Stimulation device

Abstract

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

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Patent Application Serial No. 63 / 625,043, filed January 25, 2024, the contents of which are incorporated herein by reference in their entirety for all purposes. Technical Field

[0003] The present invention generally relates to medical devices for patients, and in particular, to devices for delivering enhanced stimulation to efficiently deliver therapy while avoiding undesirable effects. Background Technology

[0004] Implantable devices for treating patients and / or recording patient data are known. For example, implants that deliver energy (such as electrical energy) or medication (pharmaceutical agents) are commercially available. Implantable electrical stimulators can be used to pace or defibrillate the heart, as well as to modulate nerve tissue (e.g., to treat pain). Most implants are relatively large devices with batteries and long catheters, such as implantable leads configured to deliver electrical energy or implantable tubes (i.e., catheters) for delivering medication. These implants require fairly invasive implantation procedures, as well as periodic battery replacements, which necessitate additional surgery. The large size and high cost of these devices limit their use in a wide range of applications.

[0005] Neurostimulation therapy has recently shown increasing promise for treating a number of chronic conditions, including drug-resistant hypertension, intestinal motility disorders, metabolic disorders caused by diabetes and obesity, and chronic and acute pain conditions. However, among other limitations, many of these implantable device configurations have not yet been effectively developed due to a lack of miniaturization and electrical efficiency.

[0006] Therefore, there is a need for devices, systems, equipment, and methods that provide one or more implantable devices and are designed to provide enhanced treatment of pain and other enhanced benefits. Summary of the Invention

[0007] This document describes systems, devices, and methods for delivering stimulation therapy to a patient. The neural modulation system may include an implantable device, a base station, and an external device. The external device may include: a first antenna configured to deliver 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 antennas. Furthermore, 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. One or more shielding layers may be configured to prevent coupling between the first and second antennas. 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 from about 30 MHz to about 50 MHz, and the second predetermined frequency range may be from about 100 kHz to about 200 kHz. In some embodiments, the external device may also include a housing enclosing the first antenna, the second antenna, and one or more shielding layers therein. Furthermore, the implantable device may be configured to stimulate the patient's tissues using power delivered by the first antenna. In addition, external devices can be configured to be positioned on the patient's body above the implantable device.

[0008] In some embodiments, the base station may further include a compressible material configured to minimize the distance between the fourth antenna and the inner surface of the base station housing. The fourth antenna may be positioned between the distal side of the compressible material and the inner surface of the housing, such that the compressible material can hold the fourth antenna near the inner surface of the housing. In some embodiments, the base station may be configured to charge an external device when the external device is located within 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 the fourth antenna of the base station may be configured to automatically align when the external device is located within or on the base station. Similarly, when the external device is located within or on the base station, the second antenna of the external device and the fourth antenna of the base station may be rotationally symmetric.

[0009] One or more shielding layers may include: a first shielding layer comprising a magnetic loss tangent of less than or equal to 0.025 at a first predetermined frequency range; and a second shielding layer comprising a magnetic loss tangent of less than or equal to 0.025 at a second predetermined frequency range. A first antenna is fixedly attached to the first shielding layer and a second antenna is fixedly attached to the second shielding layer. The first antenna may be located on the proximal side of one or more shielding layers and the second antenna may be located on the distal side of one or more shielding layers.

[0010] In some embodiments, the external device may include a compressible material configured to maintain a second antenna near the inner surface of the external device's housing. Additionally, the external device may include a power supply. The compressible material may be positioned between the distal side of the power supply and the proximal side of one or more shielding layers.

[0011] Another neural modulation system may include an implantable device, a base station, and an external device. The external device may include: a power source; a first antenna configured to power the implantable device; a second antenna configured to wirelessly charge the power source from the base station; and one or more shielding layers positioned between the first and second antennas. In some embodiments, when the external device is positioned in or on a base station, the second antenna of the external device and the third antenna of the base station may be rotationally symmetrical.

[0012] In some embodiments, the first antenna may be configured to 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 from about 30 MHz to about 50 MHz, and the second predetermined frequency range may be from about 100 kHz to about 200 kHz.

[0013] A neural modulation device may include: a first antenna configured to 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 antennas and configured to prevent coupling between the first and second antennas; and a wearable housing carrying the first antenna, the second antenna, and the one or more shielding layers. Furthermore, a neural modulation system may include: the aforementioned neural modulation device; an implantable neural modulation device including a third antenna operating within the first predetermined frequency range; and a base station having a fourth antenna and configured to operate within a second predetermined frequency range.

[0014] In some embodiments, the neural modulation device may include a compressible material configured to maintain a second antenna near the inner surface of the device's housing. Furthermore, the neural modulation device may include a power source, and the compressible material may be positioned between the distal side of the power source and the proximal side of one or more shielding layers.

[0015] In some embodiments, the neural modulation device may include a third antenna configured to transmit 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.

[0016] A method for reprogramming a neurostimulation system may include: receiving first data at a base station or remote device via a remote connection; transmitting the data from the base station or remote device to the external device via a local connection between the base station or remote device and the external device; and instructing an implantable device via the external device to use the data to stimulate a patient's tissue. 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 patient's tissue. 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 patient's tissue may include transmitting power from the external device to the implantable device. The implantable device may use the power to stimulate the patient's tissue. Furthermore, the first data may include stimulation data. The stimulation data may include one or more of stimulation parameters, stimulation procedures, stimulation programming schedules, and implantable device configurations. In some embodiments, the base station may be a charging station for the implantable device. In some embodiments, the remote device may be a smartphone.

[0017] In some embodiments, the method may include transmitting second data from one or both of a base station and an external device to a remote device. The transmission may occur via a remote connection. Furthermore, in some embodiments, transmitting first data from the base station or the remote device to the external device may include downloading the first data to the external device. The first data may be downloaded to the external device's memory. Additionally, in some embodiments, the first data may include software. The software may be a firmware update.

[0018] This document also describes a system for implanting an implantable device within a patient's tissue. The system may include an implantable device comprising: an axis; a first arm extending from the axis and configured to be positioned against the patient's skin; and a second arm extending from the axis and configured to be inserted into the patient's body to dissect tissue. The system may also include a sheath having a body with a channel configured to receive the second arm of the implantable device. The sheath may be configured to provide access to a subcutaneous space formed by the implantable device in the tissue when the implantable 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 the longitudinal axis of the axis. In some embodiments, the first and second longitudinal axes may be substantially parallel. Furthermore, in some embodiments, the angle formed between one or both of the first and second longitudinal axes and the longitudinal axis of the axis may be from 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 also include a handle coupled to a proximal end. The system may also include a second implantable device configured to be releasably coupled to the implantable device. In some embodiments, the second implantable device may include a first fork and a second fork defining a gap therebetween. The gap may be configured to receive the implantable device. Furthermore, the implantable device may also include a coupling element extending therefrom. The proximal end of the sheath may be configured to contact the coupling element to maintain the positioning of the sheath relative to the implantable device during implantation. In some variations, the coupling element may be a flange.

[0019] This document also describes a method for implanting an implantable device within a patient's tissue. The method may include: introducing a first implantable device and a sheath through an incision in the tissue, wherein a portion of the first implantable device may be positioned within a channel of the sheath; advancing the first implantable device and the sheath together through the tissue to form a subcutaneous space configured to receive the implantable device, wherein during advancement, contact between the first implantable device and the sheath maintains the positioning of the implantable device relative to the sheath; and withdrawing the implantable device from the incision while maintaining the positioning of the sheath within the tissue such that a channel of the sheath provides access to the subcutaneous space. In some embodiments, the method may further include advancing a second implantable device coupled to 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 implantable device from the incision. In some embodiments, during advancement, a coupling element of the implantable device may contact the proximal end of the sheath.

[0020] Finally, a method for reconfiguring a stimulus program may include: retrieving one or more stimulus program templates from a remote server via a programmer; determining whether at least one of the one or more stimulus program templates meets a condition; and adjusting the stimulus program to be based on the stimulus program template when the stimulus program template meets the condition.

[0021] The techniques described herein, along with their properties and accompanying advantages, will be best recognized and understood in light of the following detailed description taken in conjunction with the accompanying drawings, in which representative embodiments are described by way of example.

[0022] By incorporating via reference

[0023] All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference to the same extent that each individual publication, patent, or patent application is specifically and individually indicated to be incorporated by reference. The contents of all publications, patents, and patent applications mentioned in this specification are incorporated herein by reference, in their entirety, for all purposes. Attached Figure Description

[0024] The foregoing and other objects, features, and advantages of embodiments of the present invention will become apparent from a more detailed description of preferred embodiments, as illustrated in the accompanying drawings, wherein similar reference characters refer to the same or similar elements. The drawings are not necessarily to scale, but rather focus on illustrating the principles of the preferred embodiments.

[0025] Figure 1 A schematic anatomical view depicting an illustrative variant of a medical device comprising an external system and an implantable system, consistent with the concepts of the present invention.

[0026] Figures 2A-2B Cross-sectional views of two different illustrative embodiments of an implantable device comprising multiple leads, conforming to the concept of the present invention, are depicted.

[0027] Figure 3 A flowchart illustrating an illustrative variation of a method for updating firmware and / or other software of a medical device, consistent with the concepts of this invention, is provided.

[0028] Figure 4 Top view, side view and perspective transparent view of an illustrative variation of a lead anchor element conforming to the concept of the present invention.

[0029] Figures 4A-4D Various perspective views and cross-sectional views depicting illustrative variations of anchor elements conforming to the concept of this invention are shown.

[0030] Figure 5 A perspective view depicting an illustrative variation of a sleeve for covering a portion of a lead, the distal portion of the lead, and an applicator tool, in accordance with the concept of the present invention.

[0031] Figure 5A Side and bottom views of an illustrative variant of a sleeve for covering a portion of a lead wire, conforming to the concept of the present invention, are depicted.

[0032] Figure 5B A side view and a bottom view depict another illustrative variation of a sleeve for covering a portion of a lead wire, which conforms to the concept of the present invention.

[0033] Figure 5C and Figure 5D Another illustrative variation of the sleeve and clip for covering a portion of the lead wire, which are consistent with the concept of the present invention, is depicted.

[0034] Figure 5E Top and bottom views depict an illustrative variation of a sleeve for covering two leads, conforming to the concept of the present invention.

[0035] Figures 5F-5H A perspective view depicting an illustrative embodiment of an electrode that can be generated by a device according to the concept of the present invention and the electric field thereby generated.

[0036] Figures 6A-6I Various views depicting illustrative variations of implantation tools conforming to the concepts of this invention are shown.

[0037] Figure 7 and Figures 7A-7E Perspective view, exploded view, side view and three cross-sectional views of an illustrative variant of an external device conforming to the concept of the present invention are depicted respectively.

[0038] Figure 8 Perspective views of the rear and front sides of an illustrative variant of a charging base station conforming to the concept of the present invention are depicted. Figure 8A and Figure 8B Two perspective views and two exploded views depict an illustrative variation of a charging base station that conforms to the concept of this invention.

[0039] Figures 9A to 10B Perspective and side views depicting various illustrative embodiments of patient attachment devices conforming to the concepts of the present invention are provided.

[0040] Figure 11 and Figures 11A-11D Perspective views, as well as various side views and cross-sectional views, depict illustrative variations of the retaining components of a patient attachment device conforming to the concept of the present invention.

[0041] Figure 12 and Figures 12A-12C Perspective views and various side views, exploded views and cross-sectional views of illustrative variations of adhesive patient attachment devices conforming to the concepts of the present invention are depicted.

[0042] Figure 13A A perspective view depicting an illustrative variant of a first implantation tool conforming to the concept of the present invention is provided. Figure 13B Depicting Figure 13A Top view of the distal end of the first implantation tool. Figure 13C Depicting Figure 13A Side view of the first implantation tool.

[0043] Figure 14 A perspective view depicting an illustrative variant of a sheath for a first implantation tool, conforming to the concept of the present invention.

[0044] Figure 15A A perspective view depicting an illustrative variant of a second implantation tool conforming to the concept of the present invention is provided. Figure 15B Depicting Figure 15A A perspective view of the second implantation tool coupled to the implantable device and within the sheath.

[0045] Figure 16 An exploded view depicting an illustrative variant of a patient attachment device conforming to the concept of the present invention is shown. Detailed Implementation

[0046] The terminology used herein is for the purpose of describing exemplary embodiments and is not intended to limit the inventive concept. Furthermore, embodiments of the inventive concept may include multiple novel features, none of which alone is responsible for its desired properties or is essential for practicing the inventive concept described herein.

[0047] As used in this article, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise.

[0048] As will be further understood, the words “comprising” (and any form of inclusion, such as “comprise” and “comprises”), “having” (and any form of having, such as “have” and “has”), “including” (and any form of containing, such as “includes” and “include”), or “containing” (and any form of containing, such as “contains” and “contain”), when used in this specification, specify the presence of features, integers, steps, operations, elements and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components and / or groups thereof.

[0049] It will be understood that although the terms first, second, third, etc., may be used herein to describe various limitations, elements, parts, regions, layers, and / or portions, these limitations, elements, parts, regions, layers, and / or portions should not be limited by these terms. These terms are used only to distinguish one limitation, element, part, region, layer, or portion from another limitation, element, part, region, layer, or portion. Therefore, the first limitation, element, part, region, layer, or portion discussed below may be referred to as the second limitation, element, part, region, layer, or portion without departing from the teachings of this application.

[0050] It will be further understood that when an element is referred to as “on another element,” “attached,” “connected,” or “coupled” to another element, it may be directly on or above the other element, or connected or coupled to that other element, or one or more intervening elements may be present. Conversely, when an element is referred to as “directly on another element,” “directly attached,” “directly connected,” or “directly coupled” to another element, no intervening element is present. Other terms used to describe the relationship between elements should be interpreted in a similar manner (e.g., “between” vs. “directly between,” “adjacent” vs. “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 connecting wires (as defined below). In some embodiments, an assembly comprising multiple components connected by one or more connecting wires is created during the manufacturing process (e.g., pre-connected during the implantation procedure of the device of the present invention concept). Alternatively or additionally, the connecting wire may include one or more connectors (e.g., a connecting wire that includes connectors at one or both ends), and similar components may be created by a user (e.g., a clinician) operatively attaching one or more connectors of the connecting wire to one or more mating connectors of one or more parts of the component.

[0051] As used herein, the terms “operably attached,” “operably connected,” “operably coupled,” and similar terms related to the attachment of components shall refer to the attachment of two or more components that produces one, two, or more of the following: electrical attachment; fluid attachment; magnetic attachment; mechanical attachment; optical attachment; acoustic attachment; and / or other operable attachment arrangements. Operable attachment of two or more components can facilitate the transmission of the following between the two or more components: electricity; signals; electrical energy; fluids or other flowable materials; magnetism; mechanical linkages; light; sound, such as ultrasound; and / or other materials and / or components.

[0052] It will be further understood that when the first element is referred to as being "in the second element", "on the second element" and / or "within the second element", the first element can be positioned as: within the internal space of the second element, within a portion of the second element (e.g., within the wall of the second element); positioned on the outer and / or inner surface of the second element; and a combination of one or more of these.

[0053] Spatially relative terms such as “below,” “under,” “down,” “above,” “above,” “below,” and the like may be used to describe the relationship between an element and / or feature, as shown, for example, in the accompanying drawings, and another element and / or feature. It will be understood that spatially relative terms are intended to include different orientations of the device in use and / or operation, in addition to those depicted in the accompanying drawings. For example, if the device in the accompanying drawings is flipped, an element described as “below” and / or “under” other elements or features will subsequently be oriented “above” other elements or features. The device may be oriented in other ways (e.g., rotated 90 degrees or in other orientations), and the spatially relative descriptors used herein will be interpreted accordingly.

[0054] As used herein, the term “proximity” should include a location or other location that is relatively close to, on, in, and / or within the referenced component.

[0055] When used herein, the term “and / or” will be regarded as a specific disclosure of each of the two specified features or components having or not having the other. For example, “A and / or B” should be regarded as a specific disclosure of each of (i) A, (ii) B, and (iii) A and B, as if each were described separately herein.

[0056] The term "diameter" used in this document to describe non-circular geometries will be taken as the diameter of an imaginary circle that approximates the geometry being described. For example, when describing cross-sections, such as the cross-section of a component, the term "diameter" should be taken as the diameter of an imaginary circle that has the same cross-sectional area as the cross-section of the component being described.

[0057] As used in this article, the terms "major axis" and "minor axis" refer to the length and diameter of the smallest imaginary cylinder that can completely enclose the component.

[0058] When used herein, the term "functional element" is considered to include components comprising one, two, or more of the following: sensors; transducers; electrodes; energy delivery elements; drug delivery elements; magnetic field generating transducers; and combinations thereof. In some embodiments, a functional element includes a transducer selected from the group consisting of: light delivery elements; light-emitting diodes; wireless transmitters; Bluetooth devices; mechanical transducers; piezoelectric transducers; pressure transducers; temperature transducers; humidity transducers; vibration transducers; audio transducers; speakers; and combinations thereof. In some embodiments, a functional element includes a needle, a catheter (e.g., the distal portion of a catheter), an iontophoresis element, or a porous membrane, such as a drug delivery element configured to deliver one or more drugs. In some embodiments, the functional element includes one or more sensors selected from the group consisting of: electrodes; sensors configured to record electrical activity of tissue; blood glucose sensors, such as optical blood glucose sensors; pressure sensors; blood pressure sensors; heart rate sensors; inflammation sensors; neural activity sensors; muscle activity sensors; pH sensors; strain gauges; accelerometers; gyroscopes; GPS; respiration sensors; respiratory rate sensors; temperature sensors; magnetic sensors; optical sensors; MEMS sensors; chemical sensors; hormone sensors; impedance sensors; tissue impedance sensors; body positioning sensors; body motion sensors; body activity level sensors; perspiration sensors; patient hydration sensors; respiratory monitoring sensors; sleep monitoring sensors; food intake monitoring sensors; urine motility sensors; intestinal motility sensors; tremor sensors; pain level sensors; orientation sensors; motion sensors; and combinations of one or more of these.

[0059] As used herein, the term "transducer" will be considered to include any component or combination of components that receive energy or any input and produce an output. For example, a transducer may include electrodes that receive electrical energy and distribute it to tissue (e.g., based on electrode size). In some configurations, a transducer converts an electrical signal into any output, such as light (e.g., a transducer including a light-emitting diode or light bulb), sound (e.g., a transducer including a piezoelectric crystal configured to deliver ultrasonic energy), pressure, heat, cryogenic energy, chemical energy, mechanical energy (e.g., a transducer including a motor or solenoid), magnetic energy, and / or various electrical signals (e.g., Bluetooth or other wireless communication elements). Alternatively or additionally, a transducer may convert a physical quantity (e.g., an embodiment of the physical quantity) into an electrical signal. A transducer may include any component that delivers energy and / or agents to tissue, such as a transducer configured to deliver one or more of the following: delivering electrical energy to tissue (e.g., a transducer including one or more electrodes); delivering optical energy to tissue (e.g., a transducer including a laser, a light-emitting diode, and / or an optical component such as a lens or prism); delivering mechanical energy to tissue (e.g., a transducer including a tissue manipulation element); delivering acoustic energy to tissue (e.g., a transducer including a piezoelectric crystal); delivering thermal energy to tissue (e.g., thermal and / or cryogenic energy); chemical energy; electromagnetic energy; magnetic energy; and combinations of one or more of these.

[0060] As used herein, the term "transmitted signal" will be considered to include any signal transmitted between two components, such as via wired or wireless communication pathways. For example, a transmitted signal may include electrical and / or data signals wirelessly transmitted between a component external to the patient and one or more components implanted within the patient. A transmitted signal may include one or more signals transmitted using bodily conduction. Alternatively or additionally, a transmitted signal may include reflected energy, such as energy reflected from any electrical and / or data signal.

[0061] When used herein, the term "data signal" will be considered to include a transmission signal containing at least data. For example, a data signal may include a transmission signal comprising data transmitted between a component external to the patient and one or more components implanted within the patient. Alternatively, a data signal may include a transmission signal containing data transmitted from the implanted component to one or more components external to the patient. A data signal may include a radio frequency signal containing data (e.g., a radio frequency signal containing both electricity and data) and / or a data signal transmitted using bodily conduction.

[0062] As used herein, the term "implantable" will be understood to define a component that is constructed and arranged to be fully or partially implanted in a patient and / or that has already been fully or partially implanted in a patient. As used herein, the term "external" will be understood to define a component that is constructed and arranged to be located outside the patient's body.

[0063] As used herein, the terms “attachment,” “attached,” “attaching,” “connection,” “connected,” “connecting,” and the like will be considered as encompassing any type of connection between two or more components. This connection may include an “operable connection” or “operable attachment” that allows multiple connected components to operate together, such as to transfer information, power, and / or materials (e.g., a pharmaceutical agent to be delivered) between the components. An operable connection may include a physical connection, such as a physical connection comprising a connection between two or more components: wires or other conductors (e.g., an “electrical connection”), optical fibers, waveguides, tubes such as fluid delivery tubes, and / or links such as translational rods or other mechanical links. Alternatively or additionally, an operable connection may include a non-physical or “wireless” connection, such as a wireless connection in which electromagnetic energy is used to transfer information and / or power between components. A connection may include a connection selected from the group consisting of: wired connections; wireless connections; electrical connections; mechanical connections; optical connections; acoustic propagation connections; fluid connections; and combinations of one or more of these.

[0064] As used herein, the term "connecting filament" will be considered to define a filament that connects a first component to a second component. A connecting filament may include connectors at one or both ends, such as those allowing a user to operatively attach at least one end of the filament to a component. A connecting filament may include one or more elements selected from the group consisting of: wires; optical fibers; fluid delivery tubes; mechanical links; waveguides; flexible circuits; and combinations thereof. A connecting filament may include a rigid filament, a flexible filament, or may include one or more flexible portions and one or more rigid portions.

[0065] As used herein, the term “connectorized” refers to a wire, housing, or other component that includes one or more connectors (e.g., connectors that can be attached by a clinician or other user) for operatively connecting that component to a mating connector (e.g., a mating connector of the same or different components).

[0066] As used herein, the terms “stimulus parameter,” “stimulus setting,” “stimulus signal parameter,” “stimulus signal setting,” “stimulus waveform parameter,” or “stimulus waveform setting” can be considered as referring to one or more parameters of a stimulus waveform (also known as a stimulus signal). A “stimulus paradigm SP” can represent one or more sets of stimulus parameters to be used in delivering stimulus energy. The applicable stimulation parameters of this invention concept 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 known as "pulse mode on-time"); duration; phase; polarity; pulse shape; duty cycle parameters (e.g., frequency, pulse width, and / or off-time); inter-pulse interval (also known as "pulse mode off-time" or "inter-pulse interval"); polarity; burst on (also known as "dose on") duration; burst off (also known as "dose off") duration; inter-burst duration; pulse train; train on-time; train off-time; inter-train duration; driving impedance; pulse duration and / or amplitude level; stimulation waveform duration; stimulation waveform repetition; amplitude modulation parameters; frequency modulation parameters; burst parameters; power spectral density parameters; anode / cathode configuration parameters; amount of energy and / or power to be delivered; rate of energy and / or power delivery; time of energy delivery initiation; charge recovery method; and combinations of one or more of these. Stimulation parameters may refer to a single stimulation pulse, multiple stimulation pulses, or a portion of a stimulation pulse. As used herein, the term “amplitude” can refer to the instantaneous or continuous amplitude of one or more stimulus pulses (e.g., the instantaneous voltage or current level of a pulse). The term “pulse” as used herein can refer to a period of time during which stimulus energy is delivered relatively continuously. In some embodiments, the stimulus energy delivered during a pulse includes energy selected from the group consisting of: electrical energy; magnetic energy; electromagnetic energy; light energy; acoustic energy (such as ultrasonic energy); mechanical energy (such as vibrational energy); thermal energy (such as thermal or cryogenic energy); chemical energy; and combinations of one or more of these. In some embodiments, the stimulus energy includes electrical energy and the pulse includes a phase change in current and / or voltage. In these embodiments, a “phase gap” may exist within a single pulse. The term “phase gap” as used herein can refer to a period of time between two portions of a pulse that includes a phase change, during which zero or minimum energy is delivered. The term “quiescent period” as used herein can refer to a period of time during which zero or minimum energy is delivered (e.g., insufficient energy to elicit an action potential and / or other neuronal response). The term “inter-pulse gap” as used herein can refer to a quiescent period between the end of one pulse and the beginning of the next (sequential) pulse. The term “pulse train” or “train” as used in this article can refer to a series of pulses.The terms "burst," "burst of pulses," or "burst stimulation," when used herein, can refer to a series of pulses, each pulse being separated by a rest period. The term "series start-up period," when used herein, can refer to the time interval from the beginning of the first pulse of a single series to the end of the last pulse. The term "series close-up period," when used herein, can refer to the rest period between the end of one series and the beginning of the next. The term "burst start-up period," when used herein, can refer to the time interval from the beginning of the first pulse of the first series of a single burst to the end of the last pulse of the last series. The term "burst close-up period," when used herein, can refer to the rest period between the end of one burst and the beginning of the next burst. The term "inter-series period," when used herein, can refer to the rest period between the end of one series and the beginning of the next. The term "inter-burst period," when used herein, can refer to the rest period between the end of one burst and the beginning of the next. The term "series envelope," when used herein, can refer to a curve summarizing the extreme amplitude values ​​of a series of pulses in a series. The term "burst envelope," as used herein, can refer to a curve summarizing the amplitude extrema of a series of pulses in a burst. The term "series ramp duration," as used herein, can refer to the time from the start of a series until its series envelope reaches the desired target amplitude.

[0067] It should be understood that, for clarity, certain features of the invention described in the context of a single embodiment may also be provided in combination in a single embodiment. Conversely, for brevity, various features of the invention described in the context of a single embodiment may also be provided individually or in any suitable sub-combination. For example, it will be understood that all features set forth in any of the claims (whether independent or dependent claims) may be combined in any given manner.

[0068] This invention encompasses medical devices and clinical methods for treating patients, such as for treating pain. Patients may include human or other mammalian patients. Medical devices may include stimulation devices. Medical devices may include implantable systems and external systems. Implantable systems may include one or more similar and / or dissimilar implantable devices. Each implantable device includes a housing surrounding one or more stimulation-generating components. Leads including one or more stimulation elements may be pre-attached to the housing or may be attached to the housing (e.g., during a clinical procedure to implant the implantable device into a patient).

[0069] The device may include a test interface that provides energy to the stimulating element during the implantation procedure, such as to confirm proper placement of the stimulating element and / or titrate the delivered stimulation. In embodiments where the lead is pre-attached to the housing of the implantable device, the test interface may be configured to provide power (e.g., wireless power) to the implantable device, wherein the implantable device provides stimulating energy derived from the power provided by the test interface to the stimulating element. In embodiments where the lead is attachable to the housing of the implantable device, the test interface may be attached to the lead (before it is attached to the housing of the implantable device), and the test interface may then provide stimulating energy directly to the stimulating element.

[0070] In some embodiments, the implantable system includes: a first implantable device that delivers stimulation energy via energy wirelessly received from one or more external devices, and a second implantable device that delivers stimulation energy via an integrated (e.g., implanted) battery. In these embodiments, the first implantable device may be configured to deliver stimulation energy for a limited time period (e.g., a trial period in which stimulation settings and / or the acceptability of the device are determined), and the second implantable device may be configured to deliver stimulation energy for a longer period of time, providing long-term stimulation therapy 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 to the second implantable device. In some embodiments, the first implantable device may be configured to remain implanted in a patient for a limited time period, such as to reduce manufacturing costs, and the second implantable device may be configured for a longer implantation lifespan. The first implantable device may be used in trial procedures in which the stimulation device is evaluated and / or optimized or otherwise determined for acceptable use (e.g., by a patient and / or clinician).

