Stimulation apparatus

Abstract

Described herein are systems, devices, and methods for delivering enhanced stimulation to provide therapy for a patient. A neurostimulation system may include an implantable stimulation device, a base station, and an external device. The external device may include a first antenna for communicating with the implantable device, and a second antenna for receiving power from the base station. Additionally, the external device may have one or more shielding layers between the first and second antennae. A method for reprogramming a neurostimulation system may include receiving data at a base station via a remote connection, transferring the data from the base station to an external device via a location connection, and instructing an implantable stimulation device to stimulation tissue of a patient using the data.

Description

STIMULATION APPARATUSCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application Serial No. 63 / 625,043 filed January 25, 2024, the content of which is incorporated herein by reference in its entirety for all purposes.FIELD OF THE INVENTION

[0002] The present invention relates generally to medical apparatus for a patient, and in particular, apparatus that delivers enhanced stimulation to effectively deliver a therapy while avoiding undesired effects.BACKGROUND

[0003] Implantable devices that treat a patient and / or record patient data are known. For example, implants that deliver energy such as electrical energy, or deliver agents such as pharmaceutical agents are commercially available. Implantable electrical stimulators may be used to pace or defibrillate the heart, as well as modulate nerve tissue (e.g., to treat pain). Most implants are relatively large devices with batteries and long conduits, such as implantable leads configured to deliver electrical energy or implantable tubes (i.e., catheters) to deliver an agent. These implants require a fairly invasive implantation procedure, and periodic battery replacement, which requires additional surgery. The large sizes of these devices and their high costs have prevented their use in a variety of applications.

[0004] Nerve stimulation treatments have shown increasing promise recently, showing potential in the treatment of many chronic diseases including drug-resistant hypertension, motility disorders in the intestinal system, metabolic disorders arising from diabetes and obesity, and both chronic and acute pain conditions among others. Many of these implantable device configurations have not been developed effectively because of the lack of miniaturization and power efficiency, in addition to other limitations.

[0005] Accordingly, there is a need for apparatus, systems, devices and methods that provide one or more implantable devices and are designed to provide enhanced treatment of pain and other enhanced benefits.SUMMARY

[0006] Described herein are systems, devices, and methods for providing stimulation therapy to a patient. A neuromodulation system may include an implatable device, a base station, and an external device. The external device may include a first antenna configured to transmit power to the implantable device within a first predetermined frequency range, a second antenna configured to receive power from the base station within a second, different predetermined frequency range, and one or more shielding layers positioned between the first and second antennae. Moreover, the implantable device may include a third antenna configured to operate within the first predetermined frequency range, and the base station may include a fourth antenna configured to operate within the second predetermined frequency range. The one or more shielding layers may be configured to prevent coupling between the first and second antennae. In some embodiments, each of the one or more shielding layers may include one or both of a conductive material and a ferromagnetic material. In some embodiments, the first predetermined frequency range may be greater than the second predetermined frequency range. The first predetermined frequency range may be about 30 MHz to about 50 MHz, and the second predetermined frequency range may be about 100 kHz to about 200 kHz. In some embodiments, the external device may further include a housing enclosing the first antenna, the second antenna, and the one or more shielding layers therein. Moreover, the implantable device may be configured to stimulate tissue of a patient using the power transmitted by the first antenna.Additionally, the external device may be configured to be positioned over the implantable device on a body of a patient.

[0007] In some embodiments, the base station may further include a compressible material configured to minimize a distance between the fourth antenna and an interior surface of a housing of the base station. The fourth antenna may be positioned between a distal side of the compressible material and an interior surface of the housing such that the compressible material may maintain the fourth antenna proximate to the interior surface of the housing. In some embodiments, the base station may be configured to charge the external device when the external device is positioned in or on the base station, and the base station may include an opening configured to receive the external device therein. The second antenna of the external device and a fourth antenna of the base station may be configured to automatically align when the external device is positioned in or on the base station. Similarly, the second antenna of theexternal device and the fourth antenna of the base station may be rotationally symmetric when the external device is positioned in or on the base station.

[0008] The one or more shielding layers may include a first shielding layer including a magnetic loss tangent of less than or equal to 0.025 at the first predetermined frequency range, and a second shielding layer including a magnetic loss tangent of less than or equal to 0.025 at the second predetermined frequency range, the first antenna is fixedly attached to the first shielding layer and the second antenna is fixedly attached to the second shielding layer. The first antenna may be on a proximal side of the one or more shielding layers and the second antenna may be on a distal side of the one or more shielding layers.

[0009] In some embodiments, the external device may include a compressible material configured to maintain the second antenna proximate to an interior surface of a housing of the external device. Further, the external device may include a power supply. The compressible material may be positioned between a distal side of the power supply and a proximal side of a shielding layer of the one or more shielding layers.

[0010] Another neuromodulation system may include an implantable device, a base station, and an external device. The external device may include a power supply, a first antenna configured to power the implantable device, a second antenna configured to wirelessly charge the power supply from the base station, and one or more shielding layers positioned between the first and second antennae. In some embodiments, the second antenna of the external device and the third antenna of the base station may be rotationally symmetric when the external device is positioned in or on the base station.

[0011] In some embodiments, the first antenna may be configured operate within a first predetermined frequency range, and the second antenna may be configured to operate within a second, different predetermined frequency range. The implantable device may include a third antenna configured to operate within the first predetermined frequency range, and the base station may include a fourth antenna configured to operate within the second predetermined frequency range. The first predetermined frequency range may be about 30 MHz to about 50 MHz, and the second predetermined frequency range may be about 100 kHz to about 200 kHz.

[0012] A neuromodulation device may include a first antenna configured operate within a first predetermined frequency range, a second antenna configured to operate within a second, different predetermined frequency range, one or more shielding layers positioned between thefirst and second antennae and configured to prevent coupling between the first and second antennae, and a wearable housing carrying the first antenna, the second antenna, and the one or more shielding layers. Moreover, a neuromodulation system may include the aforementioned neuromodulation device, as well as an implantable neuromodulation device including a third antenna configured to operate within the first predetermined frequency range, and a base station having a fourth antenna and configured to operate within the second predetermined frequnecy range.

[0013] In some embodiments, the neuromodulation device may include a compressible material configured to maintain the second antenna proximate to an interior surface of a housing of the neurmodulation device. Further, the neuromodulation device may include a power supply, and the compressible material may be positioned between a distal side of the power supply and a proximal side of a shielding layer of the one or more shielding layers.

[0014] In some embodiments, the neruomodulation device may include a third antenna configured to trasnmit data to one or more remote devices. The second antenna may be a Qi charging antenna and the third antenna may be a near-field communication (NFC) antenna.

[0015] A method for reprogramming a neurostimulation system may include receiving first data at a base station or remote device via a remote connection, transfering the data from the base station or remote device to an external device via a local connection between the base station or remote device and the external device, and instructing, via the external device, an implantable device to stimulate tissue of a patient using the data. The method may further include establishing a wireless connection between the external device and the implantable device prior to instructing the implantable device to stimulate the tissue of the patient. The remote connection may be a wide area network (WAN) connection, and the local connection may be a bluetooth low energy (BLE) connection. In some embodiments, instructing the implantable device to stimulate the tissue of the patient may include transferring power from the external device to the implantable device. The implantable device may use the power to stimulate the tissue of the patient. Moreoever, the first data may include stimulation data. The stimulation data may include one or more of a stimulation parameter, a stimulation program, a stimulation programming schedule, and an implantable device configuration. In some embodiments, the base station may be a charging station for the implantable device. In some embodiments, the remote device may be a smart phone.

[0016] In some embodiments, the method may include transferring second data from one or both of the base station and the external device to the remote device. The transferring may occur via the remote connection. Additionally, in some embodiments, transferring the first data from the base station or remote device to the external device may include downloading the first data to the external device. The first data may be downloaded to a memory of the external device. Further, in some embodiments, the first data may include software. The software may be a firmware update.

[0017] A system for implanting an implantable device within tissue of a patient is also described herein. The system may include an implantation device including a shaft, a first arm extending from the shaft and configured to be positioned against skin of a patient, and a second arm extending from the shaft and configured to be inserted into a body of the patient to dissect the tissue. The system may also include a sheath having a body with a channel configured to receive the second arm of the implantation device. The sheath may be configured to provide access to a subcutaneous space formed in the tissue by the implantation device when the implantation device is withdrawn from the tissue. In some embodiments, the first arm may have a first longitudinal axis and the second arm may have a second longitudinal axis, and the first and second longitudinal axes may be transverse to a longitudinal axis of the shaft. In some embodiments, the first and second longitudinal axes may be about parallel. Additionally, in some embodiments, an angle formed between one or both of the first longitudinal axis and the second longitudinal axis and the longitudinal axis of the shaft may be about 80 degrees to about 120 degrees, or about 90 degrees. In some embodiments, the second arm may have a tapered distal tip. In some embodiments, the sheath may further include a handle coupled to the proximal end. The system may further include a second implantation device configured to releasably couple with the implantable device. In some embodiments, the second implantable device may include first and second prongs defining a gap therebetween. The gap may be configured to receive the implantable device. Furthermore, the implantation device may further include a coupling element extending therefrom. A proximal end of the sheath may be configured to contact the coupling element to maintain a position of the sheath relative to the implantation device during the implanting. In some variations, the coupling element may be a ledge.

[0018] A method for implanting an implantable device within tissue of a patient is also described herein. The method may include introducing a first implantation device and a sheath through an incision in the tissue, where a portion of the first implantation device may be positioned within in a channel of the sheath, advancing the first implantation device and the sheath together through the tissue to form a subcutaneous space configured to receive the implantable device, where contact between the first implantation device the sheath may maintain a position of the implantation device relative to the sheath during the advancing, and withdrawing the implantation device from the incision while maintaining a position of the sheath within the tissue such that the channel of the sheath may provide access to the subcutaneous space. In some embodiments, the method may further include advancing a second implantation device coupled with the implantable device through the channel of the sheath to the implantation site. In some embodiments, the method may further include withdrawing the sheath from the incision and subsequently withdrawing the second implantation device from the incision. In some embodiments, during the advancing, a coupling element of the implantation device may contact a proximal end of the sheath.

[0019] Finally, a method for reconfiguring a stimulation program may include retrieving, via a programmer, one or more stimluation program templates from a remote server, determining whether at least one of the one or more stimulation program templates satisfies a condition, and when the stimulation program template satisfies the condition, adjusting the stimulation program for the patient to be based on the stimulation program template.

[0020] The technology described herein, along with the attributes and attendant advantages thereof, will best be appreciated and understood in view of the following detailed description taken in conjunction with the accompanying drawings in which representative embodiments are described by way of example.INCORPORATION BY REFERENCE

[0021] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. The content of all publications, patents, and patent applications mentioned in this specification are herein incorporated by reference in their entirety for all purposes.BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The foregoing and other objects, features and advantages of embodiments of the present inventive concepts will be apparent from the more particular description of preferred embodiments, as illustrated in the accompanying drawings in which like reference characters refer to the same or like elements. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the preferred embodiments.

[0023] FIG. 1 depicts a schematic anatomical view of an illustrative variation of a medical apparatus comprising an external system and an implantable system, consistent with the present inventive concepts.

[0024] FIGS. 2A-2B depict sectional views of two different illustrative embodiments of an implantable device comprising multiple leads, consistent with the present inventive concepts.

[0025] FIG. 3 depicts a flow chart of an illustrative variation of a method for updating firmware and / or other software of a medical apparatus is illustrated, consistent with the present inventive concepts.

[0026] FIG. 4 depicts top, side, and perspective transparent views of an illustrative variation of a lead anchor element, consistent with the present inventive concepts.

[0027] FIGS. 4A-4D depict various perspective and sectional views of an illustrative variation of an anchor element, consistent with the present inventive concepts.

[0028] FIG. 5 depicts a perspective view of an illustrative variation of a sleeve for covering a portion of a lead, a lead distal portion, and an applicator tool, consistent with the present inventive concepts.

[0029] FIG. 5 A depicts side and bottom views of an illustrative variation of a sleeve for covering a portion of a lead, consistent with the present inventive concepts.

[0030] FIG. 5B depicts side and bottom views of another illustrative variation of a sleeve for covering a portion of a lead, consistent with the present inventive concepts.

[0031] FIGS. 5C and 5D depict another illustrative variation of a sleeve for covering a portion of a lead, and a clip, respectively, consistent with the present inventive concepts.

[0032] FIG. 5E depicts top and bottom views of an illustrative variation of a sleeve for covering two leads, consistent with the present inventive concepts.

[0033] FIGS. 5F-5H depict perspective views of illustrative embodiments of electrodes and resultant electric fields that may be generated by the apparatus of the present inventive concepts, consistent with the present inventive concepts.

[0034] FIGS. 6A-6I depict various views of an illustrative variation of an implantation tool, consistent with the present inventive concepts.

[0035] FIGS. 7 and 7A-7E depict a perspective view, an exploded view, a side view, and three sectional views of an illustrative variation of an external device, respectively, consistent with the present inventive concepts.

[0036] FIG. 8 depicts perspective views of a back side and a front side of an illustrative variation of a charging base station, consistent with the present inventive concepts. FIGS. 8A and 8B depict two perspective views and two exploded views of an illustrative variation of a charging base station, respectively, consistent with the present inventive concepts.

[0037] FIGS. 9 A through 10B depict perspective and side views of various illustrative embodiments of a patient attachment device, consistent with the present inventive concepts.

[0038] FIGS. 11 and 11 A-l ID depict a perspective view and various side and sectional views of an illustrative variation of a retention assembly of a patient attachment device, respectively, consistent with the present inventive concepts.

[0039] FIGS. 12 and 12A-12C depict a perspective view and various side, exploded, and sectional views of an illustrative variation of an adhesive patient attachment device, consistent with the present inventive concepts.

[0040] FIG. 13 A depicts a perspective view of an illustrative variation of a first implantation tool, consistent with the present inventive concepts. FIG. 13B depicts a top view of a distal end of the first implantation tool of FIG. 13A. FIG. 13C depicts a side view of the first implantation tool of FIG. 13 A.

[0041] FIG. 14 depicts a perspective view of an illustrative variation of a sheath for a first implantation tool, consistent with the present inventive concepts.

[0042] FIG. 15A depicts a perspective view of an illustrative variation of a second implantation tool, consistent with the present inventive concepts. FIG. 15B depicts a perspective view of the second implantation tool of FIG. 15A coupled with an implantable device and within a sheath.

[0043] FIG. 16 depicts an exploded view of an illustrative variation of a patient attachment device, consistent with the present inventive concepts.DETAILED DESCRIPTION

[0044] The terminology used herein is for the purpose of describing exemplary embodiments and is not intended to be limiting of the inventive concepts. Furthermore, embodiments of the present inventive concepts may include several novel features, no single one of which is solely responsible for its desirable attributes, or which is essential to practicing an inventive concept described herein.

[0045] As used herein, the singular forms “a,” “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise.

[0046] It will be further understood that the words "comprising" (and any form of comprising, such as "comprise" and "comprises"), "having" (and any form of having, such as "have" and "has"), "including" (and any form of including, such as "includes" and "include") or "containing" (and any form of containing, such as "contains" and "contain") when used herein, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0047] It will be understood that, although the terms first, second, third etc. may be used herein to describe various limitations, elements, components, regions, layers, and / or sections, these limitations, elements, components, regions, layers, and / or sections should not be limited by these terms. These terms are only used to distinguish one limitation, element, component, region, layer or section from another limitation, element, component, region, layer or section. Thus, a first limitation, element, component, region, layer or section discussed below could be termed a second limitation, element, component, region, layer or section without departing from the teachings of the present application.

[0048] It will be further understood that when an element is referred to as being “on”, “attached”, “connected” or “coupled” to another element, it may be directly on or above, or connected or coupled to, the other element, or one or more intervening elements may be present. In contrast, when an element is referred to as being “directly on”, “directly attached”, “directly connected” or “directly coupled” to another element, there are no intervening elements present.Other words used to describe the relationship between elements should be interpreted in a like fashion (e.g., “between” versus “directly between,” “adjacent” versus “directly adjacent,” etc.). A first component (e.g., a device, assembly, housing or other component) may be “attached”, “connected” or “coupled” to another component via a connecting filament (as defined below). In some embodiments, an assembly comprising multiple components connected by one or more connecting filaments is created during a manufacturing process (e.g., pre-connected at the time of an implantation procedure of the apparatus of the present inventive concepts). Alternatively, or additionally, a connecting filament may comprise one or more connectors (e.g., a connectorized filament comprising a connector on one or both ends), and a similar assembly may be created by a user (e.g., a clinician) operably attaching the one or more connectors of the connecting filament to one or more mating connectors of one or more components of the assembly.

[0049] As used herein, the terms “operably attached”, “operably connected”, “operatively coupled”, and similar terms related to attachment of components shall refer to attachment of two or more components that results in one, two, or more of: electrical attachment; fluid attachment; magnetic attachment; mechanical attachment; optical attachment; sonic attachment; and / or other operable attachment arrangements. The operable attachment of two or more components may facilitate the transmission between the two or more components of: power; signals; electrical energy; fluids or other flowable materials; magnetism; mechanical linkages; light; sound such as ultrasound; and / or other materials and / or components.

[0050] It will be further understood that when a first element is referred to as being “in”, “on” and / or “within” a second element, the first element may be positioned: within an internal space of the second element, within a portion of the second element (e.g., within a wall of the second element); positioned on an external and / or internal surface of the second element; and combinations of one or more of these.

[0051] Spatially relative terms, such as "beneath," "below," "lower," "above," "upper", under, and the like may be used to describe an element and / or feature's relationship to another element(s) and / or feature(s) as, for example, illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use and / or operation in addition to the orientation depicted in the figures. For example, if the device in a figure is turned over, elements described as "below" and / or "beneath" other elements orfeatures would then be oriented "above" the other elements or features. The device may be otherwise oriented (e.g., rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

[0052] As used herein, the term "proximate" shall include locations relatively close to, on, in, and / or within a referenced component or other location.

[0053] The term “and / or” where used herein is to be taken as specific disclosure of each of the two specified features or components with or without the other. For example, “A and / or B” is to be taken as specific disclosure of each of (i) A, (ii) B and (iii) A and B, just as if each is set out individually herein.

[0054] The term “diameter” as used herein to describe a non-circular geometry is to be taken as the diameter of a hypothetical circle approximating the geometry being described. For example, when describing a cross section, such as the cross section of a component, the term “diameter” shall be taken to represent the diameter of a hypothetical circle with the same cross- sectional area as the cross section of the component being described.

[0055] The terms “major axis” and “minor axis” of a component as used herein are the length and diameter, respectively, of the smallest volume hypothetical cylinder which may completely surround the component.

[0056] The term “functional element” where used herein, is the be taken to include a component comprising one, two or more of: a sensor; a transducer; an electrode; an energy delivery element; an agent delivery element; a magnetic field generating transducer; and combinations of one or more of these. In some embodiments, a functional element comprises a transducer selected from the group consisting of: light delivery element; light emitting diode; wireless transmitter; Bluetooth device; mechanical transducer; piezoelectric transducer; pressure transducer; temperature transducer; humidity transducer; vibrational transducer; audio transducer; speaker; and combinations of one or more of these. In some embodiments, a functional element comprises a needle, a catheter (e.g., a distal portion of a catheter), an iontophoretic element or a porous membrane, such as an agent delivery element configured to deliver one or more agents. In some embodiments, a functional element comprises one or more sensors selected from the group consisting of: electrode; sensor configured to record electrical activity of tissue; blood glucose sensor such as an optical blood glucose sensor; pressure sensor; blood pressure sensor; heart rate sensor; inflammation sensor; neural activity sensor; muscularactivity sensor; pH sensor; strain gauge; accelerometer; gyroscope; GPS; respiration sensor; respiration rate sensor; temperature sensor; magnetic sensor; optical sensor; MEMs sensor; chemical sensor; hormone sensor; impedance sensor; tissue impedance sensor; body position sensor; body motion sensor; physical activity level sensor; perspiration sensor; patient hydration sensor; breath monitoring sensor; sleep monitoring sensor; food intake monitoring sensor; urine movement sensor; bowel movement sensor; tremor sensor; pain level sensor; orientation sensor; motion sensor; and combinations of one or more of these.

[0057] The term “transducer” as used herein is to be taken to include any component or combination of components that receives energy or any input and produces an output. For example, a transducer may include an electrode that receives electrical energy and distributes the electrical energy to tissue (e.g., based on the size of the electrode). In some configurations, a transducer converts an electrical signal into any output, such as light (e.g., a transducer comprising a light emitting diode or light bulb), sound (e.g., a transducer comprising a piezo crystal configured to deliver ultrasound energy), pressure, heat energy, cryogenic energy, chemical energy, mechanical energy (e.g., a transducer comprising a motor or a solenoid), magnetic energy, and / or a different electrical signal (e.g., a Bluetooth or other wireless communication element). Alternatively, or additionally, a transducer may convert a physical quantity (e.g., embodiments in a physical quantity) into an electrical signal. A transducer may include any component that delivers energy and / or an agent to tissue, such as a transducer configured to deliver one or more of: electrical energy to tissue (e.g., a transducer comprising one or more electrodes); light energy to tissue (e.g., a transducer comprising a laser, light emitting diode and / or optical component such as a lens or prism); mechanical energy to tissue (e.g., a transducer comprising a tissue manipulating element); sound energy to tissue (e.g., a transducer comprising a piezo crystal); thermal energy to tissue (e.g., heat energy and / or cryogenic energy); chemical energy; electromagnetic energy; magnetic energy; and combinations of one or more of these.

[0058] The term “transmission signal” where used herein is to be taken to include any signal transmitted between two components, such as via a wired or wireless communication pathway. For example, a transmission signal may comprise a power and / or data signal wirelessly transmitted between a component external to the patient and one or more components implanted in the patient. A transmission signal may include one or more signals transmitted using bodyconduction. Alternatively, or additionally, a transmission signal may comprise reflected energy, such as energy reflected from any power and / or data signal.

[0059] The term “data signal” where used herein is to be taken to include a transmission signal including at least data. For example, a data signal may comprise a transmission signal including data and sent between a component external to the patient and one or more components implanted in the patient. Alternatively, a data signal may comprise a transmission signal including data sent from an implanted component to one or more components external to the patient. A data signal may comprise a radiofrequency signal including data (e.g., a radiofrequency signal including both power and data) and / or a data signal sent using body conduction.

[0060] The term “implantable” as used herein is to be taken to define a component which is constructed and arranged to be fully or partially implanted in a patient’s as and / or a component that has been fully or partially implanted in a patient. The term “external” as used herein is to be taken to define a component which is constructed and arranged to be positioned outside of the patient’s body.

[0061] The terms “attachment”, “attached”, “attaching”, “connection”, “connected”, “connecting” and the like, as used herein, are to be taken to include any type of connection between two or more components. The connection may include an “operable connection” or “operable attachment” which allows multiple connected components to operate together such as to transfer information, power, and / or material (e.g., an agent to be delivered) between the components. An operable connection may include a physical connection, such as a physical connection including a connection between two or more: wires or other conductors (e.g., an “electrical connection”), optical fibers, wave guides, tubes such as fluid transport tubes, and / or linkages such as translatable rods or other mechanical linkages. Alternatively, or additionally, an operable connection may include a non-physical or “wireless” connection, such as a wireless connection in which information and / or power is transmitted between components using electromagnetic energy. A connection may include a connection selected from the group consisting of: a wired connection; a wireless connection; an electrical connection; a mechanical connection; an optical connection; a sound propagating connection; a fluid connection; and combinations of one or more of these.

[0062] The term “connecting filament” as used herein is to be taken to define a filament connecting a first component to a second component. The connecting filament may include a connector on one or both ends, such as to allow a user to operably attach at least one end of the filament to a component. A connecting filament may comprise one or more elements selected from the group consisting of wires; optical fibers; fluid transport tubes; mechanical linkages; wave guides; flexible circuits; and combinations of one or more of these. A connecting filament may comprise rigid filament, a flexible filament or it may comprise one or more flexible portions and one or more rigid portions.

[0063] The term “connectorized” as used herein is to be taken to refer to a filament, housing or other component that includes one or more connectors (e.g., clinician or other user-attachable connectors) for operably connecting that component to a mating connector (e.g., of the same or different component).

[0064] The terms “stimulation parameter”, “stimulation setting”, “stimulation signal parameter”, “stimulation signal setting”, “stimulation waveform parameter”, or “stimulation waveform setting” as used herein may be taken to refer to one or more parameters of a stimulation waveform (also referred to as a stimulation signal). A “stimulation paradigm SP” may represent one or more sets of stimulation parameters to be used in delivering stimulation energy. Applicable stimulation parameters of the present inventive concepts shall include but are not limited to: amplitude (e.g., amplitude of voltage and / or current); average amplitude; peak amplitude; frequency; average frequency; pulse width (also referred to as “pulse pattern on time”); period; phase; polarity; pulse shape; a duty cycle parameter (e.g., frequency, pulse width, and / or off time); inter-pulse gap (also referred to as “pulse pattern off time”, or “inter-pulse interval”); polarity; burst-on (also referred to as “dosage on”) period; burst-off (also referred to as “dosage off’) period; inter-burst period; pulse train; train-on period; train-off period; intertrain period; drive impedance; duration of pulse and / or amplitude level; duration of stimulation waveform; repetition of stimulation waveform; an amplitude modulation parameter; a frequency modulation parameter; a burst parameter; a power spectral density parameter; an anode / cathode configuration parameter; amount of energy and / or power to be delivered; rate of energy and / or power delivery; time of energy delivery initiation; method of charge recovery; and combinations of one or more of these. A stimulation parameter may refer to a single stimulation pulse, multiple stimulation pulses, or a portion of a stimulation pulse. The term “amplitude” as usedherein may refer to an instantaneous or continuous amplitude of one or more stimulation pulses (e.g., the instantaneous voltage level or current level of a pulse). The term “pulse” as used herein may refer to a period of time during which stimulation energy is relatively continuously being delivered. In some embodiments, stimulation energy delivered during a pulse comprises energy selected from the group consisting of: electrical energy; magnetic energy; electromagnetic energy; light energy; sound energy such as ultrasound energy; mechanical energy such as vibrational energy; thermal energy such as heat energy or cryogenic energy; chemical energy; and combinations of one or more of these. In some embodiments, stimulation energy comprises electrical energy and a pulse comprises a phase change in current and / or voltage. In these embodiments, an “inter-phase gap” may be present within a single pulse. The term inter-phase gap as used herein may refer to a period of time between two portions of a pulse comprising a phase change during which zero energy or minimal energy is delivered. The term “quiescent period” where used herein may refer to a period of time during which zero energy or minimal energy is delivered (e.g., insufficient energy to elicit an action potential and / or other neuronal response). The term “inter-pulse gap” where used herein may refer to a quiescent period between the end of one pulse to the onset of the next (sequential) pulse. The terms “pulse train” or “train” as used herein may refer to a series of pulses. The terms “burst”, “burst of pulses” or “burst stimulation” where used herein may refer to a series of pulse trains, each separated by a quiescent period. The term “train-on period” where used herein may refer to a period of time from the beginning of the first pulse to the end of the last pulse of a single train. The term “train- off period” where used herein may refer to a quiescent period between the end of one train and the beginning of the next train. The term “burst-on period” where used herein may refer to a period of time from the beginning of the first pulse of the first train to the end of the last pulse of the last train of a single burst. The term “burst-off period” where used herein may refer to a quiescent period between the end of one burst and the beginning of the next burst. The term “inter-train period” where used herein may refer to a quiescent period between the end of one train and the beginning of the next train. The term “inter-burst period” where used herein may refer to a quiescent period between the end of one burst and the beginning of the next burst. The term “train envelope” where used herein may refer to a curve outlining the amplitude extremes of a series of pulses in a train. The term “burst envelope” where used herein may refer to a curve outlining the amplitude extremes of a series of pulses in a burst. The term “train ramp duration”where used herein may refer to the time from the onset of a train until its train envelope reaches a desired target magnitude. The term “burst ramp duration” where used herein may refer to the time from the onset of a burst until its burst envelope reaches a desired target magnitude.

[0065] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination. For example, it will be appreciated that all features set out in any of the claims (whether independent or dependent) may be combined in any given way.

[0066] The present inventive concepts include a medical apparatus and clinical methods for treating a patient, such as to treat pain. The patient may comprise a human or other mammalian patient. The medical apparatus may comprise a stimulation apparatus. The medical apparatus may comprise an implantable system and an external system. The implantable system may comprise one or more similar and / or dissimilar implantable devices. Each implantable device comprises a housing surrounding one or more stimulation producing components. A lead comprising one or more stimulation elements may be pre-attached to the housing, or attachable to the housing (e.g., attached in a clinical procedure in which the implantable device is implanted in a patient).

[0067] The apparatus may include a trialing interface which provides energy to the stimulation elements during the implantation procedure, such as to confirm proper placement of the stimulation elements and / or to titrate the stimulation delivered. In embodiments in which the lead is pre-attached to the housing of the implantable device, the trialing interface may be configured to provide power (e.g., wireless power) to the implantable device, the implantable device providing stimulation energy to the stimulation elements derived from the power provided by the trialing interface. In embodiments in which the lead is attachable to the housing of the implantable device, the trialing interface may attach to the lead (prior to its attachment to the housing of the implantable device), and the trialing interface may then provide the stimulation energy directly to the stimulation elements.

[0068] In some embodiments, the implantable system comprises a first implantable device that delivers stimulation energy via energy received wirelessly from one or more external devices, and a second implantable device that delivers stimulation energy via an integral (e.g., implanted)battery. In these embodiments, the first implantable device may be configured to deliver stimulation energy during a limited period of time (e.g., a trial period in which stimulation settings are determined and / or acceptability of the apparatus is determined), and the second implantable device may be configured to deliver stimulation energy for a prolonged period of time in which long-term stimulation therapy is provided to a patient. In these embodiments, a single implantable lead comprising one or more stimulation energy delivery elements (e.g., electrodes) may be connected to the first implantable device and then the second implantable device. In some embodiments, a first implantable device may be configured to remain implanted in the patient for a limited period of time, such as to reduce cost of manufacture, and a second implantable device is configured for a longer implant life. The first implantable device may be used in a trialing procedure in which the stimulation apparatus is assessed for acceptable use (e.g., by the patient and / or clinician) and / or one or more stimulation settings are optimized or otherwise determined.

[0069] Each implantable device may comprise one or more implantable antennas configured to receive power and / or data. Each implantable device may comprise an implantable receiver configured to receive the power and / or data from the one or more implantable antennas. Each implantable device may comprise one or more implantable functional elements (e.g., an implantable stimulation element). An implantable functional element may be configured to interface with the patient (e.g., interface with tissue of the patient or interface with any patient location). Alternatively, or additionally, an implantable functional element may interface with a portion of an implantable device (e.g., to measure an implantable device parameter). In some embodiments, the one or more implantable functional elements may comprise one or more transducers, electrodes, and / or other elements configured to deliver energy to tissue. Alternatively, or additionally, the one or more implantable functional elements may comprise one or more sensors, such as a sensor configured to record a physiologic parameter of the patient. In some embodiments, one or more implantable functional elements are configured to record device information and / or patient information (e.g., patient physiologic or patient environment information).

