 shown includes a plurality of distal feedthroughs 3612A-D. The feedthroughs 3612A-D provide pathways for conductors through the feedthrough plate 3620, for example, simultaneously providing a hermetically sealed environment or otherwise protecting the conductors therein. The conductors in the distal feedthroughs 3612A-D are each coupled to electrodes 3604A-D and circuitry 3608, for example, to pads in pad 934. Although four distal feedthroughs 3612A-D are shown in the feedthrough plate 3620, any number of distal feedthroughs can be present; for example, a single distal feedthrough for each electrode on an implantable device may be included. The feedthrough plate 3620 shown includes a cavity 3832A, and a hollow cavity portion 3606A may be located on or attached to the cavity 3832A. Therefore, the outer periphery of cavity 3832A is substantially the same as the outer periphery of hollow cavity portion 3606A. In one or more embodiments, hollow cavity portion 3606A may be welded or brazed to feedthrough plate 3620. The opposite side (e.g., proximal side) of feedthrough plate 3620 may appear the same as the side illustrated (e.g., distal side). Hollow cavity portion 3606B may be connected to cavity 3832A on the opposite side of feedthrough plate 3620.

[0451] Figure 39 A perspective view illustrating an embodiment of the feedthrough plate 3624 is provided. The feedthrough plate 3624, as shown, includes a plurality of near-side feedthrough holes 3614A-B. The feedthrough holes 3614A-B provide pathways for conductors through the feedthrough plate 3624 while also providing a hermetic seal. The conductors in the near-side feedthrough holes 3614A-B are coupled to the antenna 3610 and circuitry 3608, respectively, for example, to pads in pad 936. The feedthrough plate 3624, as shown, includes a cavity 3832B, within which a hollow cavity portion 3606B may be located. The outer periphery of the cavity 3832B is therefore larger than the outer periphery of the hollow cavity portion 3606B. In one or more embodiments, the hollow cavity portion 3606B may be soldered or brazed to the feedthrough plate 3624 around the cavity 3832A to attach the feedthrough plate 3624 to the hollow cavity portion 3606B.

[0452] Figure 40 A perspective view illustrating an embodiment of end plate 3622 is provided. As shown, end plate 3622 includes a cavity 3832C, within which a hollow cavity 3606 may be located. The outer periphery of cavity 3832C can therefore be larger than the outer periphery of hollow cavity portion 3606B. In one or more embodiments, hollow cavity portion 3606B may be welded or brazed to feedthrough plate 3624 around cavity 3832A to attach feedthrough plate 3624 to hollow cavity 3606.

[0453] Figure 41A and 41BAn illustration of technique 4100 (e.g., method) for assembling an implantable device including a hollow cavity, such as device 3600 or 3700, is provided. As shown, technique 4100 includes, at operation 4102, placing a feedthrough plate 3620 on a hollow cavity portion 3606A (and, in one or more embodiments, on the proximal end of an outer housing 3602); at operation 4108, electrically connecting a conductor (proximal to the feedthrough plate 3620) to a circuit 3608; at operation 4110, positioning the circuit 3608 within a circuit housing 3616; and at operation 4112, positioning the circuit housing 3616 (within the outer housing 3606A). 2 or feedthrough plate 3620); at operation 4114, attach the distal side of circuit housing 3616 to feedthrough plate 3620 or outer housing 3602; at operation 4116, electrically connect conductors from proximal feedthrough holes 3614A-B to circuit 3608; at operation 4118, position feedthrough plate 3624 (on circuit housing 3616 and / or on hollow cavity portion 3606B); at operation 4120, attach feedthrough plate 3624 to circuit housing 3616; at operation 4 At operation 4122, the antenna housing 3618 is positioned (located on the hollow cavity portion 3606B and / or the feedthrough plate 3624); at operation 4124, the antenna housing 3618 is attached to the feedthrough plate 3624 and / or the circuit housing 3616; at operation 4126, the end plate 3622 is positioned (located on the hollow cavity portion 3606A and / or the antenna housing 3618); at operation 4128, the end plate 3622 is attached to the antenna housing 3618; at operation 4130, the airtight seal is achieved. The area surrounding the hollow cavity portion 3606B (e.g., the area between the cavities 3832C) is sealed, for example by welding (if it is metal), brazing (if it is ceramic), or molten glass (if it is glass); at operation 4132, electrodes (via conductors) are connected to the corresponding distal feed holes 3612A-D in the feed plate 3620; and at operation 4134, the hollow cavity portions 3606A-B and / or the outer casing 3602 are attached to the feed plate 3620.

