Neuromodulation devices and associated systems and methods

Abstract

Neuromodulation devices and associated systems and methods are disclosed herein. Various embodiments of the present technology relate to devices, systems, and methods for delivering electrical energy to a hypoglossal nerve of a patient. In accordance with some embodiments, the present technology includes an implantable neuromodulation device including an electronic package, a branched lead body, and an extension between the electronic package and the lead body. The wire body can include a first arm having a first conductive element and a second arm having a second conductive element. The lead body can be configured to be positioned between a genioglossus muscle and a genioglossus muscle of a patient such that the first arm and the first conductive element are positioned proximate one of the hypoglossal nerves of the patient and the second arm and the second conductive element are positioned proximate one of the contralateral hypoglossal nerves of the patient.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Patent Application No. 63 / 377,969 filed on September 30, 2022 and U.S. Patent Application No. 63 / 502,610 filed on May 16, 2023, the contents of each of which are incorporated herein by reference in their entirety.

[0003] This application is related to the following applications, each of which is incorporated herein by reference in its entirety: U.S. Patent Application No. 16 / 865,541, filed on May 4, 2020, entitled “IMPLANTABLE STIMULATION POWER RECEIVER, SYSTEMS, AND METHODS,” U.S. Patent Application No. 16 / 866,488, filed on May 4, 2020, entitled “SYSTEMS AND METHODS TO IMPROVING SLEEP DISORDERED BREATHING USING CLOSED-LOOP FEEDBACK,” U.S. Patent Application No. 16 / 866,523, filed on May 4, 2020, entitled “SYSTEMS AND METHODS FOR IMPROVING SLEEP DISORDERED BREATHING,” and U.S. Patent Application No. 16 / 866,523, filed on May 4, 2020, entitled “BIASED NEUROMODULATION LEAD AND METHOD OF USING SAME" U.S. Patent Application No. 16 / 865,668. Technical Field

[0004] The present technology relates to neuromodulation devices and associated systems and methods. Various embodiments of the present technology relate to neuromodulation devices, systems and methods for treating sleep-disordered breathing. Background Art

[0005] Sleep-disordered breathing (SDB), such as upper airway sleep disorder (UASD), is a condition that reduces sleep time and quality, causing sufferers to experience symptoms including daytime sleepiness, fatigue, and difficulty concentrating. 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 leads to decreased quality of life measures and increased risk of disease, including high blood pressure, stroke, heart disease, and others.

[0006] OSA is characterized by complete obstruction of the airway, resulting in complete cessation (apnea) or partial cessation (hypopnea) of breathing. 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 tense shape and position. When the root of the tongue and / or the soft tissues of the upper airway collapse, the upper airway passage becomes blocked, causing an apnea event. The blockage of the upper airway prevents air from flowing into the lungs, thereby lowering the patient's blood oxygen levels, which in turn increases blood pressure and cardiac dilation. This causes a reflexive forced opening of the upper airway passage until normal patency is restored, followed by normal breathing until the next apnea event. These reflex forced openings briefly awaken the patient from sleep.

[0007] Current treatment options range from drug interventions, non-invasive methods to more invasive surgical procedures. In many of these cases, patient acceptance and therapy compliance are far below the desired level, making current solutions ineffective as long-term solutions. For example, continuous positive airway pressure (CPAP) is the standard treatment for OSA. Although CPAP is non-invasive and very effective, not all patients tolerate it well and there are several side effects. Patient compliance and / or tolerance to CPAP are often reported to be between 40% and 60%. Surgical treatments for OSA are also available, such as anterior tongue muscle repositioning, orthognathic bimaxillary advancement, uvulopalatopharyngoplasty, and tracheotomy. However, these procedures are often highly invasive, irreversible, and have poor and / or inconsistent efficacy. Even more effective surgical procedures are undesirable because they usually require multiple invasive and irreversible operations, they change the patient's appearance (e.g., maxillary and mandibular advancement), and / or they can be socially stigmatized (e.g., tracheotomy) and have a wide range of morbidity. Summary of the invention

[0008] For example, according to the various aspects described below (including reference Figure 1A-12H ) to illustrate the subject technology. For convenience, various examples of aspects of the subject technology are described in numbered clauses (1, 2, 3, etc.). These are provided only as examples and do not limit the subject technology.

[0009] 1. An implantable neuromodulation lead, comprising:

[0010] an extension portion having a distal portion and a proximal portion configured to couple to an electronic component; and

[0011] a lead body extending distally from a distal end portion of the extension portion, wherein the lead body branches into a first arm and a second arm and includes a first electrode disposed on the first arm and a second electrode disposed on the second arm,

[0012] The lead body is configured to be implanted in a patient's body at a location close to the hypoglossal nerve and to deliver electrical signals to the hypoglossal nerve via the first electrode and the second electrode.

[0013] 2. The neuromodulation lead of clause 1, wherein the lead body is configured to be implanted such that the first arm and the second arm are aligned with and extend along the left hypoglossal nerve and the right hypoglossal nerve, respectively.

[0014] 3. A neuromodulatory lead according to any of the preceding clauses, wherein the first arm comprises a proximal region and a distal region, wherein the proximal region extends laterally away from a distal portion of the extension portion and the distal region extends distally away from the proximal region, and wherein the first electrode is carried by the distal region.

[0015] 4. A neuromodulation lead according to any of the preceding clauses, wherein the distal region of the first arm extends distally away from the proximal region along the longitudinal dimension.

[0016] 5. A neuromodulation lead according to any of the preceding clauses, wherein the proximal region of the first arm is vertically angled away from the extension portion such that the distal region is positioned in a different plane than the extension portion.

[0017] 6. A neuromodulatory lead according to any of the preceding clauses, wherein the second arm comprises a proximal region and a distal region, wherein the proximal region extends laterally away from the distal portion of the extension portion and the distal region extends distally away from the proximal region, and wherein the second electrode is carried by the distal region.

[0018] 7. A neuromodulation lead according to any of the preceding clauses, wherein the distal region of the second arm extends distally away from the proximal region along the longitudinal dimension.

[0019] 8. A neuromodulation lead according to any of the preceding clauses, wherein the proximal region of the second arm is vertically angled away from the extension portion such that the distal region is positioned in a different plane than the extension portion.

[0020] 9. A neuromodulation lead according to any of the preceding clauses, wherein the proximal regions of the first arm and the second arm extend laterally away from the distal portion of the extension portion in opposite directions.

[0021] 10. The neuromodulation lead of any of the preceding clauses, further comprising a connector between the extension portion and the first arm and the second arm, wherein the connector is coupled to a distal portion of the extension portion, a proximal region of the first arm, and a proximal region of the second arm.

[0022] 11. A neuromodulation lead according to any of the preceding clauses, wherein the electrical signal is configured to treat sleep apnea.

[0023] 12. An implantable neuromodulation lead, comprising:

[0024] an extension portion having a distal portion and a proximal portion configured to couple to an electronic component; and

[0025] A lead body extending distally from a distal end portion of an extension portion, wherein the lead body branches into a left arm and a right arm and includes a left electrode deployed on the left arm and a right electrode deployed on the right arm, and wherein at least one of the left arm or the right arm is bent relative to the extension portion so that at least one of the left arm or the right arm is positioned at a different height from the extension portion.

[0026] 13. A neuromodulation lead according to any of the preceding clauses, wherein the lead body is configured to deliver electrical stimulation energy to the patient's hypoglossal nerve to treat sleep-disordered breathing.

[0027] 14. A neuromodulation lead according to any of the preceding clauses, wherein the right arm is configured to be positioned proximate to the patient's right hypoglossal nerve and the left arm is configured to be positioned proximate to the patient's left hypoglossal nerve.

[0028] 15. A neuromodulatory lead according to any of the preceding clauses, wherein, when the lead is implanted, at least one of the left arm or the right arm extends upward from a proximal portion located at the extension portion and proximal to the patient's genioglossus muscle to a distal portion positioned proximal to the patient's genioglossus muscle.

[0029] 16. A neuromodulation lead according to any of the preceding clauses, wherein, when the lead is implanted, the proximal portion of the extension portion is positioned below the patient's mylohyoid muscle and the distal portion of the extension portion is positioned above the patient's mylohyoid muscle.

[0030] 17. A neuromodulation lead according to any of the preceding clauses, wherein, when the lead is implanted, the extension portion is at least partially positioned between the patient's right and left geniohyoid muscles.

[0031] 18. An implantable neuromodulation lead, comprising:

[0032] an extension portion having a distal portion and a proximal portion configured to couple to an electronic component; and

[0033] a lead body extending distally from a distal end portion of the extension portion, wherein the lead body branches into a left arm and a right arm and includes a left electrode disposed on the left arm and a right electrode disposed on the right arm,

[0034] The lead body is constructed to be at least partially implanted in a sublingual region of a patient and is configured to deliver electrical stimulation energy to the sublingual region to treat sleep apnea.

[0035] 19. A neuromodulation lead according to any of the preceding clauses, wherein the lead body is configured to deliver electrical stimulation energy to the sublingual region to increase activity of the patient's tongue protrusion muscles.

[0036] 20. A neuromodulation lead according to any of the preceding clauses, wherein the lead body is configured to be implanted such that the left arm and the right arm are at least partially positioned between the patient's genioglossus muscle and the patient's geniohyoid muscle.

[0037] 21. A neuromodulation lead as described in any of the preceding clauses, wherein, when the lead is implanted, each of the left arm and the right arm extends upward from a proximal portion located at the extension portion and proximal to the patient's genioglossus muscle to a distal portion proximal to the patient's genioglossus muscle.

[0038] 22. A neuromodulation lead according to any of the preceding clauses, wherein the right arm is configured to be positioned proximate to the patient's right hypoglossal nerve and the left arm is configured to be positioned proximate to the patient's left hypoglossal nerve.

[0039] 23. A neuromodulation lead according to any of the preceding clauses, wherein the lead body is configured to deliver electrical stimulation energy to the patient's hypoglossal nerve to treat sleep apnea.

[0040] 24. A neuromodulation lead according to any of the preceding clauses, wherein, when the lead is implanted, the proximal portion of the extension portion is positioned below the patient's mylohyoid muscle and the distal portion of the extension portion is positioned above the patient's mylohyoid muscle.

[0041] 25. A neuromodulation lead according to any of the preceding clauses, wherein, when the lead is implanted, the extension portion is at least partially positioned between the patient's right and left geniohyoid muscles.

[0042] 26. An implantable neuromodulation lead, comprising:

[0043] a lead body comprising left and right arms coupled at proximal ends of the left and right arms, wherein the left and right arms extend laterally away from each other, and wherein the lead body comprises a left electrode disposed on the left arm and a right electrode disposed on the right arm,

[0044] The lead body is constructed to be implanted in a patient's body near the hypoglossal nerve to deliver electrical signals to the hypoglossal nerve via the left electrode and the right electrode.

[0045] 27. A neural stimulation lead for implantation at a treatment site in a patient's body, the neural stimulation lead comprising:

[0046] Conductor body;

[0047] a plurality of electrodes carried by the lead body; and

[0048] a plurality of fixation members extending radially away from the lead body, wherein the fixation members are configured to anchor the lead body to tissue at the treatment site,

[0049] The neurostimulation lead is configured to be implanted at a treatment site in a patient's body to deliver energy to the treatment site via electrodes.

[0050] 28. A neuromodulation lead according to any of the preceding clauses, wherein the lead body comprises a polymer sidewall and the fixation member is cut from the polymer sidewall.

[0051] 29. A neuromodulation lead according to any of the preceding clauses, wherein the fixation member comprises a first end located at the side wall and a second end radially spaced apart from the side wall.

[0052] 30. A neuromodulation lead as described in any of the preceding clauses, wherein the fixation member extends no more than 0.5 mm away from the lead body.

[0053] 31. A neuromodulation lead as described in any preceding clause, wherein the fixation member is cantilevered from the side wall.

[0054] 32. A neuromodulation lead according to any of the preceding clauses, wherein the polymer sidewall comprises thermoplastic polyurethane.

[0055] 33. A neuromodulation lead according to any of the preceding clauses, wherein at least some of the fixation members are spaced apart along the length of the lead body.

[0056] 34. A neuromodulation lead according to any of the preceding clauses, wherein at least some of the fixation members are spaced apart around the circumference of the lead body.

[0057] 35. A neuromodulation lead according to any of the preceding clauses, wherein the lead is configured to deliver stimulation energy at a treatment site to treat sleep apnea.

[0058] 36. A neuromodulation lead according to any of the preceding clauses, wherein the lead body is constructed to be positioned proximate to the patient's hypoglossal nerve.

[0059] 37. A neuromodulation lead according to any of the preceding clauses, wherein the lead body is configured to deliver stimulation energy to the patient's hypoglossal nerve.

[0060] 38. A neuromodulation lead according to any of the preceding clauses, wherein the lead body is configured to detect activity of the patient's tongue muscles and / or suprahyoid muscles.

[0061] 39. A neuromodulation lead, comprising:

[0062] a lead body comprising a plurality of electrodes; and

[0063] an extension portion having a proximal end configured to couple to the electronic component and a distal end configured to couple to the lead body, the distal end being opposite the proximal end along a length of the extension portion, wherein the length of the extension portion is adjustable to change the distance between the lead body and the electronic component,

[0064] The lead is configured to be implanted at a treatment site in a patient's body to deliver energy to the treatment site via the electrodes.

[0065] 40. A neuromodulation lead as described in any of the preceding clauses, wherein the extension portion is configured to bend along its longitudinal axis to change the distance between the lead body and the electronic component.

[0066] 41. A neuromodulatory lead according to any of the preceding clauses, wherein the extension portion comprises a helically wound portion.

