Neuromodulation systems and devices

Abstract

According to some embodiments, the present technology includes an implantable device including a lead comprising a proximal portion, a distal portion, and a longitudinal axis extending between the proximal and distal portions, and an electronics package coupled to the lead. The electronics package can comprise an antenna comprising one or more coil turns and a central region at least partially surrounded by at least one coil turn, and an enclosure comprising a channel that receives the proximal portion of the lead, the channel having a channel outlet that overlaps with the central region of the antenna, where the lead is bendable relative to the enclosure along the longitudinal axis at the channel outlet.

Description

Attorney Docket No.: XII.021 WONEUROMODULATION SYSTEMS AND DEVICESCROSS-REFERENCE TO RELATED APPLICATION(S)

[0001] The present application claims the benefit of priority to U.S. Provisional Application No. 63 / 742,274, filed January 6, 2025, which is incorporated by reference herein in its entirety.TECHNICAL FIELD

[0002] The present technology relates to neuromodulation systems and devices.BACKGROUND

[0003] Sleep disordered breathing (SDB), such as upper airway sleep disorders (UASDs), is a condition that occurs that diminishes sleep time and sleep quality, resulting in patients exhibiting symptoms that include daytime sleepiness, tiredness, and lack of concentration. Obstructive sleep apnea (OSA), the most common type of SDB, affects one in five adults in the United States. One in 15 adults has moderate to severe OSA and requires treatment. Untreated OSA results in reduced quality of life measures and increased risk of disease, including hypertension, stroke, heart disease, and others.

[0004] OSA is characterized by the complete obstruction of the airway, causing breathing to cease completely (apnea) or partially (hypopnea). During sleep, the tongue muscles relax. In this relaxed state, the tongue may lack sufficient muscle tone to prevent the tongue from changing its normal tonic shape and position. When the base of the tongue and / or soft tissue of the upper airway collapse, the upper airway channel is blocked, causing an apnea event. Blockage of the upper airway prevents air from flowing into the lungs, thereby decreasing the patient’s blood oxygen level, which in turn increases blood pressure and heart dilation. This causes a reflexive forced opening of the upper airway channel until normal patency is regained, followed by normal respiration until the next apneic event. These reflexive forced openings briefly arouse the patient from sleep.

[0005] Current treatment options range from drug intervention, non-invasive approaches, to more invasive surgical procedures. In many of these instances, patient acceptance and therapy compliance are well below desired levels, rendering the current solutions ineffective as a long-term solution. Continuous positive airway pressure (CPAP), forAttorney Docket No.: XII.021 WOexample, is a standard treatment for OSA. While CPAP is non-invasive and highly effective, it is not well tolerated by all patients and has several side effects. Patient compliance and / or tolerance for CPAP is often reported to be between 40% and 60%. Surgical treatment options for OSA, such as anterior tongue muscle repositioning, orthognathic bimaxillary advancement, uvula-palatalpharyngoplasty, and tracheostomy are available too. However, these procedures tend to be highly invasive, irreversible, and have poor and / or inconsistent efficacy. Even the more effective surgical procedures are undesirable because they usually require multiple invasive and irreversible operations, they may alter a patient's appearance (e.g., maxillomandibular advancement), and / or they may be socially stigmatic (e.g., tracheostomy) and have extensive morbidity.SUMMARY

[0006] The subject technology is illustrated, for example, according to various aspects described below, including with reference to FIGS. 1 A-12. Various examples of aspects of the subject technology are described as numbered clauses (1, 2, 3, etc.) for convenience. These are provided as examples and do not limit the subject technology.1. An implantable device comprising:a lead comprising a proximal portion, a distal portion, and a longitudinal axis extending between the proximal and distal portions;an antenna comprising one or more coil turns and a central region at least partially surrounded by at least one coil turn; andan enclosure comprising a channel that receives the proximal portion of the lead, the channel having a channel outlet that overlaps with the central region of the antenna,wherein the lead is bendable relative to the enclosure along the longitudinal axis at the channel outlet.2. The device of Clause 1, wherein the antenna is arranged on a substantially planar substrate.3. The device of Clause 1 or Clause 2, wherein the antenna is arranged in a first plane of the implantable device and the enclosure is arranged in a second plane of theAttorney Docket No.: XII.021 WOimplantable device different from the first plane, wherein the lead is bendable out of the second plane relative to the enclosure at the channel outlet.The device of any one of Clauses 1-3, wherein the antenna comprises a plurality of coil turns.The device of any one of Clauses 1-4, wherein the enclosure is hermetic.The device of any one of Clauses 1-5, wherein the enclosure comprises a coating comprising a polymer.The device of Clause 6, wherein the coating comprises a first region comprising a parylene and a second region comprising a ceramic.The device of Clause 7, wherein the coating comprises a plurality of first regions each comprising a parylene and a plurality of second regions each comprising a ceramic, wherein the first and second regions alternate along a thickness of the coating.The device of any one of Clauses 6-8, wherein the coating comprises one or more epoxy layers.The device of Clause 9, wherein the channel is defined at least partially within the one or more epoxy layers.The device of any one of Clauses 1-10, wherein the enclosure comprises a rigid housing.The device of Clause 11, wherein the housing comprises a plurality of hermetically sealed housing components.The device of Clause 11 or 12, wherein the housing comprises ceramic.Attorney Docket No.: XII.021 WOThe device of any one of Clauses 1-13, wherein the channel circumferentially surrounds the proximal portion of the lead.The device of any one of Clauses 1-14, further comprising electronic circuitry housed within the enclosure.The device of Clause 15, wherein the lead comprises one or more electrodes and the enclosure houses one or more electrical contacts in electrical communication with the one or more electrodes.The device of Clause 16, wherein the channel directs the proximal portion of the lead toward the one or more electrical contacts.The device of Clause 16 or 17, wherein the one or more electrodes comprises a first electrode and a second electrode, and wherein the distal portion comprises a first arm carrying the first electrode and a second arm carrying the second electrode.The device of Clause 18, wherein the lead is configured to be implanted in a patient with the first arm positioned proximate a left hypoglossal nerve of the patient and the second arm positioned proximate a right hypoglossal nerve of the patient.An implantable device comprising:a lead comprising a proximal portion, a distal portion, and a longitudinal axis extending between the proximal and distal portions;a substantially planar substrate with a central region; andan enclosure configured to couple to the proximal portion of the lead at an enclosure coupling point, wherein the enclosure coupling point overlaps with the central region of the substrate,wherein the lead is bendable relative to the enclosure along the longitudinal axis at the enclosure coupling point.The device of Clause 20, wherein the substrate is arranged in a first plane of the implantable device and the enclosure is arranged in a second plane of the implantableAttorney Docket No.: XII.021 WOdevice different from the first plane, wherein the lead is bendable out of the second plane relative to the enclosure at the enclosure coupling point.The device of Clause 20 or 21, wherein the substrate comprises an antenna having one or more coil turns, wherein the central region is surrounded by the one or more coil turns.The device of any one of Clauses 20-22, wherein the enclosure is hermetic.The device of any one of Clauses 20-23, wherein the enclosure comprises a coating comprising a polymer.The device of Clause 24, wherein the coating comprises a first region comprising a parylene and a second region comprising a ceramic.The device of Clause 25, wherein the coating comprises a plurality of first regions each comprising a parylene and a plurality of second regions each comprising a ceramic, wherein the first and second regions alternate along a thickness of the coating.The device of any one of Clauses 20-26, wherein the enclosure comprises one or more epoxy structures.The device of any one of Clauses 20-27, wherein the enclosure comprises a rigid housing.The device of Clause 28, wherein the housing comprises a plurality of hermetically sealed housing components.The device of Clause 28 or 29, wherein the housing comprises ceramic.The device of any one of Clauses 20-30, wherein the enclosure defines a channel that receives the proximal portion of the lead.Attorney Docket No.: XII.021 WOThe device of Clause 31, wherein the channel circumferentially surrounds the proximal portion of the lead.The device of any one of Clauses 20-32, further comprising electronic circuitry housed within the enclosure.The device of Clause 33, wherein the lead comprises one or more electrodes and the enclosure houses one or more electrical contacts in electrical communication with the one or more electrodes.The device of Clause 34, wherein the channel directs the proximal portion of the lead toward the one or more electrical contacts.The device of Clause 34 or 35, wherein the one or more electrodes comprises a first electrode and a second electrode, and wherein the distal portion comprises a first arm carrying the first electrode and a second arm carrying the second electrode.The device of Clause 36, wherein the lead is configured to be implanted in a patient with the first arm positioned proximate a left hypoglossal nerve of the patient and the second arm positioned proximate a right hypoglossal nerve of the patientAn implantable device comprising:a flexible lead comprising a proximal portion, a distal portion comprising one or more electrodes, and a longitudinal axis extending between the proximal and distal portions; andan electronics package coupled to the lead and comprising:an antenna comprising one or more coil turns and a central region at least partially surrounded by at least one coil turn, wherein the antenna is arranged along a first plane; andan enclosure comprising a channel that receives the proximal portion of the lead and has a channel outlet that overlaps with the central region of the antenna, wherein the enclosure is arranged along a second plane offset from the first plane,Attorney Docket No.: XII.021 WOwherein the lead extends from the enclosure at the channel outlet and is bendable out of the second plane relative to the enclosure along the longitudinal axis at the channel outlet.The device of Clause 38, wherein the enclosure is hermetic.The device of Clause 38 or 39, wherein the enclosure comprises a coating comprising a polymer.The device of Clause 40, wherein the coating comprises a first region comprising a parylene and a second region comprising a ceramic.The device of Clause 41, wherein the coating comprises a plurality of first regions each comprising a parylene and a plurality of second regions each comprising a ceramic, wherein the first and second regions alternate along a thickness of the coating.The device of any one of Clauses 38-42, wherein the enclosure comprises one or more epoxy structures defining the channel.The device of any one of Clauses 38-43, wherein the enclosure comprises a rigid housing defining the channel.The device of Clause 44, wherein the housing comprises a plurality of hermetically sealed housing components.The device of Clause 44 or 45, wherein the housing comprises ceramic.The device of any one of Clauses 38-46, wherein the channel circumferentially surrounds the proximal portion of the lead.The device of any one of Clauses 38 47, further comprising electronic circuitry housed within the enclosure.Attorney Docket No.: XII.021 WO49. The device of Clause 48, wherein the lead comprises one or more electrodes and the enclosure houses one or more electrical contacts in electrical communication with the one or more electrodes.50. The device of Clause 49, wherein the channel directs the proximal portion of the lead toward the one or more electrical contacts.51. The device of any one of Clauses 38-50, wherein the one or more electrodes comprises a first electrode and a second electrode, and wherein the distal portion comprises a first arm carrying the first electrode and a second arm carrying the second electrode.52. The device of Clause 51, wherein the lead is configured to be implanted in a patient with the first arm positioned proximate a left hypoglossal nerve of the patient and the second arm positioned proximate a right hypoglossal nerve of the patient.BRIEF DESCRIPTION OF THE DRAWINGS

[0007] Many aspects of the present disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on illustrating clearly the principles of the present disclosure.

[0008] FIG. 1 A is a fragmentary midline sagittal view of an upper airway of a human patient.

[0009] FIG. IB is an illustration of the musculature and hypoglossal innervation of the human tongue.

[0010] FIG. 1C is a schematic superior view of a distal arborization of right and left hypoglossal nerves of a human patient. The hypoglossal nerves of FIG. 1C are shown as extending anteriorly from the bottom of the page to the top of the page (e.g., from the hyoid bone to the anterior mandible).

[0011] FIG. 2A is a schematic illustration of a neuromodulation system configured in accordance with several embodiments of the present technology.

[0012] FIG. 2B is a perspective view of a neuromodulation device configured in accordance with several embodiments of the present technology.Attorney Docket No.: XII.021 WO

[0013] FIGS. 2C and 2D are top and side views, respectively, of the neuromodulation device of FIG. 2B.

[0014] FIGS. 3A-3F are various views of the neuromodulation device shown in FIGS. 2B-2D implanted in a human patient in accordance with several embodiments of the present technology.

[0015] FIG. 4 is a plan view of an antenna of a neuromodulation device configured in accordance with several embodiments of the present technology.

[0016] FIG. 5 is a plan view of an antenna of a neuromodulation device configured in accordance with several embodiments of the present technology.

[0017] FIG. 6A is an example embodiment of an electronics component in accordance with the several embodiments of the present technology.

[0018] FIG. 6B is an example embodiment of an interconnect that electrically couples the electronics component to the lead and / or antenna in accordance with the several embodiments of the present technology.

[0019] FIG. 7 is an example enclosure covering the electronics component in accordance with the several embodiments of the present technology.

[0020] FIG. 8 is an example enclosure comprising a ceramic can in accordance with several embodiments of the present technology.

[0021] FIGS. 9A-9G are schematic illustrations of an example assembly process for an implantable device in accordance with several embodiments of the present technology.

[0022] FIG. 10 is a schematic illustration of a portion of an implantable device, in which a lead of the implantable device is coupled to an enclosure in accordance with several embodiments of the present technology.

[0023] FIG. 11 is a schematic illustration of a cross-sectional view of a portion of the implantable device of FIG. 10.

[0024] FIG. 12 shows an example of volume optimization of an implantable device in accordance with several embodiments of the present technology.Attorney Docket No.: XII.021 WODETAILED DESCRIPTION[00251 The present technology relates to neuromodulation systems and devices that can be used to provide a variety of electrical therapies, including neuromodulation therapies such as nerve and / or muscle stimulation. Stimulation can induce excitatory or inhibitory neural or muscular activity. Such therapies can be used at various suitable sites within a patient's anatomy. According to some embodiments, the neuromodulation systems of the present technology are configured to treat sleep disordered breathing (SDB), including obstructive sleep apnea (OSA) and / or mixed sleep apnea, via neuromodulation of the hypoglossal nerve (HGN). Specific details of several embodiments of the technology are described below with reference to FIGS. 1A-12.