[0070] Each implantable device may comprise an implantable controller configured to control (e.g., modulate power to, send a signal to, and / or receive a signal from) the one or more implantable functional elements. In some embodiments, an implantable controller of a firstimplantable device is configured to control one or more other implantable devices. Each implantable device may comprise an implantable energy storage assembly (e.g., a battery and / or a capacitor) configured to provide power to the implantable controller (e.g., a controller comprising a stimulation waveform generator), the implantable receiver and / or the one or more implantable functional elements. In some embodiments, an implantable energy storage assembly is further configured to provide power to an assembly that transmits signals via the implantable antenna (e.g., when the implantable device is further configured to transmit data to one or more external devices). Each implantable device may comprise an implantable housing surrounding the implantable controller and the implantable receiver. In some embodiments, one or more implantable antennas are positioned within the implantable housing. Alternatively, or additionally, one or more implantable antennas and / or implantable functional elements may be positioned outside the implantable housing, and tethered (e.g., electrically tethered) to one or more electrical components of the implantable device positioned within the implantable housing. In some embodiments, one or more implantable functional elements are positioned on an implantable lead, such as a flexible lead mechanically fixed or attachable to the implantable housing and operably connected (e.g., electrically, fluidly, optically and / or mechanically) to one or more components internal to the implantable housing. The implantable lead may be inserted (e.g., tunneled) through tissue of the patient, such that its one or more functional elements are positioned proximate tissue to be treated and / or positioned at an area in which data is to be recorded. In some embodiments, the implantable lead is configured to operably attach to and / or detach from, multiple implantable devices.

[0071] The external system of the medical apparatus of the present inventive concepts may comprise one or more similar and / or dissimilar external devices. Each external device may comprise one or more external antennas configured to transmit power and / or data to one or more implanted components of the implantable system. Each external device may comprise an external transmitter configured to drive the one or more external antennas. Each external device may comprise an external power supply configured to provide power to at least the external transmitter. Each external device may comprise an external programmer configured to control the external transmitter and / or an implantable device (e.g., when an external power transmitter is not included in the apparatus or otherwise not present during use). Each external device may comprise an external housing that surrounds at least the external transmitter. In someembodiments, the external housing surrounds the one or more external antennas, the external power supply and / or the external programmer.

[0072] The external programmer may comprise a discrete controller separate from the one or more external devices, and / or a controller integrated into one or more external devices. The external programmer may comprise a user interface, such as a user interface configured to set, adjust, and / or otherwise modify one or more treatment and / or data recording settings of the medical apparatus of the present inventive concepts. In some embodiments, the external programmer is configured to collect and / or diagnose recorded patient information, such as to provide the information and / or diagnosis to a clinician of the patient, to a patient family member and / or to the patient themselves. The collected information and / or diagnosis may be used to modify treatment or other operating parameters of the medical apparatus. In some embodiments, at least two external programmers are included, such as a first external programmer configured for use by the patient, and a second external programmer configured for use by a clinician of the patient.

[0073] In some embodiments, a medical apparatus comprises a stimulation apparatus for activating, blocking, affecting or otherwise stimulating (hereinafter “stimulate” or “stimulating”) tissue of a patient, such as nerve tissue or nerve root tissue (hereinafter “nerve”, “nerves”, “nerve tissue” or “nervous system tissue”). The stimulation apparatus comprises an external system configured to transmit power, and an implanted system configured to receive the power from the external system and to deliver stimulation energy to tissue. The delivered stimulation energy may comprise one or more stimulation waveforms, such as a stimulation waveform configured to enhance treatment of pain while minimizing undesired effects. The stimulation signal (also referred to as “stimulation energy” herein) delivered by the implanted system may be independent of the power received from the external system, such as to be independent of one or more of: the position of one or more components of the external system; the changing position of one or more components of the external system; the frequency of the power received from the external system; the amplitude of the power received from the external system; changes in amplitude of the power received from the external system; duty cycle of the power received from the external system; envelope of the power received from the external system; and combinations of one or more of these.

[0074] Referring now to FIG. 1, a schematic anatomical view of a medical apparatus for providing a therapy to a patient is illustrated, consistent with the present inventive concepts. Apparatus 10 comprises implantable system 20 and external system 50. External system 50 transmits transmission signals to one or more components of implantable system 20. These transmission signals may comprise power and / or data. Implantable system 20 comprises one or more implantable devices, implantable device 200 shown, which may be implanted beneath the skin of patient P.

[0075] In some embodiments, implantable system 20 comprises multiple similar or dissimilar implantable devices 200 (singly or collectively implantable device 200), such as is described in applicant’s co-pending United States Patent Application Serial Number 17 / 372,095, titled “Apparatus with Enhanced Stimulation Waveforms”, filed July 9, 2021. Each implantable device 200 may be configured to receive power and data from a transmission signal transmitted by external system 50, such as when stimulation energy delivered to the patient (e.g., to nerve or other tissue of the patient) by implantable device 200 is provided via wireless transmissions signals from external system 50. In some embodiments, implantable system 20 comprises at least two implantable devices, such as implantable device 200 and implantable device 200’ shown in FIG. 1. Implantable device 200’ may be of similar construction and arrangement to implantable device 200, and it may include components of a different configuration. Each implantable device 200 comprises one or more housings, housing 210 shown, which surrounds various other components of device 200. Each implantable device 200 comprises one or more stimulation and / or other functional elements, such as stimulation element 260 shown, where stimulation elements 260 are configured to deliver stimulation energy, a stimulating drug or other agent, and / or another form of stimulation (e.g., another form of tissue stimulation) to the patient. In some embodiments, one or more stimulation elements 260 are further configured as a sensor (e.g., when comprising an electrode configured to both deliver electrical energy and record electrical signals). Each implantable device 200 may include one or more leads, lead 265 shown, and each lead 265 may include one or more stimulation elements 260. Alternatively, or additionally, one or more stimulation elements 260 may be positioned on housing 210 or one or more other components of implantable device 200. Each lead may include one or more elements configured to anchor lead 265 to tissue, such as anchor element 221 shown. Anchor element 221 may be configured to slidingly receive the shaft of lead 265 (e.g., to position anchor element 221about lead 265 in manufacturing and / or in an implantation procedure). Anchor element 221 may include one or more fixation points, such as one or more circumferential recesses. Surgical clips or sutures may be placed around a recess and into tissue, such as to fixate anchor element 221 and an inserted lead 265 to tissue.

[0076] Each implantable device 200 may comprise one or more other types of functional elements, such as functional element 299a shown positioned proximate housing 210 (e.g., within and / or on the external surface of housing 210) and / or functional element 299b shown positioned on lead 265. Functional element 299a and / or 299b (singly or collectively functional element 299) may comprise a transducer, a sensor, and / or other functional element as described herein. In some embodiments, a functional element 299 comprises a visualizable marker, such as a radiopaque marker, an ultrasonically visible marker, and / or a magnetic marker.

[0077] External system 50 may comprise external device 500, where external device 500 is configured to deliver power and / or data to one or more implantable devices 200. External device 500 includes one or more housings, housing 510 shown, which carries, and in some embodiments, surrounds various other components of device 500. In some embodiments, the housing 510 may be a wearable housing, such as a housing configured to be positioned on a patient’s skin. In some embodiments, external system 50 comprises multiple external devices 500 (singly or collectively external device 500), such as an external device as is described in applicant’s co-pending United States Patent Application Serial Number 17 / 372,095, titled “Apparatus with Enhanced Stimulation Waveforms”, filed July 9, 2021. In some embodiments, external system 50 comprises at least two, or at least three external devices (e.g., at least two external devices configured to deliver power and / or data to one or more implantable devices 200), such as external device 500, external device 500’, and external device 500” shown in FIG. 1. External device 500’ and / or 500” may be of similar construction and arrangement to external device 500, and these devices may include components of a different configuration.

[0078] External system 50 may comprise one or more programming devices, programmer 600, such as patient programmer 600’ and clinician programmer 600” shown. Patient programmer 600’ and clinician programmer 600” (singly or collectively programmer 600) may each comprise a user interface, such as user interfaces 680’ and 680” shown (singly or collectively user interface 680). Programmer 600 may be configured to control one or more external devices 500. Alternatively, or additionally, programmer 600 may be configured to control one or moreimplantable devices 200 (e.g., when no external device 500 is included in apparatus 10 or at least no external device 500 is available to communicate with an implantable device 200). Patient programmer 600’ may be configured to be used by the patient, patient caregiver (e.g., clinician of the patient), and / or a family member of the patient.

[0079] Clinician programmer 600” may be of similar construction and arrangement to patient programmer 600’. In some embodiments, clinician programmer 600” provides additional functions not available using patient programmer 600’. In some embodiments, clinician programmer 600” may modify the programming of patient programmer 600’ (e.g., modify the programming options available to the patient or family member of the patient).

[0080] Patient programmer 600’ may be further configured as a smart phone, a music playing device (e.g., an mp3 player), and / or other portable or non-portable electronic device. For example, patient programmer 600’ may comprise a smart phone or other commercial device onto which a software program of apparatus 10 is embedded to cause the commercial device to function as patient programmer 600’. Clinician programmer 600” may comprise a tablet-like device. For example, clinician programmer 600” may comprise a commercial tablet device onto which a software program of apparatus 10 is embedded to cause the commercial tablet to function as clinician programmer 600”.

[0081] Clinician programmer 600” may configure multiple (e.g., all) external devices 500 used by a patient, as well as patient programmer 600’, so that the set of devices are configured as a “trusted” network. Once this trusted configuration is in place, patient programmer 600’ may safely and effectively communicate with the one or more external devices 500 of the patient. The patient programmer 600’ may upload (e.g., automatically upload) configuration information from an external device 500 (e.g., stimulation settings and the like). In some embodiments, patient programmer 600’ and / or clinician programmer 600” uploads configuration information from an external device 500 any time certain information (e.g., stimulation information) on that external device 500 has changed (e.g., a change is detected by the programmer 600 or otherwise).

[0082] External system 50 may comprise one, two, three, or more functional elements, such as functional elements 599a, 599b, and / or 599c (singly or collectively functional element 599), shown positioned in external device 500, patient programmer 600’, and clinician programmer 600”, respectively.

[0083] Apparatus 10 may be configured to stimulate tissue (e.g., stimulate nerve tissue such as tissue of the central nervous system or tissue of the peripheral nervous system, such as to neuromodulate nerve tissue), such as by having one or more implantable devices 200 deliver and / or otherwise provide energy (hereinafter “deliver energy”) and / or deliver an agent (e.g., a pharmaceutical compound or other agent) to one or more tissue locations, such as via one or more stimulation elements 260. In some embodiments, one or more implantable devices 200 deliver energy and / or an agent while receiving power and / or data from one or more external devices 500. In some embodiments, one or more implantable devices 200 deliver energy and / or an agent (e.g., continuously or intermittently) using energy provided by an internal power source (e.g., a battery and / or capacitor) without receiving externally supplied power, such as for periods of at least 1 hour, at least 1 day, at least 1 month or at least 1 year. In some embodiments, one or more stimulation parameters are varied (e.g., systematically and / or randomly), during that period.

[0084] In some embodiments, apparatus 10 is further configured as a patient diagnostic apparatus, such as by having one or more implantable devices 200 record a patient parameter (e.g., a patient physiologic parameter) from one or more tissue locations, such as while receiving power and / or data from one or more external devices 500. In some embodiments, during its use, one or more implantable devices 200 at least receives power from one or more external devices 500 (e.g., with or without also receiving data). Alternatively, or additionally, one or more patient parameters may be recorded by an external device of apparatus 10, such as via a programmer 600 and / or an external device 500.

[0085] Apparatus 10 may be configured as a patient information recording apparatus, such as by having one or more implantable devices 200 and / or one or more external devices 500 record patient information (e.g., patient physiologic information and / or patient environment information). In some embodiments, one or more implantable devices 200 and / or one or more external devices 500 further collect information (e.g., status information or configuration settings) of one or more of the components of apparatus 10.

[0086] In some embodiments, apparatus 10 is configured as a stimulation apparatus in which external system 50 transmits a power signal to one or more implantable devices 200, and the one or more implantable devices 200 deliver stimulation energy to tissue with a stimulation signal (also referred to as a stimulation waveform), with the power signal and the stimulation signalhaving one or more different characteristics (e.g., as described herein). The power signal may be modulated with data (e.g., configuration or other data to be sent to one or more implantable devices 200). In these embodiments, the characteristics of the stimulation signal delivered (e.g., amplitude, frequency, duty cycle and / or pulse width) may be independent (e.g., partially or completely independent) of the characteristics of the power signal transmission (e.g., amplitude, frequency, phase, envelope, duty cycle and / or modulation). For example, the frequency and modulation of the power signal may change without affecting those or other parameters of the stimulation signal, and / or the parameters of the stimulation signal may be changed (e.g., via programmer 600), without requiring similar or any changes to the power signal. In some embodiments, implantable system 20 is configured to rectify the received power signal, and to produce a stimulation waveform with entirely different characteristics (e.g., amplitude, frequency and / or duty cycle) from the rectified power signal. Each implantable device 200 may comprise an oscillator and / or controller configured to produce the stimulation signal. In some embodiments, one or more implantable devices 200 is configured to perform frequency multiplication, in which multiple signals are multiplexed, mixed, added, and / or combined in other ways to produce a broadband stimulation signal.

[0087] In some embodiments, apparatus 10 is configured such that external system 50 transmits data (e.g., data and power) to implantable system 20, and implantable system 20 recovers (e.g., decodes, demodulates or otherwise recovers) the transmitted data without synchronizing to the carrier and / or data symbol rate of the transmitted signal from external system 50. In some embodiments, the transmitted signal comprises a power signal, and a clock and / or data is recovered without synchronizing to the power signal. In some embodiments, the transmitted signal comprises a clock and / or data signal, and a clock and / or data is recovered without synchronizing to the transmitted clock and / or data signal. In some embodiments, the recovered signal comprises a clock and / or data and a clock and / or data is recovered from the transmission signal without synchronizing to the recovered clock and / or data. Avoiding synchronization reduces power consumption of each implantable device 200, such as by obviating the need for (and avoiding the power consumed by) a frequency locked loop (FLL); phase locked loop (PLL); high frequency clock; and / or crystal oscillator needed to perform the synchronization. Avoiding these components may also be correlated to reduced package size of each implantable device 200 (e.g., avoidance of a relatively large sized crystal oscillator).Asynchronous data transfer between external system 50 and implantable system 20 is also advantageous as it relates to: increased communication data rate; power transfer efficiency; operation with more than one implantable device 200; and combinations of one or more of these. In some embodiments, one or more components of apparatus 10 are of similar construction and arrangement as similar components described in United States Patent Application Serial Number 13 / 591,188, titled “Method of Making and Using an Apparatus for a Locomotive Micro-Implant using Active Electromagnetic Propulsion”, filed August 21, 2012. In some embodiments, external system 50 and implantable system 20 provide asynchronous data transfer or are otherwise configured as described in United States Patent Application Serial Number 13 / 734,772, titled “Method and Apparatus for Efficient Communication with Implantable Devices”, filed January 4, 2013.

[0088] Apparatus 10 may be configured to treat pain, such as back pain and / or limb pain treated by stimulating dorsal root ganglia and / or other nerves or locations of the spinal cord or other nervous system locations. In some embodiments, apparatus 10 is configured to treat a type of pain selected from the group consisting of: back pain; joint pain; neuropathic pain; tennis elbow; muscle pain; shoulder pain; chronic, intractable pain of the back and / or limbs including unilateral or bilateral pain; neuropathic groin pain; perineal pain; phantom limb pain; complex regional pain syndrome; failed back surgery syndrome; cluster headaches; migraines; inflammatory pain; arthritis; abdominal pain; pelvic pain; and combinations of one or more of these. Delivered energy may comprise energy selected from the group consisting of: electrical energy; magnetic energy; electromagnetic energy; light energy such as infrared light energy, visible light energy and / or ultraviolet light energy; mechanical energy; thermal energy such as heat energy and / or cryogenic energy; sound energy such as ultrasonic sound energy (e.g., high intensity focused ultrasound and / or low intensity focused ultrasound) and / or subsonic sound energy; chemical energy; and combinations of one or more of these. In some embodiments, apparatus 10 is configured to deliver to tissue energy in a form selected from the group consisting of: electrical energy such as by providing a controlled (e.g., constant or otherwise controlled) electrical current and / or voltage to tissue; magnetic energy (e.g., magnetic field energy) such as by applying controlled current or voltage to a coil or other magnetic field generating element positioned proximate tissue; and / or electromagnetic energy such as by providing both current to tissue and a magnetic field to tissue. A coil or other magnetic fieldgenerating element may surround (e.g., at least partially surround) the target nerve. Alternatively, or additionally, the magnetic energy may be applied externally and focused to specific target tissue via an implant comprising a coil and / or ferromagnetic materials. In some embodiments, the magnetic energy is configured to induce the application of mechanical energy. Delivered energy may be supplied in one or more stimulation waveforms, each waveform comprising one or more pulses of energy, as described in detail herein.

[0089] In some embodiments, apparatus 10 is configured to treat a patient disease or disorder selected from the group consisting of: chronic pain; acute pain; migraine; cluster headaches; urge incontinence; pelvic dysfunction such as overactive bladder; fecal incontinence; bowel disorders; tremor; obsessive compulsive disorder; depression; epilepsy; inflammation; tinnitus; hypertension; heart failure; carpal tunnel syndrome; sleep apnea; obstructive sleep apnea; dystonia; interstitial cystitis; gastroparesis; obesity; mobility issues; arrhythmia; rheumatoid arthritis; dementia; Alzheimer’s disease; eating disorder; addiction; traumatic brain injury; chronic angina; congestive heart failure; muscle atrophy; inadequate bone growth; postlaminectomy pain; liver disease; Crohn’s disease; irritable bowel syndrome; erectile dysfunction; kidney disease; and combinations of one or more of these.

[0090] As described hereabove, external system 50 may be configured to transmit power and / or data (e.g., implantable system 20 configuration data) to one or more implantable devices 200 of implantable system 20. Implantable system 20 configuration data provided by external system 50 (e.g., via one or more antennas, antenna 540 shown, of one or more external devices 500) may include when to initiate stimulation delivery (e.g., energy delivery), and / or when to stop stimulation delivery, and / or it may include data related to the value or change to a value of one or more stimulation variables as described hereabove. The configuration data may include a stimulation parameter such as an agent (e.g., a pharmaceutical agent) delivery stimulation parameter selected from the group consisting of: initiation of agent delivery; cessation of agent delivery; amount of agent to be delivered; volume of agent to be delivered; rate of agent delivery; duration of agent delivery; time of agent delivery initiation; and combinations of one or more of these. The configuration data may include a sensing parameter, such as a sensing parameter selected from the group consisting of: initiation of sensor recording; cessation of sensor recording; frequency of sensor recording; resolution of sensor recording; thresholds ofsensor recording; sampling frequency of sensor recording; dynamic range of sensor recording; initiation of calibration of sensor recording; and combinations of one or more of these.

[0091] As described hereabove, external system 50 may comprise one or more external devices 500. External system 50 may comprise one or more antennas 540, such as when a single external device 500 comprises one or more antennas 540, and / or when multiple external devices 500 each comprise one or more antennas 540. The one or more antennas 540 may transmit power and / or data to one or more antennas 240 of implantable system 20, such as when a single implantable device 200 comprises one or more antennas 240, and / or when multiple implantable devices 200 each comprise one or more antennas 240. A single external antenna 540 may be configured to transmit power and / or data to multiple implantable devices 200 (e.g., each containing one or more antennas 240). In some embodiments, a single external device 500, comprising one or more antennas 540 may be configured to transmit power and / or data to multiple implantable devices 200. In some embodiments, one or more antennas 540 define a radiation footprint (e.g., a footprint defining a volume, such as a volume of tissue, in which electromagnetic transmissions radiated by antennas 540 may be properly received by antennas 240), such as is described in Applicant’s United States Patent Application Serial Number 17 / 412,044, titled “Medical Apparatus Including an Implantable System and an External System”, filed August 25, 2021.

[0092] External system 50 transmits power and / or data with a transmission signal comprising at least one wavelength, X. External system 50 and / or implantable system 20 may be configured such that the distance between an external antenna 540 transmitting the power and / or data and one or more implantable antennas 240 receiving the power and / or data transmission signal is equal to between 0.1X and 10. OX, such as between 0.2X and 2. OX. In some embodiments, one or more transmission signals are delivered by a transmitter, transmitter 530, at a frequency range (e.g., a predetermined frequency range) between 10MHz and 10.6GHz, such as between 0.1GHz and 10.6GHz, between 10MHz and 3.0GHz, between 40MHz and 1.5GHz, between 10MHz and 100MHz, between 0.902GHz and 0.928GHz, in a frequency range proximate to 40.68MHz, in a frequency range proximate to 866MHz, or approximately between 863MHz and 870MHz. As another example, the frequency range (e.g., predetermined frequency range) may be about 1 MHz to about 100 MHz, such as about 5 MHz to about 90 MHz, about 10 MHz to about 80 MHz, about 15 MHz to about 70 MHz, about 20 MHz to about 60 MHz, about 25 MHz to about55 MHz, or about 30 MHz to about 50 MHz. Transmitter 530 may comprise a transmitter that produces a transmission signal with a power level between 0.01W and 4.0W, such as a transmission signal with a power level between 0.01W and 2.0W or between 0.2W and 1.0W.

[0093] In addition to transmitting power and / or data to implantable system 20, external system 50 may be further configured to provide information (e.g., patient information and / or apparatus 10 performance information) to one or more other components of apparatus 10, such as tool 60 shown in FIG. 1 and described in detail herein.

[0094] One or more external devices 500 (singly or collectively external device 500) may be configured to transmit power and / or data (e.g., implantable system 20 configuration data) to one or more implantable devices 200 (singly or collectively implantable device 200). In some embodiments, one or more external devices 500 are configured to transmit both power and data (e.g., simultaneously and / or sequentially) to one or more implantable devices 200. In some embodiments, one or more external devices 500 are further configured to receive data from one or more implantable devices 200 (e.g., via data transmitted by one or more antennas 240 of one or more implantable devices 200). Each external device 500 may comprise housing 510, power supply 570, a transmitter 530, a controller 550, and / or one or more antennas 540, each shown in FIG. 1 and described in detail herein. Each external device 500 may further comprise one or more functional elements 599a, such as a functional element comprising a sensor, electrode, energy delivery element, a magnetic-field-generating transducer, agent delivery element, and / or any transducer, also described in detail herein. In some embodiments, a functional element 599a comprises one or more sensors configured to monitor performance of external device 500 (e.g., to monitor voltage of power supply 570, quality of transmission of power and / or data to implantable system 20, temperature of a portion of an external device 500, and the like).

[0095] One or more housings 510 (singly or collectively housing 510) of each external device 500 may comprise one or more rigid and / or flexible materials which may carry (e.g., surround) various components of external device 500 such as antenna 540, transmitter 530, controller 550, and / or power supply 570 shown in FIG. 1. In some embodiments, the housing 510 may enclose or otherwise carry one or more antennae (e.g., antenna 540 and antenna 5711) and one or more shielding layers, which may be attached (e.g., fixedly attached) to the one or more antennae (e.g., a first shielding layer may be attached to a first antenna, and a second shielding layer may be attached to a second antenna). In some embodiments, a single external device 500 comprisesmultiple discrete (i.e. separate) housings 510, two or more of which may each transfer data and / or other signals via a wired or wireless connection to the other, to an implantable device 200, and / or to another component of apparatus 10. In some embodiments, a housing 510 further surrounds a programmer 600 (e.g., programmer 600’ or 600”) and / or a power supply 570. In some embodiments, housing 510 comprises both a rigid material and a flexible material. In some embodiments, housing 510 comprises a material selected from the group consisting of: plastic; injection-molded plastic; an elastomer; metal; and combinations of one or more of these. In some embodiments, housing 510 comprises a shielded portion (e.g., shielded to prevent transmission of electromagnetic waves), and an unshielded portion, such as an unshielded portion surrounding antenna 540.

[0096] Housing 510 may comprise an adhesive element (e.g., a spacer 511, as described herein, configured as an adhesive element), such as an adhesive element configured to temporarily attach an external device 500 to the patient’s skin. Accordingly, in some embodiments, the external device 500 may be configured to be positioned on a body of a patient, over an implantable device (e.g., implantable device 200). Alternatively, or additionally, housing 510 may be constructed and arranged to engage (e.g., fit in the pocket of) a patient attachment device, such as patient attachment device 70 described herein.

[0097] One or more antennas 540 (singly or collectively antenna 540) may each comprise one, two, three, or more external antennas. Antenna 540 may comprise one or more polarizable antennas, such as one or more antennas with adjustable polarization. Antenna 540 may comprise an array of antennas, such as an array of antennas configured to: support beam shaping and / or focusing; allow adjustment of the amplitude and / or phase of the transmission signal; increase the radiation footprint; and combinations of one or more of these. An array of antennas 540 may be configured to be selectively activated, such as to improve coupling with one or more implanted antennas 240, such as to adjust for movement of the array of the antennas 540 relative to the implanted antennas 240. Antenna 540 may comprise an array of selectable conductors configured to adjust a radiation pattern and / or an electromagnetic field of a resultant antenna. Antenna 540 may comprise a surface and shield material or shielding layer (not shown) positioned on the surface, such as when the shield material is positioned on the side facing away from the patient’s skin. The shield material may comprise radio-absorptive shield material and / or radio-reflective shield material. For antenna 540 to operate effectively at higherfrequencies, the shield material may comprise a ferrite material that has a low conductivity and low magnetic loss tangent at a frequency of interest, and whereby a higher permeability is achieved. For example, one or more shielding layers of the antenna 540 may include one or both of a conductive material and a ferromagnetic material. By placing a material with a high magnetic permeability (p’), low magnetic loss tangent (p’7p’), and low conductivity at the operating frequency (such as a high frequency ferrite) between the antenna and other elements of the transmitter, the losses or loading effects due to these elements may be dramatically reduced. For example, one or more shielding layers of the antenna 540 may have a magnetic loss tangent of less than or equal to 0.025 at a predetermined frequency range, such as a range of about 30 MHz to about 50 MHz. In some cases, the magnetic field magnification of this shielding layer will enhance the overall performance. Additionally, this layer shields the outside environment from unwanted radiation from the antenna, and it protects the antenna from radiation originating in the environment. Further, the one or more shielding layers may be configured to prevent coupling between a plurality of antennae of the external device 500, such as between a first antenna (e.g., antenna 540) and second antenna (e.g., antenna 5711).

[0098] In some embodiments, a spacing layer is positioned between antenna 540 and the shield material. The spacing layer may comprise a thickness of between 0mm and 5mm, such as between 0. 25mm and 1mm. The spacing layer may comprise non-conductive dielectric materials, air, or other materials that have minimal impact on antenna performance. The spacing layer may also be incorporated into a board thickness, with the antenna being constructed on the opposite side of the board in relation to the shielding layer. The shielding layer may comprise a ferrite material as described hereabove, or any material with the desired permeability, magnetic loss, and conductivity at the frequency of interest. The thickness of the shielding layer may be dependent on its specific material properties and the application. In some embodiments, a conductive layer on the side of the shielding layer is positioned opposite the antenna to further shield unwanted radiation. To reduce weight, the shielding layer material may be porous or incorporate holes or slots spaced in a way to minimize the reduction in performance. The holes and spacings may be sized smaller than a wavelength of the RF signal. If no spacing layer is used, the shielding layer may extend inside the antenna. Additionally or alternatively, the shielding layer may be positioned on the other side or both sides of the antenna because of thefield magnification effect. In some embodiments, the shielding layer is constructed to increase the directivity of the antenna or focus the electromagnetic energy.

[0099] One or more antennas 540 may be positioned in a housing 510 that is otherwise void of other components (e.g., void of power supply 570, controller 550 and / or transmitter 530), such as when an antenna 540 is positioned within a first housing 510 and communicates with components positioned in a second housing 510.

[0100] In some embodiments, one or more spacers, spacer 511 shown, is positioned between antenna 540 and the patient’s skin, such as a spacer comprising a thickened portion of housing510 or a discrete spacer 511 placed on a side of housing 510 (as shown) or on a side of antenna 540. Spacer 511 may comprise one or more materials that match the impedance of antenna 540 to the impedance of the patient’s tissue. Spacer 511 may comprise a thickness of between 0.1cm to 3cm, such as a thickness between 0.2cm and 1.5cm. Spacer 511 may comprise materials which isolate heat (e.g., a spacer 511 comprising thermally insulating material). Alternatively, or additionally, housing 510 may comprise a heat insulating and / or dissipating material. Spacer 511 may comprise a soft or otherwise compressible material (e.g., foam) for patient comfort. Spacer511 may be inflatable, such as to control the separation distance of an external antenna 540 from the patient’s skin. An inflatable spacer 511 may be compartmentalized into several sections with independently controlled air pressure or volume to adjust the separation distance of an external antenna 540 and the patient’s skin and / or its angle (e.g., tilt) with respect to the tissue surface.

[0101] In some embodiments, antenna 540 comprises a multi-feed point antenna, such as a multi-feed point antenna configured to: support beam shaping and / or focusing; allow modification of amplitude and / or phase of a transmission signal; increase the radiation footprint; or combinations of one or more of these.

[0102] In some embodiments, antenna 540 comprises one or more antennas selected from the group consisting of patch antenna; slot antenna; array of antennas; a loop antenna (e.g., a concentric loop antenna); antenna loaded with reactive elements; dipole antenna; polarizable antenna; selectable conductors that form an antenna; and combinations of one or more of these.

[0103] Antenna 540 may comprise a major axis between 1cm and 10cm, such as a major axis between 2cm and 5cm, and / or a major axis of approximately 4cm. Antenna 540 may be further configured to receive a signal, such as when an antenna 240 is configured to transmit data to an external device 500. Antenna 540 may be positioned on (e.g., fabricated onto) a substrate, suchas a flexible printed circuit board or other printed circuit board (e.g., a single or multiple layer printed circuit board comprising electrical traces connecting components).

[0104] One or more antennas 540 may comprise a multi-turn spiral loop antenna, such as a multi-turn spiral loop antenna configured to desensitize coupling sensitivity and / or boost input voltage. In some embodiments, one or more antennas 540 comprise multiple concentric loops with varied dimensions, such as concentric loops configured to desensitize coupling sensitivity. In these embodiments, the multiple concentric loops may be: connected in parallel and driven from the same feed point; driven from the same feed point and connected using one or more of a capacitor, inductor, varactor, and combinations of one or more of these; and / or driven from multiple feed points.

