Neuromodulation devices and related systems and methods

Abstract

Neuromodulation devices, related systems, and methods are disclosed herein. Various embodiments of the present invention relate to devices, systems, and methods for delivering electrical energy to a patient's hypoglossal nerve. According to some embodiments, the present technology includes an implantable neuromodulation device comprising an electronics package, a bifurcated lead body, and an extension between the electronics package and the lead body. The lead body can comprise a first arm having a first conductive element and a second arm having a second conductive element. The lead body can be configured to position the lead body between the patient's genioglossus and geniohyoid muscles, such that the first arm and the first conductive element are positioned proximate one side of the patient's hypoglossal nerve and the second arm and the second conductive element are positioned proximate the other side of the patient's hypoglossal nerve.

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application claims priority to U.S. Patent Application No. 63 / 377,969, filed September 30, 2022, and U.S. Patent Application No. 63 / 502,610, filed May 16, 2023, the contents of each of which are incorporated herein by reference in their entirety.

[0002] This application is related to the following applications, each of which is incorporated by reference in its entirety: U.S. Patent Application No. 16 / 865,541, filed May 4, 2020, entitled "IMPLANTABLE STIMULATION POWER RECEIVER, SYSTEMS, AND METHODS," U.S. Patent Application No. 16 / 866,488, filed May 4, 2020, entitled "SYSTEMS AND METHODS TO IMPROVE SLEEP DISORDERED BREATHING USING CLOSED-LOOP FEEDBACK," U.S. Patent Application No. 16 / 866,523, filed May 4, 2020, entitled "SYSTEMS AND METHODS FOR IMPROVING SLEEP DISORDERED BREATHING USING CLOSED-LOOP FEEDBACK," and U.S. Patent Application No. 16 / 866,523, filed May 4, 2020, entitled "SYSTEMS AND METHODS FOR IMPROVING SLEEP DISORDERED BREATHING." No. 16 / 865,668, filed May 4, 2020, entitled "BIASED NEUROMODULATION LEAD AND METHOD OF USING SAME," which are incorporated herein by reference in their entireties.

[0003] TECHNICAL FIELD The present technology relates to neuromodulation devices and related systems and methods.Various embodiments of the present technology relate to neuromodulation devices, systems, and methods for treating sleep-disordered breathing. [Background technology]

[0004] Sleep-disordered breathing (SDB), including upper airway sleep-disordered breathing (UASD), shortens sleep duration and reduces sleep quality, leading to symptoms such as daytime sleepiness, fatigue, and impaired concentration. Obstructive sleep apnea (OSA) is the most common type of sleep-disordered breathing, affecting one in five adults in the United States. One in 15 adults has moderate to severe obstructive sleep apnea and requires treatment. Untreated obstructive sleep apnea can lead to a decreased quality of life and an increased risk of diseases such as high blood pressure, stroke, and heart disease.

[0005] Obstructive sleep apnea is characterized by a complete airway obstruction, resulting in either a complete cessation of breathing (apnea) or a partial cessation of breathing (hypopnea). During sleep, the tongue muscles relax. In this relaxed state, the tongue muscles may not maintain sufficient tone, preventing the tongue from maintaining its normal tone and position. Collapse of the soft tissues of the base of the tongue and / or upper airway can cause the upper airway to obstruct, resulting in an apneic episode. Upper airway obstruction impedes airflow to the lungs, reducing the oxygen concentration in the patient's blood. This causes blood pressure to rise and the heart to relax. This state is maintained until the upper airway is reflexively and forcibly opened, restoring normal airway patency. Normal breathing then resumes until the next apneic episode. This reflexive and forcible opening of the upper airway briefly arouses the patient from sleep.

[0006] Current treatment options range from medications and noninvasive approaches to more invasive surgical procedures. In many of these cases, patient acceptance and adherence to treatment are far below desirable levels, making current solutions ineffective as long-term solutions. For example, continuous positive airway pressure (CPAP) is the standard treatment for obstructive sleep apnea. While noninvasive and highly effective, CPAP is not tolerated by all patients and has several side effects. Patient adherence and / or tolerance to CPAP is typically reported to be between 40% and 60%. Surgical treatments for obstructive sleep apnea include anterior tongue muscle positioning, maxillary and mandibular advancement, uvulopalatopharyngoplasty, and tracheotomy. However, these procedures tend to be highly invasive, irreversible, and provide insufficient or inconsistent results. Even more effective surgical procedures are generally undesirable because they require multiple invasive and irreversible procedures, can disfigure the patient (e.g., maxillary and mandibular advancement), may be associated with social stigma (e.g., tracheotomy), and are associated with high morbidity. Summary of the Invention

[0007] The present technology will be described based on various aspects described below, for example, with reference to Figures 1A-12H. Examples of various aspects of the present technology are described as numbered items (1, 2, 3, etc.) for convenience, but these are provided as examples and are not intended to limit the present technology. The components in the figures are not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the present disclosure. 1. An implantable neuromodulation lead, comprising: an extension having a proximal end configured to connect to an electronic component and a distal end; a lead body extending distally from the distal end of the extension, the lead body bifurcating into a first arm and a second arm, the lead body including a first electrode disposed on the first arm and a second electrode disposed on the second arm; The implantable neuromodulation lead, wherein the lead body is configured to be implanted in a patient near a hypoglossal nerve and to transmit an electrical signal to the hypoglossal nerve via the first electrode and the second electrode. 2. The implantable neuromodulation lead described in paragraph 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. An implantable neuromodulation lead as described in any one of the preceding paragraphs, wherein the first arm includes a proximal region and a distal region, the proximal region extending laterally from the distal end of the extension portion, the distal region extending distally from the proximal region, and the first electrode being carried by the distal region. 4. An implantable neuromodulation lead as described in any one of the preceding paragraphs, wherein the distal region of the first arm extends distally from the proximal region along the longitudinal dimension. 5. An implantable neuromodulation lead as described in any one of the preceding paragraphs, wherein the proximal region of the first arm is inclined vertically away from the extension so that the distal region is located in a different plane from the extension. 6. An implantable neuromodulation lead as described in any one of the preceding paragraphs, wherein the second arm includes a proximal region and a distal region, the proximal region extending laterally from the distal end of the extension portion, the distal region extending distally from the proximal region, and the second electrode being carried by the distal region. 7. An implantable neuromodulation lead as described in any one of the preceding paragraphs, wherein the distal region of the second arm extends distally from the proximal region along a longitudinal dimension. 8. An implantable neuromodulation lead as described in any one of the preceding paragraphs, wherein the proximal region of the second arm is inclined vertically away from the extension so that the distal region is located in a different plane from the extension. 9. An implantable neuromodulation lead as described in any one of the preceding paragraphs, wherein the proximal regions of the first arm and the second arm extend in opposite directions laterally away from the distal end of the extension portion. 10. An implantable neuromodulation lead as described in any one of the preceding paragraphs, further comprising a connector between the extension and the first and second arms, the connector being coupled to the distal end of the extension, the proximal region of the first arm, and the proximal region of the second arm. 11. The implantable neuromodulation lead of any one of the preceding claims, wherein the electrical signal is configured to treat sleep apnea. 12. An implantable neuromodulation lead, comprising: an extension having a proximal end configured to connect to an electronic component and a distal end; a lead body extending distally from the distal end of the extension, the lead body branching into left and right arms and including a left electrode disposed on the left arm and a right electrode disposed on the right arm, wherein at least one of the left arm or the right arm is bent relative to the extension so that the at least one of the left arm or the right arm is disposed at a different height position from the extension. 13. An implantable neuromodulation lead described in any one of the preceding paragraphs, wherein the lead body is configured to deliver electrical stimulation energy to the patient's hypoglossal nerve to treat sleep-disordered breathing. 14. An implantable neuromodulation lead described in any one of the preceding paragraphs, wherein the right arm is configured to be placed near the patient's right hypoglossal nerve and the left arm is configured to be placed near the patient's left hypoglossal nerve. 15. An implantable neuromodulation lead as described in any one of the preceding paragraphs, wherein when the lead is implanted, at least one of the left arm or the right arm extends upward from a proximal end located in the extension and adjacent the patient's geniohyoid muscle to a distal end adjacent the patient's genioglossus muscle. 16. An implantable neuromodulation lead described in any one of the preceding paragraphs, wherein when the lead is implanted, the proximal end of the extension is positioned below the patient's mylohyoid muscle and the distal end of the extension is positioned above the patient's geniohyoid muscle. 17. An implantable neuromodulation lead described in any one of the preceding paragraphs, wherein when the lead is implanted, the extension portion is positioned so as to be at least partially located between the patient's right and left geniohyoid muscles. 18. An implantable neuromodulation lead, comprising: an extension having a proximal end configured to connect to an electronic component and a distal end; a lead body extending distally from the distal end of the extension, the lead body bifurcating into left and right arms and including a first electrode disposed on the left arm and a second electrode disposed on the right arm; An implantable neuromodulation lead, wherein the lead body is configured to be at least partially implanted in a sublingual region of a patient and configured to deliver electrical stimulation energy to the sublingual region to treat sleep apnea. 19. An implantable neuromodulation lead described in any one of the preceding paragraphs, wherein the lead body is configured to deliver electrical stimulation energy to the sublingual region and increase activity of the patient's tongue protrusor muscles. 20. An implantable neuromodulation lead described in any one of the preceding paragraphs, wherein the lead body is configured to be implanted so that the left arm and the right arm are positioned at least partially between the patient's genioglossus and geniohyoid muscles. 21. An implantable neuromodulation lead described in any one of the preceding paragraphs, wherein when the lead is implanted, each of the left arm and the right arm extends upward from a proximal end located on the extension and adjacent the patient's geniohyoid muscle to a distal end also adjacent the patient's genioglossus muscle. 22. An implantable neuromodulation lead described in any one of the preceding paragraphs, wherein the right arm is configured to be placed near the patient's right hypoglossal nerve and the left arm is configured to be placed near the patient's left hypoglossal nerve. 23. An implantable neuromodulation lead as described in any one of the preceding paragraphs, wherein the lead body is configured to deliver electrical stimulation energy to the patient's hypoglossal nerve to treat sleep apnea. 24. An implantable neuromodulation lead described in any one of the preceding paragraphs, wherein when the lead is implanted, the proximal end of the extension is positioned below the patient's mylohyoid muscle and the distal end of the extension is positioned above the patient's geniohyoid muscle. 25. An implantable neuromodulation lead as described in any one of the preceding paragraphs, wherein when the lead is implanted, the extension portion is located at least partially between the patient's right and left geniohyoid muscles. 26. An implantable neuromodulation lead, comprising: a lead body having left and right arms connected at their proximal ends, the left and right arms extending laterally apart from one another, and including 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 near a hypoglossal nerve and to transmit electrical signals to the hypoglossal nerve via the left electrode and the right electrode. 27. A neurostimulation lead for implantation at a treatment site within a patient, the neurostimulation lead comprising: A lead body; a plurality of electrodes carried by the lead body; a plurality of fixation members extending radially from the lead body, the fixation members configured to secure the lead body to tissue at the treatment site; The neural stimulation lead is configured to be implanted at the treatment site within a patient's body and to deliver energy to the treatment site via the electrodes. 28. A neuromodulation lead as described in any one of the preceding paragraphs, wherein the lead body has a polymer sidewall and the fixation member is cut out from the polymer sidewall. 29. A neuromodulation lead as described in any one of the preceding paragraphs, wherein the fixation member has a first end located on the side wall and a second end radially spaced from the side wall. 30. A neuromodulation lead as described in any one of the preceding paragraphs, wherein the fixation member extends from the lead body a distance not exceeding 0.5 mm. 31. The neuromodulation lead of any one of the preceding claims, wherein the fixation member extends in a cantilevered manner from the side wall. 32. The neuromodulation lead of any one of the preceding claims, wherein the polymer sidewall comprises thermoplastic polyurethane. 33. The neuromodulation lead of any one of the preceding claims, wherein at least some of the fixation members are spaced apart along the length of the lead body. 34. The neuromodulation lead of any one of the preceding claims, wherein at least some of the fixation members are spaced apart around the circumference of the lead body. 35. The neuromodulation lead of any one of the preceding claims, wherein the lead is configured to deliver stimulation energy to the treatment site to treat sleep apnea. 36. The neuromodulation lead of any one of the preceding claims, wherein the lead body is configured for placement near the patient's hypoglossal nerve. 37. The neuromodulation lead of any one of the preceding claims, wherein the lead body is configured to deliver stimulation energy to the patient's hypoglossal nerve. 38. A neuromodulation lead according to any one of the preceding claims, wherein the lead body is configured to detect activity of the patient's tongue and / or suprahyoid muscles. 39. A neuromodulation lead comprising: a lead body having a plurality of electrodes; an extension having a proximal end configured to connect to an electronic component and a distal end configured to connect to the lead body, the distal end being located opposite the proximal end along a length of the extension, the length of the extension being adjustable to vary the distance between the lead body and the electronic component; The neuromodulation lead is configured to be implanted at a treatment site within a patient's body and to deliver energy to the treatment site via the electrodes. 40. An implantable neuromodulation lead described in any one of the preceding paragraphs, wherein the extension is configured to bend along its longitudinal axis to vary the distance between the lead body and the electronic component. 41. The neuromodulation lead of any one of the preceding claims, wherein the extension comprises a spirally wound portion. 42. The neuromodulation lead of any one of the preceding claims, wherein the extension comprises an undulating portion. 43. The neuromodulation lead of any one of the preceding paragraphs, wherein the neurostimulation lead is configured to deliver stimulation energy to the treatment site to treat sleep apnea. 44. The neuromodulation lead of any one of the preceding claims, wherein the lead body is configured for placement near the patient's hypoglossal nerve. 45. The neuromodulation lead of any one of the preceding claims, wherein the lead body is configured to deliver stimulation energy to the patient's hypoglossal nerve via the electrode. 46. ​​The neuromodulation lead of any one of the preceding claims, wherein the lead body is configured to detect muscle activity of a patient. 47. An implantable antenna, a substrate comprising a substrate material; a coil disposed on the substrate, the coil comprising a plurality of coil windings including a first coil winding and a second coil winding adjacent to the first coil winding; An implantable antenna, wherein the substrate comprises at least one open area where the first coil winding and the second coil winding are not connected by the substrate material. 48. An implantable antenna as described in any one of the preceding paragraphs, wherein the substrate comprises at least one strut region in which the first coil winding and the second coil winding are connected by the substrate material. 49. An implantable antenna as described in any one of the preceding claims, wherein the at least one open area includes an arcuate notch extending along a partial circumference of the first coil winding. 50. An implantable antenna as described in any one of the preceding claims, wherein the at least one open area includes a plurality of arc-shaped open areas, each of which extends along a partial circumference of the first coil winding. 51. An implantable antenna as described in any one of the preceding paragraphs, wherein at least one of the partial perimeter lengths is greater than or equal to about 50% of the circumference of the first coil winding. 52. An implantable antenna as described in any one of the preceding claims, wherein at least one of the partial perimeter lengths is less than or equal to about 50% of the circumference of the first coil winding. 53. An implantable antenna according to any one of the preceding paragraphs, wherein two or more adjacent coil windings are connected to each other by the substrate material. 54. A neuromodulation lead comprising an implantable antenna according to any one of the preceding paragraphs. 55. A method for treating sleep-disordered breathing, comprising: implanting a neuromodulation lead according to any one of the preceding paragraphs at a treatment site within a patient's body; and delivering stimulation energy to the treatment site via the electrode of the neuromodulation lead.