[0454] Operations 4122, 4124, 4126, and 4128 are optional because in some embodiments, the antenna housing 3618 and end plate 3622 are not used. In such embodiments, technique 4100 may alternatively include encapsulating the antenna 3610 in a package 3630 (e.g., a dielectric material), for example, by placing the package (and in some embodiments, by curing the package). The package 3630 may be placed on the feedthrough plate 3620, for example, to cover the feedthrough holes 3614A-B on the proximal side of the feedthrough plate 3620. The package 3630 may be placed around the hollow cavity portion 3606B and the antenna 3610, for example, to encapsulate the antenna 3610. When operation 4118 is performed, these conductors generally form a corresponding service loop on the distal side of the feedthrough plate 3620.

[0455] C. Rigid implantable device Figure 42 A perspective view illustrating an embodiment of the implantable device 5600, such as that used for nerve stimulation, is shown. In several embodiments, the implantable device includes a rigid construction. In one or more embodiments, such an implantable device may include an elliptical shape. The implantable device 5600 shown includes a disc-shaped body portion 5602, a plurality of electrodes 5604, and a circuit housing 5606.

[0456] The body portion 5602 may be made of a rigid biocompatible material, such as platinum, iridium, titanium, ceramic, zirconium oxide, alumina, glass, and / or combinations thereof. Compared to its width (indicated by arrow 5610), the body portion 5602 may be longer (length indicated by arrow 5608). The thickness (indicated by arrow 5614) may be less than the width. Example length ranges for the body portion 5602 include approximately six millimeters to approximately four centimeters (e.g., six millimeters to one centimeter, eight millimeters to two centimeters, one centimeter to four centimeters, two centimeters to four centimeters, one centimeter to three centimeters, their overlapping ranges, or any value within the listed ranges). Example width ranges for the body portion 5602 include approximately six millimeters to approximately four centimeters (e.g., six millimeters to one centimeter, eight millimeters to two centimeters, one centimeter to four centimeters, two centimeters to four centimeters, one centimeter to three centimeters, their overlapping ranges, or any value within the listed ranges). Example thickness ranges for body portion 5602 include approximately half a millimeter to approximately five millimeters (e.g., half a millimeter to one millimeter, one millimeter to two millimeters, one millimeter to four millimeters, two millimeters to four millimeters, three millimeters to five millimeters, half a millimeter to 2.5 millimeters, one centimeter to three centimeters, their overlapping ranges, or any value within the listed ranges).

[0457] The body portion 5602 includes electrodes 5604 positioned along its periphery. As shown, the electrodes 5604 are disposed on this periphery. The electrodes 5604 are shown as being distributed substantially uniformly on the periphery, such that the distance between directly adjacent electrodes (directly adjacent as the periphery extends clockwise or counterclockwise) is substantially uniform (e.g., within uniform 10 percent). As shown, the electrodes 5604 are disposed at the intersections of length or width dividers with the periphery, the length dividers being indicated by dashed lines 5618 and the width dividers by dashed lines 5616. In embodiments where the body portion has an elliptical coverage area, the length divider (dashed line 5618) is the minor axis and the width divider (dashed line 5616) is the major axis of the coverage area. Although the device 5600 is shown as including four electrodes 5604, the device 5600 may include one or more electrodes. For example, the device may include two, three, four, five, six, seven, eight, or more electrodes disposed on the periphery of the device 5600.

[0458] The body portion 5602 includes a circuit housing 5606 at least partially located therein. In one or more embodiments, the circuit housing 5606 may be flush with the surface 5620 of the body portion 5602. The circuit housing 5606 may provide a hermetically sealed environment for electrical or electronic components and interconnections housed therein, or may otherwise protect the circuitry housed therein, such as by means other than a hermetically sealed environment. The electrical or electronic components may include one or more transistors, resistors, capacitors, inductors, diodes, central processing units (CPUs), field-programmable gate arrays (FPGAs), Boolean logic gates, multiplexers, converters, regulators, amplifiers, power supplies, charge pumps, oscillators, phase-locked loops (PLLs), modulators, demodulators, radios (receiving and / or transmitting radios), buffers, circulators, amplifiers, and / or antennas (e.g., helical antennas or patch antennas, etc.), such as other circuitry of implantable devices discussed elsewhere herein. The components in the circuit housing 5606 can be arranged to form a stimulation therapy generation circuit for providing stimulation therapy signals to the electrode 5604, a receiver (for receiving power and / or data signals from the field device), a transmitter (for providing data signals to the field device), and / or an electrode selection circuit (for selecting which electrode is the anode and which is the cathode). For example, by using a single-pole feedthrough and an insulating conductor 5622, the electrode 5604 can be electrically connected to the circuit in the circuit housing 5606.