[0071] Each implantable device may include one or more implantable antennas configured to receive power and / or data. Each implantable device may include an implantable receiver configured to receive power and / or data from one or more implantable antennas. Each implantable device may include one or more implantable functional elements (e.g., implantable stimulating elements). Implantable functional elements may be configured to dock with a patient (e.g., with the patient's tissue or at any patient location). Alternatively or additionally, implantable functional elements may dock with a portion of the implantable device (e.g., to measure implantable device parameters). In some embodiments, one or more implantable functional elements may include one or more transducers, electrodes, and / or other elements configured to deliver energy to tissue. Alternatively or additionally, one or more implantable functional elements may include one or more sensors, such as sensors configured to record physiological parameters of a patient. In some embodiments, one or more implantable functional elements are configured to record device information and / or patient information (e.g., patient physiological or patient environmental information).

[0072] Each implantable device may include an implantable controller configured to control (e.g., modulate power to, transmit signals to, and / or receive signals from) one or more implantable functional elements. In some embodiments, the implantable controller of a first implantable device is configured to control one or more other implantable devices. Each implantable device may include an implantable energy storage component configured to provide power to the implantable controller (e.g., a controller including a stimulation waveform generator), the implantable receiver, and / or one or more implantable functional elements. In some embodiments, the implantable energy storage component is further configured to provide power to a component transmitting signals via an implantable antenna (e.g., when the implantable device is further configured to transmit data to one or more external devices). Each implantable device may include 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 that is mechanically secured or attachable to an implantable housing and operatively connected (e.g., electrical, fluid, optical, and / or mechanical) to one or more components within the implantable housing. The implantable lead may be inserted (e.g., tunneled) through a patient's tissue such that one or more of its functional elements are positioned near the tissue to be treated and / or in an area where data is to be recorded. In some embodiments, the implantable lead is configured to operatively attach to and / or detach from multiple implantable devices.

[0073] The external system of the medical device of the present invention may include one or more similar and / or dissimilar external devices. Each external device may include one or more external antennas configured to transmit power and / or data to one or more implanted components of an implantable system. Each external device may include an external transmitter configured to drive one or more external antennas. Each external device may include an external power supply configured to provide power to at least the external transmitter. Each external device may include an external programmer configured to control the external transmitter and / or the implantable device (e.g., when the external power transmitter is not included in the device or is otherwise absent during use). Each external device may include an external housing that at least surrounds the external transmitter. In some embodiments, the external housing surrounds one or more external antennas, an external power supply, and / or an external programmer.

[0074] An external programmer may include a discrete controller separate from one or more external devices, and / or a controller integrated into one or more external devices. The external programmer may include 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 device of the present invention concept. In some embodiments, the external programmer is configured to collect and / or diagnose recorded patient information, such as providing the information and / or diagnosis to the patient's clinician, to the patient's family members, 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 device. 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 the patient's clinician.

[0075] In some embodiments, the medical device includes a stimulation device for activating, blocking, influencing, or otherwise stimulating (hereinafter “stimulate” or “stimulating”) a patient’s tissue, such as nerve tissue or nerve root tissue (hereinafter “nerve”, “nerves”, “nerve tissue”, or “nervous system tissue”). The stimulation device includes an external system configured to deliver electrical power, and an implanted system configured to receive electrical power from the external system and deliver stimulation energy to the tissue. The delivered stimulation energy may include one or more stimulation waveforms, such as stimulation waveforms configured to enhance treatment of pain while minimizing undesirable effects. The stimulation signal delivered by the implanted system (also referred to herein as “stimulation energy”) can be independent of the electrical power received from the external system, such as being independent of one or more of the following: 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 electrical power received from the external system; the amplitude of the electrical power received from the external system; the variation in the amplitude of the electrical power received from the external system; the duty cycle of the electrical power received from the external system; the envelope of the electrical power received from the external system; and a combination of one or more of these.

[0076] Now refer to Figure 1 A schematic anatomical view of a medical device for delivering therapy to a patient, consistent with the concepts of the present invention, is shown. Device 10 includes an implantable system 20 and an external system 50. The external system 50 transmits transmission signals to one or more components of the implantable system 20. These transmission signals may include power and / or data. The implantable system 20 includes one or more implantable devices, shown as implantable device 200, which can be implanted under the skin of a patient P.

[0077] In some embodiments, the implantable system 20 includes a plurality of similar or dissimilar implantable devices 200 (referred individually or collectively as implantable devices 200), such as those described in co-pending U.S. Patent Application Serial No. 17 / 372,095, filed July 9, 2021, entitled “Apparatus with Enhanced Stimulation Waveforms.” Each implantable device 200 may be configured to receive power and data from transmission signals transmitted by an external system 50, such as when stimulation energy delivered by the implantable device 200 to a patient (e.g., to the patient’s nerves or other tissues) is provided via wireless transmission signals from the external system 50. In some embodiments, the implantable system 20 includes at least two implantable devices, such as Figure 1 Implantable devices 200 and 200' are shown. Implantable device 200' may have a similar construction and arrangement to implantable device 200, and may include components with different configurations. Each implantable device 200 includes one or more housings (housing 210 shown) that surround various other components of device 200. Each implantable device 200 includes one or more stimulating and / or other functional elements, such as stimulating element 260 shown, wherein stimulating element 260 is configured to deliver stimulating energy, stimulating drugs or other agents, and / or another form of stimulation (e.g., another form of tissue stimulation) to a patient. In some embodiments, one or more stimulating elements 260 are further configured as sensors (e.g., when including electrodes configured to both deliver electrical energy and record electrical signals). Each implantable device 200 may include one or more leads (leads 265 shown), and each lead 265 may include one or more stimulating elements 260. Alternatively or additionally, one or more stimulating 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 the lead 265 to tissue, such as the anchor element 221 shown. The anchor element 221 may be configured to slidably receive the axis of the lead 265 (e.g., to position the anchor element 221 around the lead 265 during manufacturing and / or during implantation procedures). The 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 the recesses and into the tissue, such as to secure the anchor element 221 and the inserted lead 265 to the tissue.

[0078] Each implantable device 200 may include one or more other types of functional elements, such as functional element 299a shown positioned near housing 210 (e.g., within and / or on the outer surface of housing 210) and / or functional element 299b shown positioned on lead 265. Functional elements 299a and / or 299b (referred to individually or collectively as functional element 299) may include transducers, sensors, and / or other functional elements as described herein. In some embodiments, functional element 299 includes visual markers, such as radiopaque markers, ultrasound-visible markers, and / or magnetic markers.

[0079] External system 50 may include external device 500, wherein 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) that carry various other components of device 500 and, in some embodiments, surround various other components of device 500. In some embodiments, 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 includes a plurality of external devices 500 (referred to individually or collectively as external device 500), such as those described in co-pending U.S. Patent Application Serial No. 17 / 372,095, filed July 9, 2021, entitled “Apparatus with Enhanced Stimulation Waveforms.” In some embodiments, external system 50 includes at least two or at least three external devices (e.g., at least two external devices are configured to deliver power and / or data to one or more implantable devices 200), such as… Figure 1 External device 500, external device 500' and / or 500'' are shown in the diagram. External device 500' and / or 500'' may have a similar construction and arrangement to external device 500, and these devices may include components with different configurations.

[0080] External system 50 may include one or more programming devices, programmers 600, such as the patient programmer 600' and clinician programmer 600'' shown. The patient programmer 600' and clinician programmer 600'' (referred to individually or collectively as programmer 600) may each include a user interface, such as user interfaces 680' and 680'' shown (referred to individually or collectively as 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 more implantable devices 200 (e.g., when no external device 500 is included in device 10 or at least no external device 500 is available for communication with implantable device 200). Patient programmer 600' may be configured for use by a patient, patient caregiver (e.g., the patient's clinician), and / or the patient's family member.

[0081] The clinician programmer 600'' may have a similar construction and arrangement to the patient programmer 600'. In some embodiments, the clinician programmer 600'' provides additional functionality not available with the patient programmer 600'. In some embodiments, the clinician programmer 600'' may modify the programming of the patient programmer 600' (e.g., modify the programming options available to the patient or a family member of the patient).

[0082] The patient programmer 600' can be further configured as a smartphone, music playback device (e.g., an MP3 player), and / or other portable or non-portable electronic device. For example, the patient programmer 600' may include a smartphone or other commercial device on which the software program of device 10 is embedded to enable the commercial device to be used as the patient programmer 600'. The clinician programmer 600'' may include a tablet-like device. For example, the clinician programmer 600'' may include a commercial tablet device on which the software program of device 10 is embedded to enable the commercial tablet computer to be used as the clinician programmer 600''.

[0083] The clinician programmer 600'' can be configured with multiple (e.g., all) external devices 500 used by the patient, as well as the patient programmer 600', such that the group of devices is configured as a "trusted" network. Once this trust configuration is in place, the patient programmer 600' can communicate securely and efficiently with one or more of the patient's external devices 500. The patient programmer 600' can upload (e.g., automatically) configuration information (e.g., stimulation settings and the like) from the external devices 500. In some embodiments, the patient programmer 600'' and / or the clinician programmer 600'' upload configuration information from the external devices 500 whenever some information (e.g., stimulation information) on that external device 500 has changed (e.g., a change is detected by the programmer 600 or otherwise).

[0084] External system 50 may include one, two, three or more functional elements, such as functional elements 599a, 599b and / or 599c (referred to individually or collectively as functional element 599), shown as being located in external device 500, patient programmer 600' and clinician programmer 600'', respectively.

[0085] Device 10 may be configured to stimulate tissue (e.g., stimulate neural tissue, such as tissue of the central nervous system or tissue of the peripheral nervous system, such as neurally modulating neural tissue), such as by causing one or more implantable devices 200 to deliver and / or otherwise provide energy (hereinafter “deliver energy”) and / or deliver agents (e.g., pharmaceutical compounds or other agents) to one or more tissue sites, such as via one or more stimulation elements 260. In some embodiments, one or more implantable devices 200 deliver energy and / or agents 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 agents using energy provided by an internal power source (e.g., a battery and / or a capacitor), such as continuously or intermittently, without receiving externally supplied power, such as for at least 1 hour, at least 1 day, at least 1 month, or at least 1 year. In some embodiments, during this period, one or more stimulation parameters are varied (e.g., systematically and / or randomly).

[0086] In some embodiments, the device 10 is further configured as a patient diagnostic device, such as by enabling one or more implantable devices 200 to record patient parameters (e.g., patient physiological parameters) from one or more tissue locations, such as simultaneously receiving power and / or data from one or more external devices 500. In some embodiments, during its use, the one or more implantable devices 200 receive power from at least one or more external devices 500 (e.g., also receive data or do not receive data). Alternatively or additionally, one or more patient parameters may be recorded by external devices of the device 10, such as via programmer 600 and / or external devices 500.

[0087] Device 10 may be configured as a patient information recording device, such as by enabling one or more implantable devices 200 and / or one or more external devices 500 to record patient information (e.g., patient physiological information and / or patient environmental information). In some embodiments, one or more implantable devices 200 and / or one or more external devices 500 may further collect information (e.g., status information or configuration settings) of one or more components of device 10.

[0088] In some embodiments, device 10 is configured as a stimulation device, wherein an external system 50 transmits an electrical signal to one or more implantable devices 200, and the one or more implantable devices 200 deliver stimulation energy to tissue using a stimulation signal (also referred to as a stimulation waveform), wherein the electrical signal and the stimulation signal have one or more distinct characteristics (e.g., as described herein). The electrical signal may be modulated using data (e.g., configuration or other data to be sent to one or more implantable devices 200). In these embodiments, the characteristics of the delivered stimulation signal (e.g., amplitude, frequency, duty cycle, and / or pulse width) may be independent of (e.g., partially or completely independent of) the characteristics of the electrical signal transmission (e.g., amplitude, frequency, phase, envelope, duty cycle, and / or modulation). For example, the frequency and modulation of the electrical signal may be changed 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 changes or any alterations to the electrical signal. In some embodiments, the implantable system 20 is configured to rectify a received electrical signal and generate a stimulation waveform from the rectified electrical signal having entirely different characteristics (e.g., amplitude, frequency, and / or duty cycle). Each implantable device 200 may include an oscillator and / or controller configured to generate a stimulation signal. In some embodiments, one or more implantable devices 200 are configured to perform frequency multiplication, wherein multiple signals are multiplexed, mixed, added, and / or otherwise combined to generate a broadband stimulation signal.

[0089] In some embodiments, device 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 synchronization with the carrier and / or data symbol rate of the transmitted signal from external system 50. In some embodiments, the transmitted signal includes a power signal, and clock and / or data are recovered without synchronization with the power signal. In some embodiments, the transmitted signal includes a clock and / or data signal, and clock and / or data are recovered without synchronization with the transmitted clock and / or data signal. In some embodiments, the recovered signal includes clock and / or data, and clock and / or data are recovered from the transmitted signal without synchronization with the recovered clock and / or data. Avoiding synchronization reduces the power consumption of each implantable device 200, such as by eliminating the need for (and avoiding the power consumed by) frequency-locked loops (FLLs) that require synchronization; phase-locked loops (PLLs); high-frequency clocks; and / or crystal oscillators. Avoiding these components can also be associated with a reduced package size for each implantable device 200 (e.g., avoiding relatively large crystal oscillators). Asynchronous data transfer between the external system 50 and the implantable system 20 is also advantageous because it involves: increased communication data rates; power delivery efficiency; operation under more than one implantable device 200; and combinations of these. In some embodiments, one or more components of the device 10 are constructed and arranged similarly to those described in U.S. Patent Application Serial No. 13 / 591,188, filed August 21, 2012, entitled “Method of Making and Using an Apparatus for a Locomotive Micro-Implant using Active Electromagnetic Propulsion.” In some embodiments, the external system 50 and the implantable system 20 provide asynchronous data transfer or are otherwise configured as described in U.S. Patent Application Serial No. 13 / 734,772, filed January 4, 2013, entitled “Method and Apparatus for Efficient Communication with Implantable Devices.”

[0090] Device 10 can be configured to treat pain, such as back pain and / or limb pain, by stimulating the dorsal root ganglion and / or other nerves or locations in the spinal cord or other nervous system locations. In some embodiments, device 10 is configured to treat pain types selected from the group consisting of: back pain; joint pain; neuropathic pain; tennis elbow; muscle pain; shoulder pain; chronic, intractable pain in the back and / or limbs, including unilateral or bilateral pain; neurogenic groin pain; perineal pain; phantom limb pain; complex regional pain syndrome; back surgery failure syndrome; cluster headache; migraine; inflammatory pain; arthritis; abdominal pain; pelvic pain; and one or more combinations of these. The delivered energy may include 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 thermal energy and / or cryogenic energy; acoustic energy, such as ultrasonic energy (e.g., high-intensity focused ultrasound and / or low-intensity focused ultrasound) and / or subsonic acoustic energy; chemical energy; and combinations of one or more of these. In some embodiments, the device 10 is configured to deliver energy to tissue in the form of: electrical energy, such as by providing a controlled (e.g., constant or otherwise controlled) current and / or voltage to the tissue; magnetic energy (e.g., magnetic field energy), such as by applying a controlled current or voltage to a coil or other magnetic field generating element positioned near the tissue; and / or electromagnetic energy, such as by providing both a current and a magnetic field to the tissue. The coil or other magnetic field generating element may surround (e.g., at least partially surround) the target nerve. Alternatively or additionally, magnetic energy may be applied externally and focused onto a specific target tissue via an implant comprising a coil and / or ferromagnetic material. In some embodiments, magnetic energy is configured to induce the application of mechanical energy. The 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.

[0091] In some embodiments, the device 10 is configured to treat a patient condition or disorder selected from the group consisting of: chronic pain; acute pain; migraine; cluster headache; urge incontinence; pelvic dysfunction such as overactive bladder; fecal incontinence; bowel disorder; tremor; obsessive-compulsive disorder; depression; epilepsy; inflammation; tinnitus; hypertension; heart failure; carpal tunnel syndrome; sleep apnea; obstructive sleep apnea; dystonia; interstitial cystitis; gastroparesis; obesity; activity problems; arrhythmia; rheumatoid arthritis; dementia; Alzheimer's disease; eating disorders; addiction; traumatic brain injury; chronic angina; congestive heart failure; muscle atrophy; bone stunting; post-laminarectomy pain; liver disease; Crohn's disease; irritable bowel syndrome; erectile dysfunction; kidney disease; and one or more combinations of these.

[0092] As described above, external system 50 can be configured to deliver 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 of one or more external devices 500, such as antenna 540 shown) may include when stimulation delivery (e.g., energy delivery) is initiated, and / or when stimulation delivery is stopped, and / or may include data relating to the value or change in value of one or more stimulation variables as described above herein. Configuration data may include stimulation parameters, such as agent (e.g., drug agent) delivery stimulation parameters, 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. Configuration data may include sensing parameters, such as sensing parameters selected from a group consisting of: initiation of sensor recording; cessation of sensor recording; frequency of sensor recording; resolution of sensor recording; threshold of sensor 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.

[0093] As described above, the external system 50 may include one or more external devices 500. The external system 50 may include one or more antennas 540, such as when a single external device 500 includes one or more antennas 540, and / or when multiple external devices 500 each include one or more antennas 540. One or more antennas 540 may transmit power and / or data to one or more antennas 240 of the implantable system 20, such as when a single implantable device 200 includes one or more antennas 240, and / or when multiple implantable devices 200 each include 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 including one or more antennas 240). In some embodiments, a single external device 500 including 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 coverage area (e.g., a coverage area defining a volume, such as the volume of a tissue, wherein electromagnetic transmissions radiated by antenna 540 can be properly received by antenna 240), as described in U.S. Patent Application Serial No. 17 / 412,044 entitled “Medical Apparatus Including an Implantable System and An External System”, filed by the applicant on August 25, 2021.

[0094] External system 50 uses a transmission signal including at least one wavelength λ to transmit power and / or data. External system 50 and / or implantable system 20 may be configured such that the distance between external antenna 540 transmitting power and / or data and one or more implantable antennas 240 receiving power and / or data transmission signals is equal to between 0.1λ and 10.0λ, such as between 0.2λ and 2.0λ. In some embodiments, one or more transmission signals are transmitted by a transmitter (transmitter 530) in a frequency range between 10 MHz and 10.6 GHz (e.g., a predetermined frequency range), such as between 0.1 GHz and 10.6 GHz, between 10 MHz and 3.0 GHz, between 40 MHz and 1.5 GHz, between 10 MHz and 100 MHz, between 0.902 GHz and 0.928 GHz, in a frequency range close to 40.68 MHz, in a frequency range close to 866 MHz, or approximately between 863 MHz and 870 MHz. As another example, the frequency range (e.g., a predetermined frequency range) can be from about 1 MHz to about 100 MHz, such as from about 5 MHz to about 90 MHz, from about 10 MHz to about 80 MHz, from about 15 MHz to about 70 MHz, from about 20 MHz to about 60 MHz, from about 25 MHz to about 55 MHz, or from about 30 MHz to about 50 MHz. Transmitter 530 may include a transmitter that generates a transmission signal with a power level between 0.01 W and 4.0 W, such as a transmission signal with a power level between 0.01 W and 2.0 W or between 0.2 W and 1.0 W.

[0095] In addition to transmitting power and / or data to the implantable system 20, the external system 50 may be further configured to transmit power and / or data to one or more other components of the device 10 (such as...). Figure 1 The tool 60 shown and described in detail herein provides information (e.g., patient information and / or device 10 performance information).

[0096] One or more external devices 500 (referred to individually or collectively as external devices 500) may be configured to transmit power and / or data (e.g., configuration data of the implantable system 20) to one or more implantable devices 200 (referred to individually or collectively as implantable devices 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., data transmitted via one or more antennas 240 of one or more implantable devices 200). Each external device 500 may include a housing 510, a power supply 570, a transmitter 530, a controller 550, and / or one or more antennas 540, each in Figure 1 The external device 500 is shown in the diagram and described in detail herein. Each external device 500 may further include one or more functional elements 599a, such as functional elements including sensors, electrodes, energy delivery elements, magnetic field generating transducers, drug delivery elements, and / or any transducers, which are also described in detail herein. In some embodiments, the functional element 599a includes one or more sensors configured to monitor the performance of the external device 500 (e.g., to monitor the voltage of the power supply 570, the quality of power and / or data transmission to the implantable system 20, the temperature of a portion of the external device 500, and the like).

[0097] One or more housings 510 of each external device 500 (referred to individually or collectively as housings 510) may comprise one or more rigid and / or flexible materials that can support (e.g., enclose) various components of the external device 500, such as Figure 1The antenna 540, transmitter 530, controller 550, and / or power supply 570 are shown. In some embodiments, housing 510 may enclose or otherwise house one or more antennas (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 antennas (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 includes a plurality of discrete (i.e., separate) housings 510, two or more of which may each transmit data and / or other signals to another, to an implantable device 200, and / or to another component of device 10 via a wired or wireless connection. In some embodiments, housing 510 further surrounds programmer 600 (e.g., programmer 600' or 600'') and / or power supply 570. In some embodiments, housing 510 comprises both rigid and flexible materials. In some embodiments, housing 510 comprises materials selected from the group consisting of: plastics; injection-molded plastics; elastomers; metals; and combinations of one or more of these. In some embodiments, housing 510 includes a shielded portion (e.g., shielded to prevent the transmission of electromagnetic waves) and an unshielded portion, such as the unshielded portion surrounding antenna 540.

[0098] The housing 510 may include adhesive elements (e.g., spacer 511 as described herein, which is configured as an adhesive element), such as adhesive elements configured to temporarily attach the external device 500 to a patient's skin. Thus, in some embodiments, the external device 500 may be configured to be positioned on the patient's body, above an implantable device (e.g., implantable device 200). Alternatively or additionally, the housing 510 may be constructed and arranged to engage a patient attachment device (e.g., mounted in a pocket of a patient attachment device), such as the patient attachment device 70 described herein.

[0099] One or more antennas 540 (referred individually or collectively as antenna 540) may each include one, two, three, or more external antennas. Antenna 540 may include one or more polarizable antennas, such as one or more antennas with tunable polarization. Antenna 540 may include an array of antennas, such as an array of antennas configured to: support beamforming and / or focusing; allow adjustment of the amplitude and / or phase of the transmitted signal; increase the radiation coverage area; and combinations of one or more of these. The 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 the movement of the array of antennas 540 relative to the implanted antennas 240. Antenna 540 may include an array of selectable conductors configured to adjust the radiation pattern and / or electromagnetic field of the synthesized antenna. Antenna 540 may include a surface and a shielding material or shielding layer (not shown) positioned on the surface, such as when the shielding material is positioned on the side facing away from the patient's skin. The shielding material may include radio absorption shielding material and / or radio reflection shielding material. To enable antenna 540 to operate effectively at higher frequencies, the shielding material may include a ferrite material having low conductivity and low magnetic loss tangent at the frequency of interest, thereby achieving high permeability. For example, one or more shielding layers of antenna 540 may include one or both of conductive and ferromagnetic materials. By placing a material (such as high-frequency ferrite) with high permeability (μ'), low magnetic loss tangent (μ'' / μ'), and low conductivity at the operating frequency between the antenna and other components of the transmitter, losses or loading effects due to these components can be significantly reduced. For example, one or more shielding layers of antenna 540 may have a magnetic loss tangent of less than or equal to 0.025 in a predetermined frequency range (such as from about 30 MHz to about 50 MHz). In some cases, the magnetic field amplification of such a shielding layer will enhance overall performance. Furthermore, this layer shields the external environment from unwanted radiation from the antenna and protects the antenna from radiation originating from the environment. Additionally, one or more shielding layers may be configured to prevent coupling between multiple antennas of external device 500, such as coupling between a first antenna (e.g., antenna 540) and a second antenna (e.g., antenna 5711).

[0100] In some embodiments, a spacer layer is positioned between the antenna 540 and the shielding material. The spacer layer may include a thickness between 0 mm and 5 mm, such as between 0.25 mm and 1 mm. The spacer layer may include a non-conductive dielectric material, air, or other material that has minimal impact on antenna performance. The spacer layer may also be incorporated into the plate thickness, wherein the antenna is constructed on the opposite side of the plate relative to the shielding layer. The shielding layer may include ferrite materials as described above, or any material having the desired permeability, magnetic loss, and conductivity at the frequencies of interest. The thickness of the shielding layer may depend on its specific material properties and application. In some embodiments, conductive layers on the sides of the shielding layer are positioned opposite the antenna to further shield unwanted radiation. To reduce weight, the shielding material may be porous or incorporated with holes or slots spaced apart in a certain way to minimize performance degradation. The holes and spacing may be sized to be smaller than the wavelength of the RF signal. If no spacer 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 due to field amplification effects. In some embodiments, the shielding layer is configured to increase the directivity of the antenna or focus electromagnetic energy.

[0101] One or more antennas 540 may be positioned in a housing 510 that does not contain other components (e.g., power supply 570, controller 550, and / or transmitter 530), such as when the antenna 540 is positioned within the first housing 510 and communicates with components positioned in the second housing 510.

[0102] In some embodiments, one or more spacers (spacer 511 shown) are positioned between the antenna 540 and the patient's skin, such as spacers including a thickened portion of the housing 510 or discrete spacers 511 placed on one side of the housing 510 (as shown) or on one side of the antenna 540. Spacer 511 may include one or more materials that match the impedance of the antenna 540 to the impedance of the patient's tissue. Spacer 511 may include a thickness between 0.1 cm and 3 cm, such as between 0.2 cm and 1.5 cm. Spacer 511 may include a thermally insulating material (e.g., spacer 511 comprising a thermally insulating material). Alternatively or additionally, the housing 510 may include thermally insulating and / or heat-dissipating materials. Spacer 511 may include a soft or otherwise compressible material (e.g., foam) for patient comfort. Spacer 511 may be inflatable, such as to control the separation distance between the external antenna 540 and the patient's skin. The inflatable spacer 511 can be divided into multiple sections with independent controlled air pressure or volume to adjust the separation distance between the external antenna 540 and the patient's skin and / or its angle relative to the tissue surface (e.g., tilt).

[0103] In some embodiments, antenna 540 includes a multi-feed point antenna, such as a multi-feed point antenna configured to: support beamforming and / or focusing; allow modification of the amplitude and / or phase of the transmitted signal; increase the radiation coverage area; or a combination of one or more of these.

[0104] In some embodiments, antenna 540 includes one or more antennas selected from the group consisting of: patch antennas; slot antennas; arrays of antennas; loop antennas (e.g., concentric loop antennas); antennas loaded with reactive elements; dipole antennas; polarizable antennas; optional conductors forming the antenna; and combinations of one or more of these.

[0105] Antenna 540 may include a long axis between 1 cm and 10 cm, such as a long axis between 2 cm and 5 cm, and / or a long axis of approximately 4 cm. Antenna 540 may be further configured to receive signals, such as when antenna 240 is configured to transmit data to external device 500. Antenna 540 may be positioned (e.g., manufactured onto) a substrate, such as a flexible printed circuit board or other printed circuit board (e.g., a single-layer or multi-layer printed circuit board including traces of connecting components).

[0106] One or more antennas 540 may include multi-turn spiral loop antennas, such as multi-turn spiral loop antennas configured to desensitize coupling sensitivity and / or boost input voltage. In some embodiments, one or more antennas 540 include multiple concentric loops of various sizes, 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 capacitors, inductors, transformers, and combinations thereof; and / or driven from multiple feed points.