[0008] Many aspects of the present disclosure can be better understood with reference to the following drawings, in which the components are not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the present disclosure. [Brief explanation of the drawings]

[0009] [Figure 1A] FIG. 1 is a fragmentary midline sagittal cross-sectional view of the upper airway of a human patient. [Figure 1B] FIG. 1 illustrates the musculature of the human tongue and the innervation of the hypoglossal nerve. [Figure 1C] 1 is a schematic top view showing the distal branches of the right and left hypoglossal nerves in a human patient, which are shown extending anteriorly from the bottom of the drawing to the top of the drawing (e.g., from the hyoid bone to the anterior mandible). [Figure 2A] FIG. 1 is a schematic diagram of a neuromodulation system configured in accordance with embodiments of the present technology. [Figure 2B] FIG. 1 is a perspective view of a neuromodulation device configured in accordance with some embodiments of the present technology. [Figure 2C] FIG. 2C is a top view of the neuromodulation device of FIG. 2B. [Figure 2D] FIG. 2C is a side view of the neuromodulation device of FIG. 2B. [Figure 3A] FIG. 2C illustrates the neuromodulation device shown in FIGS. 2B-2D implanted in a human patient, in accordance with some embodiments of the present technology. [Figure 3B] FIG. 2C illustrates the neuromodulation device shown in FIGS. 2B-2D implanted in a human patient, in accordance with some embodiments of the present technology. [Figure 3C] FIG. 2C illustrates the neuromodulation device shown in FIGS. 2B-2D implanted in a human patient, in accordance with some embodiments of the present technology. [Figure 3D] FIG. 2C illustrates the neuromodulation device shown in FIGS. 2B-2D implanted in a human patient, in accordance with some embodiments of the present technology. [Figure 3E] FIG. 2C illustrates the neuromodulation device shown in FIGS. 2B-2D implanted in a human patient, in accordance with some embodiments of the present technology. [Figure 3F] FIG. 2C illustrates the neuromodulation device shown in FIGS. 2B-2D implanted in a human patient, in accordance with some embodiments of the present technology. [Figure 4A] FIG. 2B is a perspective view of a lead of the neuromodulation device shown in FIGS. 2B-2D. [Figure 4B] FIG. 2B is a side view of a lead of the neuromodulation device shown in FIGS. 2B-2D. [Figure 4C] FIG. 2C is an end view of the lead of the neuromodulation device shown in FIGS. 2B-2D. [Figure 5] FIG. 2C is a side view of the distal end of an arm of a lead of the neuromodulation device shown in FIGS. 2B-2D. [Figure 6A] FIG. 1 is a perspective view of a first connector of a neuromodulation device configured in accordance with some embodiments of the present technology. [Figure 6B]FIG. 10 is a top view of a first connector of a neuromodulation device configured in accordance with some embodiments of the present technology. [Figure 6C] FIG. 10 is an end view of a first connector of a neuromodulation device configured in accordance with some embodiments of the present technology. [Figure 6D] FIG. 10 is a side view of a first connector of a neuromodulation device configured in accordance with some embodiments of the present technology. [Figure 7A] 10A-10C illustrate one configuration of a lead extension of a neuromodulation device configured in accordance with some embodiments of the present technology. [Figure 7B] 10A-10C illustrate one configuration of a lead extension of a neuromodulation device configured in accordance with some embodiments of the present technology. [Figure 7C] 10A-10C illustrate one configuration of a lead extension of a neuromodulation device configured in accordance with some embodiments of the present technology. [Figure 8] FIG. 1 illustrates a second connector of a neuromodulation device configured in accordance with some embodiments of the present technology. [Figure 9] FIG. 10 illustrates an open configuration of a second connector of a neuromodulation device configured in accordance with some embodiments of the present technology. [Figure 10A] 10A-10C illustrate one configuration of electrical conductors within a lead extension of a neuromodulation device configured in accordance with some embodiments of the present technology. [Figure 10B] 10A-10C illustrate one configuration of electrical conductors within a lead extension of a neuromodulation device configured in accordance with some embodiments of the present technology. [Figure 10C] 10A-10C illustrate one configuration of electrical conductors within a lead extension of a neuromodulation device configured in accordance with some embodiments of the present technology. [Figure 11] FIG. 1 illustrates a neuromodulation device configured in accordance with some embodiments of the present technology. [Figure 12A] FIG. 1 illustrates one configuration of antennas in a neuromodulation device configured in accordance with some embodiments of the present technology. [Figure 12B]FIG. 1 illustrates one configuration of antennas in a neuromodulation device configured in accordance with some embodiments of the present technology. [Figure 12C] FIG. 1 illustrates one configuration of antennas in a neuromodulation device configured in accordance with some embodiments of the present technology. [Figure 12D] FIG. 1 illustrates one configuration of antennas in a neuromodulation device configured in accordance with some embodiments of the present technology. [Figure 12E] FIG. 1 illustrates one configuration of antennas in a neuromodulation device configured in accordance with some embodiments of the present technology. [Figure 12F] FIG. 1 illustrates one configuration of antennas in a neuromodulation device configured in accordance with some embodiments of the present technology. [Figure 12G] FIG. 1 illustrates one configuration of antennas in a neuromodulation device configured in accordance with some embodiments of the present technology. [Figure 12H] FIG. 1 illustrates one configuration of antennas in a neuromodulation device configured in accordance with some embodiments of the present technology. DETAILED DESCRIPTION OF THE INVENTION

[0010] The present disclosure relates to neuromodulation systems that can be used to deliver a variety of electrical therapies, including neuromodulation therapies such as nerve stimulation and muscle stimulation. The stimulation can induce excitatory or inhibitory neural or muscle activity. Such therapies can be used at various appropriate locations within a patient's anatomy. According to some embodiments, the neuromodulation system of the present technology is configured to treat sleep-disordered breathing (SDB), including obstructive sleep apnea (OSA) and / or mixed sleep apnea, through neuromodulation of the hypoglossal nerve (HGN).

[0011] To contextualize the structure and operation of the neuromodulation systems and devices disclosed herein, the following first describes relevant anatomy and physiology. The headings provided herein are for convenience only and do not interpret the scope or meaning of the claims. Embodiments presented under any heading can be used in combination with embodiments presented under other headings. For example, the neuromodulation systems and devices described in Section II can incorporate any of the neuromodulation devices described in Section III.

[0012] I. Anatomy and Physiology As previously mentioned, breathing in patients with sleep-disordered breathing is impaired by upper airway obstruction, narrowing, and / or collapse during sleep. As shown in Figure 1A, the upper airway comprises the nasal cavity, oral cavity, pharynx, and larynx. Upper airway patency and airflow resistance are controlled by a complex network of muscles through voluntary and involuntary neuromuscular control. For example, the muscles of the tongue, the suprahyoid muscles (e.g., geniohyoid, mylohyoid, styloglossus, hyoglossus, and anterior belly of the digastric muscle), and the muscles of the soft palate (e.g., palatal muscles) open, widen, and / or stabilize the upper airway during inspiration, thereby countering the negative pressure that draws air into the airways and lungs.

[0013] Referring to FIG. 1B, the tongue is composed of both intrinsic and extrinsic muscles. Generally, activation of the intrinsic muscles changes the shape of the tongue, while activation of the extrinsic muscles tends to shift the position of the entire tongue. The extrinsic muscles originate at bony attachments and insert within the tongue. These muscles consist of the genioglossus, styloglossus, hyoglossus, and palatoglossus. The intrinsic muscles originate within the tongue and insert within the tongue. They consist of the superior longitudinal, inferior longitudinal, transverse, and vertical muscles. In awake patients, the brain sends nerve impulses to these muscles via the hypoglossal nerve to maintain the shape and position of the tongue and prevent it from obstructing the airway.

[0014] Tongue muscles are also functionally classified as retractors and protractors, and both intrinsic and extrinsic muscles fall into these categories. Retractors include the intrinsic superior longitudinal and inferior longitudinal muscles, and the extrinsic hyoglossus and styloglossus muscles. Protractors include the intrinsic vertical and transverse muscles, and the extrinsic genioglossus muscle. Contraction of the styloglossus elevates the tongue, while contraction of the hyoglossus and genioglossus muscles depresses it. Figure 1B also shows the geniohyoid muscle, a suprahyoid muscle (not a tongue muscle). This muscle is an important protractor and pharyngeal dilator, responsible for maintaining a patent upper airway. Effective treatment of obstructive sleep apnea is believed to require stimulation of the protractors with little or no activation of the retractors. Therefore, for effective neuromodulation therapy, it may be beneficial to localize stimulation to the protractors while avoiding activation of the retractors.

[0015] The genioglossus, the largest of the tongue muscles, is morphologically and functionally divided into two compartments based on fiber distribution, action, and innervation. The first compartment is the oblique genioglossus (GGo), whose vertical fibers contract to depress the tongue without significantly affecting pharyngeal patency. The second compartment is the horizontal genioglossus (GGh), whose vertical fibers contract to protrude the posterior portion of the tongue and widen the pharyngeal opening. The GGo contains type II muscle fibers that fatigue quickly, while the GGh contains type I muscle fibers that fatigue slowly. Therefore, to effectively protrude the tongue while preventing or limiting tongue fatigue, it is advantageous to stimulate the GGh with little or no stimulation of the GGo.

[0016] The suprahyoid muscles, including the mylohyoid, geniohyoid, stylohyoid, and digastric muscles (only some of which are shown in Figure 1B), extend between the mandible and hyoid bone, forming the floor of the mouth. The geniohyoid muscle is located below the genioglossus muscle, which is located below the geniohyoid muscle. Contraction of the geniohyoid muscle and tension of the sternohyoid muscle (infrahyoid muscle, not shown) work together to pull the hyoid bone forward, opening and / or expanding the pharyngeal cavity and stabilizing the anterior wall of the hypopharynx. In contrast to the genioglossus and geniohyoid muscles, which function to protrude the tongue forward, the hyoglossus and styloglossus muscles function to retract the tongue posteriorly. Activation of the hyoglossus and styloglossus muscles tends to retract the tongue posteriorly, thereby reducing the size of the pharyngeal opening, increasing airway resistance, and impeding breathing.

[0017] As mentioned above, all extrinsic and intrinsic muscles of the tongue are innervated by the hypoglossal nerve, 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 through the hypoglossal canal, and passes inferiorly through the retrostyloid space (part of the lateral pharyngeal space) to the occipital artery. The hypoglossal nerve then curves anteriorly to the tongue muscles, passing between the anterior border of the hyoglossus muscle and the posterior border of the mylohyoid muscle to enter the hypoglossal region, where it branches into distal dendrites.

[0018] Figure 1C is a schematic superior view of the distal branches of the right and left hypoglossal nerves. Referring to Figures 1B and 1C together, the hypoglossal nerve is composed of (1) distal branches that innervate the styloglossus and hyoglossus muscles (tongue retractors) and (2) distal branches that innervate the intrinsic muscles of the tongue, the genioglossus, and the geniohyoid (tongue protractors). Furthermore, the distal branches that innervate the tongue retractors tend to be located posterior to the distal branches that innervate the tongue protractors.

[0019] Decreased activity of the muscles responsible for maintaining the airway can increase airway resistance, potentially affecting a patient's respiratory function and general health. For example, decreased activity of the genioglossus muscle during sleep, alone or in combination with other factors (e.g., airway length, airway diameter, soft tissue volume, and premature arousal), can significantly increase airway resistance or even obstruct the airway, potentially leading to sleep-related breathing disorders such as obstructive sleep apnea. For neuromodulation therapy to be effective, it may be beneficial to limit stimulation of the hypoglossal nerve primarily to the distal branch that innervates the protrusive muscles, while avoiding or limiting stimulation of the distal branch that activates the retractor muscles.

[0020] II. Neuromodulation Systems Various embodiments of the present technology relate to devices, systems, and methods for modulating the neural activity and / or control of one or more nerves associated with one or more muscles involved in airway maintenance. Such neuromodulation can increase the activity of targeted muscles, such as the genioglossus and geniohyoid muscles, reducing airway resistance and improving breathing in patients. Furthermore, targeted modulation of specific portions of the distal branch of the hypoglossal nerve can increase the activity of the tongue protractor muscles without substantially increasing the activity of the tongue retractor muscles, resulting in highly effective treatment. Additionally or alternatively, selective modulation of specific portions of the distal branch of the hypoglossal nerve that innervate the horizontal muscles (GGh), rather than the distal branch that innervates the oblique muscles (GGo), can effectively protrude the tongue while preventing tongue fatigue.