[0459] In one or more embodiments, the side surface 5624 of the device 5600 may be flat, for example, to form an edge. In one or more embodiments, the side surface 5624 may be rounded. The surface 5620 and the opposite surface (in) of the device 5600 Figure 42The opposite surface (where the view is obstructed) can be substantially flat (e.g., having a flattening ratio of about 0.9 or greater) or can be circular at least in a portion thereof. Each electrode 5604 and circuit housing 5606 can be flush with surface 5620 (and may be the same as or different on the opposite surface, possibly with...). Figure 42 The views in the images are roughly the same.

[0460] Figure 43 A perspective view illustrating another embodiment of an implantable stimulating device 5700 is provided. The implantable stimulating device 5700 is similar to stimulating device 5600, wherein device 5700 includes an implant / explant structure 5730. The implant / explant structure 5730 is located on a proximal portion 5726 of device 5700. Device 5700 includes a distal portion 5728 opposite to the proximal portion 5726. The distal and proximal portions are defined relative to the orientation in which device 5700 is implanted, but not necessarily the orientation after implantation. Device 5700 is arranged to implant the distal portion 5728 first, followed by the proximal portion 5726, although the distal portion 5728 may be closer to the skin surface than the proximal portion 5726 after implantation.

[0461] The illustrated implant / explant structure 5730 includes three rods 5732A, 5732B, and 5734. Rods 5732A-B are approximately parallel to the long axis (dashed line 5616). Rod 5734 is approximately perpendicular to rods 5732A-B. Sutures (in...) Figure 43 (Not shown) can be attached to implant / explant structure 5730. In one or more embodiments, a suture can be attached to a rod 5734. Rod 5734 may include a male or female connector (e.g., clip, screw hole, hole, or other connection or interface mechanism) to which a push rod can be attached, for example, for implantation of the device 5700. Note that although the rods of implant / explant structure 5730 are shown as straight, they can be curved or some other shape.

[0462] Figure 44 from Figure 43 The angle of the arrow marked "44" illustrates a perspective view of device 5700 by way of example. Device 5700, as shown, includes connector 5836 to which push rods and / or stitching can be attached. Connector 5836 may be a screw hole, hole, clip, brake, or other male or female interface or coupling device for attaching push rods and / or stitching to device 5700.

[0463] Figure 45A perspective view illustrating an embodiment of an implant / explant system 5900 is provided. As shown, the implant / explant system 5900 includes a suture 5938 and a pusher 5940. The pusher 5940 shown includes threads 5942. In embodiments where the connector includes screw holes, the threads 5942 can be screwed into a connector 5836. The connector 5836 and the pusher 5940 have mating connectors (e.g., in…) Figure 45 In the example, thread 5942 can be both attachable and detachable. Therefore, push rod 5940 can be used to implant device 5700 and push rod 5940 can be removed, leaving implanted device 5700.

[0464] Figure 46 A perspective view illustrating an embodiment of an implant / explant system 6000 is provided. The system 6000 shown includes a pusher 5940 attached to an implant / explant structure 5730. A device 5700 is located in a cannula 6046 that pierces the user's skin 6044. The cannula 6046 may have angled sidewalls, for example, to help guide the device 5700 to the appropriate orientation and / or to assist the cannula in piercing the skin 6044. The pusher 5940 can be used to compress the device 5700 under the skin 6044 and into the appropriate location within the body.

[0465] In one or more embodiments, the device 5600 / 5700 can be implanted into the body without the use of a cannula. In such embodiments, an incision can be made through the skin and the tissue beneath the skin to form a tunnel to the desired site. The device 5600 / 5700 can then be inserted into the tissue through the tunnel, for example by using a push rod or a flatter, more flexible barrier rod or occluder (flatter and more flexible than a push rod).

[0466] Figure 47 A perspective view illustrating an embodiment of the implant system 6100 is provided. As shown, the implant system 6100 includes a plurality of implantable devices 5700A, 5700B, 5700C and a field power supply device 6148. Stimulation devices 5700A-C are specific embodiments of device 5700. The field power supply device 6148 generates a directional and focused electromagnetic field. The field power supply device 6148 may be similar to or the same as field power supply device 5028 or source 102. The field power supply device 6148 provides electromagnetic signals to each of the stimulation devices 5700A-C, which may be used, for example, by circuitry in the circuit housing 5606, for example, to power the stimulation devices 5700A-C and generate stimulation therapy.