[0107] In some embodiments, one or more external devices 500 include multiple antennas, such as a first antenna 540 and a second antenna 540. In these embodiments, the first antenna 540 may be similar to or dissimilar to the second antenna 540. In some embodiments, the first antenna 540 and the dissimilar second antenna 540 are located within a single external device 500 (e.g., within a housing 510). In other embodiments, the first antenna 540 is located in a first external device 500, and the dissimilar second antenna 540 is located in a second external device 500. The similarity or dissimilarity of the antennas can be configured to enhance one or more design and / or performance parameters selected from the group consisting of: the operating depth of the implantable device 200; polarization; power efficiency; radiation coverage area; directional gain; beamforming and / or focusing; sensitivity to placement of the implantable device 200; patient comfort; patient usability; data transmission; and combinations of one or more of these. In some embodiments, the first antenna 540 is optimized for design parameters different from those of the second antenna 540, and each antenna 540 may be activated independently or simultaneously to achieve both benefits. In some embodiments, the first antenna 540 is similar to the second antenna 540 and is placed in an array to increase the radiation coverage area or is placed in different external locations to operate together with multiple implantable devices 200 implanted at different sites.

[0108] 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, the first antenna 540 and the second antenna 540 transmit power and / or data to one or more antennas 240, with the transmissions performed simultaneously or sequentially. In sequential power and / or data transmission, a first external device 500 including one or more first antennas 540 may be replaced (e.g., swapped) with a second external device 500 including one or more second antennas 540. Alternatively or additionally, sequential power and / or data transmission may be initiated by one or more of the following conditions: when the first external antenna 540 moves (e.g., relative to the implanted antenna 240); when the second external device 500 including the second antenna 540 is turned on or otherwise activated; when the second antenna 540 provides improved power and / or data transmission to the antenna 240 compared to the power and / or data transmission provided by the first antenna 540; and / or when the power received from the first antenna 540 decreases (e.g., decreases below a threshold). In some embodiments, antenna 240 receives power from both first antenna 540 and second antenna 540, but only receives data from the first antenna 540. In some embodiments, the first antenna (e.g., antenna 240 or antenna 540) is driven with a carrier signal different from that of the second antenna (e.g., antenna 240 or antenna 540). The two carrier signals may include differences in amplitude and / or relative phase compared to each other. Each carrier signal may include a data transmission signal (e.g., data to be transmitted from external device 500 to implantable device 200 or from implantable device 200 to external device 500).

[0109] External device 500 may include an electronic module (controller 550 shown) configured to control one or more other components of external device 500.

[0110] One or more transmitters 530 (individually or collectively referred to as external transmitters 530) may each include one or more external transmitters driving one or more antennas 540 (e.g., one or more antennas 540 positioned in a single external device 500 or multiple external devices 500). A transmitter 530 is operatively attached to an antenna 540 and configured to provide one or more drive signals to the antenna 540, such as one or more power signals and / or data signals transmitted to one or more implantable devices 200 of the implantable system 20. A transmitter 530 may be configured to perform multilevel amplitude shift keying (APS). APS 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.

[0111] 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 data transmissions generated by transmitter 530 and transmitted to one or more antennas 540. In some embodiments, transmitter 530 is configured to perform data modulation including amplitude shift keying (APS) and pulse width modulation (PWM). In these embodiments, the transmitter may be configured to perform multilevel APS. APS may be configured to provide adjustable depth modulation between 0 and 100%, such as between 5% and 75%, or such as between 10% and 50%. In some embodiments, one or more external devices 500 use time division multiple access (TDMA) to transmit data to one or more implantable devices 200. In some embodiments, one or more implantable devices 200 are independently addressable by a unique identifier (ID) code. Alternatively or additionally, transmitter 530 may be configured to transmit one or more data signals with bandwidths between 1 kHz and 100 MHz, between 0.1 MHz and 100 MHz, or between 1 MHz and 26 MHz.

[0112] As described herein, one or more external devices 500 may be configured to deliver power to one or more implantable devices 200, such as via power transmission generated 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 delivered to one or more implantable devices 200, such as by modifying one or more duty cycle parameters. In these embodiments, the delivered power may be modified to: set power delivery based on the stimulation level generated by the implantable system 20; prevent oversaturation; reduce interference with data transmission of the implantable system 20 (e.g., when one or more implantable devices 200 are further configured to transmit data to external system 50); set power delivery based on charging and / or discharging information associated with the implantable device 200 (e.g., the charging rate and / or discharging rate of the implantable energy storage component 270 described herein); and combinations of one or more of these. In some embodiments, the implantable system 20 includes a first receiver 230 (e.g., the first receiver 230 of the first implantable device 200) and a second receiver 230 (e.g., the second receiver 230 of the 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 differentiated, such as to prevent oversaturation.

[0113] In some embodiments, the transmitter 530 (and / or another component of the external system 50) is further configured as a receiver (e.g., may further include a receiver in addition to the transmitter, or include a transmitter that further functions as a receiver), such as to receive data from the implantable system 20. For example, the transmitter 530 may be configured to receive data via one or more antennas 240 of one or more implantable devices 200. The received data may include patient information (e.g., patient physiological information, patient environmental information, or other patient information) and / or information related to parameters of the implantable system 20 (e.g., stimulation parameters of the implantable device 200 and / or other configuration parameters as described herein).

[0114] In some embodiments, transmitter 530 includes a first transmitter that transmits power and / or data to one or more implantable devices 200, and a second transmitter that transmits data to different devices, as described herein. In these embodiments, the second transmitter of transmitter 530 may be configured to transmit data to tool 60 or another device, such as programmer 600; mobile phone; computer; tablet computer; computer network, such as the Internet or LAN; and combinations of one or more of these. In some embodiments, the second transmitter of transmitter 530 includes a wireless transmitter; a Bluetooth transmitter; a cellular transmitter; and combinations of one or more of these. In some embodiments, functional element 599 includes a transmitter such as a Bluetooth transmitter.

[0115] Each power source 570 (individually or collectively referred to as power source 570) may be operatively attached to transmitter 530 and one or more other electrical components of each external device 500. Power source 570 may include power and / or energy storage elements selected from the group consisting of: batteries; replaceable batteries (e.g., via a battery gate of housing 510); rechargeable batteries; AC power converters; capacitors; and combinations of one or more of these. In some embodiments, power source 570 includes two or more batteries, such as two or more rechargeable batteries, such as to allow a first battery to be replaced by a second battery (e.g., series replacement) (e.g., external device 500 may operate using a single battery). In some embodiments, power source 570 is configured to provide a voltage of at least 3V. In some embodiments, power source 570 is configured to provide a capacity between 1 watt-hour and 75 watt-hours, such as a battery or capacitor with a capacity of approximately 5 watt-hours. In some embodiments, power source 570 includes AC power. Power source 570 may include voltage and / or current control circuitry. Alternatively or additionally, the power source 570 may include charging circuitry, such as circuitry configured to interface a rechargeable battery with an external charging device. In some embodiments, the device 10 includes one or more charging devices (charger 61 shown) that can be configured to recharge components of the device 10, such as to recharge the power source 570 of one or more external devices 500. In some embodiments, the charger 61 includes one or more electrical contacts configured to be electrically connected to one or more electrical contacts of the external device 500, such as to deliver charging energy to the power source 570.

[0116] Each external device 500 may include one or more user interface components (user interface 580 shown), such as those for allowing a patient or other user to input, adjust, and / or otherwise modify (“enter,” “adjust,” and / or “modify” herein) one or more parameters of device 10 (e.g., one or more stimulation parameters of device 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 waterproof barrier.

[0117] Each patient programmer 600' or clinician programmer 600'' (referred to individually or collectively as programmer 600) includes a programming device configured as one or more components of control device 10. Programmer 600 may include a user interface 680. Programmer 600 may transmit commands to and / or receive commands from one or more external devices 500 via a wireless or wired connection (not shown but such as a wired connection with one or more insulated conductive wires). In some embodiments, one or more external devices 500 include all or part of programmer 600, such as when all or part of user interface 680 is integrated into housing 510 of external device 500. In some embodiments, device 10 includes multiple programmers 600, such as one or more patient programmers 600' and / or one or more clinician programmers 600''.

[0118] The programmer 600 may be configured to modify one or more parameters of the device 10, such as stimulation parameters (e.g., stimulation waveform parameters as described herein); sensing parameters; therapeutic parameters; data recording parameters (e.g., patient data recording parameters and / or implantable device 200 data recording parameters); power delivery; data rate; activity of one or more external transmitters 530; activity of one or more external antennas 540; stimulation element 260 parameters; functional element 299 and / or 599 parameters; and combinations of one or more of these, as described above herein. The programmer 600 may be further configured to provide information such as patient physiological information recorded by the device 10 (e.g., by one or more implantable devices 200 and / or one or more external devices 500), or device 10 information such as performance and / or configuration information of one or more components of the device 10 (e.g., one or more external devices 500 and / or implantable device 200) (referred to individually or collectively as “status information”). In some embodiments, the programmer 600 uses information recorded by one or more implantable devices 200, device 10 information, and / or information from external devices 500 to adjust configuration parameters of one or more components of the device 10.

[0119] In some embodiments, the programmer 600 is configured to confirm that sufficient power delivery and / or sufficient data transfer has occurred between one or more external devices 500 and one or more implantable devices 200. In these embodiments, the programmer 600 may include the diagnostic component 62 described herein, or may be otherwise configured to detect one or more of the following: power delivery to the implantable system 20 (e.g., to detect power delivery to the implantable system 20 below a threshold); power delivery to the implantable system 20 tending in an undesirable direction; improper and / or insufficient data transfer to the implantable system 20; and combinations of one or more of these. In some embodiments, the programmer 600 monitors power delivery in real time and modifies power delivery accordingly to optimize the rectifier efficiency (e.g., the efficiency of rectifier 232 described herein) of one or more implantable devices 200. In some embodiments, the device 10 may be configured to modify (e.g., in real time) the power transmission from one or more external devices 500 of the external system 50 to one or more implantable devices 200 of the implantable system 20, such as to optimize or otherwise improve the efficiency of the device 10, such as to improve the efficiency of transmission between the external devices 500 and the implantable devices 200. These modifications may include modifications to one or more of the following: power transmission amplitude, duty cycle, frequency, phase, and periodicity.

[0120] In some embodiments, the programmer 600 and / or another component of the device 10 includes a matching network configured to match the impedance of one or more antennas 540 to one or more transmitters 530. The matching network may include an adjustable matching network. The matching network may include a directional coupler configured to measure the reflection coefficient. The transmitter 530 may include an output, and the programmer 600 may be configured to monitor the standing wave pattern at the output of the transmitter 530.

[0121] In some embodiments, programmer 600 includes a lookup table of stimulation signal waveform patterns, such as to allow a clinician, patient, and / or other operator (“user” or “operator” herein) of device 10 to view and / or select predetermined stimulation patterns (e.g., using user interface 680). In some embodiments, programmer 600 includes a set of adjustable stimulation signal parameters configured to be changed to allow the operator to construct custom waveforms, such as by changing one or more stimulation parameters described above herein. In some embodiments, programmer 600 is configured to allow the operator to create custom waveforms by specifying the amplitude of one or more discrete pulses or steps of the stimulation signal. In some embodiments, clinician programmer 600 may include stimulation waveform customization options not provided by patient programmer 600.

[0122] In some embodiments, programmer 600 includes a transmitter configured to transmit data to tool 60 or another device, such as a mobile phone; a computer; a tablet computer; a computer network such as the Internet or a LAN; and combinations of one or more of these. In these embodiments, programmer 600 may include a wireless transmitter; a Bluetooth transmitter; a cellular transmitter; and combinations of one or more of these. In some embodiments, programmer 600 includes a receiver configured to receive data, or a transceiver configured to both transmit and receive data.

[0123] The user interface 680 of the programmer 600 may include one or more user input components and / or user output components, such as components selected from the group consisting of: keyboard; mouse; keypad; switch; membrane switch; touch screen; display; audio transducer such as speaker or buzzer; vibration transducer; light such as LED; and combinations of one or more of these.

[0124] In some embodiments, one or more components of the external system 50 and / or other external components of the device 10, including one or more functional elements 599, such as functional elements 599a, 599b and / or 599c, are shown as being positioned within the external device 500, programmer 600', and programmer 600'', respectively. Each functional element 599 may include functional elements as defined herein (e.g., sensors, transducers and / or other functional elements as described herein). In some embodiments, the functional element 599 includes a needle, catheter (e.g., the distal portion of a catheter), iontophoresis element, or porous membrane, such as a drug delivery element, configured to deliver one or more drugs contained within the external device 500 and delivered into the patient's body (e.g., into subcutaneous tissue, muscle tissue and / or blood vessels, such as veins) (e.g., one or more drugs in a reservoir, such as reservoir 525 as described herein).

[0125] In some embodiments, the functional element 599 includes electrodes for sensing electrical activity and / or delivering electrical energy. In some embodiments, the device 10 is configured to induce random resonance, and the addition of white noise can enhance the sensitivity of the nerve to be stimulated and / or amplify weak signals to be recorded by one or more stimulation elements 260.

[0126] In some embodiments, one or more functional elements 599 include sensors, such as sensors configured to record data relating to patient parameters (e.g., patient physiological parameters), external system 50 parameters, and / or implantable system 20 parameters. In some embodiments, the operation of one or more implantable devices 200 (e.g., stimulation energy delivered by one or more implantable devices 200) is configured to be based on data recorded by one or more sensor-based functional elements 599, such as in a closed-loop energy delivery mode.

[0127] Functional element 599 may include one or more sensors configured to record data about patient parameters selected from the group consisting of: blood glucose; blood pressure; EKG; heart rate; cardiac output; oxygen level; pH level; blood pH; body fluid pH; tissue temperature; inflammation level; bacterial level; type of bacteria present; gas level; blood gas level; neural activity; nerve spikes; nerve spike shape; action potential; local field potential (LFP); EEG; muscle activity (e.g., as measured using electromyography (EMG)); electrical activity generated by skeletal muscle (e.g., as measured using EMG); stomach volume; peristalsis rate; impedance; tissue impedance; electrode-tissue interface impedance; body activity level; pain level; body positioning; body movement; organ movement; respiratory rate; respiratory level; sweating rate; sleep level; sleep cycle; digestive status; digestive level; urine production; urine flow; intestinal motility; tremor; ion concentration; chemical concentration; hormone level; body fluid viscosity; patient hydration level; and combinations of one or more of these.

[0128] Functional element 599 may include one or more sensors configured to record data representing parameters of any component of external system 50 or device 10. Functional element 599 may include one or more sensors selected from the group consisting of: energy sensors; voltage sensors; current sensors; temperature sensors (e.g., temperature of one or more components of external device 500 or programmer 600); antenna matching and / or mismatch evaluation sensors; power delivery sensors; link gain sensors; power usage sensors; energy level sensors; energy charge rate sensors; energy discharge rate sensors; impedance sensors; load impedance sensors; instantaneous power usage sensors; average power usage sensors; bit error rate sensors; signal integrity sensors; and combinations of one or more of these. Device 10 may be configured to analyze (e.g., via controller 250 as described herein) data recorded by functional element 599 to evaluate one or more of the following: power delivery; link gain; power usage; energy within power supply 570; performance of power supply 570; expected lifetime 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.

[0129] In some embodiments, one or more functional elements 599 are positioned on the housing 510. Functional elements 599 may include body conduction sensors, such as those configured to record and / or receive data via skin conduction. Functional elements 599 may be configured to record data associated with stimulation delivered by one or more implantable devices 200 (e.g., data associated with stimulation energy delivered by one or more stimulation elements 260), such as to provide closed-loop or semi-closed-loop stimulation. Functional elements 599 may be configured to record temperature, such as when the device 10 is configured to deactivate or otherwise modify the performance of the external device 500 when the recorded temperature (e.g., patient temperature and / or external device 500 temperature) exceeds a threshold.

[0130] In some embodiments, the external device 500 (programmer 600' and / or programmer 600'') includes a temperature sensor, such as when functional elements 599a, 599b, and / or 599c each include a temperature sensor. The temperature-based functional element 599 may be positioned near a portion of the programmer 600, housing 510, and / or one or more antennas 540 (e.g., to measure the temperature of one or more portions of the 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 the following: the matching network; the stimulation level (e.g., the stimulation energy delivered by one or more implantable devices 200); the power transmission level (e.g., the 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-based functional element 599 is part of a safety mechanism that disables the programmer 600 and / or external device 500 if the recorded temperature exceeds a threshold. Alternatively or additionally, the temperature sensor-based functional element 599 may be configured to measure the patient’s temperature, such as when placed on the housing 510, to modify the energy and / or drug delivery performed by the implantable device 200, such as based on the recorded patient temperature.

[0131] In some embodiments, the external device 500 (programmer 600' and / or programmer 600'') includes an accelerometer, vibration sensor, and / or other motion or impact sensor, such as when functional elements 599a, 599b, and / or 599c include sensors of this type. In these embodiments, functional element 599 may include a sensor configured to generate a signal for detecting when the external device 500 (programmer 600' and / or programmer 600'') is dropped, and to assess the force generated during the drop. Alternatively or additionally, this sensor may be configured to generate a signal configured to detect a tap on the device (e.g., on the housing), such that a tap gesture can be used in place of controls on the device (e.g., a discrete switch).

[0132] As described above, the implantable system 20 includes one or more implantable devices 200, such as one or more implantable devices 200 that are aseptically provided or configured to be sterilized for implantation in a patient. The first implantable device 200 may have a similar or dissimilar construction and arrangement to the second implantable device 200'. Each implantable device 200 may be configured to treat a patient (e.g., treat the patient's pain) and / or record patient information, such as by delivering energy and / or medication to tissues and / or by recording one or more physiological parameters of the patient (e.g., parameters of the patient's tissues).

[0133] One or more portions of the implantable device 200 or other components of the implantable system 20 may be configured to be visualized or to include visualized portions or other visualized elements, such as the visualized element 222 shown. The visualized element 222 may include materials selected from the group consisting of radiopaque materials; ultrasound-reflective materials; magnetic materials; and combinations of one or more of these. In these embodiments, each implantable device 200 (e.g., at least a portion of the device 200, such as the stimulating element 260, lead 265, and / or housing 210) may be visualized via an imaging device (e.g., the imaging device 40 described herein), such as CT, X-ray, fluorescence microscope, ultrasound imager, and / or MRI.

[0134] In some embodiments, the implantable system 20 includes a plurality of implantable devices 200 (e.g. Figure 1 The implantable device 200 and implantable device 200' are shown, and the implantable system 20 includes a "multi-point ready" system in which the operation of multiple implantable devices 200 (e.g., energy delivery, drug delivery, data logging and / or other functions) is performed simultaneously, asynchronously and / or sequentially. Implantable device 200 may include one or more external devices 500 (e.g., Figure 1 As part of a network of external devices 500 and 500' (shown), patient treatment and / or recording of patient information depend on the operation of implantable devices 200 at one or more implantation sites in a synchronous, asynchronous, and / or otherwise coordinated manner. This synchronization or other coordination may be controlled by a single external device 500 and / or by multiple external devices 500, which may be further synchronized (e.g., to a single clock). Each implantable device 200 of the implantable system 20 may receive electrical signals and / or data signals from one or more external devices 500. In some embodiments of the multi-point ready implantable system 20, each implantable device 200 includes a unique ID, such that each implantable device 200 is individually addressed (e.g., receives a unique signal from external system 50). In some embodiments, external system 50 transmits high-bandwidth signals to implantable system 20, enabling time-domain multiplexing communication while operating in near real-time. In some embodiments, implantable system 20 is configured as a multi-point ready system such that the stimulation energy delivered by implantable system 20 is independent of the electrical power received by implantable system 20 from external system 50.

[0135] 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 close to the implanted first implantable device 200, and a second external device 500 is positioned on or near the patient's skin at a location close to the implanted second implantable device 200 (typically "on" the patient's skin). 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.

[0136] Each implantable device 200 may include one or more stimulating elements 260 configured to stimulate a patient, deliver energy to a patient, deliver medication to a patient, record information from a patient, and / or otherwise interface with a patient. Alternatively or additionally, one or more stimulating elements 260 may be configured as sensors, such as for recording patient information. Each implantable device 200 may include a housing 210, a receiver 230, a controller 250, an energy storage assembly 270, and / or one or more antennas 240, each described in detail herein. Each stimulating element 260 may include a sensor and / or any transducer, as described in detail herein. One or more stimulating elements 260 may be positioned on leads (leads 265 shown) (e.g., flexible filaments including wires or other conductors connecting each stimulating element 260 to electronics within the housing 210). Each implantable device 200 may include 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 include one or more other functional elements, such as functional elements 299a and 299b described herein. Each implantable device 200 may further include one or more anchoring or other fixation elements (anchor element 223 shown), as described in detail herein.

[0137] In some embodiments, one or more implantable devices 200 are further configured to transmit data to one or more external devices 500, such as transmitting signals to one or more antennas 540 via one or more antennas 240, or otherwise. The data transmitted by the implantable device 200 may include patient information (e.g., patient physiological information recorded by one or more stimulation elements 260 configured as physiological sensors), or implantable device 200 information (e.g., data recorded by one or more stimulation elements 260 configured as sensors and positioned in the implantable device 200, or other implantable device 200 configuration and / or performance data).

[0138] The housing 210 of each implantable device 200 may include one or more rigid and / or flexible materials that surround various components, such as... Figure 1 The antenna 240, energy storage assembly 270, controller 250, and / or receiver 230 are shown. In some embodiments, one or more stimulation elements 260 are positioned within, on, and / or within the housing 210. In some embodiments, the housing 210 surrounds a substrate, such as a flexible and / or foldable printed circuit board, such as a plurality of discrete or continuous printed circuit boards positioned in different planes (e.g., flexible or foldable printed circuit boards). In some embodiments, one or more antennas 240 and / or other components (e.g., functional element 299) are positioned outside the housing 210, such as when at least one antenna 240 or other component is operatively connected via a tether including one or more electrical conduits to one or more components (e.g., electrical components) positioned within the housing 210.

[0139] The housing 210 may include one or more shapes or combinations of shapes, such as shapes selected from the group consisting of: discs; spheres; cylinders; spheres; flattened spheres; disc-shaped shapes; bowl-shaped shapes; cones; rectangular prisms; trapezoidal prisms; portions of tori; and combinations of one or more of these.

[0140] The housing 210 may include a major axis and a minor axis, as defined above. In some embodiments, the housing 210 includes a major axis less than or equal to 20 mm, such as a major axis less than or equal to 15 mm, 12 mm, or 10 mm. In some embodiments, the housing 210 includes a minor axis less than or equal to 8 mm, such as a minor axis less than or equal to 6 mm or 5 mm. The housing 210 may include a wall thickness between 0.1 mm and 1.0 mm, such as a wall thickness between 0.2 mm and 0.5 mm, such as a wall thickness of about 0.3 mm. The housing 210 may include a wall thickness less than or equal to 2000 mm. 3 The displacement volume, such as less than or equal to 600 mm 3 .

[0141] The housing 210 may include one or more portions that transmit radio frequency (RF) signals. In some embodiments, the housing 210 comprises glass. In some embodiments, the housing 210 comprises a material selected from the group consisting of: glass; ceramic; stainless steel; titanium; polyurethane; organic compounds; liquid crystal polymers (LCPs); gold; platinum; platinum-iridium; tungsten; epoxy resin; thermoplastic; thermosetting plastic; and combinations of one or more of these. In some embodiments, one or more portions of the housing 210 include one or more coatings, such as one or more coatings configured to induce or prevent physiological responses and / or coatings configured to block (e.g., shield) electromagnetic transmission.

[0142] Housing 210 may include one or more channels or other feeders, such as for allowing leads, wires, optical fibers, fluid delivery tubes, mechanical links and / or other conduits to pass through the walls of housing 210, as described in U.S. Patent Application Serial No. 17 / 412,044 entitled “Medical Apparatus Including an Implantable System and an External System”, filed August 25, 2021 by the applicant.

[0143] In some embodiments, one or more inner or outer surfaces (or portions thereof) of housing 210 include insulating and / or shielding layers (e.g., conductive electromagnetic shielding layers), such as the inner coating 219a and / or outer coating 219b shown (referred to individually or collectively as coating 219). Coating 219 may include electrically insulating and / or thermally insulating layers or other coatings. In some embodiments, one or more portions of housing 210 include an electrically shielding coating (coating 219), while other portions are transmissive to electromagnetic signals such as radio frequency signals.

[0144] In some embodiments, housing 210 includes a feedthrough array, not shown. In some embodiments, housing 210 is surrounded by a covering (e.g., partially or completely surrounded), such as a flexible and / or non-conductive covering, such as a covering made of an elastomer.

[0145] In some embodiments, another component of the implantable device 200 and / or device 10 may include one or more features to prevent or at least reduce migration of the implant 200 within the patient's body. In some embodiments, one or more implantable devices 200 include one or more anchor elements configured to secure one or more portions of the implantable device 200 to tissue (e.g., anchor elements 223 described above herein and / or anchor elements positioned in an overmolded portion surrounding a portion of the housing 210). Anchor element 223 may include one or more anchoring elements selected from the group consisting of: cannulas, such as silicone cannulas; suture pieces; suture holes; bone anchors; suture loops; porous mesh; permeable wings; permeable tongues; bone screw holes; pincers; clamps; suture slits; and combinations of one or more of these. Although anchor element 223 is shown approaching housing 210 (e.g., to securely attach housing 210 to tissue), in some embodiments anchor element 223 surrounds or otherwise approaches lead 265 (e.g., to securely attach lead 265 to tissue). In some embodiments, anchor element 223 includes a porous mesh surrounding all or a portion of housing 210. The porous mesh may be configured to promote tissue inward growth to prevent or at least limit (“prevent”) migration of housing 210, such as when implantable device 200 is implanted in a patient. In some embodiments, anchor element 223 includes a mesh attached to the top side (the side closest to the patient’s skin) of implantable device 200 to prevent housing 210 from migrating away from the patient’s skin (e.g., to prevent deeper migration into the patient).

[0146] One or more antennas 240 (individually or collectively referred to as antennas 240) may be configured to receive power and / or data, and receiver 230 may receive power and / or data from one or more antennas 240. Each antenna 240 may include one or more implantable antennas, such as one or more antennas positioned within housing 210, and / or one or more antennas electrically attached to a connecting wire. In some embodiments, one or more implantable devices 200 include at least two antennas 240, or at least three antennas 240. Antennas 240 may be configured to receive power and / or data from one or more external devices 500, such that the attached receiver 230 receives power and / or data. In some embodiments, implantable system 20 includes at least two implantable devices 200, each of which includes one or more (e.g., two or three) antennas 240 positioned within housing 210 and / or electrically tethered to housing 210. In some embodiments, implantable device 200 includes a first antenna 240 positioned in a first plane and a second antenna 240 positioned in a second plane. The first and second planes can be relatively orthogonal planes, or planes oriented relative to each other between 30° and 90°, such as between 40° and 90°, approximately 30°, approximately 45°, and / or approximately 60°. In some embodiments, the implantable device 200 includes a first antenna 240 positioned in the first plane, a second antenna 240 positioned in the second plane, and a third antenna 240 positioned in the third plane.

[0147] In some embodiments, the implantable device 200 includes 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 including rigid and hinged portions). In some embodiments, the substrate is folded or otherwise pivoted to position various antennas 240 on planes with different orientations, 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 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 at approximately 45°, 60°, or 90° relative to each other.

[0148] The implantable device 200 may include three antennas 240. In some embodiments, the first antenna 240 includes an electric dipole antenna, and the second and third antennas 240 may be positioned in a different plane from the first antenna 240. In some embodiments, each of the three antennas 240 includes a loop antenna, such as when each loop antenna is positioned in a different plane. In some embodiments, the first antenna 240 includes an electric dipole antenna, and the second and third antennas 240 each include a loop antenna. In these embodiments, the second and third antennas 240 may be positioned relatively orthogonally to each other (e.g., positioned in two relatively orthogonal planes). In some embodiments, the first antenna (e.g., an electric dipole antenna) is positioned outside the housing 210, while the second antenna (e.g., a loop antenna) and the third antenna (e.g., a loop antenna) are each positioned on, in, and / or within the housing 210. In some embodiments, the implantable device 200 includes one or more antennas 240, wherein any combination of antenna types (as described herein) is used in combination.