[0021] 2A illustrates a neuromodulation system 10 for treating sleep-disordered breathing configured in accordance with the present technology. System 10 can include an implantable neuromodulation device 100 and an external system 15 configured to wirelessly connect to neuromodulation device 100. Neuromodulation device 100 can include a lead 102 having a plurality of conductive elements 114 and an electronics package 108 having a first antenna 116 and electronic components 118. Neuromodulation device 100 is configured for implantation at a treatment site comprising the submandibular and sublingual regions of a patient's head, as described below with reference to FIGS. 3A-3F.

[0022] In use, the electronics package 108, or one or more elements thereof, is configured to deliver stimulation energy having a pulse width, amplitude, duration, frequency, duty cycle, and / or polarity to the conductive elements 114, which can cause the conductive elements 114 to apply an electric field to the treatment site and modulate the hypoglossal nerve. The stimulation energy can be applied according to a periodic waveform, including, for example, a charge-balanced square wave with alternating anodal and cathodal pulses.

[0023] The pulse width of the one or more pulses of stimulation energy may be from about 10 μs to about 1000 μs, from about 50 μs to about 950 μs, from about 100 μs to about 900 μs, from about 150 μs to about 800 μs, from about 200 μs to about 850 μs, from about 250 μs to about 800 μs, from about 300 μs to about 750 μs, from about 350 μs to about 700 μs, from about 400 μs to about 650 μs, from about 450 μs to about 600 μs, from about 500 μs to about 650 μs, from about 500 μs to about 600 μs, from about 500 μs to about 75 ... The pulse width can be from about 00 μs to about 550 μs, about 50 μs, about 100 μs, about 150 μs, about 200 μs, about 250 μs, about 300 μs, about 350 μs, about 400 μs, about 450 μs, about 500 μs, about 550 μs, about 600 μs, about 650 μs, about 700 μs, about 750 μs, about 800 μs, about 850 μs, about 900 μs, about 950 μs, and / or about 1000 μs.

[0024] The one or more pulses of stimulation energy can have an amplitude sufficient to induce an increase in phasic activity of the desired muscle. For example, the current-controlled amplitude of the one or more pulses of stimulation energy can be about 0.1 mA to about 5 mA. In some embodiments, the amplitude of the stimulation energy is 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 the one or more pulses of stimulation energy can be voltage-controlled. The amplitude of the one or more pulses of stimulation energy can be determined, at least in part, based on the size and / or configuration of the conductive element 114, the position of the conductive element 114 in the patient, etc.

[0025] The frequency of the stimulation energy pulses can be about 10 Hz to about 50 Hz, about 20 Hz to 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 determined based on the desired effect of the stimulation energy on one or more muscles or nerves. For example, a low frequency may induce muscle spasms, while a high frequency may cause a muscle to fully contract.

[0026] The external system 15 can include an external device 11 and a control unit 30 communicatively connected to the external device 11. In some embodiments, the external device 11 is configured to be positioned adjacent to the patient's head while they sleep. The external device 11 can include a carrier 9 integrated with a second antenna 12. While the control unit 30 is shown separate from the external device 11 in FIG. 2A , in some embodiments, the control unit 30 can be integrated with and / or form part of the external device 11. The second antenna 12 can be configured to serve multiple purposes. For example, the second antenna 12 can be configured to deliver power to the neuromodulation device 100 via electromagnetic induction. When the first antenna 116 is positioned above the second antenna 12 of the external device 11, a current is induced in the first antenna 116 within the electromagnetic field generated by the second antenna 12. The first antenna 116 and the second antenna 12 may also be configured to transmit and / or receive data from 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. This communication may include, for example, programming, e.g., uploading software / firmware revisions to the neuromodulation device 100, changing / adjusting stimulation settings and / or parameters, and / or adjusting parameters of control algorithms.

[0027] The control unit 30 of the external system 15 can include a processor and / or memory that stores instructions (e.g., in the form of software, code, or program instructions executable by a processor or controller) that configure the external device to generate an electromagnetic field according to specific parameters. The external system can include and / or be configured to connect to a power source, such as a direct current (DC) power source, an alternating current (AC) power source, and / or a power source switchable between DC and AC. The external system's processor can be used to control various parameters, such as the intensity, amplitude, duration, frequency, duty cycle, and polarity of the energy output from the power source. Instead of or in addition to a processor, the external system can include a driver circuit. In such embodiments, the external system can include hardwired circuit elements for outputting a desired waveform rather than a software-based waveform generator. The driver circuit can include, for example, analog circuit elements (e.g., resistors, diodes, switches, etc.) that configure the power source to deliver energy to the second antenna 12 to generate an electromagnetic field according to the desired parameters. In some embodiments, the neuromodulation device 100 can be configured to communicate with the external system via inductive coupling.

[0028] 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 40 may be configured to send and receive data to and from the external system 15, the second antenna 12, the control unit 30, the neuromodulation device 100, and / or a remote computing device 80 via wired and / or wireless communication technologies (e.g., Bluetooth, WiFi, USB, etc.). In the example configuration of FIG. 2A , the patient device 70 and the physician device 75 are both smartphones. However, the types of devices may vary. One or both of the patient device 70 and the physician device 75 may have user-specific applications or “apps” installed, such as a patient app or a physician app, respectively. The patient app may enable the patient to execute specific commands necessary to control the operation of the neuromodulation device 100, such as, for example, starting / stopping treatment, increasing / decreasing stimulation power or intensity, and / or selecting a stimulation program. In addition to the controls provided to the patient, the physician app can allow the physician to modify stimulation settings such as pulse settings (e.g., pattern, duration, waveform), stimulation frequency, amplitude settings, electrode configuration, closed-loop and open-loop control settings, and adjustment parameters for the embedded software that controls therapy delivery during use.

[0029] The patient device 70 and / or the physician device 75 can be configured to communicate with other components of the system 10 via a network 50. The network 50 can be or include one or more communication networks, such as 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 other suitable types of networks, or combinations thereof. The patient device 70 and / or the physician device 75 can be configured to communicate with one or more remote computing devices 80 via the network 50, thereby enabling the transfer of data between the devices 70, 75 and the remote computing devices 80. Additionally, the external system 15 can be configured to communicate with other components of the system 10 via the network 50, thereby enabling the transfer of data between the external system 15 and the remote computing devices 80.

[0030] The external system 15 can receive programming, software / firmware, and settings / parameters through any of the communication paths described above, for example, directly (wired or wirelessly) from the user interface 40 and / or via the network 50. This communication path can also be used to download data, such as measurement data regarding completed stimulation therapy sessions, from the neuromodulation device 100 to the external system 15. The external system 15 transmits the downloaded data to the user interface 40, which can then transmit / upload the data via the network 50 to the remote computing device 80.

[0031] In addition to facilitating local control of the system 10, eg, the external system 15 and the neuromodulation device 100, the various communication paths shown in FIG. 2A also enable the following:

[0032] Distributing software / firmware updates to the patient device 70, the physician device 75, the external system 15, and / or the neuromodulation device 100 from the remote computing device 80.

[0033] Downloading treatment settings / parameters to be implemented by the patient device 70, physician device 75, external system 15, and / or neuromodulation device 100 from the remote computing device 80.

[0034] Supporting doctors in remote locations to set treatment settings, adjust parameters, and adjust algorithms.

[0035] Uploading data recorded during a therapy session.

[0036] Maintaining consistency of settings / parameters by distributing changes and adjustments across components of the system.

[0037] A therapeutic approach implemented by system 10 may involve implanting only neuromodulation device 100 within the body, with external system 15 remaining an external component used only when providing therapy. To facilitate this, neuromodulation device 100 may be configured to receive power from external system 15 via electromagnetic induction. In operation, second antenna 12, operated by control unit 30, may be positioned external to the patient's body so as to be located proximate first antenna 116 of neuromodulation device 100. In some embodiments, second antenna 12 is carried by a flexible carrier 9 configured to be placed on or sufficiently near a bed to maintain the position of first antenna 116 within a target volume of the electromagnetic field generated by second antenna 12 while the patient is sleeping. Through this approach, system 10 may provide therapy to improve sleep-disordered breathing (e.g., obstructive sleep apnea) by stimulating the hypoglossal nerve in a shorter, less invasive procedure. By using electromagnetic induction as the power source and eliminating an implanted power source, the use of batteries and the need for battery replacement over the patient's lifetime can be eliminated.

[0038] In some embodiments, the system 10 can include one or more sensors (not shown), which can be implanted and / or external. For example, the system 10 can include one or more sensors mounted on (and implanted within) the neuromodulation device 100. Such sensors can be located anywhere along the lead 102 and / or electronics package 108. In some embodiments, one, more, or all of the conductive elements 114 can be used for both sensing and stimulation. The use of a single structure or element as both a sensor and a stimulation electrode reduces the surgical invasiveness associated with implanting the system and reduces the number of foreign bodies introduced into the patient's body. In certain embodiments, at least one of the conductive elements 114 is dedicated to sensing.

[0039] In addition to, or instead of, including one or more sensors in the neuromodulation device 100, the system 10 can include one or more sensors separate from the neuromodulation device 100. In some embodiments, one or more of such sensors are hardwired to the neuromodulation device 100 but implanted in a different location than the neuromodulation device 100. In some embodiments, the system 10 includes one or more sensors configured to wirelessly connect to the neuromodulation device 100 and / or an external computing device (e.g., control unit 30, user interface 40, etc.). Such sensors can be implanted in the same location as the neuromodulation device 100, in a different location, or can be placed on the patient's skin.

[0040] The one or more sensors can be configured to record and / or detect physiological data (e.g., data originating from the patient's body) and changes therein over time. The physiological data can be used to select specific stimulation parameters or adjust one or more stimulation parameters during treatment. The physiological data can include electromyography (EMG) signals, temperature, movement, body position, electroencephalography (EEG), airflow, audio data, heart rate, pulse oximetry, eye movement, and / or combinations thereof. In some embodiments, physiological events can be used to detect and / or predict other physiological parameters. For example, the one or more sensors can be configured to detect electromyography (EMG) signals, which can be used to detect and / or predict physiological data such as phasic contractions of the anterior tongue muscles (e.g., phasic contractions of the genioglossus muscle) or measure physiological data such as basal tonic activity of the anterior tongue muscles (e.g., tonic activity of the genioglossus muscle). Phasic contractions of the genioglossus muscle can indicate inspiration, particularly phasic activity that is superimposed on the basal tonic tone of the genioglossus muscle. Changes in physiological data can include changes in one or more parameters of the measured signal (e.g., frequency, amplitude, spike rate), the onset and termination of phasic contractions of the anterior tongue muscle (e.g., phasic contractions of the genioglossus muscle), changes in the basal tonic activity of the anterior tongue muscle (e.g., changes in tonic activity of the genioglossus muscle), and combinations thereof. In particular, changes in phasic activity of the genioglossus muscle can indicate changes in respiration or inspiration and can be used to trigger stimuli. Such physiological data and changes therein can be detected from signals recorded from sensors during various phases of respiration, including inspiration. Accordingly, the one or more sensors can include an electromyography (EMG) sensor. The one or more sensors can include, for example, wireless or wired sensors that measure body temperature, movement (e.g., acceleration sensors), respiratory sounds (e.g., voice sensors), heart rate, arterial oxygen saturation, eye movement, etc.

[0041] During operation, physiological data provided by one or more sensors enables closed-loop operation of neuromodulation device 100. For example, EMG responses sensed from the genioglossus muscle enable closed-loop operation of neuromodulation device 100 without the need for chest leads to sense respiration. Operating in a closed loop allows neuromodulation device 100 to maintain stimulation synchronized with respiration, for example, while maintaining the ability to detect and account for momentary occlusions. Neuromodulation device 100 can also detect and respond to snoring, for example.

[0042] System 10 can be configured to provide open-loop control and / or closed-loop stimulation to configure stimulation parameters. In short, with respect to closed-loop stimulation, system 10 can be configured to track the patient's respiration (e.g., each patient breath), and stimulation can be applied at or before the start of inspiration. However, with respect to open-loop stimulation, stimulation can be applied without tracking specific physiological data, such as respiration or inspiration. However, system 10 can adjust stimulation, record data, and act based on such information even in such an "open-loop" scenario. For example, one way in which system 10 can act based on such information is for system 10 to set stimulation parameters and apply stimulation in an open-loop manner, while monitoring the patient's breathing to determine when to resume stimulation in a closed-loop manner, applying stimulation on a breath-by-breath basis, whereby system 10 is constantly operating in a closed-loop algorithm to evaluate the data. The system's treatment parameters may be automatically adjusted in response to physiological data. Physiological data can be stored and examined over time to modify treatment parameters. For example, treatment data can be examined in real time to modify treatment parameters in real time. In some embodiments, treatment parameters are learned from physiological data stored over time and can be used to adjust treatment in real time, both on a patient-by-patient basis and across multiple patients.

[0043] The neuromodulation device 100 operates in real time and can record data related to a stimulation session (e.g., via one or more sensors), such as stimulation settings, electromyographic (EMG) responses, respiration, and sleep states, including various stages of rapid eye movement (REM) and non-rapid eye movement (non-REM) sleep. For example, changes in phasic and tonic EMG activity of the genioglossus muscle during inspiration can serve as a trigger for stimulation, and stimulation can also be modified based on changes in phasic and tonic EMG activity of the genioglossus muscle during inspiration or various sleep states. This recorded data can be uploaded to the user interface 40 and the remote computing device 80. The patient can also be prompted using the interface 40 to record data related to their sleep quality, which can be uploaded to the remote computing device 80. Offline, the remote computing device 80 can run a software application to evaluate the recorded data and determine whether settings and control parameters can be adjusted to further optimize the stimulation therapy. The software application may include, for example, an artificial intelligence (AI) model that learns from recorded therapy sessions and understands how specific adjustments affect patient outcomes. In this way, through AI learning, the model can provide optimized treatment for each patient.