[0467] The focus and direction of the electromagnetic field generated by the field power supply device 6148 can be changed by adjusting the phase of the signal generated by one or more antennas of the field power supply device 6148.

[0468] When using a time-domain multiplexed communication system between an external transmitter and an implanted receiver, the phase and amplitude can be dynamically adjusted to help focus energy at the implanted receiver (e.g., focus energy more effectively), for example, using a power detector at the stimulation device for feedback. The mid-field device 6148 can provide power and / or data signals to the implantable devices 5700A-C in a time-domain multiplexed manner, such as providing a signal to one of the devices 5700A-C at one time and to another of the devices 5700A-C at another time.

[0469] One or more features of the implantable device discussed herein may include: (1) a generally flat (e.g. planar) and rigid (non-flexible and non-stretchable) body; (2) radially spaced electrodes (e.g., in the case of four electrodes, spaced at approximately 90 degrees between adjacent electrodes) to enable spatial stimulation distribution patterns; (3) the body may be shortened along one axis (the width discussed herein) to allow the stimulation device to pass through a smaller incision and an enlarged access path than if the two axes were of equal length; (4) it may accommodate threaded implants and explant tools, for example, by using an implant / explant structure; (5) for self-contained implantable pulse generators, the stimulation device does not require a guide tunnel or pocket, as is required by many self-contained stimulation devices; and / or (6) the stimulation device may be sized and implanted such that it is aesthetically inconspicuous in the absence of an external stimulator.

[0470] One or more embodiments of the stimulation devices discussed herein comprise a generally flat, rigid construction. These devices can be used to stimulate one or more peripheral nerves, such as the occipital nerve or supraorbital nerve structures. This implant can provide stimulation to the motor cortex. The devices discussed herein can be implanted into muscle tissue, for example, to help secure the implant in place. For example, such implants can help alleviate problems associated with Twiddler syndrome.

[0471] Stimulation devices can be used to help relieve symptoms associated with migraines, other headaches, or fibromyalgia, for example, by stimulating the occipital nerve or trigeminal nerve. Stimulation devices can provide the functionality of an occipital stimulator implant. Implanting multiple stimulation devices near the target nerve allows for more or different spatial stimulation distribution patterns.

[0472] Stimulation devices can be used to provide epidural stimulation in the spine. Stimulation devices can also be used to provide cortical stimulation, for example, in stroke patients, to help alleviate stroke-related motor and / or other neurological disorders.

[0473] D. Communication devices and methods based on surface acoustic waves According to several embodiments, the implantable stimulation device includes a surface acoustic wave (SAW) device, for example, for providing one or more backscattered signals. In one or more embodiments, the SAW device provides a time delay (e.g., a buffer) for a portion of the signal that will be fed back to a power supply and / or communication device (e.g., any of the external devices or sources described herein, such as source 102).

[0474] Mid-field power supply technology can enable the power supply of deeply implanted stimulation devices from an external source located on or near the patient's skin surface. While power transfer is critical for activating a device, bidirectional communication can help allow external sources to know that the implant is actually being powered and / or provide feedback signals for manipulating fields (e.g., one or more evanescent fields), for example, to better focus the power signal onto the implanted device. Furthermore, bidirectional communication can help allow the transmission of data from implanted sensors integrated with (or near) the implanted device.

[0475] When used to communicate with implanted devices (e.g., deeply implanted devices), such as those with stringent power limitations in the microwatt range, some communication schemes may have one or more drawbacks. Active transmission schemes that integrate on-chip oscillators in the implanted device have limited oscillator accuracy but lack integrated phase-locked loops, microelectromechanical systems (MEMS), and / or crystal oscillators. Using a phase-locked loop increases startup time and power consumption, sometimes exceeding the power buffering capacity of small off-chip capacitors, even during duty cycles. Limited oscillator accuracy can make signal detection difficult due to increased noise bandwidth and center frequency tracking.

[0476] Passive communication schemes (such as load modulation) are susceptible to strong interference from the power supply signal (typically 50 dB stronger than the communication signal). Unlike inductive coupling methods for power transmission, in the case of mid-field power supply, the tissue itself carries more signal than the receiving antenna of the implanted device. According to some embodiments, schemes such as backscattering may be difficult to use due to the finite time delay between the implanted device and the external device.