[0105] In some embodiments, one or more external devices 500 comprise a plurality of antennae, such as a first antenna 540 and a second antenna 540. In these embodiments, the first antenna 540 may be similar or dissimilar to the second antenna 540. In some embodiments, a first antenna 540 and a dissimilar second antenna 540 are positioned within a single external device 500 (e.g., within housing 510). In other embodiments, a first antenna 540 is positioned in a first external device 500, and a dissimilar second antenna 540 is positioned in a second external device 500. The similarity or dissimilarity of the antennas may be configured to enhance one or more design and / or performance parameters selected from the group consisting of implantable device 200 operation depth; polarization; power efficiency; a radiation footprint; directional gain; beam shaping and / or focusing; sensitivity to implantable device 200 placement; patient comfort; patient usability; data transfer; and combinations of one or more of these. In some embodiments, the first antenna 540 is optimized for a different design parameter than the second antenna 540, and each antenna 540 may be activated independently or simultaneously to realize both benefits. In some embodiments, the first antenna 540 is similar to the second antenna 540 and placed in an array to increase the radiation footprint or placed in different external locations to operate with multiple implantable devices 200 implanted at different sites.

[0106] In some embodiments, a first external antenna 540 and a second external antenna 540 transmit power and / or data to a single implantable antenna 240. In some embodiments, a first antenna 540 and a second antenna 540 transmit power and / or data to one or more antennas 240, the transmissions performed simultaneously or sequentially. In sequential power and / or data transfers, a first external device 500 comprising a first one or more antennas 540 may bereplaced (e.g., swapped) with a second external device 500 comprising a second one or more antennas 540. Alternatively, or additionally, sequential power and / or data transfer may be initiated by one or more of the following conditions: when a first external antenna 540 moves (e.g., moves relative to an implanted antenna 240); when a second external device 500 comprising a second antenna 540 is turned on or otherwise activated; when a second antenna 540 provides improved power and / or data transfer to antenna 240 than that which is provided by a first antenna 540; and / or when power received from a first antenna 540 decreases (e.g., decreases below a threshold). In some embodiments, an antenna 240 receives power from a first antenna 540 and a second antenna 540, but only receives data from the first antenna 540. In some embodiments, a first antenna (e.g., an antenna 240 or an antenna 540) is driven with a different carrier signal than a second antenna (e.g., an antenna 240 or an antenna 540). The two carrier signals may comprise differences in amplitudes and / or relative phases as compared to each other. Each carrier signal may include a data transmission signal (e.g., data to be transmitted to an implantable device 200 from an external device 500 or to an external device 500 from an implantable device 200).

[0107] External device 500 may comprise an electronics module, controller 550 shown, configured to control one or more other components of external device 500.

[0108] One or more transmitters 530 (singly or collectively external transmitter 530) may each comprise one or more external transmitters that drive one or more antennas 540 (e.g., one or more antennas 540 positioned in a single external device 500 or multiple external devices 500). Transmitter 530 is operably attached to antenna 540 and is configured to provide one or more drive signals to antenna 540, such as one or more power signals and / or data signals transmitted to one or more implantable devices 200 of implantable system 20. Transmitter 530 may be configured to perform multi-level amplitude shift-keying. The amplitude shift-keying may be configured to provide adjustable-depth modulation between 0-100% depth, such as between 5- 75% depth, or such as between 10-50% depth.

[0109] As described herein, one or more external devices 500 may be configured to transmit data (e.g., configuration data) to one or more implantable devices 200, such as via a data transmission produced by transmitter 530 and sent to one or more antennas 540. In some embodiments, a transmitter 530 is configured to perform data modulation comprising amplitude shift-keying with pulse width modulation. In these embodiments, the transmitter may beconfigured to perform multi-level amplitude shift-keying. The amplitude shift-keying may be configured to provide adjustable-depth modulation between 0-100% depth, such as between 5- 75% depth, or such as between 10-50% depth. In some embodiments, one or more external devices 500 transmit data to one or more implantable devices 200 using time division multiple access (TDMA). In some embodiments, one or implantable devices 200 are independently addressable through unique identification (ID) codes. Alternatively, or additionally, transmitter 530 may be configured to transmit one or more data signals with a bandwidth between 1kHz and 100MHz, between 0.1MHz and 100MHz, or between 1MHz and 26MHz.

[0110] As described herein, one or more external devices 500 may be configured to transmit power to one or more implantable devices 200, such as via a power transmission produced by transmitter 530 and set to one or more antennas 540. One or more transmitters 530 may deliver power to one or more implantable devices 200 simultaneously or sequentially. In some embodiments, one or more transmitters 530 are configured to modify the level of power transmitted to one or more implantable devices 200, such as by modifying one or more duty cycling parameters. In these embodiments, power transmitted may be modified to: set a power transfer based on a stimulation level produced by implantable system 20; prevent oversaturation; to reduce interference with implantable system 20 data transmissions (e.g., when one or more implantable devices 200 are further configured to transmit data to external system 50); set a power transfer based on charge information and / or discharge information related to an implantable device 200 (e.g., charge rate and / or discharge rate of implantable energy storage assembly 270 described herein); and combinations of one or more of these. In some embodiments, implantable system 20 comprises a first receiver 230 (e.g., of a first implantable device 200) and a second receiver 230 (e.g., of a second implantable device 200’). One or more transmitters 530 may be configured to transmit a first power transmission to the first receiver 230, and a second power transmission to the second receiver 230. The first power transmission and the second power transmission may be modified or otherwise be different, such as to prevent over saturation.[OHl] In some embodiments, transmitter 530 (and / or another component of external system 50) is further configured as a receiver (e.g., may further include a receiver, in addition to a transmitter or include a transmitter that further functions as a receiver), such as to receive data from implantable system 20. For example, a transmitter 530 may be configured to receive datavia one or more antennas 240 of one or more implantable devices 200. Data received may include patient information (e.g., patient physiologic information, patient environment information or other patient information) and / or information related to an implantable system 20 parameter (e.g., an implantable device 200 stimulation parameter and / or another configuration parameter as described herein).

[0112] In some embodiments, transmitter 530 comprises a first transmitter to transmit power and / or data to one or more implantable devices 200, and a second transmitter to transmit data to a different device, as described herein. In these embodiments, a second transmitter of transmitter 530 may be configured to transmit data to tool 60 or another device such as a programmer 600; cell phone; computer; tablet; computer network such as the internet or a LAN; and combinations of one or more of these. In some embodiments, the second transmitter of transmitter 530 comprises a wireless transmitter; a Bluetooth transmitter; a cellular transmitter; and combinations of one or more of these. In some embodiments, a functional element 599 comprises a transmitter such as a Bluetooth transmitter.

[0113] Each power supply 570 (singly or collectively power supply 570) may be operably attached to a transmitter 530, and one or more other electrical components of each external device 500. Power supply 570 may comprise a power supplying and / or energy storage element selected from the group consisting of: battery; replaceable battery (e.g., via a battery door of housing 510); rechargeable battery; AC power converter; capacitor; and combinations of one or more of these. In some embodiments, power supply 570 comprises two or more batteries, such as two or more rechargeable batteries, such as to allow the first battery to be replaced (e.g., serially replaced) by the second battery (e.g., external device 500 may function with a single battery). In some embodiments, power supply 570 is configured to provide a voltage of at least 3 V. In some embodiments, power supply 570 is configured to provide a capacity between IWatt-hour and 75Watt-hours, such as a battery or capacitor with a capacity of approximately 5Watt-hours. In some embodiments, power supply 570 comprises an AC power source. Power supply 570 may include voltage and / or current control circuitry. Alternatively, or additionally, power supply 570 may include charging circuitry, such as circuitry configured to interface a rechargeable battery with an external charging device. In some embodiments, apparatus 10 includes one or more charging devices, charger 61 shown, which may be configured to recharge a component of apparatus 10, such as to recharge power supply 570 of one or more externaldevices 500. In some embodiments, charger 61 comprises one or more electrical contacts configured to electrically connect to one or more electrical contacts of external device 500, such as to transfer charging energy to power supply 570.

[0114] Each external device 500 may include one or more user interface components, user interface 580 shown, such as to allow the patient or other user to enter, adjust and / or otherwise modify (“enter”, “adjust”, and / or “modify” herein) one or more parameters of apparatus 10 (e.g., one or more stimulation parameters of apparatus 10). User interface 580 may include one or more user input components (e.g., buttons, slides, knobs, and the like) and / or one or more user output components (e.g., lights, displays and the like). In some embodiments, user interface 580 includes one or more controls configured to provide a water-ingress-resistant barrier.

[0115] Each patient programmer 600’ or clinician programmer 600” (singly or collectively programmer 600) comprises a programming device configured to control one or more components of apparatus 10. Programmer 600 may comprise a user interface 680. Programmer 600 may send and / or receive commands to and / or from one or more external devices 500 via a wireless or wired connection (wired connection not shown but such as one or more insulated conductive wires). In some embodiments, one or more external devices 500 comprise all or a portion of programmer 600, such as when all or a portion of user interface 680 is integrated into housing 510 of external device 500. In some embodiments, apparatus 10 comprises multiple programmers 600, such as one or more patient programmers 600’ and / or one or more clinician programmers 600”.

[0116] Programmer 600 may be configured to modify one or more parameters of apparatus 10, such as a stimulation parameter (e.g., a stimulation waveform parameter as described herein); a sensing parameter; a therapy parameter; a data recording parameter (e.g., a patient data recording parameter and / or an implantable device 200 data recording parameter); power transfer; data rate; activity of one or more external transmitters 530; activity of one or more external antennas 540; a stimulation element 260 parameter; a functional element 299 and / or 599 parameter; and combinations of one or more of these, such as is described hereabove. Programmer 600 may be further configured to provide information, such as patient physiologic information recorded by apparatus 10 (e.g., by one or more implantable devices 200 and / or one or more external devices 500), or apparatus 10 information, such as performance and / or configuration information (singly or collectively “status information”) of one or more components of apparatus 10 (e.g., one ormore external devices 500 and / or implantable devices 200). In some embodiments, programmer 600 uses information recorded by one or more implantable devices 200, apparatus 10 information, and / or information from external devices 500 to adapt configuration parameters of one or more components of apparatus 10.

[0117] In some embodiments, programmer 600 is configured to confirm that an adequate power transmission and / or an adequate data transmission has occurred between one or more external devices 500 and one or more implantable devices 200. In these embodiments, programmer 600 may comprise diagnostic assembly 62 described herein, or otherwise be configured to detect one or more of: power transmission to the implantable system 20 (e.g., to detect power transmission to implantable system 20 below a threshold); power transmission to the implantable system 20 trending in an undesired direction; improper and / or inadequate data transfer to the implantable system 20; and combinations of one or more of these. In some embodiments, programmer 600 monitors power transfer in real time and modifies power transmission accordingly to optimize the rectifier efficiency (e.g., efficiency of rectifier 232 described herein) of one or more implantable devices 200. In some embodiments, apparatus 10 may be configured to modify (e.g., in real time) the power transmission from one or more external devices 500 of external system 50 to one or more implantable devices 200 of implantable system 20, such as to optimize or otherwise improve an efficiency of apparatus 10, such as to improve the efficiency of transmissions between an external device 500 and an implantable device 200. These modifications may include modification of one or more of: power transmission amplitude, duty cycle, frequency, phase, and periodicity.

[0118] In some embodiments, programmer 600 and / or another component of apparatus 10 comprises a matching network configured to match the impedance of one or more antennas 540 to one or more transmitters 530. The matching network may comprise an adjustable matching network. The matching network may comprise a directional coupler configured to measure a reflection coefficient. A transmitter 530 may comprise an output, and a programmer 600 may be configured to monitor a standing wave pattern at the output of the transmitter 530.

[0119] In some embodiments, programmer 600 comprises a lookup table of stimulation signal waveform patterns, such as to allow a clinician, patient and / or other operator (“user” or “operator” herein) of apparatus 10 to view and / or select a predetermined stimulation pattern (e.g., using user interface 680). In some embodiments, programmer 600 comprises a set ofadjustable stimulation signal parameters configured to be varied to allow an operator to construct customized waveforms, such as to vary one or more stimulation parameters described hereabove. In some embodiments, programmer 600 is configured to allow an operator to create a customized waveform by specifying an amplitude of one or more discrete pulses or steps of a stimulation signal. In some embodiments, a clinician programmer 600” may include stimulation waveform customization options not provided by a patient programmer 600’.

[0120] In some embodiments, programmer 600 comprises a transmitter configured to transmit data to tool 60 or another device such as a cell phone; computer; tablet; computer network such as the internet or a LAN; and combinations of one or more of these. In these embodiments, programmer 600 may comprise a wireless transmitter; a Bluetooth transmitter; a cellular transmitter; and combinations of one or more of these. In some embodiments, programmer 600 comprises a receiver configured to receive data, or a transceiver configured to both transmit and receive data.

[0121] User interface 680 of programmer 600 may comprise one or more user input components and / or user output components, such as a component selected from the group consisting of keyboard; mouse; keypad; switch; membrane switch; touchscreen; display; audio transducer such as a speaker or buzzer; vibrational transducer; light such as an LED; and combinations of one or more of these.

[0122] In some embodiments, one or more components of external system 50 and / or other external component of apparatus 10, comprises one or more functional elements 599, such as functional elements 599a, 599b, and / or 599c, shown positioned in external device 500, programmer 600’, and in programmer 600”, respectively. Each functional element 599 may comprise a functional element as defined hereabove (e.g., a sensor, a transducer, and / or other functional element as described herein). In some embodiments, a functional element 599 comprises a needle, a catheter (e.g., a distal portion of a catheter), an iontophoretic element or a porous membrane, such as an agent delivery element configured to deliver one or more agents contained (e.g., one or more agents in a reservoir, such as reservoir 525 described herein) within an external device 500 and delivered into the patient (e.g., into subcutaneous tissue, into muscle tissue and / or into a blood vessel such as a vein).

[0123] In some embodiments, the functional element 599 comprises an electrode for sensing electrical activity and / or delivering electrical energy. In some embodiments, apparatus 10 isconfigured to cause stochastic resonance, and the addition of white noise may enhance the sensitivity of nerves to be stimulated and / or boost weak signals to be recorded by the one or more stimulation elements 260.

[0124] In some embodiments, one or more functional elements 599 comprise a sensor, such as a sensor configured to record data related to a patient parameter (e.g., a patient physiologic parameter), an external system 50 parameter and / or an implantable system 20 parameter. In some embodiments, operation of one or more implantable devices 200 (e.g., stimulation energy delivered by one or more implantable devices 200) is configured to be delivered based on the data recorded by one or more sensor-based functional elements 599, such as in a closed-loop energy delivery mode.

[0125] Functional element 599 may comprise one or more sensors configured to record data regarding a patient parameter selected from the group consisting of: blood glucose; blood pressure; EKG; heart rate; cardiac output; oxygen level; pH level; pH of blood; pH of a bodily fluid; tissue temperature; inflammation level; bacteria level; type of bacteria present; gas level; blood gas level; neural activity; neural spikes; neural spike shape; action potential; local field potential (LFP); EEG; muscular activity (e.g., as measured using electromyography, EMG); electrical activity produced by skeletal muscles (e.g., as measured using EMG); gastric volume; peristalsis rate; impedance; tissue impedance; electrode-tissue interface impedance; physical activity level; pain level; body position; body motion; organ motion; respiration rate; respiration level; perspiration rate; sleep level; sleep cycle; digestion state; digestion level; urine production; urine flow; bowel movement; tremor; ion concentration; chemical concentration; hormone level; viscosity of a bodily fluid; patient hydration level; and combinations of one or more of these.

[0126] Functional element 599 may comprise one or more sensors configured to record data representing a parameter of external system 50 or any component of apparatus 10. Functional element 599 may comprise one or more sensors selected from the group consisting of: an energy sensor; a voltage sensor; a current sensor; a temperature sensor (e.g., a temperature of one or more components of external device 500 or programmer 600); an antenna matching and / or mismatching assessment sensor; power transfer sensor; link gain sensor; power use sensor; energy level sensor; energy charge rate sensor; energy discharge rate sensor; impedance sensor; load impedance sensor; instantaneous power usage sensor; average power usage sensor; bit error rate sensor; signal integrity sensor; and combinations of one or more of these. Apparatus 10 maybe configured to analyze (e.g., via controller 250 described herein) the data recorded by functional element 599 to assess one or more of power transfer; link gain; power use; energy within power supply 570; performance of power supply 570; expected life of power supply 570; discharge rate of power supply 570; ripple or other embodiments of power supply 570; matching of antennas 240 and 540; communication error rate between implantable device 200 and external device 500; integrity of transmission between implantable device 200 and external device 500; and combinations of one or more of these.

[0127] In some embodiments, one or more functional elements 599 are positioned on a housing 510. A functional element 599 may comprise a body conduction sensor, such as a body conduction sensor configured to record and / or receive data via skin conduction. A functional element 599 may be configured to record data associated with stimulation delivered by one or more implantable devices 200 (e.g., record data associated with stimulation energy delivered by one or more stimulation elements 260), such as to provide closed loop or semi-closed loop stimulation. A functional element 599 may be configured to record temperature, such as when apparatus 10 is configured to deactivate or otherwise modify the performance of an external device 500 when the recorded temperature (e.g., patient temperature and / or external device 500 temperature) exceeds a threshold.

[0128] In some embodiments, an external device 500, programmer 600’, and / or programmer 600” comprises a temperature sensor, such as when functional elements 599a, 599b, and / or 599c, respectively, comprise a temperature sensor. The temperature-based functional element 599 may be positioned proximate a portion of programmer 600, housing 510 and / or one or more antennas 540 (e.g., to measure the temperature of one or more portions of a programmer 600 and / or external device 500). In these embodiments, the temperature data recorded by the functional element 599 is used to modify one or more of matching network; stimulation level (e.g., stimulation energy delivered by one or more implantable devices 200); power transmission level (e.g., level of power transmitted between one or more external devices 500 and one or more implantable devices 200); and combinations of one or more of these. In some embodiments, the temperature sensor-based functional element 599 is a part of a safety mechanism that deactivates programmer 600 and / or an external device 500 if the recorded temperature exceeds a threshold. Alternatively, or additionally, a temperature sensor-based functional element 599 may be configured to measure temperature of the patient, such as whenplaced on housing 510, such as to modify energy and / or agent delivery performed by implantable device 200 based on the recorded patient temperature.

[0129] In some embodiments, an external device 500, programmer 600’, and / or programmer 600” comprise an accelerometer, vibration sensor, and / or other motion or shock sensor, such when functional elements 599a, 599b, and / or 599c comprise this type of sensor. In these embodiments, the functional elements 599 may comprise a sensor configured to produce a signal used to detect when an external device 500, programmer 600’, and / or programmer 600” is dropped, as well as assess the forces generated during the drop. Alternatively, or additionally, this sensor may be configured to produce a signal configured to detect a tap (e.g., on a housing) of the device, such that a tap gesture may be used in place of a control (e.g., a discrete switch) on the device.

[0130] As described hereabove, implantable system 20 comprises one or more implantable devices 200, such as one or more implantable devices 200 provided sterile or configured to be sterilized for implantation into the patient. A first implantable device 200 may be of similar or dissimilar construction and arrangement to a second implantable device 200’. Each implantable device 200 may be configured to treat a patient (e.g., treat pain of the patient) and / or record patient information, such as by delivering energy and / or an agent to tissue and / or by recording one or more physiologic parameters of the patient (e.g., parameters of tissue of the patient).

[0131] One or more portions of an implantable device 200 or other component of implantable system 20 may be configured to be visualized or contain a visualizable portion or other visualizable element, such as visualizable element 222 shown. Visualizable element 222 may comprise a material selected from the group consisting of: radiopaque material; ultrasonically reflective material; magnetic material; and combinations of one or more of these. In these embodiments, each implantable device 200 (e.g., at least a portion of device 200 such as stimulation elements 260, lead 265, and / or housing 210) may be visualized (e.g., during and / or after implantation) via an imaging device (e.g., imaging device 40 described herein) such as a CT, X-ray, fluoroscope, ultrasound imager and / or MRI.

[0132] In some embodiments, implantable system 20 comprises multiple implantable devices 200 (e.g., implantable device 200 and implantable device 200’ shown in FIG. 1) and implantable system 20 comprises a “multi-point ready” system, in which the operation (e.g., energy delivery, agent deliver, data recording and / or other function) of the multiple implantable devices 200 isperformed simultaneously, asynchronously, and / or sequentially. The implantable devices 200 may be part of a network including one or more external devices 500 (e.g., external device 500 and external device 500’ shown in FIG. 1) in which the treating of a patient and / or the recording of patient information relies on operation of the implantable devices 200 at one or more implantation sites in a synchronized, asynchronized, and / or otherwise coordinated way. The synchronization or otherwise coordination may be controlled by a single external device 500 and / or by multiple external devices 500, which may further be synchronized (e.g., to a single clock). Each implantable device 200 of implantable system 20 may receive a power signal and / or a data signal from one or more external devices 500. In some embodiments of the multipoint ready implantable system 20, each implantable device 200 comprises a unique ID, such that each implantable device 200 is individually addressed (e.g., receive unique signals from external system 50). In some embodiments, external system 50 transmits high-bandwidth signals to implantable system 20, such that time-domain multiple access communication is performed while operating in near real time. In some embodiments, implantable system 20 is configured as a multi-point ready system such that stimulation energy delivered by implantable system 20 is independent of power received by implantable system 20 from external system 50.

[0133] Each implantable device 200 is configured to receive power and / or data (e.g., implantable system 20 configuration data) from one or more external devices 500. In some embodiments, one or more implantable devices 200 are configured to receive both power and data (e.g., simultaneously and / or sequentially) from one or more external devices 500. In some embodiments, a single external device 500 sends power and / or data to multiple implantable devices 200. Alternatively, or additionally, a single implantable device 200 may receive power and / or data from multiple external devices 500. In some embodiments, a first external device 500 is positioned on or near the patient’s skin at a location proximate an implanted first implantable device 200, and a second external device 500 is positioned on or near the patient’s skin (generally “on” the patient’s skin) at a location proximate an implanted second implantable device 200. In these embodiments, the first external device 500 transmits data and / or power to at least the first implantable device 200 and the second external device 500 transmits data and / or power to at least the second implantable device 200.

[0134] Each implantable device 200 may comprise one or more stimulation elements 260, configured to stimulate, deliver energy to, deliver an agent to, record information from and / orotherwise interface with the patient. Alternatively, or additionally, the one or more stimulation elements 260 may be configured as a sensor, such as to record patient information. Each implantable device 200 may comprise housing 210, receiver 230, controller 250, energy storage assembly 270 and / or one or more antennas 240, each described in detail herein. Each stimulation element 260 may comprise a sensor and / or any transducer, as described in detail herein. One or more stimulation elements 260 may be positioned on a lead, lead 265 shown (e.g., a flexible filament including wires or other conductors that connect each stimulation element 260 to electronics within housing 210). Each implantable device 200 may comprise one or more leads 265, such as two leads attached to a single housing 210, or a first lead 265 attached to a first housing 210 and a second lead 265 attached to a second housing 210. Each implantable device 200 may comprise one or more other functional elements, such as functional elements 299a and 299b described herein. Each implantable device 200 may further comprise one or more anchoring or other fixation elements, anchor element 223 shown, as described in detail herein.

[0135] In some embodiments, one or more implantable devices 200 are further configured to transmit data to one or more external devices 500, such as via one or more antennas 240 transmitting a signal to one or more antennas 540, or otherwise. Data transmitted by an implantable device 200 may comprise patient information (e.g., patient physiologic information recorded by one or more stimulation elements 260 configured as a physiologic sensor), or implantable device 200 information (e.g., data recorded by one or more stimulation elements 260 configured as a sensor and positioned in implantable device 200, or other implantable device 200 configuration and / or performance data).

[0136] Housing 210 of each implantable device 200 may comprise one or more rigid and / or flexible materials which surround various components, such as antenna 240, energy storage assembly 270, controller 250 and / or receiver 230 as shown in FIG. 1. In some embodiments, one or more stimulation elements 260 are positioned in, on and / or within housing 210. In some embodiments, housing 210 surrounds a substrate, such as a flexible and / or foldable printed circuit board, such as multiple discrete or continuous printed circuit boards positioned in different planes (e.g., a flexible or foldable printed circuit board). In some embodiments, one or more antennas 240 and / or other components (e.g., a functional element 299) are positioned outside of housing 210, such as when at least one antenna 240 or other component is operablyconnected to one or more components (e.g., electrical components) positioned within housing 210 via a tether comprising one or more electrical conduits.

[0137] Housing 210 may comprise one or more shapes or combination of shapes, such as one or more shapes selected from the group consisting of: disc; pill; cylinder; sphere; oblate spheroid; dish-like shape; bowl-like shape; cone; rectangular prism; trapezoidal prism; a portion of a toroid; and combinations of one or more of these.

[0138] Housing 210 may comprise a major axis and a minor axis, defined hereabove. In some embodiments, housing 210 comprises a major axis less than or equal to 20mm, such as a major axis less than or equal to 15mm, 12mm or 10mm. In some embodiments, housing 210 comprises a minor axis less than or equal to 8mm, such as a minor axis less than or equal to 6mm, or less than or equal to 5mm. Housing 210 may comprise a wall thickness between 0.1mm and 1.0mm, such as a wall thickness between 0.2mm and 0.5mm, such as a wall thickness of approximately 0.3mm. Housing 210 may comprise a displacement volume less than or equal to 2000mm3, such as less than or equal to 600mm3.

[0139] Housing 210 may comprise one or more portions that are transmissive to radiofrequency (RF) signals. In some embodiments, housing 210 comprises glass. In some embodiments, housing 210 comprises a material selected from the group consisting of: glass; ceramic; stainless steel; titanium; polyurethane; an organic compound; liquid crystal polymer (LCP); gold; platinum; platinum iridium; tungsten; epoxy; a thermoplastic; a thermoset plastic; and combinations of one or more of these. In some embodiments, one or more portions of housing 210 comprises one or more coatings, such as one or more coatings configured to cause or prevent a physiologic reaction and / or a coating configured to block (e.g., shield) an electromagnetic transmission.

[0140] Housing 210 may comprise one or more passageways or other feedthroughs, such as for the passage of a lead, wire, optical fiber, fluid delivery tube, mechanical linkage and / or other conduit through a wall of housing 210, such as is described in applicant’s United States Patent Application Serial Number 17 / 412,044, titled “Medical Apparatus Including an Implantable System and an External System”, filed August 25, 2021.

[0141] In some embodiments, one or more inner or outer surfaces (or portions of surfaces) of housing 210 includes an insulating and / or shielding layer (e.g., a conductive electromagnetic shielding layer), such as inner coating 219a and / or outer coating 219b shown (singly orcollectively coating 219). Coating 219 may comprise an electrically insulating and / or a thermally insulating layer or other coating. In some embodiments, one or more portions of housing 210 comprise an electrically shielding coating, coating 219, while other portions are transmissive to electromagnetic signals such as radiofrequency signals.

[0142] In some embodiments, housing 210 comprises an array of feedthroughs, not shown. In some embodiments, housing 210 is surrounded (e.g., partially or fully surrounded) by a covering, such as a flexible and / or non-conductive covering, such as a covering made of an elastomer.

[0143] In some embodiments, implantable device 200 and / or another component of apparatus 10 may include one or more features to prevent or at least reduce migration of implant 200 within the patient’s body. In some embodiments, one or more implantable devices 200 comprises one or more anchor elements configured to secure one or more portions of implantable device 200 to tissue (e.g., anchor element 223 described hereabove and / or an anchor element in an overmold positioned about a portion of housing 210). Anchor element 223 may comprise one or more anchoring elements selected from the group consisting of: a sleeve such as a silicone sleeve; suture tab; suture eyelet; bone anchor, wire loops; porous mesh; penetrable wing; penetrable tab; bone screw eyelet; tine; pincers; suture slits; and combinations of one or more of these. While anchor element 223 is shown proximate housing 210 (e.g., to fixedly attach housing 210 to tissue), in some embodiments anchor element 223 surrounds or is otherwise proximate lead 265 (e.g., to fixedly attach lead 265 to tissue). In some embodiments, anchor element 223 comprises a porous mesh that surrounds all or a portion of housing 210. The porous mesh may be configured to promote tissue ingrowth, such as to prevent or at least limit (“prevent” herein) migration of housing 210 when implantable device 200 is implanted in the patient. In some embodiments, anchor element 223 comprises a mesh that is attached to the top side of implantable device 200 (side in closest proximity to the patient’s skin), such as to prevent housing 210 from migrating away from the patient’s skin (e.g., prevent from migrating deeper into the patient).

[0144] One or more antennas 240 (singly or collectively antenna 240) may be configured to receive power and / or data, and receiver 230 may receive the power and / or data from the one or more antennas 240. Each antenna 240 may comprise one or more implantable antennas, such as one or more antennas positioned within housing 210, and / or one or more antennas electricallyattached to a connecting filament. In some embodiments, one or more implantable devices 200 comprise at least two antennas 240, or at least three antennas 240. Antenna 240 may be configured to receive power and / or data from one or more external devices 500, such that an attached receiver 230 receives the power and / or data. In some embodiments, implantable system 20 comprises at least two implantable devices 200, each of which comprise one or more (e.g., two or three) antennas 240 which are positioned within a housing 210 and / or electrically tethered to a housing 210. In some embodiments, an implantable device 200 comprises a first antenna 240 positioned in a first plane and a second antenna 240 positioned in a second plane. The first plane and second plane may be relatively orthogonal planes, or planes oriented between 30° and 90° relative to each other, such as between 40° and 90°, approximately 30°, approximately 45° and / or approximately 60° relative to each other. In some embodiments, an implantable device 200 comprises a first antenna 240 positioned in a first plane, a second antenna 240 positioned in a second plane, and a third antenna 240 positioned in a third plane.

[0145] In some embodiments, implantable device 200 comprises one or more antennas 240 positioned on a substrate, such as a printed circuit board (PCB), a flexible printed circuit board and / or a foldable substrate (e.g., a substrate comprising rigid portions and hinged portions). In some embodiments, the substrate is folded or otherwise pivoted to position the various antennas 240 on differently oriented planes, such as multiple planes oriented between 5° and 90° relative to each other, such as two antennas 240 positioned on two planes oriented between 30° and 90° or between 40° and 90° relative to each other, or three antennas 240 positioned on three planes oriented between 5° and 60° relative to each other. Two or more antennas 240 may be positioned on two or more different planes that are approximately 45° relative to each other, or approximately 60° or approximately 90° relative to each other.