[0067] 42. A neuromodulatory lead according to any of the preceding clauses, wherein the extension portion comprises a wavy portion.

[0068] 43. A neuromodulation lead according to any of the preceding clauses, wherein the neurostimulation lead is configured to deliver stimulation energy at a treatment site to treat sleep apnea.

[0069] 44. A neuromodulation lead according to any of the preceding clauses, wherein the lead body is constructed to be positioned proximate to the patient's hypoglossal nerve.

[0070] 45. A neuromodulation lead according to any of the preceding clauses, wherein the lead body is configured to deliver stimulation energy to the patient's hypoglossal nerve via the electrode.

[0071] 46. ​​A neuromodulation lead as described in any of the preceding clauses, wherein the lead body is configured to detect muscle activity of the patient.

[0072] 47. An implantable antenna comprising:

[0073] a substrate comprising a substrate material; and

[0074] a coil disposed on a substrate and comprising a plurality of coil turns, the coil turns comprising a first coil turn and a second coil turn adjacent to the first coil turn;

[0075] Wherein the substrate includes at least one open area wherein a first coil turn is not coupled to a second coil turn by substrate material.

[0076] 48. An antenna according to any preceding clause, wherein the substrate comprises at least one support region, wherein a first coil turn is coupled to a second coil turn by substrate material.

[0077] 49. An antenna according to any preceding clause, wherein the at least one open area comprises an arcuate cutout extending along a portion of the circumference of the first coil turn.

[0078] 50. An antenna according to any preceding clause, wherein the at least one open area comprises a plurality of arcuate open areas, each arcuate open area extending along a respective portion of the circumference of the first coil turn.

[0079] 51. An antenna according to any preceding clause, wherein at least one of the partial circumferences is at least about 50% of the circumference of the first coil turns.

[0080] 52. An antenna according to any preceding clause, wherein at least one of the partial circumferences is approximately 50% or less of the circumference of the first coil turn.

[0081] 53. An antenna according to any preceding clause, wherein two or more adjacent coil turns are connected to each other by a substrate material.

[0082] 54. A neuromodulation lead comprising an implantable antenna according to any of the preceding clauses.

[0083] 55. A method for treating sleep apnea, comprising:

[0084] Implanting a neuromodulation lead according to any of the preceding clauses at a treatment site in a patient's body; and

[0085] Stimulation energy is delivered to the treatment site via electrodes of the neuromodulation lead. BRIEF DESCRIPTION OF THE DRAWINGS

[0086] Various aspects of the present disclosure may be better understood with reference to the following drawings. The components in the drawings are not necessarily drawn to scale. Instead, emphasis is placed on clearly illustrating the principles of the present disclosure.

[0087] Figure 1A is a midline sagittal view of a portion of the upper airway of a human patient.

[0088] Figure 1B is a diagram of the muscles of the human tongue and the hypoglossal nerve innervation.

[0089] Figure 1C is a schematic superior view of the distal branches of the right and left hypoglossal nerves in a human patient. Figure 1C The hypoglossal nerve runs forward from the bottom of the page to the top of the page (for example, from the hyoid bone to the front of the jaw).

[0090] Figure 2A is a schematic illustration of a neural modulation system configured in accordance with several embodiments of the present technology.

[0091] Figure 2B is a perspective view of a neuromodulation device configured in accordance with several embodiments of the present technology.

[0092] Figure 2C and Figure 2D They are Figure 2B Top and side views of the neuromodulation device.

[0093] Figures 3A-3F is implanted in a human patient according to several embodiments of the present technology Figure 2B-2D Various views of the neuromodulation device shown in .

[0094] Figure 4A , Figure 4B and Figure 4C They are Figure 2B-2D Perspective, side, and end views of the leads of the neuromodulation device shown in FIG.

[0095] Figure 5 yes Figure 2B-2D A side view of the distal portion of the arm of the lead of the neuromodulation device shown in FIG.

[0096] Figures 6A-6D 2. A perspective view, a top view, an end view, and a side view, respectively, of a first connector of a neuromodulation device configured according to several embodiments of the present technology.

[0097] Figures 7A-7C Various configurations of extension portions of leads of neuromodulation devices configured in accordance with several embodiments of the present technology are depicted.

[0098] Figure 8 Illustrated is a second connector of a neuromodulation device configured in accordance with several embodiments of the present technology.

[0099] Fig. 9 A second connector of a neuromodulation device is illustrated in an open configuration and configured in accordance with several embodiments of the present technology.

[0100] Figures 10A-10C Various configurations of electrical conductors within extended portions of leads of neuromodulation devices configured in accordance with several embodiments of the present technology are depicted.

[0101] Fig.11 Illustrated are neuromodulation devices configured in accordance with several embodiments of the present technology.

[0102] Figures 12A-12H Various configurations of antennas in neural modulation devices configured in accordance with several embodiments of the present technology are illustrated. DETAILED DESCRIPTION

[0103] The present disclosure relates to a neuromodulation system that can be used to provide various electrotherapies, including neuromodulation therapies, such as nerve and / or muscle stimulation. Stimulation can induce excitatory or inhibitory nerve or muscle activity. Such therapies can be used at various suitable locations within the patient's anatomy. According to some embodiments, the neuromodulation system of the present technology is configured to treat sleep disordered breathing (SDB) via neuromodulation of the hypoglossal nerve (HGN), including obstructive sleep apnea (OSA) and / or mixed sleep apnea.

[0104] To contextualize the structure and operation of the neuromodulation systems and devices disclosed herein, some 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 technology. Embodiments under any one heading may be used in conjunction with embodiments under any other heading. For example, any neuromodulation system and device described in connection with Section II may include any neuromodulation device described in connection with Section III.

[0105] I. Anatomy and Physiology

[0106] As mentioned previously, breathing in patients with SDB is impeded by obstruction, narrowing, and / or collapse of the upper airway during sleep. Figure 1A As shown in , the upper airway includes the nasal cavity, oral cavity, pharynx and larynx. The patency of the upper airway and the resistance to airflow in the upper airway are controlled by a complex network of muscles that are controlled by voluntary and involuntary neuromuscular control. For example, the muscles of the tongue, suprahyoid muscles (e.g., geniohyoid, mylohyoid, stylohyoid, hyoglossus and the anterior belly of the digastric muscle) and muscles including the soft palate (e.g., palatine muscles) open, expand and / or stabilize the upper airway during inspiration to offset the negative airway pressure that causes air to be drawn into the airways and lungs.

[0107] refer to Figure 1B , the tongue consists of intrinsic and extrinsic tongue muscles. In general, activation of the intrinsic muscles changes the shape of the tongue, while activation of the extrinsic muscles tends to move the position of the entire tongue. Extrinsic muscles originate from bony attachments and insert into the tongue. They include the genioglossus, styloglossus, hyoglossus, and palatoglossus. Intrinsic muscles originate from and insert into the tongue and include the superior longitudinal, inferior longitudinal, transverse, and vertical muscles. In awake patients, the brain supplies neural drive to these muscles through the HGN to maintain tongue shape and position, thereby preventing the tongue from blocking the airway.

[0108] Tongue muscles can also be functionally classified as either extensors or protrusors, and both intrinsic and extrinsic muscles fall into these categories. Extensors include the intrinsic superior and inferior longitudinal muscles and the extrinsic hyoglossus and styloglossus muscles. Protrusors include the intrinsic vertical and transverse abdominal muscles and the extrinsic genioglossus. Contraction of the styloglossus causes elevation of the tongue, while depression of the tongue is the result of downward movement of the hyoglossus and genioglossus muscles. Figure 1B Also labeled is the geniohyoid muscle, which is a suprahyoid muscle (not a tongue muscle), but is still an important protrusor muscle and dilator of the pharynx, thus helping to maintain upper airway patency. It is believed that effective treatment of OSA requires stimulation of the protrusor muscles with minimal or no activation of the posterior extensor muscles. Therefore, in order for neuromodulation therapy to be effective, it is believed to be beneficial to target stimulation to the protrusor muscles while avoiding activation of the protrusor muscles.

[0109] The largest tongue muscle, the genioglossus, consists of two morphological and functional compartments based on fiber distribution, action, and nerve supply. The first, the oblique compartment (GGo), includes vertical fibers that, when contracted, depress the tongue but do not greatly affect pharyngeal patency. The second, the horizontal compartment (GGh), includes longitudinal fibers that, when activated, cause protrusion of the posterior tongue and widening of the pharyngeal opening. The GGo contains type II muscle fibers that fatigue quickly, while the GGh contains type I muscle fibers that fatigue more slowly. Accordingly, it may be more advantageous to stimulate the GGh with little or no stimulation of the GGo to effectively protrude the tongue while preventing or limiting tongue fatigue.

[0110] Includes the mylohyoid, geniohyoid, stylohyoid, and digastric muscles ( Figure 1B The suprahyoid muscles (only a portion of which is shown in FIG) extend between the mandible and the hyoid bone to form the floor of the mouth. The geniohyoid bone is located below the genioglossus of the tongue, while the mylohyoid bone is located below the genioglossus. Contraction of the genioglossus and tension of the sternohyoid bone (infrahyoid muscle, not shown) cooperate to pull the hyoid bone forward to open and / or widen the pharyngeal cavity and stabilize the anterior wall of the hypopharyngeal region. The hyoglossus and styloglossus are considered tongue retraction muscles, compared to the genioglossus and genioglossus, which are considered tongue protrusion muscles. Activation of the hyoglossus and styloglossus tends to retract the tongue backward, which reduces the size of the pharyngeal opening, increases airway resistance, and impedes breathing.

[0111] As mentioned previously, all intrinsic and extrinsic muscles of the tongue are innervated by the HGN, with the exception of the palatoglossus, which is innervated by the vagus 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 from the hypoglossal nucleus in the medulla oblongata of the brainstem, exits the skull via the hypoglossal canal, and passes downward through the retrostyloid space (part of the lateral pharyngeal space) to the occipital artery. The hypoglossal nerve then curves and runs forward to the tongue muscles, passing between the anterior edge of the hyoglossus and the posterior edge of the mylohyoid muscle, and enters the sublingual region, where it is split into its distal branches.

[0112] Figure 1C is a schematic superior view of the distal branches of the right and left hypoglossal nerves. Figure 1B and Figure 1C , the HGN includes (1) the distal branches of the styloglossus and hyoglossus (tongue retractors) and (2) the distal branches of the intrinsic tongue muscles, genioglossus, and geniohyoid (tongue protractors). In addition, the distal branches of the tongue retractors are often located posterior to the distal branches of the tongue protractors.

[0113] Reduced activity of the muscles responsible for airway maintenance can lead to increased airway resistance and a myriad of subsequent effects on the patient's breathing and health. For example, the activity of the genioglossus muscle can decrease during sleep, which, either alone or in combination with other factors (e.g., airway length, airway diameter, soft tissue volume, premature arousals, etc.), can lead to considerable 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 limit stimulation of the HGN primarily to the distal branches that innervate the anterior extensor muscles while avoiding or limiting stimulation to portions of the distal branches that activate the posterior extensor muscles.

[0114] II. Neuromodulation System

[0115] Various embodiments of the present technology are directed to devices, systems, and methods for modulating neural activity and / or controlling one or more nerves associated with one or more muscles involved in airway maintenance. Such neural modulation can increase the activity of targeted muscles (e.g., the genioglossus and geniohyoid muscles) to reduce the patient's airway resistance and improve the patient's breathing. Moreover, targeted modulation of specific portions of the distal branches of the hypoglossal nerve can increase the activity of the tongue extensors without significantly increasing the activity of the tongue posterior extensors to provide highly effective treatment. Additionally or alternatively, targeted modulation of specific portions of the distal branches of the hypoglossal nerve that innervates GGh but not portions of the distal branches of the hypoglossal nerve that innervates GGo can be used to effectively protrude the tongue while preventing or limiting tongue fatigue.

[0116] Figure 2A A neuromodulation system 10 configured in accordance with the present technology for treating SDB is illustrated. The system 10 may include an implantable neuromodulation device 100 and an external system 15 configured to wirelessly couple to the neuromodulation device 100. The neuromodulation device 100 may include a lead 102 having a plurality of conductive elements 114 and an electronics package 108 having a first antenna 116 and an electronics assembly 118. The neuromodulation device 100 is configured to be implanted at a treatment site including the submental and sublingual regions of a patient's head, as described below with reference to Figures 3A-3F Detailed.

[0117] In use, the electronics package 108 or one or more components thereof may be configured to provide stimulation energy to the conductive element 114, the stimulation energy having a pulse width, amplitude, duration, frequency, duty cycle, and / or polarity such that the conductive element 114 applies an electric field that modulates the hypoglossal nerve at the treatment site. The stimulation energy may be delivered according to a periodic waveform (e.g., including a charge-balanced square wave, including alternating anodic and cathodic pulses).

[0118] The one or more pulses of stimulation energy may have a pulse width of between about 10 μs and about 1000 μs, between about 50 μs and about 950 μs, between about 100 μs and about 900 μs, between about 150 μs and about 800 μs, between about 200 μs and about 850 μs, between about 250 μs and about 800 μs, between about 300 μs and about 750 μs, between about 350 μs and about 700 μs, between about 400 μs and about 650 μs, about 450 μs. In some embodiments, the one or more pulses of stimulation energy have a pulse width between about 50 μs and about 450 μs.

[0119] One or more pulses of stimulation energy may have an amplitude sufficient to cause an increase in the phase activity of the desired muscle. For example, one or more pulses of stimulation energy may have an amplitude controlled by current 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, the amplitude of one or more pulses of stimulation energy may be voltage controlled. The amplitude of one or more pulses of stimulation energy may be based at least in part on the size and / or configuration of the conductive element 114, the position of the conductive element 114 in the patient's body, etc.