[0477] This section discusses systems and methods that may include a SAW device to an implantable device and the use of that device. One or more communication schemes between an external device and an implantable device are described. The implantable device may include a SAW device as a time-delay (e.g., signal buffer) element. The SAW device can be used to store (e.g., temporarily store) electromagnetic waves as propagating mechanical waves, for example, stored in a piezoelectric substrate. The implantable device can temporarily store wave energy in the SAW device. When the implantable device is in transmit mode, time-delayed radio frequency (RF) energy (e.g., as a carrier wave or itself) from the SAW device can be used to transmit data back to the external device. During this time, the external device can avoid transmitting excitation signals, for example, when the external device is in receive mode. In such embodiments, there may be no strong interference signals from the external device that could interfere with signals emitted from the implantable device. These embodiments can help provide communication from the implantable device to the external device with lower power. This is at least because a portion of the signal from the implantable device to the external device may not include interference signals from the transmitter, so such embodiments can help provide communication to the external device that is more easily detected at the transmitter.

[0478] Direct current (DC) energy can be stored on the implantable device to power it during its emission (e.g., stimulation energy from external device 4202 (e.g., source 102) and / or signals to the external device). This energy can be used at least partially to modulate the carrier signal emitted from the implant. In one or more embodiments, the SAW device can also be used as a bandpass filter for the implant's emission downlink, such as to help eliminate out-of-band sources, for example, to increase resistance to noise or other signal interference.

[0479] Figure 48 A logic block diagram illustrating an embodiment of system 4200 is provided. The illustrated system 4200 includes an external device 4202 and an implantable device 4201. The external device 4202 may provide power and / or communication signals to the implantable device 4201. In one or more embodiments, the external device 4202 may include a mid-field source that provides a mid-field signal to the implantable device 4201. Mid-field signals and sources are discussed elsewhere herein. Circuit 500 may include the implantable device 4201, and circuit 4400 (see [link to circuit 4201]). Figure 50 ), Circuit 4500 (see) Figure 51 Circuit 4600 (see) Figure 52 ), and / or circuit 4700 (see Figure 53 One or more components of ).

[0480] The implantable device 4201 receives signals from and provides signals to the external device 4202. These signals are represented by lines 4203. The implantable device 4201 can provide modulation (e.g., stimulation therapy, denervation, or other treatment) to sites in the body, such as to modulate (e.g., stimulate) nerves, muscles, or other tissues. The implantable device 4201 can provide data signals to the external device 4202.

[0481] The implantable device 4201 shown in the figure includes a first converter 4204, a SAW device 4206, a second converter 4208, circuitry 4210, synchronization circuitry 4218, and electrodes 4224. Converters 4204 and / or 4208 may include one or more transistor or mechanical converters for providing alternative electrical paths (receive paths) for electrical signals from external device 4202 and for providing alternative electrical paths (transmit paths) for electrical signals destined for external device 4202. The transmit paths include the "T" of each converter 4204 and 4208, and the receive paths include the "R" of each converter 4204 and 4208.

[0482] SAW device 4206 includes a resilient material that provides a medium for converting incident electrical signals into mechanical waves within the SAW device 4206. The SAW device 4206 then converts the mechanical waves back into electrical signals. Since mechanical waves propagate more slowly than electrical signals in a normal conductor, according to several embodiments, the SAW device 4206 is advantageously used as a time delay element for electrical signals. In the SAW device, piezoelectric materials can be used as transducers to switch between mechanical and electrical waves.

[0483] The circuit 4210 shown includes an energy harvesting circuit 4212, a power management circuit 424, a stimulation circuit 426, a demodulator receiving circuit 4220, a system control circuit 4222, and a capacitor 4226.

[0484] The energy harvesting circuit 4212 may include a rectifier and one or more capacitors to help store the rectified signal. The energy harvesting circuit 4212 may power the implantable device 4201, for example, when receiving a stimulation signal from an external device 4202 and, in some embodiments, after receiving a stimulation from an external device 4202.

[0485] The stimulation circuit 4216 provides an electrical signal to the electrode 4224. The stimulation circuit 4216 may include one or more transducers to select which one or more electrodes are anodes and which are cathodes.