[0146] Implantable device 200 may comprise three antennas 240. In some embodiments, a first antenna 240 comprises an electrical dipole antenna, and the second and third antennas 240 may be positioned in different planes than the first antenna 240. In some embodiments, the three antennas 240 each comprise a loop antenna, such as when each loop antenna is positioned on a different plane. In some embodiments, a first antenna 240 comprises an electrical dipole antenna, and a second antenna 240 and a third antenna 240 each comprise a loop antenna. In these embodiments, the second antenna 240 and the third antenna 240 may be positioned relatively orthogonal to each other (e.g., positioned on two relatively orthogonal planes). In someembodiments, a first antenna (e.g., an electrical dipole antenna) is positioned outside of housing 210, while a second antenna (e.g., a loop antenna) and a third antenna (e.g., a loop antenna) are each positioned on, in and / or within housing 210. In some embodiments, implantable device 200 comprises one or more antennas 240 in which any combination of antenna types (as described herein) are used in combination.

[0147] One or more antennas 240 may comprise an antenna selected from the group consisting of loop antenna; multiple-turn loop antenna; planar loop antenna; coil antenna; dipole antenna; electric dipole antenna; magnetic dipole antenna; patch antenna; loaded dipole antenna; concentric loop antenna; loop antenna with ferrite core; and combinations of one or more of these. One or more antennas 240 may comprise a loop antenna, such as an elongated loop antenna or a multiple-turn loop antenna.

[0148] One or more antennas 240 may comprise a multi-turn spiral loop antenna, such as a multi-turn spiral loop antenna configured to desensitize coupling sensitivity and / or boost input voltage. In some embodiments, one or more antennas 240 comprise multiple concentric loops with varied dimensions, such as concentric loops configured to desensitize coupling sensitivity. In these embodiments, the multiple concentric loops may be arranged as follows: connected in parallel and driven from the same feed point; driven from the same feed point and connected using one or more of a capacitor, inductor, varactor, and combinations of one or more of these; and / or driven from multiple feed points.

[0149] One or more antennas 240 may comprise a minor axis and a major axis. In some embodiments, one or more antennas 240 comprise a minor axis between 1mm and 8mm, such as between 2mm and 5mm. In some embodiments, one or more antennas 240 comprise a major axis between 3mm and 15mm, such as between 4mm and 8mm. In some embodiments, one or more antennas 240 comprise a major axis above 3mm, such as between 3mm and 15mm, such as when the antenna 240 is positioned outside of housing 210. One or more antennas 240 may comprise a foldable and / or unfoldable antenna, such as is described in applicant’s co-pending United States Patent Application Serial Number 17 / 240,629, titled “Method and Apparatus for Minimally Invasive Implantable Modulators”, filed April 26, 2021.

[0150] One or more antennas 240 may be positioned inside of housing 210. Alternatively, or additionally, one or more antennas 240 may be positioned outside of housing 210.

[0151] Implantable system 20, one or more implantable devices 200 and / or one or more antennas 240 may be configured to be positioned at a desired depth beneath the patient’s skin, such as at a depth between 0.5cm and 7.0cm, such as a depth of between 1.0cm and 3.0cm.

[0152] One or more energy storage assemblies 270 (singly or collectively energy storage assembly 270) may comprise one or more implantable energy storage components, such as one or more batteries (e.g., rechargeable batteries) and / or capacitors (e.g., a supercapacitor). Energy storage assembly 270 may be configured to provide power to one or more of one or more stimulation elements 260; controller 250; receiver 230; and combinations of one or more of these. In some embodiments, energy storage assembly 270 further provides power to one or more antennas 240 and / or circuitry configured to transmit data via antenna 240. In some embodiments, energy storage assembly 270 includes digital control for charge / discharge rates, voltage outputs, current outputs, and / or system power distribution and / or management.

[0153] Energy storage assembly 270 may comprise one or more capacitors with a single or collective capacitance between 0.01 pF and 10F, such as a capacitance between I F and l.OmF, or between I F and lOpF. The energy storage assembly 270 may comprise one or more capacitors with capacitance between ImF and 10F, such as when energy storage assembly 270 comprises a super-capacitor and / or an ultra-capacitor. Such large capacitance may be used to store sufficient charge to maintain operation (e.g., maintain delivery of stimulation energy and / or delivery of an agent) without the use (e.g., sufficient proximity) of an associated external device 500. A capacitor or other energy storage element (e.g., a battery) may be chosen to provide sufficient energy to maintain operation for at least 30 seconds, at least 2 minutes, at least 5 minutes, at least 30 minutes, and up to several hours or more (e.g., during showering, swimming or other physical activity). In some embodiments, energy storage assembly 270 is configured to provide continuous and / or intermittent stimulation energy for at least one charge-balanced pulse (e.g., for the duration of at least one charge-balanced pulse). In some embodiments, a capacitor, battery or other energy storage element is configured to provide stimulation energy without receiving externally supplied power for periods of at least 1 hour, at least 1 day, at least 1 month or at least 1 year. Energy storage assembly 270 may comprise one or more capacitors with a breakdown voltage above 1.0V, such as a breakdown voltage above 1.5 V, 4.0V, 10V, or 15 V. In some embodiments, energy storage assembly 270 may comprise capacitors distributed outside of housing 210, such as when one or more capacitors are distributed along lead 265. Energy storageassembly 270 may comprise one or more capacitors with low self-leakage, such as to maintain stored energy for longer periods of time.

[0154] In some embodiments, energy storage assembly 270 comprises a temporary energy storage component, such as a super-capacitor, configured to store a sufficient quantity of energy to provide uninterrupted stimulation, such as during time periods in which the link gain may be of poor quality or it may be temporarily unavailable (e.g., an external device 500 not being in place such as during a shower, swimming, and the like). An energy storage assembly 270 comprising an ultra-capacitor, super-capacitor or flexible battery may be charged via the wireless power transmission of the present inventive concepts, such as to store a sufficient amount of energy for one or more stimulation elements 260 to deliver stimulation energy during subsequent (intended or unintended) unavailability of one or more external devices 500 (e.g., an external device 500 is intentionally removed or unintentionally falls off or otherwise loses its position sufficiently proximate one or more implantable devices 200). An energy storage assembly 270 comprising one or more high-capacity energy storage components may be beneficial in applications where therapy interruption provides a significant risk or is otherwise relatively unacceptable, such as for life support therapies, cardiac resynchronization therapies, and the like. The high-capacity energy storage components of energy storage assembly 270 may be positioned in an assembly positioned within housing 210, on an inner or outer surface of housing 210, within a separate housing, and / or within lead 265.

[0155] In some embodiments, during use (e.g., during period of providing stimulation or other function) implantable device 200 receives power regularly from external system 50 (e.g., relatively continuously while implantable device 200 delivers stimulation energy), and energy storage assembly 270 comprises a relatively small battery or capacitor, such as a battery or capacitor that has an energy storage capacity of less than or equal to 0.6 Joules, 7 Joules or 40 Joules.

[0156] One or more controllers 250 (singly or collectively controller 250) may be configured to control one or more stimulation elements 260, such as a stimulation element 260 comprising a stimulation-based transducer (e.g., an electrode or other energy delivery element) and / or a sensor (e.g., a physiologic sensor and / or a sensor configured to monitor an implantable device 200 parameter). In some embodiments, controller 250 is configured to transmit a stimulation signal (e.g., transmit stimulation energy configured in one or more stimulation waveforms) to one ormore stimulation elements 260 (e.g., one or more stimulation elements 260 comprising an electrode and / or other energy delivery element), independent of the power signal received by one or more antennas 240 (e.g., independent of power transmitted by external system 50), such as by using energy stored in energy storage assembly 270. In these embodiments, the power signal and / or the RF path for the power signal may be modified to optimize power efficiency (e.g., by tuning matching network on transmitter 530 and / or receiver 230; configuring antennas 540 and / or 240 in an array; tuning operating frequency; duty cycling the power signal; adjusting antenna 540 and / or 240 position; and the like), and a stimulation signal may be precisely delivered (e.g., by using energy stored on energy storage assembly 270 and generating stimulation signal locally on the implantable device 200) to ensure clinical efficacy. Also, if the power signal transmission (also referred to as “power link”) is perturbed unexpectedly, the stimulation signal may be configured so that it is not significantly affected (e.g., unaffected). In some configurations, the stimulation signal being delivered by one or more implantable devices 200 is insensitive to interference that may be present. In these embodiments, a power transmission signal and stimulation signal may vary in one or more of: amplitude; changes in amplitude; average amplitude; frequency; changes in frequency; average frequency; phase; changes in phase; average phase; waveform shape; pulse shape; duty cycle; polarity; and combinations of one or more of these.

[0157] Controller 250 may receive commands from receiver 230, such as one or more commands related to one or more implantable device 200 configuration parameters selected from the group consisting of: stimulation parameter; data rate of receiver; data rate of data transmitted by the first implantable device 200 at least one implantable antenna 240; stimulation element 260 configuration; state of controller 250; antenna 240 impedance; clock frequency; sensor configuration; electrode configuration; power management parameter; energy storage assembly parameter; agent delivery parameter; sensor configuration parameter; and combinations of one or more of these.

[0158] In some embodiments, one or more stimulation elements 260 comprise a stimulation element configured to deliver energy (e.g., one or more electrodes configured to deliver monopolar or bipolar electrical energy) to tissue, and controller 250 is configured to control the energy delivery, such as to control one or more stimulation parameters. Each of these stimulation parameters may be held relatively constant, and / or varied, such as a variation performed in acontinuous or intermittent manner. In some embodiments, one or more stimulation parameters are varied in a random or pseudo-random (hereinafter “random”) manner, such as a variation performed by apparatus 10 using a probability distribution as described in applicant’s copending United States Patent Application Serial Number 17 / 372,095, titled “Apparatus with Enhanced Stimulation Waveforms”, filed July 9, 2021. In some embodiments, stimulation (e.g., stimulation comprising high frequency and / or low frequency signal components) is varied randomly to eliminate or at least reduce synchrony of neuronal firing with the stimulation signal (e.g., to reduce paresthesia or other patient discomfort). In some embodiments, one or more stimulation elements 260 comprise a stimulation element configured to stimulate a target (e.g., nerve tissue such as spinal nerve tissue and / or peripheral nerve tissue). The amount of stimulation delivered to the target may be controlled by varying a parameter selected from the group consisting of: stimulation element 260 size and / or configuration (e.g., electrode size and / or configuration); stimulation element 260 shape (e.g., electrode shape, magnetic field generating transducer shape or agent delivering element shape); shape of a generated electric field; shape of a generated magnetic field; stimulation signal parameters; and combinations of one or more of these.

[0159] In some embodiments, one or more stimulation elements 260 comprise an element configured to deliver electrical energy to tissue (e.g., one or more electrodes configured to deliver monopolar or bipolar electrical energy), and controller 250 is configured to control charge balance, such as to actively and / or passively control charge balance, as described herein. Charge balance may be essential for patient safety in electrical stimulation of nerves or other tissue. Imbalanced stimulation waveforms may cause electrode corrosion and / or dissolution which may lead to deposition of toxic materials in tissue, implant rejection, and nerve damage. The stimulation waveform may be balanced such that net outflow charge approximately equals net inflow charge. With stimulation waveform amplitudes that may vary between 0.01mA to 15mA (such as between 0.1mA and 15ma, between 0.1mA and 12mA, or between 0.1mA and 10mA), depending on the treatment, the error in charge balance may be on the order of 0.001% to 0.01%. Alternatively, or additionally, controller 250 may comprise AC coupling capacitors that are configured to balance stimulation waveforms passively. The AC coupling capacitance may be large (e.g., greater than lOpF) to pass the stimulation waveform with minimal filtering. In some embodiments, apparatus 10 is configured to perform active charge balancing. In someembodiments, an implantable device 200 comprises a precise resistor in series with a stimulation electrode-based stimulation element 260. The precise resistor may be used to measure outflow and inflow currents, such as when controller 250 comprises an analog to digital converter (ADC). Controller 250 may integrate current over time during a first phase in which stimulation energy is delivered, and during a second phase in which a reverse current is applied (e.g., a reverse current used to balance charge). Controller 250 may be configured to balance the total charge in the two phases, to ensure that the net DC current is approximately zero. The integration may be achieved using an analog integrator and / or a digital summer of controller 250, with controller 250 keeping track of one or more parameters of the pulses delivered (e.g., pulses delivered within a train or a burst). Implantable device 200 may comprise a precise series resistance comprising an “on-chip” trimmed resistor or an “off-chip” resistor. In some embodiments, implantable device 200 comprises a bank of trimmed resistors that are used to control the net series resistance, such as to adjust resistance based on stimulation amplitude requirements (e.g., to take advantage of the full dynamic range of an ADC of controller 250). In some embodiments, controller 250 comprises a shunt path with an RC -based low pass filter used for both outflow and inflow of current. RC elements of controller 250 may be chosen such that the shunt current is only a fraction of the stimulation current. Since the same RC elements may be used for both outflow and inflow current, the precision required for the RC components may be lower. An ADC may be used to sense the voltage on the capacitor at the end of a stimulation pulse. After the stimulation pulse, the capacitor may be discharged and the polarity of the stimulation current may be reversed and set to any amplitude, until the capacitor is charged to approximately the same voltage (according to the ADC precision) as it was charged during the stimulation pulse. The ADC resolution may be high enough to ensure the residual error is less than what would cause an undesired charge accumulation. ADC resolution requirements may be further reduced by reducing the net capacitance in a shunt RC circuit, to cause accelerated charging of the capacitor. The capacitor may be discharged every time the voltage exceeds a certain predefined threshold, while controller 250 keeps track of the number of times the capacitor has been charged and reset. By resetting the capacitor through a low resistance path, the discharge time may be insignificant compared to the charge time, reducing the error due to the discharge period. Since the net charge equivalent to full scale voltage on the ADC may bedivided into multiple cycles, the required resolution of the ADC to achieve the same residual error may be divided by the number of cycles.

[0160] In some embodiments, controller 250 is configured to produce a stimulation signal comprising a waveform or a waveform pattern (hereinafter stimulation waveform), for one or more stimulation elements 260 configured as a stimulation element (e.g., such that one or more stimulation elements 260 deliver stimulation energy comprising or at least resembling that stimulation waveform). Controller 250 may produce a stimulation signal comprising a waveform selected from the group consisting of: square wave; rectangle wave; sine wave; sawtooth; triangle wave (e.g., symmetric or asymmetric); trapezoidal; ramp; waveform with exponential increase; waveform with exponential decrease; pulse shape which minimizes power consumption; Gaussian pulse shape; pulse train; root-raised cosine; bipolar pulses; and combinations of one or more of these. In some embodiments, controller 250 is configured to produce a stimulation signal comprising a waveform including a combination of two or more waveforms selected from the group consisting of: square wave; rectangle wave; sine wave; triangle wave (symmetric or asymmetric); ramp; waveform with exponential increase; waveform with exponential decrease; pulse shape which minimizes power consumption; Gaussian pulse shape; pulse train; root-raised cosine; bipolar pulses; and combinations of one or more of these. In some embodiments, controller 250 is configured to construct a custom waveform (e.g., an operator customized waveform), such as by adjusting amplitude at specified time steps (e.g., for one or more pulses). In some embodiments, controller 250 is configured to generate a waveform including one or more random parameters (e.g., random timing of pulses or random changes in frequency, rate of change or amplitude).

[0161] In some embodiments, controller 250 is configured to provide a stimulation signal comprising waveforms and / or pulses repeated at a frequency (e.g., includes a frequency component) between 1.0Hz and 50KHz, such as between 10Hz and 500Hz, between 40Hz and 160Hz and / or between 5KHz and 15KHz. In some embodiments, controller 250 is configured to produce a stimulation signal comprising a frequency between 1Hz and 1000Hz, such as a stimulation signal with a frequency between 10Hz and 500Hz. In some embodiments, controller 250 is configured to produce a stimulation signal comprising a duty cycle between 0.1% and 99%, such as a duty cycle between 1% and 10% or between 1% and 25%. In some embodiments, controller 250 is configured to produce a stimulation signal comprising a frequency modulatedstimulation waveform, such as a stimulation waveform comprising a frequency component (e.g., signal) between 1kHz and 20kHz. In some embodiments, controller 250 is configured to produce a stimulation signal comprising a mix and / or modulation of low frequency and high frequency signals, which comprise any of the waveform types, shapes and other configurations. In these embodiments, the stimulation signal may comprise low frequency signals between 1Hz and 1000Hz, and high frequency signals between 600Hz and 50kHz, or between 1kHz and 20kHz. Alternatively, or additionally, the stimulation signal may comprise a train of high frequency signals and bursts of low frequency signals, and / or a train of low frequency signals and bursts of high frequency signals. Alternatively, or additionally, the stimulation signal may comprise one or more high frequency signals modulated with one or more low frequency signals, such as one or more high frequency signals frequency modulated (FM), amplitude modulated (AM), phase modulated (PM) and / or pulse width modulated (PWM) with one or more low frequency signals. The stimulation signal may cycle among different waveforms shapes at specified time intervals. The stimulation signal may comprise a pseudo random binary sequence (PRBS) non-retum-to- zero or return-to-zero waveform, such as with a fixed and / or time-varying pulse width and / or frequency of the pulses.

[0162] Controller 250 may comprise a clamping circuit configured to allow fast charging and / or discharging of the energy storage assembly 270, stimulation element 260 drivers (e.g., electrode drivers) of controller 250, and / or other components of implantable device 200. The clamping circuit may improve pulse shape by offering additional control and / or configuration of rise and fall times in the shape of the waveform (e.g., to create rapid rise or fall times). In some embodiments, the clamping circuit may be configured to limit the rise and / or fall time to be less than or equal to one-tenth (10%) of the pulse width of an applied stimulation pulse (e.g., less than or equal to Ipsec rise and / or fall time for a lOpsec stimulation pulse).

[0163] In some embodiments, controller 250 comprises a matching network configured to match the impedance of a first antenna 240 with the impedance of the receiver 230. In these embodiments, controller 250’ s matching network may be adjustable. Alternatively, or additionally, controller 250 may comprise an adjustable loading impedance to stabilize the load seen at an antenna 240 under different operating conditions. In some embodiments, the adjustable loading impedance is controlled according to the charge rate of the energy storage assembly 270.

[0164] Controller 250 and / or any other component of each implantable device 200 may comprise an integrated circuit comprising one or more components selected from the group consisting of: matching network; rectifier; DC-DC converter; regulator; bandgap reference; overvoltage protection; overcurrent protection; active charge balance circuit; analog to digital converter (ADC); digital to analog converter (DAC); current driver; voltage driver; digital controller; clock generator; data receiver; data demodulator; data modulator; data transmitter; electrode drivers; sensing interface analog front end; power management circuit; energy storage interface; memory register; timing circuit; and combinations of one or more of these.

[0165] One or more receivers 230 (singly or collectively receiver 230) may comprise one or more components, such as demodulator 231, rectifier 232, and / or power converter 233 shown in FIG. 1. In some embodiments, receiver 230 may comprise a DC-DC converter such as a boost converter. Receiver 230 may comprise a data receiver, such as a data receiver including an envelope detector and demodulator and / or an envelope averaging circuit. In some embodiments, one or more antennas 240 separately connect to one or more receivers 230. In some embodiments, one or more antennas 240 connect to a single receiver 230, such as via a series connection or a parallel connection.

[0166] One or more implantable devices 200 may be configured to transmit a data signal to external system 50. In some embodiments, receiver 230 is configured to drive one or more antennas 240 to transmit data to external system 50 (e.g., to an antenna 540 of an external device 500). Alternatively, or additionally, implantable device 200 may be configured to transmit a data signal by having receiver 230 adjust a load impedance to backscatter energy, such as a backscattering of energy which may be detected by external system 50. In some embodiments, data transmission is accomplished by receiver 230 manipulating a signal at a tissue interface, such as to transmit a data signal using body conduction.

[0167] In some embodiments, receiver 230 comprises a matching network, such as a matching network configured to detune to prevent over saturation. For example, implantable system 20 may comprise two or more implantable devices 200 each of which includes a receiver 230 comprising a matching network. A first implantable device 200’ s receiver 230’ s matching network may be configured to detune based on power received by the second implantable device 200’s receiver 230.

[0168] Demodulator 231 may comprise circuitry that asynchronously recovers signals modulated on the power signal provided by external system 50, and that converts the modulated signals into digital signals. In some embodiments, demodulator 231 asynchronously recovers the modulated signal by comparing a dynamically generated moving average with the envelope, outputting a high voltage when the envelope is greater than the moving average and a low voltage when the envelope is less than the moving average. Data may then be extracted from this resulting digital signal from the width and / or amplitude of the pulses in the signal, according to the encoding method used by external system 50. In some embodiments, demodulator 231 recovers a digital signal that is used as timing information for an implantable device 200, similar to an on-chip clock. The recovered clock signal may also be used to synchronize an on-chip clock generator of controller 250, such as through the use of a frequency and / or phase locked loop (FLL or PLL).

[0169] Rectifier 232 may comprise a power signal rectifier, such as to provide power to the energy storage assembly 270 and / or controller 250. In some embodiments, rectifier 232 comprises one or more self-driven synchronous rectifier (SDSR) stages connected in chargepump configuration, to boost the voltage from input RF amplitude to the rectifier to a higher voltage. The boosted voltage may directly charge energy storage assembly 270, or it may be further boosted by a DC-DC converter or boost converter. In some embodiments, rectifier 232 comprises diode-capacitor ladder stages instead of, or in addition to, SDSR stages. On-chip diodes, such as Schottky diodes, or off-chip diodes may be used in one or more rectifier 232 stages. For maximum efficiency, the rectification elements, such as diodes, may be optimized to minimize forward conduction and / or reverse conduction losses by properly sizing the components and selecting appropriate number of stages based on the input RF voltage and load current.

[0170] Power converter 233 may comprise one or more voltage conversion elements such as DC-DC converters that boost or otherwise change the voltage to a desired level. In some embodiments, voltage conversion is achieved with a buck-boost converter, a boost converter, a switched capacitor, and / or charge pumps. One or more power converters 233 may interface with energy storage assembly 270 and charge up associated energy storage components to desired voltages. In some embodiments, power converter 233 receives control signals from controller250, such as to configure voltages, currents, charge / discharge rates, switching frequencies, and / or other operating parameters of power converter 233.

[0171] One or more implantable leads 265 (singly or collectively lead 265) may be attached to one or more housings 210, such as a lead 265 comprising one or more stimulation elements 260. Lead 265 may comprise one or more stimulation elements 260 configured as a stimulation element (e.g., an electrode configured to deliver electrical energy in monopolar or bipolar mode or an agent delivery element such as an output port fluidly connected to a reservoir within housing 210). Alternatively, or additionally, lead 265 may comprise one or more stimulation elements 260 and / or functional elements 299b that is configured as a physiologic sensor (e.g., an electrode configured to record electrical activity of tissue or another physiologic sensor as described herein). Alternatively, or additionally, lead 265 may comprise one or more stimulation elements 260 and / or functional elements 299b that is configured to transmit signals through tissue to external system 50, such as through body conduction.

[0172] In some embodiments, implantable device 200 comprises a connector, connector 215, that operably attaches (e.g., electrically attaches) one or more stimulation elements 260 to one or more components (e.g., electronic components) internal to housing 210 (e.g., to transfer power and / or data therebetween). In some embodiments, connector 215 is operably attached (e.g., in a manufacturing process) or attachable (e.g., in a clinical procedure) to lead 265 as shown in FIG. 1. Alternatively, connector 215 may be operably attached and / or attachable to a lead attachment assembly, assembly 280, which in turn may be attached to a lead 265. In some embodiments, connector 215 passes through an opening in housing 210, in a feed-through arrangement. In some embodiments, an overmold or other sealing element, sealing element 205 shown, provides a seal about connector 215, the opening in housing 210 and / or the interface between connector 215 and housing 210.

[0173] In some embodiments, lead 265 comprises a removable stylet configured to aid in the implantation of lead 265, such as is described in applicant’s United States Patent Application Serial Number 17 / 412,044, titled “Medical Apparatus Including an Implantable System and an External System”, filed August 25, 2021. In some embodiments, implantable system 20 comprises more than one lead 265, comprising one or more stimulation elements 260 and attached to one or more housings 210 of one or more implantable devices 200. In some embodiments, one or more leads 265 may be attached to a single housing 210.

[0174] In some embodiments, lead 265 comprises a diameter between 1mm and 4mm, such as a diameter between 1mm and 2mm, such as a lead with a diameter of approximately 1.35mm. In some embodiments, lead 265 comprises a length between 3cm and 60cm, such as a length between 6cm and 30cm. One or more leads 265 may include between 2-64 stimulation elements 260, such as when a lead 265 comprises between 2 and 64 electrodes, such as between 4 and 32 electrodes. In some embodiments, lead 265 comprises a paddle lead. In some embodiments, lead 265 comprises a single or multi-lumen catheter, such as when an attached implantable device 200 is configured as an agent delivery apparatus as described herein (e.g., a stimulation element 260 configured as a catheter comprises at least a portion of lead 265).

[0175] In some embodiments, lead 265 comprises one or more tines, such as tines 266 shown. Tines 266 may be configured to anchor or otherwise stabilize (“anchor” or “stabilize” herein) lead 265 relative to patient tissue, such as to prevent undesired movement during and / or after an implantation procedure for lead 265. One or more tines 266 may be configured to biodegrade after implantation in the patient, such that the stabilization provided is temporary. Tines 266 may be configured to biodegrade over a time period of approximately 4 to 12 weeks. In some embodiments, biodegradable tines 266 are configured to be incorporated when lead stimulation elements 260 are positioned to stimulate a peripheral nerve (e.g., lead 265 is implanted such that one or more stimulation elements 260 are positioned proximate one or more peripheral nerves).

[0176] In some embodiments, one or more tines 266 are configured to be deployed, such as via an operator-accessible control.

[0177] One or more stimulation elements 260 (singly or collectively stimulation element 260) and / or functional element 299 (e.g., functional element 299a and / or 299b) may comprise one or more sensors, transducers and / or other functional elements. In some embodiments, one or more stimulation elements 260 and / or functional elements 299 comprise at least one sensor and / or at least one transducer (e.g., a single stimulation element 260 or multiple stimulation elements 260). In some embodiments, stimulation element 260 and / or functional element 299 comprises a functional element configured to provide a therapy, such as one or more stimulation elements 260 configured to deliver an agent to tissue (e.g., a needle or catheter), to deliver energy to tissue and / or to otherwise therapeutically affect tissue. In some embodiments, stimulation element 260 and / or functional element 299 comprises one or more functional elements configured to record patient information, such as when stimulation element 260 and / or functional element 299comprises one or more sensors configured to measure a patient physiologic parameter, as described herein. In some embodiments, stimulation element 260 and / or functional element 299 comprises one or more sensors configured to record an implantable device 200 parameter, also as described herein.

[0178] One or more stimulation elements 260 may be positioned on lead 265 as shown in FIG. 1. Alternatively, or additionally, one or more stimulation elements 260 may be positioned on housing 210. One or more functional elements 299 may be positioned on lead 265 (e.g., functional element 299b shown) and / or positioned on and / or within housing 210 (e.g., functional element 299a shown).

[0179] Stimulation element 260 may comprise one or more stimulation elements positioned at one or more internal body locations. Stimulation element 260 may comprise one or more stimulation elements positioned to interface with (e.g., deliver energy to and / or record a physiologic parameter from) spinal cord tissue, spinal canal tissue, epidural space tissue, spinal root tissue (dorsal or ventral), dorsal root ganglion, nerve tissue (e.g., peripheral nerve tissue, spinal nerve tissue or cranial nerve tissue), brain tissue, ganglia (e.g., sympathetic or parasympathetic) and / or a plexus. In some embodiments, stimulation element 260 comprises one or more elements positioned proximate and / or within one or more tissue types and / or locations selected from the group consisting of one or more nerves; one or more locations along, in and / or proximate to the spinal cord; peripheral nerves of the spinal cord including locations around the back; the knee; the tibial nerve (and / or sensory fibers that lead to the tibial nerve); the occipital nerve; the sphenopalatine ganglion; the sacral and / or pudendal nerve; brain tissue, such as the thalamus; baroreceptors in a blood vessel wall, such as in the carotid artery; one or more muscles; the medial nerve; the hypoglossal nerve and / or one or more muscles of the tongue; cardiac tissue; the anal sphincter; the dorsal root ganglion; motor nerves; muscle tissue; the spine; the vagus nerve; the renal nerve; an organ; the heart; the liver; the kidney; an artery; a vein; bone; and combinations of one or more of these, such as to stimulate and / or record data from the tissue and / or location in which the stimulation element 260 is positioned proximate to and / or within.

[0180] In some embodiments, stimulation element 260 and / or functional element 299 comprises one or more sensors configured to record data representing a parameter of implantable device 200. In these embodiments, stimulation element 260 and / or functional element 299 maycomprise one or more sensors selected from the group consisting of: an energy sensor; a voltage sensor; a current sensor; a temperature sensor (e.g., a temperature of one or more components of implantable device 200); a contamination detector (e.g., to detect undesired material that has passed through housing 210); an antenna matching and / or mismatching assessment sensor; power transfer sensor; link gain sensor; power use sensor; energy level sensor; energy charge rate sensor; energy discharge rate sensor; impedance sensor; load impedance sensor; instantaneous power usage sensor; average power usage sensor; bit error rate sensor; signal integrity sensor; and combinations of one or more of these. Apparatus 10 may be configured to analyze (e.g., via implantable controller 250, programmer 600 and / or diagnostic assembly 62 described herein) the data recorded by stimulation element 260 and / or functional element 299 to assess one or more of: power transfer; link gain; power use; energy within energy storage assembly 270; performance of energy storage assembly 270; expected life of energy storage assembly 270; discharge rate of energy storage assembly 270; ripple or other embodiments of energy storage assembly 270; matching of antenna 240 and 540; communication error rate between implantable device 200 and external device 500; integrity of transmission between implantable device 200 and external device 500; and combinations of one or more of these. A stimulation element 260 may be configured to record temperature, such as when apparatus 10 is configured to deactivate or otherwise modify the performance of an implantable device 200 when the recorded temperature exceeds a threshold.

[0181] In some embodiments, apparatus 10 comprises one or more tools, tool 60 shown. Tool 60 may comprise a data logging and / or analysis tool configured to receive data from external system 50 or implantable system 20, such as data comprising: diagnostic information recorded by external system 50 and / or implantable system 20; therapeutic information recorded by external system 50 and / or implantable system 20; patient information (e.g., patient physiologic information) recorded by implantable system 20; patient environment information recorded by implantable system 20; and combinations of one or more of these. Tool 60 may be configured to receive data from wired or wireless (e.g., Bluetooth) means. Tool 60 may comprise a tool selected from the group consisting of: a data logging and / or storage tool; a data analysis tool; a network such as a LAN or the Internet; a cell phone; and combinations of one or more of these.

[0182] In some embodiments, tool 60 comprises a battery charging assembly, such as an assembly configured to recharge one or more power supplies 570 comprising a rechargeable battery or capacitor.