[0044] III. Neuromodulation Devices 2B-2D show various views of a neuromodulation device 100. As previously described, the device 100 can be configured for implantation at a treatment site within the submandibular and sublingual regions of a patient's head and can deliver electrical energy to the treatment site to stimulate the hypoglossal nerve and / or one or more tongue protruding muscles (e.g., the genioglossus, the geniohyoid, etc.). The device 100 can include an electronics package 108 and a lead 102 connected to and extending from the electronics package 108. The lead 102 can include a lead body 104 having a plurality of conductive elements 114 and an extension 106 extending between the lead body 104 and the electronics package 108. The extension 106 can have a proximal end 106a connected to the electronics package 108 via a first connector 110 and a distal end 106b connected to the lead body 104 via a second connector 112. The first connector 110 and / or the second connector 112 can be constructed from a suitable biocompatible material, including one or more polymers. For example, the first connector 110 and / or the second connector 112 can include a thermoplastic elastomer, a thermoplastic polyurethane, a silicone, and / or other suitable material. The material of the first connector 110 and / or the second connector 112 can be a material that has characteristics such as high flexibility, good resistance to liquid ingress, low oxidation, and good biocompatibility. In some embodiments, the material of the first connector 110 and / or the second connector 112 can be determined at least in part based on the anatomical environment in which the device 100 will be implanted. For example, aromatic thermoplastic polyurethanes (e.g., Pellethane™) are highly hydrophilic and are suitable for moist anatomical environments rich in interstitial fluid. However, polycarbonate-based thermoplastic polyurethanes (e.g., Carbothane™) may be less susceptible to degradation than Pellethane™ in anatomical environments with high blood volumes, such as peripheral and subcutaneous tissue.Therefore, in devices 100 configured for implantation in the sublingual and submandibular regions, the first connector 110 and / or the second connector 112 are preferably made from a polycarbonate-based thermoplastic polyurethane such as Carbothane™.

[0045] The electronics package 108 can be configured to deliver electrical current to the conductive element 114 (e.g., to provide stimulation) and / or receive electrical energy from the conductive element 114 (e.g., to detect physiological data). The extension 106 of the lead 102 can mechanically and / or electrically connect the electronics package 108 to the lead body 104. The extension 106 can be constructed from a polymeric material, such as, but not limited to, a thermoplastic elastomer, a thermoplastic polyurethane, a silicone, or other suitable material. The extension 106 is sufficiently flexible so that it can be bent away from the electronics package 108 while still allowing the lead body 104 to rest on top of the electronics package 108. As described below in FIGS. 3A-3F , the neuromodulation device 100 is configured to be implanted in both the submandibular and sublingual regions, with the electronics package 108 and the lead body 104 stacked vertically with one or more muscle and / or other tissue layers disposed therebetween. The flexibility of the extension 106 enables this configuration.

[0046] In some embodiments, the extension 106 includes sidewalls that define a lumen extending therethrough. The conductive elements 114 can be electrically connected to the first antenna 116 and / or the electronic component 118 via one or more electrical connections (also referred to herein as “conductors”) that pass through the lumen of the extension 106. For example, the proximal ends of the electrical connections can be routed to the electronic component 118 on the electronics package 108 via the first connector 110. The electrical connections can comprise, for example, one or more wires, cables, traces, vias, etc. that extend through, on, and / or along the extension 106 and lead body 104. The electrical connections can be constructed of a conductive material, such as silver, copper, etc., and each electrical connection can be insulated along its entire length or a portion. In some embodiments, the device 100 includes an independent electrical connection for each conductive element 114. For example, in embodiments (and other embodiments) in which device 100 includes eight conductive elements 114, device 100 can include eight electrical connections, each extending through the lumen of extension 106 from the proximal end of electronic component 118 to the distal end of one of the conductive elements 114.

[0047] In some embodiments, electronic component 118 comprises an application-specific integrated circuit (ASIC), discrete electronic components, and / or electrical connectors. In these and other embodiments, electronic component 118 may include, for example, processing and storage components (e.g., microcomputers, microprocessors, computers-on-chips, etc.), charge storage and / or delivery components (e.g., batteries, capacitors, electrical conductors) for receiving, storing, and / or delivering electrical energy, switching components (e.g., solid-state, pulse-width modulated, etc.) for selecting and / or controlling conductive elements 114. In some embodiments, electronic component 118 includes a data communications unit for communicating with external devices (e.g., external system 15) via communications standards, including, but not limited to, near-field communication (NFC), infrared wireless communication, Bluetooth, ZigBee, Wi-Fi, inductive coupling, capacitive coupling, or other suitable wireless communications standards. In some examples, electronic component 118 includes one or more processors with one or more computing components configured to control the delivery of energy through conductive elements 114 and / or process energy and / or data received by conductive elements 114 according to instructions stored in memory. Memory may be a tangible, non-transitory, computer-readable medium configured to store instructions executable by one or more processors. For example, memory may be data storage into which one or more software components executable by one or more processors to implement particular functions may be loaded. In some examples, a function may include causing conductive elements 114 to acquire data characterizing muscle activity of a patient. In another example, a function may include processing the data to determine one or more parameters of the data (e.g., variability in muscle activity, etc.).According to various embodiments, electronic component 118 may include a wireless charging unit for delivering power to other electronic components 118 of device 100 and / or recharging a battery (if included) of device 100.

[0048] The electronics package 108 can also be configured to wirelessly receive energy from a power source and deliver power to the neuromodulation device 100. In some embodiments, the electronics package 108 includes a first antenna 116 configured to wirelessly communicate with the external system 15. As shown in FIG. 2B , in some implementations, the electronic component 118 can be positioned in an opening in the center of the first antenna 116. In other embodiments, the electronic component 118 and antenna 116 can have other configurations and arrangements.

[0049] The second antenna 12 can be configured to radiate an electromagnetic field to induce a current in the first antenna 116, which can be delivered to the electronic component 118 and / or the conductive element 114. In some embodiments, the first antenna 116 comprises a coil or multiple coils. For example, the first antenna 116 can comprise one or more coils disposed on a flexible substrate. The substrate can be a single substrate or multiple substrates secured together 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. The substrate, whether single-layer or multi-layer, can have one or more vias that extend partially or completely through its thickness, and one or more electrical connectors can pass through the vias to electrically connect the first antenna 116 and / or specific electronic components of the electronics package 108, such as the aforementioned electronic component 118.

[0050] In some embodiments, the first antenna 116 includes multiple coils. For example, the first antenna 116 can include a first coil on a first side of the substrate and a second coil on a second side of the substrate. This configuration can be prone to power loss due to substrate losses and parasitic capacitance between the multiple coils and between the individual coil windings. Substrate losses arise from eddy currents within the substrate due to the non-zero resistivity of the substrate material. Parasitic capacitance arises when adjacent components have different voltages, creating electric fields and charge accumulation. Because all circuit elements have this internal capacitance, it can cause deviations from the behavior of "ideal" circuit elements.

[0051] Advantageously, in some embodiments, the first antenna 116 can have a two-layer pancake coil configuration, with an upper coil and a lower coil configured in parallel. As a result, the coils can generate equal or substantially equal induced voltage potentials when exposed to an electromagnetic field. This helps equalize the voltages in the coils during use and has been demonstrated to significantly reduce parasitic capacitance in the first antenna 116. In this parallel coil configuration, the upper and lower coils are shorted within each winding. This design has been shown to significantly reduce parasitic capacitance and generate high maximum power output while maintaining the low series resistance benefits of a two-coil design. More details regarding the two-coil configuration are described in U.S. Patent Application No. 16 / 866,523, filed May 4, 2020, the entire contents of which are incorporated herein by reference.

[0052] The first antenna 116 (or one or more portions thereof) may be flexible so that the first antenna 116 can at least partially conform to the patient's anatomy after implantation. In some embodiments, the first antenna 116 includes an outer coating configured to accommodate and / or support the first antenna 116. The coating may include, but is not limited to, a biocompatible material such as epoxy, urethane, silicone, or other biocompatible polymers. In some embodiments, the coating includes multiple layers of different materials. In some embodiments, different regions of the first antenna 116 may be coated with different distinct materials. For example, a first region including the electronic component 118 (e.g., a central region of the first antenna 116) may be coated with a first material (e.g., epoxy, urethane, silicone, etc.), and a second region including the coil windings may be coated with a second material.

[0053] In some embodiments, the first antenna 116 can include one or more open areas (e.g., cuts) through the substrate (or substrates) between the coil windings. Such open areas can separate selected portions of the coil windings, increasing their relative movement, thereby improving the overall antenna flexibility and adaptability. The open areas can be formed, for example, by a laser cutting process, which removes substrate material between adjacent coil windings in a selected pattern. A first antenna 116 with such open areas can be formed from a single substrate or by subsequently joining multiple substrates (e.g., with a suitable overmolding process). As described in more detail below with respect to the examples shown in Figures 12A-12H, in some embodiments, the pattern can include one or more open areas where substrate material has been removed, thereby partially or completely isolating one or more coil windings. Additionally, in some embodiments, the pattern can include one or more strut regions where substrate material remains, which help maintain spacing between adjacent coil windings.

[0054] 12A shows an example electronics package 1208a with a first antenna 1216 and an electronic component 1218. The first antenna 1216 includes multiple coil windings 1230, each of which is separated circumferentially for a majority of its length from an adjacent coil winding 1230 by an arcuate open region 1220 extending around the coil winding, except for a strut region 1219 (e.g., located near the connector 110). For example, the arcuate open region 1220 can extend continuously over 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 winding. In the example electronics package 1208a, the arcuate open region 1220 is rotationally aligned, configured to leave a single strut region 1219 of substrate material. However, in other embodiments, some or all of the arcuate open regions may be rotationally offset (e.g., at least 10 degrees, at least 30 degrees, at least 60 degrees, at least 90 degrees, etc.) to leave multiple strut regions 1219 of substrate material. Figure 12B shows an example of an electronics package 1208b including a first antenna 1216 having a pattern similar to that shown in Figure 12A. As shown in Figure 12B, at least a portion of each coil winding of the antenna 1216 is separated to allow movement out of the plane of the substrate relative to adjacent coil windings, at least prior to coating or covering the substrate.

[0055] As another example, Figure 12C illustrates an example electronics package 1208c that includes a first antenna 1216 and an electronic component 1218. The first antenna 1216 is similar to the first antenna 1216 illustrated in Figure 12A, except that in the first antenna 1216 of Figure 12C, each set of two adjacent coil windings 1230 is separated from the adjacent coil winding 1230 by an arc-shaped open region 1220 that extends around the entire coil winding except for strut regions 1219 (e.g., located near connector 110). In other words, every other ring of substrate material separating adjacent coil windings is cut, removed, or omitted (radially), leaving one or more sets of two adjacent coil windings 1230 circumferentially connected by the ring of substrate material. Thus, at least a portion of each set of circumferentially coupled coil windings 1230 is separated to allow movement out of the substrate plane relative to adjacent coil windings 1230, at least prior to coating or covering the substrate. While FIG. 12C shows the first antenna 1216 with arcuate open regions 1220 separating every other ring of substrate material between the coil windings 1230, in other embodiments, the antenna 1216 can include arcuate open regions 1220 separating any number of circumferentially coupled coil windings 1230 (e.g., two coupled coil windings, three coupled coil windings, etc.). For example, the arcuate open regions 1220 can partially separate sets of three circumferentially coupled coil windings 1230, or can partially separate sets of various numbers of circumferentially coupled coil windings 1230 (e.g., alternating patterns of partially separating two coupled coil windings and one coil winding).

[0056] As another example, Figure 12D illustrates an example electronics package 1208d that includes a first antenna 1216 and an electronic component 1218. The first antenna 1216 is similar to the first antenna 1216 illustrated in Figure 12A, except that in the first antenna 1216 of Figure 12D, multiple individual circumferential portions of each coil winding 1230 are separated from adjacent coil windings 1230 by arcuate open regions 1220 that extend around a portion of each coil winding except for strut regions 1219a (e.g., located near the connector 110) and strut regions 1219b (e.g., located on the opposite side of the antenna 1216 from the connector 110). Thus, at least two portions of each coil winding 1230 are separated from adjacent coil windings, and are separated to allow the coil winding 1230 to move out of the plane of the substrate relative to adjacent coil windings 1230, at least prior to coating or covering the substrate (e.g., the coil windings 1230 may be "butterfly" shaped).

[0057] As another example, Figure 12E illustrates an example electronics package 1208e that includes a first antenna 1216 and an electronic component 1218. The first antenna 1216 is similar to the first antenna 1216 illustrated in Figure 12C, except that in the first antenna 1216 of Figure 12E, multiple individual circumferential portions of each coil winding 1230 are separated from adjacent coil windings 1230 by arcuate open regions 1220 that extend around a portion of the coil winding except for strut regions 1219a (e.g., located near the connector 110) and strut regions 1219b (e.g., located on the opposite side of the antenna 1216 from the connector 110), similar to that described above with respect to Figure 12D. Thus, at least a portion of each set of circumferentially coupled coil windings 1230 are separated to allow movement out of the plane of the substrate relative to adjacent coil windings 1230, at least prior to coating or covering the substrate. 12E shows the first antenna 1216 with arcuate open regions 1220 separating every other ring of substrate material between the coil turns 1230, in other embodiments, the antenna 1216 can include arcuate open regions 1220 separating any number of circumferentially coupled coil turns 1230 (e.g., two coupled coil turns, three coupled coil turns, etc.). For example, the arcuate open regions 1220 can partially separate sets of three circumferentially coupled coil turns 1230, or can partially separate sets of various numbers of circumferentially coupled coil turns 1230 (e.g., alternating between separating two coupled coil turns and separating one coil turn).