[0149] One or more antennas 240 may include an antenna selected from the group consisting of: a loop antenna; a multi-turn loop antenna; a planar loop antenna; a coil antenna; a dipole antenna; an electric dipole antenna; a magnetic dipole antenna; a patch antenna; a loaded dipole antenna; a concentric loop antenna; a loop antenna with a ferrite core; and combinations of one or more of these. One or more antennas 240 may include a loop antenna, such as an elongated loop antenna or a multi-turn loop antenna.

[0150] One or more antennas 240 may include multi-turn spiral loop antennas, such as multi-turn spiral loop antennas configured to desensitize coupling sensitivity and / or boost input voltage. In some embodiments, one or more antennas 240 include multiple concentric loops of different sizes, 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 capacitors, inductors, transformers, and combinations thereof; and / or driven from multiple feed points.

[0151] One or more antennas 240 may include a short axis and a long axis. In some embodiments, one or more antennas 240 include a short axis between 1 mm and 8 mm, such as between 2 mm and 5 mm. In some embodiments, one or more antennas 240 include a long axis between 3 mm and 15 mm, such as between 4 mm and 8 mm. In some embodiments, one or more antennas 240 include a long axis greater than 3 mm, such as between 3 mm and 15 mm, for example when the antennas 240 are positioned outside the housing 210. One or more antennas 240 may include foldable and / or deployable antennas, such as those described in co-pending U.S. Patent Application Serial No. 17 / 240,629, filed April 26, 2021, entitled “Method and Apparatus for Minimally Invasive Implantable Modulators”.

[0152] One or more antennas 240 may be positioned within the housing 210. Alternatively or additionally, one or more antennas 240 may be positioned outside the housing 210.

[0153] The implantable system 20, one or more implantable devices 200 and / or one or more antennas 240 can be configured to be positioned at a desired depth below the patient's skin, such as at a depth between 0.5 cm and 7.0 cm, or at a depth between 1.0 cm and 3.0 cm.

[0154] One or more energy storage components 270 (referred individually or collectively as energy storage components 270) may include one or more implantable energy storage components, such as one or more batteries (e.g., rechargeable batteries) and / or capacitors (supercapacitors). Energy storage components 270 may be configured to provide power to one or more of the following: one or more stimulation elements 260; a controller 250; a receiver 230; and combinations of one or more of these. In some embodiments, energy storage components 270 further provide power to one or more antennas 240 and / or circuitry configured to transmit data via antennas 240. In some embodiments, energy storage components 270 include digital controls for charge / discharge rates, voltage output, current output, and / or system power distribution and / or management.

[0155] Energy storage component 270 may include one or more capacitors, the individual or collective capacitance of which is between 0.01 μF and 10 F, such as between 1 μF and 1.0 mF, or between 1 μF and 10 μF. Energy storage component 270 may include one or more capacitors with capacitance between 1 mF and 10 F, such as when energy storage component 270 includes supercapacitors and / or hypercapacitors. Such large capacitors can be used to store sufficient charge to sustain operation (e.g., sustaining the delivery of stimulation energy and / or medication) without using (e.g., being sufficiently close to) the associated external device 500. Capacitors or other energy storage elements (e.g., batteries) may be selected to provide sufficient energy to sustain operation for at least 30 seconds, at least 2 minutes, at least 5 minutes, at least 30 minutes, and for hours or longer (e.g., during bathing, swimming, or other physical activity). In some embodiments, energy storage component 270 is configured to provide continuous and / or intermittent stimulation energy for at least one charge balancing pulse (e.g., for the duration of at least one charge balancing pulse). In some embodiments, capacitors, batteries, or other energy storage elements are configured to provide stimulating energy for a period of at least one hour, at least one day, at least one month, or at least one year without receiving externally supplied power. Energy storage component 270 may include one or more capacitors with a breakdown voltage higher than 1.0V, such as those with a breakdown voltage higher than 1.5V, 4.0V, 10V, or 15V. In some embodiments, energy storage component 270 may include capacitors distributed outside housing 210, such as when one or more capacitors are distributed along lead 265. Energy storage component 270 may include one or more capacitors with low self-leakage, for example, to maintain stored energy over a longer period.

[0156] In some embodiments, the energy storage component 270 includes a temporary energy storage component, such as a supercapacitor, configured to store sufficient energy to provide uninterrupted stimulation, such as during periods when link gain may be of poor quality or when it may be temporarily unavailable (e.g., when external device 500 is not in a suitable location, such as during showering, swimming, etc.). The energy storage component 270, including a supercapacitor, a supercapacitor, or a flexible battery, can be charged via wireless power transmission according to the present invention concept to store sufficient energy for one or more stimulation elements 260 to deliver stimulation energy during subsequent (expected or unexpected) unavailability of one or more external devices 500 (e.g., when external device 500 is intentionally removed or unintentionally dislodged or otherwise loses its position sufficiently close to one or more implantable devices 200). The energy storage component 270, including one or more high-capacity energy storage components, can be beneficial in applications where therapy interruption poses a significant risk or is otherwise relatively unacceptable, such as for life support therapy, cardiac resynchronization therapy, and the like. The high-capacity energy storage component of the energy storage assembly 270 can be located in an assembly located within the housing 210, located on the inner or outer surface of the housing 210, located in a separate housing, and / or located within the lead wire 265.

[0157] In some embodiments, during use (e.g., during periods of stimulation or other function delivery), the implantable device 200 periodically receives power from the external system 50 (e.g., relatively continuously receives power when the implantable device 200 delivers stimulation energy), and the energy storage component 270 includes a relatively small battery or capacitor, such as a battery or capacitor having an energy storage capacity of less than or equal to 0.6 joules, 7 joules, or 40 joules.

[0158] One or more controllers 250 (referred individually or collectively as controller 250) may be configured to control one or more stimulation elements 260, such as stimulation elements 260 including stimulation-based transducers (e.g., electrodes or other energy delivery elements) and / or sensors (e.g., physiological sensors and / or sensors configured to monitor parameters of implantable device 200). In some embodiments, controller 250 is configured to transmit stimulation signals (e.g., transmit stimulation energy configured with one or more stimulation waveforms) to one or more stimulation elements 260 (e.g., one or more stimulation elements 260 including electrodes and / or other energy delivery elements) independently of electrical signals 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 used for the power signal can be modified to optimize power efficiency (e.g., by tuning the matching network on transmitter 530 and / or receiver 230; configuring antennas 540 and / or 240 in the array; tuning the operating frequency; the duty cycle of the power signal; adjusting the positioning of antennas 540 and / or 240; etc.), and the stimulation signal can be delivered precisely (e.g., by using energy stored on energy storage component 270 and locally generating the stimulation signal on implantable device 200) to ensure clinical efficacy. Furthermore, if the power signal transmission (also referred to as the “power link”) is accidentally disturbed, the stimulation signal can be configured such that it is not significantly affected (e.g., unaffected). In some configurations, the stimulation signal delivered by one or more implantable devices 200 is insensitive to potential interference. In these embodiments, the electrical transmission signal and the stimulation signal may vary in one or more of the following: amplitude; amplitude variation; average amplitude; frequency; frequency variation; average frequency; phase; phase variation; average phase; waveform shape; pulse shape; duty cycle; polarity; and combinations of one or more of these.

[0159] The controller 250 may receive commands from the receiver 230, such as one or more commands relating to configuration parameters of one or more implantable devices 200 selected from the group consisting of: stimulation parameters; receiver data rate; data rate at which data is transmitted from the first implantable device 200 to at least one implantable antenna 240; configuration of the stimulation element 260; state of the controller 250; impedance of the antenna 240; clock frequency; sensor configuration; electrode configuration; power management parameters; energy storage component parameters; drug delivery parameters; sensor configuration parameters; and combinations of one or more of these.

[0160] In some embodiments, one or more stimulation elements 260 include stimulation elements configured to deliver energy to tissue (e.g., one or more electrodes configured to deliver monopolar or bipolar electrical energy), and controller 250 is configured to control energy delivery, such as controlling one or more stimulation parameters. Each of these stimulation parameters may remain relatively constant and / or vary, such as variations performed in a continuous or intermittent manner. In some embodiments, one or more stimulation parameters vary in a random or pseudo-random (hereinafter “random”) manner, such as variations performed by device 10 using a probability distribution, as described in co-pending U.S. Patent Application Serial No. 17 / 372,095, filed July 9, 2021, entitled “Apparatus with Enhanced Stimulation Waveforms”. In some embodiments, the stimulation (e.g., stimulation including high-frequency signal components and / or low-frequency signal components) is randomly varied to eliminate or at least reduce the synchronicity between neuronal firing and the stimulation signal (e.g., to reduce sensory abnormalities or other patient discomfort). In some embodiments, one or more stimulation elements 260 include stimulation elements configured to stimulate a target (e.g., neural tissue, such as spinal nerve tissue and / or peripheral nerve tissue). The amount of stimulation delivered to the target can be controlled by changing parameters selected from the group consisting of: the size and / or configuration of the stimulation element 260 (e.g., electrode size and / or configuration); the shape of the stimulation element 260 (e.g., electrode shape, magnetic field generating transducer shape, or drug delivery element shape); the shape of the generated electric field; the shape of the generated magnetic field; stimulation signal parameters; and combinations of one or more of these.

[0161] In some embodiments, one or more stimulation elements 260 include elements 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 actively and / or passively controlling charge balance, as described herein. Charge balance can be critical for patient safety in electrical stimulation of nerves or other tissues. Unbalanced stimulation waveforms can lead to electrode corrosion and / or dissolution, which can result in the deposition of toxic materials in tissue, implant rejection, and nerve damage. The stimulation waveform can be balanced such that the net outflow charge is approximately equal to the net inflow charge. With stimulation waveform amplitudes that can vary between 0.01 mA and 15 mA (e.g., between 0.1 mA and 15 mA, between 0.1 mA and 12 mA, or between 0.1 mA and 10 mA), depending on the treatment, errors in charge balance can be on the order of 0.001% to 0.01%. Alternatively or additionally, controller 250 may include an AC coupling capacitor configured to passively balance the stimulation waveform. The AC coupling capacitance can be large (e.g., greater than 10 μF) to allow minimal filtering of the stimulation waveform. In some embodiments, device 10 is configured to perform active charge balancing. In some embodiments, implantable device 200 includes a precision resistor in series with stimulation element 260 based on stimulation electrodes. This precision resistor can be used to measure outflow and inflow currents, such as when controller 250 includes an analog-to-digital converter (ADC). Controller 250 can integrate the current over time during a first phase in which stimulation energy is delivered and during a second phase in which a reverse current (e.g., a reverse current for charge balancing) is applied. Controller 250 can be configured to balance the total charge in both phases to ensure that the net DC current is approximately zero. This integration can be implemented using an analog integrator and / or a digital integrator of controller 250, wherein controller 250 keeps track of one or more parameters of the delivered pulse (e.g., pulses delivered within a string or burst). Implantable device 200 may include a precision series resistor, which may include an "on-chip" trimming resistor or an "off-chip" resistor. In some embodiments, the implantable device 200 includes a set of trimming resistors used to control the net series resistance, such as adjusting the resistance based on stimulation amplitude requirements (e.g., to utilize the full dynamic range of the ADC of the controller 250). In some embodiments, the controller 250 includes a shunt path with an RC-based low-pass filter for both outflow and inflow current. The RC element of the controller 250 can be selected such that the shunt current is only a fraction of the stimulation current. Since the same RC element can be used for both outflow and inflow currents, the required accuracy of the RC component may be lower. The ADC can be used to sense the voltage across the capacitor at the end of the stimulation pulse.After the stimulation pulse, the capacitor can be discharged and the polarity of the stimulation current can be reversed and set to any amplitude until the capacitor is charged to approximately the same voltage as it was charged during the stimulation pulse (according to ACD accuracy). The ADC resolution can be high enough to ensure that the residual error is less than the error that leads to unwanted charge accumulation. The ADC resolution requirement can be further reduced by decreasing the net capacitance in the shunt RC circuit to accelerate the charging of the capacitor. The capacitor can be discharged each time the voltage exceeds a certain predefined threshold, while the 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 can be negligible compared to the charging time, which reduces the error caused by the discharge period. Since the net charge equivalent to the full-scale voltage on the ADC can be divided into multiple cycles, the ADC resolution required to achieve the same residual error can be divided by the number of cycles.

[0162] In some embodiments, controller 250 is configured to generate a stimulation signal comprising a waveform or waveform pattern (hereinafter referred to as a stimulation waveform) for one or more stimulation elements 260 configured as stimulation elements (e.g., such that one or more stimulation elements 260 deliver stimulation energy comprising the stimulation waveform or at least similar to the stimulation waveform). Controller 250 may generate a stimulation signal comprising a waveform selected from the group consisting of: square wave; rectangular wave; sine wave; sawtooth wave; triangular wave (e.g., symmetrical or asymmetrical); trapezoidal wave; ramp; exponentially increasing waveform; exponentially decreasing waveform; pulse shape that minimizes power consumption; Gaussian pulse shape; pulse train; root raised cosine; bipolar pulse; and combinations of one or more of these. In some embodiments, controller 250 is configured to generate a stimulation signal comprising a waveform including a combination of two or more waveforms selected from the group consisting of: square wave; rectangular wave; sine wave; triangular wave (symmetric or asymmetric); ramp; exponentially increasing waveform; exponentially decreasing waveform; pulse shape that minimizes power consumption; Gaussian pulse shape; pulse train; root raised cosine; bipolar pulse; 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 the 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 or frequency of the pulse, rate of change, or random variation of amplitude).

[0163] In some embodiments, the controller 250 is configured to provide a stimulation signal comprising waveforms and / or pulses repeating at frequencies between 1.0 Hz and 50 kHz (e.g., including frequency components), such as between 10 Hz and 500 Hz, between 40 Hz and 160 Hz, and / or between 5 kHz and 15 kHz. In some embodiments, the controller 250 is configured to generate a stimulation signal comprising frequencies between 1 Hz and 1000 Hz, such as a stimulation signal having frequencies between 10 Hz and 500 Hz. In some embodiments, the controller 250 is configured to generate a stimulation signal comprising a duty cycle between 0.1% and 99%, such as between 1% and 10% or between 1% and 25%. In some embodiments, the controller 250 is configured to generate a stimulation signal comprising a frequency-modulated stimulation waveform, such as a stimulation waveform comprising frequency components (e.g., signals) between 1 kHz and 20 kHz. In some embodiments, the controller 250 is configured to generate a stimulation signal comprising a mixture and / or modulation of low-frequency and high-frequency signals, which includes any of the waveform types, shapes, and other configurations. In these embodiments, the stimulus signal may include a low-frequency signal between 1 Hz and 1000 Hz, and a high-frequency signal between 600 Hz and 50 kHz, or between 1 kHz and 20 kHz. Alternatively or additionally, the stimulus signal may include a high-frequency signal string and a low-frequency signal pulse burst, and / or a low-frequency signal string and a high-frequency signal pulse burst. Alternatively or additionally, the stimulus signal may include one or more high-frequency signals modulated using one or more low-frequency signals, such as one or more high-frequency signal frequency modulation (FM), amplitude modulation (AM), phase modulation (PM), and / or pulse width modulation (PWM) using one or more low-frequency signals. The stimulus signal may cycle between different waveform shapes at specified time intervals. The stimulus signal may include a pseudo random binary sequence (PRBS) non-return-to-zero or return-to-zero waveform, such as having a fixed and / or time-varying pulse width and / or pulse frequency.

[0164] The controller 250 may include clamping circuitry configured to allow rapid charging and / or discharging of the energy storage component 270, the stimulator element 260 driver (e.g., electrode driver) of the controller 250, and / or other components of the implantable device 200. The clamping circuitry can improve pulse shape by providing additional control and / or configuration of the rise and fall times of the waveform (e.g., to create rapid rise or fall times). In some embodiments, the clamping circuitry may be configured to limit the rise and / or fall times to less than or equal to one-tenth (10%) of the pulse width of the applied stimulation pulse (e.g., for a 10-microsecond stimulation pulse, the rise and / or fall times are less than or equal to 1 microsecond).

[0165] In some embodiments, controller 250 includes a matching network configured to match the impedance of first antenna 240 to the impedance of receiver 230. In these embodiments, the matching network of controller 250 may be adjustable. Alternatively or additionally, controller 250 may include an adjustable load impedance to stabilize the load seen at antenna 240 under different operating conditions. In some embodiments, the adjustable load impedance is controlled according to the charging rate of energy storage component 270.

[0166] The controller 250 and / or any other component of each implantable device 200 may include an integrated circuit comprising one or more components selected from the group consisting of: a matching network; a rectifier; a DC-DC converter; a regulator; a bandgap reference; overvoltage protection; overcurrent protection; an active charge balancing circuit; an analog-to-digital converter (ADC); a digital-to-analog converter (DAC); a current driver; a voltage driver; a digital controller; a clock generator; a data receiver; a data demodulator; a data modulator; a data transmitter; an electrode driver; a sensing interface analog front end; a power management circuit; an energy storage interface; a memory register; a timing circuit; and combinations of one or more of these.

[0167] One or more receivers 230 (referred individually or collectively as receivers 230) may include one or more components, such as Figure 1 The demodulator 231, rectifier 232, and / or power converter 233 are shown. In some embodiments, receiver 230 may include a DC-DC converter such as a boost converter. Receiver 230 may include a data receiver, such as a data receiver including an envelope detector and demodulator and / or envelope averaging circuitry. In some embodiments, one or more antennas 240 are individually connected to one or more receivers 230. In some embodiments, one or more antennas 240 are connected to a single receiver 230, such as via a series connection or a parallel connection.

[0168] One or more implantable devices 200 may be configured to transmit data signals to an external system 50. In some embodiments, a receiver 230 is configured to drive one or more antennas 240 to transmit data to the external system 50 (e.g., antenna 540 to the external device 500). Alternatively or additionally, the implantable device 200 may be configured to transmit data signals by causing the receiver 230 to adjust its load impedance to backscatter energy (such as backscattering energy detectable by the external system 50). In some embodiments, data transmission is accomplished by manipulating signals at a tissue interface via the receiver 230, such as by transmitting data signals using body conduction.

[0169] In some embodiments, receiver 230 includes a matching network, such as a matching network configured to detune to prevent oversaturation. For example, implantable system 20 may include two or more implantable devices 200, each including receiver 230 which includes a matching network. The matching network of receiver 230 of the first implantable device 200 may be configured to detune based on power received by receiver 230 of the second implantable device 200.

[0170] Demodulator 231 may include circuitry for asynchronously recovering a signal modulated on a power signal provided by external system 50 and converting the modulated signal into a digital signal. In some embodiments, demodulator 231 asynchronously recovers the modulated signal by comparing a dynamically generated moving average with an 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 can then be extracted from the resulting digital signal from the pulse width and / or amplitude in the signal, according to an encoding method used by external system 50. In some embodiments, demodulator 231 recovers a digital signal used as timing information for implantable device 200, similar to an on-chip clock. The recovered clock signal can also be used in an on-chip clock generator of synchronization controller 250, such as by using a frequency and / or phase-locked loop (FLL or PLL).

[0171] Rectifier 232 may include a power signal rectifier, such as one for supplying power to energy storage component 270 and / or controller 250. In some embodiments, rectifier 232 includes one or more self-driven synchronous rectifier (SDSR) stages connected in a charge pump configuration to boost the voltage from the input RF amplitude to the rectifier to a higher voltage. The boosted voltage may directly charge energy storage component 270, or it may be further boosted by a DC-DC converter or a boost converter. In some embodiments, rectifier 232 includes a diode-capacitor ladder stage instead of an SDSR stage or anything other than an SDSR stage. On-chip diodes (such as Schottky diodes) or off-chip diodes may be used in one or more rectifier 232 stages. For maximum efficiency, rectifier elements (such as diodes) can be optimized by appropriately adjusting component size and selecting an appropriate number of stages based on the input RF voltage and load current to minimize forward and / or reverse conduction losses.

[0172] Power converter 233 may include one or more voltage conversion elements, such as a DC-DC converter, which boosts or otherwise changes a voltage to a desired level. In some embodiments, voltage conversion is achieved using a buck-boost converter, a boost converter, a switched capacitor, and / or a charge pump. One or more power converters 233 may interface with energy storage component 270 and charge the associated energy storage component to a desired voltage. In some embodiments, power converter 233 receives control signals from controller 250, such as to configure the voltage, current, charge / discharge rate, switching frequency, and / or other operating parameters of power converter 233.

[0173] One or more implantable leads 265 (referred individually or collectively as leads 265) may be attached to one or more housings 210, such as leads 265 including one or more stimulation elements 260. Leads 265 may include one or more stimulation elements 260 configured as stimulation elements (e.g., electrodes configured to deliver electrical energy in a monopolar or bipolar mode, or drug delivery elements, such as output ports of a reservoir fluidly connected within housing 210). Alternatively or additionally, leads 265 may include one or more stimulation elements 260 and / or functional elements 299b configured as physiological sensors (e.g., electrodes configured to record electrical activity in tissue or another physiological sensor as described herein). Alternatively or additionally, leads 265 may include one or more stimulation elements 260 and / or functional elements 299b configured to transmit signals through tissue to an external system 50, such as through bodily conduction.

[0174] In some embodiments, the implantable device 200 includes a connector, namely connector 215, which operatively attaches (e.g., electrically attaches) one or more stimulation elements 260 to one or more components (e.g., electronic components) within the housing 210 (e.g., to transmit power and / or data therebetween). In some embodiments, connector 215 is operatively attached to lead 265 (e.g., during manufacturing) or is attachable to lead 265 (e.g., during clinical procedures), such as... Figure 1 As shown. Alternatively, connector 215 may be operatively attached to a lead attachment assembly (assembly 280) and / or attachable to a lead attachment assembly (assembly 280), which in turn may be attached to lead 265. In some embodiments, connector 215 is arranged in a feedthrough configuration through an opening in housing 210. In some embodiments, an overmolded member or other sealing element (sealing element 205 shown) provides a seal around connector 215, the opening in housing 210, and / or the interface between connector 215 and housing 210.

[0175] In some embodiments, lead 265 includes a removable probe configured to assist implantation of lead 265, such as that described in U.S. Patent Application Serial No. 17 / 412,044, filed August 25, 2021, entitled "Medical Apparatus Including an Implantable System and an External System". In some embodiments, implantable system 20 includes more than one lead 265, which includes one or more stimulation elements 260 and is 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.

[0176] In some embodiments, lead 265 includes a diameter between 1 mm and 4 mm, such as a diameter between 1 mm and 2 mm, such as a lead with a diameter of approximately 1.35 mm. In some embodiments, lead 265 includes a length between 3 cm and 60 cm, such as a length between 6 cm and 30 cm. One or more leads 265 may include 2 to 64 stimulation elements 260, such as when lead 265 includes 2 to 64 electrodes, such as 4 to 32 electrodes. In some embodiments, lead 265 includes a paddle lead. In some embodiments, lead 265 includes a single-lumen or multi-lumen catheter, such as when the attached implantable device 200 is configured as a drug delivery device as described herein (e.g., stimulation elements 260 configured as catheters include at least a portion of lead 265).

[0177] In some embodiments, lead 265 includes one or more fangs, such as fang 266 shown. Fang 266 may be configured to anchor or otherwise stabilize (“anchor” or “stabilize” herein) lead 265 relative to patient tissue, such as to prevent undesirable movement during and / or after implantation of lead 265. One or more fangs 266 may be configured to biodegrade after implantation in the patient, such that the provided stability is temporary. Fang 266 may be configured to biodegrade over a period of approximately 4 to 12 weeks. In some embodiments, the biodegradable fang 266 is configured to be incorporated when lead stimulating element 260 is positioned to stimulate peripheral nerves (e.g., lead 265 is implanted such that one or more stimulating elements 260 are positioned near one or more peripheral nerves).

[0178] In some embodiments, one or more fangs 266 are configured to be deployed, such as via operator-accessible controls.

[0179] One or more stimulation elements 260 (referred individually or collectively as stimulation elements 260) and / or functional elements 299 (e.g., functional elements 299a and / or 299b) may include one or more sensors, transducers, and / or other functional elements. In some embodiments, one or more stimulation elements 260 and / or functional elements 299 include 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 elements 260 and / or functional elements 299 include functional elements configured to provide therapy, such as one or more stimulation elements 260 configured to deliver an agent to tissue (e.g., a needle or catheter), deliver energy to tissue, and / or otherwise therapeutically affect tissue. In some embodiments, stimulation elements 260 and / or functional elements 299 include one or more functional elements configured to record patient information, such as when stimulation elements 260 and / or functional elements 299 include one or more sensors configured to measure patient physiological parameters, as described herein. In some embodiments, the stimulation element 260 and / or the functional element 299 include one or more sensors configured to record parameters of the implantable device 200, as also described herein.

[0180] One or more stimulating elements 260 can, as Figure 1 The element is positioned on lead 265. 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).

[0181] Stimulation element 260 may include one or more stimulation elements positioned at one or more internal body locations. Stimulation element 260 may include one or more stimulation elements positioned to dock with spinal cord tissue, spinal canal tissue, epidural space tissue, spinal root tissue (dorsal or ventral), dorsal root ganglia, neural tissue (e.g., peripheral nerve tissue, spinal nerve tissue, or cranial nerve tissue), brain tissue, ganglia (e.g., sympathetic or parasympathetic nerves), and / or nerve plexuses (e.g., to deliver energy to them or record physiological parameters from them). In some embodiments, the stimulation element 260 includes one or more elements located near 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 near the spinal cord; peripheral spinal nerves including locations around the back; the knee; the tibial nerve (and / or sensory fibers leading to the tibial nerve); the occipital nerve; the sphenopalatine ganglion; the sacral and / or pudendal nerves; brain tissue, such as the thalamus; baroreceptors in the walls of blood vessels (such as in the carotid arteries); 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; organs; the heart; the liver; the kidney; arteries; veins; bones; and combinations of one or more of these, such as to stimulate and / or record data from tissues and / or locations where the stimulation element 260 is located near and / or within it.

[0182] In some embodiments, the stimulation element 260 and / or functional element 299 include one or more sensors configured to record data representing parameters of the implantable device 200. In these embodiments, the stimulation element 260 and / or functional element 299 may include one or more sensors selected from the group consisting of: energy sensors; voltage sensors; current sensors; temperature sensors (e.g., temperature of one or more components of the implantable device 200); contamination detectors (e.g., to detect unwanted material that has penetrated the housing 210); antenna matching and / or mismatch assessment sensors; power delivery sensors; link gain sensors; power usage sensors; energy level sensors; energy charge rate sensors; energy discharge rate sensors; impedance sensors; load impedance sensors; instantaneous power usage sensors; average power usage sensors; bit error rate sensors; signal integrity sensors; and combinations of one or more of these. Device 10 may be configured to analyze (e.g., via the implantable controller 250, programmer 600, and / or diagnostic component 62 described herein) data recorded by stimulating element 260 and / or functional element 299 to evaluate one or more of the following: power delivery; link gain; power usage; energy within energy storage component 270; performance of energy storage component 270; expected lifetime of energy storage component 270; discharge rate of energy storage component 270; ripple or other embodiments of energy storage component 270; 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. Stimulating element 260 may be configured to record temperature, such as in cases where device 10 is configured to deactivate or otherwise modify the performance of implantable device 200 when the recorded temperature exceeds a threshold.

[0183] In some embodiments, device 10 includes one or more tools (tool 60 shown). Tool 60 may include data recording and / or analysis tools configured to receive data from external system 50 or implantable system 20, such as data including: 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 physiological information) recorded by implantable system 20; patient environmental 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) devices. Tool 60 may include tools selected from the group consisting of: data recording and / or storage tools; data analysis tools; networks such as LAN or the Internet; mobile phones; and combinations of one or more of these.

[0184] In some embodiments, tool 60 includes a battery charging component, such as a component configured to recharge one or more power sources 570 including a rechargeable battery or capacitor.