[0120] The frequency of the stimulation energy pulses 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 the desired response of the stimulation energy to one or more muscles or nerves. For example, a lower frequency can cause a muscle twitch, while a higher frequency can include a full contraction of the muscle.

[0121] The external system 15 may include 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 close to the patient's head while the patient is sleeping. The external device 11 may include a carrier 9 integrated with the second antenna 12. Although Figure 2A The control unit 30 is shown separately from the external device 11, but in some embodiments, the control unit 30 can be integrated with the external device 11 and / or be part 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 by electromagnetic induction. When the first antenna 116 is positioned above the second antenna 12 of the external device 11, a current can be induced in the first antenna 116 in the electromagnetic field generated by the second antenna 12. The first and second antennas 116, 12 can also be configured to send and / or receive data to each other via one or more wireless communication technologies (e.g., Bluetooth, WiFi, USB, etc.) to facilitate communication between the neuromodulation device 100 and the external system 15. Such communication can, for example, include programming, such as uploading software / firmware revisions to the neuromodulation device 100, changing / adjusting stimulation settings and / or parameters, and / or adjusting parameters of the control algorithm.

[0122] The control unit 30 of the external system 15 may include a processor and / or a memory storing instructions (e.g., in the form of software, code, or program instructions executable by the processor or controller) to cause the external device to generate an electromagnetic field according to certain parameters provided by the instructions. The external system may 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 may 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 the processor, the external system may also include a drive circuit system. In such embodiments, the external system may include hard-wired circuit elements to provide the desired waveform delivery, rather than a software-based generator. The drive circuit system may 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 generate an electromagnetic field according to the desired parameters. In some embodiments, the neuromodulation device 100 may be configured to communicate with the external system via inductive coupling.

[0123] The system 10 may 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 may be configured to send 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.). Figure 2A In the example configuration of , both the patient device 70 and the physician device 75 are smartphones. However, the type of device may vary. One or both of the patient device 70 and the physician device 75 may have a user-specific application or "app" installed thereon, for example, a patient app or a physician app, respectively. The patient app may allow the patient to execute certain commands necessary to control the operation of the neuromodulation device 100, such as, for example, starting / stopping therapy, increasing / decreasing stimulation power or intensity, and / or selecting a stimulation program. In addition to the controls available to the patient, the physician app may also allow the physician to modify stimulation settings, such as pulse settings (mode, duration, waveform, etc.), stimulation frequency, amplitude settings and electrode configuration, closed-loop and open-loop control settings, and tuning parameters of embedded software that controls therapy delivery during use.

[0124] The patient and / or physician devices 70, 75 may be configured to communicate with other components of the system 10 via the network 50. The network 50 may be or include one or more communication 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), the Internet, an extranet, an intranet, and / or any other suitable type of network or combination thereof. The patient and / or physician devices 70, 75 may be configured to communicate with one or more remote computing devices 80 via the network 50 to enable data to be transferred between the devices 70, 75 and the (one or more) remote computing devices 80. In addition, the external system 15 may be configured to communicate with other components of the system 10 via the network 50. This may also enable data to be transferred between the external system 15 and the (one or more) remote computing devices 80.

[0125] The external system 15 may receive programming, software / firmware, and settings / parameters via any of the communication pathways described above, for example, directly from the user interface 40 (wired or wireless) and / or via the network 50. The communication pathway may also be used to download data (such as measured data regarding completed stimulation therapy sessions) from the neuromodulation device 100 to the external system 15. The external system 15 may transmit the downloaded data to the user interface 40, which may send / upload the data to the remote computing device(s) 80 via the network 50.

[0126] In addition to facilitating local control of system 10 (e.g., external system 15 and neuromodulation device 100), Figure 2A The various communication paths shown in may also enable:

[0127] Software / firmware updates for the patient device 70 , physician device 75 , external system 15 , and / or neuromodulation device 100 are distributed from the remote computing device(s) 80 .

[0128] Therapy settings / parameters to be implemented by the patient device 70 , physician device 75 , external system 15 , and / or neuromodulation device 100 are downloaded from the remote computing device(s) 80 .

[0129] Facilitates remotely located physicians to perform therapy settings / parameter adjustments / algorithm adjustments.

[0130] Upload data recorded during therapy.

[0131] Maintain consistency of settings / parameters by distributing changes and adjustments throughout system components.

[0132] Therapeutic methods implemented using the system 10 may involve implanting only the neuromodulation device 100, 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 may be configured to be powered by the external system 15 via electromagnetic induction. In operation, a second antenna 12 operated by the control unit 30 may be positioned outside the patient near 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 close enough to the sleeping surface while the patient is sleeping to maintain the position of the first antenna 116 within a target volume of the electromagnetic field generated by the second antenna 12. In this way, the system 10 can deliver therapy to improve SDB (such as OSA), for example by stimulating HGN via a shorter, less invasive procedure. Eliminating an onboard implanted power source in favor of an inductive power solution can eliminate the need for batteries and associated battery replacements throughout the patient's lifetime.

[0133] In some embodiments, the system 10 may include one or more sensors (not shown), which may be implanted and / or external. For example, the system 10 may include one or more sensors carried by (and implanted in) the neuromodulation device 100. These sensors may be deployed anywhere along the lead 102 and / or the electronic package 108. In some embodiments, one, some, or all of the conductive elements 114 may be used for both sensing and stimulation. The use of a single structure or element as a sensor and stimulation electrode reduces the invasive nature of the surgical procedures associated with the implant system while also reducing the number of foreign objects introduced into the patient. In some embodiments, at least one of the conductive elements 114 is dedicated solely to sensing.

[0134] In addition to or in lieu of including one or more sensors on the neuromodulation device 100, the system 10 may 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 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 may be implanted at the same or different location as the neuromodulation device 100, or may be deployed on the patient's skin.

[0135] One or more sensors may be configured to record and / or detect physiological data (e.g., data originating from the patient's body) over time, including changes therein. Physiological data may be used to select certain stimulation parameters and / or adjust one or more stimulation parameters during therapy. Physiological data may include electromyography (EMG) signals, temperature, movement, body position, electroencephalogram (EEG), airflow, audio data, heart rate, pulse oximetry, eye movements, and / or combinations thereof. In some embodiments, physiological events may be used to detect and / or predict other physiological parameters. For example, one or more sensors may be configured to sense EMG signals, which may be used to detect and / or predict physiological data (such as phasic contractions of the anterior tongue muscle (such as phasic genioglossus contractions)) and measure physiological data (such as underlying tension activity of the anterior tongue muscle (such as tension activity of the genioglossus muscle)). The phasic contraction of the genioglossus muscle may indicate inspiration, particularly phasic activity layered within the underlying tension tone of the genioglossus muscle. Changes in physiological data include changes in one or more parameters of the measured signal (e.g., frequency, amplitude, spike rate, etc.), the start and end of the phasic contraction of the anterior tongue muscle (such as the phasic genioglossus contraction), changes in the underlying tonic activity of the anterior tongue muscle (such as the change in the tonic activity of the genioglossus muscle), and combinations thereof. In particular, changes in the phasic activity of the genioglossus muscle can indicate changes in breathing or inspiration and can be used to trigger stimulation. Such physiological data and changes therein can be identified from the signals recorded by the sensor during different respiratory phases including inspiration. Therefore, one or more sensors may include an EMG sensor. One or more sensors may also include, for example, wireless or tethered sensors that measure body temperature, movement (e.g., accelerometer), breathing sounds (e.g., audio sensor), heart rate, pulse oximetry, eye movements, etc.

[0136] In operation, the physiological data provided by the one or more sensors enables closed-loop operation of the neuromodulation device 100. For example, EMG responses sensed from the genioglossus muscle can enable closed-loop operation of the neuromodulation device 100 while eliminating the need for chest wires to sense respiration. In closed-loop operation, the neuromodulation device 100 can maintain stimulation in sync with respiration, for example, while retaining the ability to detect and interpret transient obstructions. For example, the neuromodulation device 100 can also detect and respond to snoring.

[0137] The system 10 can be configured to provide open-loop control and / or closed-loop stimulation to configure parameters for stimulation. In other words, for closed-loop stimulation, the system 10 can be configured to track the patient's breathing (such as each breath of the patient), and stimulation can be applied during or before the start of inspiration. However, for open-loop stimulation, stimulation can be applied without tracking specific physiological data (such as breathing or inspiration). However, even in this "open-loop" scenario, the system 10 can still adjust the stimulation and record data to act on such information. For example, one way that the system 10 can act on such information is that the system 10 can configure the parameters for stimulation so that the stimulation is applied in an open-loop manner but can monitor the patient's breathing to know when to return to applying the stimulation in a breath-to-breath, closed-loop manner, so that the system 10 always works in a closed-loop algorithm to evaluate the data. The treatment parameters of the system can be automatically adjusted in response to physiological data. The physiological data can be stored and checked over time to change the treatment parameters; for example, the treatment data can be checked in real time to make real-time changes 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.

[0138] When operating in real time, the neuromodulation device 100 can record data related to the stimulation session (e.g., via one or more sensors), including, for example, stimulation settings, EMG responses, breathing, sleep states (including different stages of REM and non-REM sleep), etc. For example, changes in the phase and tense EMG activity of the genioglossus muscle during inspiration can be used as a trigger for stimulation, or stimulation can be changed based on changes in the phase and tense 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 the (one or more) remote computing devices 80. Moreover, the patient can be asked to log data about his perceived sleep quality using the interface 40, which can also be uploaded to the (one or more) remote computing devices 80. Offline, the (one or more) remote computing devices 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. For example, the software application can include an artificial intelligence (AI) model that learns from recorded therapy sessions how certain adjustments affect the patient's therapy results. In this way, through AI learning, the model can provide optimized therapy specific to the patient.

[0139] III. Neuromodulation Devices

[0140] Figure 2B-2DVarious views of a neuromodulation device 100 are illustrated. As previously mentioned, the device 100 can be configured to be implanted at a treatment site within the submental and sublingual regions of a patient's head and deliver electrical energy at the treatment site to stimulate the HGN and / or one or more tongue extensor muscles (e.g., the genioglossus, 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 include 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 portion 106a coupled to the electronics package 108 via a first connector 110 and a distal portion 106b coupled to the lead body 104 via a second connector 112. The first connector 110 and / or the second connector 112 can include any suitable biocompatible material, such as one or more polymers. For example, the first connector 110 and / or the second connector 112 may 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 may be a material having high flexibility, good resistance to fluid invasion, low oxidation, good biocompatibility, etc. In some embodiments, the material of the first connector 110 and / or the second connector 112 may be based at least in part on the anatomical environment in which the device 100 is configured to be implanted. For example, an aromatic thermoplastic polyurethane (such as Pellethane) TM ) can be highly hydrophobic and well suited for wet anatomical environments with large amounts of interstitial fluid. However, when positioned in anatomical environments with large amounts of blood, such as in peripheral or subcutaneous environments, polycarbonate-based thermoplastic polyurethanes (such as Carbothane TM ) can be degraded to a lower degree than Pellethane TM Thus, for a device 100 configured to be implanted in the sublingual and submental regions, the first connector 110 and / or the second connector 112 include a polycarbonate-based thermoplastic polyurethane (such as Carbothane TM ) may be preferred.

[0141] The electronic package 108 can be configured to supply current to the conductive element 114 (e.g., for stimulation) and / or receive electrical energy from the conductive element 114 (e.g., for sensing physiological data). The extension portion 106 of the lead 102 can mechanically and / or electrically couple the electronic package 108 to the lead body 104. The extension portion 106 can include a polymer material such as, but not limited to, a thermoplastic elastomer, a thermoplastic polyurethane, a silicone, or other suitable material. The extension portion 106 can be sufficiently flexible so that it can be bent to position the lead body 104 on top of the electronic package 108, but spaced apart from the electronic package 108. As described below with reference to Figures 3A-3F Discussed in more detail, the neuromodulation device 100 is configured to be implanted in both the submental region and the sublingual region such that the electronics package 108 and the lead body 104 are vertically stacked and one or more muscle layers and / or other tissue layers are positioned therebetween. The flexibility of the extension portion 106 enables this configuration.

[0142] In some embodiments, the extension portion 106 includes a sidewall that defines a lumen extending through the extension portion 106. The conductive element 114 can be electrically coupled to the first antenna 116 and / or the electronic component 118 via one or more electrical connectors (also referred to herein as "electrical conductors") extending through the lumen of the extension portion 106. For example, the proximal portion of the electrical connector can be routed to the electronic component 118 on the electronic package 108 through the first connector 110. The electrical connector can include, for example, one or more wires, cables, traces, through-holes, and others extending through the extension portion 106 and the lead body 104, on and / or along it. The electrical connector can include a conductive material such as silver, copper, etc., and each electrical connector can be insulated along all or part of its length. In some embodiments, the device 100 includes a separate electrical connector for each conductive element 114. For example, in those embodiments (and other embodiments) where the device 100 includes eight conductive elements 114, the device 100 may include eight electrical connectors, each extending from a proximal end at the electronic component 118 through the lumen of the extension portion 106 to a distal end at one of the conductive elements 114.

