Stimulating electrode assembly, system and method for treating sleep disordered breathing

Abstract

A stimulation electrode assembly for applying bilateral stimulation, for example, to stimulate both the left and right hypoglossal nerves of a patient in the treatment of sleep-disordered breathing. In some methods, the stimulation electrode assembly is inserted through an incision on the side of the patient and implanted in a position extending across the patient's midline.

Description

[Background technology]

[0001] A significant portion of the population suffers from various forms of sleep apnea, and some patients may exhibit more than one type of sleep apnea. [Brief explanation of the drawings]

[0002] [Figure 1A] FIG. 1 is a simplified top view of a stimulation electrode assembly according to the principles of the present disclosure. [Figure 1B] FIG. 1B is a side view of the stimulation electrode assembly of FIG. 1A. [Figure 2] FIG. 1 is a schematic lateral view showing the position and action of the muscles of the upper airway. [Figure 3] FIG. 3 is a schematic diagram showing the location of the hypoglossal nerve and its branches in relation to the anatomy of FIG. 2. [Figure 4] FIG. 1 is a schematic diagram showing the position of the left and right hypoglossal nerves relative to the muscles of the upper airway from an anterior view. [Figure 5A] 1B is a schematic diagram illustrating an implantable location of the stimulation electrode assembly of FIG. 1A relative to the anatomical structure of FIG. 4, in accordance with the principles of the present disclosure. [Figure 5B] FIG. 5B is a schematic diagram representing a simplified profile of the arrangement of FIG. 5A. [Figure 5C] 1 is a schematic diagram illustrating an implantable location according to the principles of the present disclosure. [Figure 6] FIG. 10 is a simplified top view of another stimulation electrode assembly according to the principles of the present disclosure. [Figure 7] FIG. 10 is a simplified top view of another stimulation electrode assembly according to the principles of the present disclosure. [Figure 8] FIG. 10 is a simplified top view of another stimulation electrode assembly according to the principles of the present disclosure. [Figure 9] FIG. 10 is a simplified top view of another stimulation electrode assembly according to the principles of the present disclosure. [Figure 10] FIG. 10 is a simplified top view of another stimulation electrode assembly according to the principles of the present disclosure. [Figure 11]FIG. 10 is a simplified top view of another stimulation electrode assembly according to the principles of the present disclosure. [Figure 12] FIG. 10 is a simplified top view of another stimulation electrode assembly according to the principles of the present disclosure. [Figure 13] FIG. 10 is a simplified top view of another stimulation electrode assembly according to the principles of the present disclosure. [Figure 14] FIG. 10 is a simplified top view of another stimulation electrode assembly according to the principles of the present disclosure. [Figure 15] FIG. 10 is a simplified top view of another stimulation electrode assembly according to the principles of the present disclosure. [Figure 16A] FIG. 10 is a simplified top view of another stimulation electrode assembly according to the principles of the present disclosure. [Figure 16B] 16B is an enlarged cross-sectional view of the stimulating electrode assembly of FIG. 16A taken through one of the stimulating electrodes. [Figure 16C] 16B is an enlarged cross-sectional view of an alternative electrode arrangement that can be used with the stimulating electrode assembly of FIG. 16A. FIG. [Figure 17A] FIG. 10 is a simplified top view of another stimulation electrode assembly according to the principles of the present disclosure. [Figure 17B] FIG. 10 is a simplified top view of another stimulation electrode assembly according to the principles of the present disclosure. [Figure 17C] FIG. 10 is a simplified top view of another stimulation electrode assembly according to the principles of the present disclosure. [Figure 18] FIG. 1 is a simplified perspective view of a portion of the upper airway anatomy illustrating a method according to the principles of the present disclosure; [Figure 19] 1 is a simplified cross-sectional view showing an introducer according to the principles of the present disclosure together with a stimulation electrode assembly; [Figure 20] 1 is a simplified cross-sectional view showing another introducer according to the principles of the present disclosure together with a stimulation electrode assembly; [Figure 21A] FIG. 10 is a simplified end view of another stimulation electrode assembly according to the principles of the present disclosure. [Figure 21B] FIG. 21B is a side view of the stimulation electrode assembly of FIG. 21A. [Figure 22]FIG. 1 is a schematic diagram showing a stimulation electrode assembly implanted for two nerves in accordance with the principles of the present disclosure, together with an implantable pulse generator connected to the stimulation electrode assembly. [Figure 23A] FIG. 2 is a block diagram illustrating an example control portion. [Figure 23B] 23B is a diagram that schematically illustrates at least some examples of different modalities of the control portion of FIG. 23A. [Figure 23C] FIG. 2 is a block diagram that schematically represents an exemplary user interface. DETAILED DESCRIPTION OF THE INVENTION

[0003] In the following detailed description, reference is made to the accompanying drawings that form a part hereof, and in which are shown, by way of illustration, specific examples in which the disclosure may be practiced. Other examples may be utilized, and structural or logical changes may be made without departing from the scope of the present disclosure. Therefore, the following detailed description is not to be taken in a limiting sense. It should be understood that the features of the various examples described herein may be combined with each other, either in part or in whole, unless otherwise specified.