[0185] In some embodiments, tool 60 includes a user interface of device 10, such as a user interface configured to allow patients, clinicians or other users to create a set of stimulation settings based on various user inputs.

[0186] Device 10 may include one or more placement tools (positioning tool 67 shown) that can be configured to assist in the positioning and / or maintenance of one or more external devices 500 on the patient’s skin (e.g., in the vicinity of the implantable device 200).

[0187] Device 10 may include one or more imaging devices (illustrating device 40 shown), which may include 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 thereof. In some embodiments, image data provided by imaging device 40 is used to perform the localization (e.g., selecting an anatomical location for implantation) of one or more portions of device 200 (e.g., one or more leads 265 and / or one or more stimulating elements 260). In some embodiments, one or more leads 265 and / or stimulating elements 260 are localized based on eCAP data (e.g., for indicating correct localization relative to one or more nerves) and data provided by imaging device 40 (e.g., a fluoroscope and / or an ultrasound imager). In some embodiments, imaging device 40 includes a fluoroscope and / or other X-ray imaging device, which is used (e.g., by an implantation clinician) to localize leads 265 and / or stimulating elements 260 (e.g., with or without eCAP data). In some embodiments, imaging device 40 includes an ultrasound imager, which is used (e.g., by an implantation clinician) to locate lead 265 and / or stimulating element 260 (e.g., with or without eCAP data). In some embodiments, the placement of one or more leads 265 and / or one or more stimulating elements 260 (e.g., close proximity to one or more peripheral nerves or other body nerves to be stimulated) is performed using imaging device 40 (e.g., a fluorescence microscope or other X-ray imaging device) that does not allow visualization (e.g., adequate visualization) of neural tissue (e.g., the neural tissue to be stimulated). In these embodiments, device 10 may be configured to utilize data from at least one or more eCAP measurements to identify and / or allow a clinician to identify the correct implantation location for one or more leads 265 and / or one or more stimulating elements 260. For example, in peripheral nerve stimulation applications, where the nerve trajectory is not sufficiently clear under X-ray visualization, device 10 may be configured to use both X-ray data and eCAP measurement data to identify the implantation location for element 260 (e.g., such that one or more elements 260 are sufficiently close to the target nerve to effectively stimulate the nerve during subsequent stimulation energy delivery).

[0188] Device 10 may include one or more implantation tools (implantation tool 65 shown). Implantation tool 65 may include an introducer, a tunneler, and / or other implantation tools configured and arranged for implantation of the auxiliary housing 210, the implantable antenna 240, the lead 265, and / or one or more stimulating elements 260. In some embodiments, implantation tool 65 includes a component configured to anchor the implantable device 200 to tissue, such as a mesh or wrapping that slides around at least a portion of the implantable device 200 and is configured to engage tissue (e.g., via tissue inward growth) or to engage with tissue (e.g., via sutures or clips). In some embodiments, implantation tool 65 has the same features as referenced herein. Figures 6A-6I The tool described has a similar construction and arrangement to 650.

[0189] Device 10 may include one or more positioning devices, such as Figure 1 The patient attachment device 70 shown is used to attach one or more components of the external system 50 to a patient or at least to a location close to the patient. In some embodiments, the patient attachment device 70 is constructed and arranged as described in U.S. Patent Application Serial No. 17 / 187,654, entitled “Method and Apparatus for Neuromodulation Treatments of Pain and Other Conditions,” filed February 26, 2021, and published January 7, 2025, as U.S. Patent No. 12,186,563.

[0190] The patient attachment device 70 may include one or more elements configured to attach one or more external devices 500 and / or programmers 600 to one or more locations on or near the patient's skin, relatively close to one or more implantable devices 200 already implanted in the patient. The patient attachment device 70 may include components selected from the group consisting of: straps; straps with pockets; straps with adhesive; shoulder straps; shoulder straps with pockets; shoulder straps with adhesive shoulder straps; shoulder straps; shirts; shirts with pockets; clothing; clothing with pockets; epidural electronic packages; clips; bracelets; wristbands; wristwatches; anklets; ankle bracelets; knee straps; thigh straps; thigh straps; necklaces; hats; headbands; collars; glasses; goggles; earpieces; behind earpieces; and combinations of one or more of these. In some embodiments, the patient attachment device 70 includes at least one antenna 540 configured to 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). The patient attachment device 70 may include one or more pockets, such as those configured to collectively enclose one or more of the following: an external device 500; one or more antennas 540; a power supply 570; a programmer 600; and combinations thereof. In some embodiments, the patient attachment device 70 includes multiple pockets, such as to allow the external antenna 540, programmer 600, external transmitter 530, and / or external power supply 570 to be repositioned to various different locations to, for example, improve power and / or data transmission to one or more implantable devices 200 and / or improve patient comfort. In some embodiments, one or more antennas 540, power supply 570, and / or transmitter 530 are connected via a flexible cable positioned within the patient attachment device 70. In some embodiments, the flexible cable is a small coaxial cable that houses the power level and frequency of the carried signal. In some embodiments, one or more antennas 540 are connected to one or more attachments of the external device 500 via a single cable having local power splitting components and / or active matching elements that modulate the signal power to each of the one or more antennas 540.

[0191] In some embodiments, the patient attachment device 70 and / or external device 500 may be configured to prevent adverse effects on the skin portions contacted by either device. Alternatively or additionally, the patient attachment device 70 and / or external device 500 may be configured to clean one or more skin contact portions and / or promote healing of one or more skin contact portions. For example, the patient attachment device 70 may include agents (e.g., coatings or other included agents) selected from the group consisting of: bactericides; antifungal agents; and combinations thereof.

[0192] Device 10 may include a device configured to operate (e.g., temporarily operate) one or more implantable devices 200, such as Figure 1 The test interface 80 is shown. The test interface 80 can be configured to wirelessly deliver power to, wirelessly deliver data to, and / or wirelessly receive data from the implantable device 200. The test interface 80 can be configured to interface with one or more implantable devices 200 during implantation procedures in patients in which one or more implantable devices 200 are implanted (e.g., aseptic clinical procedures in patients in which implantable devices 200 are implanted, including pre-attached leads 265). In some embodiments, the construction and arrangement of the test interface 80 are similar to those described in U.S. Patent Application Serial No. 17 / 187,654, entitled “Method and Apparatus for Neuromodulation Treatments of Pain and Other Conditions,” filed February 26, 2021, and published January 7, 2025, as U.S. Patent No. 12,186,563, or in U.S. Patent Application Serial No. 17 / 379,928, entitled “Stimulation Apparatus,” filed July 19, 2021, and published January 21, 2025, as U.S. Patent No. 12,201,829.

[0193] The test interface 80 can be used in clinical procedures involving the implantable device 200, which includes a pre-attached lead 265. In some embodiments, the implantable device 200 includes an attachable lead 265, and the device 10 includes a test interface (test interface 90) configured for use with the attachable lead. The test interface 90 can be configured to be operatively (e.g., electrically) attached to the lead 265, such as to deliver stimulation energy via a wired connection during a test procedure, as described herein. For example, the test interface 90 can deliver stimulation energy to one or more stimulation elements 260 on the lead 265 during a test procedure to confirm and / or modify the correct placement of the stimulation element 260 and / or test one or more stimulation waveforms. The test interface 90 can include an interface connector 95, which can include a connector configured to operatively attach (e.g., electrically) the test interface 90 to the lead 265 (e.g., after the lead 265 has been implanted in the patient's tissue). Connector 95 can be configured for use in a single trial procedure (e.g., on a single patient), while the remainder of trial interface 90 can be reused (e.g., in multiple trial procedures for multiple patients). Trial interface 90 may include sterile devices, and it may be a device that can be resterilized (e.g., for use in multiple sterile clinical procedures). In some embodiments, trial interface 80 and trial interface 90 include similar components (e.g., similar components for creating similar stimulation waveforms to be used in the trial procedure).

[0194] In some embodiments, the device 10 includes a diagnostic component ( Figure 1 The diagnostic component 62 shown herein. In some embodiments, the programmer 600 and / or implantable controller 250 include all or part of the diagnostic component 62. The diagnostic component 62 may be configured to evaluate, 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 sensors to record patient information (e.g., patient physiological information and / or patient environmental information) and / or device 10 information (e.g., implantable device 200 information), as described herein.

[0195] In some embodiments, the device 10 is configured to provide therapy by delivering stimulation energy to tissue, such as electrical energy delivered to tissue by one or more stimulation elements 260 including one or more electrodes. Alternatively or additionally, the device 10 may be configured as a drug delivery device (e.g., a drug or other drug delivery device). In some embodiments, the device 10 includes one or more reservoirs for storing a drug, such as a reservoir 525 of an external device 500 and / or a reservoir 225 of an implantable device 200, each shown in Figure 1The reservoirs 525 and / or 225 may be fluidly connected to one or more functional elements 599 and / or 299 (e.g., via one or more tubes). Reservoirs 525 and / or 225 may include one or more chambers (e.g., independent chambers configured to individually contain incompatible drugs or otherwise prevent unwanted interactions between multiple drugs). Reservoirs 525 and / or 225 may include volumes between 0.1 ml and 50 ml (such as volumes for storing one or more agents), such as between 0.1 ml and 3.0 ml, or between 0.1 ml and 1.0 ml. Reservoirs 525 and / or 225 may include pressurized reservoirs or otherwise include fluid pumping mechanisms (e.g., peristaltic mechanisms, syringe pumps, or other fluid pumps). Reservoirs 525 and / or 225 may also include refillable reservoirs (e.g., when the reservoir 225 of the implantable device 200 includes a valve-like opening such as a silicone septum or mechanical valve, or when it can be accessed via a needle for refilling). The fluid-attached functional element 599 and / or functional element 299 may include a fluid delivery element selected from the group consisting of: catheters; porous membranes; iontophoresis elements; needles; or combinations thereof. The delivered and / or stored (e.g., in a reservoir) pharmaceutical agent may include an agent selected from the group consisting of: analgesics, such as morphine, fentanyl, lidocaine, or other agents delivered to treat pain; chemotherapeutic agents, such as those delivered systemically (e.g., throughout the patient's bloodstream) and / or delivered to a location in or near an organ (such as the liver or brain) to treat cancer; antibiotics for treating or preventing infection; hormones, such as hormones delivered intravenously in hormone therapy; cardiac medications, such as nitroglycerin, beta-blockers, or antihypertensive drugs; carbohydrates, such as glucose or dextran delivered to treat hypoglycemia; insulin, such as for treating hyperglycemia; diabetes medications; neurological medications; epilepsy medications; and combinations thereof.

[0196] In some embodiments, device 10 is configured to deliver low-frequency stimulation energy (e.g., electrical energy including low-frequency signals) to stimulate motor nerves, such as to improve tone and structural support (e.g., physical therapy). In these embodiments, device 10 may be further configured to provide high-frequency stimulation, such as to treat pain (e.g., to suppress and / or control pain). This combined effect can be used not only for pain management but also for muscle strengthening and the gradual healing of supporting structures. Alternatively or additionally, as described herein, device 10 may be configured to deliver low-frequency stimulation energy (e.g., electrical energy) to induce sensory abnormalities, which may also be accompanied by the delivery of high-frequency stimulation (e.g., to suppress and / or control pain). In some embodiments, device 10 is configured to deliver low-frequency stimulation (e.g., electrical energy including low-frequency signals) and burst stimulation—simultaneously or sequentially. Low-frequency stimulation and burst stimulation may be delivered on similar and / or dissimilar stimulation elements 260 (e.g., similar or dissimilar electrode-based stimulation elements 260).

[0197] In some embodiments, the implantable device 200 has an internal battery or other power source such that stimulation (e.g., stimulation energy and / or stimulating agents) is delivered to one or more locations within the patient over an extended period of time (e.g., at least 1 hour, at least 1 day, at least 1 month, or at least 1 year), during which no power transmission is received (e.g., from an external device such as external device 500 as described herein). In some embodiments, at least a portion (e.g., at least a single phase) of a single pulse of energy is delivered by the implantable device 200 using energy provided by an internal power source 570 such as a battery or capacitor. In these embodiments, data may be transmitted by one or more of external device 500 and / or programmer 600, for example, to activate or modify the stimulation being delivered, and power may or may not be transmitted.

[0198] One or more implantable devices 200 may be configured to deliver stimulation energy having a stimulation waveform that varies over time. In some embodiments, one or more stimulation parameters of the stimulation waveform vary randomly over time, such as by using a probability distribution as described in co-pending U.S. Patent Application Serial No. 17 / 372,095, filed July 9, 2021, entitled “Apparatus with Enhanced Stimulation Waveforms.” Each stimulation waveform may include one or more pulses, such as a set of pulses repeated at regular and / or irregular intervals. In some embodiments, the pulses may include the delivery of electrical energy, such as electrical energy delivered in one or more phases (e.g., a pulse comprising at least a cathode or anode portion, followed by passive capacitive recovery, wherein there is an optional open-circuit time between the first portion and the recovery). In some embodiments, a set of pulses is delivered, each pulse comprising an anode or cathode portion, which may include charge recovery after each pulse, such as charge recovery comprising active (opposite polarity pulses) 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 first (anode or cathode) portions. In some embodiments, a single pulse or group of pulses is provided in a time-varying repetitive pattern (e.g., a period of time with regular intervals followed by a period of time with irregular intervals) or in regular intervals interspersed with occasional (random) stray pulses (creating a single irregular event in an otherwise regular series). Non-limiting examples of waveform embodiments include: variations in frequency (e.g., the frequency of one or more signals of the waveform); variations in signal amplitude; variations in interval time periods (e.g., at time periods between pulses or between pulse sequences); variations in pulse width; multiple segmented or continuous embodiments of one of multiple stimulation parameters in a single pulse (e.g., multi-step, multi-amplitude in a “super pulse”); variations in pulse symmetry (e.g., via active drive, passive recovery, and / or active-assisted passive recovery); variations in stimulation energy over time windows and / or overlapping time windows; variations in electrical activity in the spectrum of the stimulation waveform; and combinations of one or more of these. In some embodiments, the device 10 and / or implantable device 200 may be configured to "systematically" (e.g., automatically and / or at least semi-automatically by the device 10) change the stimulation waveform, such as temporarily performed changes (e.g., at predetermined similar or dissimilar time intervals) and / or parameter-based changes, such as measurement parameters that may be based on signals generated by sensors of the implantable device 200 or another component of the device 10. Alternatively or additionally, the device 10 and / or implantable device 200 may be configured to randomly change the stimulation waveform.The random variation should include discrete or continuous embodiments that can be selected from distributions, such as probability distributions selected from the group consisting of: uniform distribution; arbitrary distribution; gamma distribution; normal distribution; log-normal distribution; Pareto distribution; Gaussian distribution; Poisson distribution; Rayleigh distribution; triangular distribution; statistical distribution; and combinations of one or more of these. Random pulses or pulse groups can be generated based on one or more randomly varied stimulus signal parameters. One or more stimulus parameters can be randomly varied using one or more probability distributions, as described herein.

[0199] The stimulation waveform delivered by the implantable device 200 may include one or more high frequencies. The stimulation waveform frequency or other stimulation parameters may be set, adjusted, and / or modified (“set,” “adjusted,” and / or “modified” herein) to optimize therapeutic benefits for the patient and minimize undesirable effects (e.g., paresthesia or other patient discomfort). In some embodiments, the stimulation waveform is adjusted based on signals generated by sensors of the device 10 (e.g., sensors of the implantable device 200, such as stimulation element 260 configured as a sensor or other sensors of the implantable device 200 as described above). Adjustment of the stimulation waveform parameters may be performed automatically by the implantable device 200 and / or via an external device 500 and / or programmer 600.

[0200] In some embodiments, the pulse shape of the stimulation waveform can vary, such as pulse shapes including: sinusoidal geometry; square geometry (e.g., waveforms including square waves); rectangular geometry; triangular geometry (e.g., symmetrical or asymmetrical); trapezoidal geometry; sawtooth geometry; ramp geometry; exponential geometry; piecewise step function geometry; root-raised cosine geometry; and combinations of one or more of these.

[0201] In some embodiments, the charge recovery phase (e.g., anodic phase) of the stimulation waveform can be altered by the implantable device 200.

[0202] The inter-pulse gap, i.e., the time between one or more pulses (e.g., continuously repeating biphasic or other polyphasic pulses), can be systematically and / or randomly varied by the implantable device 200. In some embodiments, the inter-pulse gap between one or more pulses includes zero time (i.e., a first pulse immediately followed by a similar or dissimilar second pulse). In some embodiments, the inter-pulse gap is systematically varied, such as on a conventional basis (i.e., temporarily) and / or based on signals generated by sensors of device 10. Alternatively or additionally, the inter-pulse gap can be randomly varied, such as based on random variations of a distribution as described herein (e.g., a probability distribution with a predetermined shape).

[0203] In some embodiments, the implantable device 200 delivers a stimulation waveform comprising a series of frequency-modulated (FM) pulses, such that the frequency of the stimulation varies. The implantable device 200 may be configured to deliver a stimulation waveform comprising a frequency-modulated carrier signal at a carrier frequency, continuously modulated between a first frequency and a second frequency. For example, the implantable device 200 may deliver a stimulation waveform modulated between 2.0 kHz and 3.0 kHz per second (e.g., comprising a 2.5 kHz carrier signal modulated at 1 Hz), with a modulation range (offset from the carrier signal) of + / - 500 Hz. In some embodiments, the implantable device 200 may deliver a stimulation waveform comprising: a carrier frequency between 1 kHz and 50 kHz, a modulation frequency between 0.1 Hz and 10 kHz, and / or a modulation range between 1 Hz and the carrier frequency.

[0204] In some embodiments, the implantable device 200 delivers a stimulation waveform comprising a series of amplitude-modulated (AM) pulses, such that the amplitude of the stimulation is altered (e.g., the amplitude of the voltage and / or current of the stimulation signal is changed). The amplitude of the delivered current can vary in a single amplitude-modulated scan, such as a scan from 2 mA to 3 mA. In some embodiments, the amplitude of the signal can vary continuously, such as when the current varies between 2 mA and 3 mA per second (e.g., a signal comprising a modulation frequency of 1 Hz). In these embodiments, the modulation depth will be 33%, where the modulation depth is equal to 1 - [lower range / upper range]. In some embodiments, the amplitude of the delivered current fluctuates between 1 mA and 3 mA (i.e., 66% modulation depth), while in other embodiments, the current fluctuates between 0 mA and 10 mA (e.g., 100% modulation depth). In some embodiments, the implantable device 200 is configured to deliver an amplitude modulation signal comprising: a carrier frequency between 1 kHz and 50 kHz; a modulation frequency between 0.1 Hz and the carrier frequency; and / or a modulation depth between 0.1% and 100%.

[0205] In some embodiments, the implantable device 200 delivers a stimulation waveform comprising the delivery of multiple pulse trains delivered intermittently, such as a “burst stimulation” waveform as defined above. For example, the implantable device 200 may be configured to deliver a series of pulses or a train of five pulses, each pulse having a pulse width of 1 msec. Each of the five pulses may be separated by a 4 msec interpulse gap, thereby creating a 16 msec train-on period. These five pulses may be repeated once every 25 msec (“inter-train period”). In some embodiments, the implantable device 200 may be configured to deliver a burst stimulation waveform comprising pulse widths between 5 μsec and 1 msec. The implantable device 200 may deliver trains or burst stimulation waveforms comprising pulses having constant pulse widths and / or varying pulse widths, such as when the pulse width (and / or other stimulation parameters) are changed randomly and / or systematically. The implantable device 200 can deliver train or burst stimulation waveforms having varying or constant pulse shapes selected from the group consisting of: sine curves; squares, rectangles; triangles (symmetric or asymmetric); trapezoids; sawtooth patterns; ramps (e.g., linear ramps); exponential curves; piecewise step functions; and combinations of one or more of these. The implantable device 200 can deliver train or burst stimulation waveforms having inter-pulse gaps shorter than the inter-train duration. The inter-pulse gap can be relatively constant, and / or it can be varied, such as when the implantable device 200 randomly changes the inter-pulse gap or systematically changes the inter-pulse gap. In some embodiments, the inter-pulse gap between any two pulses within a pulse train (or burst) can vary between 0.1 μsec and the inter-train duration (or burst duration). The implantable device 200 can deliver train stimulation waveforms with inter-pulse gaps between 1 μsec and 1 second. The implantable device 200 can deliver burst stimulation waveforms with inter-train durations between 1 μsec and 1 second. The implantable device 200 can deliver burst stimulation waveforms with an interburst duration between 20 μsec and 24 hours. The interburst duration can be relatively constant, and / or it can be variable, such as when the implantable device 200 randomly or systematically changes the interburst duration. In some embodiments, the interburst duration is changed by the user, such as via the user using a programmer 600. In these embodiments, user activation can be modulated using one or more safeguards or other restrictions, such as those incorporated into a patient-controlled analgesic device. The inter-string duration can vary between 1 μsec and 24 hours. The implantable device 200 can deliver string or burst stimulation waveforms with a string-on period (the time between the start of the first pulse in the string and the end of the last pulse in the string) between 10 μsec and 24 hours. This string-on and / or burst-on period can be relatively constant, and / or it can be variable, such as when the implantable device 200 randomly or systematically changes the string-on and / or burst-on period.The implantable device 200 can deliver string or burst stimulation waveforms having a string or burst envelope selected from the group consisting of: cosine; cosine square; sine; square; rectangle; triangle (symmetric or asymmetric); trapezoid; sawtooth; ramp (e.g., linear ramp); and combinations of one or more of these. The implantable device 200 can deliver string and / or burst stimulation waveforms with a string ramp duration or burst ramp duration between 1 μsec and 10 minutes. The implantable device 200 can deliver string and / or burst stimulation waveforms with a modulation depth between 1% and 99% between string and / or burst. For example, between some or all of the string and / or bursts (burst off or string off periods), a signal may be present, and the signal may contain the same or different elements contained in the string on and / or burst on periods. These burst off or string off periods may include rest periods. The amplitude of the signal contained in these resting periods can be 0% to 99% of the signal amplitude during the string-on and / or burst-on periods, such as a signal with an amplitude less than 50% of the signal amplitude during the string-on and / or burst-on periods or with another amplitude below the neuronal excitation threshold.

[0206] Each implantable device 200 of the present invention can be configured to deliver stimulation energy to one, two, three, four or more anatomical locations of a patient, such as via a set 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 include tonic stimulation and / or more complex stimulation waveforms (e.g., as represented by the stimulation example SP of device 10). A first set of stimulation elements 260 may be positioned in a first anatomical location to deliver therapy and / or receive current for therapy delivery (e.g., pain treatment), while a second set of stimulation elements 260 may be positioned in a second anatomical location to deliver therapy and / or receive current for therapy delivery (e.g., pain treatment). The first and second anatomical locations may include overlapping portions (e.g., the same tissue is included in each location) or they may be tissues of completely different volumes. 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.

[0207] In some embodiments, one or more sets of stimulation elements 260 are configured to provide “combined waveform therapy,” wherein the stimulation waveforms defined by the stimulation paradigm SP and delivered by the elements 260 comprise a combination of two or more waveforms. For example, a first waveform may be delivered to a first anatomical location where pain is present, and a second waveform may be delivered to a second anatomical location. The first waveform may include stimulation energy delivered at frequencies up to 100 Hz (e.g., to treat pain). The second waveform may include stimulation energy delivered at frequencies higher than the first waveform, such as 1 kHz or higher (e.g., for subthreshold stimulation).

[0208] In some embodiments, one or more sets of stimulation elements 260 are configured to provide “microburst waveform therapy”, wherein the stimulation waveform defined by the stimulation paradigm SP and delivered by the element 260 includes the delivery of stimulation energy that is repeatedly turned on and off to provide therapy such as repetitive enhancement based on the start of stimulation energy delivery (e.g., relative to continuous stimulation energy delivery).

[0209] In some embodiments, one or more stimulation elements 260 are configured to provide “paired stimulation therapy”, wherein the stimulation waveform defined by the stimulation paradigm SP and delivered by the element 260 includes at least two different types of waveforms delivered simultaneously, such as when the stimulation waveform includes two or more of the following: tetanic stimulation waveform; microburst stimulation waveform; and / or waveforms including a combination of pulses, bursts and / or bursts.

[0210] Each implantable device 200 can be configured to perform charge recovery in an “active” and / or “passive” manner. For example, device 200 can perform active recovery by including pulses of opposite polarity to the stimulation pulses to result in zero net charge at stimulation element 260 (e.g., stimulation charge = recovery charge). Device 200 can perform passive charge recovery by electrically connecting stimulation element 260 for a period of time after the delivery of stimulation energy to allow charge dissipation (e.g., to allow charge dissipation on the included blocking capacitor), thereby generating a net zero charge at stimulation element 260. In some embodiments, implantable device 200 can perform charge recovery as described in co-pending U.S. Patent Application Serial No. 17 / 384,020, entitled “Stimulation Apparatus,” filed July 23, 2021. The configuration of active and / or passive charge recovery can be defined by stimulation paradigm SP.

[0211] In some embodiments, the device 10 may be configured to apply a “pulse width constraint” when evaluating the compatibility of a set of stimulation parameters and / or when determining an acceptable range of values ​​for stimulation parameters that will be used with other sets of stimulation parameters. For example, when the delivered stimulation includes stimulation delivered at a relatively high rate (e.g., above 1 kHz, such as approximately 1.5 kHz), there may be parameter constraints applied due to the shorter pulse width of the stimulation pulses. The implantable device 200 may include a “minimum switching time” to be taken into account when determining stimulation setup compatibility, such as a switching time of approximately 180 μsec. In some embodiments, the device 10 is configured to deliver pulses to each region before the start of a subsequent stimulation cycle. For example, the minimum amount of time available to deliver all pulses is determined by the highest programmed stimulation rate (i.e., the waveform including the shortest interval), while taking into account any other associated requirements, “overhead” herein, such as switching time requirements (e.g., switching requirements for the current source, such as a time requirement of approximately 180 μsec). In other words, the minimum stimulation interval must be at least the sum of all pulse widths plus the overhead time. In some embodiments, the delivered stimulation comprises a high-rate stimulation waveform of 1.5 kHz, and the device 10 may limit the passive recovery pulse width to a maximum of 110 μsecs and the active recovery pulse width to a maximum of 55 μsecs.

[0212] In some embodiments, the device 10 can be configured to base the drug delivery on-off and off times (D, respectively). ON and D OFF Each administration period (as described herein) applies an envelope for stimulation. Device 10 can provide up to two administration periods, which can be correlated with the rate of stimulation. In some embodiments, device 10 constrains D... ON and / or D OFF D ON The maximum time interval can be limited to 1 second. (D) OFF It can be limited to a time period of 2 seconds, such as during the administration period (D). ON Add D OFFWhen the time period is limited to 2 seconds. The device 10 can be configured to deliver stimulation energy at multiple rates, wherein a first rate (e.g., a relatively high rate) is delivered at a predetermined rate (e.g., a rate input via user interface 680), and a second rate (e.g., a relatively low rate or otherwise lower than the first rate) is generated using a subset N of M pulses delivered at the higher rate to effectively achieve a "N of M scheme" of the lower rate, as described in International Application Serial No. PCT / US2021 / 047815 entitled "Apparatus for Delivering Customized Stimulation Waveforms" filed by the applicant on August 26, 2021.

[0213] External device 500 may include one or more sensors (sensor 595 shown). In some embodiments, sensor 595 includes sensor-based functional elements 599a as described herein. In some embodiments, sensor 595 includes a sensor configured to detect a control for user input.