[0183] In some embodiments, tool 60 comprises a user interface of apparatus 10, such as a user interface configured to allow the patient, clinician, or other user to create a set of stimulation settings based on various user input.

[0184] Apparatus 10 may include one or more placement tools, positioning tool 67 shown, which may be configured to aid in the positioning and / or maintenance of one or more external devices 500 on the patient’s skin (e.g., at a location proximate an implanted implantable device 200).

[0185] Apparatus 10 may include one or more imaging devices, imaging device 40 shown, which may comprise one, two, or more imaging devices selected from the group consisting of a CT scanner; a fluoroscope or other X-ray imaging device; an ultrasound imager; an MRI; and combinations of these. In some embodiments, positioning (e.g., selection of anatomical location for implantation) of one or more portions of device 200 (e.g., one or more leads 265 and / or one or more stimulation elements 260) is performed using image data provided by imaging device 40. In some embodiments, one or more leads 265 and / or stimulation elements 260 are positioned based on both eCAP data (e.g., to indicate proper positioning relative to one or more nerves), as well as data provided by imaging device 40 (e.g., a fluoroscope and / or an ultrasound imager). In some embodiments, imaging device 40 comprises a fluoroscope and / or other X-ray imaging device that is used (e.g., by an implanting clinician) to position leads 265 and / or stimulation elements 260 (e.g., with or without the use of eCAP data). In some embodiments, imaging device 40 comprises an ultrasound imager that is used (e.g., by an implanting clinician) to position leads 265 and / or stimulation elements 260 (e.g., with or without the use of eCAP data). In some embodiments, placement of one or more leads 265 and / or one or more stimulation elements 260 (e.g., proximate one or more peripheral nerves or other body nerves to be stimulated) is performed using an imaging device 40 (e.g., a fluoroscope or other X-ray imaging device) that does not allow visualization (e.g., adequate visualization) of nerve tissue (e.g., the nerve tissue to be stimulated). In these embodiments, apparatus 10 may be configured to utilize at least data from one or more eCAP measurements to identify and / or allow a clinician to identify a proper implant location for the one or more leads 265 and / or the one or morestimulation elements 260. For example, in peripheral nerve stimulation applications, where nerve trajectory is not sufficiently apparent under X-ray visualization, apparatus 10 may be configured to identify an implant location for elements 260 using both the X-ray data and eCAP measurement data (e.g., such that the one or more elements 260 are sufficiently proximate a target nerve to effectively stimulate the nerve during subsequent stimulation energy delivery).

[0186] Apparatus 10 may include one or more implantation tools, implantation tool 65 shown. Implantation tool 65 may comprise an introducer, tunneller, and / or other implantation tool constructed and arranged to aid in the implantation of housing 210, implantable antenna 240, lead 265 and / or one or more stimulation elements 260. In some embodiments, implantation tool 65 comprises a component configured to anchor implantable device 200 to tissue, such as a mesh or wrap that slides around at least a portion of implantable device 200 and is configured to engage tissue (e.g., via tissue ingrowth) or be engaged with tissue (e.g., via suture or clips). In some embodiments, implantation tool 65 is of similar construction and arrangement as tool 650 described in reference to FIGS. 6A-I herein.

[0187] Apparatus 10 may include one or more positioning devices, such as patient attachment device 70 shown in FIG. 1, that is used to attach one or more components of external system 50 to a location on or at least proximate the patient. In some embodiments, patient attachment device 70 is constructed and arranged as described in applicant’s United States Patent Application Serial Number 17 / 187,654, titled "Method and Apparatus for Neuromodulation Treatments of Pain and Other Conditions ", filed February 26, 2021, issued as U.S. Pat. No. 12,186,563 on January 7, 2025.

[0188] Patient attachment device 70 may comprise one or more elements configured to attach one or more external devices 500 and / or programmer 600 at one or more locations on or proximate the patient’s skin, that are relatively close to one or more implantable devices 200 that have been implanted in the patient. Patient attachment device 70 may comprise a component selected from the group consisting of: belt; belt with pockets; belt with adhesive; adhesive; strap; strap with pockets; strap with adhesive shoulder strap; shoulder band; shirt; shirt with pockets; clothing; clothing with pockets; epidural electronics packaging; clip; bracelet; wrist band; wrist watch; anklet; ankle bracelet; knee strap; knee band; thigh strap; thigh band; necklace; hat; headband; collar; glasses; goggles; earpiece; behind-the-earpiece; and combinations of one or more of these. In some embodiments, patient attachment device 70 comprises a belt configuredto surround at least one antenna 540 (e.g., at least one antenna 540 mounted to or otherwise positioned on a printed circuit board such as a flexible printed circuit board). Patient attachment device 70 may include one or more pockets, such as one or more pockets configured to collectively surround one or more of: external device 500; one or more antennas 540; power supply 570; programmer 600; and combinations of one or more of these. In some embodiments, patient attachment device 70 comprises multiple pockets, such as to allow repositioning of an external antenna 540, programmer 600, external transmitter 530 and / or external power supply 570 to various different locations, such as to improve transmission of power and / or data to one or more implantable devices 200 and / or improve patient comfort. In some embodiments, one or more antennas 540, power supplies 570, and / or transmitters 530 are connected through flexible cables positioned in patient attachment device 70. In some embodiments, the flexible cables are small coax cables that accommodate the power levels and frequencies of the carried signals. In some embodiments, the one or more antennas 540 are connected to one or more additional components of external device 500 through a single cable with a local power splitting component and / or active matching element that adjusts signal power to each of the one or more antennas 540.

[0189] In some embodiments, patient attachment device 70 and / or external device 500 may be configured to prevent adversely affecting portions of the skin contacted by either device. Alternatively, or additionally, patient attachment device 70 and / or external device 500 may be configured to clean and / or to promote healing of one or more skin-contacting portions. For example, patient attachment device 70 may include an agent (e.g., a coating or other included agent) selected from the group consisting of a bactericidal agent; an anti-fungal agent; and combinations thereof.

[0190] Apparatus 10 may comprise a device configured to operate (e.g., temporarily operate) one or more implantable devices 200, such as trialing interface 80 shown in FIG. 1. Trialing interface 80 may be configured to wirelessly deliver power to an implantable device 200, wirelessly deliver data to an implantable device 200, and / or wirelessly receive data from an implantable device 200. Trialing interface 80 may be configured to interface with one or more implantable devices 200 during an implantation procedure in which one or more implantable devices 200 are implanted in a patient (e.g., a sterile clinical procedure in which an implantable device 200 comprising a pre-attached lead 265 is implanted in a patient). In some embodiments,trialing interface 80 is of similar construction and arrangement to the trialing interface described in applicant’s United States Patent Application Serial Number 17 / 187,654, titled "Method and Apparatus for Neuromodulation Treatments of Pain and Other Conditions ", filed February 26, 2021, issued as U.S. Pat. No. 12,186,563 on January 7, 2025, or applicant’s United States Patent Application Serial Number 17 / 379,928, titled “Stimulation Apparatus”, filed July 19, 2021, issued as U.S. Pat. No. 12,201,829 on January 21, 2025.

[0191] Trialing interface 80 may be used in clinical procedures in which an implantable device 200 including a pre-attached lead 265 is implanted. In some embodiments, implantable device 200 includes an attachable lead 265, and apparatus 10 includes a trialing interface configured for use with an attachable lead, trialing interface 90. Trialing interface 90 may be configured to operably (e.g., electrically) attach to lead 265, such as to deliver stimulation energy via a wired connection during a trialing procedure, as described herein. For example, trialing interface 90 may deliver stimulation energy to one or more stimulation elements 260 of lead 265 during a trialing procedure in which proper position of stimulation element 260 is confirmed and / or modified, and / or one or more stimulation waveforms are tested. Trialing interface 90 may include interface connector 95, which may comprise a connector that is configured to operably attach (e.g., electrically attach) trialing interface 90 to lead 265 (e.g., after lead 265 has been implanted in tissue of the patient). Connector 95 may be configured to be used in a single trialing procedure (e.g., on a single patient), while the remainder of trialing interface 90 may be reused (e.g., in multiple trialing procedures for multiple patients). Trialing interface 90 may comprise a device that is sterilized, and it may be a device that may be re-sterilized (e.g., to be used in multiple sterile clinical procedures). In some embodiments, trialing interface 80 and trialing interface 90 include similar components, (e.g., similar components used to create similar stimulation waveforms to be used in a trialing procedure).

[0192] In some embodiments, apparatus 10 comprises a diagnostic assembly, diagnostic assembly 62 shown in FIG. 1. In some embodiments, programmer 600 and / or implantable controller 250 comprise all or a portion of diagnostic assembly 62. Diagnostic assembly 62 may be configured to assess, monitor, determine and / or otherwise analyze patient information and / or implantable device 200 information, such as when one or more stimulation elements 260, functional elements 299, and / or functional elements 599 are configured as a sensor configured to record patient information (e.g., patient physiologic information and / or patient environmentinformation) and / or apparatus 10 information (e.g., implantable device 200 information) as described herein.

[0193] In some embodiments, apparatus 10 is configured to provide a therapy by delivering stimulation energy to tissue, such as electrical energy delivered to tissue by one or more stimulation elements 260 comprising one or more electrodes. Alternatively, or additionally, apparatus 10 may be configured as an agent-delivery apparatus (e.g., a pharmaceutical or other agent delivery apparatus). In some embodiments, apparatus 10 comprises one or more reservoirs for storing the agent, such as reservoir 525 of external device 500 and / or reservoir 225 of implantable device 200, each shown in FIG. 1. Reservoirs 525 and / or 225 may be fluidly connected to one or more functional elements 599 and / or functional elements 299, respectively (e.g., via one or more tubes). Reservoirs 525 and / or 225 may comprise one or more chambers (e.g., independent chambers configured to separately contain incompatible drugs or otherwise prevent undesired multiple drug interactions). Reservoirs 525 and / or 225 may comprise a volume (e.g., a volume to store one or more agents) between 0.1ml and 50ml, such as between 0.1 ml and 3.0ml, or between 0.1ml and 1.0ml. Reservoirs 525 and / or 225 may comprise pressurized reservoirs or otherwise comprise a fluid pumping mechanism (e.g., a peristaltic mechanism, syringe pump or other fluid pump). Reservoirs 525 and / or 225 and may comprise refillable reservoirs (e.g., when reservoir 225 of an implantable device 200 comprises a valved opening such as a silicone septum or a mechanical valve, either accessible via a needle for refilling). The fluidly attached functional elements 599 and / or functional elements 299 may comprise a fluid delivery element selected from the group consisting of: a catheter; a porous membrane; an iontophoretic element; a needle; or combinations of one or more of these. Delivered and / or stored (e.g., in a reservoir) agents may comprise an agent selected from the group consisting of: an analgesic agent such as morphine, fentanyl, lidocaine or other agent delivered to treat pain; a chemotherapeutic agent such as a chemotherapeutic agent delivered systemically (e.g., throughout the blood system of the patient) and / or to a location in or proximate an organ such as the liver or brain to treat cancer; an antibiotic configured to treat or prevent an infection; a hormone such as a hormone delivered intravenously in hormonal therapy; heart medications such as nitroglycerin, a beta blocker or a blood pressure lowering medication; a carbohydrate such as glucose or dextrose delivered to treat a low blood sugar condition; insulinsuch as to treat a high blood sugar condition; a diabetic medication; a neurological medication; an epilepsy medication; and combinations of one or more of these.

[0194] In some embodiments, apparatus 10 is configured to deliver low frequency stimulation energy (e.g., electrical energy comprising a low frequency signal) to stimulate motor nerves, such as to improve tone and structural support (e.g., physical therapy). In these embodiments, apparatus 10 may be further configured to provide high frequency stimulation, such as to treat pain (e.g., suppress and / or control pain). The combined effect may be used not only for pain management but also muscle strengthening and gradual healing of supportive structures. Alternatively, or additionally, as described herein, apparatus 10 may be configured to deliver low frequency stimulation energy (e.g., electrical energy) to induce paresthesia, which may also be accompanied by the delivery of high frequency stimulation (e.g., to suppress and / or control pain). In some embodiments, apparatus 10 is configured to deliver low frequency stimulation (e.g., electrical energy comprising a low frequency signal) and burst stimulation, delivered simultaneously or sequentially. The low frequency stimulation and the burst stimulation may be delivered on similar and / or dissimilar stimulation elements 260 (e.g., similar or dissimilar electrode-based stimulation elements 260).

[0195] In some embodiments, implantable device 200 has an internal battery or other power supply such that stimulation (e.g., stimulation energy and / or a stimulation agent) is delivered to one or more locations within a patient for an extended time period (e.g., at least 1 hour, at least 1 day, at least 1 month or at least 1 year), without receiving a power transmission (e.g., as described herein from an external device such as external device 500) during that time period. In some embodiments, at least a portion of a single pulse of energy (e.g., at least a single phase) is delivered by implantable device 200 using energy provided by an internal power supply 570 such as a battery or a capacitor. In these embodiments, data may be transmitted by one or more of an external device 500 and / or a programmer 600, such as to activate or modify stimulation being delivered, with or without also transmitting power.

[0196] One or more implantable devices 200 may be configured to deliver stimulation energy with a stimulation waveform that varies over time. In some embodiments, one or more stimulation parameters of the stimulation waveform are randomly varied over time, such as by using a probability distribution as described in applicant’s co-pending United States Patent Application Serial Number 17 / 372,095, titled “Apparatus with Enhanced StimulationWaveforms”, filed July 9, 2021. Each stimulation waveform may comprise one or more pulses, such as a group of pulses that are repeated at regular and / or irregular intervals. In some embodiments, a pulse may comprise delivery of electrical energy, such as electrical energy delivered in one or more phases (e.g., a pulse comprising at least a cathodic or anodic portion followed by passive capacitive recovery with an optional open circuit time between the first portion and recovery). In some embodiments, a group of pulses is delivered, each pulse comprising an anodic or cathodic portion that may include charge recovery after each pulse, such as charge recovery comprising active (opposite polarity pulse) recovery, and / or passive (capacitive) recovery. In some embodiments, there is no recovery between pulses, but instead active or passive recovery is included at the end of the set of the first (anodic or cathodic) portions. In some embodiments, single or groups of pulses are provided at time-varying modes of repetition (e.g., regular intervals for a period, then a period of irregular intervals) or at regular intervals with occasional (random) spurious pulses inserted (creating a single irregular event in an otherwise regular series). Non-limiting examples of waveform embodiments include: a variation in frequency (e.g., frequency of one or more signals of the waveform); variation of a signal amplitude; variation of interval time period (e.g., at time period between pulses or a time period between pulse trains); variation of a pulse width; multiple piecewise or continuous embodiments of one of more stimulation parameters in a single pulse (e.g., multi-step, multiamplitude in one “super-pulse”); variation of pulse symmetry (e.g., via active drive, passive recovery and / or active-assisted passive recovery); variation of stimulation energy over a time window and / or overlapping time windows; variation of the power in the frequency spectrum of the stimulation waveform; and combinations of one or more of these. In some embodiments, apparatus 10 and / or implantable device 200 may be configured to vary a stimulation waveform “systematically” (e.g., automatically and / or at least semi-automatically by apparatus 10) such as a variation performed temporally (e.g., on predetermined similar or dissimilar time intervals) and / or a variation performed based on a parameter, such as a measured parameter that may be based on a signal produced by a sensor of implantable device 200 or another component of apparatus 10. Alternatively, or additionally, apparatus 10 and / or implantable device 200 may be configured to vary a stimulation waveform randomly. Random variation shall include discrete or continuous embodiments that may be selected from a distribution, such as a probability distribution selected from the group consisting of a uniform distribution; an arbitrarydistribution; a gamma distribution; a normal distribution; a log-normal distribution; a Pareto distribution; a Gaussian distribution; a Poisson distribution; a Rayleigh distribution; a triangular distribution; a statistic distribution; and combinations of one or more of these. Random pulses or groups of pulses may be generated based on randomly varying one or more stimulation signal parameters. One or more stimulation parameters may be varied randomly through the use of one or more probability distributions, as described herein.

[0197] The stimulation waveforms delivered by implantable device 200 may comprise one or more high frequencies. The stimulation waveform frequency or other stimulation parameter may be set, adjusted, and / or modified (“set”, “adjusted”, and / or “modified” herein) to optimize therapeutic benefit to the patient and minimize undesired effects (e.g., paresthesia or other patient discomfort). In some embodiments, a stimulation waveform is adjusted based on a signal produced by a sensor of apparatus 10 (e.g., a sensor of implantable device 200, such as a stimulation element 260 configured as a sensor or other sensor of implantable device 200 as described hereabove). Adjustment of a stimulation waveform parameter may be performed automatically by the implantable device 200 and / or via an external device 500 and / or programmer 600).

[0198] In some embodiments, a pulse shape of a stimulation waveform may be varied, such as a pulse shape comprising: a sinusoidal geometry; a square geometry (e.g., a waveform comprising a square wave); a rectangular geometry; a triangular geometry; (e.g., symmetric or asymmetric); a trapezoidal geometry; a sawtooth geometry; a ramped geometry; an exponential geometry; a piece-wise step function geometry; a root-raised cosine geometry; and combinations of one or more of these.

[0199] In some embodiments, a charge recovery phase (e.g., anodal phase) of a stimulation waveform is varied by implantable device 200.

[0200] Inter-pulse gap, the time between one or more pulses (e.g., a biphasic or other multiphasic pulse that is repeated continuously), may be varied systematically and / or randomly by implantable device 200. In some embodiments, inter-pulse gap between one or more pulses comprises zero time (i.e. a first pulse is immediately followed by a similar or dissimilar second pulse). In some embodiments, inter-pulse gap is varied systematically, such as on a routine basis (i.e. temporally) and / or varied based on a signal produced by a sensor of apparatus 10. Alternatively, or additionally, inter-pulse gap may be varied randomly, such as a randomvariation based on a distribution (e.g., a probability distribution with a pre-determined shape) as described herein.

[0201] In some embodiments, implantable device 200 delivers a stimulation waveform comprising a series of frequency modulated (FM) pulses, such that the frequency of stimulation varies. Implantable device 200 may be configured to deliver a frequency modulated stimulation waveform comprising a carrier signal, at a carrier frequency, that is modulated continuously between a first frequency and a second frequency. For example, implantable device 200 may deliver a stimulation waveform that modulates between 2.0kHz and 3.0kHz every second (e.g., comprising a carrier signal at 2.5kHz that is modulated at 1Hz) with a modulation range (the excursion from the carrier signal) of + / -500Hz. In some embodiments, implantable device 200 may deliver a stimulation waveform that comprises: a carrier frequency between 1kHz and 50kHz, a modulation frequency between 0.1Hz and 10kHz and / or a modulation range between 1Hz and the carrier frequency.

[0202] In some embodiments, implantable device 200 delivers a stimulation waveform comprising a series of amplitude modulated (AM) pulses, such that the amplitude of stimulation varies (e.g., varying the amplitude of the voltage and / or current of the stimulation signal). The amplitude of delivered current may be varied in a single amplitude modulated sweep, such as a sweep from 2mA to 3mA. In some embodiments, amplitude of a signal may be varied continuously, such as when current is varied between 2mA and 3mA every second (e.g., a signal comprising a modulation frequency of 1Hz). In these embodiments, the depth of modulation would be 33%, where depth of modulation is equal to 1- [lower range / upper range]. In some embodiments, amplitude of delivered current fluctuates between 1mA and 3mA (i.e. a depth of modulation of 66%), while in other embodiments, current fluctuates between 0mA and 10mA (e.g., a depth of modulation of 100%). In some embodiments, implantable device 200 is configured to deliver an amplitude modulated signal comprising: a carrier frequency between IKhz and 50kHz; a modulation frequency between 0.1Hz and the carrier frequency and / or a depth of modulation between 0.1% and 100%.

[0203] In some embodiments, implantable device 200 delivers a stimulation waveform comprising delivery of multiple trains of pulses that are delivered intermittently, a “burst stimulation” waveform as defined hereabove. For example, implantable device 200 may be configured to deliver a series or train of five pulses, each with a 1msec pulse width. Each of thefive pulses may be separated by an inter-pulse gap of 4msec, creating a train-on period of 16msec. These five pulses may be repeated every 25msec (the “inter-train period”). In some embodiments, implantable device 200 may be configured to deliver a burst stimulation waveform comprising a pulse width between 5psec and 1msec. Implantable device 200 may deliver a train or burst stimulation waveform comprising pulses with constant pulse widths and / or varying pulse widths, such as when the pulse widths (and / or other stimulation parameters) are varied randomly and / or systematically. Implantable device 200 may deliver a train or burst stimulation waveform with a varied or constant pulse shape selected from the group consisting of: sinusoid; square, rectangle; triangle (symmetric or asymmetric); trapezoid; sawtooth; ramp (e.g., a linear ramp); exponential curve; piece-wise step function; and combinations of one or more of these. Implantable device 200 may deliver a train or burst stimulation waveform with an inter-pulse gap less than inter-train period. The inter-pulse gap may be relatively constant, and / or it may be varied, such as when implantable device 200 randomly varies the inter-pulse gap or varies the inter-pulse gap systematically. In some embodiments, the inter-pulse gap between any two pulses within a pulse train (or burst) may be varied between O.lpsec and the inter-train period (or inter-burst period). Implantable device 200 may deliver a train stimulation waveform with an inter-pulse gap between Ipsec and 1 second. Implantable device 200 may deliver a burst stimulation waveform with an inter-train period between Ipsec and 1 second. Implantable device 200 may deliver a burst stimulation waveform with an inter-burst period between 20psec and 24 hours. The inter-burst period may be relatively constant, and / or it may be varied, such as when implantable device 200 randomly varies the inter-burst period or varies the inter-burst period systematically. In some embodiments, interburst period is varied by the user, such as via a user using programmer 600. In these embodiments, user activation may be regulated with one or more safeguards or other limits such as those incorporated into patient-controlled analgesia devices. The inter-train period may be varied between I sec and 24 hours. Implantable device 200 may deliver a train or burst stimulation waveform with a train-on period (the time between the onset of a first pulse in a pulse train to the end of the last pulse in a pulse train) between lOpsec and 24 hours. The train- on and / or burst-on period may be relatively constant, and / or it may be varied, such as when implantable device 200 randomly varies the train-on and / or burst-on period or varies the train-on and / or burst-on period systematically. Implantable device 200 may deliver a train or burststimulation waveform with a train or burst envelope selected from the group consisting of: cosine; cosine-squared; sine; square; rectangle; triangle (symmetric or asymmetric); trapezoid: sawtooth; ramp (e.g., linear ramp); and combinations of one or more of these. Implantable device 200 may deliver a train and / or burst stimulation waveform with a train ramp duration or burst ramp duration between Ipsec to 10 minutes. Implantable device 200 may deliver a train and / or burst stimulation waveform with a depth of modulation between train and / or bursts of between 1% and 99%. For example, between some or all of the trains and / or bursts (burst-off or train-off periods), a signal may be present and may contain the same or different elements contained in the train-on and / or burst-on period. These burst-off or train-off periods may comprise a quiescent period. The amplitude of the signal contained in these quiescent periods may be from 0% to 99% of the signal amplitude during the train-on and / or burst-on period, such as a signal with an amplitude less than 50% of the signal amplitude during the train-on and / or burst-on period or another amplitude below a neuronal excitation threshold.

[0204] Each implantable device 200 of the present inventive concepts may be configured to deliver stimulation energy to one, two, three, four, or more anatomical locations of a patient, such as via sets of one or more stimulation elements 260 (e.g., electrodes) positioned on one or more leads 265. The stimulation energy delivered by the elements 260 may comprise tonic stimulation and / or more complex stimulation waveforms (e.g., as represented by stimulation paradigm SP of apparatus 10). A first set of stimulation elements 260 may be positioned and deliver and / or receive electrical current to deliver therapy (e.g., treat pain) in a first anatomical location, while a second set of stimulation elements 260 may be positioned and deliver and / or receive electrical current to deliver therapy (e.g., treat pain) in a second anatomical location. The first and second anatomical locations may include overlapping portions (e.g., the same tissue is included in each location) or they may be completely different volumes of tissue. The stimulation energy delivered to the two locations may be delivered sequentially, and / or simultaneously. In some embodiments, three, four or more anatomical locations receive therapy from corresponding sets of stimulation elements 260.

[0205] In some embodiments, one or more sets of stimulation elements 260 are configured to provide “combination waveform therapy”, where the stimulation waveform defined by stimulation paradigm SP and delivered by elements 260 comprises a combination of two or more waveforms. For example, a first waveform may be delivered to a first anatomical location inwhich pain is present, and a second waveform may be delivered to a second anatomical location. The first waveform may comprise stimulation energy delivered at a frequency up to 100Hz (e.g., to treat pain). The second waveform may comprise stimulation energy delivered at a higher frequency than the first waveform, such as a frequency of IKHz or more (e.g., for sub-threshold stimulation).

[0206] In some embodiments, one or more sets of stimulation elements 260 are configured to provide “microburst waveform therapy”, where the stimulation waveform defined by stimulation paradigm SP and delivered by elements 260 comprises delivery of stimulation energy that is repeatedly turned on and off, such as to provide a therapy based on the repeated enhancement of onset of stimulation energy delivery (e.g., versus continuous stimulation energy delivery).

[0207] In some embodiments, one or more stimulation elements 260 are configured to provide “paired stimulation therapy”, wherein the stimulation waveform defined by stimulation paradigm SP and delivered by elements 260 comprises at least two different types of waveforms that are delivered simultaneously, such as when the stimulation waveform comprises two or more of: a tonic stimulation waveform; a microburst stimulation waveform; and / or a waveform comprising a combination of pulses, trains, and / or bursts.

[0208] Each implantable device 200 may be configured to perform charge recovery in an “active” and / or a “passive” manner. For example, device 200 may perform active recovery by including a pulse of opposite polarity to the stimulating pulse(s) such that the net charge at the stimulation element 260 is zero (e.g., stimulating charge = recovery charge). Device 200 may perform passive charge recovery by electrically connecting the stimulation elements 260 for a period of time after delivery of stimulation energy to allow charge to dissipate (e.g., to allow the charge on included blocking capacitors to dissipate), thereby resulting in net zero charge at the stimulation elements 260. In some embodiments, implantable device 200 may perform charge recovery as described in applicant’s co-pending United States Patent Application Serial Number 17 / 384,020, titled “Stimulation Apparatus”, filed July 23, 2021. Configuration of active and / or passive charge recovery may be defined by stimulation paradigm SP.

[0209] In some embodiments, apparatus 10 may be configured to apply a “pulse width constraint” when assessing the compatibility of a set of stimulation parameters, and / or when determining an acceptable range of values for a stimulation parameter to be used with a set of other stimulation parameters. For example, when a delivered stimulation includes delivery ofstimulation at a relatively high rate (e.g., above 1kHz, such as approximately 1.5kHz), there may be parameter limitations applied due to the shorter pulse widths of stimulation pulses.Implantable device 200 may include a “minimum switching time” to account for in determining stimulation setting compatibility, such as a switching time of approximately 180psecs. In some embodiments, apparatus 10 is configured to deliver the pulses for each area before a subsequent stimulation cycle begins. For example, the minimum amount of time available to deliver all the pulses is determined by the highest programmed stimulation rate (i.e. the waveform including the shortest interval), while considering any associated other requirements, “overhead” herein, such as the switching time requirements (e.g., switching requirements of the current sources, such as a time requirement of approximately 180psecs). In other words, the minimum stimulation interval must be at least the time of the sum of all the pulse widths plus the overhead. In some embodiments, the stimulation delivered includes a high rate stimulation waveform of 1.5kHz, and apparatus 10 may limit passive recovery pulse width to a maximum of 1 lOpsecs, and active recovery pulse width to a maximum of 55psecs.

[0210] In some embodiments, apparatus 10 may be configured to apply an envelope for stimulation based on dosage on and off times (DON and DOFF times, respectively, each as described herein). Apparatus 10 may provide up to two dosing periods, which may be associated with the rate of stimulation. In some embodiments, apparatus 10 constrains DON and / or DOFF. DON may be limited to a maximum time period of 1 second. DOFF may be limited to a time period of 2 seconds, such as when the dosage period (DON plus DOFF) is limited to a time period of 2 seconds. Apparatus 10 may be configured to deliver stimulation energy at multiple rates, where a first rate (e.g., a relatively high rate) is delivered at a prescribed rate (e.g., a rate entered via user interface 680), while a second rate (e.g., a relatively low rate or otherwise lower than the first rate) is generated using a “N of M scheme” where a subset N of M pulses of the higher rate are delivered to effectively achieve the lower rate, such as is described in applicant’s Int’l Application Serial Number PCT / US2021 / 047815, titled “Apparatus for Delivering Customized Stimulation Waveforms”, filed August 26,2021.

[0211] External device 500 may include one or more sensors, sensor 595 shown. In some embodiments, sensor 595 comprises a sensor-based functional element 599a as described herein. In some embodiments, sensor 595 comprises a sensor configured as a control to detect user input.

[0212] The apparatus 10 may further comprise a programmer 600 (e.g., patient programmer 600’ and / or clinician programmer 600”). In some embodiments, the programmer 600 may be configured to cause information stored in one or more devices 500 to be transferred to one or more other devices 500, such as via a “synchronization routine” that is facilitated by programmer 600. For example, programmer 600 may upload information from a first device 500a (e.g., all or a portion of the information stored on the device 500a uploaded into memory of device 600) and upload similar types of information from a second device 500b (e.g., into a different portion of memory of device 600). If the information on the two devices 500 is different, a synchronization routine may be performed, such as a synchronization routine in which a user (e.g., the patient, their clinician, or other user) is asked to confirm which sets of information (e.g., stimulation settings) are to be synchronized (e.g., which are to be stored on both devices, which are to be used as stimulation settings for the next or a future stimulation session, which are to be overwritten and potentially erased, and the like). In some embodiments, one or more stimulation programs (e.g., one or more sets of stimulation settings) and / or firmware (e.g., firmware for one or more external devices 500) stored in a programmer 600 (e.g., sent to a programmer 600) may be downloaded to one or more external devices 500. Information transferred from one external device 500 to one or more other external devices 500 in a synchronization routine may include but is not limited to: stimulation settings or other stimulation program information; other apparatus 10 settings; apparatus 10 use information (e.g., history); and / or patient use information.