[0004] At least some examples of the present disclosure relate to implantable stimulation electrode assemblies, methods of implanting such stimulation electrode assemblies, and methods of delivering therapy, useful, for example, in conjunction with implantable systems for delivering stimulation therapy to a patient. In some non-limiting examples, the stimulation electrode assemblies are configured to selectively deliver stimulation energy to individual nerves / nerve segments, e.g., on a bilateral basis. In some embodiments, a single stimulation electrode assembly of the present disclosure can selectively affect individual bilateral nerves / nerve segments (e.g., nerve trunks, nerve fiber endings, etc.), such as the left and right hypoglossal nerves. In related embodiments, the single stimulation electrode assembly may be implanted through a single incision (e.g., on or near the side of the patient's jaw) and positioned to extend across the patient's midline.

[0005] At least some examples of the disclosed assemblies, systems, and methods relate to sleep-disordered breathing (SDB) therapy, such as obstructive sleep apnea (OSA) therapy, which may include monitoring, diagnostic, and / or stimulation therapy. However, in other examples, the disclosed assemblies, systems, and methods are used for other types of therapy, including, but not limited to, neurostimulation or cardiac therapy. In some embodiments, such other implementations include, but are not limited to, therapy for central sleep apnea, complex sleep apnea, cardiac disorders, pain management, stroke, deep brain stimulation, and disordered breathing.

[0006] These and additional examples are further described in connection with at least Figures 1-23C.

[0007] An example of a stimulating electrode assembly 20 according to the principles of the present disclosure is shown in simplified form in FIGS. 1A and 1B. The stimulating electrode assembly 20 includes a support 22 and a plurality of stimulating electrodes or a stimulating electrode array 24. For reference, in some non-limiting examples, the stimulating electrode assembly of the present disclosure can be provided as part of a stimulation lead. Thus, in the illustrations of FIGS. 1A and 1B, the stimulating electrode assembly 20 is optionally provided as part of a stimulation lead 30 that further includes a lead body 32. The lead body 32 provides or carries wires (not shown) electrically connected to the stimulating electrodes 24 and is of a structure and length sufficiently flexible for placement within a patient and for coupling to an implanted generator device (not shown) or the like known in the art to deliver electrical energy to the stimulating electrodes 24. In other embodiments, energy can be supplied to the stimulating electrodes 24 by other techniques that do not require the lead body 32.

[0008] The support 22 is configured to maintain the stimulating electrodes 24 (as well as any other electrical components) in an electrically isolated state and is formed from a biocompatible material suitable for implantation in the human body. The support 22 may be flexible to increase patient comfort and allow for adaptation to various patient anatomies. For example, the support 22 may be sufficiently malleable or flexible to conform to the general shape of the target implantation site and, optionally, may be configured to further exert gentle pressure against tissue at the target site to maintain neural contact. As described in more detail below, the support 22 may form or bear one or more features that facilitate delivery / implantation and / or fixation. In any case, the form factor, or footprint, or shape, of the support 22 defines a first end 40 opposite a second end 42, and a top surface 44 opposite a bottom surface 46. In any embodiment in which a lead body 32 is provided, the first end 40 may be considered the leading end of the electrode assembly 20 (e.g., because the first end 40 is opposite the lead body 32), and the second end 42 may be considered the terminal end. As seen in FIG. 1A, the support 22 may have an elongated shape defining a length between the first end 40 and the second end 42 and a width perpendicular to the length (the thickness of the support 22 is seen in FIG. 1B). The length may be greater than the width, and a central major axis A of the shape of the support 22 is defined along or relative to the length. A central minor axis I of the support 22 is defined perpendicular to the central major axis A between the first end 40 and the second end 42. While FIG. 1A illustrates the support 22 as having a paddle or paddle-like shape, other shapes are possible, as described in more detail below. Similarly, FIG. 1B illustrates the support 22 as having a generally linear shape in longitudinal extension, but other shapes are possible. For example, the support 22 may have a preformed or predefined U-shape, W-shape, or other complex shape. In any related embodiment, in addition to the preformed or predefined shape, the support 22 may exhibit sufficient flexibility or "springiness" to flex slightly when implanted relative to the native anatomical structure or tissue.