[0026] For the purpose of contextualizing the structure and operation of the neuromodulation systems and devices disclosed herein, some of the relevant anatomy and physiology are first described below. The headings provided herein are for convenience only and do not interpret the scope or meaning of the claimed present technology. Embodiments under any one heading may be used in conjunction with embodiments under any other heading. For example, any of the neuromodulation systems and devices described in connection with Section II can include any of the neuromodulation devices described in connection with Section III.I. Anatomy and Physiology

[0027] As previously mentioned, respiration in patients with SDB is frustrated due to obstruction, narrowing, and / or collapse of the upper airway during sleep. As shown in FIG.1 A, the upper airway comprises the nasal cavity, the oral cavity, the pharynx, and the larynx. Patency of the upper airway and resistance to airflow in the upper airway are controlled by a complex network of muscles under both voluntary and involuntary neuromuscular control. For example, the muscles of the tongue, the suprahyoid muscles (e.g., the geniohyoid, mylohyoid, stylohyoid, hyoglossus, and the anterior belly of the digastric muscle), and the muscles comprising the soft palate (e.g., palatal muscles) open, widen, and / or stabilize the upper airway during inspiration to counteract the negative airway pressure responsible for drawing air into the airway and the lungs.

[0028] With reference to FIG. IB, the tongue comprises both intrinsic and extrinsic lingual muscles. Generally, activation of the intrinsic muscles changes the shape of the tongue while activation of the extrinsic muscles tends to move the position of the whole tongue. TheAttorney Docket No.: XII.021 WOextrinsic muscles originate at a bony attachment and insert within the tongue. They comprise the genioglossus muscle, the styloglossus muscle, the hyoglossus muscle, and the palatoglossus muscle. The intrinsic muscles both originate and insert within the tongue, and comprise the superior longitudinalis, the inferior longitudinalis, the transversal! s, and the verticalis. In a patient who is awake, the brain supplies neural drive to these muscles through the HGN to maintain tongue shape and position, preventing the tongue from blocking the airway.|0029] The lingual muscles are also functionally categorized as either retrusor or protrusor muscles and both intrinsic and extrinsic muscles fall into these categories. The retrusor muscles include the intrinsic superior and inferior longitudinalis muscles and the extrinsic hyoglossus and styloglossus muscles. The protrusor muscles include the intrinsic verticalis and transversalis muscles and the extrinsic genioglossus muscle. Contraction of the styloglossus muscle causes elevation of the tongue while depression of the tongue is the result of downward movements of hyoglossus and genioglossus muscles. Also labeled in FIG. IB is the geniohyoid muscle, which is a suprahyoid muscle (not a tongue muscle) but still an important protrusor and pharyngeal dilator, and thus contributes to maintaining upper airway patency. It is believed that effective treatment of OSA requires stimulation of the protrusor muscles with minimal or no activation of the retrusor muscles. Thus, for neuromodulation therapy to be effective it is considered beneficial to localize stimulation to the protrusor muscles while avoiding activation of the retrusor muscles.

[0030] The largest of the tongue muscles, the genioglossus, comprises two morphological and functional compartments according to fiber distribution, action, and nerve supply. The first, the oblique compartment (GGo), includes vertical fibers that, when contracted, depress the tongue without substantially affecting pharyngeal patency. The second, the horizontal compartment (GGh), contains longitudinal fibers that, when activated, protrude the posterior part of the tongue and enlarge the pharyngeal opening. The GGo contains Type II muscle fibers that are quickly fatigued, whereas the GGh contains Type I muscle fibers that are slower to fatigue. Accordingly, it can be advantageous to stimulate the GGh with little or no stimulation of the GGo to effectively protrude the tongue while preventing or limiting fatigue of the tongue.

[0031] The suprahyoid muscles, which comprise the mylohyoid, the geniohyoid, the stylohyoid, and the digastric (only a portion of which is shown in FIG. IB), extend between the mandible and the hyoid bone to form the floor of the mouth. The geniohyoid is situated inferior to the genioglossus muscle of the tongue and the mylohyoid is situated inferior to theAttorney Docket No.: XII.021 WOgeniohyoid. Contraction of the geniohyoid and tone of the sternohyoid (an infrahyoid muscle, not shown) cooperate to pull the hyoid bone anteriorly to open and / or widen the pharyngeal lumen and stabilize the anterior wall of the hypopharyngeal region. In contrast to the genioglossus and geniohyoid, which are considered tongue protrusors, the hyoglossus and styloglossus are considered tongue retrusors. Activation of the hyoglossus and styloglossus tends to retract the tongue posteriorly, which reduces the size of the pharyngeal opening, increases airway resistance, and frustrates respiration.

[0032] As previously mentioned, all of the extrinsic and intrinsic muscles of the tongue are innervated by the HGN, with the exception of the palatoglossus, which is innervated by the vagal nerve. There are two hypoglossal nerves in the body, one on the right side of the head and one on the left side. Each hypoglossal nerve originates at a hypoglossal nucleus in the medulla oblongata of the brainstem, exits the cranium via the hypoglossal canal, and passes inferiorly through the retrostyloid space (a portion of the lateral pharyngeal space) to the occipital artery. The hypoglossal nerve then curves and courses anteriorly to the muscles of the tongue, passing between the anterior edge of the hyoglossus muscle and the posterior edge of the mylohyoid muscle into the sublingual area where it splits into its distal arborization.

[0033] FIG. 1C is a schematic superior view of the distal arborization of the right and left hypoglossal nerves. Referring to FIGS. IB and 1C together, the HGN comprises (1) portions of the distal arborization that innervate the styloglossus and the hyoglossus (tongue retrusor muscles) and (2) portions of the distal arborization that innervate the intrinsic muscles of the tongue, the genioglossus, and the geniohyoid (tongue protrusor muscles). Additionally, the portions of the distal arborization that innervate the tongue retrusor muscles tend to be located posterior of the portions of the distal arborization that innervate the tongue protrusor muscles.

[0034] A reduction in activity of the muscles responsible for airway maintenance can result in an increase in airway resistance and a myriad of downstream effects on a patient’s respiration and health. Activity of the genioglossus muscle, for example, can decrease during sleep which, whether alone or in combination with other factors (e.g., airway length, airway diameter, soft tissue volume, premature wakening, etc.), can result in substantial airway resistance and / or airway collapse leading to sleep disordered breathing, such as OSA. It is believed that in order for neuromodulation therapy to be effective, it may be beneficial to largely confine stimulation of the HGN to the portions of the distal arborization that innervateAttorney Docket No.: XII.021 WOprotrusor muscles while avoiding or limiting stimulation of the portions of the distal arborization that activate the retrusor muscles.II. Neuromodulation Systems

[0035] Various embodiments of the present technology are directed to devices, systems, and methods for modulating neurological activity and / or control of one or more nerves associated with one or more muscles involved in airway maintenance. Such neuromodulation can increase activity in targeted muscles, for example the genioglossus and geniohyoid, to reduce a patient’s airway resistance and improve the patient’s respiration. Moreover, targeted modulation of specific portions of the distal arborization of the hypoglossal nerve can increase activity in tongue protrusor muscles without substantially increasing activity in tongue retrusor muscles to provide a highly efficacious treatment. Additionally or alternatively, targeted modulation of specific portions of the distal arborization of the hypoglossal nerve that innervate the GGh but not portions of the distal arborization of the hypoglossal nerve that innervate the GGo can be used to effectively protrude the tongue while preventing or limiting fatigue of the tongue.

[0036] FIG. 2 A shows a neuromodulation system 10 for treating SDB configured in accordance with the present technology. The system 10 can include an implantable neuromodulation device 100 and an external system 15 configured wirelessly couple to the neuromodulation device 100. The neuromodulation device 100 can include a lead 102 having a plurality of conductive elements 114 and an electronics package 108 having a first antenna 116 and an electronics component 118. The neuromodulation device 100 is configured to be implanted at a treatment site comprising submental and sublingual regions of a patient's head, as detailed below with reference to FIGS. 3A-3F.

[0037] In use, the electronics package 108 or one or more elements thereof can be configured provide a stimulation energy to the conductive elements 114 that has a pulse width, amplitude, duration, frequency, duty cycle, and / or polarity such that the conductive elements 114 apply an electric field at the treatment site that modulates the hypoglossal nerve. The stimulation energy can be delivered according to a periodic waveform including, for example, a charge-balanced square wave comprising alternating anodic and cathodic pulses.

[0038] One or more pulses of the stimulation energy can have a pulse width between about 10 ps and about 1000 ps, between about 50 ps and about 950 ps, between about 100 ps and about 900 ps, between about 150 ps and about 800 ps, between about 200 ps and aboutAttorney Docket No.: XII.021 WO850 ps, between about 250 jus and about 800 jus, between about 300 jus and about 750 jus, between about 350 jus and about 700 jus, between about 400 jus and about 650 jus, between about 450 jus and about 600 jus, between about 500 jus and about 550 jus, about 50 jus, about 100 ps, about 150 jus, about 200 jus, about 250 jus, about 300 jus, about 350 jus, about 400 jus, about 450 jus, about 500 jus, about 550 jus, about 600 jus, about 650 jus, about 700 jus, about 750 ps, about 800 jus, about 850 jus, about 900 jus, about 950 jus, and / or about 1000 ps. In some embodiments, one or more pulses of the stimulation energy has a pulse width of between about 50 ps and about 450 ps.

[0039] One or more pulses of the stimulation energy can have an amplitude sufficient to cause an increase in phasic activity of a desired muscle. For example, one or more pulses of the stimulation energy can have a current-controlled amplitude between about 0.1 mA and about 5 mA. In some embodiments, the stimulation energy has an amplitude of about 0.3 mA, about 0.4 mA, about 0.5 mA, about 0.6 mA, about 0.7 mA, about 0.8 mA, about 0.9 mA, about 1 mA, about 1.5 mA, about 2 mA, about 2.5 mA, about 3 mA, about 3.5 mA, about 4 mA, about 4.5 mA, and / or about 5 mA. Additionally or alternatively, an amplitude of one or more pulses of the stimulation energy can be voltage-controlled. An amplitude of one or more pulses of the stimulation energy can be based at least in part on a size and / or configuration of the conductive elements 114, a location of the conductive elements 114 in the patient, etc.

[0040] A frequency of the pulses of the stimulation energy can be between about 10 Hz and about 50 Hz, between about 20 Hz and about 40 Hz, about 10 Hz, about 15 Hz, about 20 Hz, about 25 Hz, about 30 Hz, about 35 Hz, about 40 Hz, about 45 Hz, and / or about 50 Hz. In some embodiments, the frequency can be based on a desired effect of the stimulation energy on one or more muscles or nerves. For example, lower frequencies may induce a muscular twitch whereas higher frequencies may include complete contraction of a muscle.

[0041] The external system 15 can comprise an external device 11 and a control unit 30 communicatively coupled to the external device 11. In some embodiments, the external device 11 is configured to be positioned proximate a patient’s head while they sleep. The external device 11 can comprise a carrier 9 integrated with a second antenna 12. While the control unit 30 is shown separate from the external device 11 in FIG. 2A, in some embodiments the control unit 30 can be integrated with and / or a portion of the external device 11. The second antenna 12 can be configured for multiple purposes. For example, the second antenna 12 can be configured to power the neuromodulation device 100 through electromagnetic induction. Electrical current can be induced in the first antenna 116 when it is positioned above the secondAttorney Docket No.: XII.021 WOantenna 12 of the external device 11, in an electromagnetic field produced by second antenna 12. The first and second antennas 116, 12 can also be configured transmit data to and / or receive data from one another via one or more wireless communication techniques (e.g., Bluetooth, WiFi, USB, etc.) to facilitate communication between the neuromodulation device 100 and the external system 15. This communication can, for example, include programming, e.g., uploading software / firmware revisions to the neuromodulation device 100, changing / adjusting stimulation settings and / or parameters, and / or adjusting parameters of control algorithms.

[0042] The control unit 30 of the external system 15 can include a processor and / or a memory that stores instructions (e.g., in the form of software, code or program instructions executable by the processor or controller) for causing the external device to generate an electromagnetic field according to certain parameters provided by the instructions. The external system can include and / or be configured to be coupled to a power source such as a direct current (DC) power supply, an alternating current (AC) power supply, and / or a power supply switchable between DC and AC. The processor of the external system can be used to control various parameters of the energy output by the power source, such as intensity, amplitude, duration, frequency, duty cycle, and polarity. Instead of or in addition to a processor, the external system can include drive circuitry. In such embodiments, the external system can include hardwired circuit elements to provide the desired waveform delivery rather than a software-based generator. The drive circuitry can include, for example, analog circuit elements (e.g., resistors, diodes, switches, etc.) that are configured to cause the power source to supply energy to the second antenna 12 to produce an electromagnetic field according to the desired parameters. In some embodiments, the neuromodulation device 100 can be configured for communication with the external system via inductive coupling.

[0043] The system 10 can also include a user interface 40 in the form of a patient device 70 and / or a physician device 75. The user interface(s) 40 can be configured to transmit and / or receive data with the external system 15, the second antenna 12, the control unit 30, the neuromodulation device 100, and / or the remote computing device(s) 80 via wired and / or wireless communication techniques (e.g., Bluetooth, WiFi, USB, etc.). In the example configuration of FIG. 2A, both the patient device 70 and physician device 75 are smartphones. The type of device could, however, vary. One or both of the patient device 70 and physician device 75 can have an application or “app” installed thereon that is user specific, e.g., a patient app or a physician app, respectively. The patient app can allow the patient to execute certainAttorney Docket No.: XII.021 WOcommands necessary for controlling operation of neuromodulation device 100, such as, for example, start / stop therapy, increase / decrease stimulation power or intensity, and / or select a stimulation program. In addition to the controls afforded the patient, the physician app can allow the physician to modify stimulation settings, such as pulse settings (patterns, duration, waveforms, etc.), stimulation frequency, amplitude settings, and electrode configurations, closed-loop and open loop control settings and tuning parameters for the embedded software that controls therapy delivery during use.