[0214] The device 10 may further include a programmer 600 (e.g., a patient programmer 600' and / or a 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" facilitated by the programmer 600. For example, the programmer 600 may upload information from a first device 500a (e.g., uploading all or part of the information stored on device 500a to the memory of device 600) and upload similar type of information from a second device 500b (e.g., uploading to a different portion of the memory of device 600). If the information on the two devices 500 is different, a synchronization routine may be executed, such as requiring a user (e.g., a patient, their clinician, or other user) to confirm which sets of information (e.g., stimulation settings) should be synchronized (e.g., which will be stored on both devices, which will be used as stimulation settings for the next or future stimulation session, which will be overwritten and may be erased, etc.). 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 programmer 600 (e.g., sent to programmer 600) can be downloaded to one or more external devices 500. Information transmitted 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 device 10 settings; device 10 usage information (e.g., history); and / or patient usage information.

[0215] In some embodiments, device 10 may be configured to provide a user with feedback (“user feedback”) regarding one or more parameters and / or conditions of device 10 (e.g., current or past parameters and / or conditions). For example, device 10 may provide user feedback including an assessment of the alignment of external device 500 relative to implantable device 200, and / or an assessment of the quality of the connection between external device 500 and implantable device 200 (e.g., a wireless connection for power and / or data transfer, as described herein). In some embodiments, user interface 580 of external device 500 provides feedback to the patient, such as audible, visual, tactile, and / or other forms of feedback. In some embodiments, feedback may include “binary feedback,” such as “go, no-go” type feedback, which acknowledges and / or alerts the user whether the device alignment and / or connection between the devices is adequate or unacceptable. For example, an indicator (e.g., an acknowledgment beep and / or vibration) may acknowledge when adequate alignment has been achieved as external device 500 is being positioned on the patient. Alternatively or additionally, the feedback provided may include “scalar feedback.” For example, when the external device 500 is being positioned on a patient, audible feedback (e.g., a buzzer) can increase and / or decrease in volume based on the quality of alignment and / or connection between the devices. When the connection quality reaches a sufficient level, the buzzer can be altered (e.g., by changing the tone and / or pattern) to indicate the correct placement of the external device 500. As another example, when the external device 500 is being positioned on a patient, the programmer 600 can provide visual indications (e.g., color-coded indicators and / or signal strength “bars”) based on the quality of alignment and / or wireless connection between the devices. In some embodiments, the device 10 provides feedback related to one or more usage parameters of the device 10, such as the power consumption of the implantable device 200 and / or the external device 500, such as power consumption during various types of stimulation (e.g., power consumption of different stimulation procedures performed by the device 10). In some embodiments, an indication of sufficient signal quality determined by the device 10 can be incorporated with information about the expected power consumption of the implantable device, and this indication can be adjusted accordingly. In this configuration, the indication of sufficient signal quality is adaptive to the programming behavior of the device 10.

[0216] In some embodiments, device 10 may be configured to operate in a closed-loop configuration. For example, device 10 may record diagnostic and / or usage information, such as patient-specific information that may be associated with the implantation site of implantable device 200, the patient's proficiency in placing external device 500 relative to implantable device 200, usage history (e.g., patient adherence to prescribed usage of device 10), patient outcomes (e.g., patient-reported pain relief), and / or other parameters that may be monitored and / or evaluated over time. The diagnostic and usage information recorded by device 10 may be analyzed, and the resulting analysis may be used to adjust these and / or other parameters of device 10, such as parameters of one or more stimulation procedures. The diagnostic and usage information recorded by device 10 may be analyzed, and the resulting analysis may be used to: alert patients, caregivers, and / or clinicians to deviations from prescribed usage; alert clinicians to problems with components of device 10 (e.g., the need to replace and / or adjust the implantation site of implantable device 200); and / or initiate (e.g., automatically initiated and / or alerting user-initiated) further changes or adjustments to one or more parameters of device 10 (e.g., iterative changes or adjustments). In some embodiments, device 10 may be configured to allow clinicians to remotely monitor one or more patients (e.g., via a clinician programmer 600'' connected to a patient programmer 600' and / or an external device 500, via a server of device 10 and / or a wide area network such as the Internet) and, for example, adjust therapies delivered by device 10 based on recorded diagnostic and / or usage information. In some embodiments, device 10 may be configured to analyze diagnostic and usage information from multiple patients using device 10, such as to identify trends, problems, beneficial treatment parameter adjustments, and / or information for clinicians to review in order to benefit one or more patients using device 10.

[0217] In some embodiments, one or more devices of the apparatus 10 may be configured to send information to a remote data processing device, receive information from a remote data processing device, and / or otherwise communicate with a remote data processing device, such as... Figure 1The server 700 is depicted herein. Server 700 may include “off-site” servers (e.g., outside the clinical setting and / or patient location where device 10 is used by a patient), such as servers owned, maintained, and / or otherwise provided by the manufacturer of device 10. Alternatively or additionally, server 700 may include a cloud-based server. Server 700 may include the processing unit 710 shown herein, which may include modules (e.g., electronic modules) that can be configured to perform and / or facilitate one or more functions of device 10, such as one or more processing, data collection, data analysis, data transmission, signal processing, and / or other functions of device 10 (“functions of device 10” or “device functions” herein). Processing unit 710 may include one or more electronic components, electronic assemblies, and / or other electronic parts, such as those selected from the group consisting of: microprocessors; microcontrollers; state machines; memory storage components; analog-to-digital converters; rectifier circuits; filters and other signal conditioners; sensor interface circuits; transducer interface circuits; and combinations of one, two, or more of these. For example, the processing unit 710 may include at least one processor and at least one memory storage component, such as processor 712 and memory 713 that may be coupled to processor 712.

[0218] In some embodiments, server 700 may be configured to receive and store data in various forms, such as data 720, which may be data recorded by implantable device 200, external device 500, and / or other components of device 10. In some embodiments, data 720 may be collected by charger 61, such as during charging of external device, and may then be uploaded to server 700. The data 720 may then be used for a variety of purposes, such as for analysis and / or troubleshooting. For example, data 720 may be analyzed to monitor device malfunctions (e.g., device malfunctions of external device 500 and / or implantable device 200), device misuse (e.g., incorrect alignment between external device 500 and implantable device 200), therapeutic efficacy, and / or the like.

[0219] Data 720 may include data collected from one or more patients (e.g., multiple patients treated using device 10), and may include data collected over extended time periods (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 (inclusive of all values ​​and subranges thereof)). In some embodiments, devices of device 10 may be configured to communicate with server 700 via a network, such as a wide area network like the Internet. Alternatively or additionally, device 10 may include a virtual private network (VPN) through which various devices of device 10 may transmit data.

[0220] In some embodiments, data 720 can be used to detect potential device malfunctions and, in some embodiments, proactively initiate the replacement of one or more components of device 10. For example, device 10 can be configured to detect one or more indications of external device 500 and / or implantable device 200 (e.g., a degraded external device 500 and / or implantable device 200) by analyzing data 720. Upon such detection, a notification can be automatically generated (e.g., via a programmer 600 associated with external device 500 and / or implantable device 200) to initiate the replacement of external device 500 and / or implantable device 200. This notification can be provided to a clinician via clinician programmer 600'' and / or to a patient via patient programmer 600''. If the patient requires a device replacement (e.g., due to damage or loss), a new external device 500 and / or implantable device 200 can be sent to the patient (e.g., directly from the manufacturer of device 10) for remote device setup. The replacement external device 500 may have the configuration data preloaded before sending the patient's configuration data (e.g., a portion of data 720) to the patient. This data may include one or more of device identification information, safety information, and therapy information (e.g., stimulation programming specific to the patient).

[0221] Additionally or alternatively, data 720 may be used to identify or confirm misuse of one or more components of device 10. For example, misalignment of external device 500 and / or selection of parameter settings exceeding predefined thresholds or values. For instance, the selection of parameter settings that produce excessive amplitude or power consumption (i.e., meet or exceed their predefined thresholds) can be detected by analyzing data 720. In response, a notification including instructions for modifying usage to improve effectiveness can be automatically generated via the associated programmer 600. As another example, device 10 may periodically (e.g., periodically and / or upon request) monitor the quality of the connection between external device 500 and implantable device 200. As explained above, alignment between external device 500 and implantable device 200 can affect the power and / or data link between the two devices. Device 10 may be configured to compare a portion of data 720, including relevant connection measurements, with predefined thresholds to detect a decline in alignment quality. If the alignment quality falls below a predefined threshold, device 10 may generate a notification via server 700 via programmer 600 (e.g., patient programmer 600'). For example, in some embodiments, the notification may include instructions to the patient on how to adjust the placement of external device 500 or stimulation parameters used for device 10 to restore connectivity or otherwise increase the strength and / or consistency of the connection between external device 500 and implantable device 200. Additionally or alternatively, device 10 may be configured to automatically adjust one or more stimulation parameters to improve connectivity.

[0222] In some embodiments, server 700 may be configured to allow data 720 (e.g., at least a portion thereof) to be shared across multiple devices 10 (e.g., multiple programmers 600), such as multiple devices 10 associated with multiple corresponding patients and / or clinicians. For example, data from one or more first patient programmers 600' may be shared via server 700 with one or more second patient programmers 600' and / or one or more clinician programmers 600''. In some embodiments, data from at least one patient programmer 600' may be shared via server 700 with multiple clinician programmers 600''. Thus, any of the multiple clinician programmers 600'' can be used to reprogram and / or update a given patient programmer 600'.

[0223] In some embodiments, device 10 may be configured to remotely interface with one or more patient devices (e.g., external devices 500, implantable devices 200, chargers 61, and / or other device 10 devices maintained by the patient) used by one or more patients using device 10 (e.g., one or more patients having an implantable device 200 implanted in the patient and one or more external devices 500 communicating with the device 200). For example, a clinician of a patient using device 10 may interface remotely with the patient device, such as via a clinician programmer 600 remotely connected via the Internet. In some embodiments, server 700 may be configured to provide a secure connection between the clinician and the patient using device 10. Device 10 can be configured to enable a clinician or other user of device 10 (e.g., another patient caregiver) to initiate a remote programming session (as described below), initiate device 10 component updates (e.g., firmware updates for external device 500, implantable device 200, charger 61, and / or other components of device 10), and / or remotely configure and / or guide the setup process of components of device 10 (e.g., a new external device 500, which may be shipped directly from the manufacturer of device 10 to the patient, allowing the device to be set up without clinician access). In some embodiments, one or more components of device 10 may be interchangeable (e.g., external device 500 may be delivered to the patient as a new hardware version becomes available).

[0224] Remote or assisted reprogramming sessions can facilitate the selection of new or predefined stimulation protocol templates in response to common patient complaints, such as overstimulation, insufficient amplitude, loss of efficacy, and / or hypersensory disturbances. In some embodiments, a combination of remote and assisted reprogramming can help streamline therapy modulation. During a remote reprogramming session, the patient can directly retrieve or otherwise receive (e.g., via server 700) stimulation protocol templates via external device 500 and / or patient programmer 600', allowing for remotely driven modulation of stimulation parameters. Once new or predefined stimulation protocol templates are uploaded to external device 500 and / or patient programmer 600', they can be selected by the patient as needed. In some embodiments, the patient can assess the effectiveness of a stimulation protocol template by temporarily replacing their current stimulation protocol with the template. For example, programmer 600' can be configured to receive selection via input through a user interface and can transmit stimulation protocol templates to external device 500, which can then transmit update instructions containing the stimulation protocol templates to implantable device 200 for implementation. Next, the stimulation program template can be used for predefined time periods, such as approximately 5 minutes to approximately 1 week, approximately 15 minutes to approximately 5 days, approximately 30 minutes to approximately 1 day, approximately 1 hour to approximately 12 hours, or approximately 3 hours to approximately 8 hours (including all ranges and subranges in between). If, during or after the predefined time period, the patient determines that the stimulation program template meets the desired conditions, the patient can request (e.g., via the patient programmer 600') to use the stimulation program template as their permanent or semi-permanent stimulation program. Conditions can be, for example, reduced overstimulation, reduced paresthesia, and / or increased therapeutic benefits (e.g., by increasing amplitude, frequency, etc.). For example, a patient who determines that the stimulation program template induces fewer paresthesias than their current stimulation program can optionally select the stimulation program template for permanent or semi-permanent use. As another example, a patient who determines that the stimulation program template provides more pain relief than their current stimulation program can optionally select the stimulation program template for permanent or semi-permanent use. In such cases, the stimulation program template can be provided to the patient (e.g., via the programmer 600') as a new stimulation program.

[0225] Additionally or alternatively, assisted reprogramming sessions can be performed in person or via a secure link to upload new or predefined stimulation program templates. For example, various combinations of stimulation programs selected based on, for instance, historical data, observed patient responses, and / or patient surveys can be input into a programmer (e.g., clinician programmer 600''). The stimulation program template can be transmitted (e.g., via a wired or wireless link) to an external device 500 for testing on patients, while clinicians observe their responses. Similar to the remote sessions described above, patient responses can 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 treatment benefits).

[0226] Reference Figure 2A A cross-sectional view of an implantable device comprising multiple leads, consistent with the concept of the present invention, is shown. Figure 2A The implantable device 200 includes two leads, as shown in the figure, leads 265a and 265b. Each lead 265 includes a proximal portion having one or more electrical contacts (contacts 267). Each contact 267 is electrically connected to a corresponding set of one or more stimulating elements 260 positioned on the distal portion of each lead 265. Figure 2A The eight contacts 267 and eight stimulation elements 260 are shown.

[0227] The implantable device 200 may include one or more attachment components 280 (two shown, 280a, 280b), each configured to slidably receive and securely attach to the proximal portion of the lead 265. Each attachment component 280 may include an attachment port (port 285 shown) configured to slidably receive the proximal end of the lead 265. Each attachment component 280 may include one or more contacts (contacts 287 shown) within each port 285, wherein the contacts 287 are configured to electrically contact a corresponding contact 267 of the inserted lead 265 (forming an electrical path between the electronics of the implantable device 200, such as the controller 250, and each stimulating element 260). Figure 2A In the diagram, lead 265a is shown disconnected from attachment assembly 280a, and lead 265b is shown fully inserted into attachment assembly 280b.

[0228] Each lead 265 may include a rigid band, such as a ring 268 as shown, on which a fastening element may be secured (e.g., frictionally engaged with the ring 268). Each attachment assembly 280 may include one or more such fastening elements, such as a fastener 284 as shown. The fastener 284 may include a set screw configured to fasten (e.g., frictionally engage with) the ring 268 of the inserted lead 265. The ring 268 may include a conductive material and may be aligned with a contact 287 of the attachment assembly 280 such that the ring 268 is electrically connected to the implantable device 200 (e.g., to a controller 250). When the lead 265 is fully inserted into the attachment assembly 280, the ring 268 may extend from within the attachment assembly 280 to a location beyond the distal end of the attachment assembly 280, such that the ring 268 may contact surrounding tissue (e.g., provide electrical contact to the tissue). In this arrangement, the ring 268 may be used as a unipolar return electrode when stimulation energy is delivered to the tissue in a unipolar mode via one or more stimulation elements 260 and “collected” by the ring 268. The distal end of the ring 268 may be located within 5 cm of the distal end of the connecting assembly 280 into which the lead 265 is inserted. In some embodiments, the next proximal stimulation element 260 is located at least 10 cm from the distal end of the ring 268 corresponding to the lead 265.

[0229] The ring 268 may comprise platinum, platinum / iridium, or a more durable material, such as alloy MP35N. In some embodiments, the attachment assembly 280 includes nine contacts 287 (as shown), and up to eight contacts 267 of the ring 268 and the lead 265 (shown as eight) may be electrically connected to corresponding contacts 287. In other embodiments, the attachment assembly 280 includes eight contacts 287, and up to seven contacts 267 of the ring 268 and the lead 265 may be electrically connected to corresponding contacts 287 (e.g., when the lead 265 includes the ring 268 and between four and seven contacts 267). In some embodiments, the implantable device 200 includes one or more attachment assemblies 280 that collectively include a plurality of contacts 287, such as four, eight, twelve, sixteen, 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 components 280 are each 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 component 280 is attached to a ring 268 configured as a return electrode, and the remaining contacts 287 are available to contact a corresponding number of contacts 267. In some embodiments, two or more contacts 267 and / or 287 are electrically connected (i.e., “short-circuited together”), such as to serve as a single contact (e.g., a single contact configured as a unipolar return electrode).

[0230] See also Figure 2B The diagram shows a cross-sectional view of another implantable device 200 comprising a plurality of leads 265, which is consistent with the concept of the present invention. Figure 2B The implantable device 200 can be with Figure 2A The implantable device has a similar structure and arrangement to 200 other implantable devices. Figure 2B In this embodiment, as an alternative to the ring 268 serving as a unipolar return electrode, each lead 265 includes a proximally positioned stimulation element (stimulation element 260R shown), which may include an electrode that can be configured as a unipolar return electrode (e.g., an electrode that collects energy delivered via one or more stimulation elements 260, as described herein, when stimulation is delivered in unipolar mode). In some embodiments, element 260R may include a ring electrode, such as a conductive ring surrounding a portion of lead 265. Stimulation element 260R is located relatively close to the distal end of the associated attachment assembly 280 (when lead 265 is fully inserted into that attachment assembly 280), such as within 5 cm of the distal end of that attachment assembly 280. In some embodiments, the next proximal stimulation element 260 is located at least 10 cm from the stimulation element 260R of the corresponding lead 265.

[0231] Now refer to Figure 3 The diagram illustrates a flowchart of a method for updating the firmware and / or other software of a medical device in accordance with the concepts of this invention. Figure 3 Method 1000 may include a method for updating firmware and / or software (e.g., software excluding firmware) of one or more components of the device 10 described herein. In step 1100, one or more components of the device 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 the device 10) to perform a check for potential software updates (e.g., software changes and / or additions) applicable to those one or more components of the device 10.

[0232] In step 1200, if at least one software update is available for device 10 components, method 1000 proceeds to step 1300. If the software currently in place (e.g., currently installed) in one or more device 10 components is up-to-date, method 1000 returns to step 1100. In some embodiments, a time delay (e.g., a delay for a predetermined time period), such as optional step 1150 as shown, may be included, wherein the duration of this time period is the periodicity of repeated checks by one or more device 10 components to determine the applicable software update (e.g., daily or weekly).

[0233] In step 1300, one or more new versions of software are installed on one or more applicable device 10 components. Also in step 1300, one or more device 10 components (e.g., those that have just undergone or otherwise received a software update) may perform a check for potential firmware updates for that component and / or another component of device 10. For example, programmer 600 may track the firmware versions of external device 500 and / or implantable device 200. Upon receiving a software update (e.g., which may include information related to currently available firmware versions for various components of device 10) or otherwise, programmer 600 and / or other device 10 components may determine whether external device 500 and / or implantable device 200 is available (e.g., requires) for a firmware update.

[0234] In step 1400, if one or more firmware updates are available, method 1000 proceeds to step 1600. Otherwise, method 1000 returns to step 1100 (e.g., via a delayed step 1150, if present).

[0235] In step 1600, the components of the device 10 requiring firmware updates are updated (e.g., via programmer 600 receiving firmware updates from a server). After step 1600, method 1000 returns to step 1100 (e.g., via a delayed step 1150, if present).

[0236] Another method for reprogramming a neurostimulation system may include: receiving data at a base station (e.g., charger 61) via, for example, a remote connection; transmitting the data from the base station to an external device (e.g., external device 500) via, for example, a local connection; and instructing (e.g., via external device 500) an implantable device (e.g., implantable device 200) to use the data to stimulate the patient's tissue. In some embodiments, the method may additionally or alternatively include: receiving data at a remote device (e.g., a smart device such as a smartphone, smartwatch, smart ring, and / or the like); transmitting the data from the remote device to the external device; and instructing the implantable device to use the data to stimulate 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. Furthermore, the external device may instruct the implantable device via, for example, a wireless connection. In some embodiments, the base station may receive data via, for example, a remote connection (e.g., a WAN connection) via, for example, one or more remote devices (e.g., patient programmer 600' or clinician programmer 600''). Similarly, one or more remote devices may be configured to retrieve data from the base station and / or the external device (e.g., via a remote connection). In some embodiments, data may be downloaded to an external device (e.g., to the memory of external device 500). Non-limiting examples of data may include, but are not limited to, software, such as firmware updates described herein, and / or stimulation data including one or more of stimulation parameters, stimulation programs, stimulation programming schedules, and implantable device configurations. In some embodiments, data received at a base station or a first remote device and transmitted to an external device to indicate an implantable device may be first data, and any data retrieved by one or more second remote devices from the base station, the first remote device, and / or the external device may be second data. First data and second data may be the same data or different data. For example, second data may include data related to the stimulation program (e.g., statistics on stimulation program usage) and / or device or system configuration data (e.g., charging / lifetime statistics for the power supply 570 of external device 500).

[0237] Now refer to Figure 4 The diagram shows a top view, a side view, and a perspective transparent view of a lead anchor element conforming to the concept of this invention. Figure 4 The anchor element 221 is configured to anchor the lead wire 265 to the patient's tissue. Figure 4A yes Figure 4A perspective cross-sectional view of the overmolded part 2220 of the anchor element 221. Figure 4B This is a perspective view of the compression assembly (compression assembly 2210) of anchor element 221. Figure 4C yes Figure 4 A cross-sectional view of the anchor element 221 along line AA shows the compression assembly 2210 positioned within the cavity of the anchor element 221. Figure 4D This is a cross-sectional side view of the compression component 2210.

[0238] Compression assembly 2210 includes a housing, namely housing 2211, which may include a rigid housing surrounded (e.g., at least partially surrounded) by a flexible outer cover (overmolded member 2220), each as shown in the figure. Overmolded member 2220 may include a silicone material and / or other materials created via an overmolding process. Overmolded member 2220 may include a Shore hardness of at least 40 (e.g., to improve slippage along lead 265 and / or prevent buckling). Overmolded member 2220 and compression assembly 2210 may each include lumens, lumens 2221 and 2214, through which lead 265 may be inserted. Overmolded member 2220 may include a tapered portion (taper 2222). Taper 2222 may be positioned toward the distal end of lead 265 when implanted in a patient (e.g., the distal end of lead 265 may be inserted through lumens 2221 and 2214, such that lead 265 is withdrawn from taper 2222). The tapered portion 2222 may include geometry that effectively expands the soft tissue when inserted through it. The tapered portion 2222 may include a tapered portion that minimizes the forces exerted on the lead 265 by the tissue, such as minimizing undesirable migration of the lead 265 after implantation. The tapered portion 2222 and other portions of the overmolding member 2220 may be configured to reduce migration of the lead 265 once it is implanted into the patient's tissue. The tapered portion 2222 may allow for more precise placement of the lead 265, such as due to the lower insertion force required by the tapered portion. Furthermore, the lower insertion force may result in a more "tight fit" of the lead 265 within the tissue. The overmolding member 2220 may serve as a strain relief member that can reduce bending of the lead 265 (e.g., reduce bending that would otherwise lead to migration of the lead 265).

[0239] The overmolded component 2220 may include one or more locations where sutures, clips, staples, and / or other fixation elements (“sutures” herein) may be applied to secure the anchor element 221 to the tissue. For example, the overmolded component 2220 may include one or more complete or partial circumferential recesses (fixation points 2224). Figure 4(Two are shown in the diagram), and sutures can be placed around it and secured to the tissue. Alternatively or additionally, the overmolding 2220 may include one or more through holes (suture tongues 2224a) to which sutures can be attached and secured to the tissue. Secure the overmolding 2220 (e.g., anchor element 221 and any one or more inserted leads 265) to the tissue with sutures using the suture tongues 2224a also prevents or at least reduces twisting of the anchor element 221 (e.g., reduces twisting of one or more inserted leads 265).

[0240] Compression assembly 2210 may include a translational element (translatable element 2216) that is translated via rotation of a mating element (driver 2212), each as shown in the figure. For example, element 2216 and driver 2212 may include mating threads as shown in the figure, causing the translational element 2216 to translate upward (e.g., Figure 4D Rotation of the actuator 2212 (shown) correspondingly pushes the compression sleeve (sleeve 2215 shown) against a section of the lead 265 (not shown) that has been inserted through the lumen 2214, thereby securing the lead 265 between the inner top surface of the lumen 2214 and the compression sleeve 2215. The actuator 2212 may include an engagement portion (port 2217) that engages with a rotatable tool 2230 (tool 2230) (e.g., Figure 4D (As shown). Port 2217 may include a flange feature (linear stop 2218) that prevents tool 2230 from extending through driver 2212 (e.g., to prevent tool 2230 from contacting translational element 2216, such as to prevent translational element 2216 from stopping without completing its intended translation).

[0241] The overmolded component 2220 may include one or more engaging elements (protrusions 2223 shown). The housing 2211 of the compression assembly 2210 may include one or more mating engaging elements (recesses 2213 shown) that may be sized and arranged to frictionally engage the protrusions 2223 of the overmolded component 2220. In an alternative embodiment, each of the protrusions 2223 may include a recess, and each of the recesses 2213 may include a mating protrusion. The housing 2211 may include a titanium housing. The engagement of the protrusions 2223 and the recesses 2213 helps to retain the housing 2211 within the overmolded component 2220. The engagement of the protrusions 2223 and the recesses 2213 may be configured to resist undesirable effects of torsion and / or other applied loads (e.g., caused by the fastening actuator 2212), such as preventing (or at least limiting) decoupling of the housing 2211 from the overmolded component 2220. The engagement of the protrusion 2223 and the recess 2213 can also prevent (or at least reduce) the vertical decoupling, swaying and / or tilting of the housing 2211 within the overmolded part 2220.

[0242] In some embodiments, the anchor element 221 (e.g., overmolded member 2220) includes one or more openings configured to align with one or more stimulation elements 260 of the inserted lead 265, such as to allow directional stimulation from the lead 265, as described herein with reference to window 2242 of the anchor element 221.

[0243] Now refer to Figure 5 The image shows a perspective view of a sleeve, a lead, and an applicator tool for covering a portion of a lead, in accordance with the concept of the present invention. Figure 5A The side and bottom views of the sleeve used to cover a portion of the lead wire are shown. Figure 5B A side view and a bottom view of another embodiment of the sleeve used to cover a portion of the lead wire are shown. Figure 5C and Figure 5D Another embodiment of a sleeve and clamp for covering a portion of the lead wire is shown. Figure 5E The top and bottom views of the sleeve used to cover the two leads are shown. Figures 5F-5H It is a perspective view of the electrodes and the electric field generated therefrom that can be generated by the device of the present invention.

[0244] Device 10 may include a sleeve, such as Figure 5 and Figures 5A-5E The cannula 224 is shown. The cannula 224 may include a housing (outer shell 2240) comprising a lumen (lumen 2241) at least partially passing through it, each as shown in the figure. The lumen 2241 may be sized and arranged to slidably receive a distal portion of a lead 265 (e.g., the lead 265 includes 2, 4, 6, 8, 12, or 16 electrode-based stimulation elements 260). The cannula 224 may include one or more openings (windows 2242) (such as 2, 4, 6, 8, 12, or 16 openings). Figure 5 (As shown in the diagram, four openings are provided.) When the lead 265 is correctly inserted through the lumen 2241, one or more openings are aligned with the stimulating element 260 of the lead 265 (e.g., when the cannula 224 is positioned above the lead 265, the window 2242 is aligned with the element 260). The window 2242 is configured (e.g., sized and positioned) to expose only a portion (e.g., less than 100%) of the surface area of ​​each stimulating element 260 (otherwise, that surface area would be fully exposed) (e.g., exposing only the circumferential portion between 45° and 180° of the annular element 260), such as to allow (e.g., cause) “directional stimulation” from the stimulating element 260 (e.g., element 260 including an annular electrode). When the lead 265 is implanted, the window 2242 may be positioned toward the tissue to be stimulated (e.g., rotated and positioned by a clinician). The cannula 224 may comprise one or more materials, such as polyurethane and / or silicone materials.