[0009] Each of the stimulation electrodes 24 is formed from a conductive material suitable for delivering stimulation energy into the human body. The stimulation electrodes 24 can have an elongated (e.g., rectangular) block-like structure as shown in FIGS. 1A and 1B. In other embodiments, one or more or all of the stimulation electrodes 24 can have other shapes (e.g., square, cylindrical, etc.) or structures (e.g., similar to a wire, coil, etc.). While each of the stimulation electrodes 24 is shown in FIG. 1A as having substantially the same shape and orientation relative to the form factor or footprint of the support 22, in other embodiments, each of the stimulation electrodes 24 can have a different shape or orientation, as described in more detail below. In any case, the stimulation electrodes 24 are positioned along the support 22 so as to provide an exposed surface (from which stimulation energy is emitted) at or relative to the top surface 44 of the support 22. The stimulation electrodes 24 are encapsulated by the support 22, electrically insulated from each other, and not otherwise exposed to the bottom surface 46. Although not shown in the view of FIG. 1B, individual electrically insulated wires may extend from each of the stimulation electrodes 24 within the thickness of the support 22.

[0010] The stimulating electrode assembly of the present disclosure includes at least two stimulating electrodes, but may include any number greater than two. In some embodiments, the case of an energy source connected to the stimulating electrode assembly (e.g., the case of an implantable power generator (IPG)) can serve as an electrode. As in the exemplary stimulating electrode assembly 20 shown in FIGS. 1A and 1B , the plurality of stimulating electrodes 24 includes a first end electrode 24 a and a second end electrode 24 b. The first end electrode 24 a is considered to be the electrode closest to the first end 40 of the support 22, and the second end electrode 24 b is considered to be the electrode closest to the second end 42 of the support 22. Alternatively, the first end electrode 24 a and the second end electrode 24 b are located on opposite sides of a central minor axis I, with the first end electrode 24 a being the electrode located farthest from the central minor axis I in a first direction of the central major axis A compared to all other electrodes, and the second end electrode 24 b being the electrode located farthest from the central minor axis I in a second, opposite direction of the central major axis A. Thus, consistent with the above description, the first end electrode 24a can be viewed as the distal electrode of the plurality of electrodes 24, and the second end electrode 24b can be viewed as the distal electrode of the plurality of stimulation electrodes 24. Any number of stimulation electrodes 24 can be positioned intermediate the first end electrode 24a and the second end electrode 24b (multiple of which are shown in dashed lines). The stimulation electrodes 24 can all have a similar shape, or each of the stimulation electrodes 24 can exhibit a different shape. Regardless of the number, shape, orientation, and configuration of the stimulation electrodes 24 provided in the stimulation electrode assembly 20, the distance between the opposing first end electrode 24a and second end electrode 24b serves as the effective length EL of the stimulation electrode assembly 20. The stimulation electrode assembly 20 is configured such that the effective length EL corresponds to (e.g., approximates or exceeds) the expected span dimension of the anatomical target site upon final implantation, for example, the expected span dimension of the bilateral anatomical target sites, as described below.

[0011] For example, in some non-limiting embodiments, the disclosed stimulation electrode assemblies and corresponding systems and methods are configured or formatted to enable selective stimulation of bilateral nerves to treat SDB. By way of background, FIG. 2 illustrates a simplified representation of the musculature of the upper airway in an adult human at the mandible, along with the directional effects of their contraction on various airway structures. The anatomy of the mandible can be described with reference to the connections between the mandible 100, hyoid bone 102, and tongue 104. The sternohyoid muscle 106 extends superiorly from the sternum and clavicle (not shown) and attaches to the hyoid bone 102. The sternothyroid muscle 108 extends superiorly from the cartilage of the sternum and first rib (not shown) and attaches to the thyroid cartilage (not shown). The thyrohyoid muscle 110 extends from the thyroid cartilage and, similar to an extension of the sternohyoid muscle 108, attaches superiorly to the hyoid bone 102. The sternohyoid, sternothyroid, and thyrohyoid muscles 106-110 act to depress the larynx and hyoid bone 102.