[0044] The patient and / or physician devices 70, 75 can be configured to communicate with the other components of the system 10 via a network 50. The network 50 can be or include one or more communications networks, such as any of the following: a wired network, a wireless network, a metropolitan area network (MAN), a local area network (LAN), a wide area network (WAN), a virtual local area network (VLAN), an internet, an extranet, an intranet, and / or any other suitable type of network or combinations thereof. The patient and / or physician devices 70, 75 can be configured to communicate with one or more remote computing devices 80 via the network 50 to enable the transfer of data between the devices 70, 75 and the remote computing device(s) 80. Additionally, the external system 15 can be configured to communicate with the other components of the system 10 via the network 50. This can also enable the transfer of data between the external system 15 and remote computing device(s) 80.

[0045] The external system 15 can receive the programming, software / firmware, and settings / parameters through any of the communication paths described above, e.g., from the user interface(s) 40 directly (wired or wirelessly) and / or through the network 50. The communication paths can also be used to download data from the neuromodulation device 100, such as measured data regarding completed stimulation therapy sessions, to the external system 15. The external system 15 can transmit the downloaded data to the user interface 40, which can send / upload the data to the remote computing device(s) 80 via the network 50.

[0046] In addition to facilitating local control of the system 10, e.g., the external system 15 and the neuromodulation device 100, the various communication paths shown in FIG. 2A can also enable:

[0047] Distributing from the remoting computing device(s) 80 software / firmware updates for the patient device 70, physician device 75, external system 15, and / or neuromodulation device 100.Attorney Docket No.: XII.021 WO

[0048] Downloading from the remote computing device(s) 80 therapy settings / parameters to be implemented by the patient device 70, physician device 75, external system 15, and / or neuromodulation device 100.

[0049] Facilitating therapy setting / parameter adjustments / algorithm adjustments by a remotely located physician.

[0050] Uploading data recorded during therapy sessions.

[0051] Maintaining coherency in the settings / parameters by distributing changes and adjustments throughout the system components.

[0052] The therapeutic approach implemented with the system 10 can involve implanting only the neuromodulation device 100 and leaving the external system 15 as an external component to be used only during the application of therapy. To facilitate this, the neuromodulation device 100 can be configured to be powered by the external system 15 through electromagnetic induction. In operation, the second antenna 12, operated by control unit 30, can be positioned external to the patient in the vicinity of the neuromodulation device 100 such that the second antenna 12 is close to the first antenna 116 of the neuromodulation device 100. In some embodiments, the second antenna 12 is carried by a flexible carrier 9 that is configured to be positioned on or sufficiently near the sleeping surface while the patient sleeps to maintain the position of the first antenna 116 within the target volume of the electromagnetic field generated by the second antenna 12. Through this approach, the system 10 can deliver therapy to improve SDB (such as OSA), for example, by stimulating the HGN through a shorter, less invasive procedure. The elimination of an on-board, implanted power source in favor of an inductive power scheme can eliminate the need for batteries and the associated battery changes over the patient's life.

[0053] In some embodiments, the system 10 can include one or more sensors (not shown), which may be implanted and / or external. For example, the system 10 can include one or more sensors carried by (and implanted with) the neuromodulation device 100. Such sensors can be disposed at any location along the lead 102 and / or electronics package 108. In some embodiments, one, some, or all of the conductive elements 114 can be used for both sensing and stimulation. Use of a single structure or element as the sensor and the stimulating electrode reduces the invasive nature of the surgical procedure associated with implanting the system, while also reducing the number of foreign bodies introduced into a patient. In certain embodiments, at least one of the conductive elements 114 is dedicated to sensing only.Attorney Docket No.: XII.021 WO

[0054] In addition to or instead of inclusion of one or more sensors on the neuromodulation device 100, the system 10 can include one or more sensors separate from the neuromodulation device 100. In some embodiments, one or more of such sensors are wired to the neuromodulation device 100 but implanted at a different location than the neuromodulation device 100. In some embodiments, the system 10 includes one or more sensors that are configured to be wirelessly coupled to the neuromodulation device 100 and / or an external computing device (e.g., control unit 30, user interface 40, etc.). Such sensors can be implanted at the same or different location as the neuromodulation device 100, or may be disposed on the patient’s skin.

[0055] The one or more sensors can be configured to record and / or detect physiological data (e.g., data originating from the patient's body) over time including changes therein. The physiological data can be used to select certain stimulation parameters and / or adjust one or more stimulation parameters during therapy. Physiological data can include an electromyography (EMG) signal, temperature, movement, body position, electroencephalograph (EEG), air flow, audio data, heart rate, pulse oximetry, eye motion, and / or combinations thereof. In some embodiments, the physiological events can be used to detect and / or anticipate other physiological parameters. For example, the one or more sensors can be configured to sense an EMG signal which can be used to detect and / or anticipate physiological data such as phasic contraction of anterior lingual musculature (such as phasic genioglossus muscle contraction) and measure physiological data such as underlying tonic activity of anterior lingual musculature (such as tonic activity of the genioglossus muscle). Phasic contraction of the genioglossus muscle can be indicative of inspiration, particularly the phasic activity that is layered within the underlying tonic tone of the genioglossus muscle. Changes in physiological data include changes in one or more parameters of a measured signal (e.g., frequency, amplitude, spike rate, etc.), start and end of phasic contraction of anterior lingual musculature (such as phasic genioglossus muscle contraction), changes in underlying tonic activity of anterior lingual musculature (such as changes in tonic activity of the genioglossus muscle), and combinations thereof. In particular, changes in phasic activity of the genioglossus muscle can indicate a respiration or inspiration change and can be used to trigger stimulation. Such physiological data and changes therein can be identified in signals recorded from sensors during different phases of respiration including inspiration. As such, the one or more sensors can include EMG sensors. The one or more sensors can also include, for example,Attorney Docket No.: XII.021 WOwireless or tethered sensors that measure, body temperature, movement (e.g., an accelerometer), breath sounds (e.g., audio sensors), heart rate, pulse oximetry, eye motion, etc.

[0056] In operation, the physiological data provided by the one or more sensors enables closed-loop operation of the neuromodulation device 100. For example, the sensed EMG responses from the genioglossus muscle can enable closed-loop operation of the neuromodulation device 100 while eliminating the need for a chest lead to sense respiration. Operating in closed-loop, the neuromodulation device 100 can maintain stimulation synchronized with respiration, for example, while preserving the ability to detect and account for momentary obstruction. The neuromodulation device 100 can also detect and respond to snoring, for example.

[0057] The system 10 can be configured to provide open-loop control and / or closed-loop stimulation to configure parameters for stimulation. In other words, with respect to closed-loop stimulation, the system 10 can be configured to track the patient's respiration (such as each breath of the patient) and stimulation can be applied during or prior to the onset of inspiration, for example. However, with respect to open-loop stimulation, stimulation can be applying without tracking specific physiological data, such as respiration or inspiration. However, even under such an “open loop” scenario, the system 10 can still adjust stimulation and record data, to act on such information. For example, one way the system 10 can act upon such information is that the system 10 can configure parameters for stimulation to apply stimulation in an open loop fashion but can monitor the patient's respiration to know when to revert to applying stimulation on a breath to breath, close-loop fashion such that the system 10 is always working in a closed-looped algorithm to assess data. Treatment parameters of the system may be automatically adjusted in response to the physiological data. The physiological data can be stored over time and examined to change the treatment parameters; for example, the treatment data can be examined in real time to make a real time change to the treatment parameters. In some embodiments, the treatment parameters can be learned from the physiological data stored over time and used to adjust the therapy in real time. This learning can be patient-specific and / or across multiple patients.

[0058] Operating in real-time, the neuromodulation device 100 can record data (e.g., via one or more sensors) related to the stimulation session including, for example, stimulation settings, EMG responses, respiration, sleep state including different stages of REM and non-REM sleep, etc. For example, changes in phasic and tonic EMG activity of the genioglossus muscle during inspiration can serve as a trigger for stimulation or changes in stimulation canAttorney Docket No.: XII.021 WObe made based on changes in phasic and tonic EMG activity of the genioglossus muscle during inspiration or during different sleep states. This recorded data can be uploaded to the user interface 40 and to the remote computing device(s) 80. Also, the patient can be queried to use the interface 40 to log data regarding their perceived quality of sleep, which can also be uploaded to the remote computing device(s) 80. Offline, the remote computing device(s) 80 can execute a software application to evaluate the recorded data to determine whether settings and control parameters can be adjusted to further optimize the stimulation therapy. The software application can, for example, include artificial intelligence (Al) models that learn from recorded therapy sessions how certain adjustments affect the therapeutic outcome for the patient. In this manner, through Al learning, the model can provide patient-specific optimized therapy.III. Neuromodulation Devices

[0059] FIGS. 2B-2D illustrate various views of an example neuromodulation device 100. As previously mentioned, the device 100 can be configured to be implanted at a treatment site within submental and sublingual regions of the patient’s head and deliver electrical energy at the treatment site to stimulate the HGN and / or one or more tongue protruser muscles (e.g., the genioglossus, the geniohyoid, etc.). The device 100 can include an electronics package 108 and a lead 102 coupled to and extending away from the electronics package 108. The lead 102 can comprise a lead body 104 having a plurality of conductive elements 114 and an extension portion 106 extending between the lead body 104 and the electronics package 108. The extension portion 106 can have a proximal end portion 106a coupled to the electronics package 108 via a first connector 110 and a distal end portion 106b coupled to the lead body 104 via a second connector 112. The first connector 110 and / or the second connector 112 can comprise any suitable biocompatible material, such as one or more polymers. For example, the first connector 110 and / or the second connector 112 can include a thermoplastic elastomer, a thermoplastic polyurethane, a silicone, and / or other suitable materials. The material of the first connector 110 and / or the second connector 112 can be a material with high flexibility, good resistance to fluid ingress, low oxidation, good biocompatibility, etc. In some embodiments, the material of the first connector 110 and / or the second connector 112 can be based at least in part on an anatomical environment that the device 100 is configured to be implanted within. For example, an aromatic thermoplastic polyurethane, such as Pellethane™, may be highly hydrophobic and well suited to a wet anatomical environment with substantial interstitial fluid. However, a polycarbonate-basedAttorney Docket No.: XII.021 WOthermoplastic polyurethane, such as Carbothane™, may degrade less than Pellethane™ when positioned within an anatomical environment with substantial amounts of blood, such as in peripheral or subcutaneous environments. Thus, for the device 100 configured to be implanted in sublingual and submental regions, it may be preferable for the first connector 110 and / or the second connector 112 to comprise a polycarbonate-based thermoplastic polyurethane, such as Carbothane™.|0060] The electronics package 108 can be configured to supply electrical current to the conductive elements 114 (e.g., to stimulate) and / or receive electrical energy from the conductive elements 114 (e.g., to sense physiological data). The extension portion 106 of the lead 102 can mechanically and / or electrically couple the electronics package 108 to the lead body 104. The extension portion 106 can comprise a polymeric material such as, but not limited to, a thermoplastic elastomer, a thermoplastic polyurethane, a silicone, or other suitable materials. The extension portion 106 can be sufficiently flexible such that it can bend so as to position the lead body 104 on top of, but spaced apart from, the electronics package 108. As discussed in greater detail below with reference to FIGS. 3A-3F, the neuromodulation device 100 is configured to be implanted within both a submental region and a sublingual region such that the electronics package 108 and lead body 104 are vertically stacked with one or more muscle and / or other tissue layers positioned therebetween. The flexibility of the extension portion 106 enables such a configuration.

[0061] In some embodiments, the extension portion 106 comprises a sidewall defining a lumen extending through the extension portion 106. The conductive elements 114 can be electrically coupled to the first antenna 116 and / or the electronics component 118 via one or more electrical connections (also referred to as “electrical conductors” herein) extending through the lumen of the extension portion 106. For example, the proximal end portions of the electrical connections can be routed through the first connector 110 to the electronics component 118 on the electronics package 108. The electrical connections may comprise, for example, one or more wires, cables, traces, vias, and others extending through, on, and / or along the extension portion 106 and lead body 104. The electrical connections can comprise a conductive material such as silver, copper, etc., and each electrical connection can be insulated along all or a portion of its length. In some embodiments, the device 100 includes a separate electrical connection for each conductive element 114. For example, in those embodiments in which the device 100 comprises eight conductive elements 114 (and other embodiments), the device 100 can comprise eight electrical connections, each extending through the lumen of theAttorney Docket No.: XII.021 WOextension portion 106 from a proximal end at the electronics component 118 to a distal end at one of the conductive elements 114.