[0058] Additionally, the cut pattern can define any suitable number of strut regions in the substrate material around the coil windings. For example, Figure 12F shows an example electronics package 1208f including a first antenna 1216 similar to the first antenna 1216 of Figure 12D, except that in the first antenna 1216 of Figure 12F, multiple discrete circumferential portions of each coil winding 1230 are separated from adjacent coil windings 1230 by arcuate open regions 1220 that extend around a portion of each coil winding, except for eight circumferentially distributed strut regions 1219. As another example, Figure 12G shows an exemplary electronics package 1208g including a first antenna 1216 similar to the first antenna of Figure 12E, except that in the first antenna 1216 of Figure 12G, multiple discrete circumferential portions of each set of linked coil windings 1230 are separated from adjacent coil windings 1230 by arcuate open regions 1220 that extend around a portion of each coil winding except for four circumferentially distributed strut regions 1219. However, in some embodiments, the pattern can include one, two, three, four, five, six, seven, eight, nine, ten, or more strut regions spaced equally or unevenly around the circumference of the first antenna 1216.

[0059] In some embodiments, the first antenna 1216 can include one or more coil windings completely separated circumferentially by open regions (e.g., cut regions) (without strut regions 1219). Any of the examples described above with respect to FIGS. 12A-12G can include at least one, two, three, four, five, six, seven, eight, or more coil windings completely separated circumferentially by open regions (e.g., cut regions). For example, FIG. 12H shows an example of an electronics package 1208h that includes a first antenna 1216 and an electronic component 1218. The first antenna 1216 is similar to the first antenna 1216 of FIG. 12A except that in the first antenna 1216 of FIG. 12H, all of the coil windings 1230 are completely separated circumferentially by arc-shaped open regions 1220 that extend around the entire coil winding (without strut regions 1219). In another example, the first antenna 1216 shown in Figures 12B-12G can be modified so that one or more of the coil windings 1230 (or sets of radially adjacent coil windings 1230) are completely separated circumferentially by an arc-shaped open region 1220.

[0060] In embodiments in which strut regions are present, the pattern of strut regions between adjacent coil windings or adjacent sets of linked coil windings can also include circumferentially aligned strut regions 1219 (e.g., as shown in FIG. 12F). Additionally or alternatively, the pattern of strut regions 1219 can include strut regions 1219 that are circumferentially offset from one another (e.g., as shown in FIG. 12G), such as by about 15 degrees, about 30 degrees, about 45 degrees (e.g., as shown in FIG. 12G), about 60 degrees, about 75 degrees, about 90 degrees, or about 90 degrees. Furthermore, the size of the strut regions 1219 can be varied in any suitable manner, depending, for example, on the desired spacing between the coil windings 1230. For example, in some embodiments, the strut regions 1219 have a width (e.g., arc length around the antenna) of about 15 μm to about 25 μm, or about 20 μm.

[0061] In some embodiments, the region including the electronic component 1218 (e.g., the central region of the first antenna 116) can be coated or otherwise covered with a first material (e.g., epoxy), and the region including one or more partially or completely separated coil windings can be coated or otherwise covered with a second material (e.g., urethane, silicone, or other low-hardness polymer) configured to allow the coil windings to flex and move. In some embodiments, the region including the coil windings can be overmolded with the second material. For example, any of the exemplary electronics packages described above with respect to FIGS. 12A-12H can include a region of the electronic component 1218 covered with a first material and the coil windings covered with a second material. In some embodiments, the first material and / or second material covering at least a portion of the first antenna can contribute to maintaining spacing between adjacent separated coil windings (e.g., in embodiments without strut regions).

[0062] 2B-2D, the lead body 104 can include a substrate carrying one or more conductive elements 114 configured to deliver and / or receive electrical energy. In some embodiments, the lead body 104 (or one or more portions thereof) comprises a flexible tube with a sidewall defining a lumen. The lead body 104 can be constructed from a polymeric material, such as, but not limited to, a thermoplastic elastomer, a thermoplastic polyurethane, a silicone, or other suitable material. The lead body 104 can be constructed from the same material as the extension 106 or from a different material. The lead body 104 can be constructed from the same material as the extension 106. In some embodiments, the lead body 104 has a different hardness (durometer) than the extension 106. For example, the hardness of the lead body 104 can be lower than that of the extension 106, thereby improving patient comfort.

[0063] As shown in FIGS. 2B-2D , the lead body 104 has a bifurcated shape including a first arm 122 and a second arm 124. To facilitate this configuration, for example, the second connector 112 can be bifurcated and / or bifurcated. The first arm 122 and the second arm 124 can extend distally and laterally from the second connector 112 and / or the distal end 106b of the extension 106, respectively. The first arm 122 can 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 can 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 can include a cantilevered free distal end 123 and / or the second arm 124 can include a cantilevered free distal end 125. The first arm 122 and / or the second arm 124 can include one or more fixation elements 130, such as those shown in Figures 2B-2D at the distal ends 122b, 124b of the first arm 122 and the second arm 124. The fixation elements 130 can be configured to securely, and optionally removably, engage the patient's tissue to prevent or limit movement of the lead body 104 relative to the tissue.

[0064] The lead 102 and / or one or more portions thereof (e.g., lead body 104, extension 106, etc.) can also be configured to be flexible yet maintain a desired shape. This feature can be achieved, for example, by electrical conductors electrically connecting the conductive element 114 carried by the lead body 104 to the electronics package 108, by additional internal shape-retaining structures (e.g., metals, shape-memory alloys, etc.) (not shown), by shaping the substrate that includes 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 allow the lead 102 to be formed into a desired shape or to maintain a predetermined shape. Additionally or alternatively, the lead 102 and / or portions thereof (e.g., lead body 104, extension 106, etc.) can be sufficiently flexible to at least partially conform to a patient's anatomy after implantation or to enhance patient comfort.

[0065] The conductive elements 114 can be carried on the sidewalls of the lead body 104. For example, the conductive elements 114 can be disposed on the outer surface of the sidewalls and / or within recesses in the sidewalls. In some embodiments, one or more of the conductive elements 114 are disposed on the outer surface of the sidewalls and extend around at least a portion of the periphery of the sidewalls. The lumen of the lead body 104 can accommodate one or more electrical conductors that extend through the lumen of the lead body 104 and the lumen of the extension 106 from the conductive elements 114 to the electronics package 108. The sidewalls can define one or more openings through which electrical connectors can pass.

[0066] As described above, the conductive element 114 can be connected to the electronics package 108 via one or more electrical conductors. The electrical conductors can be disposed on the sidewalls of the lead 102 (e.g., the extension 106 and / or the lead body 104) and / or in the lumen of the lead 102. In some embodiments, if an electrical conductor is disposed in the lumen of the extension 106 of the lead 102, the lumen can be filled after the conductor is disposed in the lumen. The lumen can be filled with an adhesive and / or elastomer. In some embodiments, the lumen is filled with a silicone adhesive. In some embodiments, the extension 106 can be injection molded around the electrical conductors. Backfilling the lumen and / or injection molding the extension 106 around the electrical conductors can fill the space in the lumen of the extension 106 not occupied by the conductors, which can help, for example, prevent or limit fluids from entering the lead 102 and corroding or degrading the conductors.

[0067] In some embodiments, each conductive element 114 is connected to one conductor, such that the number of conductors equals the number of conductive elements 114. Nevertheless, in some embodiments, a device may include more or fewer conductors than conductive elements 114 (e.g., a conductor may be connected to multiple conductive elements 114). The conductive elements 114 may be connected to the 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 conductors. For example, the conductive elements 114 may be connected to the conductors by tack welding. The conductive elements 114 may be connected to their respective conductors at one or more locations along the length of the conductors.

[0068] In some embodiments, the material and / or configuration of the conductor can be selected based on the desired mechanical performance of the conductor. For example, stranded conductors may be more flexible and fatigue-resistant than solid wires, making them suitable for use on the human body. In some embodiments, it may be advantageous for the conductor to comprise a material with low resistivity, as such a conductor may consume less power than a comparable conductor with a higher resistivity. The conductors of the present technology may comprise any suitable metal, such as titanium, chromium, niobium, tantalum, vanadium, zirconium, aluminum, cobalt, nickel, stainless steel, or an alloy of any of the foregoing metals.

[0069] Each of the conductive elements 114 may comprise an electrode, an exposed portion of conductive material, printed conductive material, or other suitable form. In some embodiments, one or more of the conductive elements 114 comprises a ring electrode. The conductive elements 114 may be crimped, welded, glued, or disposed on the outer surface and / or recess of the lead body 104. Additionally or alternatively, each of the conductive elements 114 may be welded, soldered, crimped, or otherwise electrically connected to a corresponding conductor. In some embodiments, one or more of the conductive elements 114 comprises a flexible conductive material disposed on the lead body 104 by printing, thin film deposition, or other suitable technique. Each of the conductive elements 114 may comprise any suitable conductive material, including, but not limited to, platinum, iridium, silver, gold, nickel, titanium, copper, combinations thereof, and / or other materials. For example, one or more of the conductive elements 114 may be a ring 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, electrical conductivity, corrosion resistance, surface roughness, durability, or other parameters of the conductive elements 114. As an example, one or more of the conductive elements 114 may include a coating of titanium and nitride.

[0070] In some embodiments, the length of one or more conductive elements 114 is about 1 mm. Additionally or alternatively, the length of one or more conductive elements 114 can be 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 either case, adjacent conductive elements 114 carried by either 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 be the same length or different lengths.

[0071] 2B-2D includes conductive elements 114 that are approximately equally spaced from one another on the first arm 122 and the second arm 124, other distributions of conductive elements 114 are within the scope of the present technology. For example, in the first arm 122 and / or the second arm 124, at least some of the conductive elements 114 can be equally spaced along the length of the arm, and / or at least some of the conductive elements 114 can be unequally spaced along the length of the arm.

[0072] For example, in some embodiments in which the conductive elements 114 are unequally spaced, 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 ends of the lead body arms 122, 124 can be spaced closer together compared to the conductive elements 114 located at the proximal ends of the lead body arms). As another example, in some embodiments in which the conductive elements 114 are unequally spaced, 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 ends of the lead body arms 122, 124 can be spaced farther apart compared to the conductive elements 114 located at the proximal ends of the lead body arms). As another example, in some embodiments in which the conductive elements 114 are unequally spaced, the spacing between the conductive elements 114 along the first arm 122 and / or the second arm 124 can regularly alternate between a first distance and a second distance (different from the first distance and the second distance). As another example, in some embodiments in which the conductive elements 114 are unequally spaced, the spacing between the conductive elements 114 along the first arm 122 and / or the second arm 124 can be irregular or random.

[0073] The spacing or distribution of the conductive elements 114 on the first arm 122 can be a mirror image of 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 can be different from the spacing or distribution of the conductive elements 114 on the second arm 124.

[0074] 2B-2D includes eight conductive elements 114 (four conductive elements 114 carried by the first arm 122 and four conductive elements 114 carried by the second arm 124), although other numbers and configurations of conductive elements 114 are within the scope of the present technology. For example, the first arm 122 can carry the same number of conductive elements 114 as the second arm 124, or the first arm 122 can carry a different number of conductive elements 114 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 is provided with no conductive elements 114.

[0075] The conductive element 114 can be configured for stimulation and / or sensing. The stimulating conductive element 114 can be configured to deliver energy to an anatomical structure, such as a nerve or a muscle. In some embodiments, the conductive element 114 can be configured to deliver energy to a patient's hypoglossal nerve to increase activity of the patient's tongue protractor muscles. The sensing conductive element 114 can be used to obtain data characterizing the patient's physiological activity (e.g., muscle activity, temperature, etc.). In some embodiments, the sensing conductive element 114 is configured to detect electrical energy generated by the patient's muscles and obtain electromyogram (EMG) data characterizing the muscle activity. In some embodiments, the sensing conductive element is configured to measure impedance between conductive elements. By way of example only, in some embodiments, the conductive element 114 is configured to deliver energy to the patient's hypoglossal nerve to increase activity of the genioglossus and / or geniohyoid muscles and obtain EMG data characterizing the activity of the patient's genioglossus and / or geniohyoid muscles. Additionally, the conductive element 114 may be configured to deliver energy to and / or measure physiological electrical signals from other patient tissue.

[0076] The function that each of the conductive elements 114 is configured to perform (e.g., delivering energy to, receiving energy from, the patient's tissue) can be controlled by a processor of the electronics component 118 of the electronics package 108. In some embodiments, one or more of the conductive elements 114 are configured to either deliver energy to, or receive energy from, the patient's tissue. In various embodiments, one or more of the conductive elements 114 are configured to both deliver energy to, and receive energy from, the patient's tissue. In some embodiments, the function of the conductive elements 114 can be determined, at least in part, based on the intended location of the device 100 within the patient's body and / or the location of the conductive elements 114 on the lead body 104. One, more, or all of the conductive elements 114 can be positioned relative to patient tissue, such as nerves and / or muscles, and therefore, it may be desirable for the conductive elements 114 to be able to not only deliver energy to, but also receive energy from, the patient's tissue. Additionally or alternatively, some conductive elements 114 may be positioned to only deliver stimulation energy to particular patient tissues, while other conductive elements 114 may be positioned to only receive sensing energy to particular patient tissues. Advantageously, the configuration of the conductive elements 114 is configurable by software settings (which may be achieved by electronic components 118 of electronics package 108), allowing the configuration of the conductive elements 114 to be easily changed.