[0245] In some embodiments, the cannula 224 may be configured and arranged to be secured to tissue to correspondingly secure an inserted lead 265 (e.g., its electrode or other stimulation element 260) at a desired tissue location. For example, the cannula 224 may include one or more complete or partial circumferential recesses (fixation points 2246). Figure 5A (Two are shown in the figure), sutures can be attached around and secured to the tissue. Alternatively or additionally, cannula 224 may include one or more other types of anchoring locations, such as suture tongues (e.g., similar to suture tongue 2224a described herein), loops, needle-permeable materials and / or other anchoring elements that can be secured to the tissue (e.g., using sutures, clips, pins and / or other fixation elements).

[0246] In some embodiments, the sleeve 224 may include an insulating material (e.g., an electrically insulating material), such as silicon, to prevent electrical connections between two or more stimulating elements 260.

[0247] Device 10 may include an applicator tool (tool 229 shown) configured to allow a clinician to position cannula 224 onto a distal portion of lead 265. For example, lumen 2241 may include a diameter smaller than (e.g., slightly smaller than) the outer diameter (OD) of lead 265, and applicator tool 229 may be used to stretch cannula 224 to engage lead 265, after which cannula 224 may frictionally engage lead 265 (e.g., to prevent undesirable movement between cannula 224 and lead 265). In some embodiments, tool 229 may include a scissor-like tool, as shown, including a split shaft attached to a handle, the split shaft being configured to separate the two halves of the shaft when the handle is closed. The split shaft of tool 229 may be slidably positioned within lumen 2241 of cannula 224 and unfolded to stretch lumen 2241 such that lead 265 can be positioned within lumen 2241. In some embodiments, tool 229 may include an opening through a hinged portion of the tool such that lead wire 265 can be inserted into lumen 2241 from the handle side of tool 229 (e.g., when both tool 229 and lead wire 265 are inserted into lumen 2241 from the same direction), and / or such that tool 229 can be removed from lumen 2241 after lead wire 265 has been inserted (e.g., removed from lead wire 265).

[0248] In some embodiments, the sleeve 224 includes an anchoring mechanism based on a set screw. Figure 5A Anchor assembly 2243 is shown in the figure. Anchor assembly 2243 may be similar to compression assembly 2210, and assembly 2243 may be configured to securely attach sleeve 224 to lead wire 265 (e.g., via rotation of set screw).

[0249] In some embodiments, the sleeve 224 includes a cavity for adhesive. Figure 5B The adhesive well 2244 is shown in the figure. In these embodiments, adhesive can be injected into the well 2244 to adhesively secure the sleeve 224 to the lead 265.

[0250] In some embodiments, sleeve 224 includes a clamp ( Figure 5C and Figure 5D The clip 2245 shown in the figure), and the recess on which the clip 2245 can be attached (e.g., as shown in the figure). Figure 5C (As shown in the attachment). In some embodiments, the fixed point 2246 (e.g., as shown in the attachment) Figure 5C (As shown) a recess to which a clip 2245 can be attached. In these embodiments, a suture can be positioned around the clip 2245, and when tightened, a force applied to the suture and the clip 2245 causes the sleeve 224 to frictionally engage the inserted lead 265. The clip 2245 may include a split loop design, as shown, which can be configured to close as the suture is tightened around the clip.

[0251] The sleeve 224 may include multiple lumens (e.g., two to four lumens) such that the sleeve 224 can slidably receive up to a corresponding number of leads 265, such as two lumens 2241a and 2241b, each of which can receive a separate lead 265, as shown below. Figure 5E As shown in the diagram. In this particular arrangement of multiple lumens, the sleeve 224 can maintain a fixed distance and fixed alignment between the multiple leads 265, such as to effectively mimic the functionality of the paddle-electrode type lead 265.

[0252] and Figure 5G Compared to the stimulation field generated by the fully exposed (unshielded) element 260 (which generates a 360° stimulation field) illustrated in the middle, Figure 5F An example of a stimulation field smaller than 360° generated by a partially shielded stimulation element 260 (e.g., enclosed within a sleeve 224 as described above) is shown. The window 2242 can be positioned in various modes, such as a rotational mode, to generate a stimulation field smaller than 360°. Figure 5H The "bottle opener-shaped" stimulus field pattern shown.

[0253] Now refer to Figures 6A-6I Various views of an implantable tool conforming to the concept of the present invention are shown. Tool 650 and / or implantable device 200 may be as described in the reference. Figure 1Similar construction and arrangement to similar components described elsewhere herein. Tool 650 may include an elongated tunneling tool including a fixation mechanism configured to temporarily attach (e.g., removably attach) to the implantable device 200 while it is being inserted into a patient (e.g., during the tunneling portion of the implantation procedure). For example, tool 650 may include a shaft (shaft 651) extending from a handle (handle 652), as shown. The distal end of shaft 651 may include a protrusion or other connecting element (connector 653) configured to temporarily attach to the implantable device 200. For example, connector 653 may be inserted into a recess (port 253 shown) in the housing of the implantable device 200. Tool 650 may include a fixation mechanism, a cage 655, which at least partially surrounds the implantable device 200 to secure the device 200 to tool 650 during the tunneling process. The retainer 655 can be slidably received on the shaft 651, such that the retainer 655 can be retracted (e.g., as shown in the image). Figure 6A As shown), to expose connector 653 for subsequent connection to implantable device 200. Cage 655 can be advanced over the distal portion of shaft 651 (e.g., as shown). Figure 6B As shown), to implantable device 200 ( Figure 6B (Not shown) can be operatively connected and secured to tool 650 for tunneling.

[0254] The tool 650, including the retainer 655, may include a plurality of "anchor points" at which the tool 650 abreastly or otherwise engages the implantable device 200. For example, as Figure 6C As shown, retainer 655 may include two lateral protrusions (arms 6551a, 6552b shown) secured to the side of implantable device 200. Additionally or alternatively, retainer 655 may include one or more longitudinal protrusions, such as arms 6552a, 6552b shown, secured to the top and bottom of implantable device 200. Arm 6552a may extend to and over the distal end of implantable device 200, as shown. Alternatively, arms 6552a and / or 6552b may terminate before 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 beyond the edge of the device). In some embodiments, one or more of arms 6551 and / or 6552 wrap around the edge of implantable device 200, frictionally engaging and “gripping” implantable device 200.

[0255] Figure 6DA top view of an implantable device 200 is shown, positioned within a retainer 655 and operatively attached to a tool 650 via a shaft 651. Arms 6551a, 6551b, and 6552a are shown below the 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 the implantable device 200, such that arms 6551 and 6552 surround the implantable device 200, securing the device to the tool 650. Figure 6E and Figure 6F It shows along Figure 6D A cross-sectional view of tool 650 with section AA, wherein implantable device 200 is shown or not shown. Figure 6G and Figure 6H It shows along Figure 6D A cross-sectional view of tool 650 with section BB, wherein implantable device 200 is shown or not shown. Figure 6H In the middle, the arm 6552a does not extend the length of the implantable device 200.

[0256] Figure 6I A perspective view of tool 650 is shown, in which a retainer 655 is positioned on shaft 651. Retainer 655 may include an elongated portion comprising a lumen (lumen 6553) that slidably receives shaft 651, as shown. Retainer 655 may be configured to lock in a retracted position and / or an advanced position, such as when tool 650 includes a locking mechanism (lock 6554 shown), which can be configured to lock the position of retainer 655. In some embodiments, lock 6554 includes a magnetic locking mechanism.

[0257] Figures 13A-13C The image depicts multiple views of another variant of the implantation tool. Figure 13AA side view of a first implantation tool 1300 is depicted, which may be a tunneling device or tunneling tool configured to create a subcutaneous space or pocket between the skin and / or muscle layers within a patient, such as during an implantation procedure for an implantable device. The first implantation tool 1300 may include a handle 1302 configured to be grasped by an operator so that the tool 1300 can be moved through tissue. A shaft 1304 may extend from the handle 1302, and the tool 1300 may include a first arm 1304a and a second arm 1304b extending from the shaft 1304. In some embodiments, the first arm 1304a may include a first longitudinal axis, and the second arm 1304b may include a second longitudinal axis, and the first and second longitudinal axes may be transverse to the longitudinal axis of the shaft 1304. For example, the angle formed between the first longitudinal axis and / or the second longitudinal axis and the longitudinal axis of shaft 102 can be from about 80 degrees to about 120 degrees, such as from about 85 degrees to about 115 degrees, from about 90 degrees to about 110 degrees, or from about 95 degrees to about 105 degrees (e.g., about 80 degrees, about 85 degrees, about 90 degrees, or about 95 degrees), including all ranges and subranges therein. In some embodiments, the first longitudinal axis and the second longitudinal axis can be parallel or substantially parallel.

[0258] In some embodiments, the first arm 1304a and the second arm 1304b may be integrally formed with the shaft 1304, and the shaft 1304 may be split into the first arm 1304a and the second arm 1304b. In other embodiments, the first arm 1304a and the second arm 1304b may be separately formed from the shaft 1304 and coupled to its distal end. The second arm 1304b may be positioned below the first arm 1304a and may be configured to be inserted into tissue. The first arm 1304a may be positioned above the second arm 1304b and may be configured to be held on an external surface of the patient's body, in which the second arm 1304b is positioned. Thus, the first arm 1304a and the second arm 1304b may define a gap 1306 therebetween, which is configured to receive tissue as the first implantation tool moves through the body. The gap 1306 may include heights of about 0.005 mm to about 1 in (inch), 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 subranges thereof. Furthermore, the height of one or both of the first arm 1304a and the second arm 1304b can be from about 0.05 in to about 1 in, such as from about 0.075 in to about 0.75 in, from about 0.1 in to about 0.5 in, from about 0.125 in to about 0.25 in, or from about 0.15 in to 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 in, about 0.19 in, about 0.195 in, or about 0.2 in), including all values ​​and subranges thereof. In some embodiments, the first arm 1304a and the second arm 1304b can have different lengths. For example, the second arm 1304b can be longer than the first arm 1304a. The length difference between the first arm 1304a and the second arm 1304b can be (e.g., the second arm 1304b can be longer than the first arm 1304a) 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 0.95 in, about 0.95 in, about 1 in, about 1.05 in), including all values ​​and subranges thereof.The distal end of one or both of the first arm 1304a and the second arm 1304b may include one or more features to facilitate the formation of a subcutaneous space in the tissue, as will be described in more detail herein.

[0259] Reference Figure 13B The diagram depicts a top view of the distal ends of the first arm 1304a and the second arm 1304b. In some embodiments, the second arm 1304b may include an elongated tip 1310, which may be tapered in some embodiments. For example, the width of the tip 1310 may increase proximally (or decrease distally) along the longitudinal axis of the second arm 1304b (linear or non-linear). In some embodiments, at least a portion of the tip 1310 may include a pointed or beveled shape. Additionally or alternatively, in some embodiments, at least a portion of the tip 1310 may include an arched or rounded shape. In some embodiments, the distal portion of the tip 1310 may taper at a first angle, and the proximal portion of the tip 1310 may taper at a second, different (larger or smaller) angle. In some embodiments, the tip 1310 may include a surface angled relative to the longitudinal axis. For example, the tip 1310 may include a tip angle (A) of about 5 degrees (deg) to about 45 degrees, 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 (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) relative to the longitudinal axis, including all values ​​and subranges therein. Additionally or alternatively, the tip 1310 may include one or more side surfaces 1312 that may form an edge with the top surface 1316 of the second arm 1304b. In some embodiments, the edge may be sharpened to facilitate tissue anatomy. In addition, the first arm 1304a may include a rounded distal end to prevent scratching or abrasion of the skin as the first arm 1304a moves along the external skin surface during tissue tunneling.

[0260] Back Figure 13AThe first implantation tool 1300 may further include a coupling element 1308 configured to be releasably coupled to a sheath (not shown). The sheath may be configured to receive a portion of the first implantation tool 1300 via its channel. The sheath and the first implantation tool 1300 may be introduced together through an incision site and advanced through tissue to form a subcutaneous space. The coupling element 1308 may be configured to contact or receive a portion of the sheath to maintain the positioning of the sheath relative to the first implantation tool 1300 during advancement. In some embodiments, the coupling element 1308 may include a flange or projection extending from the shaft 1304 and configured to adjoin a portion of the sheath. For example, the coupling element 1308 may be a flange configured to abut against the proximal end of the sheath as the first implantation tool 1300 is advanced to move the sheath through the tissue. Once the subcutaneous space is formed, the first implantation tool 1300 may be withdrawn from the tissue, while the sheath remains in place to provide access to the subcutaneous space.

[0261] Figure 13C An illustrative variation of this type of sheath (sheath 1320) is depicted. As shown, sheath 1320 can be configured to slidably receive the second arm 1304b of the implantation tool 1300. The second arm 1304b and sheath 1320 can be configured to be inserted into tissue when coupled. Figure 13A As shown, the coupling element 1308 can be configured to maintain the relative positioning of the first implantation tool 1300 and the sheath 1320 by pushing against the proximal end 1322 of the sheath 1320, while the first implantation tool 1300 is moved through the tissue. Once the subcutaneous space is created, the first implantation tool 1300 can be removed from the incision site, while the sheath 1320 can remain within the subcutaneous space. Thus, the sheath 1320 can provide access to the subcutaneous space and maintain one or more dimensions (e.g., length, width, and / or depth) of the subcutaneous space without the first implantation tool 1300, while performing the remainder of the procedure (as described in more detail below).

[0262] Figure 14A perspective view of a sheath 1400 is shown, which may include one or more features identical to those of the sheath 1320 and may be configured to be releasably coupled to a tunneling tool including one or more features identical to those of the first implantation tool 1300. In some embodiments, the sheath 1400 may include one or more metals and one or more plastic materials. In some embodiments, the sheath 1400 may be semi-rigid or rigid to maintain its shape when surrounded by tissue. The sheath 1400 may include 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 the sheath 1400, such as to prevent movement of the sheath 1400 when the tunneling tool is removed from the sheath 1400 and / or when the sheath 1400 is withdrawn from the subcutaneous space. In some embodiments, the handles 1408 may be flexible (e.g., foldable, deformable). The distal end 1404 of the sheath 1400 may be at least partially tapered to facilitate tissue anatomy. For example, the width of at least a portion of the distal end may increase proximally (or decrease distally) along the longitudinal axis of the sheath 1400 (linearly or non-linearly). The body 1406 may include a length approximately equal to or less than the length of one or both arms of the tunneling tool. Additionally or alternatively, the body 1406 may include a width approximately equal to or greater than the width of the first and / or second arms of the tunneling tool. For example, the width of the body 1406 can be from about 0.05 in to about 2 in, such as from about 0.075 in to about 1.75 in, from about 0.1 in to about 1.5 in, from about 0.125 in to about 1.25 in, from about 0.15 in to about 1 in, from about 0.175 in to about 0.75 in, from about 0.2 in to about 0.7 in, or from about 0.25 in to about 0.6 in (e.g., from about 0.5 in, from about 0.51 in, from about 0.52 in, from about 0.53 in, from about 0.54 in, from about 0.55 in, from about 0.56 in, from about 0.57 in, from about 0.58 in, from about 0.59 in, or from about 0.6 in), including all values ​​and subranges thereof. The body 1406 may include a wall 1410 defining a passage 1416 therein. The height of the wall 1410 may be approximately equal to or greater than the height of the arm of the tunneling tool. For example, the height of wall 1410 can be from about 0.05 in to about 1 in, such as from about 0.075 in to about 0.75 in, from about 0.1 in to about 0.5 in, from about 0.125 in to about 0.25 in, or from 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 therein.In some embodiments, one or both of the walls 1410 may be curved such that they follow the curvature of at least a portion of the first implantation tool and extend over it (e.g., above the edge of the second arm 1304b of the first implantation tool 1300). For example, the walls 1410 may include an arched or semi-circular shape and height that is close to but greater than the height of the arm (e.g., the second, lower arm) of the tunneling tool received between the walls 1410 (e.g., greater than about 0.0001 in to about 0.05 in). Furthermore, the body 1406 may include engagement features 1412 (e.g., a tongue, a protrusion) configured to engage directly with the tunneling tool. For example, the engagement features 1412 may be configured to apply force against a portion of the tunneling tool (e.g., against the second arm 1304b of the first implantation tool 1300). In embodiments where the engagement features include a tongue, the tongue may include an arched member 1414 extending toward the tunneling tool and configured to apply force. The arched member 1414 may be pointed, as shown, or it may be rounded. In some embodiments, the arch 1414 may include a stand. The arch 1414 can help prevent the sheath 1400 from slipping unintentionally relative to the tunneling tool (e.g., during transport and / or during tissue dissection).

[0263] After the tunneling tool is removed from its sheath (once tissue dissection is complete), one or more individual implantation tools can be guided through the sheath to perform other parts of the implantation procedure, while the sheath provides access to the subcutaneous space by maintaining its size within the tissue. For example, the insertion tool can be moved through the sheath to place an implantable device in the subcutaneous space (e.g., at its distal end). In other words, the sheath body provides a path for both the insertion tool and the implantable device to reach the implantation site within the subcutaneous space.

[0264] Figure 15A The image depicts a second implantation tool 1500, which may be an insertion tool. The second implantation tool 1500 may include a handle 1502 configured for gripping by an operator, a body 1504, and a first fork 1506a and a second fork 1506b configured to receive an implantable device therein. The first fork 1506a may be an upper fork configured to abut or be adjacent to a first surface of the implantable device, while the second fork 1506b may be an opposing lower fork configured to abut or be adjacent to a second, opposite surface of the implantable device. In some embodiments, the first fork 1506a and the second fork 1506b may include one or more of the same dimensions. In some variations, the first fork 1506a and the second fork 1506b may be parallel or substantially parallel to each other.

[0265] Figure 15BA second implantation tool 1500 coupled to the implantable device 1530 is depicted. As discussed above, the sheath 1520 can be guided to implant the implantable device 1530 via the second implantation tool 1500. In some embodiments, the height of the gap 1508 defined by the first fork 1506a and the second fork 1506b (e.g., Figure 15A The height of the implantable device (as shown) can be approximately equal to the height of the implantable device. Therefore, the first fork 1506a and the second fork 1506b can be configured for interference or transitional engagement with the implantable device 1530. In some embodiments, the length of the first fork 1506a and the second fork 1506b can be less than the length of the implantable device 1530. Therefore, at least a portion of the implantable device can extend beyond the distal ends of the first fork 1506a and the second fork 1506b. The second implantable device 1500 can be configured to deliver the implantable device 1530 to an implantation site located distal to the distal end of the sheath 1520. Once the second implantation tool 1500 has advanced the implantable device 1530 to the implantation site in the subcutaneous space (via the sheath channel), the force of the surrounding tissue against the exposed portion of the implantable device 1530 can overcome the force maintaining the coupling between the implantable device 1530 and the first fork 1506a and the second fork 1506b, thereby allowing the second implantation tool 1500 to be withdrawn while leaving the implanted implantable device 1530 within the tissue.

[0266] Now refer to Figure 7 and Figures 7A-7E The diagram shows a perspective view, an exploded view, a side view, and three cross-sectional views of an external device that conforms to the concept of this invention. Figure 7 and Figures 7A-7E Other components of the external device 500 and / or device 10 described herein may be consistent with those in the reference. Figure 1 Similar construction and arrangement to similar components described elsewhere in this article. Figure 7 A perspective view of an embodiment of the external device 500 of the device 10 is shown. Figure 7A It shows Figure 7 An exploded view of the external device 500, illustrating the components inside the housing 510 of the external device 500. Figure 7B A side view of the external device 500 is shown, indicating... Figure 7C The section AA is shown in the figure. Figure 7D A bottom view of the external device 500 is shown, with a portion of the housing 510 removed to illustrate the components within the housing. Figure 7E It shows the result of Figure 7C Detail B in the diagram indicates a cross-sectional detail view of a portion of the external device 500.

[0267] External device 500 may include housing 510, such as a two-part housing including a top section 5101 and a bottom section 5102, as shown below. Figure 7A As shown. Controller 550 may include a printed circuit board assembly (PCBA) located within housing 510. Controller 550 may be attached to housing 510 via one or more attachment devices (such as screws 5501a, 5501b shown) that secure controller 550 to bottom region 5102 of housing 510. Controller 550 may include one or more spacers, such as spacer 5502 shown. External device 500 may include power source 570, such as a power source including a battery, e.g., a rechargeable battery. Controller 550 may include a power connector, such as connector 5503, that operatively connects controller 550 to power source 570. In some embodiments, connector 5503 includes a flexible circuit board. Power source 570 may include a wireless charging assembly 5710, such as one including at least one wireless charging antenna (such as... Figure 7DThe wireless charging component includes antenna 5711. In some embodiments, antenna 5711 includes one or both of a wireless charging antenna (e.g., a Qi charging antenna) and a near-field communication (NFC) antenna. For example, 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 antennas 5711 (e.g., a Qi charging antenna and an NFC antenna) may be configured to operate at the same frequency or at different frequencies, or within the same or different frequency ranges (e.g., a predetermined frequency range, such as one or more predetermined frequency ranges). For example, one or both of the first antenna 5711 (e.g., a Qi charging antenna) and the second antenna 5711 (e.g., an NFC antenna) may be configured to operate at frequencies from about 1 kHz to about 500 kHz, such as from about 10 kHz to about 450 kHz, from about 20 kHz to about 400 kHz, from about 30 kHz to about 350 kHz, from about 40 kHz to about 300 kHz, from about 50 kHz to about 250 kHz, from about 75 kHz to about 225 kHz, or from about 100 kHz to about 200 kHz. As another example, one or both of the first antenna 5711 (e.g., a Qi charging antenna) and the second antenna 5711 (e.g., an NFC antenna) may be configured to operate at frequencies ranging from about 1 MHz to about 50 MHz, such as from about 3 MHz to about 45 MHz, from about 5 MHz to about 40 MHz, from about 7 MHz to about 35 MHz, from about 9 MHz to about 30 MHz, from about 10 MHz to about 25 MHz, or from about 11 MHz to about 20 MHz, from about 12 MHz to about 15 MHz, or from about 13 MHz to about 14 MHz. In some embodiments, the first antenna 5711 may be a Qi charging antenna and may operate from about 100 kHz to about 200 kHz, and the second antenna may be an NFC antenna, which may operate between about 13 MHz and about 14 MHz, such as at about 13.56 MHz.

[0268] In some embodiments, antenna 5711 may be configured to receive one or both of power and data and / or transmit one or both of power and data from another antenna of the system (e.g., device 10 as described herein). For example, antenna 5711 may be a charging antenna, such as a Qi charging antenna, configured to receive power from an antenna of a charging base station (e.g., antenna 6121 of charger 61). In such embodiments, power may be transmitted via a local connection, such as a Bluetooth Low Energy (BLE) connection.

[0269] Antenna 5711 may include a surface and a shielding material or shielding layer (not shown) positioned on that surface. The shielding material may include radio absorption shielding material and / or radio reflection shielding material. To enable antenna 5711 to operate effectively at higher frequencies, the shielding material may include a ferrite material having low conductivity and low magnetic loss tangent at the frequency of interest, thereby achieving high permeability. For example, one or more shielding layers of antenna 5711 may include one or both of conductive and ferromagnetic materials. By placing a material (such as high-frequency ferrite) with high permeability (μ'), low magnetic loss tangent (μ'' / μ'), and low conductivity between the antenna and other components of the transmitter, losses or loading effects due to these components can be significantly reduced. For example, one or more shielding layers of antenna 5711 may have a magnetic loss tangent of less than or equal to 0.025 in a predetermined frequency range (such as from about 100 kHz to about 200 kHz). In some cases, the magnetic field amplification of such a shielding layer will enhance overall performance. Furthermore, this layer shields the external environment from unwanted radiation from the antenna, and it protects the antenna from radiation originating from the environment. Additionally, one or more shielding layers can be configured to prevent coupling between multiple antennas of the external device 500, such as coupling between a first antenna (e.g., antenna 540) and a second antenna (e.g., antenna 5711).

[0270] The wireless charging assembly 5710 can be positioned on the opposite side of the external device 500 of the antenna assembly 5400, as shown. In some embodiments, the wireless charging assembly 5710 is positioned relative to the power source 570 to allow for expansion of the power source 570 (e.g., expansion of the power source 570 due to battery expansion), for example, when the antenna 5711 is positioned off-center from the power source 570. Additionally or alternatively, the wireless charging assembly 5710 may include a compressible material (not shown), such as a foam layer, positioned between the power source 570 and the antenna 5711. In some embodiments, the compressible material, such as the foam layer, may be configured to bias the antenna 5711 toward the inner surface and / or inner wall of the housing 510 to maintain the antenna 5711 in a position close to the housing 510 (e.g., to increase charging efficiency). In other words, the compressible material may be configured to minimize the distance between the antenna 5711 and the inner surface of the housing 510. In some embodiments, compressible material may be positioned between the power supply 570 and one or more shielding layers of the external device 500 (e.g., the shielding layer of the antenna assembly 5400), such as between the far side of the power supply 570 and the near side of the shielding layer of one or more shielding layers.

[0271] As described herein, external device 500 may include antenna assembly 5400, which may include one or more similar and / or different antennas, such as antenna 540 described herein. Antenna assembly 5400 may include adhesive elements, such as tape 5401 shown. Tape 5401 may adhesively maintain positioning between controller 550 and antenna assembly 5400, such as to maintain electrical connection between controller 550 and antenna assembly 5400 (e.g., even when device 500 is discarded). Power supply 570 may be concentrically adhered 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 includes battery protection circuitry (e.g., circuitry separate from controller 550). In some embodiments, power supply 570 includes a “D”-shaped battery, as shown. In some embodiments, power supply 570 includes a “fuel gauge” feature configured to track battery usage and / or state of charge.

[0272] The top region 5101 and the bottom region 5102 can be fixedly attached (e.g., attached during the manufacturing process). In some embodiments, the top region 5101 and the bottom region 5102 are ultrasonically welded together, for example as... Figure 7E As shown. In some embodiments, a nodal plunger angle may be used to create the weld. The nodal plunger angle may include a damper at its center that contacts the top region 5101 and dampens vibrations at the center of the housing 510 to mitigate cracking and / or other damage to the housing 510 (e.g., plastic portions of the housing 510 that are welded together). In some embodiments, the plunger angle directs vibrational energy to the weld location on the edge of the housing 510 and away from damage-sensitive areas of the housing 510. Directing energy in this way allows more energy to be provided to the weld site, resulting in a stronger weld without damaging the housing 510 (e.g., without damaging the remaining plastic portions of the housing 510). In some embodiments, the external device 500 includes a height not exceeding 0.55 inches, such as approximately 0.521 inches.

[0273] As described throughout this document, 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, antenna 540 may be configured to transmit one or both of power and data to antenna 240 of implantable device 200. In some embodiments, data may include one or more of stimulation parameters, stimulation procedures, stimulation programming schedules, and implantable device configurations. Additionally or alternatively, data may include software, such as firmware updates for implantable device 200. In some embodiments, external device 500 may be configured to instruct implantable device 200 to use data to stimulate a patient's tissue via antenna 540. Antennas 540 and 240 may be configured to communicate wirelessly.

[0274] In some embodiments, multiple antennas of the external device 500 (e.g., antenna 5711 and antenna 540) may be positioned at multiple different locations within the external device 500. For example, a first antenna (e.g., antenna 540) may be positioned at or near a first end of the external device 500, and a second antenna (e.g., antenna 5711) may be positioned at or near a second (e.g., opposite) end of the external device 500. In some embodiments, the first antenna may be positioned proximal to one or more shielding layers (e.g., a first shielding layer) of the external device 500, and the second antenna may be positioned distal to 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 the first end of the external device 500 and proximal to the first shielding layer, and the second antenna may be positioned proximal to the second end of the external device 500 and distal to the second shielding layer. In such embodiments, a first antenna, such as antenna 540, may be configured to communicate with one or more implantable devices (e.g., implantable device 200), and a 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 antennas, 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, antenna 5711 may be configured to transmit 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 stimulation parameters, stimulation procedures, stimulation programming schedules, and implantable device configurations. Additionally or alternatively, the data may include software, such as firmware updates for implantable device 200. In some embodiments, external device 500 may include one or both of a BLE module and a WiFi module with built-in antennas. The BLE and / or Wi-Fi module can be configured to communicate with one or more remote devices or equipment (e.g., one or both of patient programmer 600' and clinician programmer 600''). The BLE and / or Wi-Fi module antenna can operate at or within a predetermined frequency range. For example, the BLE and / or Wi-Fi module antenna can operate at frequencies from about 1 GHz to about 10 GHz, such as from about 1.5 GHz to about 8 GHz, from about 2 GHz to about 6 GHz, from about 2.1 GHz to about 4 GHz, from about 2.2 GHz to about 3 GHz, from about 2.3 GHz to about 2.5 GHz, or at about 2.4 GHz.