[0062] In some embodiments, the electronics component 118 comprise an applicationspecific integrated circuit (ASIC), a discrete electronic component, and / or an electrical connector. In these and other embodiments, the electronics component 118 can comprise, for example, processing and memory components (e.g., microcomputers, microprocessors, computers-on-a-chip, etc.), charge storage and / or delivery components (e.g., batteries, capacitors, electrical conductors) for receiving, accumulating, and / or delivering electrical energy, switching components (e.g., solid state, pulse-width modulation, etc.) for selection and / or control of the conductive elements 114. In some embodiments, the electronics component 118 comprise a data communications unit for communicating with an external device (such as external system 15) via a communication standard such as, but not limited to, near-field communication (NFC), infrared wireless, Bluetooth, ZigBee, Wi-Fi, inductive coupling, capacitive coupling, or any other suitable wireless communication standard. In some examples, the electronics component 118 include one or more processors having one or more computing components configured to control energy delivery via the conductive elements 114 and / or process energy and / or data received by the conductive elements 114 according to instructions stored in the memory. The memory may be a tangible, non-transitory computer-readable medium configured to store instructions executable by the one or more processors. For instance, the memory may be data storage that can be loaded with one or more of the software components executable by the one or more processors to achieve certain functions. In some examples, the functions may involve causing the conductive elements 114 to obtain data characterizing activity of a patient’s muscles. In another example, the functions may involve processing data to determine one or more parameters of the data (e.g., a change in muscle activity, etc.). According to various embodiments, the electronics component 118 can comprise a wireless charging unit for providing power to other electronics component 118 of the device 100 and / or recharging a battery of the device 100 (if included).

[0063] The electronics package 108 can also be configured to wirelessly receive energy from a power source to power the neuromodulation device 100. In some embodiments, the electronics package 108 comprises a first antenna 116 configured to wirelessly communicate with the external system 15. As shown in FIG. 2B, in some embodiments the electronics component 118 can be disposed in an opening at a central portion of the first antenna 116. InAttorney Docket No.: XII.021 WOother embodiments, the electronics component 118 and antenna 116 may have other configurations and arrangements.

[0064] The second antenna 12 can be configured to emit an electromagnetic field to induce an electrical current in the first antenna 116, which can then be supplied to the electronics component 118 and / or conductive elements 114. In some embodiments, the first antenna 116 comprises a coil or multiple coils. For example, the first antenna 116 can comprise one or more coils disposed on a flexible substrate. The substrate can comprise a single substrate or multiple substrates secured to one another via adhesive materials. For instance, in some embodiments the substrate comprises multiple layers of a heat resistant polymer (such as polyimide) with adhesive material between adjacent layers. Whether comprising a single layer or multiple layers, the substrate can have one or more vias extending partially or completely through a thickness of the substrate, and one or more electrical connectors can extend through the vias to electrically couple certain components of the electronics package 108, such as the first antenna 116 and / or the previously discussed electronics component 118.

[0065] In some embodiments, the first antenna 116 comprises multiple coils. For example, the first antenna 116 can comprise a first coil at a first side of the substrate and a second coil at a second side of the substrate. This configuration can be susceptible to power losses due to substrate losses and parasitic capacitance between the multiple coils and between the individual coil turns. Substrate losses occur due to eddy currents in the substrate due to the non-zero resistance of the substrate material. Parasitic capacitance occurs when these adjacent components are at different voltages, creating an electric field that results in a stored charge. All circuit elements possess this internal capacitance, which can cause their behavior to depart from that of “ideal” circuit elements.

[0066] Advantageously, in some embodiments the first antenna 116 can comprise a two-layer, pancake style coil configuration in which the top and bottom coils are configured in parallel. As a result, the coils can generate an equal or substantially equal induced voltage potential when subjected to an electromagnetic field. This can help to equalize the voltage of the coils during use, and has been shown to significantly reduce the parasitic capacitance of the first antenna 116. In this parallel coil configuration, the top and bottom coils are shorted together within each turn. This design has been found to retain the benefit of lower series resistance in a two-coil design while, at the same time, greatly reducing the parasitic capacitance and producing a high maximum power output. Additional details regarding theAttorney Docket No.: XII.021 WOtwo-coil configuration can be found in U.S. Application No. 16 / 866,523, filed May 4, 2020, which is incorporated by reference herein in its entirety.

[0067] The first antenna 116 (or one or more portions thereof) can be flexible such that the first antenna 116 is able to conform at least partially to the patient’s anatomy once implanted. In some embodiments, the first antenna 116 comprises an outer coating configured to encase and / or support the first antenna 116. The coating can comprise a biocompatible material such as, but not limited to, epoxy, urethane, silicone, or other biocompatible polymers. In some embodiments, the coating comprises multiple layers of distinct materials. In some embodiments, different distinct materials can coat different regions of the first antenna 116. For example, a first material (e.g., epoxy, urethane, silicone, etc.) can coat a first region including the electronics component 118 (e.g., a central region of the first antenna 116) and a second material can coat a second region including the coil turns. As described in greater detail below, in some embodiments the electronics component 118 is hermetically contained within an enclosure, which can comprise one or more coatings and / or one or more housings, while the coil and / or substrate of the first antenna 116 may or may not be hermetically enclosed.

[0068] In some embodiments, a region including the electronics component (e.g., a central region of the first antenna 116) can be coated or otherwise covered by a first material (e.g., epoxy) and a region including the one or more partially or fully isolated coil turns can be coated or otherwise covered by a second material (e.g., urethane, silicone, other polymer of low durometer) configured to enable the coil turns to bend and move. In some embodiments, the region including the coil turns can be overmolded with the second material. For example, any of the example electronics packages described herein can include an electronics component region covered with a first material, and coil turns covered with a second material. In some embodiments, the first material and / or the second material covering at least a portion of the first antenna may help contribute to maintaining spacing between adjacent isolated coil turns (e.g., in embodiments that lack strut regions). Further details regarding covering a region including the electronics component in a material (e.g., enclosure) are described below.

[0069] With continued reference to FIGS. 2B-2D, the lead body 104 can comprise a substrate carrying one or more conductive elements 114 configured to deliver and / or receive electrical energy. In some embodiments, the lead body 104 (or one or more portions thereof) comprises flexible tubing with a sidewall defining a lumen. The lead body 104 can comprise a polymeric material such as, but not limited to, a thermoplastic elastomer, a thermoplastic polyurethane, a silicone, or other suitable materials. The lead body 104 can comprise the sameAttorney Docket No.: XII.021 WOmaterial as the extension portion 106 or a different material. The lead body 104 can comprise the same material as the extension portion 106. In some embodiments, the lead body 104 has a different durometer than the extension portion 106. For example, the lead body 104 can have a lower durometer than the extension portion 106, which can enhance patient comfort.

[0070] As shown in FIGS. 2B-2D, the lead body 104 has a branched shape comprising a first arm 122 and a second arm 124. To facilitate this configuration, for example, the second connector 112 can be bifurcated and / or branching. The first arm 122 and the second arm 124 can each extend distally and laterally from the second connector 112 and / or the distal end portion 106b of the extension portion 106. The first arm 122 can comprise a proximal portion 122a, a distal portion 122b, and an intermediate portion 122c extending between the proximal portion 112a and the distal portion 122b. Similarly, the second arm 124 can comprise a proximal portion 124a, a distal portion 124b, and an intermediate portion 124c extending between the proximal portion 124a and the distal portion 124b. In some embodiments, the first arm 122 can comprise a cantilevered, free distal end 123 and / or the second arm 124 can comprise a cantilevered, free distal end 125. The first arm 122 and / or the second arm 124 can include one or more fixation elements 130, for example the fixation elements 130 shown at the distal end portions 122b, 124b of the first and second arms 122, 124 in FIGS. 2B-2D. The fixation elements 130 can be configured to securely, and optionally releasably, engage patient tissue to prevent or limit movement of the lead body 104 relative to the tissue.

[0071] While being flexible, the lead 102 and / or one or more portions thereof (e.g., the lead body 104, the extension portion 106, etc.) can also be configured to maintain a desired shape. This feature can, for example, be facilitated by electrical conductors that electrically connect the conductive elements 114 carried by the lead body 104 to the electronics package 108, by an additional internal shape-maintaining (e.g., a metal, a shape memory alloy, etc.) support structure (not shown), by shape setting the substrate comprising the lead 102, etc. In any case, one or more portions of the lead 102 can have a physical property (e.g., ductility, elasticity, etc.) that enable the lead 102 to be manipulated into a desired shape or maintain a preset shape. Additionally or alternatively, the lead 102 and / or one or more portions thereof (e.g., the lead body 104, the extension portion 106, etc.) can be sufficiently flexible to at least partially conform to a patient’s anatomy once implanted and / or to enhance patient comfort.

[0072] The conductive elements 114 can be carried by the sidewall of the lead body 104. For example, the conductive elements 114 can be positioned on an outer surface of the sidewall and / or within a recessed portion of the sidewall. In some embodiments, one or moreAttorney Docket No.: XII.021 WOof the conductive elements 114 is positioned on an outer surface of the sidewall and extends at least partially around a circumference of the sidewall. The lumen of the lead body 104 can carry one or more electrical conductors that extend through the lumen of the lead body 104 and the lumen of the extension portion 106 from the conductive elements 114 to the electronics package 108. The sidewall can define one or more apertures through which an electrical connector can extend.|0073] As previously described, the conductive elements 114 can be connected to electronics package 108 via one or more electrical conductors. The electrical conductors can be positioned on the sidewall of the lead 102 (e.g., the extension portion 106 and / or the lead body 104) and / or within a lumen of the lead 102. In some embodiments in which the electrical conductors are positioned within the lumen of the extension portion 106 of the lead 102, the lumen can be backfilled once the electrical conductors have been positioned within the lumen. The lumen can be backfilled with an adhesive and / or an elastomer. In some embodiments, the lumen is backfilled with a silicone adhesive, for example. In some embodiments, the extension portion 106 can be injection molded around the electrical conductors. Backfilling the lumen and / or injection molding the extension portion 106 around the electrical conductors can fill space within the lumen of the extension portion 106 otherwise not occupied by the electrical conductors, which may, for example, help prevent or limit fluid from entering the lead 102 and corroding or degrading the electrical conductors.

[0074] In some embodiments, each conductive element 114 is connected to one respective electrical conductor such that the number of electrical conductors equals the number of conductive elements 114. Still, in some embodiments, the device can include more or fewer electrical conductors than conductive elements 114 (e.g., an electrical conductor can be connected to multiple conductive elements 114). A conductive element 114 can be connected to an electrical conductor via welding, soldering, and / or any other suitable technique for forming an electrical and / or mechanical connection between the conductive element 114 and the electrical conductor. For example, the conductive element 114 can be connected to an electrical conductor via tack welding. The conductive element 114 can be connected to the respective electrical conductor at one or more locations along a length of the electrical conductor.

[0075] In some embodiments, a material and / or configuration of an electrical conductor can be selected based on a desired mechanical performance of the electrical conductor. For example, a stranded electrical conductor may have better flexibility and fatigue resistance thanAttorney Docket No.: XII.021 WOa solid core wire, which may be desirable for use in the human body. In some embodiments, it may be advantageous for the electrical conductors to comprise a material having a low resistivity, as such electrical conductors may draw less power than equivalent electrical conductors with higher resistivity. An electrical conductor of the present technology can comprise any suitable metal such as titanium, chromium, niobium, tantalum, vanadium, zirconium, aluminum, cobalt, nickel, stainless steels, or alloys of any of the foregoing metals.|0076] Each of the conductive elements 114 may comprise an electrode, an exposed portion of a conductive material, a printed conductive material, and other suitable forms. In some embodiments, one or more of the conductive elements 114 comprises a ring electrode. The conductive elements 114 can be crimped, welded, adhered to, or positioned over an outer surface and / or recessed portion of the lead body 104. Additionally or alternatively, each of the conductive elements 114 can be welded, soldered, crimped, or otherwise electrically coupled to a corresponding electrical conductor. In some embodiments, one or more of the conductive elements 114 comprises a flexible conductive material disposed on the lead body 104 via printing, thin film deposition, or other suitable techniques. Each one of the conductive elements 114 can comprise any suitable conductive material including, but not limited to, platinum, iridium, silver, gold, nickel, titanium, copper, combinations thereof, and / or others. For example, one or more of the conductive elements 114 can be a ring electrode comprising a platinum iridium alloy. In some embodiments, one or more of the conductive elements 114 comprises a coating configured to improve biocompatibility, conductivity, corrosion resistance, surface roughness, durability, or other parameter(s) of the conductive element 114. As but one example, one or more of the conductive elements 114 can comprise a coating of titanium and nitride.

[0077] In some embodiments, one or more conductive elements 114 has a length of about 1 mm. Additionally or alternatively, one or more conductive elements 114 can have a length of about 0.25 mm, about 0.5 mm, about 0.75 mm, about 1.25 mm, about 1.5 mm, about 1.75 mm, about 2 mm, about 2.25 mm, about 2.5 mm, about 2.75 mm, about 3 mm, about 3.25 mm, about 3.5 mm, about 3.75 mm, about 4 mm, about 4.25 mm, about 4.5 mm, about 4.75 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, more than 10 mm, or less than 0.25 mm. In any case, adjacent conductive elements 114 carried by one of the first or second arms 122, 124 can be spaced apart along a length of the arm by about 0.25 mm, about 0.5 mm, about 0.75 mm, about 1 mm, about 1.25 mm, about 1.5 mm, about 1.75 mm, about 2 mm, about 2.25 mm, about 2.5 mm, about 2.75 mm, about 3 mm, about 3.25 mm,Attorney Docket No.: XII.021 WOabout 3.5 mm, about 3.75 mm, about 4 mm, about 4.25 mm, about 4.5 mm, about 4.75 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, more than 10 mm, or less than 0.25 mm. The conductive elements 114 can have the same length or different lengths.

[0078] Furthermore, while the device 100 shown in FIGS. 2B-2D includes conductive elements 114 that are generally equally spaced apart from each other on the first arm 122 and on the second arm 124, other distributions of conductive elements 114 are within the scope of the present technology. For example, on the first arm 122 and / or the second arm 124, at least a portion of the conductive elements 114 can be equally spaced apart along the length of the arm, and / or at least a portion of the conductive elements 114 can be unequally spaced apart along the length of the arm.