[0012] The geniohyoid muscle 112 extends from the medial side of the symphysis of the mandible 100 to the hyoid bone 102. The geniohyoid muscle 112 functions as a superior elevator muscle for the hyoid bone 102 and the base of the tongue 104. The genioglossus muscle 114 is a fan-shaped extrinsic pharyngeal muscle that connects the base of the tongue 104 to the jaw and has attachment points to the mandible 100, hyoid bone 102, and tongue 104. With its posterior fibers, the genioglossus muscle 114 functions to draw the base of the tongue 104 anteriorly, thereby protruding the top of the tongue 104 from the mouth. The styloglossus muscle 116 extends from the styloid process (not shown) to the tongue 104 and functions to draw the tongue 104 upward and posteriorly. The hyoglossus muscle 118 extends from the hyoid bone 102 to the tongue 104 and has a thin, quadrilateral shape. The hyoglossus muscle 118 functions to retract the tongue 104 and depress the tongue 104 on its sides, making the tongue 104 convex from side to side. The genioglossus, styloglossus, and hyoglossus muscles 114-118 are extrinsic muscles of the tongue 104.

[0013] As shown schematically in FIG. 3 , the aforementioned muscles are innervated by the hypoglossal nerve 130. The hypoglossal nerve 130 includes a proximal trunk 131 that divides into a carotid branch 132 and a first medial trunk 134. The carotid branch 132 innervates the sternothyroid muscle 108. The first medial trunk 134 includes a first branch 136 that innervates the thyrohyoid muscle 110, a second branch 138 that innervates the styloglossus muscle 116, and a third branch 140 that innervates the hyoglossus muscle 118. An extension of the first medial trunk 134 is a second medial trunk 142 that has a branch 144 that innervates the geniohyoid muscle 112. An extension of the second medial trunk 142 is a third medial trunk 146 that includes a first branch 148 that innervates the muscles of the tongue 104 and a second branch 150 that innervates the genioglossus muscle 114. For reference, the order of nerve branches reflected by Figure 3 is not necessarily the same in all subjects.

[0014] It will be appreciated that the diagrams of FIGS. 2 and 3 omit various other anatomical structures to better depict the hypoglossal nerve 130. For example, the mylohyoid muscle (as a pair of muscles) runs from the mandible (not shown) to the hyoid bone 102 and extends at least partially over various other anatomical structures, such as the genioglossus muscle 114. Furthermore, the various muscles can be considered to have respective sections on opposite sides of the patient's medial plane or midline (and thus can be considered bilateral). For example, in the simplified illustration of FIG. 4 , the patient's midline or medial plane M is identified, and the genioglossus muscle, which generally arises from the hyoid bone 102, is shown on opposite sides of the midline M as genioglossus muscle sections 114a and 114b (e.g., section 114a can also be considered the left genioglossus muscle and section 114b can also be considered the right genioglossus muscle (the terms "left" and "right" are used relative to the patient's perspective)). For reference, only about 80% of the genioglossus muscle goes to the hyoid bone 102. Similarly, the hyoid muscle arises from the hyoid bone 102 as hyoid muscle sections 118a and 118b on opposite sides of the midline M (e.g., section 118a can be considered the left hyoid muscle and section 118b can be considered the right hyoid muscle). These and other individual muscles or muscle segments are innervated separately by individual or separate nerves. For example, the left genioglossus muscle 114a and the left hyoid muscle 118a are innervated by the first or left hypoglossal nerve 130a, and the right genioglossus muscle 114b and the right hyoid muscle 118b are innervated by the second or right hypoglossal nerve 130b. Thus, the hypoglossal nerves 130a and 130b are located on opposite sides of the midline M (at least from the perspective of FIG. 4). The left and right hypoglossal nerves 130a, 130b extend forward from opposite sides of the midline M, with the second branch 150a of the third medial trunk of the left hypoglossal nerve 130a innervating the left genioglossus muscle 114a and the second branch 150b of the third medial trunk of the right hypoglossal nerve 130b innervating the right genioglossus muscle 114b. Similarly, the third branch 140a of the first medial trunk of the left hypoglossal nerve 130a innervates the left hyoglossus muscle 118a, and the third branch 140b of the first medial trunk of the right hypoglossal nerve 130b innervates the right hyoglossus muscle 118b.The left and right hypoglossal nerves 130a, 130b, and particularly the corresponding bilateral branches 140a, 140b and 150a, 150b, are discrete or separate from one another. For reference, Figure 4 also shows the branches of each of the hypoglossal nerves 130a, 130b that extend to the geniohyoid muscle (not shown).