[0143] In some embodiments, the electronic assembly 118 includes an application specific integrated circuit (ASIC), a discrete electronic component, and / or an electrical connector. In these and other embodiments, the electronic assembly 118 may include, for example, a processing and memory component (e.g., a microcomputer, a microprocessor, a computer on a chip, etc.), a charge storage and / or delivery component (e.g., a battery, a capacitor, an electrical conductor) for receiving, accumulating and / or delivering electrical energy, a switch component (e.g., solid state, pulse width modulation, etc.) for selecting and / or controlling the conductive element 114. In some embodiments, the electronic assembly 118 includes a data communication unit for communicating with an external device (such as an 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 electronic assembly 118 includes one or more processors having one or more computing components configured to control energy delivery via the conductive element 114 and / or process energy and / or data received by the conductive element 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 one or more processors. For example, the memory may be a data storage device that may be loaded with one or more of the software components executable by one or more processors to implement certain functions. In some examples, these functions may involve causing the conductive element 114 to obtain data characterizing the activity of the patient's muscles. In another example, these functions may involve processing the data to determine one or more parameters of the data (e.g., changes in muscle activity, etc.). According to various embodiments, the electronic component 118 may include a wireless charging unit for providing power to other electronic components 118 of the device 100 and / or recharging the battery of the device 100 (if included).

[0144] The electronic package 108 may also be configured to wirelessly receive energy from a power source to power the neuromodulation device 100. In some embodiments, the electronic package 108 includes a first antenna 116 that is configured to wirelessly communicate with the external system 15. Figure 2B As shown in FIG. 1 , in some embodiments, the electronic component 118 can be disposed in an opening at a central portion of the first antenna 116. In other embodiments, the electronic component 118 and the antenna 116 can have other configurations and arrangements.

[0145] The second antenna 12 can be configured to transmit an electromagnetic field to induce a current in the first antenna 116, which can then be supplied to the electronic component 118 and / or the conductive element 114. In some embodiments, the first antenna 116 includes one or more coils. For example, the first antenna 116 may include one or more coils deployed on a flexible substrate. The substrate may include a single substrate or multiple substrates fixed to each other via an adhesive material. For example, in some embodiments, the substrate includes multiple layers of a heat-resistant polymer (such as polyimide) with an adhesive material between adjacent layers. Whether including a single layer or multiple layers, the substrate can have one or more through holes extending partially or completely through the thickness of the substrate, and one or more electrical connectors can extend through the through holes to electrically couple certain electronic components of the electronic package 108, such as the first antenna 116 and / or the electronic component 118 discussed previously.

[0146] In some embodiments, the first antenna 116 includes multiple coils. For example, the first antenna 116 may include a first coil located on a first side of the substrate and a second coil located on a second side of the substrate. This configuration may be susceptible to power losses due to substrate losses and parasitic capacitance between the multiple coils and between individual coil turns. Substrate losses occur due to eddy currents in the substrate caused by 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 stored charge. All circuit elements have this internal capacitance, which can cause their behavior to deviate from that of an "ideal" circuit element.

[0147] Advantageously, in some embodiments, the first antenna 116 may include a double-layer, pancake-style coil configuration in which the top and bottom coils are configured in parallel. Thus, when subjected to an electromagnetic field, the coils can generate equal or substantially equal induced voltage potentials. This can help 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. It has been found that this design retains the benefits of lower series resistance in a dual coil design while greatly reducing parasitic capacitance and producing a high maximum power output. Additional details regarding the dual coil configuration can be found in U.S. Application No. 16 / 866,523, filed May 4, 2020, which is incorporated herein by reference in its entirety.

[0148] The first antenna 116 (or one or more portions thereof) can be flexible so that the first antenna 116 can at least partially conform to the patient's anatomy once implanted. In some embodiments, the first antenna 116 includes an outer coating configured to wrap and / or support the first antenna 116. The coating can include a biocompatible material such as, but not limited to, epoxy, polyurethane, silicone, or other biocompatible polymers. In some embodiments, the coating includes layers of multiple unique materials. In some embodiments, different unique materials can coat different areas of the first antenna 116. For example, a first material (e.g., epoxy, polyurethane, silicone, etc.) can coat a first area including an electronic component 118 (e.g., a central area of ​​the first antenna 116), while a second material can coat a second area including coil turns.

[0149] In some embodiments, the first antenna 116 can include one or more open areas (e.g., cutouts) through a substrate (or multiple substrates) between coil turns. Such open areas can isolate selected portions of the coil turns and increase movement relative to each other, thereby increasing the flexibility and conformability of the entire antenna. For example, the open areas can be formed by a laser cutting process that removes substrate material between adjacent coil turns in a selected pattern. The first antenna 116 having such open areas can be formed from a single substrate, or can be formed from multiple substrates that are subsequently connected together (e.g., in a suitable overmolding process). As described below with respect to Figures 12A-12H As further described in detail in the examples depicted in , in some embodiments, the pattern can include one or more open areas where substrate material is removed to partially or completely isolate one or more of the coil turns. In addition, in some embodiments, the pattern can include one or more pillar areas where substrate material is retained to help maintain the spacing between adjacent coil turns.

[0150] For example, Fig. 12AAn example electronic package 1208a is illustrated having a first antenna 1216 and an electronic assembly 1218. The first antenna 1216 includes a plurality of coil turns 1230, wherein a substantial portion of the circumference of each coil turn 1230 is separated from adjacent coil turns 1230 by an arcuate open area 1220 that extends around the entire coil turn, except for a support area 1219 (e.g., located near the connector 110). For example, the arcuate open area 1220 may extend continuously around at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, or at least 95% of the circumference of the adjacent coil turns. In the example electronic package 1208a, the arcuate open area 1220 is rotationally aligned so that a single support area 1219 of substrate material remains. However, in other embodiments, some or all of the arcuate open regions may be rotationally offset (e.g., offset by at least 10 degrees, at least 30 degrees, at least 60 degrees, at least 90 degrees, etc.) such that multiple pillar regions 1219 of substrate material remain. Fig. 12B An example electronic package 1208b is depicted having a pattern in a first antenna 1216 that is similar to Fig. 12A The pattern shown in is similar to that shown in Fig. 12B As shown in , at least a portion of each coil turn of antenna 1216 is isolated so that it can be moved out of the plane of the substrate relative to adjacent coil turns, at least prior to any substrate coating or covering.

[0151] As another example, Fig. 12C An example electronic package 1208c is shown having a first antenna 1216 and an electronic component 1218. The first antenna 1216 may be similar to Fig. 12A The first antenna 1216 is different in that Fig. 12C In the first antenna 1216, each set of two adjacent coil turns 1230 is separated from the adjacent coil turns 1230 by an arcuate open area 1220 that extends around the entire coil turn, except for the support area 1219 (for example, located near the connector 110). In other words, every other ring (in the radial direction) of substrate material separating adjacent coil turns can be cut, removed, or otherwise omitted, leaving one or more sets of two adjacent coil turns 1230 circumferentially connected by a ring of substrate material. Accordingly, at least prior to any substrate coating or covering, at least a portion of each circumferentially connected set of (one or more) coil turns 1230 is isolated so that it can be moved out of the substrate plane relative to the (one or more) adjacent coil turns 1230. Although Fig. 12CA first antenna 1216 is illustrated having an arcuate open area 1220 separating every other turn of substrate material between coil turns 1230, but in other embodiments, the antenna 1216 may include an arcuate open area 1220 separating any number of circumferentially connected coil turns 1230 (e.g., two connected coil turns, three connected coil turns, etc.). For example, the arcuate open area 1220 may partially isolate a set of three circumferentially connected coil turns 1230, or may partially isolate a set of different numbers of circumferential coil turns 1230 (e.g., alternating between partially isolating two connected coil turns and one coil turn).

[0152] As another example, Fig.12D An example electronic package 1208d is shown having a first antenna 1216 and an electronic component 1218. The first antenna 1216 may be similar to Fig. 12A The first antenna 1216 is different in that Fig.12D In the first antenna 1216, multiple discrete circumferential portions of each coil turn 1230 are separated from adjacent coil turns 1230 by an arcuate open area 1220 that extends around a portion of each coil turn, except for a support area 1219a (e.g., located near the connector 110) and a support area 1219b (e.g., across the antenna 1216 and opposite the connector 110). Accordingly, at least two portions of each coil turn 1230 are isolated from adjacent coil turns so that, at least prior to any substrate coating or covering, the coil turn 1230 can be moved out of the substrate plane relative to the adjacent coil turn(s) 1230 (e.g., the coil turn 1230 can be "butterflyed").

[0153] As another example, Fig.12E An example electronic package 1208e is shown having a first antenna 1216 and an electronic component 1218. The first antenna 1216 may be similar to Fig. 12C The first antenna 1216 is different in that Fig.12E In the first antenna 1216, the multiple discrete circumferential portions of each coil turn 1230 are separated from adjacent coil turns 1230 by an arcuate open area 1220, which extends around a portion of the coil turn, except for a support area 1219a (e.g., located near the connector 110) and a support area 1219b (e.g., across the antenna 1216 and opposite the connector 110), similar to the above with respect to Fig.12D Accordingly, at least prior to any substrate coating or covering, at least a portion of each set of circumferentially connected coil turns 1230 is isolated so that it can be moved out of the plane of the substrate relative to (one or more) adjacent coil turns 1230. Although Fig.12EA first antenna 1216 is illustrated with an arcuate open area 1220 separating every other turn of substrate material between coil turns 1230, but in other embodiments, the antenna 1216 may include an arcuate open area 1220 separating any number of circumferentially connected coil turns 1230 (e.g., two connected coil turns, three connected coil turns, etc.). For example, the arcuate open area 1220 may partially isolate a set of three circumferentially connected coil turns 1230, or may partially isolate a set of different numbers of circumferential coil turns 1230 (e.g., alternating between partially isolating two connected coil turns and one coil turn).

[0154] Furthermore, the cut pattern may define any suitable number of support areas of substrate material around the coil turns. For example, Fig.12F An example electronic package 1208f is shown having a first antenna 1216 coupled to Fig.12D The first antenna 1216 is similar to the first antenna 1216, except that Fig.12F In the first antenna 1216, multiple discrete circumferential portions of each coil turn 1230 are separated from adjacent coil turns 1230 by arcuate open areas 1220 that extend around a portion of each coil turn, except for eight circumferentially distributed support areas 1219. As another example, Figure 12G An example electronic package 1208g is shown having a first antenna 1216 coupled to Fig.12E The first antenna is similar to the Figure 12G In the first antenna 1216, the plurality of discrete circumferential portions of each set of connected coil turns 1230 are separated from (one or more) adjacent coil turns 1230 by an arcuate open area 1220 extending around a portion of each coil turn, except for four circumferentially distributed strut areas 1219. However, in some embodiments, the pattern may include one, two, three, four, five, six, seven, eight, nine, ten, or more than ten strut areas that are equidistant or unequally spaced around the circumference of the first antenna 1216.

[0155] In some embodiments, the first antenna 1216 may include one or more coil turns that are completely circumferentially isolated (without the support region 1219) by an open region (eg, a cut region). Figures 12A-12G Any of the examples described may include at least one, two, three, four, five, six, seven, eight, or more than eight coil turns that are completely circumferentially isolated by open areas (e.g., cut areas). Fig.12HAn example electronic package 1208h is shown having a first antenna 1216 and an electronic component 1218. The first antenna 1216 may be similar to Fig. 12A The first antenna 1216 is different in that Fig.12H In the first antenna 1216, each coil turn 1230 is completely circumferentially isolated by an arcuate open area 1220 extending around the entire coil turn (without the support area 1219). In other examples, the Figures 12B-12G The first antenna 1216 shown in is such that any one or more of the coil turns 1230 (or a set of radially adjacent coil turns 1230 ) are completely circumferentially isolated by the arcuate open region 1220 .

[0156] In embodiments where there are (one or more) pillar regions, the pattern of pillar regions between adjacent coil turns or sets of adjacent (one or more) connected coil turns may also include circumferentially aligned pillar regions 1219 (e.g., as shown in FIG. Fig.12F Additionally or alternatively, the pattern of (one or more) pillar regions 1219 may include pillar regions 1219 that are offset from one another along a circumference (e.g., as shown in Figure 12G ), such as offset by about 15 degrees, about 30 degrees, about 45 degrees (as shown in Figure 12G ), about 60 degrees, about 75 degrees, about 90 degrees, or greater than about 90 degrees. In addition, the size of the pillar region 1219 can vary in any suitable manner, such as depending on the desired spacing between coil turns 1230. For example, in some embodiments, the pillar region 1219 can have a width (e.g., an arc length around the antenna) between about 15 μm and about 25 μm or about 20 μm.

[0157] In some embodiments, an area including electronic components 1218 (e.g., a central area of ​​first antenna 116) can be coated or otherwise covered with a first material (e.g., epoxy), and an area including one or more partially or completely isolated coil turns can be coated or otherwise covered with a second material (e.g., polyurethane, silicone, other low-durometer polymer) that is configured to enable the coil turns to flex and move. In some embodiments, the area including the coil turns can be overmolded with the second material. For example, the above description of Figures 12A-12H Any of the example electronic packages described may include an electronic component 1218 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 maintain spacing between adjacent isolated coil turns (e.g., in embodiments lacking a post region).

[0158] Continue to refer Figure 2B-2D, the lead body 104 may include a substrate carrying one or more conductive elements 114, which are configured to deliver and / or receive electrical energy. In some embodiments, the lead body 104 (or one or more portions thereof) includes a flexible tube whose sidewalls define a lumen. The lead body 104 may include a polymer material, such as but not limited to a thermoplastic elastomer, a thermoplastic polyurethane, a silicone, or other suitable material. The lead body 104 may include the same material as the extension portion 106 or a different material. The lead body 104 may include the same material as the extension portion 106. In some embodiments, the lead body 104 has a different hardness than the extension portion 106. For example, the lead body 104 may have a lower hardness than the extension portion 106, which may enhance the comfort of the patient.