[0077] Whether configured for stimulation and / or sensing, each conductive element 114 can be configured and used independently of the other conductive elements 114. Thus, when applying a stimulation therapy, all or a portion of the conductive elements 114 determined to be most effective for a particular implementation can be used. For example, one conductive element 114 on the first arm 122 can be used as a cathode and one conductive element 114 on the second arm 124 can be used as an anode (or vice versa); two or more conductive elements 114 on the first arm 122 (one as a cathode and one as an anode) can be used without any conductive elements 114 on the second arm 124 (or vice versa); multiple pairs of conductive elements 114 on the first and second arms 122, 124 can be used; or any other suitable combination can be used. As described in more detail below, the conductive elements 114 used for sensing and / or stimulation can be selected based on the desired data to be collected and / or the desired modulation of neural or muscular activity. For example, particular pairs of conductive elements 114 can be used to generate electric fields tailored to stimulate particular regions of muscles and / or the hypoglossal nerve (HGN) that cause favorable changes in tongue position and / or pharyngeal expansion. Additionally or alternatively, conductive elements 114 that are positioned in contact with muscle tissue when device 100 is implanted may be preferable for use in electromyogram (EMG) sensing than conductive elements 114 that are not in contact with muscle tissue.

[0078] The lead body 104 can have a shape configured to facilitate delivery of electrical energy to a particular treatment site within a patient and / or detection of electrical energy from a sensing site within the patient. The conductive element 114 carried by the first arm 122 can be configured to deliver electrical stimulation energy to one hypoglossal nerve of the patient (e.g., the right hypoglossal nerve or the left hypoglossal nerve), and the conductive element 114 carried by the second arm 124 can be configured to deliver electrical stimulation energy to the other hypoglossal nerve of the patient (e.g., the other of the right hypoglossal nerve or the left hypoglossal nerve).

[0079] Without being bound by theory, it is believed that increased activity of the tongue protractor muscle during sleep reduces upper airway resistance and improves breathing. Accordingly, devices according to the present technology are configured to deliver stimulation energy to motor nerves controlling the tongue protractor muscle. In some embodiments, device 100 is configured to deliver stimulation energy to the hypoglossal nerve to induce tongue protrusion. Additionally or alternatively, device 100 can be configured to receive sensing energy generated by activity of one or more muscles (such as the genioglossus muscle) of the patient, which can be used for closed-loop delivery of stimulation energy, assessment of the patient's breathing, etc.

[0080] The device can be configured for implantation in a patient's anatomical location bounded anteriorly and laterally by the patient's mandible, superiorly by the superior surface of the tongue, and inferiorly by the patient's platysma muscle. Such anatomical regions include, for example, the submandibular and sublingual regions. The sublingual region is bounded superiorly by the mucosa of the floor of the mouth and inferiorly by the mylohyoid muscle, and includes the plane between the genioglossus and geniohyoid muscles. The submandibular region is bounded superiorly by the mylohyoid muscle and inferiorly by the platysma muscle. FIGS. 3A-3F show various views of the device 100 implanted within a patient. As shown in FIGS. 3A-3F, the neuromodulation device 100 is configured such that the electronics package 108 is positioned at or near the inferior surface of the mylohyoid muscle in the submandibular region, the lead body 104 is positioned between the geniohyoid and genioglossus muscles in the sublingual region, and the arms 122, 124 are positioned along the left and right hypoglossal nerves. The arms 122, 124 can be positioned to position the conductive element 114 near the distal branch of the hypoglossal nerve, which innervates the genioglossus muscle. In particular, the conductive element 114 can be positioned near the distal branch that innervates the horizontal fibers of the genioglossus muscle, while limiting and / or avoiding stimulation of the distal branch of the hypoglossal nerve, which activates the retractor muscle. When implanted, the extension 106 of the lead 102 extends anteriorly (toward the mandible) from the electronics package 108, then curves upward, penetrates the geniohyoid muscle, and curves posteriorly, extending within the tissue plane between the geniohyoid muscle and the genioglossus muscle. In some embodiments, the extension 106 spans the right and left geniohyoid muscles.

[0081] Electronics package 108 can be sufficiently flexible to at least partially conform to the curvature of the mylohyoid muscle after implantation. Additionally, or alternatively, electronics package 108 can have a shape that reflects the curvature of the mylohyoid muscle. In some embodiments, electronics package 108 can include a fixation element (similar to fixation element 130, fixation element 1132, etc.) configured to engage the mylohyoid muscle (and / or other surrounding tissue) and prevent or limit movement of electronics package 108 after implantation.

[0082] The lead body 104 can be configured to be positioned between the patient's genioglossus and geniohyoid muscles, thereby positioning the conductive element 114 near the hypoglossal nerve. Although not shown in FIGS. 3A-3F , the hypoglossal nerve is located between the genioglossus and the fascia and / or fat located between the genioglossus and geniohyoid muscles. In some embodiments, the lead body 104 is configured to be positioned at or just below the fat between the hypoglossal nerve and the geniohyoid muscle, and therefore is not positioned in direct contact with the hypoglossal nerve. In either case, after implantation of the device 100, the lead body 104 is positioned to extend posteriorly from the distal end 106b of the extension 106. The lead body 104 can then bifurcate or diverge laterally, such that a first arm 122 of the lead body 104 is positioned near one patient's hypoglossal nerve and a second arm 124 is positioned near the opposite hypoglossal nerve. The fixation element 130 can engage the patient's tissue (eg, 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's tissue.

[0083] 3C and described in more detail below, the arms 122, 124 of the lead body 104, in addition to extending laterally away from the extension 106, can bend out of the plane of the extension 106, resulting in the arms 122, 124 taking on a somewhat concave profile. Advantageously, this concave shape can accommodate the convex undersurface of the genioglossus muscle while maintaining the arms 122, 124 in proximity to the distal branch of the hypoglossal nerve.

[0084] In some embodiments, the conductive elements 114 are selected and used to selectively activate the patient's tongue protractor muscles. In these and other embodiments, the specific locations of the first and second arms 122, 124 relative to specific branches of the hypoglossal nerve need not be identified before stimulating the desired nerve and / or muscle. For example, in embodiments including more than two conductive elements 114 on the lead body 104, a combination of conductive elements 114 to treat the patient can be selected based on the physiological response to test stimulation. For example, multiple combinations of conductive elements 114 can be used to deliver stimulation energy to the hypoglossal nerve, and each combination can be evaluated for physiological response (e.g., EMG data, tongue position, pharyngeal opening size) and / or functional outcome (e.g., Fatigue Severity Scale, Epworth Sleepiness Scale, etc.). Based on the evaluation results, the conductive elements 114 selected to deliver stimulation energy can be the conductive elements 114 associated with the desired response / outcome.

[0085] The shape of the lead body 104 facilitates electrical coupling between the conductive element 114 and the patient's hypoglossal nerve. To further illustrate the shape of the lead body 104, FIGS. 4A-4C show perspective, side, and end views, respectively, of the lead 102 separated from the electronics package 108 and first connector 110. Referring to FIGS. 3A-4C, the first arm 122 and the second arm 124 can branch distally and laterally from the distal end 106b of the extension 106. As shown in FIGS. 4B and 4C, the proximal portion 122a of the first arm 122 extends distally and laterally from the distal end 106b of the extension 106. 1a The proximal portion 124a of the second arm 124 extends laterally from the distal end 106b of the extension 106 by a second lateral dimension L 2a The diverging lateral dimension L 1a ,L 2aBy extending the proximal portions 122a, 124a from the distal end 106b of the extension portion 106 and / or the second connector 112, the first arm 122 and the second arm 124 can be positioned on opposite sides of the patient, and the first arm 122 and the second arm 124 can be positioned near the right or left hypoglossal nerve, respectively. As shown in FIG. 4B, the proximal portion 124a of the second arm 124 extends from the distal end 106b of the extension portion 106 and / or the second connector 112 along the longitudinal axis L of the lead 102. L Horizontal dimension L inclined at angle α2 to 2b The longitudinal axis L of the lead 102 can extend distally by L can be aligned with extension 106 of lead 102 (eg, as shown in FIG. 4B) or can be positioned offset from extension 106.

[0086] As shown in FIG. 4C, the proximal portion 122a of the first arm 122 is aligned with the transverse axis L of the lead 102. S , such that the proximal portion 122a is inclined at a first angle θ1 relative to the lateral axis L S the first distance d from 1a The first distance d 1a increases from the proximal to the distal direction and / or increases with increasing lateral distance from the distal end 106b of the extension 106 or the second connector 112. As shown in FIGS. 4B and 4C, the proximal portion 124a of the second arm 124 is aligned with the lateral axis L of the lead 102. S , at a second angle θ2 (which may be the same as or different from the first angle θ1) relative to the transverse axis L, such that the proximal portion 124a is inclined relative to the transverse axis L. S the second distance d from 2a The second distance d 2a increases in the proximal to distal direction and / or increases with increasing lateral distance from the distal end 106b of the extension 106 or the second connector 112.

[0087] The distal portion 122b of the first arm 122 can extend distally from the intermediate portion 122c in a first longitudinal dimension (not shown), and the distal portion 124b of the second arm 124 can extend distally from the intermediate portion 122c in a second longitudinal dimension L 2c In some embodiments, the first longitudinal dimension and / or the second longitudinal dimension L 2c is the longitudinal axis L of the lead 102 L In either case, the distal portion 124b of the second arm 124 may be substantially parallel to the longitudinal axis L of the lead. L Perpendicular distance d from 2b Similarly, the distal portion 122b of the first arm 122 may be spaced apart from the longitudinal axis L of the lead. L can be spaced a vertical distance from

[0088] The distal portion 122b of the first arm 122 and / or the distal portion 124b of the second arm 124 can be positioned in a different plane and / or at a different height than the extension 106. Inclining the proximal portions 122a, 124a of the arms 122, 124 vertically away from the extension 106 can facilitate establishing a sufficient and stable electrical connection between the fat beneath the hypoglossal nerve and the conductive element 114. As shown in FIGS. 3B-3F , the distal end 106b of the lead extension 106 can be configured to be located at, near, and / or just superior to the geniohyoid bone when the device is implanted. However, the bifurcated, angled structure of the lead body 104 allows the lead body 104 to extend superiorly toward the genioglossus muscle. Specifically, the proximal portions 122a, 124a of the arms 122, 124 can extend superiorly. In some embodiments, when the device 100 is implanted, the genioglossus muscle (and the underlying branches of the hypoglossal nerve, fascia, fat, etc.) can be positioned over the first arm 122 and second arm 124 of the lead body 104, thereby facilitating electrical contact between the conductive element 114 and the patient's tissue.

[0089] The device 100 may include a fixation element 130 configured to engage with a patient's tissue to secure the device 100 to the tissue. For example, the fixation element 130 on the lead body 104 may further facilitate engagement of the lead body 104 with the patient's tissue. FIG. 5 is an enlarged side view illustrating an example of a distal end 124b of a second arm 124 and a corresponding fixation element 130. One or more of the fixation elements 130 may extend from a first end 130a at the outer surface of the sidewall 500 of the lead to a second end 130b radially spaced from the outer surface of the sidewall. In other words, the second end 130b may be radially spaced from the cylindrical outer surface of the sidewall 500. Each fixation element 130 may have a length 1 defined between the first end 130a and the second end 130b of the fixation element 130 and a thickness t. In some embodiments, the length(s) l of the fixation element 130 is about 0.7 mm to about 1.5 mm, about 0.8 mm to about 1.4 mm, about 0.9 mm to about 1.3 mm, about 1.0 mm to 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(es) t of the fixation element 130 is about 0.1 mm to about 0.5 mm, about 0.2 mm to 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 determined based on and / or substantially equal to the thickness of the sidewall 500 of the lead body. In some embodiments, the thickness t may vary (e.g., decrease from the first end 130a to the second end 130b). The second end 130b is spaced a height h from the sidewall 500 such that the fixation element 130 is angled at an angle b relative to the sidewall. The height h can be 1 mm or less, 0.75 mm or less, 0.5 mm or less, 0.4 mm or less, 0.3 mm or less, 0.2 mm or less, 0.1 mm or less, about 1 mm, about 0.5 mm, about 0.1 mm, or greater than 1 mm.According to various embodiments, angle b can be less than 90 degrees, e.g., 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. While fixation element 130 is shown in FIG. 5 as having a generally linear profile along its length l, in other embodiments, one or more fixation elements 130 can have any suitable profile, such as a curved shape (e.g., concave, convex, etc.). Fixation element 130 can be configured to engage a patient's tissue (e.g., fat, muscle tissue underlying the hypoglossal nerve, etc.) to prevent or limit movement of one or more portions of device 100 relative to the tissue. Any of the fixation elements 130 disclosed herein can be configured to prevent or limit movement of portions of the device anteriorly, posteriorly, medially, laterally, superiorly, and / or inferiorly.

[0090] The anchoring element 130 can be provided on any portion of the device 100. For example, the anchoring element 130 can be provided on the proximal portion 122a of the first arm 122, the distal portion 122b of the first arm 122, the intermediate portion 122c of the first arm 122, the proximal portion 124a of the second arm 124, the distal portion 124b of the second arm 124, the intermediate portion 124c of the second arm 124, the extension 106, the electronics package 108, and / or another suitable portion of the device 100. In some embodiments, the device 100 includes an anchoring element 130 disposed between adjacent conductive elements 114. For example, one or more fixation elements 130 can be positioned between the distal-most conductive element 114 of an arm and the conductive element 114 of an adjacent arm, between the proximal-most conductive element 114 of an arm and the conductive element 114 of the adjacent arm, between intermediate conductive elements 114 between the distal-most conductive element 114 and the proximal-most conductive element 114, etc. In some embodiments, for example, as shown in FIG. 5 , fixation elements 130 can be positioned at the distal end of one or both arms 122, 124, e.g., between the distal-most conductive element 114 and the distal tip of each arm. Because the weight and / or stiffness of device 100 is greater in one or more regions of electronics package 108 and / or extension 106 than at the distal ends of arms 122, 124, the arms 122, 124 may tend to migrate away from the fat pad near the hypoglossal nerve during implantation of device 100. However, such distal placement of the fixation elements 130 allows the arms 122, 124 to better grip the fat pad, thereby helping to keep the arms 122, 124 in their intended position during implantation of the device 100. In some embodiments, one or more fixation elements 130 can be positioned near the proximal-most conductive element 114 of a given arm, for example, at or near the middle of the arm and / or at or near the proximal portion of the arm.