[0015] In some embodiments of the present disclosure, the stimulation electrode assembly, upon final implantation, has a form factor (or size and shape) suitable for providing stimulation energy to both the left and right hypoglossal nerves 130a, 130b, for example, in the region of the third medial trunk second branch 150a of the left hypoglossal nerve 130a and the third medial trunk second branch 150b of the right hypoglossal nerve 130b, or in the region of the first medial trunk third branch 140a of the left hypoglossal nerve 130a and the first medial trunk third branch 140b of the right hypoglossal nerve 130b. These and other corresponding or bilateral regions can collectively define a spanning distance of the target site extending across the midline M. For example, FIG. 4 identifies a first spanning distance S1 encompassing both the third medial trunk second branch 150a of the left hypoglossal nerve 130a and the third medial trunk second branch 150b of the right hypoglossal nerve 130b. A second spanning distance S2 is also identified that encompasses both the first medial trunk third branch 140a of the left hypoglossal nerve 130a and the first medial trunk third branch 140b of the right hypoglossal nerve 130b. Other spanning distances that cross the midline M and encompass at least a portion (e.g., branches, nerve endings, etc.) of two separate nerves of interest may also be identified.

[0016] 1A and 1B, the effective length EL can be selected according to a spanning distance (e.g., S1, S2, etc.). For example, in some embodiments, the stimulation electrode assembly 20 is configured for bilateral application to act on both the left and right hypoglossal nerves 130a, 130b within or near the innervation areas of the left and right genioglossus muscles 114a, 114b. In these and related embodiments, the effective length EL is approximately equal to or greater than the expected first spanning distance S1 (in a human adult, the identified first spanning distance S1 is typically about 3 cm). Additionally or alternatively, the stimulation electrode assembly 20 can be configured to act on the left and right hypoglossal nerves 130a, 130b within or near the innervation areas of the left and right hyoglossus muscles 118a, 118b. In these and related embodiments, the effective length EL is approximately equal to or greater than the expected second spanning distance S2 (in a human adult, the identified second spanning distance S2 is typically about 5 cm). Other anatomical spanning distances can be accommodated by the selected effective length EL, and the present disclosure is not limited to stimulation of the left and right hypoglossal nerves 130 a, 130 b. For example, the spatial distance can be selected to encompass the ends (nerve fiber ends) of the left and right hypoglossal nerves 130 a, 130 b.

[0017] Several methods of the present disclosure for delivering the stimulation electrode assembly 20 to a desired target site are described in more detail below. One possible final implantation configuration is identified at 200 in FIG. 5A . As shown, the stimulation electrode assembly 20 extends across the patient's midline M and provides at least one electrode 24 positioned to affect the left hypoglossal nerve 130a (e.g., the third medial nerve trunk second branch 150a of the left hypoglossal nerve 130a) and at least one other electrode 24 positioned to affect the right hypoglossal nerve 130b (e.g., the third medial nerve canal second branch 150B of the right hypoglossal nerve 130b), e.g., on a bilateral basis. By providing opposing end electrodes 24a, 24b (FIGS. 1A and 1B) with an effective length EL (FIGS. 1A and 1B) corresponding to (e.g., greater than) the expected span distance S1 (FIG. 4), the at least one electrode 24 will be correctly positioned to best interact with the left and right hypoglossal nerves 130a and 130b. Additional stimulation electrodes between the end electrodes 24a and 24b allow for stimulation of the right and / or left hypoglossal nerves, accounting for variations in patient anatomy and implantation location. Figure 5B shows one possible profile view of the final implantation configuration of Figure 5A. As shown, the stimulation electrode assembly 20 may be implanted between the left and right genioglossus muscle sections 114a, 114b and the left and right geniohyoid muscle sections 112a, 112b. At least one of the electrodes 24 is positioned to affect the left hypoglossal nerve 130a, and another of the electrodes 24 is positioned to affect the right hypoglossal nerve 130b. The electrodes 24 may be slightly spaced from or in contact with the corresponding nerves 130a, 130b. Other target sites are possible, and the present disclosure is not limited to stimulation of the left and right hypoglossal nerves 130a and 130b. For reference, in the non-limiting example of Figure 5B, the support 22, and thus the stimulation electrode assembly 20 as a whole, is illustrated as having or assuming a generally uniform, slightly U-like shape upon final implantation. This shape may be a preformed attribute of the support 22.In other embodiments, the supports of the present disclosure can be configured (e.g., material, size, shape, etc.) to conform to various curvatures imposed by the native anatomy of the target site (e.g., conforming to the curvature of genioglossus muscle sections 114a, 114b, geniohyoid muscle sections 112a, 112b, etc.). This, in turn, can, for example, allow the stimulation electrode assembly 20 to have a more "W" or W-like shape (or other complex shape) upon final implantation. Some non-limiting examples of stimulation electrode assembly configurations that may be suitable for better conforming to muscle profiles are described below with respect to FIGS. 12-14. The supports and stimulation electrode assemblies of the present disclosure can optionally have or exhibit sufficient malleability or flexibility to maintain good neural contact upon final implantation into a particular native anatomical target site. In another non-limiting example, the supports and stimulation electrode assemblies of the present disclosure can have a preformed or predefined shape and exhibit sufficient flexibility to apply gentle pressure against the native anatomy to maintain neural contact. For example, for a target implantation site suggested by FIG. 5B, the support 22 may have a narrower, stiffer U- or W-shape (or other complex shape) that can exert "upward pressure" and maintain closer nerve contact (e.g., the shape and / or "elasticity" of the support 22 is such that contact with the geniohyoid muscle sections 112a, 112b brings one or more of the electrodes 24 carried by the support 22 into contact with the nerves 130a, 130b).