[0159] like Figure 2B-2D As shown in , the lead body 104 has a branched shape, including a first arm 122 and a second arm 124. To facilitate this configuration, for example, the second connector 112 may be forked and / or branched. The first arm 122 and the second arm 124 may each extend distally and laterally from the second connector 112 and / or the distal portion 106b of the extension portion 106. The first arm 122 may include 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 may include 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 may include a cantilevered free distal end 123 and / or the second arm 124 may include a cantilevered free distal end 125. The first arm 122 and / or the second arm 124 may include one or more fixing elements 130, for example Figure 2B-2D The fixation element 130 is shown at the distal portions 122b, 124b of the first and second arms 122, 124. The fixation element 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.

[0160] Although the lead 102 and / or one or more portions thereof (e.g., the lead body 104, the extension portion 106, etc.) are 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. For example, this feature can be achieved by electrically connecting the conductive element 114 carried by the lead body 104 to an electrical conductor of the electronic package 108, by additional internal shape-maintaining (e.g., metal, shape memory alloy, etc.) support structure (not shown), by shape-setting a substrate including the lead 102, etc. In any case, one or more portions of the lead 102 can have physical properties (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 so as to at least partially conform to the patient's anatomy and / or enhance patient comfort once implanted.

[0161] Conductive elements 114 may be carried by the sidewalls of lead body 104. For example, conductive elements 114 may be positioned on an outer surface of the sidewall and / or within a recessed portion of the sidewall. In some embodiments, one or more of conductive elements 114 are positioned on an outer surface of the sidewall and extend at least partially around the circumference of the sidewall. The lumen of lead body 104 may carry one or more electrical conductors extending from conductive elements 114 through the lumen of lead body 104 and the lumen of extension portion 106 to electronic package 108. The sidewalls may define one or more apertures through which electrical connectors may extend.

[0162] As previously described, the conductive element 114 can be connected to the electronic package 108 via one or more electrical conductors. The electrical conductors can be positioned on the sidewalls of the lead 102 (e.g., the extension 106 and / or the lead body 104) and / or within the lumen of the lead 102. In some embodiments where the electrical conductor is positioned within the lumen of the extension 106 of the lead 102, once the electrical conductor has been positioned within the lumen, the lumen can be backfilled. The lumen can be backfilled with an adhesive and / or an elastomer. In some embodiments, the lumen is backfilled with, for example, a silicone adhesive. In some embodiments, the extension 106 can be injection molded around the electrical conductor. Backfilling the lumen and / or injection molding the extension 106 around the electrical conductor can fill the space within the lumen of the extension 106 that was not originally occupied by the electrical conductor, which can, for example, help prevent or limit fluid from entering the lead 102 and corroding or degrading the electrical conductor.

[0163] In some embodiments, each conductive element 114 is connected to a corresponding electrical conductor such that the number of conductive elements 114 is equal to the number of conductive elements 114. Also, in some embodiments, the device may include more or fewer conductive conductors than conductive elements 114 (e.g., an conductive conductor may be connected to multiple conductive elements 114). The conductive elements 114 may be connected to the conductive conductors via welding, soldering, and / or any other suitable technique for forming an electrical and / or mechanical connection between the conductive elements 114 and the conductive conductors. For example, the conductive elements 114 may be connected to the conductive conductors via spot welding. The conductive elements 114 may be connected to the corresponding conductive conductors at one or more locations along the length of the conductive conductors.

[0164] In some embodiments, the material and / or configuration of the electrical conductor can be selected based on the desired mechanical properties of the electrical conductor. For example, a stranded electrical conductor can have better flexibility and fatigue resistance than a solid core wire, which can be ideal for use in the human body. In some embodiments, it can be advantageous for the electrical conductor to include a material having a low resistivity because such an electrical conductor can draw less power than an equivalent electrical conductor having a higher resistivity. The electrical conductors of the present technology can include any suitable metal, such as titanium, chromium, niobium, tantalum, vanadium, zirconium, aluminum, cobalt, nickel, stainless steel, or alloys of any of the foregoing metals.

[0165] Each conductive element 114 may include 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 include an annular electrode. The conductive element 114 may be crimped, welded, adhered, or positioned on the outer surface and / or recessed portion of the lead body 104. Additionally or alternatively, each conductive element 114 may be welded, brazed, crimped, or otherwise electrically coupled to a corresponding electrical conductor. In some embodiments, one or more of the conductive elements 114 include a flexible conductive material disposed on the lead body 104 via printing, thin film deposition, or other suitable techniques. Each conductive element 114 may include any suitable conductive material, including but not limited to platinum, iridium, silver, gold, nickel, titanium, copper, combinations thereof, and / or other. For example, one or more of the conductive elements 114 may be an annular electrode comprising a platinum-iridium alloy. In some embodiments, one or more of the conductive elements 114 include a coating configured to improve the biocompatibility, conductivity, corrosion resistance, surface roughness, durability, or (one or more) other parameters of the conductive element 114. As just one example, one or more of the conductive elements 114 may include a coating of titanium and nitride.

[0166] In some embodiments, one or more conductive elements 114 have a length of about 1 mm. Additionally or alternatively, one or more conductive elements 114 may 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 arm 122 or the second arm 124 can be spaced apart along the 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, 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. The conductive elements 114 can have the same length or different lengths.

[0167] In addition, although Figure 2B-2D The device 100 shown in FIG. 1 includes conductive elements 114 that are spaced approximately equidistant from one another on a first arm 122 and a second arm 124, but other distributions of the conductive elements 114 are also 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 may be spaced equidistantly along the length of the arm, and / or at least a portion of the conductive elements 114 may be spaced unequally along the length of the arm.

[0168] For example, in some embodiments where the conductive elements 114 are not equally spaced apart, the spacing between the conductive elements 114 along the first arm 122 and / or the second arm 124 can decrease in the proximal to distal direction (e.g., the conductive elements 114 located at the distal portions of the lead body arms 122, 124 can be positioned closer to each other than the conductive elements 114 located at the proximal portions of the lead body arms). As another example, in some embodiments where the conductive elements 114 are not equally spaced apart, the spacing between the conductive elements 114 along the first arm 122 and / or the second arm 124 can increase in the proximal to distal direction (e.g., the conductive elements 114 located at the distal portions of the lead body arms 122, 124 can be positioned farther away from each other than the conductive elements 114 located at the proximal portions of the lead body arms). As another example, in some embodiments where the conductive elements 114 are not equally spaced apart, the spacing between the conductive elements 114 along the first arm 122 and / or the second arm 124 may regularly alternate between a first distance and a second distance, wherein the first distance is different from the second distance. As another example, in some embodiments where the conductive elements 114 are not equally spaced apart, the spacing between the conductive elements 114 along the first arm 122 and / or the second arm 124 may be irregular or random.

[0169] The spacing or distribution of the conductive elements 114 on the first arm 122 may mirror the spacing or distribution of the conductive elements 114 on the second arm 124 , or the spacing or distribution of the conductive elements 114 on the first arm 122 may be different than the spacing or distribution of the conductive elements 114 on the second arm 124 .

[0170] Although Figure 2B-2D The device 100 shown in FIG. 1 includes eight conductive elements 114 (the first arm 122 carries four conductive elements 114 and the second arm 124 carries four conductive elements 114), although other numbers and configurations of conductive elements 114 are also 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 than 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.

[0171] Conductive element 114 can be configured for stimulation and / or sensing. Stimulating conductive element 114 can be configured to deliver energy to anatomical structures, such as, for example, nerves or muscles. In some embodiments, conductive element 114 is configured to deliver energy to the hypoglossal nerve of the patient to increase the activity of the tongue extensor muscles of the patient. Sensing conductive element 114 can be used to obtain data characterizing the physiological activity (e.g., muscle activity, temperature, etc.) of the patient. In some embodiments, sensing conductive element 114 is configured to detect the electrical energy generated by the patient's muscles to obtain EMG data characterizing the activity of the muscles. In some embodiments, sensing conductive element is configured to measure the impedance across conductive element. To give just one example, in some embodiments, conductive element 114 is configured to deliver energy to the hypoglossal nerve of the patient to increase the activity of the genioglossus and / or geniohyoid muscle, and obtain EMG data characterizing the activity of the genioglossus and / or geniohyoid muscle of the patient. Also, conductive element 114 can be configured to deliver energy to other patient tissues and / or measure physiological electrical signals from other patient tissues.

[0172] The function that each conductive element 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 electronic assembly 118 of the electronic package 108. In some embodiments, one or more of the conductive elements 114 are configured to be used only for one of delivering energy to patient tissue or receiving energy from patient tissue. In various embodiments, one or more of the conductive elements 114 are configured to both deliver energy to patient tissue and receive energy from patient tissue. In some embodiments, the functionality of the conductive elements 114 can be based at least in part on the intended positioning of the device 100 in the patient's body and / or the location of the conductive elements 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), and therefore, it can be desirable for (one or more) conductive elements 114 to be able to both deliver energy to patient tissue and receive energy from patient tissue. Additionally or alternatively, some of the conductive elements 114 may have an intended location relative to a particular patient tissue such that only delivery of stimulation energy is desired, while other conductive elements 114 may have an intended location relative to a particular patient tissue such that only reception of sensing energy is desired. Advantageously, the configuration of the conductive elements 114 may be configured in a software setting (which may be facilitated by the electronic components 118 of the electronic package 108) so that the configuration of the conductive elements 114 can be easily modified.

[0173] Regardless of being configured for stimulation and / or sensing, each conductive element 114 can be configured and used independently of the other conductive elements 114. Because of this, during application of stimulation therapy, all or some of the conductive elements 114 (whichever is determined to be most effective for a particular embodiment) can be used. 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 (one as a cathode and one as an anode) can be used without using 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 more detail below, the conductive element(s) 114 used for sensing and / or stimulation can be selected based on the desired data to be collected and / or the desired modulation of nerve or muscle activity. For example, specific pairs of conductive elements 114 may be used to create electric fields tailored for stimulation of certain areas of muscle and / or HGN, which results in favorable changes in tongue position and / or pharyngeal expansion. Additionally or alternatively, conductive element(s) 114 that are in contact with muscle tissue when device 100 is implanted may be more suitable for EMG sensing than conductive element(s) 114 that are not positioned in contact with muscle tissue.

[0174] 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 a patient. Conductive element 114 carried by first arm 122 can be configured to deliver electrical stimulation energy to one hypoglossal nerve (e.g., the right or left hypoglossal nerve) of the patient, while conductive element 114 carried by second arm 124 can be configured to deliver electrical stimulation energy to another hypoglossal nerve (e.g., the other of the right or left hypoglossal nerves) of the patient.

[0175] Without being bound by theory, it is believed that increased activity of the tongue extensor muscles during sleep reduces upper airway resistance and improves breathing. Therefore, the device of the present technology is configured to deliver stimulation energy to the motor nerves that control the tongue extensor muscles. 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 sensed energy generated by the activity of one or more muscles of the patient (such as the genioglossus muscle), which can be used for closed-loop delivery of stimulation energy, assessment of patient breathing, etc.

[0176] The device can be configured to be implanted in an anatomical region of the patient that is bounded anteriorly and laterally by the patient's mandible, superiorly by the upper surface of the tongue, and inferiorly by the patient's platysma. Such anatomical regions can include, for example, a submental region and a sublingual region. The sublingual region is superiorly bounded by the mucosa of the floor of the mouth, inferiorly by the mylohyoid bone, and includes a plane between the genioglossus and geniohyoid muscles. The submental region is superiorly bounded by the mylohyoid bone and inferiorly by the platysma. Figures 3A-3F Various views of the device 100 implanted in a patient are depicted. Figures 3A-3F As shown in , the neuromodulation device 100 is configured to be positioned so that the electronic component package 108 is deployed on or near the inferior surface of the mylohyoid bone in the submental region, and the lead body 104 is positioned between the geniohyoid bone and the genioglossus muscle in the sublingual region, and the arms 122, 124 are deployed along the left and right hypoglossal nerves. The arms 122, 124 can be positioned so that the conductive element 114 is deployed near a portion of the distal branch of the hypoglossal nerve that innervates the genioglossus muscle. In particular, the conductive element 114 can be positioned close to a portion of the distal branch of the horizontal fibers that innervate the genioglossus muscle, while limiting and / or avoiding stimulation of a portion of the distal branch of the hypoglossal nerve that activates the retractor muscle. When implanted, the extension portion 106 of the lead 102 can extend forward away from the electronic package 108 (toward the mandible), then bend upward and extend through the genioglossus muscle until it bends backward and extends within a tissue plane between the genioglossus muscle and the genioglossus muscle. In some embodiments, the extension 106 straddles the right and left geniohyoid muscles.

[0177] The electronic package 108 can be sufficiently flexible so that once implanted, the electronic package 108 at least partially conforms to the curvature of the mylohyoid bone. Additionally or alternatively, the electronic package 108 can have a shape that reflects the curvature of the mylohyoid bone. In some embodiments, the electronic package 108 can include a fixation element (similar to fixation element 130, fixation element 1132, or others) configured to engage the mylohyoid bone (and / or other surrounding tissue) and prevent or limit movement of the electronic package 108 after implantation.

[0178] Lead body 104 may be configured to be positioned between the patient's genioglossus and geniohyoid muscles such that conductive element 114 is positioned proximate to the hypoglossal nerve. Figures 3A-3F106 , but the hypoglossal nerve is located between the genioglossus muscle and the fascia and / or fat located between the genioglossus muscle and the geniohyoid bone. In some embodiments, the lead body 104 is configured to be positioned at or below the fat between the hypoglossal nerve and the genioglossus bone, and is therefore 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 portion 106b of the extension portion 106. The lead body 104 can then branch or bifurcate laterally so that the first arm 122 of the lead body 104 is positioned proximate to one of the patient's hypoglossal nerves and the second arm 124 is positioned proximate to the contralateral hypoglossal nerve. The fixation element 130 can engage patient tissue (e.g., fat below the hypoglossal nerve, etc.) to prevent or limit movement of the first arm 122 and the second arm 124 relative to the patient tissue.