[0213] In some embodiments, the apparatus 10 may be configured to provide feedback to a user (“user feedback”) regarding one or more parameters and / or conditions of apparatus 10 (e.g., current or past parameters and / or conditions). For example, the apparatus 10 may provide user feedback that comprises an assessment of the alignment of external device 500 relative to implantable device 200, and / or comprises an assessment of the quality of the connection (e.g., the wireless connection for the transfer of power and / or data, as described herein) between external device 500 and implantable device 200. In some embodiments, user interface 580 of external device 500 provides feedback to the patient, such as audible, visual, haptic, and / or other forms of feedback. In some embodiments, the feedback may comprise “binary feedback”, for example “go, no-go” types of feedback that confirms and / or alerts the user whether the alignment of the devices and / or the connection between the devices is adequate or unacceptable.For example, when external device 500 is being positioned on the patient, an indicator (e.g., a confirmatory beep and / or vibration) may confirm when adequate alignment is achieved. Alternatively, or additionally, the feedback provided may comprise “scalar feedback”. For example, when external device 500 is being positioned on the patient, audible feedback (e.g., a beep) may increase and / or decrease in volume based on the alignment and / or the quality of the connection between the devices. When the connection quality reaches an adequate level, the beep may change (e.g., change tone and / or pattern) to indicate a proper placement of external device 500. As another example, when external device 500 is being positioned on the patient, the programmer 600 may provide a visual indication (e.g., a color-coded indicator and / or “bars” of signal strength) based on the alignment and / or the quality of the wireless connection between the devices. In some embodiments, apparatus 10 provides feedback related to one or more usage parameters of apparatus 10, for example power consumption of implantable device 200 and / or external device 500, such as the power consumption during various types of stimulation (e.g., power consumption of different stimulation programs performed by apparatus 10). In some embodiments, an indication of sufficient signal quality determined by apparatus 10 may incorporate information about the anticipated power consumption of the implantable device, and that indication may be adjusted accordingly. In this configuration, the indication of sufficient signal quality is adaptive to the programmed behavior of the apparatus 10.

[0214] In some embodiments, the apparatus 10 may be configured to operate in a closed loop configuration. For example, apparatus 10 may record diagnostic and / or usage information, such as patient specific information that may be related to implant location of implantable device 200, patient proficiency in placement of external device 500 relative to implantable device 200, usage history (e.g., patient adherence to prescribed usage of apparatus 10), patient outcomes (e.g., pain relief reported by the patient), and / or other parameters that may be monitored and / or assessed over time. Diagnostic and usage information recorded by apparatus 10 may be analyzed, and the resultant analysis used to adjust these and / or other parameters of apparatus 10, such as the parameters of one or more stimulation programs. Diagnostic and usage information recorded by apparatus 10 may be analyzed, and the resultant analysis used to: alert the patient, caregiver, and / or clinician of a deviation from a prescribed usage; alert the clinician of an issue with a component of apparatus 10 (e.g., the need to replace and / or adjust the implant location of implantable device 200); and / or to initiate (e.g., to automatically initiate and / or to alert a user toinitiate) other changes or adjustments (e.g., iterative changes or adjustments) to one or more parameters of apparatus 10. In some embodiments, apparatus 10 may be configured to allow a clinician to remotely monitor one or more patients using apparatus 10 (e.g., via clinician programmer 600” connected to patient programmer 600’ and / or external device 500 via a server of apparatus 10 and / or a wide area network such as the Internet), and to adjust therapy delivered by apparatus 10, for example based on the recorded diagnostic and / or usage information. In some embodiments, apparatus 10 may be configured to analyze diagnostic and usage information from multiple patients using apparatus 10, such as to identify trends, issues, beneficial treatment parameter adjustments, and / or information for a clinician to review to benefit one or more patients of apparatus 10.

[0215] In some embodiments, one or more devices of apparatus 10 may be configured to send information to, receive information from, and / or otherwise communicate with a remote data processing device, such as server 700 depicted in FIG. 1. The server 700 may comprise an “offsite” server (e.g., outside of the clinical site and / or patient location in which apparatus 10 is used by the patient), such as a server owned, maintained, and / or otherwise provided by the manufacturer of apparatus 10. Alternatively, or additionally, server 700 may comprise a cloudbased server. Server 700 may include processing unit 710 shown, which may comprise a module (e.g., an electronics module) that may be configured to perform and / or facilitate one or more functions of apparatus 10, such as one or more processes, data collections, data analyses, data transfers, signal processing, and / or other functions of apparatus 10 (“functions of apparatus 10” or “apparatus functions” herein). Processing unit 710 may comprise one or more electronic elements, electronic assemblies, and / or other electronic components, such as components selected from the group consisting of: microprocessors; microcontrollers; state machines; memory storage components; analog-to-digital converters; rectification circuitry; filters and other signal conditioners; sensor interface circuitry; transducer interface circuitry; and combinations of one, two, or more of these. For example, processing unit 710 may include at least one processor and at least one memory storge component, such as processor 712, and memory 713, which may be coupled to processor 712.

[0216] In some embodiments, the server 700 may be configured to receive and store various forms of data, such as data 720, which may be data recorded by implantable device 200, external device 500, and / or other component of apparatus 10. In some embodiments, the data 720 may becollected by the charger 61, such as during charging of the external device, and may then be uploaded to the server 700. The data 720 may then be used for a variety of purposes, such as, for example, for analysis and / or troubleshooting. For example, the data 720 may be analyzed to monitor device failure (e.g., of the external device 500 and / or implantable device 200), device misuse (e.g., incorrect alignment between the external device 500 and the implantable device 200), treatment efficacy, and / or the like.

[0217] The data 720 may comprise data collected from one or more patients (e.g., a plurality of patients treated with apparatus 10), and may include data collected over extended periods of time (e.g., at least one month, at least two months, at least three months, at least four months, at least five months, at least six months, at least one year, between one month and one year, between one month and six months, between six months and one year (including all values and sub-ranges therein). In some embodiments, devices of apparatus 10 may be configured to communicate with server 700 over a network, for example, a wide area network such as the Internet. Alternatively, or additionally, apparatus 10 may may include a virtual private network (VPN) through which various devices of apparatus 10 may transfer data.

[0218] In some embodiments, the data 720 may be used to detect potential device failures and, in some embodiments, proactively initiate replacements for one or more components of apparatus 10. For example, the apparatus 10 may be configured to detect, by analyzing the data 720, one or more indications of a failing external device 500 and / or implantable device 200 (e.g., an external device 500 and / or implantable device 200 of reduced functionality). Upon such a detection, a notification may be automatically generated (e.g., via a programmer 600 associated with external device 500 and / or implantable device 200) to initiate a replacement for external device 500 and / or implantable device 200. The notification may be provided to a clinician via clinician programmer 600”, and / or to the patient via patient programmer 600’. If a patient requires a replacement device (e.g., due to damage or loss), a new external device 500 and / or implantable device 200 may be sent to the patient (e.g., directly from a manufacturer of apparatus 10), facilitating remote device setup. The replacement external device 500 may be preloaded with the patient’s configuration data (e.g., a portion of data 720) prior to sending it to the patient. This data may include one or more of apparatus identification information, security information, and therapy information (e.g., stimulation program(s) for the patient).

[0219] Additionally, or alternatively, the data 720 may be used to identify or confirm misuse of one or more components of apparatus 10. For example, misplacement of an external device 500 and / or selection of parameter settings that exceed predefined threshold or values. For example, selection of parameter settings that yield excessive amplitude or power consumption (i.e., meeting or exceeding a predefined threshold thereof) may be detected by analyzing the data 720. In response, a notification comprising instructions for modifying usage to improve effectiveness may be automatically generated via an associated programmer 600. As another example, apparatus 10 may monitor a quality of a connection between an external device 500 and an implantable device 200 on a regular basis (e.g., periodically and / or upon request). As explained above, an alignment between external device 500 and implantable device 200 may affect a power and / or data link between the two devices. Apparatus 10 may be configured to compare a portion of the data 720 comprising relevant connection measurements to a predefined threshold to detect a decline in alignment quality. If alignment quality is below the predefined threshold, apparatus 10, via server 700, may generate a notification via programmer 600 (e.g., patient programmer 600’). For example, in some embodiments, the notification may comprise instructions to a patient on how to adjust placement of external device 500 or stimulation parameters for apparatus 10 to restore connectivity or otherwise increase the strength and / or consistency of the strength of the connection between external device 500 and implantable device 200. Additionally, or alternatively, the apparatus 10 may be configured to automatically adjust one or more stimulation parameters to improve connectivity.

[0220] In some embodiments, server 700 may be configured to allow data 720 (e.g., at least a portion thereof) to be shared across a plurality of apparatuses 10 (e.g., a plurality of programmers 600), such as a plurality of apparatuses 10 associated with a plurality of corresponding patients and / or clinicians. For example, data from one or more first patient programmers 600’ may be shared with one or more second patient programmers 600’ and / or one or more clinician programmers 600” via server 700. In some embodiments, data from at least one patient programmer 600’ may be shared with a plurality of clinician programmers 600” via server 700. Accordingly, any one of the plurality of clinician programmers 600” may be used to reprogram and / or update the given patient programmer 600’.

[0221] In some embodiments, apparatus 10 may be configured to remotely interface with one or more patient devices (e.g., external device 500, implantable device 200, charger 61, and / orother apparatus 10 device maintained by the patient) that are used by one or more patients using apparatus 10 (e.g., one or more patients with an implantable device 200 implanted in the patient and one or more external devices 500 in communication with the device 200). For example, the clinicians of the patients using apparatus 10 may remotely interface with the patient devices, such as via clinician programmer 600” remotely connected via the Internet. In some embodiments, server 700 may be configured to provide secure connections between clinicians and patients of apparatus 10. Apparatus 10 may be configured to enable clinicians or other users of apparatus 10 (e.g., other patient caregivers) to initiate remote programming sessions (described below), to initiate apparatus 10 component updates (e.g., firmware updates for external device 500, implantable device 200, charger 61, and / or other component of apparatus 10), and / or to remotely configure and / or guide a setup process of a component of apparatus 10 (e.g., a new external device 500, that may be shipped directly from a manufacturer of apparatus 10 to the patient, such that the device may be setup without a clinician visit). In some embodiments, one or more components of apparatus 10 may be interchangeable (e.g., external device 500 which may be delivered to the patient as new hardware versions become available).

[0222] A remote or assisted reprogramming session may facilitate selection of new or predefined stimulation program templates in response to common patient complaints (e.g., overstimulation, insufficient amplitude, loss of efficacy, and / or excess paresthesia). In some embodiments, a combination of remote and assisted reprogramming may help to streamline therapy adjustments. During a remote reprogramming session, a patient, via external device 500 and / or patient programmer 600’, may directly retrieve or otherwise receive (e.g., via server 700) the stimulation program templates, allowing for remote-driven stimulation parameter adjustments. Once the new or predefined stimulation program templates are uploaded to external device 500 and / or patient programmer 600’, they may be selected from by the patient as desired. In some embodiments, the patient may evaluate an effectiveness of a stimulation program template by temporarily substituting their current stimulation program for the stimulation program template. For example, programmer 600’ may be configured to receive the selection via input via a user interface and may transmit the stimulation program template to external device 500, which may then transmit updated instructions comprising the stimulation program template to the implantable device 200 for implementation. Next, the stimulation program template may be used for a predefined time period, such as about 5 minutes to about 1 week, about 15 minutesto about 5 days, about 30 minute to about 1 day, about 1 hr to about 12 hrs, or about 3 hrs to about 8 hrs (including all ranges and subranges therebetween). If, during or following the predefined time period, the patient determines that the stimulation program template meets a desired condition, the patient may request (e.g., via patient programmer 600’) the stimulation program template be used as their permanent or semi-permanent stimulation program. The condition may be, for example, to reduce overstimulation, reduce paresthesia, and / or increase therapeutic benefit (e.g., by increasing amplitude, frequency, etc.). For example, a patient who determines that a stimulation program template induces less paresthesia than their current stimulation program may opt to select the stimulation program template for permanent or semipermanent use. As another example, a patient who determines that a stimulation program template provides more pain relief than their current stimulation program may opt to select the stimulation program template for permanent or semi-permanent use. In such cases, the stimulation program template may be offered to the patient (e.g., via programmer 600’) as a new stimulation program.

[0223] Additionally, or alternatively, an assisted reprogramming session may be performed in- person or via a secure link to upload the new or predefined stimulation program templates. For example, various stimulation program combinations, chosen based on, for example, historical data, observed patient responses, and / or patient surveys, may be input to a programmer (e.g., clinician programmer 600”). The stimulation program template(s) may be transmitted (e.g., via a wired or wireless link) to external device 500, to be tested on the patient while their responses are observed by the clinician. Like the remote session described above, the patient’s responses may relate to whether a given stimulation program template meets one or more of their desired conditions (e.g., to reduce overstimulation, reduce paresthesia, and / or increase therapeutic benefit).

[0224] Referring now to FIG. 2A, a sectional view of an implantable device comprising multiple leads is illustrated, consistent with the present inventive concepts. Implantable device 200 of FIG. 2A comprises two leads, leads 265a and 265b as shown. Each lead 265 comprises a proximal portion with one or more electrical contacts, contacts 267. The contacts 267 are each electrically connected to a corresponding set of one or more stimulation elements 260 positioned on a distal portion of each lead 265 (eight contacts 267 and eight stimulation elements 260 shown in FIG. 2A).

[0225] Implantable device 200 may include one or more attachment assemblies 280 (two shown, 280a, b) each configured to slidingly receive and fixedly attach to the proximal portion of a lead 265. Each attachment assembly 280 may include an attachment port, port 285 shown, that is configured to slidingly receive a proximal end of a lead 265. Each attachment assembly 280 may include one or more contacts, contacts 287 shown, that are within each port 285, where contacts 287 are configured to electrically contact a corresponding contact 267 of an inserted lead 265 (forming an electrical path between the electronics of implantable device 200, such as controller 250, and each stimulation element 260). In FIG. 2A, lead 265a is shown disconnected from attachment assembly 280a, and lead 265b is shown fully inserted into attachment assembly 280b.

[0226] Each lead 265 may comprise a rigid band, such as ring 268 shown, onto which a fastening element may be secured (e.g., frictionally engaged with ring 268). Each attachment assembly 280 may include one or more such fastening elements, such as fastener 284 shown. Fastener 284 may comprise a set screw configured to tighten onto (e.g., frictionally engage with) ring 268 of an inserted lead 265. Ring 268 may comprise a conductive material and may align with a contact 287 of attachment assembly 280 such that ring 268 is electrically connected to implantable device 200 (e.g., to controller 250). When lead 265 is fully inserted into attachment assembly 280, ring 268 may extend from within attachment assembly 280 to a location beyond the distal end of attachment assembly 280, such that ring 268 may contact surrounding tissue (e.g., providing electrical contact to the tissue). In this arrangement, ring 268 may be used as a monopolar return electrode when stimulation energy is delivered to tissue in a monopolar mode via one or more stimulation elements 260 and “collected” by ring 268. The distal end of ring 268 may be at a location within 5cm of the distal end of the connection assembly 280 into which the lead 265 is inserted. In some embodiments, the next most proximal stimulation element 260 is located at least 10cm from the distal end of ring 268 of the corresponding lead 265.

[0227] Ring 268 may comprise platinum, platinum / iridium, or something more durable such as the alloy MP35N. In some embodiments, attachment assembly 280 comprises nine contacts 287 (as shown), and ring 268 and up to eight contacts 267 of a lead 265 (eight shown), may each electrically connect to a corresponding contact 287. In other embodiments, attachment assembly 280 comprises eight contacts 287, and ring 268 and up to seven contacts 267 of a lead 265 may each electrically connect to a corresponding contact 287 (e.g., when lead 265 comprises ring 268and between four and seven contacts 267). In some embodiments, implantable device 200 comprises one or more attachment assemblies 280, which collectively comprise multiple contacts 287, such as 4, 8, 12, 16 or more contacts 287 (e.g., eight contacts 287 on a first attachment assembly 280a and eight contacts 287 on a second attachment assembly 280b). In some embodiments, one, two or more attachment assemblies 280 are each are configured to attach to a lead 265 comprising at least three stimulation elements 260 (e.g., electrodes), such as a lead 265 comprising between three and eight stimulation elements 260. In some embodiments, one contact 287 of each attachment assembly 280 is attached to a ring 268 configured as a return electrode, and the remaining contacts 287 are available to contact to a corresponding quantity of contacts 267. In some embodiments, two or more contacts 267 and / or 287 are electrically connected (i.e. “shorted together”) such as to function as a single contact (e.g., a single contact configured as a monopolar return electrode).

[0228] Referring additionally to FIG. 2B, a sectional view of another implantable device 200 comprising multiple leads 265 is illustrated, consistent with the present inventive concepts. Implantable device 200 of FIG. 2B may be of similar construction and arrangement to implantable device 200 of FIG. 2 A. In FIG. 2B, as an alternative to ring 268 functioning as a monopolar return electrode, each lead 265 comprises a proximally positioned stimulation element, element 260R shown, which may comprise an electrode that may be configured as a monopolar return electrode (e.g., an electrode that collects energy delivered via one or more stimulation elements 260 when stimulation is delivered in a monopolar mode, as described herein). In some embodiments, element 260R may comprise a ring-shaped electrode, such as a conductive ring that surrounds a portion of lead 265. Stimulation element 260R is located relatively proximate the distal end of the associated attachment assembly 280 (when lead 265 is fully inserted into that attachment assembly 280), such as at a location within 5cm of the distal end of that connection assembly 280. In some embodiments, the next most proximal stimulation element 260 is located at least 10cm from stimulation element 260Rof the corresponding lead 265.

[0229] Referring now to FIG. 3, a flow chart of a method of updating firmware and / or other software of a medical apparatus is illustrated, consistent with the present inventive concepts. Method 1000 of FIG. 3 may comprise a method for updating firmware and / or software (e.g., software not comprising firmware) of one or more components of apparatus 10 described herein.In STEP 1100, one or more components of apparatus 10, such as implantable device 200 (e.g., via communication with external device 500), external device 500, and / or programmer 600 may communicate with a server (e.g., a server hosted by the manufacturer of apparatus 10), to perform a check of potential software updates (e.g., software changes and / or additions) that are applicable to those one or more apparatus 10 components.

[0230] In STEP 1200, if at least one software update is available for an apparatus 10 component, method 1000 continues to STEP 1300. If the software currently in place (e.g., currently installed) in the one or more apparatus 10 components is up to date, method 1000 returns to STEP 1100. In some embodiments, a time delay (e.g., a delay for a pre-determined time period) may be included, such as an optional STEP 1150 as shown, where the duration of the time period determines the periodicity of the repeated checks for applicable software updates (e.g., daily or weekly) for the one or more apparatus 10 components.

[0231] In STEP 1300, one or more new versions of software is installed on the applicable one or more apparatus 10 components. Also in STEP 1300, one or more apparatus 10 components (e.g., a component in which a software update was just performed or otherwise) may perform a check for potential firmware updates that are applicable to that component and / or another component of apparatus 10. For example, a programmer 600 may track the firmware versions of an external device 500 and / or an implantable device 200. After receiving a software update (e.g., which may include information relating to currently available firmware versions of the various components of apparatus 10) or otherwise, a programmer 600 and / or other apparatus 10 component, may determine if an external device 500 and / or an implantable device 200 is available for (e.g., requires) a firmware update.

[0232] In STEP 1400, if one or more firmware updates are available, method 1000 continues to STEP 1600. Otherwise, method 1000 returns to STEP 1100 (e.g., via delay STEP 1150, if present).

[0233] IN STEP 1600, components of apparatus 10 requiring a firmware update are updated (e.g., via programmer 600 that receives the firmware update from the server). After STEP 1600, method 1000 returns to STEP 1100 (e.g., via delay STEP 1150, if present).

[0234] Another method for reprogramming a neurostimulation system may include receiving data at a base station (e.g., charger 61) via, e.g., a remote connection, transferring the data from the base station to an external device (e.g., external device 500) via, e.g., a local connection, andinstructing (e.g., via the external device 500) an implantable device (e.g., implantable device 200) to stimulate tissue of a patient using the data. In some embodiments, the method may additionally or alternatively include receiving the data at a remote device (e.g., a smart device such as a smart phone, smart watch, smart ring, and / or the like), transferring the data from the remote device to an external device, and instructing an implantable device to stimulate the patient using the data. The remote connection may be a wide area network (WAN) connection, and the local connection may be a Bluetooth Low Energy (BLE) connection. Moreover, the external device may instruct the implantable device via, e.g., a wireless connection. In some embodiments, the base station may receive the data via, e.g., one or more remote devices, such as patient programmer 600’ or clinician programmer 600”, over a remote connection (e.g., a WAN connection). Similarly, one or more remote devices may be configured to retrieve data from the base station and / or the external device (e.g., via remote connections). In some embodiments, the data may be downloaded to the external device (e.g., to a memory of the external device 500). Nonlimiting examples of the data may include, but are not limited to, software, such as the firmware update described herein, and / or stimulation data including one or more of a stimulation parameter, a stimulation program, a stimulation programming schedule, and an implantable device configuration. In some embodiments, the data received at the base station or first remote device and transferred to the external device for instructing the implantable device may be first data, and any data retrieved from the base station, the first remote device, and / or the external device by one or more second remote devices may be second data. The first and second data may be the same data or different data. For example, the second data may include data related to a stimulation program (e.g., statistics for stimulation program usage) and / or device or system configuration data (e.g., charge / life statistics for the power supply 570 of external device 500).

[0235] Referring now to FIG. 4, top, side, and perspective transparent views of a lead anchor element are illustrated, consistent with the present inventive concepts. Anchor element 221 of FIG. 4 is configured to anchor a lead 265 to tissue of a patient. FIG. 4A is a perspective, sectional view of an overmold 2220 of the anchor element 221 of FIG. 4. FIG. 4B is a perspective view of a compression assembly of anchor element 221, compression assembly 2210. FIG. 4C is a sectional view of the anchor element 221 of FIG. 4, along line A- A, showingcompression assembly 2210 positioned within a cavity of anchor element 221. FIG. 4D is a sectional side view of compression assembly 2210.

[0236] Compression assembly 2210 includes a housing, housing 2211, which may comprise a rigid housing that is surrounded (e.g., at least partially surrounded) by a flexible outer covering, overmold 2220, each as shown. Overmold 2220 may comprise a silicone material and / or other material that is created via an overmolding process. Overmold 2220 may comprise a durometer of at least 40 Shore A (e.g., to improve sliding along lead 265 and / or to prevent buckling). Overmold 2220 and compression assembly 2210 may each include a lumen, lumens 2221 and 2214 respectively, through which a lead 265 may be inserted. Overmold 2220 may include a tapered portion, taper 2222. Taper 2222 may be positioned toward the distal end of lead 265 when implanted into the patient (e.g., the distal end of lead 265 may be inserted through lumens 2221 and 2214 such that lead 265 exits taper 2222). Taper 2222 may comprise a geometry that effectively dilates soft tissue while being inserted through the tissue. Taper 2222 may comprise a gradual taper that minimizes force applied by the tissue to lead 265, such as to minimize undesired migration of lead 265 after implantation. Taper 2222 and other portions of overmold 2220 may be configured to reduce migration of lead 265 once lead 265 is implanted in tissue of the patient. Taper 2222 may allow more precise placement of the lead 265, such as due to lower insertion forces required due to the taper. Also, lower insertion forces may result in a more “snug fit” of lead 265 in tissue. Overmold 2220 may function as a strain relief which may reduce bending of lead 265 (e.g., reduce bending that might otherwise cause migration of lead 265).

[0237] Overmold 2220 may comprise one or more locations at which suture, clips, staples and / or other securing elements (“suture” herein) may be applied to secure anchor element 221 to tissue. For example, overmold 2220 may comprise one or more full or partial circumferential recesses, fixation point 2224 (two shown in FIG. 4), around which suture may be placed and secured to tissue. Alternatively, or additionally, overmold 2220 may comprise one or more pass- through holes, suture tab 2224a, to which suture may be attached and secured to tissue. Securing overmold 2220 (e.g., anchor element 221 and any one or more inserted leads 265) to tissue with suture using suture tab 2224a also prevents or at least reduces twisting of anchor element 221 (e.g., reduces twisting of one or more inserted leads 265).

[0238] Compression assembly 2210 may include an element that translates, translatable element 2216, via rotation of a mating element, driver 2212, each as shown. For example,element 2216 and driver 2212 may comprise mating threads as shown, such that rotation of driver 2212 that causes translatable element 2216 to translate upward (as shown in FIG. 4D) correspondingly pushes a compression sleeve, sleeve 2215 shown, against a segment of a lead 265 that has been inserted through lumen 2214 (lead 265 not shown), such that the lead 265 is secured between the inner top surface of lumen 2214 and compression sleeve 2215. Driver 2212 may include an engagement portion, port 2217, that engages with a rotatable tool, tool 2230 (shown in FIG. 4D). Port 2217 may include a ledge feature, linear stop 2218, that prevents tool 2230 from extending through driver 2212 (e.g., to prevent tool 2230 from contacting translatable element 2216, such as to prevent translatable element 2216 from stopping without completing its intended translation).

[0239] Overmold 2220 may comprise one or more engagement elements, projections 2223 shown. Housing 2211 of compression assembly 2210 may comprise one or more mating engagement elements, recesses 2213 shown, which may be sized and arranged to fried onally engage projections 2223 of overmold 2220. In alternative embodiments, projections 2223 may each comprise a recess, and recesses 2213 may each comprise a mating projection. Housing 2211 may comprise a titanium housing. Engagement of projections 2223 and recesses 2213 assists in retaining housing 2211 within overmold 2220. Engagement of projections 2223 and recesses 2213 may be configured to resist undesired effects of torsion and / or other applied loads (e.g., caused by tightening driver 2212), such as to prevent (or at least limit) housing 2211 from decoupling from overmold 2220. Engagement of projections 2223 and recesses 2213 may also prevent (or at least reduce) vertical decoupling, rocking, and / or tilting of housing 2211 within overmold 2220.

[0240] In some embodiments, anchor element 221 (e.g., overmold 2220) comprises one or more openings configured to align with one or more stimulation elements 260 of an inserted lead 265, such as to allow directional stimulation from lead 265, such as is described in reference to windows 2242 of anchor element 221 described herein.

[0241] Referring now to FIG. 5, a perspective view of a sleeve for covering a portion of a lead, a lead, and an applicator tool are illustrated, consistent with the present inventive concepts. FIG.5 A illustrates side and bottom views of a sleeve for covering a portion of a lead. FIG. 5B illustrates side and bottom views of another embodiment of a sleeve for covering a portion of a lead. FIGS. 5C and 5D illustrate another embodiment of a sleeve for covering a portion of a lead,and a clip, respectively. FIG. 5E illustrates top and bottom views of a sleeve for covering two leads. FIGS. 5F-H are perspective views of electrodes and resultant electric fields that may be generated by the apparatus of the present inventive concepts.

[0242] Apparatus 10 may include a sleeve, such as sleeve 224 shown in FIGS. 5 and 5A-E. Sleeve 224 may comprise a housing, casing 2240 that includes a lumen at least partially therethrough, lumen 2241, each as shown. Lumen 2241 may be sized and arranged to slidingly receive the distal portion of a lead 265 (e.g., a lead 265 comprising 2, 4, 6, 8, 12, or 16 electrodebased stimulation elements 260) . Sleeve 224 may include one or more openings, windows 2242 (such, as 2, 4, 6, 8, 12, or 16 openings, 4 shown in FIG. 5), that align with the stimulation elements 260 of lead 265 when lead 265 is properly inserted through lumen 2241 (e.g., windows 2242 are aligned with elements 260 when sleeve 224 is positioned over lead 265). Windows 2242 are configured (e.g., sized and positioned) to expose only a portion (e.g., less than 100%) of the otherwise fully exposed surface area of each stimulation element 260 (e.g., expose only a circumferential portion between 45° and 180° of a ring-shaped element 260), such as to allow (e.g., cause) “directional stimulation” from a stimulation element 260 (e.g., an element 260 comprising a ring-shaped electrode). Windows 2242 may be positioned (e.g., rotationally positioned by a clinician) toward tissue to be stimulated when lead 265 is implanted. Sleeve 224 may comprise one or more materials, such as polyurethane and / or silicone materials.

[0243] In some embodiments, sleeve 224 may be constructed and arranged to be secured to tissue, to correspondingly secure an inserted lead 265 (e.g., and its electrodes or other stimulation elements 260) at a desired tissue location. For example, sleeve 224 may include one or more full or partial circumferential recesses, fixation point 2246 (two shown in FIG. 5 A) around which suture may be attached and secured to tissue. Alternatively, or additionally, sleeve 224 may include one or more other types of anchoring locations, such as suture tabs (e.g., similar to suture tab 2224a described herein), rings, needle-penetrable materials, and / or other anchoring elements which may be secured to tissue (e.g., using suture, clips, staples, and / or other securing elements).

[0244] In some embodiments, sleeve 224 may include an insulating material (e.g., an electrically insulating material), such as silicon, such as to prevent electrical connection between two or more stimulation elements 260.

[0245] Apparatus 10 may include an applicator tool, tool 229 shown, that may be configured to allow a clinician to position sleeve 224 onto the distal portion of lead 265. For example, lumen 2241 may comprise a diameter that is less than (e.g., slightly less than) the outer diameter (OD) of lead 265, and applicator tool 229 may be used to stretch sleeve 224 to fit over lead 265, after which sleeve 224 may frictionally engage lead 265 (e.g., to prevent undesired motion between sleeve 224 and lead 265). In some embodiments, tool 229 may comprise a scissor-like tool, as shown, comprising a split shaft attached to a handle configured to separate the halves of the shaft when the handle is closed. The split shaft of tool 229 may be slidingly positioned within lumen 2241 of sleeve 224, and expanded to stretch lumen 2241, such that lead 265 may be positioned within lumen 2241. In some embodiments, tool 229 may include an opening through the hinged portion of the tool, such that lead 265 may be inserted from the handle side of tool 229 into lumen 2241 (e.g., when both tool 229 and lead 265 are inserted into lumen 2241 from the same direction), and / or such that tool 229 may be removed from lumen 2241 after lead 265 has been inserted (e.g., removed over lead 265).

[0246] In some embodiments, sleeve 224 includes a set screw-based anchoring mechanism, anchor assembly 2243 shown in FIG. 5 A. Anchor assembly 2243 may be similar to compression assembly 2210, and assembly 2243 may be configured to fixedly attach sleeve 224 to lead 265 (e.g., via rotation of a set screw).

[0247] In some embodiments, sleeve 224 includes a cavity for adhesive, adhesive well 2244 shown in FIG. 5B. In these embodiments, adhesive may be injected into well 2244 to adhesively secure sleeve 224 to lead 265.

[0248] In some embodiments, sleeve 224 includes a clip, clip 2245 as shown in FIGS. 5C and 5D, and a recess into which clip 2245 may be attached (e.g., attached as shown in FIG. 5C). In some embodiments, a fixation point 2246 (e.g., as shown in FIG. 5C) functions as the recess into which clip 2245 may be attached. In these embodiments, suture may be placed around clip 2245, and when tightened, cause sleeve 224, via force applied the suture and clip 2245, to frictionally engage an inserted lead 265. Clip 2245 may comprise a split ring design, as shown, that may be configured to close as suture is tightened around the clip.