[0018] Any of the disclosed stimulation electrode assemblies and corresponding leads can be alternatively configured and implanted such that the stimulation electrodes are positioned to stimulate or "capture" the endings of the nerve fibers of interest (e.g., located near the nerve ends). As a non-limiting example, in the arrangement of FIG. 5C , the electrode assembly 20 is implanted at or near the bases of the genioglossus muscles 114a, 114b, with selected ones of the stimulation electrodes 24 positioned near the nerve ends of the left and right hypoglossal nerves 130a, 130b to deliver stimulation energy (from near the bases of the genioglossus muscles 114a, 114b). One or more of the stimulation electrodes 24 may reside at or within the tissue of the genioglossus muscles 114a, 114b. Additionally, the support 22 can optionally incorporate tension-relieving properties (e.g., in the region corresponding to the "20" arrow in FIG. 5C) to accommodate relative movement between the left and right genioglossus sections 114a, 114b. In the embodiment of FIG. 5C and related structures, the electrode assembly 20 can be operated to capture the nerve fiber endings by applying stimulation energy near the nerve endings at a level sufficient to stimulate the nerve endings, rather than necessarily directly stimulating the genioglossus muscle.

[0019] 1A and 1B, a stimulating electrode assembly of the present disclosure, e.g., stimulating electrode assembly 20, can include multiple stimulating electrodes 24 arranged in a single row, with the elongated shape of each of the stimulating electrodes 24 oriented perpendicular to the central longitudinal axis A of the support 22. Other configurations or arrangements of the stimulating electrodes 24 relative to the shape or footprint of the support 22 are also contemplated. For example, another stimulating electrode assembly 220 according to the principles of the present disclosure is shown in simplified form in FIG. 6. The stimulating electrode assembly 220 includes the support 22 described above and a plurality or array of stimulating electrodes 224. The stimulating electrode assembly 220 is optionally provided as part of a stimulation lead 230, which further includes the lead body 32 described above.

[0020] Each of the stimulation electrodes 224 is formed from a conductive material suitable for delivering stimulation energy into the human body. Each of the stimulation electrodes 224 can have an elongated, block-like structure as shown in FIG. 6 . In other embodiments, one, more, or all of the stimulation electrodes 224 can have other shapes (e.g., square, cylindrical, etc.) or structures (e.g., similar to a wire, coil, etc.). While each of the stimulation electrodes 224 is shown in FIG. 6 as having substantially the same shape and orientation relative to the form factor or footprint of the support 22, in other embodiments, each of the stimulation electrodes 224 can have a different shape or orientation, as described in more detail below. In any case, the stimulation electrodes 224 are positioned along the support 22 to provide an exposed surface (from which stimulation energy is emitted) at or relative to the top surface 44 of the support 22. The stimulation electrodes 224 are encapsulated by the support 22 and electrically insulated from one another. In some embodiments, one or more of the stimulation electrodes 224 may be electrically common. Although not visible in the view of FIG. 6, individual electrically insulated wires may extend from each of the stimulation electrodes 224 within the thickness of the support 22.