[0179] like Figure 3C As best shown in FIG. 1 and described in more detail below, the arms 122, 124 of the lead body 104, in addition to extending laterally away from the extension portion 106, can also bend out of the plane of the extension portion 106 such that the arms 122, 124 outline a slightly concave shape. Advantageously, this concave shape can accommodate the convex inferior surface of the genioglossus muscle and still maintain the arms 122, 124 positioned proximal to the distal branches of the hypoglossal nerve.

[0180] In some embodiments, the conductive element 114 is selected to selectively activate the patient's protruding muscles. In these and other embodiments, it is not necessary to identify the specific positioning of the first and second arms 122, 124 relative to a particular branch of the hypoglossal nerve prior to stimulating the desired portion of the nerve and / or muscle. For example, in embodiments where the lead body 104 includes more than two conductive elements 114, a combination of conductive elements 114 for treating the patient can be selected based on a physiological response to a test stimulus. For example, stimulation energy can be delivered to (one or more) hypoglossal nerves via multiple combinations of conductive elements 114, and the physiological response (e.g., EMG data, tongue position, pharyngeal opening size, etc.) and / or functional results (e.g., fatigue severity scale, Epworth sleepiness scale, etc.) can be evaluated for each combination. Based on the (one or more) evaluations, the conductive element 114 selected to deliver the stimulation energy can be the conductive element 114 associated with a favorable response / result.

[0181] The shape of lead body 104 may facilitate electrical coupling between conductive element 114 and the patient's hypoglossal nerve. Figures 4A-4C 102 are perspective, side, and end views, respectively, of the lead 102 isolated from the electronic package 108 and the first connector 110 for further discussion of the shape of the lead body 104. Figures 3A-4C , the first arm 122 and the second arm 124 can branch distally and laterally from the distal end portion 106b of the extension portion 106. Figure 4B and Figure 4C As shown in FIG. 1 , the proximal portion 122a of the first arm 122 may be in the first lateral dimension L 1a The distal portion 106b of the second arm 124 extends laterally away from the distal portion 106b of the extension portion 106, while the proximal portion 124a of the second arm 124 can extend in the second lateral dimension L 2a The upper side extends laterally away from the distal end portion 106b of the extension portion 106. The proximal portions 122a, 124a diverge in a lateral dimension L 1a , L 2a The extension enables the first and second arms 122, 124 to be positioned bilaterally within the patient such that each of the first and second arms 122, 124 is positioned proximate to one of the right hypoglossal nerve or the left hypoglossal nerve. Figure 4B As shown in FIG. 1 , the proximal portion 124a of the second arm 124 can be 2b The horizontal dimension L extends distally away from the distal end portion 106b of the extension portion 106 and / or the second connector 112. 2b With respect to the longitudinal axis L of the wire 102 L The longitudinal axis L of the wire 102 is L can be aligned with the extension portion 106 of the conductor 102 (e.g., as Figure 4B ) or may be offset from the extension portion 106.

[0182] like Figure 4C As shown in FIG. 1 , the proximal portion 122a of the first arm 122 can be aligned with the transverse axis L of the guide wire 102. S The first angle θ1 is formed so that the proximal portion 122a is aligned with the transverse axis L S Separated by a first distance d 1a The first distance d 1a The distance between the distal end 106b and the distal end 106b of the extension 106 and / or the second connector 112 may increase from the proximal end to the distal end and / or may increase with increasing lateral distance. Figure 4B and Figure 4C As shown in FIG. 1 , the proximal portion 124a of the second arm 124 can be aligned with the transverse axis L of the guide wire 102. S The second angle θ2 (which may be the same as or different from the first angle θ1) is formed so that the proximal portion 124a is aligned with the transverse axis L. S Separated by a second distance d 2a The second distance d 2a The distance may increase from proximally to distally and / or may increase with increasing lateral distance from the distal portion 106 b of the extension portion 106 and / or the second connector 112 .

[0183] The distal portion 122b of the first arm 122 can extend distally away from the intermediate portion 122c in a first longitudinal dimension (not shown), while the distal portion 124b of the second arm 124 can extend distally away from the intermediate portion 122c in a second longitudinal dimension (not shown). 2c The first longitudinal dimension L extends distally away from the middle portion 124c of the second arm 124. In some embodiments, the first longitudinal dimension and / or the second longitudinal dimension L 2c can be substantially aligned with the longitudinal axis L of the wire 102 L In any case, the distal portion 124b of the second arm 124 can be parallel to the longitudinal axis L of the guide wire. L The vertical distance d 2b Similarly, the distal portion 122b of the first arm 122 can be aligned with the longitudinal axis L of the guide wire. L Space the vertical distance apart.

[0184] The distal portion 122b of the first arm 122 and / or the distal portion 124b of the second arm 124 may be positioned in a different plane and / or at a different height than the extension portion 106. Angling the proximal portions 122a, 124a of the arms 122, 124 vertically away from the extension portion 106 facilitates establishing adequate and stable electrical coupling of the conductive element 114 with the fat beneath the hypoglossal nerve. Figures 3B-3F As shown in , the distal portion 106b of the extension portion 106 of the wire can be configured to be positioned at, near and / or directly above the geniohyoid bone when implanted. However, due to the branching and angled structure of the wire body 104, the wire body 104 can extend upward toward the geniohyoid bone. Specifically, the proximal portions 122a, 124a of the arms 122, 124 can extend upward. In some embodiments, when the device 100 is implanted, the genioglossus muscle (and the underlying hypoglossal nerve branches, fascia, fat, etc.) can rest on the first arm 122 and the second arm 124 of the wire body 104, which can facilitate electrical contact between the conductive element 114 and the patient's tissue.

[0185] The device 100 may include a fixation element 130 configured to engage patient tissue to secure the device 100 to the tissue. For example, the fixation element 130 of the lead body 104 may further facilitate engagement of the lead body 104 with the patient tissue. Figure 51 is an enlarged side view of the distal portion 124b of the second arm 124 and a corresponding example fixation element 130. One or more of the fixation elements 130 can extend from a first end portion 130a at the outer surface of the side wall 500 of the guide wire to a second end portion 130b radially spaced from the outer surface of the side wall. In other words, the second end portion 130b can be radially spaced from the cylindrical outer surface of the side wall 500. Each fixation element 130 can have a length l and a thickness t, the length l being defined between the first and second end portions 130a, 130b of the fixation element 130. In some embodiments, the length l of one or more of the fixing elements 130 is between about 0.7 mm and about 1.5 mm, between about 0.8 mm and about 1.4 mm, between about 0.9 mm and about 1.3 mm, between about 1.0 mm and about 1.2 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1.0 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, or about 1.5 mm. In some embodiments, the thickness t of one or more of the fixing elements 130 is between about 0.1 mm and about 0.5 mm, between about 0.2 mm and about 0.4 mm, about 0.1 mm, about 0.2 mm, about 0.3 mm, about 0.4 mm, or about 0.5 mm. In some embodiments, the thickness t can be based on the thickness of the side wall 500 of the wire body and / or substantially equal to the thickness. In some embodiments, the thickness t can vary (e.g., the thickness gradually decreases from the first portion 130a to the second portion 130b). The second end portion 130b can be spaced apart from the side wall 500 by a height h so that the fixing element 130 is at an angle b relative to the side wall. The height h can be no greater than 1 mm, no greater than 0.75 mm, no greater than 0.5 mm, no greater than 0.4 mm, no greater than 0.3 mm, no greater than 0.2 mm, no greater than 0.1 mm, about 1 mm, about 0.5 mm, about 0.1 mm, or greater than 1 mm. According to various embodiments, the angle b can be less than 90 degrees, such as about 80 degrees, about 75 degrees, about 70 degrees, about 65 degrees, about 60 degrees, about 55 degrees, about 50 degrees, about 45 degrees, about 40 degrees, about 35 degrees, about 30 degrees, about 25 degrees, about 20 degrees, about 15 degrees, or about 10 degrees. Although the fixing element 130 is at Figure 51 is shown as having a generally linear cross-section along its length l, but in other embodiments, one or more fixation elements 130 can have any suitable cross-section, such as curved (e.g., concave, convex, etc.). The fixation elements 130 can be configured to engage patient tissue (e.g., fat, muscle tissue, etc. beneath the hypoglossal nerve) to prevent or limit movement of one or more portions of the device 100 relative to the tissue. Any fixation element 130 disclosed herein can be configured to prevent or limit movement of portions of the device in an anterior, posterior, medial, lateral, superior, and / or inferior direction.

[0186] Any portion of the device 100 may include a fixation element 130. For example, a proximal portion 122a of the first arm 122, a distal portion 122b of the first arm 122, a middle portion 122c of the first arm 122, a proximal portion 124a of the second arm 124, a distal portion 124b of the second arm 124, a middle portion 124c of the second arm 124, an extension portion 106, an electronic package 108, and / or another suitable portion of the device 100 may include a fixation element 130. In some embodiments, the device 100 includes a fixation element 130 positioned between adjacent conductive elements 114. For example, one or more fixation elements 130 may be positioned between a distal-most conductive element 114 of an arm and an adjacent conductive element 114 of an arm, between a proximal-most conductive element 114 of an arm and an adjacent conductive element 114 of an arm, between a distal-most conductive element 114 and an intermediate conductive element 114 between the proximal-most conductive element 114 and the proximal-most conductive element 114, and the like. In some embodiments, for example, Figure 5 As shown in , the fixation element 130 can be deployed at the distal portion of one or both of the arms 122, 124, such as between the distal-most conductive element 114 and the distal tip of the corresponding arm. Because the weight and / or stiffness of the device 100 can be greater at one or more areas of the electronic package 108 and / or the extension portion 106 than at the distal portions of the arms 122, 124, during implantation of the device 100, the arms 122, 124 can tend to be displaced away from the fat pad near the hypoglossal nerve. However, such distal positioning of the fixation element 130 can allow the arms 122, 124 to better grasp the fat pad and remain in their intended position during implantation of the device 100. In some embodiments, one or more fixation elements 130 can be positioned proximal to the proximal-most conductive element 114 of a given arm, such as at or near the middle portion of the arm and / or the proximal portion of the arm.

[0187] Although Figure 5Six fixing elements 130 are depicted as being carried by the distal portion 124b of the second arm 124, but other numbers of fixing elements 130 are possible. For example, the distal portion of each arm may include one fixing element 130, two fixing elements 130, three fixing elements 130, four fixing elements 130, five fixing elements 130, six fixing elements 130, seven fixing elements 130, eight fixing elements 130, nine fixing elements 130, ten fixing elements 130, eleven fixing elements 130, twelve fixing elements 130, and / or more than twelve fixing elements 130. However, in some applications, it may be desirable to limit the number of fixing elements 130 carried by each arm. For example, it may be desirable to use fewer fixing elements 130 so that the arm can releasably engage the tissue. If the arm includes too many fixing elements 130, then after the fixing elements 130 engage the tissue, the arm may not be able to separate from the tissue without causing trauma to the tissue. In some embodiments, it may be desirable to reposition the arms after the fixation elements 130 engage the tissue, such as to move the conductive element 114 to a more favorable position relative to the HGN. Limiting the number of fixation elements 130 per arm may provide a desired balance between secure engagement of the arm with the tissue while still allowing the arm to separate from the tissue after the fixation elements 130 engage the tissue. In some embodiments, each arm may include no more than eight fixation elements 130, such as two fixation elements 130, four fixation elements 130, six fixation elements 130, or eight fixation elements 130.

[0188] Additionally or alternatively, it may be desirable to limit the length of the distal portions 122b, 124b of the arms 122, 124, which may limit the number of fixation elements 130 included in the distal portions 122b, 124 of the arms 122, 124. For example, it may be desirable for the distance between the distal-most conductive element 114 and the distal tip of the corresponding arm to be less than about 12 mm, less than about 11 mm, less than about 10 mm, less than about 9 mm, less than about 8 mm, less than about 7 mm, or less than about 6 mm to prevent or limit the distal tip of the arm from inadvertently contacting the hyoid bone or other anatomical structures (e.g., bone, muscle, nerve, etc.) when the conductive element 114 is aligned with the HGN.

[0189] Some or all of the fixing elements 130 may be distributed around the circumference of the arm or may be aligned along the circumference. Additionally or alternatively, some or all of the fixing elements 130 may be spaced apart along the length of the arm or may be axially aligned along the length of the arm. For example, in some embodiments, the fixing elements 130 include a first set of fixing elements and a second set of fixing elements. The first set of fixing elements may be arranged around the arm in a circumferential direction at a first axial position along the arm, and the second set of fixing elements may be arranged around the arm in a circumferential direction at a second axial position along the arm, wherein the second axial position is axially offset or spaced apart from the first axial position (e.g., the second axial position may be close to or away from the first axial position). In some embodiments, the first set of fixing elements is spaced apart or offset from the second set of fixing elements in a circumferential direction. The fixing elements 130 may be distributed symmetrically or asymmetrically around the circumference of the arm, along the length of the arm, and / or between the components of the device 100. The number of axially spaced fixing elements 130 deployed along the length of the arm may be based on the length of the fixing elements 130 and / or the distance between axially adjacent fixing elements 130. As just one example, if the distal portion 122b of the first arm 122 has a length of about 6 mm, and each fixation element 130 has a length of about 1 mm, the distal portion 122b may include a maximum of about six fixation elements 130 along its length. In this example, if axially adjacent fixation elements 130 are spaced apart from each other, the distal portion 122b may include two, three, four, or five fixation elements 130 along its length.