[0486] Synchronization circuitry 4218 may include circuitry for determining when implantable device 4201 will be in transmit mode and when implantable device 4201 will be in receive mode. Synchronization circuitry 4218 may determine the amplitude of the envelope of a signal from external device 4202. Based on the envelope amplitude, synchronization circuitry 4218 may determine an appropriate mode. When the envelope is sufficiently large (e.g., above a threshold), implantable device 4201 may be in or switched to receive mode, and external device 4202 may be in transmit mode. When the envelope is sufficiently small (e.g., below a second threshold, which may sometimes be a different threshold), implantable device 4201 may be switched to or in transmit mode, and external device 4202 may be in or switched to receive mode. The amplitude of the envelope is the difference between successive maximum and minimum voltages of the signal.

[0487] Figure 49 A waveform diagram illustrating an embodiment of electrical signal 4300 in a system including a SAW device is provided. The signal 4300 shown includes a signal 4302 from an external device, a signal 4304 representing the power received at the implantable device 4201, a signal 4306 delayed by the SAW device 4206; a signal 4308, which will be used as (1) a carrier wave when modulating the signal transmission to the external...

Claims

1. An implantable device, comprising: The shell includes the distal end and the opposite proximal end; The circuitry housed within the casing; An antenna, configured to receive field radio frequency energy and electrically connected to the circuit; An elongated member comprising a distal end and an opposite proximal end, the proximal end of the elongated member being mechanically coupled to the distal end of the housing; A plurality of ring electrodes in an elongated member, the plurality of ring electrodes comprising a plurality of annular conductive strips circumferentially surrounding the elongated member, and configured to receive electrical energy from the circuit; and A suture, which is mechanically coupled to and extends from the proximal end of the housing.

2. The implantable device according to claim 1, further comprising: The attachment structure includes a distal end and an opposite proximal end, the distal end of which is mechanically coupled to the proximal end of the housing. The suture is mechanically attached to the proximal end of the attachment structure.

3. The implantable device of claim 1, wherein, The housing is a circuit housing, and the implantable device further includes: An antenna housing comprising a distal end and an opposite proximal end, the distal end of the antenna housing being mechanically connected to the proximal end of the circuit housing, the antenna being housed within the antenna housing.

4. The implantable device of claim 2, wherein, The suture extends to a point further proximal than the proximal end of the attachment structure.

5. The implantable device of claim 4, wherein, The suture does not extend to the distal side of the proximal end of the attachment structure.

6. The implantable device according to claim 1, wherein, The slender member is made of a flexible material.

7. The implantable device according to claim 6, wherein, The elongated member is shaped to include a curved portion when unconstrained.

8. The implantable device according to claim 7, wherein, The flexible material is reflowed to include a defined curved shape.

9. The implantable device according to claim 1, wherein, The sutures are not electrically activated.

10. The implantable device of claim 3, further comprising a fork portion mechanically connected to the implantable device.

11. The implantable device according to claim 10, wherein, The fork-tooth portion is located closer to the near end of the antenna housing.

12. The implantable device according to claim 8, wherein, The flexible material is straight when inside the conduit and has a set curved shape when outside the conduit.

13. An implantable device system, comprising: Implantable devices; Delivery tools including the distal end and the opposite proximal portion; and catheter; The implantable device includes: The shell includes the distal end and the opposite proximal end; Circuitry housed within the housing; An antenna configured to receive field radio frequency energy and electrically connected to the circuit; An elongated member comprising a distal end and an opposite proximal end, the proximal end of the elongated member being mechanically coupled to the distal end of the housing; A plurality of ring electrodes in an elongated member, the plurality of ring electrodes comprising a plurality of ring conductive strips circumferentially surrounding the elongated member, are configured to receive electrical energy from the circuit; The attachment structure includes a distal end and an opposite proximal end, the distal end of which is mechanically coupled to the proximal end of the housing, the proximal end of which is configured to mate with the distal end of the delivery tool; and A suture, which is mechanically connected to and extends from the proximal end of the attachment structure.

14. The system according to claim 13, wherein, The length of the suture is greater than the length of the conveying tool.

15. The system according to claim 14, wherein, The conveying tool includes a cavity extending through the proximal end of the conveying tool to the distal end of the conveying tool.

16. The system according to claim 15, wherein, The suture is sized to fit through the cavity.

17. The system according to claim 16, wherein, The delivery tool includes a structure in its proximal portion configured to hold the suture.

18. The system according to claim 17, wherein, The structure in question is a Ruhr cap.

19. The system according to claim 13, wherein, The elongated component is made of a flexible material and is shaped to include a curved portion when unrestrained, the flexible material being reflowed to include a defined curved shape.

20. The system according to claim 13, wherein, The sutures are not electrically activated.

Images