[0021] The stimulation electrodes 224 are arranged in a two-row array across the support 22, with the elongated shape of each of the stimulation electrodes 224 oriented substantially parallel (i.e., within 5 degrees of a perfectly parallel relationship) to the central longitudinal axis A. Other numbers of rows (three or more) are possible. The plurality of stimulation electrodes 224 includes a first end electrode 224 a and a second end electrode 224 b. The first end electrode 224 a is the stimulation electrode closest to the first end 40 of the support 22, and the second end electrode 224 b is the stimulation electrode closest to the second end 42 of the support 22. Thus, the first end electrode 224 a can be viewed as the leading electrode of the plurality of stimulation electrodes 224, and the second end electrode 224 b can be viewed as the trailing electrode of the plurality of stimulation electrodes 224. In embodiments in which two or more rows of stimulating electrodes are aligned (e.g., similar to the embodiment of FIG. 6), there may be two (or more) aligned first or tip electrodes 224a and / or two (or more) aligned second or terminal electrodes 224b. Any number of stimulating electrodes 224 may be positioned intermediate the first end electrodes 224a and the second end electrodes 224b. Regardless of the number, shape, orientation, and configuration of the stimulating electrodes 224 provided on the stimulating electrode assembly 220, the distance between the opposing first end electrodes 224a and second end electrodes 224b serves as the effective length EL of the stimulating electrode assembly 220. In accordance with the above description, the stimulation electrode assembly 220 is configured such that its effective length EL corresponds to (e.g., approximates or exceeds) the expected span dimension of the anatomical target site upon final implantation, e.g., the expected span dimension of the bilateral anatomical target sites (e.g., with further reference to FIG. 4 , the span distance S1 between the left and right hypoglossal nerves 130a, 130b within or near the region of innervation corresponding to the left and right genioglossus muscles 114a, 114b, or the span distance S2 between the left and right hypoglossal nerves 130a, 130b within or near the region of innervation corresponding to the left and right hyoglossus muscles 118a, 118b, or the span distance between the nerve endings of the left and right hypoglossal nerves 130a, 130b).

[0022] Although some embodiments have been illustrated with the stimulation electrodes in the stimulation electrode assembly having a common orientation relative to the central longitudinal axis A, other configurations are possible. For example, another stimulation electrode assembly 320 according to the principles of the present disclosure is shown in simplified form in FIG. 7. The stimulation electrode assembly 320 includes the support 22 described above and a plurality or array of stimulation electrodes 324. The stimulation electrode assembly 320 is optionally provided as part of a stimulation lead 330, which further includes the lead body 32 described above.

[0023] Each of the stimulation electrodes 324 is formed from a conductive material suitable for delivering stimulation energy into the human body. Each of the stimulation electrodes 324 can have an elongated, block-like structure as shown in FIG. 7 . In other embodiments, one, more, or all of the stimulation electrodes 324 can have other shapes (e.g., square, cylindrical, etc.) or structures (e.g., similar to a wire, coil, etc.). The stimulation electrodes 324 are positioned along the support 22 to provide an exposed surface (from which stimulation energy is emitted) at or relative to the top surface 44 of the support 22. The stimulation electrodes 324 are encapsulated by the support 22 and electrically insulated from one another. In some embodiments, one or more of the stimulation electrodes 324 may be electrically common. Although not visible in the view of FIG. 7 , individual, electrically insulated wires can extend from each of the stimulation electrodes 324 within the thickness of the support 22.

[0024] The stimulation electrodes 324 are arranged symmetrically about the central minor axis I and include one or more stimulating electrodes whose elongated shapes are oriented substantially parallel to the central major axis A (i.e., within 5 degrees of true parallel relationship) and one or more stimulating electrodes whose elongated shapes are oriented substantially perpendicular to the central major axis A (i.e., within 5 degrees of true perpendicular relationship). In either case, the plurality of stimulating electrodes 324 includes a first end electrode 324 a and a second end electrode 324 b. The first end electrode 324 a is the stimulating electrode closest to the first end 40 of the support 22, and the second end electrode 324 b is the stimulating electrode closest to the second end 42 of the support 22. Thus, the first end electrode 324 a can be viewed as the leading electrode of the plurality of stimulating electrodes 324, and the second end electrode 324 b can be viewed as the trailing electrode of the plurality of stimulating electrodes 324. In some embodiments (e.g., similar to the embodiment of FIG. 7 ), there may be two (or more) aligned first or tip electrodes 324 a and / or two (or more) aligned second or terminal electrodes 324 b. Any number of stimulation electrodes 324 may be positioned intermediate the first end electrode 324 a and the second end electrode 324 b. Regardless of the number, shape, orientation, and configuration of stimulation electrodes 324 provided in the stimulation electrode assembly 320, the distance between the opposing first end electrode 324 a and second end electrode 324 b serves as the effective length EL of the stimulation electrode assembly 320. In accordance with the above description, the stimulation electrode assembly 320 is configured such that its effective length EL corresponds to (e.g., approximates or exceeds) the expected span dimension of the anatomical target site upon final implantation, e.g., the expected span dimension of the bilateral anatomical target sites (e.g., with further reference to FIG. 4 , the span distance S1 between the left and right hypoglossal nerves 130a, 130b within or near the region of innervation corresponding to the left and right genioglossus muscles 114a, 114b, or the span distance S2 between the left and right hypoglossal nerves 130a, 130b within or near the region of innervation corresponding to the left and right hyoglossus muscles 118a, 118b, or the span distance between the nerve endings of the left and right hypoglossal nerves 130a, 130b, etc.).