[0079] For example, in some embodiments with unequal spacing of conductive elements 114, the spacing between conductive elements 114 along the first arm 122 and / or the second arm 124 can decrease in a proximal-to-distal direction (e.g., conductive elements 114 located at a distal portion of a lead body arm 122, 124 can be located closer to each other compared to conductive elements 114 located at a proximal portion of the lead body arm). As another example, in some embodiments with unequal spacing of conductive elements 114, the spacing between conductive elements 114 along the first arm 122 and / or the second arm 124 can increase in a proximal-to-distal direction (e.g., conductive elements 114 located at a distal portion of a lead body arm 122, 124 can be located farther from each other compared to conductive elements 114 located at a proximal portion of the lead body arm). As another example, in some embodiments with unequal spacing of conductive elements 114, the spacing between conductive elements 114 along the first arm 122 and / or the second arm 124 can regularly alternate between a first distance and a second distance, where the first and second distances are different. As another example, in some embodiments with unequal spacing of conductive elements 114, the spacing between conductive elements 114 along the first arm 122 and / or the second arm 124 can be irregular or random.

[0080] The spacing or distribution of conductive elements 114 on the first arm 122 can mirror that of conductive elements 114 on the second arm 124, or the spacing or distribution of conductive elements 114 can be different on the first arm 122 compared to the second arm 124.Attorney Docket No.: XII.021 WO

[0081] While the device 100 shown in FIGS. 2B-2D includes eight conductive elements 114 (four conductive elements 114 carried by the first arm 122 and four conductive elements 114 carried by the second arm 124), other numbers and configurations of conductive elements 114 are within the scope of the present technology. For example, the first arm 122 can carry the same number of conductive elements 114 as the second arm 124, or the first arm 122 can carry a different number of conductive elements 114 as the second arm 124 (e.g., the first arm 122 can carry more or fewer conductive elements 114 than the second arm 124). The first arm 122 and / or the second arm 124 can carry one conductive element 114, two conductive elements 114, three conductive elements 114, four conductive elements 114, five conductive elements 114, six conductive elements 114, seven conductive elements 114, eight conductive elements 114, nine conductive elements 114, ten conductive elements 114, or more than ten conductive elements 114. In some embodiments, one of the first arm 122 or the second arm 124 does not carry any conductive elements 114.

[0082] The conductive elements 114 can be configured for stimulation and / or sensing. Stimulating conductive elements 114 can be configured to deliver energy to an anatomical structure, such as, for example, a nerve or muscle. In some embodiments, the conductive elements 114 are configured to deliver energy to a hypoglossal nerve of a patient to increase the activity of the patient’s tongue protrusor muscles. Sensing conductive elements 114 can be used obtain data characterizing a physiological activity of a patient (e.g., muscle activity, temperature, etc.). In some embodiments, the sensing conductive elements 114 are configured to detect electrical energy produced by a muscle of a patient to obtain EMG data characterizing an activity of the muscle. In some embodiments, the sensing conductive elements are configured to measure impedance across the conductive elements. As but one example, in some embodiments the conductive elements 114 are configured to deliver energy to a hypoglossal nerve of a patient to increase activity of the genioglossus and / or geniohyoid muscles, and obtain EMG data characterizing activity of the genioglossus muscle and / or the geniohyoid muscle of the patient. Still, the conductive elements 114 can be configured to deliver energy to and / or measure physiological electrical signals from other patient tissues.

[0083] The function that each of the conductive elements 114 is configured to perform (e.g., delivering energy to patient tissue, receiving energy from patient tissue, etc.) can be controlled by a processor of the electronics component 118 of the electronics package 108. In some embodiments, one or more of the conductive elements 114 is configured for only one of delivering energy to patient tissue or receiving energy from patient tissue. In variousAttorney Docket No.: XII.021 WOembodiments, one or more of the conductive elements 114 is configured for both delivering energy to patient tissue and receiving energy from patient tissue. In some embodiments, the functionality of a conductive element 114 can be based, at least in part, on an intended positioning of the device 100 within a patient and / or the position of the conductive element 114 on the lead body 104. One, some, or all of the conductive elements 114 can be positioned relative to patient tissue, such as nerves and / or muscles, so that it may be desirable for the conductive element(s) 114 to be able to both deliver energy to the patient tissue and receive energy from the patient tissue. Additionally or alternatively, some conductive elements 114 can have an intended position relative to specific patient tissues so that only delivery of stimulation energy is desired while other conductive elements 114 can have an intended position relative to specific patient tissues so that only receipt of sensing energy is desired. Advantageously, the configurations of the conductive elements 114 can be configured in software settings (which can be facilitated by electronics component 118 of the electronics package 108) so that the configurations of the conductive elements 114 are easily modifiable.

[0084] Whether configured for stimulating and / or sensing, each of the conductive elements 114 can be configured and used independently of the other conductive elements 114. Because of this, all or some of conductive elements 114, whichever is determined to be most effective for a particular implementation, can be utilized during the application of stimulation therapy. For example, one conductive element 114 of the first arm 122 can be used as a cathode while one conductive element 114 of the second arm 124 is used as an anode (or vice versa), two or more conductive elements 114 of the first arm 122 can be used (one as the cathode and one as the anode) without use of any conductive elements 114 of the second arm 124 (or vice versa), multiple pairs of conductive elements 114 of the first and second arms 122, 124 can be used, or any other suitable combination. As discussed in greater detail below, the conductive element(s) 114 used for sensing and / or stimulation can be selected based on desired data to be collected and / or desired modulation of neural or muscle activity. For example, specific pairs of the conductive elements 114 can be used for creating an electric field tailored to stimulation of certain regions of the muscle and / or HGN that causes favorable changes in tongue position and / or pharyngeal dilation. Additionally or alternatively, conductive element(s) 114 that are positioned in contact with muscle tissue when the device 100 is implanted may be more favorable to use for EMG sensing than conductive element(s) 114 that are not positioned in contact with muscle tissue.Attorney Docket No.: XII.021 WO

[0085] The lead body 104 can have a shape configured to facilitate delivery of electrical energy to a specific treatment location within a patient and / or detection of electrical energy from a sensing location within the patient. The conductive elements 114 carried by the first arm 122 can be configured to deliver electrical stimulation energy to one hypoglossal nerve (e.g., the right or the left hypoglossal nerve) of a patient and the conductive elements 114 carried by the second arm 124 can be configured to deliver electrical stimulation energy to the other hypoglossal nerve (e.g., the other of the right or the left hypoglossal nerve) of the patient.

[0086] Without being bound by theory, it is believed that increased activity of the tongue protrusor muscles during sleep reduces upper airway resistance and improves respiration. Thus, devices of the present technology are configured to deliver stimulation energy to motor nerves that control the tongue protrusors. In some embodiments, the device 100 is configured to deliver stimulation energy to the hypoglossal nerve to cause protrusion of the tongue. Additionally or alternatively, the device 100 can be configured to receive sensing energy produced by activity of one or more muscles of a patient (such as the genioglossus muscle), which can be used for closed-loop delivery of stimulation energy, evaluation of patient respiration, etc.

[0087] The device can be configured to be implanted at an anatomical region of a patient that is bound anteriorly and laterally by the patient's mandible, superiorly by the superior surface of the tongue, and inferiorly by the patient's platysma. Such an anatomical region can include, for example, a submental region and a sublingual region. The sublingual region is bound superiorly by the oral floor mucosa and inferiorly by the mylohyoid and includes the plane between the genioglossus muscle and the geniohyoid muscle. The submental region is bound superiorly by the mylohyoid and inferiorly by the platysma muscle. FIGS. 3 A-3F depict various views of the device 100 implanted within a patient. As shown in FIGS. 3A-3F, the neuromodulation device 100 is configured to be positioned such that the electronics package 108 is disposed on or near the inferior surface of the mylohyoid in a submental region while the lead body 104 is positioned between the geniohyoid and genioglossus in a sublingual region with the arms 122, 124 disposed along the left and right hypoglossal nerves. The arms 122, 124 can be positioned such that the conductive elements 114 are disposed near the portions of the distal arborization of the hypoglossal nerves that innervate the genioglossus. In particular, the conductive elements 114 can be positioned proximate the portions of the distal arborization that innervate the horizontal fibers of the genioglossus while limiting and / or avoiding stimulation of the portions of the distal arborization of the hypoglossal nerve thatAttorney Docket No.: XII.021 WOactivate retrusor muscles. When implanted, the extension portion 106 of the lead 102 can extend in an anterior direction away from the electronics package 108 (towards the mandible), then bend superiorly and extend through the geniohyoid muscle until bending back posteriorly and extending within a tissue plane between the geniohyoid and genioglossus muscles. In some embodiments, the extension portion 106 straddles the right and left geniohyoid muscles.

[0088] The electronics package 108 can be sufficiently flexible so that, once implanted, the electronics package 108 at least partially conforms to the curvature of the mylohyoid. Additionally or alternatively, the electronics package 108 can have a shape reflecting the curvature of the mylohyoid. In some embodiments, the electronics package 108 can comprise fixation elements (similar to fixation elements 130, or otherwise) that are configured to engage the mylohyoid (and / or other surrounding tissue) and prevent or limit motion of the electronics package 108 once implanted.

[0089] The lead body 104 can be configured to be positioned between the genioglossus and geniohyoid muscles of a patient so that the conductive elements 114 are positioned proximate the hypoglossal nerve. Although not shown in FIGS. 3A-3F, the hypoglossal nerve is located between the genioglossus and fascia and / or fat located between the genioglossus and the geniohyoid. In some embodiments, the lead body 104 is configured to be positioned at or just inferior to the fat between the hypoglossal nerve and the geniohyoid and thus is not positioned in direct contact with the hypoglossal nerve. In any case, once the device 100 is implanted, the lead body 104 can extend posteriorly away from the distal end portion 106b of the extension portion 106. The lead body 104 can then branch or diverge laterally such that the first arm 122 of the lead body 104 is positioned proximate one of the patient’s hypoglossal nerves and the second arm 124 is positioned proximate the contralateral hypoglossal nerve. The fixation elements 130 can engage patient tissue (e.g., the fat underlying the hypoglossal nerves, etc.) to prevent or limit motion of the first and second arms 122, 124 relative to the patient tissue.

[0090] As best shown in FIG. 3C, and as described in greater detail below, the arms 122, 124 of the lead body 104 can bend out of the plane of the extension portion 106, in addition to extending laterally away from the extension portion 106, such that the arms 122, 124 outline a somewhat concave shape. Advantageously, this concave shape can accommodate the convex inferior surface of the genioglossus and still keep the arms 122, 124 positioned near the distal arborization of the hypoglossal nerve.Attorney Docket No.: XII.021 WO

[0091] In some embodiments, conductive elements 114 are selected for use that selectively activate the protrusor muscles of a patient. In these and other embodiments, the specific positioning of the first and second arms 122, 124 relative to specific branches of the hypoglossal nerves need not be identified prior to stimulation of desired portions of the nerve and / or muscles. For example, in embodiments in which the lead body 104 includes more than two conductive elements 114, the combination of conductive elements 114 that is used for treating a patient can be selected based on physiological responses to test stimulations. For example, stimulation energy can be delivered to the hypoglossal nerve(s) via multiple combinations of conductive elements 114 and a physiological response (e.g., EMG data, tongue position, pharyngeal opening size, etc.) and / or a functional outcome (e.g., Fatigue Severity Scale, Epworth Sleepiness Scale, etc.) can be evaluated for each combination. Based on the evaluation(s), the conductive elements 114 that are selected to deliver stimulation energy can be conductive elements 114 that are associated with favorable responses / outcomes.

[0092] As previously noted, it can be advantageous for a first antenna of a neuromodulation device of the present technology to be flexible and / or conformable so that the first antenna mimics the shape of the patient’s anatomy once implanted. However, if the coil of the first antenna includes a material that is corrosive, toxic, carcinogenic, thrombogenic, allergenic, inflammatory, or otherwise not biocompatible, extra precautions should be taken to isolate the coil from the body. For example, copper is susceptible to corrosion in the human body, which can release metallic ions into the body and degrade the performance of a first antenna formed from copper. A coating can be applied to a copper coil to hermetically surround the coil and isolate the coil from the body. However, such a coating is typically thick and / or rigid, which can limit the flexibility and conformability of the first antenna. Moreover, testing and quality requirements for first antennas with non-biocompatible and / or corrosive materials tend to be extensive and may increase the time and costs of development and manufacturing.

[0093] To address the aforementioned challenges, some embodiments of the present technology are directed to a first antenna comprising a coil formed from a conductive wire consisting of or encapsulated itself in biocompatible materials (e.g., materials that cause minimal or low thrombogenic, toxic, cancerous, or allergic inflammatory, etc. response when implanted in a patient’s body) and / or non-corrosive materials (e.g., materials that do not substantially corrode when implanted in a patient’s body). Because such materials may not need to be hermetically contained, the first antenna can include a flexible, soft, and / or thinAttorney Docket No.: XII.021 WOcoating or housing over the coil, thereby enhancing the flexibility and / or conformability of the first antenna.

[0094] A coil of a first antenna of the present technology can be formed from a conductive wire wound into a desired pattern of coil turns. The wire can have mechanical properties (e.g., stiffness, diameter, etc.) that provide a desired flexibility and / or conformability to the first antenna. A coil comprising a wound wire also has certain benefits as compared to a coil comprising traces of conductive material laminated and / or deposited onto a printed circuit board substrate (e.g., polyimide, etc.). Printed circuit board substrates often include multiple layers secured together with adhesive and are susceptible to delamination and degradation due to fluid ingress into the substrate once implanted in the body. Thus, such substrates may be hermetically sealed or otherwise contained, to isolate the substrate from the environment of the body. A wire can be carried by a greater variety of substrates than a conductive trace (and also can be standalone with no substrate) and thus, a substrate can be selected that does not require a hermetic seal. For example, the substrates carrying the coil wires of the present technology can be biocompatible, hydrophobic, and highly stable within the body. Substrates carrying wires can also be soft and flexible to provide a desired flexibility and / or conformability to the first antenna.