[0091] Although FIG. 5 illustrates six fixation elements 130 carried on the distal end 124b of the second arm 124, the number of fixation elements 130 is not limited to this number. For example, the distal end of each arm can carry one fixation element 130, two fixation elements 130, three fixation elements 130, four fixation elements 130, five fixation elements 130, six fixation elements 130, seven fixation elements 130, eight fixation elements 130, nine fixation elements 130, ten fixation elements 130, eleven fixation elements 130, twelve fixation elements 130, and / or more than twelve fixation elements 130. However, in some applications, it may be desirable to limit the number of fixation elements 130 carried by each arm. For example, it may be desirable to have fewer fixation elements 130 so that the arms can releasably engage tissue. If an arm includes too many fixation elements 130, the arm may not be able to separate from the tissue after the fixation elements 130 engage the tissue without causing trauma to the tissue. In some embodiments, it may be desirable to reposition the arm after the fixation elements 130 engage the tissue, e.g., to move the conductive element 114 to a more favorable position relative to the hypoglossal nerve (HGN). By limiting the number of fixation elements 130 per arm, a desirable balance can be achieved between ensuring that the arm can be reliably engaged with the tissue while still being able to separate from the tissue after the fixation elements 130 engage the tissue. In some embodiments, each arm may include eight or fewer fixation elements 130, e.g., two fixation elements 130, four fixation elements 130, six fixation elements 130, or eight fixation elements 130.

[0092] Additionally or alternatively, it may be desirable to limit the length of the distal ends 122b, 124b of the arms 122, 124, thereby limiting the number of fixation elements 130 included on the distal ends 122b, 124b of the arms 122, 124. For example, when the conductive elements 114 are aligned with the hypoglossal nerve (HGN), it may be desirable to have the distance between the distal-most conductive element 114 and the distal end of each arm 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 inadvertent contact of the distal ends of the arms with the hyoid bone or other anatomical structures (e.g., bones, muscles, nerves, etc.).

[0093] Some or all of the fixation elements 130 can be distributed around the circumference of the arm or aligned circumferentially. Additionally or alternatively, some or all of the fixation elements 130 can be spaced apart along the length of the arm or aligned axially along the length of the arm. For example, in some embodiments, the fixation elements 130 include a first set of fixation elements and a second set of fixation elements. The first set of fixation elements can be circumferentially disposed around the arm at a first axial position along the arm, and the second set of fixation elements can be circumferentially disposed around the arm at a second axial position along the arm, where the second axial position is axially offset or spaced from the first axial position (e.g., the second axial position can be proximal or distal to the first axial position). In some embodiments, the first set of fixation elements are circumferentially spaced or offset from the second set of fixation elements. The fixation elements 130 can be distributed symmetrically or asymmetrically around the circumference of the arm, along the length of the arm, and / or between components of the device 100. The number of axially spaced fixation elements 130 disposed along the length of the arm can be determined based on the length of the fixation elements 130 and / or the distance between axially adjacent fixation elements 130. As an example, if the distal end 122b of the first arm 122 is approximately 6 mm long and each of the fixation elements 130 is approximately 1 mm long, the distal end 122b can include up to approximately six fixation elements 130 along its length. In this example, if axially adjacent fixation elements 130 are spaced apart from each other, the distal end 122b can include two, three, four, or five fixation elements 130 along its length.

[0094] In some embodiments, the second ends 130b of the fixation elements 130 are radially spaced from the sidewall 500 to prevent or limit forward movement of the lead body 104 when the device 100 is implanted. Nevertheless, the orientation of one, more, or all of the fixation elements 130 can be opposite to the orientation of the fixation elements 130 shown in FIG. 5 , where the first ends 130a of the fixation elements 130 are positioned away from the sidewall 500 and the second ends 130b of the fixation elements 130 are positioned at the sidewall 500. The second ends 130b of one or more of the fixation elements 130 can be positioned proximal or distal to the corresponding first ends 130a of the fixation elements 130.

[0095] The fixation element 130 can be comprised of a portion of the lead's sidewall 500 and / or a separate element secured to the lead's sidewall 500. In some embodiments, the fixation element 130 can be formed by cutting a notch in the lead's sidewall and lifting the second end 130b of the fixation element 130 from the sidewall 500. The fixation element 130 can be formed by laser cutting (e.g., UV laser cutting, gas laser cutting, crystal laser cutting, fiber laser cutting, etc.), mechanical cutting (e.g., cutting with a blade), electron beam machining, water jet cutting, or other suitable methods. In some embodiments, the lead or one or more portions thereof (e.g., lead body, extension, etc.) includes a polymeric tube, and the fixation element 130 is cut from the sidewall of the polymeric tube. The polymer can be a thermoplastic material, such as thermoplastic polyurethane. The fixation element 130 can be bent radially from the cylindrical surface of the sidewall, and heat can be applied to hold the fixation element 130 in the bent configuration. In some embodiments, the lead is backfilled (eg, with silicone) to further secure the fixation element 130 .

[0096] 6A-6D are perspective, top, end, and side views, respectively, of the first connector 110 of FIGS. 2B-2D , which can be configured to connect the electronics package 108 to the extension 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 fastening portions 602 for fastening to another component of the device 100. For example, as shown in FIGS. 6A-6D , the housing 600 can include a first fastening portion 602a for fastening to an electrical conductor carried by the extension 106, a second fastening portion 602b for fastening to the extension 106, and a third fastening portion 602c for fastening to the electronics package 108. The first fastening portion 602a can include a first broad surface 604, a second broad surface 606, and a plurality of recesses 608, each configured to receive an electrical conductor. The first fastening portion 602a is configured to be secured to the electrical conductor and is designed to provide strain relief for the electrical conductor, prevent or limit separation of the electrical conductor from the first fastening portion 602a, and / or prevent damage to the electrical conductor. In some embodiments, the electrical conductor is at least partially soldered, welded, glued, or otherwise secured to the first fastening portion 602a. The second fastening portion 602b can include a lumen 610 configured to receive the proximal end 106a of the extension 106. In some embodiments, the proximal end 106a of the extension 106 is at least partially disposed within the lumen 610, and the second fastening portion 602b can prevent or limit movement of the extension 106 relative to the electronics package 108. The proximal end 106a of the extension 106 can be secured to the first connector 110 by welding, soldering, gluing, adhesive bonding, or the like. The third fastening portion 602c may be spaced apart from the second broad surface 606 of the first fastening portion 602a and may include a protrusion 612 that defines a gap 614 for receiving the electronics package 108.In some embodiments, the electronics package 108 is at least partially disposed within the gap 614, and the protrusion 612 and / or the second broad surface 606 can prevent or limit movement of the electronics package 108 relative to the first connector 110. The electronics package 108 can be secured to the first connector 110 by welding, soldering, bonding, gluing, or the like. The housing 600 can be comprised of a one-piece body or multiple individual components secured together after molding. In some embodiments, the housing 600 includes a polymer material and / or is molded by injection molding, additive manufacturing, or other suitable manufacturing techniques. The housing 600 can be sufficiently flexible to reduce forces exerted on the electrical conductors by movement of the electronics package and / or the extension 106.

[0097] 7A-7C show the extension 106 of the lead 102 separated from the other components of the device 100. The extension 106 can have a number of suitable shapes. For example, the extension 106 can be substantially straight along its longitudinal axis L (see FIG. 7A). In some embodiments, the extension 106 is undulating along its longitudinal axis L between peaks 700 and valleys 702 (see FIG. 7B). As shown in FIG. 7C, the extension 106 can include one or more spirally wound regions 704 wound about its longitudinal axis L. The shape, material, and / or other characteristics of the extension 106 can be determined based on the desired function of the extension 106. For example, the lead body 104 can be configured to be positioned between the genioglossus and geniohyoid muscles, and the electronics package 108 can be configured to be positioned below the mylohyoid muscle. Thus, extension 106 can be configured to extend upward from electronics package 108 to lead body 104 and wrap around the anterior mylohyoid and geniohyoid muscles. Extension 106 can therefore have a length based on the combined thickness of the mylohyoid and geniohyoid muscles, such that when conductive element 114 is positioned at a desired location on a patient, extension 106 has sufficient length to wrap around the mylohyoid and geniohyoid muscles, allowing electronics package 108 to be positioned at a desired location below the mylohyoid muscles. The length of extension 106 can 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 the extension 106 is determined based on the distance between the target location of the conductive elements 114 in the population and the target location of the electronics package 108. For example, the length of the extension 106 can be determined based at least in part on the average thickness of the geniohyoid and mylohyoid muscles for a particular population (e.g., men aged 18 years and older).

[0098] In some embodiments, the extension 106 can be extended to accommodate various combined thicknesses of the geniohyoid and mylohyoid muscles. Any extension 106 disclosed herein (such as those shown in FIGS. 7A-7C ) can be configured to allow the extension 106 to elongate under tension due to the material properties of the extension 106 and / or the shape of the extension 106 (e.g., the undulating and wound shapes shown in FIGS. 7B and 7C , respectively). In some embodiments, the extension 106 has a sufficiently high ductility to allow it to be elongated without deformation or fracture, yet a sufficiently low elasticity to maintain a desired shape after elongation.

[0099] FIG. 8 illustrates the second connector 112 separated from the other components of the device 100. The second connector 112 may be comprised of a single, integrally molded piece, or the second connector 112 may be comprised of multiple, separately formed, independent pieces that are later secured together. In some embodiments, the second connector 112 comprises three tubular portions: a first tubular portion 800a for securing to the extension 106 of the lead 102, a second tubular portion 800b for securing to the first arm 122 of the lead, and a third tubular portion 800c for securing to the second arm 124 of the lead (collectively, "tubular portions 800"). The tubular portions 800 may be integrally formed or may be formed as separate components that are later joined together. Each of the tubular portions 800 may define a lumen configured to accommodate the sidewall of the corresponding component. For example, the first tubular portion 800a can be configured to receive the sidewall of the distal end 106b of the extension 106 therein.

[0100] In some embodiments, the second connector 112 can have a clamshell structure in which the second connector 112 is movable between an open and a closed configuration. FIG. 9 illustrates such a second connector 112 in an open configuration. As illustrated in FIG. 9, the second connector 112 can have a first component 900a and a second component 900b that is movable relative to the first component 900a. The first component 900a and the second component 900b of the clamshell-type second connector 112 can have substantially the same shape or different shapes. In the open configuration, the second component 900b is at least partially separated from the first component 900a. The first component 900a and the second component 900b can each define an open interior space when the second connector 112 is in the open configuration. The first component 900a can be coupled to the second component 900b in one or more positions in the open configuration. For example, the first component 900a can be coupled to the second component 900b via a hinge. In some embodiments, the hinge comprises a thin, flexible piece of material extending between a portion of the first component 900a and a portion of the second component 900b. In some embodiments, the first component 900a can be completely separated from the second component 900b in the open configuration. In the closed configuration, the first component 900a and the second component 900b can be brought close together and aligned to define an enclosed space within the second connector 112.

[0101] This clamshell structure can facilitate assembly of the lead 102 and tunneling of electrical conductors from the lumen of the lead body 104 to the lumen of the extension 106. For example, by moving the second connector 112 to an open configuration, electrical conductors can be placed flat in each branch of the first component 900a (or second component 900b) of the second connector 112. The second component 900b can then be placed over the first component 900a and the second connector 112 moved to a closed configuration, thereby constraining the conductors within each branch of the two connectors 112. This process can be performed more quickly and easily than threading the conductors through the tubular portion of the second connector 112. The discrete components of the second connector 112 can be configured to be secured together mechanically (e.g., using mechanical fasteners, mechanical interfitting such as frictional or snap-fitting) and / or with adhesives. In some embodiments, it may be advantageous to reduce or limit the number of joints between individual components, which can prevent or limit fluid ingress into the second connector 112 and / or mechanical failure of the second connector 112.

[0102] As previously mentioned, one or more electrical conductors connecting the conductive element 114 to the electronics package 108 may be carried by the lead 102. The electrical conductors may be disposed in, along, and / or within a lumen of one or more portions of the lead 102 (e.g., the extension 106, the first arm 122, the second arm 124, etc.). In some embodiments, for example, as shown in FIG. 10A , the electrical conductor 1000 may extend along a substantially linear path through the lumen of the extension 106. Additionally or alternatively, the electrical conductor 1000 may extend along a substantially linear path through a lumen of the lead body 104 (e.g., the lumen of the first arm 122, the lumen of the second arm 124, etc.).

[0103] In some embodiments, it may be useful for the conductors to extend along a curved path through the lumen of the extension 106. For example, as shown in FIG. 10B, the conductors 1000 can be wound together such that each conductor 1000 extends along a helical path through the lumen of the extension 106. FIG. 10C illustrates another example configuration in which a first group of conductors 1000a is wound around one another and a second group of conductors 1000b is wound around one another. The first group of conductors 1000a and the second group of conductors 1000b can be positioned adjacent to one another within the lumen of the extension 106 (e.g., as shown in FIG. 10C). Additionally or alternatively, the first group of conductors 1000a can be wound around the second group of conductors 1000b to form a nested coil structure. In these and other examples, the curved helical path followed by each conductor provides a stress relief feature that reduces stresses caused by stretching of the conductor, thereby improving the fatigue resistance of the conductor.