[0249] Sleeve 224 may comprise multiple lumens (e.g., two to four lumens) such that sleeve 224 may slidingly receive up to a corresponding number of leads 265, such as the two lumens 2241a and 2241b that may each receive a separate lead 265, as shown in FIG. 5E. In thisparticular arrangement of multiple lumens, sleeve 224 may maintain a fixed distance and a fixed alignment between the multiple leads 265, such as to effectively mimic the functionality of a paddle-electrode type lead 265.

[0250] FIG. 5F illustrates an example of a less than 360° stimulation field generated by stimulation elements 260 that are partially shielded (e.g., enclosed within sleeve 224 as described hereinabove) as compared to the stimulation field illustrated in FIG. 5G that is generated by fully exposed (unshielded) elements 260 which generate a 360° stimulation field. Windows 2242 may be positioned in various patterns, such as in a rotating pattern to generate a “corkscrew-like” stimulation field pattern as shown in FIG. 5H.

[0251] Referring now to FIGS. 6A-6I, various views of an implantation tool are illustrated, consistent with the present inventive concepts. Tool 650 and / or implantable device 200 may be of similar construction and arrangement as the similar components described in reference to FIG. 1 and otherwise herein. Tool 650 may comprise an elongate tunneling tool including a securing mechanism configured to temporarily attach (e.g., removably attach) to an implantable device 200 while the implantable device 200 is being inserted into the patient (e.g., during a tunneling portion of an implantation procedure). For example, tool 650 may comprise a shaft, shaft 651, extending from a handle, handle 652, as shown. The distal end of shaft 651 may comprise a projection or other connecting element, connector 653, which may be configured to temporarily attach to implantable device 200. For example, connector 653 may be inserted into a recess of the housing of implantable device 200, port 253 shown. Tool 650 may include a securing mechanism, cage 655, that at least partially surrounds implantable device 200 to secure the device 200 to tool 650 during the tunneling procedure. Cage 655 may be slidingly received on shaft 651, such that cage 655 may be retracted (e.g., as shown in FIG. 6A) exposing connector 653 for subsequent connection to implantable device 200. Cage 655 may be advanced over the distal portion of shaft 651, (e.g., as shown in FIG. 6B), operably connecting and securing implantable device 200 (not shown in FIG. 6B) to tool 650 for tunneling.

[0252] Tool 650, including cage 655, may include multiple “anchor points” where tool 650 frictionally or otherwise engages implantable device 200. For example, and as shown in FIG. 6C, cage 655 may include two lateral projections, arms 655 la, b shown, that secure to the sides of implantable device 200. Additionally or alternatively, cage 655 may include one or more longitudinal projections, such as arms 6552a, b shown, that secure to the top and bottom ofimplantable device 200. Arm 6552a may extend to and overhang the distal end of implantable device 200, as shown. Alternatively, arms 6552a and / or 6552b may terminate prior to the distal end of implantable device 200, such as when arms 6552a and / or 6552b frictionally engage the top and bottom of implantable device 200 (e.g., without extending over an edge of the device). In some embodiments, one or more of arms 6551 and / or 6552 wrap around the edges of implantable device 200, frictionally engaging and “grasping” implantable device 200.

[0253] FIG. 6D shows a top view of an implantable device 200 positioned within cage 655 and operably attached to shaft 651 of tool 650. Arms 655 la, b, and arm 6552a are shown below implantable device 200 (relative to the page), with the arms extending upward along the side edges of the device 200. Arm 6552b is shown above implantable device 200, such that arms 6551 and 6552 surround implantable device 200, securing the device to tool 650. FIGS. 6E and 6F show sectional views of tool 650 along section A-A of FIG. 6D, with and without, respectively, implantable device 200 being shown. FIGS. 6G and 6H show sectional views of tool 650 along section B-B of FIG. 6D, with and without, respectively, implantable device 200 being shown. In FIG. 6H, arm 6552a does not extend the length of implantable device 200.

[0254] FIG. 61 shows a perspective view of tool 650, with cage 655 positioned on shaft 651. Cage 655 may include an elongate portion including a lumen, lumen 6553, that slidingly receives shaft 651, as shown. Cage 655 may be configured to lock in the retracted and / or the advanced positions, such as when tool 650 comprises a locking mechanism, lock 6554 shown, which may be configured to lock the position of cage 655. In some embodiments, lock 6554 comprises a magnetic locking mechanism.

[0255] Several views of another variation of an implantation tool are depicted in FIGS. 13A- 13C. FIG. 13A depicts a side view of a first implantation tool 1300, which may be a tunneller or tunneling tool configured to create a subcutaneous space or pocket between layers of skin and / or muscle within a patient, such as during an implantation procedure for an implantable device. The first implantation tool 1300 may comprise a handle 1302 configured to be gripped by an operator so that the tool 1300 may be moved through tissue. Shaft 1304 may extend from handle 1302 and the tool 1300 may comprise first and second arms 1304a and 1304b extending from shaft 1304. In some embodiments, first arm 1304a may comprise a first longitudinal axis and second arm 1304a may comprise a second longitudinal axis, and the first and second longitudinal axes may be transverse to a longitudinal axis of shaft 1304. For example, an angle formed betweenthe first longitudinal axis and / or the second longitudinal axis and the longitudinal axis of shaft 102 may be about 80 degrees (deg) to about 120 deg, such as about 85 deg to about 115 deg, about 90 deg to about 110 deg, or about 95 deg to about 105 deg (e.g., about 80 deg, about 85 deg, about 90 deg, or about 95 deg), including all ranges and subranges therebetween. In some embodiments, the first and second longitudinal axes may be parallel or about parallel.

[0256] In some embodiments, first and second arms 1304a, 1304b may be formed integrally with shaft 1304 and shaft 1304 may split into first and second arms 1304a, 1304b, while in other embodiments, first and second arms 1304a, 1304b may be formed separately from shaft 1304 and coupled to a distal end thereof. Second arm 1304b may be positioned below first arm 1304a and may be configured to be inserted into tissue. First arm 1304a may be positioned above second arm 1304b and may be configured to remain on an external surface of a patient’s body while second arm 1304b is positioned therein. Accordingly, first and second arms 1304a, 1304b may define a gap 1306 therebetween configured to receive tissue as first implantation tool is moved through the body. Gap 1306 may comprise a height of about 0.005 mm to about 1 in, such as about 0.05 in to about 0.75 in, about 0.075 in to about 0.5 in, about 0.1 in to about 0.25 in (e.g., about 0.09 in, about 0.1 in, about 0.12 in, about 0.13 in, about 0.14 in, about 0.15 in), including all values and sub-ranges therein. Further, a height of one or both of the first and second arms 1304a, 1304b may be about 0.05 in to about 1 in, such as about 0.075 in to about 0.75 in, about 0.1 in to about 0.5 in, about 0.125 in to about 0.25 in, or about 0.15 in to about 0.2 in (e.g., about 0.16 in, about 0.165 in, about 0.17 in, about 0.175 in, about 0.18 in, about 0.185, about 0.19 in, about 0.195 in, or about 0.2 in), including all values and sub-ranges therein. In some embodiments, first and second arms 1304a, 1304b may have different lengths. For example, second arm 1304b may be longer than first arm 1304a. A length differential between first and second arms 1304a, 1304b may be (e.g., second arm 1304b may be longer than first arm 1304a by) about 0.025 in to about 5 in, such as about 0.05 in to about 2.5 in, about 0.075 in to about 2.25 in, about 0.1 in to about 2 in, about 0.25 in to about 1.75 in, about 0.5 in to about 1.5 in, about 0.75 in to about 1.25 in, or about 0.9 in to about 1.1 in (e.g., about 0.85 in, about 0.9 in, about 0.95 in, about 1 in, about 1.05 in), including all values and sub-ranges therein. A distal end of one or both of first and second arms 1304a, 1304b may comprise one or more features to facilitate formation of the subcutaneous space in tissue as will be described in more detail herein.

[0257] Referring to FIG. 13B, which depicts a top view of the distal ends of first and second arms 1304a, 1304b, in some embodiments, second arm 1304b may comprise an elongated tip 1310, which may, in some embodiments, be tapered. For example, a width of tip 1310 may increase (linearly or nonlinearly) proximally (or decrease distally), along a longitudinal axis of second arm 1304b. In some embodiments, at least a portion of tip 1310 may comprise a pointed or beveled shape. Additionally, or alternatively, in some embodiments, at least a portion of tip 1310 may comprise an arched or rounded shape. In some embodiments, a distal portion of tip 1310 may be tapered at a first angle, and a proximal portion of tip 1310 may be tapered at a second, different (larger or smaller) angle. In some embodiments, tip 1310 may comprise surfaces that are angled with respect to the longitudinal axis. For example, tip 1310 may comprise a tip angle (A) of about 5 degrees (deg) to about 45 deg, such as about 10 deg to about 40 deg, about 15 deg to about 35 deg, about 20 deg to about 30 deg, or about 22.5 deg to about 27.5 deg with respect to the longitudinal axis (e.g., about 20 deg, about 21 deg, about 22 deg, about 23 deg, about 24 deg, about 25 deg, about 26 deg, about 27 deg, about 28 deg, about 29 deg, or about 30 deg), including all values and sub-ranges therein. Additionally, or alternatively, tip 1310 may comprise one or more side surfacesl312, which may form edges with a top surface 1316 of second arm 1304b. In some embodiments, the edges may be sharpened to facilitate tissue dissection. Moreover, first arm 1304a may comprise a rounded distal end to prevent skin scraping or scratching as first arm 1304a is moved along an exterior skin surface during tissue tunneling.

[0258] Turning back to FIG. 13A, first implantation tool 1300 may also include a coupling element 1308 configured to releasably couple with a sheath (not shown). The sheath may be configured to receive a portion of first implantation tool 1300 via a channel thereof. Together, the sheath and first implantation tool 1300 may be introduced through an incision site and advanced through tissue to form a subcutaneous space. Coupling element 1308 may be configured to contact or receive a portion of the sheath to maintain a position of the sheath relative to first implantation tool 1300 during the advancement. In some embodiments, coupling element 1308 may comprise a ledge or projection extending from shaft 1304 and configured to abut a portion of the sheath. For example, coupling element 1308 may be a ledge configured to push against a proximal end of the sheath to move the sheath through tissue while first implantation tool 1300 is being advanced. Once the subcutaneous space is formed, firstimplantation tool 1300 may be withdrawn from the tissue while the sheath is left in place to provide access to the subcutaneous space.

[0259] An illustrative variation of such a sheath, sheath 1320, is depicted in FIG. 13C. As shown, sheath 1320 may be configured to slidingly receive second arm 1304b of implantation tool 1300. Second arm 1304b and sheath 1320 may be configured to be inserted into tissue when coupled. Coupling element 1308, as shown in FIG. 13A, may be configured to maintain relative positions of first implantation tool 1300 and sheath 1320 by pushing against a proximal end 1322 of sheath 1320 while first implantation tool 1300 is moved through tissue. Once a subcutaneous space has been created, first implantation tool 1300 may be removed from the incision site while sheath 1320 may be left within the subcutaneous space. Accordingly, sheath 1320 may provide access to and maintain one or more dimensions (e.g., length, width, and / or depth) of the subcutaneous space in absence of the first implantation tool 1300 while a remainder of the procedure is executed (as described in more detail below).

[0260] FIG. 14 shows a perspective view of sheath 1400, which may comprise one or more of the same features as sheath 1320, and may be configured to releasably couple with a tunnelling tool comprises one or more of the same features as first implantation tool 1300. In some embodiments, sheath 1400 may comprise one or more of metal and one or more plastic materials. In some embodiments, sheath 1400 may be semi-rigid or rigid so that its shape is maintained when surrounded by tissue. Sheath 1400 may comprise a proximal end 1402, a distal end 1404, and a body 1406 therebetween. One or more handles (e.g., two) 1408 may be coupled to the proximal end 1402 to allow an operator to grip sheath 1400, such as to prevent movement of sheath 1400 when the tunneling tool is removed therefrom and / or to withdraw sheath 1400 from the subcutaneous space. In some embodiments, handles 1408 may be flexible (e.g., foldable, deformable). Distal end 1404 of sheath 1400 may be at least partially tapered to aid in tissue dissection. For example, a width of at least a portion of the distal end may increase (linearly or nonlinearly) proximally (or decrease distally), along a longitudinal axis of sheath 1400. Body 1406 may comprise a length that is about equal to or less than a length of one or both arms of the tunnelling tool. Additionally, or alternatively, body 1406 may comprise a width that is about equal to or greater than a width of first and / or second arms of the tunnelling tool. For example, the width of body 1406 may be about 0.05 in to about 2 in, such as about 0.075 in to about 1.75 in, about 0.1 in to about 1.5 in, about 0.125 in to about 1.25 in, about 0.15 in toabout 1 in, about 0.175 in to about 0.75 in, about 0.2 in to about 0.7 in, or about 0.25 in to about 0.6 in (e.g., about 0.5 in, about 0.51 in, about 0.52 in, about 0.53 in, about 0.54 in, about 0.55, about 0.56 in, about 0.57 in, about 0.58, about 0.59, or about 0.6 in), including all values and sub-ranges therein. Body 1406 may comprise walls 1410 defining channel 1416 therebetween. A height of the walls 1410 may be about equal to or greater than a height of arms of the tunnelling tool. For example, the height of walls 1410 may be about 0.05 in to about 1 in, such as about 0.075 in to about 0.75 in, about 0.1 in to about 0.5 in, about 0.125 in to about 0.25 in, or about 0.15 in to about 0.2 in (e.g., about 0.16 in, about 0.165 in, about 0.17 in, about 0.175 in, about 0.18 in, about 0.185, about 0.19 in, about 0.195 in, or about 0.2 in), including all ranges and subranges therebetween. In some embodiments, one or both of walls 1410 may be curved so that they follow a curvature of and extend over at least a portion of a first implantation tool (e.g., over the edges of second arm 1304b of first implantation tool 1300). For example, walls 1410 may comprise an arched or semicircular shape and a height that is close to, but greater than, (e.g., by about 0.0001 in to about 0.05 in) a height of an arm (e.g., a second, lower arm) of the tunnelling tool received between walls 1410 . Moreover, body 1406 may comprise an engagement feature 1412 (e.g., tab, projection) configured to directly engage with the tunneller tool. For example, the engagement feature 1412 may be configured to apply a force against a portion of the tunneller tool (e.g., against second arm 1304b of first implantation tool 1300). In embodiments in which the engagement feature comprises a tab, the tab may comprise an arch 1414 extending toward the tunneller tool and configured to apply the force. Arch 1414 may be pointed, as shown, or may be rounded. In some embodiments, arch 1414 may comprise a plateau. Arch 1414 may aid in preventing sheath 1400 from sliding unintentionally with respect to the tunneller tool (e.g., during shipping and / or during tissue dissection).

[0261] After a tunneller tool is removed from its sheath (once tissue dissection is complete), one or more separate implantation tools may be guided through the sheath to perform other parts of an implantation procedure while the sheath provides access to the subcutaneous space by maintaining the dimensions of the subcutaneous space in the tissue. For example, an insertion tool may be moved through the sheath to place an implantable device in the subcutaneous space (e.g., at a distal end thereof). That is, the sheath body may provide a path for the insertion tool and implantable device to reach the implantation site within the subcutaneous space.

[0262] A second implantation tool 1500, which may be an insertion tool, is depicted in FIG. 15 A. The second implantation tool 1500 may comprise a handle 1502 configured to be gripped by an operator, a body 1504, and first and second prongs 1506a, 1506b, which may be configured to receive an implantable device therein. First prong 1506a may be an upper prong configured to be positioned against or adjacent to a first surface of the implantable device, while second prong 1506b may be an opposite, lower prong configured to be positioned against or adjacent to a second, opposite surface of the implantable device. In some embodiments, first and second prongs 1506a, 1506b may comprise one or more of the same dimensions. In some variations, first and second prongs 1506a, 1506b may be parallel or about parallel to each other.

[0263] FIG. 15B depicts second implantation tool 1500 coupled with implantable device 1530. As discussed above, sheath 1520 may guide implantation of implantable device 1530 via second implantation tool 1500. In some embodiments, a height of a gap 1508 (as in FIG. 15 A) defined by first and second prongs 1506a, 1506b may be about equal to a height of the implantable device. As such, first and second prongs 1506a, 1506b may be configured for an interference fit or transition fit with implantable device 1530. In some embodiments, a length of first and second prongs 1506a, 1506b may be less than a length of implantable device 1530. Thus, at least a portion of implantable device may extend beyond a distal end of the first and second prongs 1506a, 1506b. Second implantable device 1500 may be configured to deliver implantable device 1530 to an implantation site that is distal to a distal end of sheath 1520. Once second implantation tool 1500 has advanced implantable device 1530 to the implantation site in the subcutaneous space (via the sheath channel), the forces of the surrounding tissue against the exposed portion of the implantable device 1530 may overcome the forces maintaining the coupling between implantable device 1530 and first and second prongs 1506a, 1506b, thereby allowing second implantation tool 1500 to be withdrawn while leaving implantable device 1530 implanted within the tissue.

[0264] Referring now to FIGS. 7 and 7A-E, a perspective view, an exploded view, a side view, and three sectional views of an external device are illustrated, respectively, consistent with the present inventive concepts. External device 500 and / or other components of apparatus 10 described in FIGS. 7 and 7A-E may be of similar construction and arrangement as the similar components described in reference to FIG. 1 and otherwise herein. FIG. 7 shows a perspective view of an embodiment of external device 500 of apparatus 10. FIG. 7A shows an explodedview of external device 500 of FIG. 7, illustrating components internal to housing 510 of external device 500. FIG. 7B shows a side view of the external device 500, indicating a section A-A, which is shown in FIG. 7C. FIG. 7D shows a bottom view of external device 500 with a portion of housing 510 removed to illustrate components within the housing. FIG. 7E shows a cross-sectional detail view of a portion of external device 500 that is indicated by detail B in FIG. 7C.

[0265] External device 500 may include housing 510, such as a two-part housing comprising top section 5101 and bottom section 5102, as shown in FIG. 7A. Controller 550 may comprise a printed circuit board assembly (PCBA), that is located within housing 510. Controller 550 may be secured to housing 510 via one or more attachment devices, such as screws 5501a, b shown, that secure controller 550 to bottom section 5102 of housing 510. Controller 550 may include one or more spacers, such as spacer 5502 shown. External device 500 may include power supply 570, such as a power supply comprising a battery, for example a rechargeable battery. Controller 550 may include a power connector, such as connector 5503, that operably connects controller 550 to power supply 570. In some embodiments, connector 5503 comprises a flexible circuit board. Power supply 570 may include wireless charging assembly 5710, such as a wireless charging assembly including at least one wireless charging antenna, such as antenna 5711 shown in FIG. 7D. In some embodiments, antenna 5711 comprises one or both of a wireless charging antenna (e.g., a Qi charging antenna) and a near-field communication (NFC) antenna. For example, the antenna 5711 may include a first antenna 5711 (e.g., a Qi charging antenna) and a second antenna 5711 (e.g., an NFC antenna). In some embodiments, two or more antennae 5711 (e.g., a Qi charging antenna and an NFC antenna) may be configured to operate at a same frequency or at different frequencies, or within a same or different frequency range (e.g., a predetermined frequency range, such as one or more predetermined frequency ranges). For example, one or both of a first antenna 5711 (e.g., the Qi charging antenna) and a second antenna 5711 (e.g., the NFC antenna) may be configured to operate at a frequency within about 1 kHz to about 500 kHz, such as within about 10 kHz to about 450 kHz, within about 20 kHz to about 400 kHz, within about 30 kHz to about 350 kHz, within about 40 kHz to about 300 kHz, within about 50 kHz to about 250 kHz, within about 75 kHz to about 225 kHz, or within about 100 kHz to about 200 kHz. As another example, one or both of a first antenna 5711 (e.g., the Qi charging antenna) and a second antenna 5711 (e.g., the NFC antenna) may be configured tooperate at a frequency within about 1 MHz to about 50 MHz, such as within about 3 MHz to about 45 MHz, within about 5 MHz to about 40 MHz, within about 7 MHz to about 35 MHz, within about 9 MHz to about 30 MHz, within about 10 MHz to about 25 MHz, or within about 11 MHz to about 20 MHz, within about 12 MHz to about 15 MHz, or within about 13 MHz to about 14 MHz. In some embodiments, the first antenna 5711 may be a Qi charging antenna and may operate within about 100 kHz to about 200 kHz, and the second antenna may be an NFC antenna which may operate between about 13 MHz to about 14 MHz, such as at about 13.56 MHz.

[0266] In some embodiments, the antenna 5711 may be configured to receive and / or transmit one or both of power and data from another antenna of the system (e.g., apparatus 10, as described herein). For example, the antenna 5711 may be a charging antenna, such as a Qi charging antenna, configured to receive power from an antenna of the charging base station (e.g., antenna 6121 of charger 61). In such embodiments, the power may be transferred via a local connection, such as a Bluetooth Low Energy (BLE) connection.

[0267] The antenna 5711 may include a surface and shield material or shielding layer (not shown) positioned on the surface. The shield material may include radio-absorptive shield material and / or radio-reflective shield material. For antenna 5711 to operate effectively at higher frequencies, the shield material may comprise a ferrite material that has a low conductivity and low magnetic loss tangent at a frequency of interest, and whereby a higher permeability is achieved. For example, one or more shielding layers of the antenna 5711 may include one or both of a conductive material and a ferromagnetic material. By placing a material with a high magnetic permeability (p’), low magnetic loss tangent (p” / p’), and low conductivity at the operating frequency (such as a high frequency ferrite) between the antenna and other elements of the transmitter, the losses or loading effects due to these elements may be dramatically reduced. For example, one or more shielding layers of the antenna 5711 may have a magnetic loss tangent of less than or equal to 0.025 at a predetermined frequency range, such as a range of about 100 kHz to about 200 kHz. In some cases, the magnetic field magnification of this shielding layer will enhance the overall performance. Additionally, this layer shields the outside environment from unwanted radiation from the antenna, and it protects the antenna from radiation originating in the environment. Further, the one or more shielding layers may be configured to preventcoupling between a plurality of antennae of the external device 500, such as between a first antenna (e.g., antenna 540) and second antenna (e.g., antenna 5711).

[0268] Wireless charging assembly 5710 may be positioned on the opposite side of external device 500 of antenna assembly 5400, as shown. In some embodiments, wireless charging assembly 5710 is positioned relative to power supply 570 to allow for expansion of power supply 570 (e.g., expansion of supply 570 due to battery swelling), for example when antenna 5711 is positioned off center from power supply 570. Additionally, or alternatively, wireless charging assembly 5710 may include a compressible material (not shown), such as a foam layer, positioned between power supply 570 and antenna 5711. In some embodiments, a compressible material, such as a foam layer, may be configured to bias antenna 5711 toward an interior surface and / or interior wall of housing 510 to maintain the position of antenna 5711 in close proximity to housing 510 (e.g., to increase charging efficiency). In other words, the compressible material may be configured to minimize a distance between the antenna 5711 and an interior surface of the housing 510. In some embodiments, the compressible material may be positioned between the power supply 570 and one or more shielding layers (e.g., shield of antenna assembly 5400) of the external device 500, such as between a distal side of the power supply 570 and a proximal side of a shielding layer of the one or more shielding layers.

[0269] As described herein, external device 500 may include antenna assembly 5400, which may comprise one or more similar and / or different antennas, such as antenna 540 described herein. Antenna assembly 5400 may include an adhesive element, such as tape 5401 shown. Tape 5401 may adhesively maintain the position between controller 550 and antenna assembly 5400, such as to maintain electrical connections between controller 550 and antenna assembly 5400 (e.g., even when device 500 is dropped). Power supply 570 may be adhered concentrically to antenna assembly 5400. Power supply 570 may be oriented parallel to controller 550 (e.g., one or more control boards of power supply 570 may be parallel to one or more PCBAs of controller 550). In some embodiments, power supply 570 comprises a battery protection circuit (e.g., a circuit that is separate from controller 550). In some embodiments, power supply 570 comprises a “D” shaped battery, as shown. In some embodiments, power supply 570 includes a “fuel gauge” feature, configured to track battery usage and / or charge status.

[0270] Top section 5101 and bottom section 5102 may be fixedly attached (e.g., attached during a manufacturing process). In some embodiments, top section 5101 and bottom section5102 are ultrasonically welded together, for example as indicated in FIG. 7E. In some embodiments, a nodal plunger horn may be used for creating the weld. The nodal plunger horn may include a dampener in its center that contacts top section 5101 and dampens vibrations at the center of the housing 510 to mitigate cracking and / or other damage to housing 510 (e.g., plastic portions of housing 510 that are being welded together). In some embodiments, the plunger horn directs vibration energy to the weld location on the edge of housing 510 and away from areas of housing 510 that are sensitive to damage. Directing the energy in this way allows for more energy to be provided to the weld site, resulting in a stronger weld while not damaging housing 510 (e.g., without damaging the remaining plastic portions of housing 510). In some embodiments, external device 500 comprises a height of no more than 0.55 inches, such as approximately 0.521 inches.

[0271] As described herein throughout, the antenna assembly 5400 may include antenna 540, which may be configured to communicate with one or more implantable devices (e.g., implantable device 200). For example, the antenna 540 may be configured to transfer one or both of power and data to antenna 240 of the implantable device 200. In some embodiments, the data may include one or more of a stimulation parameter, a stimulation program, a stimulation programming schedule, and an implantable device configuration. Additionally, or alternatively, the data may include software, such as a firmware update for the implantable device 200. In some embodiments, the external device 500 may be configured to instruct the implantable device 200, via antenna 540, to stimulate tissue of a patient using the data. The antennae 540, 240 may be configured to communicate via a wireless connection.

[0272] In some embodiments, a plurality of antennae of the external device 500 (e.g., antenna 5711 and antenna 540) may be positioned in a plurality of different locations within the external device 500. For example, a first antenna (e.g., antenna 540) may be positioned at or proximal to a first end of the external device 500, and a second antenna (e.g., antenna 5711) may be positioned at or proximal to a second (e.g., opposite) end of the external device 500. In some embodiments, the first antenna may be positioned on a proximal side of one or more shielding layers (e.g., a first shielding layer) of the external device 500, and the second antenna may be positioned on a distal side of the one or more shielding layers (e.g., a second shielding layer) of the external device 500. For example, the first antenna may be positioned proximal to a first end of the external device 500 and on a proximal side of a first shielding layer, and the secondantenna may be positioned proximal to a second end of the external device 500 and on a distal side of a second shielding layer. In such embodiments, the first antenna, such as antenna 540, may be configured to communicate with one or more implantable devices (e.g., implantable device 200), and the second antenna, such as antenna 5711, may be configured to communicate with one or more charging devices (e.g., charger 61). In some embodiments, one or both of the first and second antennae, such as antenna 540 and antenna 5711, may be configured to communicate with one or more remote devices, such as patient programmer 600’ and / or clinician programmer 600”. For example, the antenna 5711 may be configured to transfer data to a remote device (e.g., a remote device) via a remote connection (e.g., a wide area network (WAN) connection). The data may include, for example, one or more of a stimulation parameter, a stimulation program, a stimulation programming schedule, and an implantable device configuration. Additionally, or alternatively, the data may include software, such as a firmware update for the implantable device 200. In some embodiments, the exernal device 500 may include one or both of a BLE module and a WiFi module having a built-in antenna. The BLE and / or Wifi module may be configured to communicate with one or more remote devices or devices (e.g., with one or both of the patient programmer 600’ and clinician programmer 600”). The BLE and / or Wifi module antenna may operate at a predetermined frequency or within a predetermined frequency range. For example, the BLE and / or Wifi module antenna may operate at a frequency within about 1 GHz to about 10 GHz, such as within about 1.5 GHz to about 8 GHz, within about 2 GHz to about 6 GHz, within about 2.1 GHz to about 4 GHz, within about 2.2 Ghz to about 3 GHz, within about 2.3 GHz to about 2.5 GHz, or at about 2.4 GHz.

[0273] In some embodiments, controller 550 comprises a flexible, folded PCB design.

[0274] In some embodiments, bottom section 5102 of housing 510 includes a recess 5103 that receives a portion of antenna assembly 5400. Recess 5103 and / or the position of antenna 540 may be configured to minimize the distance between antenna 540 and implantable device 200 when external device 500 is positioned in contact with the skin of the patient proximate the implant location of implantable device 200. In some embodiments, antenna assembly 5400 comprises an antenna shield, such as a ferrite material, for example as described herein. The antenna shield may be positioned outside of recess 5103 and may extend beyond the perimeter of antenna 540. In some embodiments, antenna assembly 5400 comprises an antenna tuning mechanism, such as a variable capacitor. The antenna tuning mechanism may be accessiblethrough the antenna shield, such as via a hole in a shield comprising a ferrite backing of antenna assembly 5400. In some embodiments, an antenna tuning mechanism of antenna assembly 5400 may comprise a programmable capacitor. The programmable capacitor may adaptively adjust the tuning in response to damage, aging, and / or changes in the environment of device 500. The programmable capacitor may be configured to be set digitally, such as by controlling switches connected to a capacitor bank. Alternatively, or additionally, the programmable capacitor may be set through analog control, such as by controlling a voltage level to a varactor.

[0275] In some embodiments, housing 510 of external device 500 does not include any buttons and / or in-mold decorations (e.g., the surface of housing 510 is relatively continuous and / or smooth). In some embodiments, controller 550 comprises an indicator (e.g., a light such as an LED, of user interface 580). Light from the indicator may be directed through a portion of housing 510 (e.g., to avoid a disruption in the surface of housing 510 via a protruding LED), the directed light visible outside of housing 510, such as a light-penetrating portion of housing 510 created via a two-shot molding process of housing 510.

[0276] In some embodiments, external device 500 is configured to operate (e.g., intermittently operate) in an “always on, low-power” mode (“low-power mode” herein), in addition to operating in a “standard mode” of operation (e.g., a mode in which additional functions are available and more energy is consumed as compared to the low-power mode). In some embodiments, the switching between power modes of external device 500 is controlled via charger 61, for example as described herein. For example, wireless charging detection may be configured to transition external device 500 between lower-power mode and standard mode. External device 500 may be controlled via a wireless connection (e.g., a Bluetooth wireless connection), such as when device 500 receives commands to perform one or more functions, such as to transition between the lower-power mode and a standard mode. External device 500 may be configured to operate using a “gesture-recognition” protocol, for example when controller 550 includes an accelerometer configured to detect tactile interaction with external device 500 (e.g., rapid or other movement of device 500 by a user), such as to cause device 500 to perform a function based on that interaction, such as to transition from the low-power mode to a standard mode. In some embodiments, external device 500 includes a vibrational energy harvesting element. In some embodiments, the vibrational energy harvesting element is used to initiate a turn-on sequence to cause external device 500 to transition into a different power state.In some embodiments, external device 500 comprises a real-time clock (e.g., controller 550 of device 500 comprises a real-time clock). In these embodiments, external device 500 may use data from the real-time clock to more accurately log patient usage and / or other events.