[0190] In some embodiments, the second end portion 130b of the fixation element 130 is radially spaced from the sidewall 500 to prevent or limit forward movement of the lead body 104 when the device 100 is implanted. Also, one, some, or all of the fixation elements 130 may be oriented in a manner similar to that of the device 100. Figure 5 The orientation of the fixation elements 130 shown in FIG. 5 is opposite, such that the first end portion 130a of such fixation element 130 is spaced apart from the side wall 500, while the second end portion 130b of such fixation element 130 is positioned at the side wall 500. The second end portion 130b of one or more of the fixation elements 130 may be positioned proximal or distal to the corresponding first end portion 130a of the fixation element 130.

[0191] The fixing element 130 may include a portion of the side wall 500 of the wire and / or may include a discrete element fixed to the side wall 500 of the wire. In some embodiments, the fixing element 130 is formed by cutting the side wall of the wire and lifting the second end portion 130b of the fixing element 130 away from the side wall 500. The fixing element 130 may be formed by laser cutting (e.g., UV laser cutting, gas laser cutting, crystal laser cutting, fiber laser cutting, etc.), mechanical cutting (e.g., with a blade), electron beam processing, water jet cutting, or another suitable method. In some embodiments, the wire or one or more parts thereof (e.g., the wire body, extension, etc.) include a polymer tube, and the fixing element 130 is cut from the side wall of the polymer tube. The polymer may be a thermoplastic material, such as thermoplastic polyurethane. The fixing element 130 may be radially bent away from the cylindrical plane of the side wall, and heat may be applied to keep the fixing element 130 in a bent configuration. In some embodiments, the wire is backfilled (e.g., with silicone) to further fix the fixing element 130.

[0192] Figures 6A-6D They are Figure 2B-2D 100, the first connector 110 can be configured to connect the electronic package 108 to the extension portion 106. The first connector 110 can include a proximal portion 110a and a distal portion 110b. The housing 600 of the first connector 110 can include one or more fixing portions 602 for fixing to another component of the device 100. For example, as shown in FIG. Figures 6A-6DAs shown in , the housing 600 may include a first fixed portion 602a for fixing to an electrical conductor carried by the extension portion 106, a second fixed portion 602b for fixing to the extension portion 106, and / or a third fixed portion 602c for fixing to the electronic package 108. The first fixed portion 602a may include a first wide surface 604, a second wide surface 606, and a plurality of recesses 608, each of which may be configured to receive an electrical conductor. The first fixed portion 602a may be configured to be fixed to the electrical conductor in a manner that provides strain relief for the electrical conductor to prevent or limit separation of the electrical conductor from the first fixed portion 602a and / or damage to the conductor. In some embodiments, the electrical conductor is at least partially soldered, welded, bonded, or otherwise fixed to the first fixed portion 602a. The second fixed portion 602b may include a lumen 610 configured to receive the proximal portion 106a of the extension portion 106. In some embodiments, the proximal portion 106a of the extension portion 106 can be at least partially positioned in the lumen 610 so that the second fixing portion 602b prevents or limits the movement of the extension portion 106 relative to the electronic package 108. The proximal portion 106a of the extension portion 106 can be securely fixed to the first connector 110 by welding, soldering, bonding, gluing, etc. The third fixing portion 602c can include a protrusion 612 spaced apart from the second wide surface 606 of the first fixing portion 602a to define a gap 614 for receiving the electronic package 108. In some embodiments, the electronic package 108 can be at least partially positioned in the gap 614 so that the protrusion 612 and / or the second wide surface 606 prevent or limit the movement of the electronic package 108 relative to the first connector 110. The electronic package 108 can be fixed to the first connector 110 by welding, soldering, bonding, gluing, etc. The housing 600 can include one unitary body, or can include multiple discrete components that are fixed together after the assembly is formed. In some embodiments, housing 600 includes a polymer material and / or is formed by injection molding, additive manufacturing, or another suitable manufacturing technique. Housing 600 can be sufficiently flexible to reduce forces applied to the electrical conductors due to movement of the electronic package and / or extension 106 .

[0193] Figures 7A-7C The extension portion 106 of the wire 102 is shown isolated from other components of the device 100. The extension portion 106 can have a variety of suitable shapes. For example, the extension portion 106 can be substantially straight along its longitudinal axis L (see Fig. 7A In some embodiments, the extension portion 106 undulates between peaks 700 and valleys 702 along its longitudinal axis L (see Figure 7B ).like Figure 7CAs shown in , the extension portion 106 may include one or more helically wound regions 704, wherein the extension portion 106 is wound around its longitudinal axis L. The shape, material, and / or other characteristics of the extension portion 106 may be based on the desired functionality of the extension portion 106. For example, the lead body 104 may be configured to be positioned between the genioglossus and geniohyoid muscles, while the electronic assembly 108 is configured to be positioned below the mylohyoid muscle. Accordingly, the extension portion 106 may be configured to extend upward from the electronic assembly 108 and forwardly around the mylohyoid and geniohyoid muscles to the lead body 104. Thus, the extension portion 106 may have a length based on the combined thickness of the mylohyoid and geniohyoid muscles, such that when the conductive element 114 is located at a desired location in the patient's body, the extension portion 106 has sufficient length to surround the mylohyoid and mylohyoid muscles, thereby positioning the electronic assembly 108 at a desired location below the mylohyoid muscle. The length of extension 106 may be between about 30 mm and about 90 mm, between about 40 mm and about 80 mm, between about 50 mm and about 70 mm, less than 30 mm, greater than 90 mm, about 10 mm, about 20 mm, about 30 mm, about 40 mm, about 50 mm, about 60 mm, about 70 mm, about 80 mm, about 90 mm, or about 100 mm. In some embodiments, the length of extension 106 is based on the distance between the target location of conductive element 114 and the target location of electronic package 108 in the population. For example, the length of extension 106 may be based at least in part on the average thickness of the geniohyoid muscle and the mylohyoid muscle in a particular population (e.g., males 18 years of age and older, etc.).

[0194] In some embodiments, the extension portion 106 may be extendable to accommodate a range of combined geniohyoid and geniohyoid thicknesses. Figures 7A-7C , etc.) can be extensible because the material properties of the extension portion 106 and / or the shape of the extension portion 106 promote the extension portion 106 to elongate under tension (for example, as shown in Figure 7B and Figure 7C In some embodiments, extension portion 106 may have a sufficiently high ductility such that extension portion 106 may be elongated without yielding or failing, and a sufficiently low elasticity such that extension portion 106 maintains a desired shape after elongation.

[0195] Figure 8A second connector 112 is shown isolated from other components of the device 100. The second connector 112 may include a single integral body, or the second connector 112 may include multiple discrete components that are formed separately and later fixed to each other. In some embodiments, the second connector 112 includes three tubular portions: a first tubular portion 800a for fixing to the extension portion 106 of the wire 102, a second tubular portion 800b for fixing to the first arm 122 of the wire, and a third tubular portion 800c for fixing to the second arm 124 of the wire (collectively referred to as "tubular portions 800"). The tubular portions 800 may be formed as a whole, or as separate components that are later fixed together. Each tubular portion 800 may define a lumen that is configured to receive the sidewalls of the corresponding components therein. For example, the first tubular portion 800a may be configured to receive the sidewalls of the distal portion 106b of the extension portion 106 therein.

[0196] In some embodiments, the second connector 112 may have a clamshell configuration, wherein the second connector 112 is movable between an open configuration and a closed configuration. Fig. 9 This second connector 112 is shown in an open configuration. Fig. 9 As shown in, the second connector 112 can have a first component 900a and a second component 900b movable relative to the first component 900a. The first and second components 900a, 900b of the flip cover second connector 112 can have substantially the same shape or can have different shapes. In the open configuration, the second component 900b is at least partially separated from the first component 900a. When the second connector 112 is in the open configuration, each of the first and second components 900a, 900b can define an open internal volume. In the open configuration, the first component 900a can be connected to the second component 900b at one or more locations. For example, the first component 900a can be connected to the second component 900b by a hinge. In some embodiments, the hinge includes a thin flexible material sheet extending between a portion of the first component 900a and a portion of the second component 900b. In some embodiments, in the open configuration, the first component 900a can be completely separated from the second component 900b. In the closed configuration, the first and second components 900a, 900b may be brought together and aligned with each other to define an enclosed interior volume of the second connector 112.

[0197] This flip-top configuration can facilitate assembly of the lead 102 and tunneling the electrical conductor from the lumen of the lead body 104 into the lumen of the extension portion 106. For example, the second connector 112 can be moved to an open configuration so that the electrical conductor can be laid flat into the corresponding branch of the first component 900a (or the second component 900b) of the second connector 112. Then, the second connector 112 can be moved to a closed configuration by placing the second component 900b on the first component 900a so as to confine the electrical conductor within the corresponding branch of the second connector 112. This process can be faster and easier to perform than inserting the electrical conductor into the tubular portion of the second connector 112. The discrete components of the second connector 112 can be configured to be fixed to each other via mechanical fastening (e.g., with (one or more) mechanical fasteners, mechanical fit (such as friction fit or snap fit, etc.) and / or adhesive. In some embodiments, it can be advantageous to reduce or limit the number of joints between the discrete components, which can prevent or limit fluid from entering the second connector 112 and / or mechanical breakage of the second connector 112.

[0198] As previously described, one or more electrical conductors that connect conductive element 114 to electronic package 108 can be carried by lead 102. The electrical conductors can be positioned on, along, and / or within a lumen of one or more portions of lead 102 (e.g., extension portion 106, first arm 122, second arm 124, etc.). Fig. 10A As shown in , the electrical conductor 1000 can extend along a substantially straight path through the lumen of the extension portion 106. Additionally or alternatively, the electrical conductor 1000 can extend along a substantially straight path through the lumen of the lead body 104 (e.g., through the lumen of the first arm 122, the lumen of the second arm 124, etc.).

[0199] In some embodiments, it may be useful for the electrical conductor to extend along a tortuous path through the lumen of the extension portion 106. For example, Fig. 10B As shown in , the electrical conductors 1000 can be twisted together so that each individual electrical conductor 1000 extends through the lumen of the extension portion 106 along a helical path. Fig. 10C Another example configuration is shown in FIG. 1 , where the first set of electrical conductors 1000a are twisted together and the second set of electrical conductors 1000b are twisted together. The first and second sets of electrical conductors 1000a, 1000b may be positioned adjacent to each other within the lumen of the extension portion 106 (e.g., as shown in FIG. 1 ). Fig. 10C). Additionally or alternatively, the first set of electrical conductors 1000a can be wrapped around the second set of electrical conductors 1000b, thereby creating a nested coil configuration. In these and other examples, the tortuous spiral path followed by each electrical conductor provides strain relief, so that elongation of the electrical conductors produces less strain in the electrical conductors, thereby improving fatigue resistance of the electrical conductors.

[0200] Fig.11 An example neuromodulation device 1100 is illustrated in accordance with several embodiments of the present technology. Features of the device 1100 may be similar to Figure 2A-10C The features of the device 100 in FIG. 1 are substantially similar. Accordingly, similar numbers (eg, fixing element 1130 and fixing element 130) are used to identify Figure 2A-11 similar or identical components in Fig.11 Discussion of device 1100 will be largely limited to those features that differ from device 100. Furthermore, any features of device 1100 may be combined with features of device 100.

[0201] Similar to the device 100, Fig.11 The device 1100 shown in includes a first arm 1122 and a second arm 1124, each arm including a fixation element 1130 located distal to the conductive element 1114 of the arm and configured to engage fat surrounding the hypoglossal nerve. In addition, the device 1100 includes one or more fixation elements 1132 configured to fix at least a portion of the device 1100 to the patient's tissue. The fixation element 1132 may include a clip, a clamp, a staple, a tine, a hook, a barb, an anchor, or any other suitable element for fixing the device 1100 to the patient's tissue. In some embodiments, the fixation element 1132 includes a surgical clip. For example, as Fig.11 As shown in , one or more of the fixation elements 1132 may include a surgical clip having two extensions with a bend between the two extensions. The ends of the extensions may include barbs that are configured to penetrate the tissue and, once engaged, prevent it from separating from the tissue. In some embodiments, the extensions may have equal lengths so that their ends have approximately equal penetration depths, but in some embodiments, the extensions may have different lengths so that their ends have unequal penetration depths. Additionally, in some embodiments, the bend may include a curve, such as a "U" shaped or a "J" shaped curve.

[0202] According to various embodiments, fixation element 1132 is configured to simultaneously engage a portion of the device and tissue surrounding the device when device 100 is implanted. For example, the extension and bend of fixation element 1132 can define a space configured to receive a portion of device 1100 therein. Fig.11As shown in , the first connector 1110 can be configured to hold one or more first fixing elements 1132a. The first connector 1110 can include one or more openings, each of which is configured to receive an extension of one of the first fixing elements 1132a therein. Fig.11 , the second fixation element 1132b can be configured to be positioned around the second connector 1112. In some embodiments, the second connector 1112 includes one or more ridges and / or channels to facilitate maintaining the second fixation element 1132b in a desired position relative to the second connector 1112. In any case, the fixation element 1132 can be a distinct component from the lead 1102 and / or the electronic package 1108, such that the device 1100 can be positioned relative to the patient's tissue prior to securing the device 1100 to the tissue with the fixation element 1132.