[0095] FIG. 4 is a plan view of an electronics package 1308 including a first antenna 1316 and an electronics component 1318 (shown schematically) in accordance with various embodiments of the present technology. The first antenna 1316 can comprise a coil 1334 formed from a wire 1335 having a first end portion 1336 (shown schematically by dashed line) coupled to the electronics component 1318, a second end portion 1338 (shown schematically by dashed line) coupled to the electronics component 1318, and a wound portion 1340 including a plurality of turns 1342 surrounding an opening 1348. In some embodiments, for example as shown in FIG. 4, the electronics component 1318 is positioned within the opening 1348. According to various embodiments, the coil 1334 can be substantially planar such that each of the turns 1342 lies within a two-dimensional plane. Still, in some embodiments individual turns of the coil 1334 can lie within different two-dimensional planes and / or the coil 1334 can be bent such that certain regions of the coil 1334 are at different elevations to one another.

[0096] The wire 1335 can be conductive and configured to carry a current. The wire 1335 can comprise a biocompatible material that, when implanted in a submental region of a patient, does not substantially cause a thrombogenic, toxic, cancerous, or allergicAttorney Docket No.: XII.021 WOinflammatory response. In various embodiments, the wire 1335 can comprise a material that is configured to experience little to no corrosion when implanted in the submental region. The wire 1335 can comprise or consist of, for example, gold, graphene, platinum, titanium, and / or alloys thereof. The wire 1335 can comprise a single strand or a plurality of strands. Additionally or alternatively, the wire 1335 can comprise a single material or multiple materials. In various embodiments, the wire 1335 can be include a first, core material and a second material disposed on the first material. In some embodiments, the first material is not biocompatible and / or non-corrosive but the second material is biocompatible and / or non-corrosive and isolates the first material from the environment. The second material can be conductive. The wire 1335 can be formed with the first and second materials by plating, sputtering, drawing, or any other suitable method.

[0097] The wire 1335 can have surface treatments (e.g., plasma treatments, surface roughening, etc.) to facilitate coupling of the wire 1335 to a substrate and / or a coating. In some embodiments, the wire 1335 can be insulated in a non-conductive material along some or all of the length of the wire 1335. The non-conductive insulating material can comprise, for example, polyimide, PTFE, urethanes, silicones, Parylene, combinations thereof, or other suitable materials. The non-conductive insulation wire may be applied before the coiling process or may be applied after coiling the wire in the desired geometry. In various embodiments, the wire 1335 can be insulated such that, when implanted in the body, a resonant frequency of the first antenna 1316 does not substantially change. In contrast, when a first antenna comprising a conductive trace carried on a polyimide is implanted in the body, the resonant frequency of the first antenna may change, which may require tuning of the resonant circuit of the first antenna and / or a second antenna which the first antenna is intended to inductively couple to.

[0098] The wire 1335 can comprise an elongate member having any suitable shape and / or dimensions. In some embodiments, the wire 1335 has a cross-sectional shape that is round, rectangular, triangular, polygonal, or irregular. The wire 1335 can comprise material that has been extruded, drawn, cast, deposited, cut, stamped, machined, rolled, or otherwise formed into an elongate member that can then be shaped to form the desired turns 1342 of the wound portion 1340 of the coil 1334.

[0099] The wire 1335 can have a constant diameter or a varying diameter. In some embodiments, the diameter of the wire 1335 can be based on a desired power harvesting performance of the first antenna 1316. For example, a wire 1335 with a larger diameter createsAttorney Docket No.: XII.021 WOa larger surface area of conductive material for inducing current, which can facilitate greater power harvesting. However, for a fixed area of the coil 1334, adjacent turns 1342 formed from a wire 1335 with a larger diameter will be closer together and may generate greater parasitic capacitance. Thus, the diameter of the wire 1335 may be selected to balance surface area and parasitic capacitance. A wire 1335 with a larger diameter will also be stiffer and the first antenna 1316 will be less flexible. Such a first antenna 1316 may, however, advantageously be configured to retain a shape corresponding to the shape of the submental region within which the first antenna 1316 is configured to be placed. Accordingly, the diameter of the wire 1335 may be selected to balance flexibility and conformability of the first antenna 1316. In various embodiments, the diameter of the wire 1335 can be between about 0.15 mm and about 0.30 mm, about 0.15 mm, about 0.20 mm, about 0.25 mm, or about 0.30 mm.

[0100] As shown in FIG. 4, the coil 1334 can have a width W measured in a first dimension and a length L measured in a second dimension. According to various embodiments, the width W can be larger than the length L. The coil 1334 can have a shape that is generally oblong and / or elongated (e.g., obround, stadium, elliptical, ovular, rectangular, etc.). The coil 1334 can have a shape and / or dimensions based on a desired anatomical placement of the coil 1334. For example, as previously described herein, the coil 1334 can be configured to be implanted in a submental region bound superiorly by the mylohyoid and inferiorly by the platysma. The submental region can also be bound in the sagittal plane anteriorly by the mentum and posteriorly by the hyoid. The coil 1334 can be configured to be implanted in the submental region with the length L of the coil 1334 aligned with the sagittal plane and thus, the dimension of the length L can be based on a distance between the mentum and the hyoid for a particular patient and / or a population of patients. Moreover, the dimension of the length L can be based on the distance between the mentum and the hyoid in one or more postures. For example, the distance between the mentum and the hyoid with the neck in a neutral posture can be between about 35 mm and about 55 mm in a population of patients. However, when the neck is flexed, the distance between the mentum and the hyoid can decrease about 30% to about 40%. Thus, in some embodiments the length L is selected to prevent or limit contact between the coil 1334 and the hyoid or the mentum during neck flexion. For example, the length L can be no greater than about 40 mm, no greater than about 35 mm, no greater than about 30 mm, no greater than about 25 mm, or no greater than about 20 mm. For a given device to accommodate patients with a range of mentum to hyoid distances, the length L can be based on a minimum expected hyoid to mentum distance in a population of patients. In theseAttorney Docket No.: XII.021 WOembodiments, and others, the length L can be about 25 mm, about 24 mm, about 23 mm, about 22 mm, about 21 mm, about 20 mm, about 19 mm, about 18 mm, or about 17 mm.

[0101] Additionally or alternatively, the coil 1334 can have a shape based on a desired power to be harvested by the coil 1334. For example, if the length L of the coil 1334 is decreased relative to the diameter of a circular coil based on a desired fit of the first antenna 1316 within an anatomical region, the width W of the coil 1334 can be increased to maintain a desired surface area of conductive material within the coil 1334, which influences how much power the coil 1334 can harvest within a given electromagnetic field. Additionally or alternatively, the width W of the coil 1334 can be selected to enable the placement of the electronics component 1318, securing element, or other component within the opening 1348. The width W of the coil 1334 may also be limited by anatomical constraints. For example, the width W of the coil can be selected to prevent or limit contact between the coil 1334 and the mandible when implanted in a submental region of a patient. Thus, the oblong shape of the coil 1334 facilitates both anatomical placement and power harvesting. In some embodiments, the width W of the coil 1334 can be between about 35 mm and about 50 mm, between about 40 mm and about 50 mm, between about 45 mm and about 50 mm, about 35 mm, about 40 mm, about 45 mm, or about 50 mm. In various embodiments, a ratio of the width W of the coil 1334 to the length L of the coil 1334 can be about 1.5 to 1, about 2 to 1, about 2.5 to 1, or about 3 to 1.

[0102] Referring still to FIG. 4, each of the turns 1342 can extend from a first end 1342a to a second end 1342b. The first ends 1342a of the turns 1342 can be generally aligned with one another in a radial direction, and similarly the second ends 1342b of the turns 1342 can be generally aligned with one another in a radial direction (e.g., the first ends 1342a and / or the second ends 1342b can be aligned along a ray extending generally from a central region of the coil toward the outermost coil turn 1342). In the example shown in FIG. 4, the first ends 1342a of the turns 1342 can be substantially aligned with one another at any given location along the width W of the coil 1334 and located at different locations along the length L of the coil 1334. Likewise, the second ends 1342b of the turns 1342 can be substantially aligned with one another at any given location along the width W of the coil 1334 and located at different locations along the length L of the coil 1334. As yet another example, the first ends 1342a of the turns 1342 can be substantially aligned with one another at any given location along the length L of the coil 1334 and located at different locations along the width W of the coil 1334 and the second ends 1342b of the turns 1342 can be substantially aligned withAttorney Docket No.: XII.021 WOone another at any given location along the length L of the coil 1334 and / or located at different locations along the width W of the coil 1334. It should be understood that the first ends 1342a and the second ends 1342b can each be positioned at any suitable perimetral location around the coil 1334.

[0103] As shown in FIG. 4, the first end 1342a of a given turn 1342 (excluding the innermost turn 1342) can be positioned at, continuous with, and / or electrically coupled to the second end 1342b of a preceding turn 1342. Thus, the coil 1334 can comprise a continuous coil with sequential turns 1342 electrically coupled to their preceding turns 1342. In other words, the turns 1342 are spiral turns that form a spiral wound portion 1340 of the coil 1334. One, some, or all of the turns 1342 can form a substantially complete loop with the second end 1342b of the turn 1342 aligned with or proximate to the first end 1342a of the turn 1342 along the width W of the coil 1334. In some embodiments, the first end 1342a of a given turn 1342 can be spaced apart from the second end 1342b of the preceding turn 1342 along the length L and / or width W of the coil 1334.[0104[ In various embodiments, one or more of the turns 1342 can include one or more straight portions 1344 and / or one or more curved portions 1346. In some embodiments, the straight portions 1344 and curved portions 1346 alternate along the length of the turn 1342. For example, FIG. 4 illustrates each of the turns 1342 having two straight portions 1344 (only labeled on the innermost turn 1342 for clarity of illustration) opposite one another along the length L of the coil 1334 and two curved portions 1346 (only labeled on the innermost turn 1342 for clarity of illustration) opposite one another along the width W of the coil 1334. Thus, the turns 1342 shown in FIG. 4 define the obround shape of the coil 1334. In embodiments in which the coil 1334 has an elliptical or ovular shape, for example, one or more of the turns 1342 can include only curved portions 1346. Conversely, in embodiments in which the coil 1334 has a rectangular shape, for example, one or more of the turns 1342 can include only straight portions 1344.

[0105] Although FIG. 4 illustrates the wound portion 1340 including seven turns 1342, the wound portion 1340 can include any suitable number of turns 1342. For example, the wound portion 1340 can include four turns 1342, five turns 1342, six turns 1342, seven turns 1342, or eight turns 1342. The number of turns 1342 can be based at least in part on a desired power harvesting performance of the first antenna 1316. Increasing the number of turns 1342 will increase the surface area of the conductive material of the coil 1334, thereby increasing the amount of power the coil 1334 can harvest from a given electromagnetic field.Attorney Docket No.: XII.021 WOHowever, for a given coil 1334 width W and length L, a wound portion 1340 with a greater number of turns 1342 will have a smaller pitch with adjacent turns 1342 positioned closer together, which can increase the parasitic capacitance of the coil 1334. Thus, the wound portion 1340 can include a number of turns 1342 that balances conductive surface area and parasitic capacitance to enhance the power harvesting capacity of the first antenna 1316.

[0106] The coil 1334 can have a constant pitch or a variable pitch. For example, FIG.4 illustrates the coil 1334 having a constant pitch with a distance 1350 between adjacent turns 1342 being substantially constant at all regions of the coil 1334. As another example, FIG. 5 is a plan view of an electronics package 1408 comprising a first antenna 1416 including a coil 1434 formed from a wire 1435 and having a variable pitch. The electronics package 1408, first antenna 1416, coil 1434, and wire 1435 of FIG. 5 can be similar to the electronics package 1308, first antenna 1316, coil 1334, and wire 1335 respectively, of FIG. 4, except as detailed below.

[0107] Any of the first antennas disclosed herein can include a substrate carrying one or more coils. The substrate can comprise a single substrate or multiple substrates secured to one another via adhesive, welding, heat, etc. According to various embodiments, the substrate can include features configured to facilitate winding and / or retention of a wire in a desired pattern of turns. In some embodiments, the antenna can be similar to those described in U.S. Patent Application No. 63 / 573,726 filed April 3, 2024, titled NEUROMODULATION DEVICES AND ASSOCIATED SYSTEMS AND METHODS, which is incorporated by reference herein in its entirety.IV. Electronics Package

[0108] While implanted, it may be desirable for electrical components (e.g., electronics package 108, electronics component 118, electronics component 1318) to be shielded from environmental factors such as the ingress of fluids into the device which can interfere with the operation of said components. To mitigate against such factors, described herein is an implantable device with a bendable lead and an electronics package comprising an antenna and an enclosure, wherein the enclosure shields the electrical components from environmental factors (e.g., ingress of fluid, electromagnetic interference) and comprises a channel to receive a proximal portion of the lead, and wherein the channel outlet overlaps with a central region of the antenna. The enclosure can comprise one or more non-conductive, biocompatible materials (e.g., epoxy, ceramic).Attorney Docket No.: XII.021 WO

[0109] For example, in some embodiments, the implantable device comprises a lead with a longitudinal axis that extends between a proximal and distal portion, and an electronics package coupled to the lead that comprises a substantially planar substrate with a central region and an enclosure configured to couple to the proximal portion of the lead at an enclosure coupling point that overlaps with the central region of the substrate. In some embodiments, the lead is bendable relative to the enclosure along the longitudinal axis at the enclosure coupling point.[OHO] Furthermore, in some example embodiments, the implantable device comprises a flexible lead with one or more electrodes, and an electronics package coupled to the flexible lead, wherein the electronics package comprises an antenna arranged along a first plane with one or more coil turns and a central region at least partially surrounded by at least one coil turn, and a hermetic enclosure that has a channel to receive a proximal portion of the flexible lead. The channel of the enclosure is arranged along a second plane offset from the first plane and has a channel outlet that overlaps with the central region of the antenna. To minimize an overall implantable volume, the lead extends from the enclosure at the channel outlet and is bendable out of the second plane relative to the enclosure along the longitudinal axis at the channel outlet.