[0277] In some embodiments, user interface 580 of external device 500 is configured to provide haptic and / or audible feedback and / or alerts to the user.

[0278] Referring now to FIGS. 8, 8A, and 8B, a perspective view and two exploded views of a charging base station are illustrated, respectively, consistent with the present inventive concepts. Base station or charger 61 and / or other components of apparatus 10 described in FIGS. 8 and 8A-B may be of similar construction and arrangement as the similar components described in reference to FIG. 1 and otherwise herein. FIG. 8 shows two perspective views of an embodiment of charger 61 of apparatus 10. One perspective of the charger 61 shown is from a back of the charger 61, where the charger may be connected to an external power source (e.g., via power port 6132). The other perspective of the charger 61 is from a front of the charger, which may have an opening configured to receive an external device, such as external device 500 of FIG. 1. FIGS. 8 A and 8B show exploded views of charger 61 of FIG. 8 from opposite perspectives, illustrating components internal to the housing of charger 61.

[0279] Base station or charger 61 may comprise a housing, housing 6110, such as a three-part housing including top section 6111, middle section 6112, and bottom section 6113 as shown. Top section 6111 and middle section 6112 may attach to form a top chamber of housing 6110, and middle section 6112 and bottom section 6113 may attach to form a bottom chamber of housing 6110. In some embodiments, housing 6110 may include one or more non-slip features, such as rubber feet and / or a surface comprising a non-slip coating and / or contour. Charger 61 may include wireless charging assembly 6120 that wirelessly transfers energy to power supply 570 of external device 500 when external device 500 is operably engaged with charger 61, as described herein. Wireless charging assembly 6120 may include one or more wireless charging antennas, such as antenna 6121 shown in FIG. 8B. The charging assembly 6120 may be configured to transmit power to the external device 500 (e.g., to antenna 5711 of external device 500). In some embodiments, wireless charging assembly 6120 comprises a Qi charging system. Middle section 6112 of housing 6110 may comprise a void or opening between opposing surfaces of the housing (e.g., a void between a top projection and a bottom projection of middle section 6112), such as slot 6114, as shown, that slidingly receives external device 500. In someembodiments, slot 6114 is angled downward (e.g., when charger 61 is positioned on a flat level surface, the opening of slot 6114 is positioned higher than the inward portion of slot 6114), such as to hold external device 500 within slot 6114 during charging. Alternatively, or additionally, opening, (e.g., slot 6114) may include one or more retention features, not shown, but such as one or more features configured to frictionally and / or otherwise engage external device 500 to prevent unwanted disengagement of external device 500 and charger 61.

[0280] Wireless charging assembly 6120 may be located within the top chamber of housing 6110, such that antenna 6121 is located adjacent to opening (e.g., slot 6114). Opening may be constructed and arranged such that antenna 5711 of external device 500 and antenna 6121 of charger 61 are properly aligned for wireless charging when external device 500 is positioned at least partially within opening. In some embodiments, charger 61 and external device 500 are constructed and arranged such that when external device 500 is positioned in or on the charger 61, such as when the external device 500 is partially or fully seated within opening, the antennas 5711 and 6121 may automatically align regardless of the relative rotational orientation of external device 500 relative to charger 61 (e.g., opening (e.g., slot 6114) may include a symmetric structure that does not include any rotational “keying” features). That is, the antennae 5711, 6121 may be rotationally symmetric when the external device 500 is positioned on or near the charger 61. In some embodiments, middle section 6112 comprises one or more alignment features, recess 6115 shown. At least a portion of antenna 6121 may be located within recess 6115 when the top chamber of housing 6110 is assembled (e.g., in a manufacturing process) such that antenna 6121 is consistently properly aligned (e.g., consistently aligned from charger to charger in the manufacturing of charger 61) for optimal charging efficiency when external device 500 is operably engaged with charger 61. In some embodiments, antenna 6121 and / or antenna 5711 of external device 500 are rotationally symmetric. In some embodiments, top section 6111 includes a biasing feature, not shown, but such as a feature configured to bias antenna 6121 towards opening (e.g., biased against the bottom surface of the top chamber of housing 6110). In some embodiments, the biasing feature may include a compressible material (not shown), such as a foam layer, configured to bias antenna 6121 towards opening (e.g., slot 6114). That is, the compressible material, such as a foam layer, may be configured to bias antenna to maintain the position of antenna 6121 proximal to an interior surface of housing 6110 (e.g., to increase charging efficiency). In other words, the compressible material may beconfigured to minimize a distance between the antenna 6121 and an interior surface of housing 6110.

[0281] In some embodiments, one or more wall portions of housing 6110 are thinner than other portions of housing 6110, such as when the portion of middle section 6112 between antenna 6121 and opening (e.g., the surface of recess 6115) is thinner. Antenna 6121 may be oriented parallel with the surface of recess 6115, such that antenna 6121 is oriented parallel with antenna 5711 of external device 500 when external device 500 is operably engaged with charger 61.

[0282] Charger 61 may include one or more attachment devices, such as screws 6101a, b, 6102a,b, and 6103a,b shown. Charger 61 may include one or more insulators, such as one or more dielectric and / or thermal insulators, such as insulator 6104 shown. Charger 61 may include one or more charging control assemblies, controller 6130 shown. Controller 6130 may include one or more heat sinks. Insulator 6104 and / or one or more heat sinks of controller 6130 may be configured to reduce the temperature near a battery and / or critical circuits of controller 6130. Controller 6130 may include one or more wireless antennas, such as wireless antennas that provide NFC. In some embodiments, wireless charging assembly 6120 comprises an NFC antenna and a Qi antenna, such as when an NFC antenna is printed on wirelessly charging assembly 6120 and a Qi antenna is separately soldered to wireless charging assembly 6120. Both antennas may be connected to controller 6130 via coaxial connectors. In some embodiments, wireless charging assembly 6120 comprises a temperature sensor, not shown, but such as a temperature sensor that is connected to controller 6130 via a cable (e.g., a cable that is routed through middle portion 6112). External device 500 and charger 61 may communicate via NFC, for example when external device 500 is positioned in charger 61, NFC communication may be used to initiate a charging cycle. Additionally, or alternatively, external device 500 and charger 61 may communicate via Bluetooth (e.g., a Bluetooth low energy, or “BLE” connection) and / or other wired or wireless communication protocol. In some embodiments, NFC communication is used as a “gatekeeper” for BLE or other wireless connections established between external device 500 and charger 61. In some embodiments, charger 61 and / or external device 500 (e.g., via charger 61) may connect to a local area network (LAN), such as a wi-fi network, to connect to a server of apparatus 10 (e.g., a cloud-based server), such as to upload diagnostic and / orpatient usage data (described herein) and / or to download information, such as stimulation program information and / or firmware or software update information.

[0283] In some embodiments, antenna 6121 may be configured to communicate with one or more remote devices, such as with patient programmer 600’ and / or clinician programmer 600”. For example, one or more antennae 6121 (e.g., an NFC antenna) may be configured to transfer data to a remote device (e.g., a remote device) via a remote connection (e.g., a wide area network (WAN) connection). The data may include, for example, one or more of a stimulation parameter, a stimulation program, a stimulation programming schedule, and an implantable device configuration. Additionally, or alternatively, the data may include software, such as a firmware update for the implantable device 200.

[0284] In some embodiments, antennae 6121 may be configured to operate at a frequency or within a same frequency range (e.g., a predetermined frequency range) or different frequency ranges (e.g., within predetermined frequency ranges). For example, a first antenna 6121 (e.g., the Qi charging antenna) may be configured to operate at a frequency within about 1 kHz to about 500 kHz, such as within about 10 kHz to about 450 kHz, within about 20 kHz to about 400 kHz, within about 30 kHz to about 350 kHz, within about 40 kHz to about 300 kHz, within about 50 kHz to about 250 kHz, within about 75 kHz to about 225 kHz, or within about 100 kHz to about 200 kHz. As another example, a second antenna 6121 (e.g., the NFC antenna) may be configured to operate within about 1 MHz to about 100 MHz, such as about 5 MHz to about 90 MHz, about 10 MHz to about 80 MHz, about 15 MHz to about 70 MHz, about 20 MHz to about 60 MHz, about 25 MHz to about 55 MHz, or about 30 MHz to about 50 MHz.

[0285] In some embodiments, charger 61 is configured to charge external device 500 in a closed-loop manner. For example, controller 6130 and / or controller 550 of external device 500 may include one or more temperature sensors (e.g., thermocouples) configured to monitor the temperature of power supply 570 of external device 500 during charging, the thermocouples providing signals used in closed-loop charging, such as when controller 6130 includes an algorithm configured to adjust the charging parameters based on the temperature of power supply 570 (e.g., to prevent overheating and / or overcharging). In some embodiments, charger 61 is configured to control one or more functions of external device 500, for example to turn external device 500 on or off, to transition external device 500 from a low-power mode to a standard mode (e.g., as described herein), and / or to turn one or more features of external device500 on or off. For example, external device 500 may be configured to detect when it is positioned within opening or slot 6114 of charger 61 (e.g., via a Qi detection process of controller 550), and to automatically activate one or more communication protocols (e.g., NFC and / or BLE), such that external device 500 may communicate with charger 61. In some embodiments, one or more communication protocols of external device 500 are disabled (e.g., to save battery power) unless external device 500 is positioned within opening (e.g., slot 6114) of charger 61. In some embodiments, controller 6130 is configured to implement a battery health management protocol configured to prolong the battery life of power supply 570 (e.g., a power supply comprising one or more batteries) of external device 500. In some embodiments, the battery health management protocol is based on patient usage of one or more components of apparatus 10. In some embodiments, the battery health management protocol disables further charging once a target battery voltage is reached.

[0286] In some embodiments, charger 61 includes one or more user output components that are configured to alert the user to the charging status of external device 500, such as via one or more audio, tactile, and / or visual output components. For example, charger 61 may include light 6131 that provides a visual indicator of the charging status (e.g., charging, charged, and / or that an error has occurred). In some embodiments, light 6131 comprises an illuminated ring that surrounds at least a portion of charger 61. In some embodiments, charger 61 includes one or more power connectors, such as power port 6132, that operably attach to an external power source that provides energy to charge external device 500. For example, power port 6132 may comprise a USB port, such as a USB C port configured to attach to a DC power source via a USB cable.

[0287] In some embodiments, controller 6130, and insulator 6104 may be located within the chamber of housing 6110 between bottom section 6113 and middle section 6112. Insulator 6104 may be located between controller 6130 and middle section 6112.

[0288] In some embodiments, one or more wires, not shown, extend through middle section 6112 of housing 6110, such as one or more wires that operably connect wireless charging assembly 6120 to controller 6130. In some embodiments, the one or more wires comprise one or more coaxial wires. In some embodiments, wireless charging assembly 6120 is fixedly attached to top section 6111 of housing 6110, such as when attached with screws 6101a, b shown. In some embodiments, middle section 6112 is fixedly attached to top section 6111 of housing 6110, suchas with screws 6102a,b shown. Alternatively, or additionally, middle section 6112 and top section 6111 may be attached via a snap-fit, weld (e.g., ultrasonic weld), and / or adhesive bond. In some embodiments, light 6131 is positioned between an outer portion of bottom section 6113 and middle section 6112, such that when bottom section 6113 and middle section 6112 are attached, and light 6131 comprises a ring of light between bottom section 6113 and middle section 6112. Bottom section 6113 and middle section 6112 may be fixedly attached, such as with screws 6103a, b shown. Alternatively, or additionally, bottom section 6113 and middle section 6112 may be attached via a snap-fit, weld (e.g., ultrasonic weld), and / or adhesive bond. In some embodiments, charger 61 may comprise one or more decals, labels and / or other coverings, such as label 6105 shown. Label 6105 may be adhered to the outside of bottom section 6113, such as to cover screws 6013a, b (e.g., to resist tampering) and / or to prevent contaminants from entering housing 6110 (e.g., via screw holes in bottom section 6113).

[0289] In some embodiments, charger 61 includes one or more thermal management mechanisms, not shown, such as mechanisms configured to dissipate or otherwise mitigate heat generated during charging. For example, charger 61 may include one or more fans that move air through the top chamber of housing 6110 to cool wireless charging assembly 6120 (e.g., move air via a flow path from outside of housing 6110, into the top chamber, through the bottom chamber, and out the bottom of housing 6110).

[0290] Referring now to FIGS. 9A through 10B, perspective and side views of various embodiments of a patient attachment device are illustrated, consistent with the present inventive concepts. Patient attachment device 70 and / or other components of apparatus 10 described in FIGS. 9 A through 10B may be of similar construction and arrangement as the similar components described in reference to FIG. 1 and otherwise herein. FIGS. 9A and 10A show perspective exploded views of various embodiments of a patient attachment device 70 of apparatus 10. FIGS. 9B and 10B each show top and side views of the devices of FIGS. 9A and 10 A, respectively.

[0291] In some embodiments, patient attachment device 70 comprises a strap configured to be secured about the patient (e.g., around the chest, arm, and / or leg of the patient) and to hold external device 500 against the skin of the patient. Patient attachment device 70 may include strap assembly 7010, for example a strap comprising an elongate strap, strap 7011, such as an elongate strap including a first portion 7011a and second portion 7011b. The first and secondportions of strap 7011 may comprise similar and / or dissimilar materials or configurations. For example, first portion 7011a may comprise a relatively flat shape and material (e.g., similar to a belt), such as a neoprene strap. Second portion 7011b may comprise different material, for example a nylon-spandex blend (e.g., 95% nylon and 5% spandex), and may be located around the perimeter of first portion 7011a, as shown. In some embodiments, strap assembly 7010 includes one or more closure assemblies, such as loop 7012 shown. Loop 7012 may be fixedly attached to (e.g., sewn onto) a first end of strap 7011. Strap assembly 7010 may include one or more fixation elements, such as hook 7013, located on the second end of strap 7011. Hook 7013 may removably secure to loop 7012 when strap 7011 is wrapped about a portion of the patient. Alternatively, or additionally, strap assembly 7010 may comprise a hook and loop attachment mechanism, such as when the second end of strap 7011 is configured to be passed through loop 7012 and then pulled away from loop 7012 (e.g., in the opposite direction that strap 7011 surrounded the patient) such as to tighten strap 7011. The second end of strap 7011 may comprise a hook and loop type fastener that secures to strap 7011 when doubled back in this way. In some embodiments, at least a portion of the inner surface (e.g., the patient facing surface) of strap 7011 is tacky, for example when strap 7011 includes silicone dotting that provides a non-slip surface. In some embodiments, the tacky surface is localized to the region around opening 7014.

[0292] In some embodiments, patient attachment device 70 may include one or more connectors that connect external device 500 to strap assembly 7010, such as retention assembly 7020 shown and described in detail in reference to FIGS. 11 and 11 A-D herein. Strap assembly 7010 may include opening 7014, and retention assembly 7020 may be fixedly attached to strap assembly 7010 proximate opening 7014 (e.g., in a coaxial location, such that when external device 500 is positioned within retention assembly 7020 it may be positioned against the skin of the patient). In some embodiments, strap assembly 7010 includes an attachment portion configured to fixedly attach retention assembly 7020 to strap assembly 7010. For example, strap assembly 7010 may include cover 7015 that includes a ring (e.g., a fabric ring, such as a cotton fabric ring). Retention assembly 7020 may be positioned between (e.g., “sandwiched between”) cover 7015 and strap 7011. Cover 7015 may be sewn, adhered, and / or otherwise connected to strap 7011, fixedly attaching retention assembly 7020 to strap assembly 7010. In someembodiments, hook 7013 may be provided on a same, first side of strap 7011 as retention assembly 7020.

[0293] In some embodiments, the patient attachment device may be designed to facilitate removal of excess strap material. For example, turning to patient attachment device 1600 depicted in FIG. 16, like patient attachment device 70, patient attachment device 1600 may be configured to be secured on a body part of the patient, such as the torso (e.g., chest), arm (e.g., upper arm and / or lower arm), and / or leg (e.g. upper leg and / or lower leg) of the patient. Patient attachment device 1600 may comprise a strap 1611 comprising an opening 1614 at a first end 1611a. Retention assembly 1620 may be fixed proximate opening 1614, such as along a perimeter of and / or overlapping with opening 1614. Cover 1615, which may comprise a ring of material(s), may be used to secure retention assembly 1620 to strap 1611. In some embodiments, grip 1616 may also be positioned at the first end 1611a. Grip 1616 may be configured to interface with a patient’s skin when patient attachment device 1600 is on the patient’s body. Grip may comprise a surface configured to increase a frictional force between the patient attachment device 1600 and the patient’s skin (e.g., a nonslip and / or tacky surface). In some embodiments, grip 1616 may be secured to (e.g., sewn, adhered to) at least a portion of a perimeter of patient attachment device 1600, such as to a perimeter of first end 1611a. Furthermore, patient attachment device 1600 may comprise fastener 1613 (e.g., hook or loop of hook and loop fastener, adhesive, hook or eye of hook and eye fastener, etc.) configured to removably secure second end 161 lb of strap 1611 thereto. As shown, fastener 1613 may be provided on an opposite side of the strap 1611 as retention assembly 1620 and grip 1616. In some embodiments, second end 161 lb of strap 1611 may be adjusted to remove excess material length, such as by cutting, to enhance comfort and usability for the patient. By trimming second end 1611b, the patient may effectively eliminate some to all excess strap material that might interfere with wearing the attachment device. This adjustment may ensure that second end 1611b will align just enough to reach the fastener 1613 when strap 1611 is wrapped around the patient’s body (e.g., thigh).

[0294] Referring again to the patient attachment device 70, in some embodiments, and as shown in FIGS. 10A and 10B, the strap assembly 7010 may have a split end. For example, strap assembly 7010 may be sized and arranged for attachment to the patient’s thigh, and the split endshown provides adjustment that may improve comfort (e.g. to achieve a more comfortable fit by allowing adjustment along a tapered portion of the patient’s thigh).

[0295] Referring now to FIGS. 11 and 11 A-D, a perspective view and various side and sectional views of a retention assembly of a patient attachment device are illustrated, consistent with the present inventive concepts. Retention assembly 7020 and / or other components of apparatus 10 described in FIGS. 11 and 11 A-D may be of similar construction and arrangement as the similar components described in reference to FIG. 1 and otherwise herein. FIG. 11 shows a perspective view of retention assembly 7020 of apparatus 10. FIG. 11 A shows a top view of retention assembly 7020, indicating section A-A, which is shown in FIG. 1 IB. FIG. 11C shows a side view of retention assembly 7020, and FIG. 1 ID shows a bottom view of retention assembly 7020.

[0296] Retention assembly 7020 may comprise a device- surrounding structure, ring 7021, with a recess, port 7022, that receives and removably attaches to external device 500. Port 7022 may include one or more retention elements, such as six projections 7023 shown, that frictionally and / or otherwise engage housing 510 of external device 500. In some embodiments, external device 500 is positioned off-center when fully engaged within retention assembly 7020, such that the surface of external device 500 protrudes from ring 7021 and may be positioned in contact with the skin of the patient when strap assembly 7010 is worn by the patient. Retention assembly 7020 may comprise a relatively rigid structure, for example when retention assembly 7020 comprises a thermoplastic material, such as a polyether-based thermoplastic polyurethane.

[0297] Referring now to FIGS. 12 and 12A-C, a perspective view and various side, exploded, and sectional views of an embodiment of an adhesive patient attachment device are illustrated, consistent with the present inventive concepts. Patient attachment device 70 and / or other components of apparatus 10 described in FIGS. 12 and 12A-C may be of similar construction and arrangement as the similar components described in reference to FIG. 1 and otherwise herein. FIG. 12 shows a perspective view of an embodiment of patient attachment device 70. FIG. 12A shows an exploded view of patient attachment device 70 of FIG. 12 illustrating the various layers of the device. FIG. 12B shows a top view of patient attachment device 70, and FIG. 12C shows a side view of patient attachment device 70.

[0298] In some embodiments, patient attachment device 70 comprises a clip configured to be secured to the skin of the patient and to hold external device 500 proximate the skin of thepatient. For example, patient attachment device 70 may include a retention mechanism, clip 7031, with a recess, port 7032, that receives and removably attaches to external device 500. Patient attachment device 70 may comprise a relatively flat portion, plate 7033, that is parallel to the plane of antenna assembly 5400 of external device 500 (e.g., as described herein) when external device 500 is attached to clip 7031. In some embodiments, patient attachment device 70 comprises a multi-part assembly, for example, when plate 7033 is adhesively attached to clip 7031. In some embodiments, plate 7033 is adhesively attached to clip 7031, such as via adhesive layer 7034 shown. In some embodiments, clip 7031 and / or plate 7033 comprise a material comprising polypropylene. In some embodiments, clip 7031 and / or plate 7033 include openings that are concen...

Claims

CLAIMSWHAT IS CLAIMED IS:

1. A neuromodulation system comprising: an implatable device; a base station; and an external device comprising: a first antenna configured to transmit power to the implantable device within a first predetermined frequency range; a second antenna configured to receive power from the base station within a second, different predetermined frequency range; and one or more shielding layers positioned between the first and second antennae.

2. The neurmodulation system of claim 1, wherein the implantable device comprises a third antenna configured to operate within the first predetermined frequency range.

3. The neurmodulation system of claim 1, wherein the base station comprises a fourth antenna configured to operate within the second predetermined frequency range.

4. The neuromodulation system of claim 3, wherein the base station further comprises a compressible material configured to minimize a distance between the fourth antenna and an interior surface of a housing of the base station.

5. The neurmodulation system of claim 4, wherein the fourth antenna is positioned between a distal side of the compressible material and an interior surface of the housing such that the compressible material maintains the fourth antenna proximate to the interior surface of the housing.

6. The neurmodulation system of claim 1, wherein the base station is configured to charge the external device when the external device is positioned in or on the base station.

7. The neurmodulation system of claim 6, wherein the base station comprises an opening configured to receive the external device therein.

8. The neurmodulation system of claim 7, wherein the second antenna of the external device and a fourth antenna of the base station are configured to automatically align when the external device is positioned in or on the base station.

9. The neurmodulation system of claim 8, wherein the second antenna of the external device and the fourth antenna of the base station are rotationally symmetric when the external device is positioned in or on the base station.

10. The neurmodulation system of claim 1, wherein the one or more shielding layers are configured to prevent coupling between the first and second antennae.

11. The neurmodulation system of claim 1, wherein each of the one or more shielding layers comprises one or both of a conductive material and a ferromagnetic material.

12. The neurmodulation system of claim 1, wherein the one or more shielding layers comprise: a first shielding layer comprising a magnetic loss tangent of less than or equal to 0.025 at the first predetermined frequency range; and a second shielding layer comprising a magnetic loss tangent of less than or equal to 0.025 at the second predetermined frequency range.

13. The neurmodulation system of claim 12, wherein the first antenna is fixedly attached to the first shielding layer and the second antenna is fixedly attached to the second shielding layer.

14. The neurmodulation system of claim 1, wherein the first antenna is on a proximal side of the one or more shielding layers and the second antenna is on a distal side of the one or more shielding layers.

15. The neurmodulation system of claim 1, wherein the external device further comprises a compressible material configured to maintain the second antenna proximate to an interior surface of a housing of the external device.

16. The neurmodulation system of claim 15, wherein the external device further comprises a power supply, and wherein the compressible material is positioned between a distal side of the power supply and a proximal side of a shielding layer of the one or more shielding layers.

17. The neurmodulation system of claim 1, wherein the first predetermined frequency range is greater than the second predetermined frequency range.

18. The neurmodulation system of claim 1, wherein the first predetermined frequency range is about 30 MHz to about 50 MHz.

19. The neurmodulation system of claim 1, wherein the second predetermined frequency range is about 100 kHz to about 200 kHz.

20. The neurmodulation system of claim 1, wherein the external device further comprises a housing enclosing the first antenna, the second antenna, and the one or more shielding layers therein.

21. The neurmodulation system of claim 1, wherein the implantable device is configured to stimulate tissue of a patient using the power transmitted by the first antenna.

22. The neurmodulation system of claim 1, wherein the external device is configured to be positioned over the implantable device on a body of a patient.

23. A neuromodulation system comprising: an implantable device; a base station; and an external device comprising:a power supply; a first antenna configured to power the implantable device; a second antenna configured to wirelessly charge the power supply from the base station; and one or more shielding layers positioned between the first and second antennae.

24. The neuromodulation system of claim 23, wherein the first antenna is configured operate within a first predetermined frequency range and the second antenna is configured to operate within a second, different predetermined frequency range.

25. The neuromodulation system of claim 24, wherein the implantable device comprises a third antenna configured to operate within the first predetermined frequency range.

26. The neuromodulation system of claim 24, wherein the base station comprises a fourth antenna configured to operate within the second predetermined frequency range.

27. The neurmodulation system of claim 24, wherein the first predetermined frequency range is about 30 MHz to about 50 MHz.

28. The neurmodulation system of claim 24, wherein the second predetermined frequency range is about 100 kHz to about 200 kHz..

29. The neurmodulation system of claim 23, wherein the second antenna of the external device and the third antenna of the base station are rotationally symmetric when the external device is positioned in or on the base station.

30. A neuromodulation device comprising: a first antenna configured operate within a first predetermined frequency range; a second antenna configured to operate within a second, different predetermined frequency range;one or more shielding layers positioned between the first and second antennae and configured to prevent coupling between the first and second antennae; and a wearable housing carrying the first antenna, the second antenna, and the one or more shielding layers.

31. A neuromodulation system comprising: the device of claim 30; an implantable neuromodulation device comprising a third antenna configured to operate within the first predetermined frequency range; and a base station comprising a fourth antenna configured to operate within the second predetermined frequnecy range.

32. The neurmodulation device of claim 30 further comprising a compressible material configured to maintain the second antenna proximate to an interior surface of a housing of the neurmodulation device.

33. The neurmodulation device of claim 32 further comprising a power supply, wherein the compressible material is positioned between a distal side of the power supply and a proximal side of a shielding layer of the one or more shielding layers.

34. The neurmodulation device of claim 30 further comprising a third antenna configured to trasnmit data to one or more remote devices.

35. The The neurmodulation device of claim 34, wherein the second antenna comprises a Qi charging antenna and the third antenna comprises a near-field communication (NFC) antenna.

36. A method for reprogramming a neurostimulation system comprising: receiving first data at a base station or a remote device via a remote connection; transfering the data from the base station or remote device to an external device via a local connection between the base station or remote device and the external device; andinstructing, via the external device, an implantable device to stimulate tissue of a patient using the data.

37. The method of claim 36 further comprising establishing a wireless connection between the external device and the implantable device prior to instructing the implantable device to stimulate the tissue of the patient.

38. The method of claim 36, wherein the remote connection is a wide area network (WAN) connection.

39. The method of claim 36 further comprising transferring second data from one or both of the base station and the external device to the remote device.

40. The method of claim 39, wherein the transferring is via the remote connection.

41. The method of claim 36, wherein the local connection is a bluetooth low energy (BLE) connection.

42. The method of claim 36, wherein instructing the implantable device to stimulate the tissue of the patient comprises transferring power from the external device to the implantable device.

43. The method of claim 42, wherein the implantable device uses the power to stimulate the tissue of the patient.

44. The method of claim 36, wherein transferring the first data from the base station or remote device to the external device comprises downloading the first data to the external device.

45. The method of claim 44, wherein the first data is downloaded to a memory of the external device.

46. The method of claim 36, wherein the first data comprises stimulation data.

47. The method of claim 46, wherein the stimulation data comprises one or more of a stimulation parameter, a stimulation program, a stimulation programming schedule, and an implantable device configuration.

48. The method of claim 36, wherein the first data comprises software.

49. The method of claim 48, wherein the software comprises a firmware update.

50. The method of claim 36, wherein the base station comprises a charging station for the implantable device.

51. The method of claim 36, wherein the remote device comprises a smart phone.

52. A system for implanting an implantable device within tissue of a patient, comprising: an implantation device comprising: a shaft; a first arm extending from the shaft and configured to be positioned against skin of a patient; a second arm extending from the shaft and configured to be inserted into a body of the patient to dissect the tissue; and a sheath comprising a body with a channel configured to receive the second arm of the implantation device, wherein the sheath is configured to provide access to a subcutaneous space formed in the tissue by the implantation device when the implantation device is withdrawn from the tissue.

53. The system of claim 52, wherein the first arm comprises a first longitudinal axis and the second arm comprises a second longitudinal axis, and wherein the first and second longitudinal axes are transverse to a longitudinal axis of the shaft.

54. The system of claim 53, wherein the first and second longitudinal axes are about parallel.

55. The system of claim 53, wherein an angle formed between one or both of the first longitudinal axis and the second longitudinal axis and the longitudinal axis of the shaft is about 80 degrees to about 120 degrees.

56. The system of claim 55, wherein the angle formed between one or both of the first longitudinal axis and the second longitudinal axis and the longitudinal axis of the shaft is about 90 degrees.

57. The system of claim 52, wherein the second arm comprises a tapered distal tip.

58. The system of claim 52, wherein the sheath further comprises a handle coupled to the proximal end.

59. The system of claim 52 further comprising a second implantation device configured to releasably couple with the implantable device.

60. The system of claim 59, wherein the second implantable device comprises first and second prongs defining a gap therebetween, and wherein the gap is configured to receive the implantable device.

61. The system of claim 52, wherein the implantation device further comprises a coupling element extending therefrom, and wherein a proximal end of the sheath is configured to contact the coupling element to maintain a position of the sheath relative to the implantation device during the implanting.

62. The system of claim 61, wherein the coupling element comprises a ledge.

63. A method for implanting an implantable device within tissue of a patient, comprising:introducing a first implantation device and a sheath through an incision in the tissue, wherein a portion of the first implantation device is positioned within in a channel of the sheath and; advancing the first implantation device and the sheath together through the tissue to form a subcutaneous space configured to receive the implantable device, wherein contact between the first implantation device the sheath maintains a position of the implantation device relative to the sheath during the advancing; and withdrawing the implantation device from the incision while maintaining a position of the sheath within the tissue such that the channel of the sheath provides access to the subcutaneous space.

64. The method of claim 63 further comprising advancing a second implantation device coupled with the implantable device through the channel of the sheath to the implantation site.

65. The method of claim 64 further comprising withdrawing the sheath from the incision and subsequently withdrawing the second implantation device from the incision.

66. The method of claim 63, wherein during the advancing, a coupling element of the implantation device contacts a proximal end of the sheath.

67. A method for reconfiguring a stimulation program for a patient, comprising: retrieving, via a programmer, one or more stimluation program templates from a remote server; determining whether at least one of the one or more stimulation program templates satisfies a condition; and when the stimulation program template satisfies the condition, adjusting the stimulation program to be based on the stimulation program template.

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