[0203] The fixing elements 1132 can be configured to fix various parts of the device 1100 to different patient tissues. For example, the second fixing element 1132b can be configured to fix the second connector 1112 to the patient's genioglossus muscle. Additionally or alternatively, the first fixing element 1132a can be configured to fix the first connector 1110 to the patient's myloglossus muscle. In some embodiments, the second fixing element 1132b can be configured to prevent or limit the forward and / or backward movement of the device 1100 relative to the genioglossus muscle once implanted. Additionally or alternatively, the second fixing element 1132b can be configured to prevent or limit the medial and / or lateral movement of the device 1100 once implanted. The first fixing element 1132a can be configured to prevent or limit the forward, backward, medial and / or lateral movement of the device 1100 relative to the mylohyoid bone once implanted. In some embodiments, the device 1100 includes at least two first fixation elements 1132a to prevent or limit rotation of the electronic package 1108 relative to the mylohyoid bone, which would occur when only a single first fixation element 1132a is used. For example, the device 1100 can include at least one first fixation element 1132a on each of two opposing sides of the electronic component 1108 or adjacent to the side (e.g., on the inside and outside of the electronic package 1108 or the extension 1106) to help prevent or limit rotation of the electronic component 1108 around the axis of the extension 1106.

[0204] in conclusion

[0205] Although many embodiments are described above with respect to systems, devices, and methods for modulating a patient's hypoglossal nerve, the technology is also applicable to other applications and / or other methods, such as modulating other nerves in a patient. Moreover, other embodiments than those described herein are also within the scope of the technology. In addition, several other embodiments of the technology may have different configurations, components, or procedures than those described herein. Therefore, a person of ordinary skill in the art will accordingly understand that the technology may have other embodiments with additional elements, or the technology may have other embodiments without the above referenced components. Figure 1A-12H Other embodiments of several of the features shown and described.

[0206] The description of the embodiments of the technology is 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 plural or singular terms, respectively. Although specific embodiments and examples of the technology are described above for illustrative purposes, various equivalent modifications may be made within the scope of the technology as will be appreciated by those skilled in the relevant art. For example, although the steps are presented in a given order, alternative embodiments may perform the steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.

[0207] As used herein, the terms "substantially," "approximately," and similar terms are used as terms of approximation rather than terms of degree, and are intended to account for the inherent variations in measured or calculated values ​​that those of ordinary skill in the art would recognize.

[0208] Moreover, unless the term "or" is explicitly limited to refer to a single item in a list of two or more items that is independent of other items, the use of "or" in such a list should be interpreted as including (a) any single item in the list, (b) all items in the list, or (c) any combination of items in the list. In addition, the term "comprising" is always used to refer to including at least (one or more) of the stated features, so that any greater number of the same features and / or other features of additional types are not excluded. It should also be recognized that specific embodiments have been described herein for illustrative purposes, but various modifications may be made without departing from the technology. In addition, although the advantages associated with certain embodiments of the technology have been described in the context of these embodiments, other embodiments may also exhibit such advantages, and not all embodiments must exhibit such advantages to fall within the scope of the technology. Accordingly, the present disclosure and associated technology may cover other embodiments not explicitly shown or described herein.

Claims

1. An implantable neuromodulation lead, comprising: an extension portion having a distal portion and a proximal portion configured to couple to an electronic component; as well as a lead body extending distally from a distal end portion of the extension portion, wherein the lead body branches into a first arm and a second arm and includes a first electrode disposed on the first arm and a second electrode disposed on the second arm, The lead body is configured to be implanted in a patient's body at a location close to the hypoglossal nerve and to deliver electrical signals to the hypoglossal nerve via the first electrode and the second electrode.

2. The neuromodulation lead of claim 1, wherein the lead body is configured to be implanted such that the first arm and the second arm are aligned with and extend along the left hypoglossal nerve and the right hypoglossal nerve, respectively.

3. A neuromodulatory lead as described in claim 1 or claim 2, wherein the first arm includes a proximal region and a distal region, wherein the proximal region extends laterally away from the distal portion of the extension portion and the distal region extends distally away from the proximal region, and wherein the first electrode is carried by the distal region.

4. A neuromodulation lead as described in claim 3, wherein the distal region of the first arm extends distally away from the proximal region along the longitudinal dimension.

5. A neuromodulation lead as described in claim 3 or 4, wherein the proximal region of the first arm is vertically angled away from the extension portion so that the distal region is positioned in a different plane than the extension portion.

6. A neuromodulatory lead as described in any of claims 1-5, wherein the second arm includes a proximal region and a distal region, wherein the proximal region extends laterally away from the distal portion of the extension portion and the distal region extends distally away from the proximal region, and wherein the second electrode is carried by the distal region.

7. A neuromodulation lead as described in claim 6, wherein the distal region of the second arm extends distally away from the proximal region along the longitudinal dimension.

8. A neuromodulation lead as described in claim 6 or 7, wherein the proximal region of the second arm is vertically angled away from the extension portion so that the distal region is positioned in a different plane than the extension portion.

9. The neuromodulation lead of any one of claims 6-8, wherein the proximal regions of the first arm and the second arm extend laterally away from the distal portion of the extension portion in opposite directions.

10. The neuromodulation lead of any one of claims 1-9, further comprising a connector between the extension portion and the first arm and the second arm, wherein the connector is coupled to a distal portion of the extension portion, a proximal region of the first arm, and a proximal region of the second arm.

11. The neural modulation lead of any one of claims 1-10, wherein the electrical signal is configured to treat sleep apnea.

12. An implantable neuromodulation lead, comprising: an extension portion having a distal portion and a proximal portion configured to couple to an electronic component; as well as A lead body extending distally from a distal end portion of an extension portion, wherein the lead body branches into a left arm and a right arm and includes a left electrode deployed on the left arm and a right electrode deployed on the right arm, and wherein at least one of the left arm or the right arm is bent relative to the extension portion so that at least one of the left arm or the right arm is positioned at a different height from the extension portion.

13. The neuromodulation lead of claim 12, wherein the lead body is configured to deliver electrical stimulation energy to a hypoglossal nerve of a patient to treat sleep-disordered breathing.

14. The neuromodulation lead of claim 12 or 13, wherein the right arm is configured to be positioned proximate to the patient's right hypoglossal nerve and the left arm is configured to be positioned proximate to the patient's left hypoglossal nerve.

15. The neuromodulation lead of any one of claims 12 to 14, wherein: When the lead is implanted, at least one of the left arm or the right arm extends upward from a proximal portion located at the extension portion and proximal to the patient's genioglossus muscle to a distal portion positioned proximal to the patient's genioglossus muscle.

16. The neuromodulation lead of any one of claims 12-15, wherein: When the lead is implanted, the proximal portion of the extension is positioned below the patient's mylohyoid muscle and the distal portion of the extension is positioned above the patient's mylohyoid muscle.

17. The neuromodulation lead of any one of claims 12 to 16, wherein: When the lead is implanted, the extension portion is at least partially positioned between the patient's right and left geniohyoid muscles.

18. An implantable neuromodulation lead, comprising: an extension portion having a distal portion and a proximal portion configured to couple to an electronic component; as well as a lead body extending distally from a distal end portion of the extension portion, wherein the lead body branches into a left arm and a right arm and includes a left electrode disposed on the left arm and a right electrode disposed on the right arm, The lead body is constructed to be at least partially implanted in a sublingual region of a patient and is configured to deliver electrical stimulation energy to the sublingual region to treat sleep apnea.

19. The neuromodulation lead of claim 18, wherein the lead body is configured to deliver electrical stimulation energy to the sublingual region to increase activity of the patient's tongue protrusion muscles.

20. The neuromodulation lead of claim 18 or 19, wherein the lead body is configured to be implanted such that the left arm and the right arm are at least partially positioned between the patient's genioglossus muscle and the patient's geniohyoid muscle.

21. The neuromodulation lead of any one of claims 18-20, wherein: When the lead is implanted, each of the left arm and the right arm extends upward from a proximal portion located at the extension portion and proximal to the patient's genioglossus muscle to a distal portion proximal to the patient's genioglossus muscle.

22. The neuromodulation lead of any of claims 18-21, wherein the right arm is configured to be positioned proximate to a right hypoglossal nerve of the patient and the left arm is configured to be positioned proximate to a left hypoglossal nerve of the patient.

23. The neuromodulation lead of any of claims 18-22, wherein the lead body is configured to deliver electrical stimulation energy to a hypoglossal nerve of a patient to treat sleep apnea.

24. The neuromodulation lead of any one of claims 18-23, wherein: When the lead is implanted, the proximal portion of the extension is positioned below the patient's mylohyoid muscle and the distal portion of the extension is positioned above the patient's mylohyoid muscle.

25. The neuromodulation lead of any one of claims 18-24, wherein: When the lead is implanted, the extension portion is at least partially positioned between the patient's right and left geniohyoid muscles.

26. An implantable neuromodulation lead, comprising: a lead body comprising left and right arms coupled at proximal ends of the left and right arms, wherein the left and right arms extend laterally away from each other, and wherein the lead body comprises a left electrode disposed on the left arm and a right electrode disposed on the right arm, The lead body is configured to be implanted in a patient's body near the hypoglossal nerve to deliver electrical signals to the hypoglossal nerve via the left electrode and the right electrode.

27. A neural stimulation lead for implantation at a treatment site in a patient's body, the neural stimulation lead comprising: Conductor body; a plurality of electrodes carried by the lead body; as well as a plurality of fixation members extending radially away from the lead body, wherein the fixation members are configured to anchor the lead body to tissue at the treatment site, The neurostimulation lead is configured to be implanted at a treatment site in a patient's body to deliver energy to the treatment site via electrodes.

28. The neuromodulation lead of claim 27, wherein the lead body comprises a polymer sidewall and the fixation member is cut from the polymer sidewall.

29. The neuromodulation lead of claim 28, wherein the fixation member comprises a first end located at the side wall and a second end radially spaced apart from the side wall.

30. The neuromodulation lead of any of claims 27-29, wherein the fixation member extends no more than 0.5 mm away from the lead body.

31. The neuromodulation lead of any one of claims 28-30, wherein the fixation member is cantilevered from the side wall.

32. The nerve modulation lead of any of claims 28-31, wherein the polymer sidewall comprises thermoplastic polyurethane.

33. The neuromodulation lead of any of claims 27-32, wherein at least some of the fixation members are spaced apart along the length of the lead body.

34. The neuromodulation lead of any of claims 27-33, wherein at least some of the fixation members are spaced apart around the circumference of the lead body.

35. The neural modulation lead of any of claims 27-34, wherein the lead is configured to deliver stimulation energy at a treatment site to treat sleep apnea.

36. The neuromodulation lead of any of Claims 27-35, wherein the lead body is configured to be positioned proximate to a hypoglossal nerve of the patient.

37. The neuromodulation lead of any of Claims 27-36, wherein the lead body is configured to deliver stimulation energy to a hypoglossal nerve of a patient.

38. The neuromodulation lead of any of claims 27-37, wherein the lead body is configured to detect activity of the patient's tongue muscles and / or suprahyoid muscles.

39. A neuromodulation lead, comprising: a lead body, the lead body comprising a plurality of electrodes; as well as an extension portion having a proximal end configured to couple to the electronic component and a distal end configured to couple to the lead body, the distal end being opposite the proximal end along a length of the extension portion, wherein the length of the extension portion is adjustable to change the distance between the lead body and the electronic component, The lead is configured to be implanted at a treatment site in a patient's body to deliver energy to the treatment site via the electrodes.

40. The neuromodulation lead of claim 39, wherein the extension portion is configured to bend along its longitudinal axis to change the distance between the lead body and the electronic component.

41. The neuromodulation lead of claim 39 or 40, wherein the extension portion comprises a helically wound portion.

42. The neuromodulation lead of any of claims 39-41, wherein the extension portion comprises a wavy portion.

43. The neural modulation lead of any of claims 39-42, wherein the neural stimulation lead is configured to deliver stimulation energy at a treatment site to treat sleep apnea.

44. The neuromodulation lead of any of Claims 39-43, wherein the lead body is configured to be positioned proximate to a hypoglossal nerve of the patient.

45. The neuromodulation lead of any of claims 39-44, wherein the lead body is configured to deliver stimulation energy to a hypoglossal nerve of the patient via the electrode.

46. ​​The neuromodulation lead of any of claims 39-45, wherein the lead body is configured to detect activity of a muscle of the patient.

47. An implantable antenna comprising: a substrate, the substrate comprising a substrate material; as well as a coil disposed on a substrate and comprising a plurality of coil turns, the coil turns comprising a first coil turn and a second coil turn adjacent to the first coil turn; Wherein the substrate includes at least one open area wherein a first coil turn is not coupled to a second coil turn by substrate material.

48. The antenna of claim 47, wherein the substrate includes at least one post region, wherein the first coil turn is coupled to the second coil turn by the substrate material.

49. An antenna as claimed in claim 47 or 48, wherein the at least one open area comprises an arcuate cut-out extending along a portion of the circumference of the first coil turn.

50. The antenna of any one of claims 47-49, wherein the at least one open area comprises a plurality of arcuate open areas, each arcuate open area extending along a respective portion of the circumference of the first coil turn.

51. The antenna of any of claims 47-50, wherein at least one of the partial circumferences is at least about 50% of the circumference of the first coil turn.

52. The antenna of any of claims 47-51, wherein at least one of the partial circumferences is approximately 50% or less of the circumference of the first coil turn.

53. An antenna as claimed in any one of claims 47 to 52, wherein two or more adjacent coil turns are connected to each other by a substrate material.

54. A neuromodulation lead comprising an implantable antenna as claimed in any one of claims 47-53.

55. A method for treating sleep apnea, comprising: Implanting the neuromodulator lead as described in any one of claims 1 to 54 at a treatment site in a patient's body; as well as Stimulation energy is delivered to the treatment site via electrodes of the neuromodulation lead.

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