[0275] In some embodiments, the controller 550 includes a flexible, foldable PCB design.

[0276] In some embodiments, the bottom region 5102 of the housing 510 includes a recess 5103 that receives a portion of the antenna assembly 5400. The position of the recess 5103 and / or the antenna 540 can be configured to minimize the distance between the antenna 540 and the implantable device 200 when the external device 500 is positioned to contact the patient's skin near the implantation site of the implantable device 200. In some embodiments, the antenna assembly 5400 includes an antenna shield, such as a ferrite material as described herein. The antenna shield can be positioned outside the recess 5103 and can extend beyond the perimeter of the antenna 540. In some embodiments, the antenna assembly 5400 includes an antenna tuning mechanism, such as a variable capacitor. The antenna tuning mechanism can be accessed through the antenna shield, such as via a hole in the shield including the ferrite backing of the antenna assembly 5400. In some embodiments, the antenna tuning mechanism of the antenna assembly 5400 can include a programmable capacitor. The programmable capacitor can adaptively adjust the tuning in response to damage, aging, and / or changes in the environment of the device 500. Programmable capacitors can be configured to be set digitally, such as by controlling a switch connected to the capacitor bank. Alternatively or additionally, programmable capacitors can be set by analog control, such as by controlling the voltage level to the capacitor.

[0277] In some embodiments, the housing 510 of the external device 500 does not include any buttons and / or in-mold decorations (e.g., the surface of the housing 510 is relatively continuous and / or smooth). In some embodiments, the controller 550 includes an indicator (e.g., a light such as an LED of the user interface 580). Light from the indicator may be directed through a portion of the housing 510 (e.g., to avoid interruption in the surface of the housing 510 via the protruding LED), and the directed light is visible from the outside of the housing 510, such as the light-transmitting portion of the housing 510 created via a two-stage molding process of the housing 510.

[0278] In some embodiments, in addition to operating in a "standard mode" (e.g., a mode where additional functionality is available and more energy is consumed compared to a low-power mode), external device 500 is configured to operate in an "always-on, low-power" mode ("low-power mode" herein) (e.g., intermittent operation). In some embodiments, switching between power modes of external device 500 is controlled via charger 61, as described herein, for example. For example, wireless charging detection can be configured to switch external device 500 between a low-power mode and a standard mode. External device 500 can be controlled via a wireless connection (e.g., Bluetooth wireless connection), such as when device 500 receives a command to perform one or more functions, such as to switch between a low-power mode and a standard mode. External device 500 can be configured to operate using a "gesture recognition" protocol—for example, when controller 550 includes acceleration timing configured to detect tactile interactions with external device 500 (e.g., rapid or other movements of the user on device 500), to cause device 500 to perform functions based on that interaction, such as to switch from low-power mode to standard mode. In some embodiments, the external device 500 includes a vibration energy harvesting element. In some embodiments, the vibration energy harvesting element is used to initiate an activation sequence that causes the external device 500 to switch to different power states. In some embodiments, the external device 500 includes a real-time clock (e.g., the controller 550 of the device 500 includes a real-time clock). In these embodiments, the external device 500 can use data from the real-time clock to more accurately record patient usage and / or other events.

[0279] In some embodiments, the user interface 580 of the external device 500 is configured to provide tactile and / or audible feedback and / or alarms to the user.

[0280] Now refer to Figure 8 , Figure 8A and Figure 8B The figures show a perspective view and two exploded views of a charging base station that conforms to the concept of the present invention. Figure 8 and Figures 8A-8B Other components of the base station or charger 61 and / or device 10 described herein may be consistent with those in the reference. Figure 1 Similar construction and arrangement of similar components as described in other parts of this document. Figure 8 Two perspective views of an embodiment of the charger 61 of device 10 are shown. One angle of the charger 61 shown is from the rear of the charger 61, where the charger can be connected to an external power source (e.g., via power port 6132). Another angle of the charger 61 is from the front of the charger, which may have an opening configured to receive an external device, such as... Figure 1 500 external devices. Figure 8A and8B It shows from the opposite perspective Figure 8 An exploded view of the charger 61, illustrating the components inside the casing of the charger 61.

[0281] The base station or charger 61 may include a housing (housing 6110), such as a three-part housing including a top region 6111, a middle region 6112, and a bottom region 6113, as shown. The top region 6111 and the middle region 6112 may be attached to form a top chamber of the housing 6110, and the middle region 6112 and the bottom region 6113 may be attached to form a bottom chamber of the housing 6110. In some embodiments, the housing 6110 may include one or more anti-slip features, such as rubber feet and / or surfaces including an anti-slip coating and / or contours. The charger 61 may include a wireless charging assembly 6120 that wirelessly transfers energy to a power source 570 of the external device 500 when the external device 500 is operatively engaged with the charger 61, as described herein. The wireless charging assembly 6120 may include one or more wireless charging antennas, such as Figure 8B Antenna 6121 is shown. Charging assembly 6120 can be configured to deliver power to external device 500 (e.g., to antenna 5711 of external device 500). In some embodiments, wireless charging assembly 6120 includes a Qi charging system. The middle portion 6112 of housing 6110 may include a gap or opening between opposing surfaces of housing (e.g., a gap between a top protrusion and a bottom protrusion of middle portion 6112), such as a slot 6114, as shown, which slidably receives external device 500. In some embodiments, slot 6114 is angled downward (e.g., when charger 61 is positioned on a flat horizontal surface, the opening of slot 6114 is positioned above the inward portion of slot 6114), such as to retain external device 500 within slot 6114 during charging. Alternatively or additionally, the opening (e.g., slot 6114) may include one or more retaining features, not shown, but such as one or more features configured to frictionally and / or otherwise engage the external device 500 to prevent undesirable disengagement of the external device 500 and the charger 61.

[0282] The wireless charging assembly 6120 may be located within the top cavity of the housing 6110, such that the antenna 6121 is located adjacent to an opening (e.g., slot 6114). The opening may be constructed and arranged such that when the external device 500 is at least partially positioned within the opening, the antenna 5711 of the external device 500 and the antenna 6121 of the charger 61 are properly aligned for wireless charging. In some embodiments, the charger 61 and the external device 500 are constructed and arranged such that when the external device 500 is positioned in or on the charger 61, such as when the external device 500 is partially or fully seated within the opening, the antennas 5711 and 6121 can automatically align regardless of the relative rotational orientation of the external device 500 relative to the charger 61 (e.g., the opening (e.g., slot 6114) may include a symmetrical structure excluding any rotational "keying" features). That is, when the external device 500 is positioned on or near the charger 61, the antennas 5711 and 6121 may be rotationally symmetrical. In some embodiments, the intermediate region 6112 includes one or more alignment features (recesses 6115 shown). When the top chamber of the housing 6110 is assembled (e.g., during manufacturing), at least a portion of the antenna 6121 may be located within the recesses 6115 such that the antenna 6121 is consistently and correctly aligned when the external device 500 is operatively engaged with the charger 61 (e.g., consistent alignment from charger to charger during the manufacturing of the charger 61) for optimal charging efficiency. In some embodiments, the antennas 6121 and / or 5711 of the external device 500 are rotationally symmetric. In some embodiments, the top region 6111 includes biasing features, not shown, but such as features configured to bias the antenna 6121 toward an opening (e.g., biasing against the bottom surface of the top chamber of the housing 6110). In some embodiments, the biasing features may include a compressible material (not shown), such as a foam layer, configured to bias the antenna 6121 toward an opening (e.g., slot 6114). In other words, a compressible material, such as a foam layer, can be configured to bias the antenna to maintain the antenna 6121 close to the inner surface of the housing 6110 (e.g., to increase charging efficiency). Alternatively, the compressible material can be configured to minimize the distance between the antenna 6121 and the inner surface of the housing 6110.

[0283] In some embodiments, one or more wall portions of housing 6110 are thinner than other portions of housing 6110, such as when a portion of the intermediate region 6112 between antenna 6121 and the opening (e.g., the surface of recess 6115) is thinner. Antenna 6121 may be oriented parallel to the surface of recess 6115 such that when external device 500 is operatively engaged with charger 61, antenna 6121 is oriented parallel to antenna 5711 of external device 500.

[0284] Charger 61 may include one or more attachment devices, such as screws 6101a, 6101b, 6102a, 6102b and 6103a, 6103b 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 components (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 the battery and / or critical circuitry of controller 6130. Controller 6130 may include one or more wireless antennas, such as a wireless antenna providing NFC. In some embodiments, wireless charging component 6120 includes an NFC antenna and a Qi antenna, such as when the NFC antenna is printed on wireless charging component 6120 and the Qi antenna is separately soldered to wireless charging component 6120. Both antennas may be connected to controller 6130 via a coaxial connector. In some embodiments, the wireless charging assembly 6120 includes a temperature sensor, not shown, but such as a temperature sensor connected to the controller 6130 via a cable (e.g., a cable routed through intermediate section 6112). The external device 500 and the charger 61 may communicate via NFC, for example, when the external device 500 is positioned in the charger 61, NFC communication can be used to initiate a charging cycle. Additionally or alternatively, the external device 500 and the charger 61 may communicate via Bluetooth (e.g., Bluetooth Low Energy, or "BLE" connection) and / or other wired or wireless communication protocols. In some embodiments, NFC communication is used as a "gatekeeper" for establishing a BLE or other wireless connection between the external device 500 and the charger 61. In some embodiments, the charger 61 and / or external device 500 (e.g., via the charger 61) may be connected to a local area network (LAN), such as a Wi-Fi network, to connect to a server of device 10 (e.g., a cloud-based server) to upload diagnostic and / or patient usage data (described herein) and / or download information, such as stimulation procedure information and / or firmware or software update information.

[0285] In some embodiments, antenna 6121 may be configured to communicate with one or more remote devices, such as patient programmer 600' and / or clinician programmer 600''. For example, one or more antennas 6121 (e.g., NFC antennas) may be configured to transmit 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 stimulation parameters, stimulation procedures, stimulation programming schedules, and implantable device configurations. Additionally or alternatively, the data may include software, such as firmware updates for implantable device 200.

[0286] In some embodiments, antenna 6121 may be configured to operate at a frequency or within the same frequency range (e.g., a predetermined frequency range) or different frequency ranges (e.g., within a predetermined frequency range). For example, the first antenna 6121 (e.g., a Qi charging antenna) may be configured to operate at frequencies from about 1 kHz to about 500 kHz, such as from about 10 kHz to about 450 kHz, from about 20 kHz to about 400 kHz, from about 30 kHz to about 350 kHz, from about 40 kHz to about 300 kHz, from about 50 kHz to about 250 kHz, from about 75 kHz to about 225 kHz, or from about 100 kHz to about 200 kHz. As another example, the second antenna 6121 (e.g., an NFC antenna) can be configured to operate in the range of 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.

[0287] In some embodiments, the charger 61 is configured to charge the external device 500 in a closed-loop manner. For example, the controller 6130 and / or controller 550 of the external device 500 may include one or more temperature sensors (e.g., thermocouples) configured to monitor the temperature of the power supply 570 of the external device 500 during charging. The thermocouples provide signals used in closed-loop charging, such as when the controller 6130 includes an algorithm configured to adjust charging parameters based on the temperature of the power supply 570 (e.g., to prevent overheating and / or overcharging). In some embodiments, the charger 61 is configured to control one or more functions of the external device 500, such as turning the external device 500 on or off, switching the external device 500 from a low-power mode to a standard mode (e.g., as described herein), and / or turning one or more features of the external device 500 on or off. For example, external device 500 may be configured to detect when it is positioned within an opening or slot 6114 of charger 61 (e.g., via a Qi detection process of controller 550) and automatically activate one or more communication protocols (e.g., NFC and / or BLE) to enable external device 500 to communicate with charger 61. In some embodiments, one or more communication protocols of external device 500 are disabled (e.g., to conserve battery power) unless external device 500 is positioned within an opening (e.g., slot 6114) of charger 61. In some embodiments, controller 6130 is configured to implement a battery health management protocol configured to extend the battery life of power source 570 of external device 500 (e.g., a power source including one or more batteries). In some embodiments, the battery health management protocol is based on patient usage of one or more components of device 10. In some embodiments, the battery health management protocol prohibits further charging once a target battery voltage is reached.

[0288] In some embodiments, the charger 61 includes one or more user output components configured to alert the user to the charging status of the external device 500, such as via one or more audio, haptic, and / or visual output components. For example, the charger 61 may include a lamp 6131 that provides a visual indicator of the charging status (e.g., charging, charged, and / or an error has occurred). In some embodiments, the lamp 6131 includes an illumination ring surrounding at least a portion of the charger 61. In some embodiments, the charger 61 includes one or more power connectors, such as a power port 6132, operatively attachable to an external power source that provides power to charge the external device 500. For example, the power port 6132 may include a USB port, such as a USB-C port configured to be attached to a DC power source via a USB cable.

[0289] In some embodiments, the controller 6130 and the insulator 6104 may be located within the cavity of the housing 6110 between the bottom region 6113 and the middle region 6112. The insulator 6104 may be located between the controller 6130 and the middle region 6112.

[0290] In some embodiments, one or more wires (not shown) extend through the middle portion 6112 of the housing 6110, such as one or more wires operatively connecting the wireless charging assembly 6120 to the controller 6130. In some embodiments, the one or more wires include one or more coaxial wires. In some embodiments, the wireless charging assembly 6120 is securely attached to the top portion 6111 of the housing 6110, such as when attached using screws 6101a, 6101b shown. In some embodiments, the middle portion 6112 is securely attached to the top portion 6111 of the housing 6110, such as using screws 6102a, 6102b shown. Alternatively or additionally, the middle portion 6112 and the top portion 6111 may be attached via snap-fit, welding (e.g., ultrasonic welding), and / or adhesive bonding. In some embodiments, a lamp 6131 is positioned between the outer portion of a bottom region 6113 and a middle region 6112, such that when the bottom region 6113 and the middle region 6112 are attached, the lamp 6131 includes a ring between the bottom region 6113 and the middle region 6112. The bottom region 6113 and the middle region 6112 can be securely attached, such as using screws 6103a, 6103b shown. Alternatively or additionally, the bottom region 6113 and the middle region 6112 can be attached via snap-fit, welding (e.g., ultrasonic welding), and / or adhesive bonding. In some embodiments, the charger 61 may include one or more decals, labels, and / or other coverings, such as the label 6105 shown. The label 6105 can be adhered to the outside of the bottom section 6113 to cover screws 6013a, 6013b (e.g., to resist tampering) and / or prevent contaminants from entering the housing 6110 (e.g., via screw holes in the bottom section 6113).

[0291] In some embodiments, the 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, the charger 61 may include one or more fans that move air through the top chamber of the housing 6110 to cool the wireless charging assembly 6120 (e.g., moving air from outside the housing 6110 into the top chamber via a flow path, through the bottom chamber, and out from the bottom of the housing 6110).

[0292] Now refer to Figures 9A to 10BThe illustration shows perspective and side views of various embodiments of a patient attachment device conforming to the concept of the present invention. Figures 9A to 10B Other components of the patient attachment device 70 and / or device 10 described herein may be consistent with those in the reference. Figure 1 Similar construction and arrangement to similar components described elsewhere in this article. Figure 9A and Figure 10A An exploded perspective view of various embodiments of the patient attachment device 70 of the device 10 is shown. Figure 9B and Figure 10B Each is shown separately. Figure 9A and Figure 10A Top and side views of the equipment.

[0293] In some embodiments, the patient attachment device 70 includes a strap configured to secure around a patient (e.g., around the patient's chest, arm, and / or leg) and against the patient's skin to maintain the external device 500. The patient attachment device 70 may include a strap assembly 7010, such as a strap (strap 7011) including an elongated band, such as an elongated strap 7011 comprising a first portion 7011a and a second portion 7011b. The first and second portions of the strap 7011 may include similar and / or dissimilar materials or configurations. For example, the first portion 7011a may include a relatively flat shape and material (e.g., similar to a band), such as a neoprene strap. The second portion 7011b may include a different material, such as a nylon-spandex blend (e.g., 95% nylon and 5% spandex), and may be located around the periphery of the first portion 7011a, as shown. In some embodiments, the strap assembly 7010 includes one or more closure components, such as the loop 7012 shown. The loop 7012 may be securely attached (e.g., sewn to) a first end of the bandage 7011. The bandage assembly 7010 may include one or more fastening elements, such as a hook 7013, located on a second end of the bandage 7011. The hook 7013 may be removably secured to the loop 7012 when the bandage 7011 is wrapped around a portion of the patient. Alternatively or additionally, the bandage assembly 7010 may include hook and loop attachment mechanisms, such as to tighten the bandage 7011 when the second end of the bandage 7011 is configured to pass through the loop 7012 and then pulled away from the loop 7012 (e.g., in the direction opposite to when the bandage 7011 surrounds the patient). The second end of the bandage 7011 may include a hook and loop type fastener that is secured to the bandage 7011 when folded back in this manner. In some embodiments, at least a portion of the inner surface of the bandage 7011 (e.g., the patient-facing surface) is adhesive, for example when the bandage 7011 includes silicone dots that provide an anti-slip surface. In some embodiments, the adhesive surface is limited to the area around the opening 7014.

[0294] In some embodiments, the patient attachment device 70 may include one or more connectors for connecting the external device 500 to the bandage assembly 7010, such as those referenced herein. Figure 11 and Figures 11A-11D The retaining component 7020 is shown and described in detail. The bandage assembly 7010 may include an opening 7014, and the retaining component 7020 may be securely attached to the bandage assembly 7010, proximity to the opening 7014 (e.g., in a coaxial position such that it can be positioned against the patient's skin when the external device 500 is positioned within the retaining component 7020). In some embodiments, the bandage assembly 7010 includes an attachment portion configured to securely attach the retaining component 7020 to the bandage assembly 7010. For example, the bandage assembly 7010 may include a cap 7015 comprising a loop (e.g., a fabric loop, such as a cotton fabric loop). The retaining component 7020 may be positioned between the cap 7015 and the bandage 7011 (e.g., "clipped in the middle"). The cap 7015 may be sewn, adhered, and / or otherwise attached to the bandage 7011 to securely attach the retaining component 7020 to the bandage assembly 7010. In some embodiments, the hook 7013 may be disposed on the first side of the same strap 7011 as the fixing component 7020.

[0295] In some embodiments, the patient attachment device may be designed to facilitate the removal of excess bandage material. For example, turning Figure 16The patient attachment device 1600 depicted is similar to the patient attachment device 70. The patient attachment device 1600 can be configured to be attached to a body part of a patient, such as the patient's torso (e.g., chest), arm (e.g., upper arm and / or lower arm), and / or leg (e.g., thigh and / or calf). The patient attachment device 1600 may include a strap 1611 with an opening 1614 at a first end 1611a. A retaining component 1620 may be secured near the opening 1614, such as along the periphery of the opening 1614 and / or over...

Claims

1. A neural modulation system, comprising: Implantable devices; Base station; as well as External device, the external device including: 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 are positioned between the first antenna and the second antenna.

2. The neural modulation system according to claim 1, wherein, The implantable device includes a third antenna configured to operate within the first predetermined frequency range.

3. The neural modulation system according to claim 1, wherein, The base station includes a fourth antenna configured to operate within a second predetermined frequency range.

4. The neural modulation system according to claim 3, wherein, The base station also includes a compressible material configured to minimize the distance between the fourth antenna and the inner surface of the base station housing.

5. The neural modulation system according to claim 4, wherein, The fourth antenna is positioned between the distal side of the compressible material and the inner surface of the housing, such that the compressible material holds the fourth antenna near the inner surface of the housing.

6. The neural modulation system according to claim 1, wherein, The base station is configured to charge the external device when the external device is located in or on the base station.

7. The neural modulation system according to claim 6, wherein, The base station includes an opening configured to receive the external device therein.

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

9. The neural modulation system according to claim 8, wherein, When the external device is located in or on the base station, the second antenna of the external device and the fourth antenna of the base station are rotationally symmetrical.

10. The neural modulation system according to claim 1, wherein, The one or more shielding layers are configured to prevent coupling between the first antenna and the second antenna.

11. The neural modulation system according to claim 1, wherein, Each of the one or more shielding layers comprises one or both of conductive and ferromagnetic materials.

12. The neural modulation system according to claim 1, wherein, The one or more shielding layers include: A first shielding layer, comprising a magnetic loss tangent of less than or equal to 0.025 at a first predetermined frequency range; and The second shielding layer includes a magnetic loss tangent of less than or equal to 0.025 at a second predetermined frequency range.

13. The neural modulation system according to 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 neural modulation system according to claim 1, wherein, The first antenna is on the proximal side of the one or more shielding layers and the second antenna is on the distal side of the one or more shielding layers.

15. The neural modulation system according to claim 1, wherein, The external device also includes a compressible material configured to hold the second antenna near the inner surface of the housing of the external device.

16. The neural modulation system according to claim 15, wherein, The external device also includes a power supply, and wherein the compressible material is positioned between the distal side of the power supply and the proximal side of the shielding layer of the one or more shielding layers.

17. The neural modulation system according to claim 1, wherein, The first predetermined frequency range is greater than the second predetermined frequency range.

18. The neural modulation system according to claim 1, wherein, The first predetermined frequency range is from about 30 MHz to about 50 MHz.

19. The neural modulation system according to claim 1, wherein, The second predetermined frequency range is from about 100 kHz to about 200 kHz.

20. The neural modulation system according to claim 1, wherein, The external device also includes a housing that encloses the first antenna, the second antenna, and the one or more shielding layers therein.

21. The neural modulation system according to claim 1, wherein, The implantable device is configured to stimulate the patient's tissues using electrical current transmitted by the first antenna.

22. The neural modulation system according to claim 1, wherein, The external device is configured to be positioned on the patient's body above the implantable device.

23. A neural modulation system, comprising: Implantable devices; Base station; as well as External devices, including: power supply; A first antenna, configured to power the implantable device; A second antenna, configured to wirelessly charge the power source from the base station; and One or more shielding layers are positioned between the first antenna and the second antenna.

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

25. The neural modulation system according to claim 24, wherein, The implantable device includes a third antenna configured to operate within the first predetermined frequency range.

26. The neural modulation system according to claim 24, wherein, The base station includes a fourth antenna configured to operate within a second predetermined frequency range.

27. The neural modulation system according to claim 24, wherein, The first predetermined frequency range is from about 30 MHz to about 50 MHz.

28. The neural modulation system according to claim 24, wherein, The second predetermined frequency range is from about 100 kHz to about 200 kHz.

29. The neural modulation system according to claim 24, wherein, When the external device is located in or on the base station, the second antenna of the external device and the third antenna of the base station are rotationally symmetrical.

30. A neural modulation device, comprising: A first antenna, configured to 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 are positioned between the first antenna and the second antenna and are configured to prevent coupling between the first antenna and the second antenna; as well as A wearable housing that carries the first antenna, the second antenna, and the one or more shielding layers.

31. A neural modulation system, comprising: The device according to claim 30; An implantable neural modulation device, the implantable neural modulation device including a third antenna configured to operate within a first predetermined frequency range; as well as A base station, the base station including a fourth antenna configured to operate within a second predetermined frequency range.

32. The neural modulation device of claim 30, further comprising a compressible material configured to hold the second antenna near an inner surface of the housing of the neural modulation device.

33. The neural modulation device according to claim 32, further comprising a power supply, wherein, The compressible material is positioned between the far side of the power source and the near side of the shielding layer of the one or more shielding layers.

34. The neural modulation device of claim 30, further comprising a third antenna configured to transmit data to one or more remote devices.

35. The neural modulation device according to claim 34, wherein, The second antenna includes a Qi charging antenna and the third antenna includes a near field communication (NFC) antenna.

36. A method for reprogramming a neural stimulation system, comprising: Receive the first data at a base station or remote device via a remote connection; Data is transmitted from the base station or remote device to the external device via a local connection between the base station or remote device and the external device. as well as The external device instructs an implantable device to use the data to stimulate the patient's tissues.

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 patient's tissue.

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

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

40. The method according to claim 39, wherein, The transmission is performed via the remote connection.

41. The method according to claim 36, wherein, The local connection is a Bluetooth Low Energy (BLE) connection.

42. The method according to claim 36, wherein, Instructing the implantable device to stimulate the patient's tissues includes transmitting power from the external device to the implantable device.

43. The method according to claim 42, wherein, The implantable device uses the electricity to stimulate the patient's tissues.

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

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

46. ​​The method of claim 36, wherein, The first data includes stimulus data.

47. The method according to claim 46, wherein, The stimulation data includes one or more of the following: stimulation parameters, stimulation procedures, stimulation programming schedules, and implantable device configurations.

48. The method according to claim 36, wherein, The first data includes software.

49. The method according to claim 48, wherein, The software includes firmware updates.

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

51. The method according to claim 36, wherein, The remote device includes a smartphone.

52. A system for implanting an implantable device within a patient's tissue, comprising: Implantable devices, including: axis; A first arm extends from the axis and is configured to be positioned against the patient's skin; A second arm, extending from the axis and configured to be inserted into the patient's body to dissect the tissues; and A sheath comprising a body having a channel configured to receive a second arm of the implanted device, wherein the sheath is configured to provide access to a subcutaneous space formed by the implanted device in the tissue when the implanted device is withdrawn from the tissue.

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

54. The system according to claim 53, wherein, The first longitudinal axis and the second longitudinal axis are approximately parallel.

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

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

57. The system according to claim 52, wherein, The second arm includes a tapered distal tip.

58. The system according to claim 52, wherein, The sheath also includes a handle coupled to the proximal end.

59. The system of claim 52 further includes a second implantable device configured to be releasably coupled to the implantable device.

60. The system according to claim 59, wherein, The second implantable device includes a first fork and a second fork defining a gap therebetween, wherein the gap is configured to receive the implantable device.

61. The system according to claim 52, wherein, The implantation device also includes a coupling element extending therefrom, wherein the proximal end of the sheath is configured to contact the coupling element to maintain the positioning of the sheath relative to the implantation device during implantation.

62. The system according to claim 61, wherein, The coupling element includes a flange.

63. A method for implanting an implantable device within a patient's tissue, comprising: A first implantable device and a sheath are introduced through an incision in the tissue, wherein a portion of the first implantable device is positioned within a channel of the sheath; The first implantable device and the sheath are advanced together through the tissue to form a subcutaneous space configured to receive the implantable device, wherein, during the advancement, contact between the first implantable device and the sheath maintains the positioning of the implantable device relative to the sheath; and The implanted device is withdrawn from the incision while maintaining the sheath's position within the tissue, so that the sheath's channel provides access to the subcutaneous space.

64. The method of claim 63, further comprising advancing a second implantable device coupled to 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 implanted device from the incision.

66. The method according to claim 63, wherein, During advancement, the coupling element of the implanted device contacts the proximal end of the sheath.

67. A method for reconfiguring a stimulation program for a patient, comprising: The programmer retrieves one or more stimulus templates from a remote server. Determine whether at least one of the one or more stimulus program templates meets the conditions; as well as When the stimulation program template meets the conditions, the stimulation program is adjusted based on the stimulation program template.

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