[0111] In some embodiments, the channel may have a cross-sectional shape that substantially matches at least a portion of the cross-section of the proximal end of the lead, so as to receive and / or secure the proximal end of the lead within the channel (and to the enclosure of the electronics package). For example, the channel may have an arcuate shape (e.g., circular channel forming a lumen, or a semi-circular or other suitable arc sweep or arc length forming a trough-like channel) that substantially matches the cross-section of the proximal end of the lead. In some embodiments, the channel may additionally or alternatively have a diameter about equal to the diameter of the lead. Accordingly, in some embodiments the channel may be sized and / or shaped couple securely to the lead. In some embodiments, the channel may have the same cross-sectional shape along its length, or may have varying cross-sectional shape along its length (e.g., varying arcuate sweep, such as 180 degrees at one end of the channel and 270 degrees at an opposite end of the channel, or a tapering diameter). As another example, in some embodiments, the enclosure may additionally or alternatively include one or more lateral members extending over a trough-like channel to help secure the lead within the channel.

[0112] FIG. 6A shows an example embodiment of an electronics component 600 in accordance with the present technology. The electronics component 600 may be of any type described herein (e.g., electronics component 118, electronics component 1318). As shown inAttorney Docket No.: XII.021 WOFIG. 6A, the electronics component 600 can comprise one or more discrete electronic components (e.g., resistors, capacitors, conductors, etc.) arranged such that taller components are around the periphery of the electronics component 600 (e.g., a printed circuit board) and shorter components are located more centrally, so as to provide a region 602 of the electronics component 600 to facilitate a channel (shown in FIG. 6C) on the enclosure to receive a lead. The electronics component 600 can have one or more vias 604 to electrically couple the electronics component 600 to the lead and / or antenna via an interconnect (shown in FIG. 6B). In some embodiments, the one or more vias 604 are of the same type (e.g., comprising gold, comprising copper). In some embodiments, the one or more vias 604 comprises at least two different types. For example, those vias that electrically couple to the antenna can comprise a first material (e.g., gold) with low impedance to ensure high fidelity of signal transmission while those vias which electrically couple to the lead can comprise a second material (e.g., copper) able to transmit high powered stimulation. In some embodiments, the one or more vias 604 comprise 10 vias (e.g., through-hole vias), with two vias coupled to the antenna and eight vias coupled to the lead (e.g., a lead comprising four stimulating electrodes). In some embodiments, a pair of vias can correspond to an antenna connection or a lead electrode. (0113] FIG. 6B shows an example embodiment of an interconnect 606 that electrically couples the electronics component 600 to the lead and / or antenna. The interconnect 606 comprises a main body 608 through which one or more pins 610 pass. The main body 608 comprises a nonconductive material, while the one or more pins 610 comprise a conductive material (e.g., platinum iridium). The main body 608 has one or more holes through which the one or more pins 610 fit tightly, such that no fluid can traverse from a distal side of the interconnect 606 to a proximal side. The interconnect 606 thus allows electricity (e.g., electrical power, electrical communications) to go from one side of the main body 608 to another without allowing fluids to do so.

[0114] The one or more pins 610 can be substantially straight, and / or they can be bent into a desired configuration. For example, as seen in FIG. 6B, proximal ends 612 of the one or more pins 610 can be straight so as to align with the one or more vias 604 of the electronics component 600 while distal ends 614 of the one or more pins 610 can be bent to facilitate electrical coupling between the one or more pins 610 and the lead and / or the antenna.

[0115] FIG. 7 shows an example enclosure 616 covering the electronics component 600. The enclosure allows the distal ends 614 of the one or more pins 610 to be exposed for further coupling to other components (e.g., the lead, the antenna) while preventing the ingressAttorney Docket No.: XII.021 WOof fluids. The enclosure comprises a channel 618 configured to receive a portion of the lead. The enclosure 618 is configured to house the electronics component 600, which is a substantially planar substrate with a central region. The channel 618 of the enclosure 616 is configured to couple to a proximal portion of the lead at a location (e.g., enclosure coupling point) which overlaps with the central region of the substrate of the electronics component 600. Such a configuration enables the lead to be bendable relative to the enclosure along the longitudinal axis at such a location. For example, in some embodiments, the channel 618 of the enclosure 616 includes a channel outlet 622 that overlaps with the central region of the antenna, and the lead, when coupled to the channel 618, is configured to bend relative to the enclosure 616 along the longitudinal axis of the channel 618 at the channel outlet 622. In some embodiments, the antenna is arranged on a first plane of the implantable device and the enclosure 616 is arranged in a second plane of the implantable device different from the first plane, and lead is bendable out of the second plane relative to the enclosure 616 at the channel outlet 622 or other enclosure coupling point (e.g., at a location that is more radially central relative to the antenna, compared to a location that is along the periphery of the antenna or electronics package).[Oil 6] In some embodiments, the overall thickness of the enclosure 616 is less than or about equal to 5 mm. In some embodiments, taller electronic components are placed one side of the electronics component 600, such that when coated, covered, or otherwise encapsulated by the one or more layers, the thickness of enclosure is biased the direction of the taller electronic components. Therefore, in some embodiments, the enclosure 616 is biased to be thicker on top than bottom.

[0117] The enclosure may be formed as a hermetic enclosure (e.g., to reduce or eliminate fluid ingress) in one or more manners. For example, in some embodiments, the enclosure 616 comprises a coating with one or more layers. In some embodiments, the enclosure 616 comprises a combination two or more layers of two or more different materials (e.g., a combination of two or more alternating parylene and ceramic layers). By combining two or more different materials, certain desired properties of a first material can be retained while other properties of the first material can be compensated for by a second material, third material, or more. For example, in some embodiments, the enclosure can comprise a combination (e.g., alternating layers) of parylene and ceramic to form a hermetic structure to resist fluid ingress, while parylene provides some flexibility to help compensate for the generally brittle nature of ceramic, and / or provides material deposition or attachmentAttorney Docket No.: XII.021 WOcharacteristics that ceramic generally lacks. Additionally or alternatively the enclosure can further comprise one or more layers of epoxy to provide an additional fluid barrier to improve the hermetic quality of the enclosure, and / or provide some additional rigidity to the enclosure to protect the components housed within the enclosure.

[0118] Thickness of the one or more layers can be controlled by a material deposition process (e.g., applying a liquid, using an airbrush, atomic layer deposition) and deposited to elicit desired material properties (e.g., flexibility, rigidity, conductivity, etc.). In some cases, the thickness of one or more layers can be on the order of angstroms (e.g., 1 A, 3 A, 5 A, 10 A). In some embodiments, the thickness of the one or more layers is on the order of nanometers (e.g., 1 nm, 3 nm, 5 nm, 10 nm, 50 nm, 100 nm). In some embodiments, the thickness of the one or more layers is on the order of micrometers (e.g., 1 pm, 3 pm, 5 pm, 10 pm, 50 pm, 100 pm). In some embodiments, the thickness of the one or more layers is on the order of millimeters (e.g., 1 mm, 2 mm, 3 mm, 4 mm, 5 mm).

[0119] In some embodiments, the enclosure 616 comprises a rigid material such as a ceramic and / or epoxy. In some embodiments, the enclosure 616 comprises a composite of an epoxy and a ceramic. In some embodiments, the enclosure 616 is hermetically sealed (e.g., two or more housing components that are hermetically sealed, such as with laser welding and / or epoxy). In some embodiments, the electronics component 600 is hermetically sealed within the enclosure 616. In some embodiments, the rigid housing is configured to protect components (e.g., the electronics component 600 contained within, the proximal portion of the lead body coupled to the enclosure 616) from excessive strain.

[0120] In some embodiments, the enclosure comprises a smoothed transition region 624 along edges of the device which helps to minimize tissue irritation and damage. The smoother transition region along the edges of the device can be produced via a molding process and / or a material removal process (e.g., cutting, milling, sanding).

[0121] The channel 618 of the enclosure 616 can lie on a plane offset from a plane defining the electronics component 600. The channel 618 can extend from a region where the one or more pins 610 cross the interconnect main body 608 to an opposite side of the device along the plane offset from the plane defining the electronics component 600. The channel 618 can be configured to tightly receive a portion of the lead body. For example, the width of the channel 618 can be approximately the diameter of the lead body so that the lead body can be press fit into the channel 618. In some embodiments, the channel 618 can is a groove with aAttorney Docket No.: XII.021 WOdiameter about equal to the diameter of the lead body. In some embodiments, the depth of the groove can be about equal to the diameter of the lead body so that the portion of the lead body coupled to the enclosure 616 is flush with the enclosure 616. In some embodiments, the channel 616 circumferentially surrounds the proximal portion of the lead. While shown in FIG. 6C as straight, the channel 618 can take on many configurations such as a slight bend or a wavy path.

[0122] The channel 618 can be defined within one or more material layers. For example, in some embodiments, the channel 618 is defined within one or more epoxy layers. In some embodiments, the channel 618 is defined within a ceramic layer (e.g., a top ceramic can).

[0123] For example, an enclosure of the present technology (e.g., enclosure 616) can comprise a first coating comprising an epoxy, a second coating comprising multiple regions of different materials, and a third coating comprising a polymer. The second coating can comprise, for example, a first region comprising a parylene and a second region comprising a ceramic. In some embodiments, the second coating comprises multiple alternating regions of parylene and ceramic. In any case, the regions can be thin (e.g., about 1 pm to about 10 pm, etc.), flexible, and / or hermetically sealing. In some embodiments, the first coating and / or the second coating are configured to provide a hermetic environment for contents housed within the enclosure. Additionally or alternatively, the third coating can be similar to the coating of the first antenna. For example, the third coating can be soft, flexible, hydrophobic, biocompatible, and / or non-corrosive. In some embodiments, the third coating comprises the same material as the coating of the first antenna, such that a single molding process can be employed to apply the coating to the first antenna and the electronics component. Any of the aforementioned coatings can be applied in any suitable order. For example, either the first coating or the second coating can be applied over the PCB substrate and / or components carried by the substrate. Then the other of the first coating or the second coating can be applied over the coating applied to the PCB substrate and / or components. In some embodiments, the enclosure does not include the first coating, the second coating, and / or the third coating. One or more of the coatings can be applied via atomic layer deposition (ALD). Application of one or more of the coatings can be facilitated by one or more molds (e.g., a silicone mold). In some embodiments, one or more of the coatings can be applied using heat and pressure to bond the coating(s). In some embodiments, bonding of the one or more coatings is achieved through chemical means. For example, depositing the one or more coatings through ALD produces a strong chemical bond without the need for additional heat and / or pressure.Attorney Docket No.: XII.021 WO

[0124] FIG. 8 shows a portion of an implantable device 800 according to the present technology including an enclosure 802 comprising a ceramic can. The enclosure 802 can comprise two or more components coupled together (e.g., press fit together, laser welded, etc.) to produce a hermetically sealed enclosure around the electronics component (e.g., similar to electronics components 600). For example, in some embodiments the ceramic can comprises a top can component 804 and a bottom can component 806 which snugly fit together to enclose an electronics component in a waterproof housing. In some embodiments, the top can component 804 and the bottom can component 806 are brazed together to encapsulate the electronics component. Solder and / or solder paste can be used to braze together the top can component and the bottom can component. The enclosure 802 includes a channel 808 (e.g., similar or equivalent to channel 618) configured to receive a proximal portion of a lead body. The channel 808 can include an enclosure coupling point or channel outlet at which the proximal portion of the lead body is bendable away from the enclosure 802. The proximal portion of the lead body can electrically couple to the enclosure through one or more pins 810 coupled to an electronics component (e.g., through vias) to facilitate electronic communication, electrical stimulation, and / or electrical sensation, while maintaining a hermetic seal to prevent ingress of fluids toward the electronics component.

[0125] FIGS. 9A-9G show an example assembly process for an implantable device in accordance with the present technology.

[0126] An electronics component 900 can be assembled as shown in FIG. 9A. The electronics component 900 may be of any sort described herein (e.g., electronics component 600).

[0127] Next, an interconnect 902 (e.g., such as interconnect 606, see FIG. 6B), is electrically coupled to the to the electronics component 900 through one or more pins connected to one or more vias of the electronics component 900. The interconnect 902 is designed to enable electricity to pass through the one or more pins, while simultaneously preventing ingress of fluids from one side of the interconnect 902 to another. The one or more pins can be substantially straight when the interconnect 902 is initially connected to the electronics component 900. Once connected to the electronics component 900, the one or more pins can be bent at an angle so as to align with one or more wires of a lead and / or an antenna to facilitate bonding (e.g., soldering) and improve the electrical connection.Attorney Docket No.: XII.021 WO

[0128] After the interconnect 902 has been electrically coupled to the electronics component 900, an enclosure 904 to shield the electronics component 900 from environmental factors may be added to the implantable device, as shown in FIG. 9C. The enclosure 904 may be of any type described herein (e.g., enclosure 616, enclosure 802). In some embodiments, the enclosure 904 comprises one or more layers of one or more materials (e.g., as shown in FIG.7). In some embodiments, the enclosure 904 comprises a ceramic can (e.g., as shown in FIG.8). The enclosure 904 includes a channel 906 along a surface of the enclosure 904 (e.g., a top surface). The channel 906 is configured to receive a proximal portion of the lead.