[0104] FIG. 11 illustrates an example of a neuromodulation device 100 in accordance with some embodiments of the present technology. The functionality of device 1100 is generally similar to the functionality of device 100 shown in FIGS. 2A-10C. Accordingly, like numbers are used in FIGS. 2A-11 to identify similar or identical components (e.g., fixation element 1130 and fixation element 130), and the description of device 1100 in FIG. 11 is primarily limited to features that differ from device 100. Furthermore, any features of device 1100 may be combined with features of device 100.

[0105] Similar to device 100, device 1100 shown in FIG. 11 includes a first arm 1122 and a second arm 1124, each arm including a fixation element 1130 disposed distal to the arm's conductive element 1114 and configured to engage fat surrounding the hypoglossal nerve. Additionally, device 1100 includes one or more fixation elements 1132 configured to secure at least a portion of device 1100 to a patient's tissue. Fixation elements 1132 may include clips, clamps, staples, tines, hooks, barbs, anchors, or other suitable elements for securing device 1100 to a patient's tissue. In some embodiments, fixation elements 1132 include surgical clips. For example, as shown in FIG. 11 , one or more of fixation elements 1132 may comprise a surgical clip having two extensions and a bend between the two extensions. The ends of the two extensions may include barbs configured to penetrate tissue and prevent detachment from the tissue once engaged. In some embodiments, the two extensions can be configured to be equal in length and have approximately equal penetration depths at both ends, while in some embodiments, the two extensions can be configured to be unequal in length and have unequal penetration depths at both ends. Additionally, in some embodiments, the bend can include a curve, such as a "U" or "J" shape.

[0106] According to various embodiments, the fixation element 1132 is configured to simultaneously engage a portion of the device 100 and tissue surrounding the device when the device is implanted. For example, the extensions and bends of the fixation element 1132 can define a space configured to accommodate a portion of the device 1100. For example, as shown in FIG. 11 , the first connector 1110 can be configured to hold one or more first fixation elements 1132 a. The first connector 1110 can include one or more openings configured to receive the extensions of the first fixation elements 1132 a. As shown in FIG. 11 , the second fixation element 1132 b can be configured to be disposed around the second connector 1112. In some embodiments, the second connector 1112 includes one or more ridges and / or channels to facilitate holding the second fixation element 1132 b in a desired position relative to the second connector 1112. In either case, the fixation element 1132 can be a separate component from the lead 1102 and / or electronics package 1108, allowing the device 1100 to be positioned against the patient's tissue before the fixation element 1132 is used to secure the device 1100 to the tissue.

[0107] The fixation elements 1132 can be configured to secure various portions of the device 1100 to various patient tissues. For example, the second fixation element 1132b can be configured to secure the second connector 1112 to the patient's genioglossus muscle. Additionally or alternatively, the first fixation element 1132a can be configured to secure the first connector 1110 to the patient's mylohyoid muscle. In some embodiments, the second fixation element 1132b can be configured to prevent or limit anterior and / or posterior movement of the device 1100 relative to the genioglossus muscle once implanted. Additionally or alternatively, the second fixation element 1132b can be configured to prevent or limit medial and / or lateral movement of the device 1100 after implantation. The first fixation element 1132a can be configured to prevent or limit anterior, posterior, medial, and / or lateral movement of the device 1100 relative to the mylohyoid bone after implantation. In some embodiments, the device 1100 includes at least two first fixation elements 1132a to prevent or limit rotation of the electronics package 1108 relative to the mylohyoid muscle, which may occur if there is only one first fixation element 1132a. For example, the device 1100 may include at least one first fixation element 1132a on or adjacent to each of two opposing sides of the electronics package 1108 (e.g., the inner and outer sides of the electronics package 1108, or the extension 1106) to prevent or limit rotation of the electronics package 1108 about the axis of the extension 1106.

[0108] [Summary] Although systems, devices, and methods for modulating a patient's hypoglossal nerve using a number of embodiments have been described above, the technology is applicable to other applications and / or other approaches, such as modulating other nerves in a patient. Furthermore, other embodiments beyond those described herein are also within the scope of the technology. Furthermore, some other embodiments of the technology may have different configurations, components, or procedures than those described herein. Thus, those skilled in the art will appreciate that the technology may have other embodiments with additional elements, or may have other embodiments that omit some of the features shown and described above with reference to FIGS. 1A-12H.

[0109] The description of the embodiments of the present technology is not exhaustive and is not intended to limit the technology to the precise form disclosed above. Where the context allows, singular or plural terms may also include the plural or singular term, respectively. While specific embodiments and examples of the present invention have been described above for illustrative purposes, those skilled in the art will recognize that various equivalent modifications are possible within the scope of the present invention. For example, while steps are presented in a particular order, in alternative embodiments, steps may be performed in a different order. The various embodiments described herein may also be combined to provide further embodiments.

[0110] As used herein, the terms "generally," "substantially," "about," and similar terms are used as terms of approximation, not degree, and are intended to reflect inherent variations in measurements or calculations that will be appreciated by those of ordinary skill in the art.

[0111] Furthermore, unless the term "or" in a list of two or more items is expressly limited to mean a single item exclusive of the other items, the use of "or" in such a list is to 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. Furthermore, the term "comprising" is used throughout this specification to mean the inclusion of at least the recited features, but not the exclusion of more of the same features and / or other additional features. It will also be understood that, while specific embodiments have been described herein for illustrative purposes, various modifications are possible without departing from the present technology. Furthermore, while advantages of certain embodiments of the present technology have been described in the context of those embodiments, other embodiments may also obtain such advantages, and not all embodiments necessarily need to possess such advantages to be within the scope of the present technology. Accordingly, the present disclosure and related technology may encompass other embodiments not expressly shown or described herein.

Claims

1. 1. An implantable neuromodulation lead, comprising: an extension having a proximal end configured to connect to an electronic component and a distal end; a lead body extending distally from the distal end of the extension, the lead body bifurcating into a first arm and a second arm, the lead body including 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 near a hypoglossal nerve and to transmit an electrical signal to the hypoglossal nerve via the first electrode and the second electrode.

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

3. 3. The implantable neuromodulation lead of claim 1, wherein the first arm includes a proximal region and a distal region, the proximal region extending laterally from the distal end of the extension and the distal region extending distally from the proximal region, and the first electrode is carried by the distal region.

4. The implantable neuromodulation lead of claim 3 , wherein the distal region of the first arm extends distally from the proximal region along a longitudinal dimension.

5. 5. The implantable neuromodulation lead of claim 3 or 4, wherein the proximal region of the first arm is angled vertically away from the extension such that the distal region lies in a different plane than the extension.

6. 6. The implantable neuromodulation lead of claim 1, wherein the second arm includes a proximal region and a distal region, the proximal region extending laterally from the distal end of the extension portion and the distal region extending distally from the proximal region, and the second electrode is carried by the distal region.

7. The implantable neuromodulation lead of claim 6 , wherein the distal region of the second arm extends distally from the proximal region along a longitudinal dimension.

8. 8. The implantable neuromodulation lead of claim 6 or 7, wherein the proximal region of the second arm is angled vertically away from the extension such that the distal region lies in a different plane from the extension.

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

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

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

12. 1. An implantable neuromodulation lead, comprising: an extension having a proximal end configured to connect to an electronic component and a distal end; a lead body extending distally from the distal end of the extension, the lead body branching into left and right arms and including a left electrode disposed on the left arm and a right electrode disposed on the right arm, wherein at least one of the left arm or the right arm is bent relative to the extension so that the at least one of the left arm or the right arm is disposed at a different height than the extension.

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

14. 14. The implantable neuromodulation lead of claim 12 or 13, wherein the right arm is configured for placement near a patient's right hypoglossal nerve and the left arm is configured for placement near a patient's left hypoglossal nerve.

15. 15. The implantable neuromodulation lead of claim 12, wherein when the lead is implanted, at least one of the left arm or the right arm extends upward from a proximal end located at the extension and adjacent the patient's geniohyoid muscle to a distal end adjacent the patient's genioglossus muscle.

16. 16. The implantable neuromodulation lead of claim 12, wherein when the lead is implanted, the proximal end of the extension is located below the patient's mylohyoid muscle and the distal end of the extension is located above the patient's geniohyoid muscle.

17. 17. The implantable neuromodulation lead of claim 12, wherein when the lead is implanted, the extension is positioned to be at least partially located between the patient's right and left geniohyoid muscles.

18. 1. An implantable neuromodulation lead, comprising: an extension having a proximal end configured to connect to an electronic component and a distal end; a lead body extending distally from the distal end of the extension, the lead body bifurcating into left and right arms and including a first electrode disposed on the left arm and a second electrode disposed on the right arm; An implantable neuromodulation lead, wherein the lead body is configured to be at least partially implanted in a sublingual region of a patient and configured to deliver electrical stimulation energy to the sublingual region to treat sleep apnea.

19. 20. The implantable 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 protrusor muscles.

20. 20. The implantable 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 positioned at least partially between the patient's genioglossus and geniohyoid muscles.

21. 21. The implantable neuromodulation lead of claim 18, wherein when the lead is implanted, each of the left arm and the right arm extends upward from a proximal end located at the extension and adjacent the patient's geniohyoid muscle to a distal end also adjacent the patient's genioglossus muscle.

22. 22. The implantable neuromodulation lead of claim 18, wherein the right arm is configured for placement near a patient's right hypoglossal nerve and the left arm is configured for placement near a patient's left hypoglossal nerve.

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

24. 24. The implantable neuromodulation lead of claim 18, wherein when the lead is implanted, the proximal end of the extension is located below the patient's mylohyoid muscle and the distal end of the extension is located above the patient's geniohyoid muscle.

25. 25. The implantable neuromodulation lead of claim 18, wherein when the lead is implanted, the extension is located at least partially between the patient's right and left geniohyoid muscles.

26. 1. An implantable neuromodulation lead, comprising: a lead body having left and right arms connected at their proximal ends, the left and right arms extending laterally apart from one another, and including 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 near a hypoglossal nerve and to transmit electrical signals to the hypoglossal nerve via the left electrode and the right electrode.

27. 1. A neurostimulation lead for implantation at a treatment site within a patient, the neurostimulation lead comprising: A lead body; a plurality of electrodes carried by the lead body; a plurality of fixation members extending radially from the lead body, the fixation members configured to secure the lead body to tissue at the treatment site; The neural stimulation lead is configured to be implanted at the treatment site within a patient's body and to deliver energy to the treatment site via the electrodes.

28. 28. The neuromodulation lead of claim 27, wherein the lead body comprises a polymeric sidewall, and the fixation members are cut out of the polymeric sidewall.

29. 30. 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 from the side wall.

30. The neuromodulation lead of any one of claims 27 to 29, wherein the fixation members extend from the lead body a distance not greater than 0.5 mm.

31. The neuromodulation lead of any one of claims 28 to 30, wherein the fixation member extends in a cantilevered manner from the side wall.

32. The neuromodulation lead of any one of claims 28 to 31, wherein the polymer sidewall comprises a thermoplastic polyurethane.

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

35. The neuromodulation lead of any one of claims 27 to 34, wherein the lead is configured to deliver stimulation energy to the treatment site to treat sleep apnea.

36. The neuromodulation lead of any one of claims 27 to 35, wherein the lead body is configured for placement near the patient's hypoglossal nerve.

37. The neuromodulation lead of any one of claims 27 to 36, wherein the lead body is configured to deliver stimulation energy to the patient's hypoglossal nerve.

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

39. 1. A neuromodulation lead, comprising: a lead body having a plurality of electrodes; an extension having a proximal end configured to connect to an electronic component and a distal end configured to connect to the lead body, the distal end being located opposite the proximal end along a length of the extension, the length of the extension being adjustable to vary the distance between the lead body and the electronic component; The neuromodulation lead is configured to be implanted at a treatment site within a patient's body and to deliver energy to the treatment site via the electrodes.

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

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

42. The neuromodulation lead of any one of claims 39 to 41, wherein the extension comprises an undulating portion.

43. The neuromodulation lead of any one of claims 39 to 42, wherein the neurostimulation lead is configured to deliver stimulation energy to the treatment site to treat sleep apnea.

44. The neuromodulation lead of any one of claims 39 to 43, wherein the lead body is configured for placement near the patient's hypoglossal nerve.

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

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

47. An implantable antenna, a substrate comprising a substrate material; a coil disposed on the substrate, the coil comprising a plurality of coil windings including a first coil winding and a second coil winding adjacent to the first coil winding; An implantable antenna, wherein the substrate comprises at least one open area where the first coil winding and the second coil winding are not connected by the substrate material.

48. 48. The implantable antenna of claim 47, wherein said substrate comprises at least one strut region where said first coil turn and said second coil turn are connected by said substrate material.

49. 49. An implantable antenna as described in claim 47 or 48, wherein the at least one open area comprises an arcuate notch extending along a partial circumference of the first coil winding.

50. An implantable antenna as described in any one of claims 47 to 49, wherein the at least one open area includes a plurality of arc-shaped open areas, each of which extends along a partial circumference of the first coil winding.

51. An implantable antenna as claimed in any one of claims 47 to 50, wherein at least one of the partial perimeter lengths is greater than or equal to about 50% of the circumference of the first coil winding.

52. An implantable antenna as claimed in any one of claims 47 to 51, wherein at least one of the partial perimeter lengths is less than or equal to about 50% of the circumference of the first coil winding.

53. An implantable antenna according to any one of claims 47 to 52, wherein two or more adjacent coil windings are connected to each other by the substrate material.

54. A neuromodulation lead comprising an implantable antenna according to any one of claims 47 to 53.

55. 1. A method of treating sleep-disordered breathing, comprising: Implanting a neuromodulation lead according to any one of claims 1 to 54 at a treatment site within a patient's body; and delivering stimulation energy to the treatment site via the electrode of the neuromodulation lead.

Images