[0129] As shown in FIG. 9D, the electronics component 900 has been encased in the enclosure 904, a lead 908 and is coupled to the enclosure 904. The lead 908 comprises a proximal portion 910 and a distal portion 912. The proximal portion 910 of the lead 908 fits into the channel 906 of the enclosure 904 and and electrically connects to one or more pins of the interconnect 902, thereby electrically coupling to the electronics component 900 (e.g., using solder, crimping the pins). The proximal portion 910 of the lead 908 can be press fit into the channel 906 of the enclosure 904 and / or chemically fixed into the channel (e.g., using an adhesive, using an epoxy) to ensure stable mechanical coupling. The distal portion 912 of the lead 908 can comprise one or more electrodes (e.g., TiN coated electrodes). The one or more electrodes of the lead 908 can be connected to one or more electrical contacts in electrical communication with the electronics component 900, such as by one or more wires (e.g., coiled wires running down the length of the lead). In some embodiments, the one or more electrodes comprise a first electrode carried on a first arm of the lead 908 and a second electrode carried on a second arm of the lead 908. In some embodiments, one or more electrodes are carried on each arm of the lead 908. For example, the first arm of the lead 908 can be configured to carry one or more electrodes (e.g., two electrodes) and the second arm of the lead 908 can be configured to carry one or more electrodes (e.g., two electrodes). In some embodiments, the lead 908 is configured to be implanted in a patient with the first arm positioned proximate a left hypoglossal nerve of the patient and the second arm positioned proximate a right hypoglossal nerve of the patient. Flexibility of the first and / or second arms can be controlled by adding or removing material (e.g., applying an epoxy backfill to each of the arms).

[0130] An antenna 914 (e.g., any of the antennas described herein) is also coupled to the enclosure 904 through a similar process of establishing electrical and mechanical coupling. For example, the ends of a wire defining the antenna 914 can be electrically coupled to the interconnect 902 and a surface of the enclosure 904 can be bonded to a surface of the antennaAttorney Docket No.: XII.021 WO914 through means described herein (e.g., using heat, using pressure, using one or more chemicals). In some embodiments, a portion of the antenna 914 is mechanically coupled to the enclosure, such that the channel 906 of the enclosure 904 overlaps with a region of the antenna 914 (e.g., a central region of the antenna 914). The antenna 914 can include one or more features 916 that facilitate assembly of the implantable device. For example, in some embodiments the one or more features 916 comprise holes that mate to features of a mold to hold the assembly in place while components are connected.

[0131] As shown in FIG. 9E, one or more layers 918 can be added to the enclosure 904 to further bond the lead 908 to the enclosure 904. The one or more layers 918 added to the enclosure 904 can include additional nonconductive and / or water resistant layers.

[0132] FIG. 9F shows that the implantable device can be further covered by an encapsulation material 920. The encapsulation material 920 can include a thermoplastic polyurethane (e.g., Pellethane™, Carbothane™) suited for a wet anatomical environment.

[0133] To complete assembly of the implantable device, the one or more features 916 of the antenna 914 can be filled in so as to create a smooth surface 922 where once were the one or more features 916. After encapsulated and smoothed, the implantable device can be sterilized for packaging.

[0134] FIG. 10 shows a portion of the completed assembly of an example implantable device 1000, in which a lead 1002 of the implantable device 1000 is coupled to an enclosure 1004 (e.g., similar to enclosure 904). A proximal end 1006 of the lead 1002 is coupled to an enclosure coupling point 1008 which overlaps with a central region of an electronics package (e.g., central region of an antenna surrounding the electronics component). The proximal end 1006 of the lead 1002 may be rigidly held in a channel and yet allow the lead to extend freely from the enclosure at the coupling point 1008, where the lead can bend relative to the enclosure 1004 so that the lead can conform to patient anatomy and thereby improve patient comfort.

[0135] FIG. 11 shows a cross-sectional view of a portion of the implantable device of FIG. 10, in which a portion of a proximal end of a lead is held fixed and straight within a channel of an enclosure and another portion of the proximal end extends from a channel outlet and allows bending of the lead relative to the enclosure.

[0136] FIG. 12 demonstrates the volumetric advantages enabled by the present disclosure. An implantable device 1200 in accordance with the present technology in which a channel is included in an enclosure allows for a shorter distance DI over which a lead bendsAttorney Docket No.: XII.021 WOrelative to the enclosure as compared to another implantable device 1202 without a channel in its enclosure as described herein which requires a longer distance D2 over which a lead bends relative to the enclosure. In some applications, it may be advantageous for the lead to be bendable away from the antenna beginning at a location that is more radially central than the peripheral edge of the antenna (as in implantable device 1200) to reduce physical interference with surrounding anatomy, thereby increasing patient comfort.CONCLUSION

[0137] Although many of the embodiments are described above with respect to neuromodulation systems and devices, the technology is applicable to other applications and / or other approaches. Moreover, other embodiments in addition to those described herein are within the scope of the technology. Additionally, several other embodiments of the technology can have different configurations, components, or procedures than those described herein. A person of ordinary skill in the art, therefore, will accordingly understand that the technology can have other embodiments with additional elements, or the technology can have other embodiments without several of the features shown and described above with reference to FIGS. 1A-12.

[0138] The descriptions of embodiments of the technology are not intended to be exhaustive or to limit the technology to the precise form disclosed above. Where the context permits, singular or plural terms may also include the plural or singular term, respectively. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology, as those skilled in the relevant art will recognize. For example, while steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.

[0139] As used herein, the terms “generally,” “substantially,” “about,” and similar terms are used as terms of approximation and not as terms of degree, and are intended to account for the inherent variations in measured or calculated values that would be recognized by those of ordinary skill in the art.

[0140] Moreover, unless the word “or” is expressly limited to mean only a single item exclusive from the other items in reference to a list of two or more items, then the use of “or” in such a list is to be interpreted as including (a) any single item in the list, (b) all of the itemsAttorney Docket No.: XII.021 WOin the list, or (c) any combination of the items in the list. Additionally, the term "comprising" is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and / or additional types of other features are not precluded. It will also be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Further, while advantages associated with certain embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.

Claims

1. Attorney Docket No.: XII.021 WOCLAIMSI / We claim:

1. An implantable device comprising:a lead comprising a proximal portion, a distal portion, and a longitudinal axis extending between the proximal and distal portions;an antenna comprising one or more coil turns and a central region at least partially surrounded by at least one coil turn; andan enclosure comprising a channel that receives the proximal portion of the lead, the channel having a channel outlet that overlaps with the central region of the antenna,wherein the lead is bendable relative to the enclosure along the longitudinal axis at the channel outlet.

2. The device of claim 1, wherein the antenna is arranged on a substantially planar substrate.

3. The device of claim 1 or claim 2, wherein the antenna is arranged in a first plane of the implantable device and the enclosure is arranged in a second plane of the implantable device different from the first plane, wherein the lead is bendable out of the second plane relative to the enclosure at the channel outlet.

4. The device of any one of claims 1-3, wherein the antenna comprises a plurality of coil turns.

5. The device of any one of claims 1-4, wherein the enclosure is hermetic.

6. The device of any one of claims 1-5, wherein the enclosure comprises a coating comprising a polymer.

7. The device of claim 6, wherein the coating comprises a first region comprising a parylene and a second region comprising a ceramic.Attorney Docket No.: XII.021 WO8. The device of claim 7, wherein the coating comprises a plurality of first regions each comprising a parylene and a plurality of second regions each comprising a ceramic, wherein the first and second regions alternate along a thickness of the coating.

9. The device of any one of claims 6-8, wherein the coating comprises one or more epoxy layers.

10. The device of claim 9, wherein the channel is defined at least partially within the one or more epoxy layers.

11. The device of any one of claims 1-10, wherein the enclosure comprises a rigid housing.

12. The device of claim 11, wherein the housing comprises a plurality of hermetically sealed housing components.

13. The device of claim 11 or 12, wherein the housing comprises ceramic.

14. The device of any one of claims 1-13, wherein the channel circumferentially surrounds the proximal portion of the lead.

15. The device of any one of claims 1-14, further comprising electronic circuitry housed within the enclosure.

16. The device of claim 15, wherein the lead comprises one or more electrodes and the enclosure houses one or more electrical contacts in electrical communication with the one or more electrodes.

17. The device of claim 16, wherein the channel directs the proximal portion of the lead toward the one or more electrical contacts.

18. The device of claim 16 or 17, wherein the one or more electrodes comprises a first electrode and a second electrode, and wherein the distal portion comprises a first arm carrying the first electrode and a second arm carrying the second electrode.Attorney Docket No.: XII.021 WO19. The device of claim 18, wherein the lead is configured to be implanted in a patient with the first arm positioned proximate a left hypoglossal nerve of the patient and the second arm positioned proximate a right hypoglossal nerve of the patient.

20. An implantable device comprising:a lead comprising a proximal portion, a distal portion, and a longitudinal axis extending between the proximal and distal portions;a substantially planar substrate with a central region; andan enclosure configured to couple to the proximal portion of the lead at an enclosure coupling point, wherein the enclosure coupling point overlaps with the central region of the substrate,wherein the lead is bendable relative to the enclosure along the longitudinal axis at the enclosure coupling point.

21. The device of claim 20, wherein the substrate is arranged in a first plane of the implantable device and the enclosure is arranged in a second plane of the implantable device different from the first plane, wherein the lead is bendable out of the second plane relative to the enclosure at the enclosure coupling point.

22. The device of claim 20 or 21, wherein the substrate comprises an antenna having one or more coil turns, wherein the central region is surrounded by the one or more coil turns.

23. The device of any one of claims 20-22, wherein the enclosure is hermetic.

24. The device of any one of claims 20-23, wherein the enclosure comprises a coating comprising a polymer.

25. The device of claim 24, wherein the coating comprises a first region comprising a parylene and a second region comprising a ceramic.Attorney Docket No.: XII.021 WO26. The device of claim 25, wherein the coating comprises a plurality of first regions each comprising a parylene and a plurality of second regions each comprising a ceramic, wherein the first and second regions alternate along a thickness of the coating.

27. The device of any one of claims 20-26, wherein the enclosure comprises one or more epoxy structures.

28. The device of any one of claims 20-27, wherein the enclosure comprises a rigid housing.

29. The device of claim 28, wherein the housing comprises a plurality of hermetically sealed housing components.

30. The device of claim 28 or 29, wherein the housing comprises ceramic.

31. The device of any one of claims 20-30, wherein the enclosure defines a channel that receives the proximal portion of the lead.

32. The device of claim 31, wherein the channel circumferentially surrounds the proximal portion of the lead.

33. The device of any one of claims 20-32, further comprising electronic circuitry housed within the enclosure.

34. The device of claim 33, wherein the lead comprises one or more electrodes and the enclosure houses one or more electrical contacts in electrical communication with the one or more electrodes.

35. The device of claim 34, wherein the channel directs the proximal portion of the lead toward the one or more electrical contacts.Attorney Docket No.: XII.021 WO36. The device of claim 34 or 35, wherein the one or more electrodes comprises a first electrode and a second electrode, and wherein the distal portion comprises a first arm carrying the first electrode and a second arm carrying the second electrode.

37. The device of claim 36, wherein the lead is configured to be implanted in a patient with the first arm positioned proximate a left hypoglossal nerve of the patient and the second arm positioned proximate a right hypoglossal nerve of the patient.

38. An implantable device comprising:a flexible lead comprising a proximal portion, a distal portion comprising one or more electrodes, and a longitudinal axis extending between the proximal and distal portions; andan electronics package coupled to the lead and comprising:an antenna comprising one or more coil turns and a central region at least partially surrounded by at least one coil turn, wherein the antenna is arranged along a first plane; andan enclosure comprising a channel that receives the proximal portion of the lead and has a channel outlet that overlaps with the central region of the antenna, wherein the enclosure is arranged along a second plane offset from the first plane,wherein the lead extends from the enclosure at the channel outlet and is bendable out of the second plane relative to the enclosure along the longitudinal axis at the channel outlet.

39. The device of claim 38, wherein the enclosure is hermetic.

40. The device of claim 38 or 39, wherein the enclosure comprises a coating comprising a polymer.

41. The device of claim 40, wherein the coating comprises a first region comprising a parylene and a second region comprising a ceramic.Attorney Docket No.: XII.021 WO42. The device of claim 41, wherein the coating comprises a plurality of first regions each comprising a parylene and a plurality of second regions each comprising a ceramic, wherein the first and second regions alternate along a thickness of the coating.

43. The device of any one of claims 38-42, wherein the enclosure comprises one or more epoxy structures defining the channel.

44. The device of any one of claims 38-43, wherein the enclosure comprises a rigid housing defining the channel.

45. The device of claim 44, wherein the housing comprises a plurality of hermetically sealed housing components.

46. The device of claim 44 or 45, wherein the housing comprises ceramic.

47. The device of any one of claims 38-46, wherein the channel circumferentially surrounds the proximal portion of the lead.

48. The device of any one of claims 38-47, further comprising electronic circuitry housed within the enclosure.

49. The device of claim 48, wherein the lead comprises one or more electrodes and the enclosure houses one or more electrical contacts in electrical communication with the one or more electrodes.

50. The device of claim 49, wherein the channel directs the proximal portion of the lead toward the one or more electrical contacts.

51. The device of any one of claims 38-50, wherein the one or more electrodes comprises a first electrode and a second electrode, and wherein the distal portion comprises a first arm carrying the first electrode and a second arm carrying the second electrode.Attorney Docket No.: XII.021 WO52. The device of claim 51, wherein the lead is configured to be implanted in a patient with the first arm positioned proximate a left hypoglossal nerve of the patient and the second arm positioned proximate a right hypoglossal nerve of the patient.

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