[0025] Although some embodiments have been illustrated with the stimulation electrodes in the stimulation electrode assembly having a substantially parallel or substantially perpendicular orientation relative to the central longitudinal axis A, other configurations are possible. For example, another stimulation electrode assembly 420 according to the principles of the present disclosure is shown in simplified form in FIG. 8. The stimulation electrode assembly 420 includes the support 22 described above and a plurality or array of stimulation electrodes 424. The stimulation electrode assembly 420 is optionally provided as part of a stimulation lead 430, which further includes the lead body 32 described above.

[0026] Each of the stimulation electrodes 424 is formed from a conductive material suitable for delivering stimulation energy into the human body. Each of the stimulation electrodes 424 can have an elongated block-like structure as shown in FIG. 8 . In other embodiments, one, more, or all of the stimulation electrodes 424 can have other shapes (e.g., square, cylindrical, etc.) or structures (e.g., similar to a wire, coil, etc.). The stimulation electrodes 424 are positioned along the support 22 to provide an exposed surface (from which stimulation energy is emitted) at or relative to the top surface 44 of the support 22. The stimulation electrodes 424 are encapsulated by the support 22 and electrically insulated from one another. In some embodiments, one or more of the stimulation electrodes 424 may be electrically common. Although not visible in the view of FIG. 8 , individual electrically insulated wires can extend from each of the stimulation electrodes 424 within the thickness of the support 22.

[0027] The overall arrangement of the stimulating electrodes 424 relative to the central minor axis I may be symmetrical or may include one or more stimulating electrodes oriented in an elongated shape that is non-parallel and non-perpendicular to the central major axis A (e.g., disposed at a 45-degree angle relative to the central major axis A). In either case, the plurality of stimulating electrodes 424 includes a first end electrode 424a and a second end electrode 424b. The first end electrode 424a is the stimulating electrode closest to the first end 40 of the support 22, and the second end electrode 424b is the stimulating electrode closest to the second end 42 of the support 22. Thus, the first end electrode 424a can be viewed as the leading electrode of the plurality of stimulating electrodes 424, and the second end electrode 424b can be viewed as the trailing electrode of the plurality of stimulating electrodes 424. In some embodiments (e.g., similar to the embodiment of FIG. 8), there may be two (or more) aligned first or leading electrodes 424a and / or two (or more) aligned second or trailing electrodes 424b. Any number of stimulation electrodes 424 may be positioned intermediate the first end electrode 424 a and the second end electrode 424 b. Regardless of the number, shape, orientation, and configuration of the stimulation electrodes 424 provided in the stimulation electrode assembly 420, the distance between the opposing first end electrode 424 a and second end electrode 424 b serves as the effective length EL of the stimulation electrode assembly 420. In accordance with the above description, the stimulation electrode assembly 420 is configured such that its effective length EL corresponds to (e.g., approximates or exceeds) the expected span dimension of the anatomical target site upon final implantation, e.g., the expected span dimension of the bilateral anatomical target sites (e.g., with further reference to FIG. 4 , the span distance S1 between the left and right hypoglossal nerves 130a, 130b within or near the region of innervation corresponding to the left and right genioglossus muscles 114a, 114b, or the span distance S2 between the left and right hypoglossal nerves 130a, 130b within or near the region of innervation corresponding to the left and right hyoglossus muscles 118a, 118b, or the span distance between the nerve terminals of the left and right hypoglossal nerves 130a, 130b).

[0028] Although some embodiments are shown with the stimulation electrodes in the stimulation electrode assembly having substantially the same size, other configurations are possible. For example, another stimulation electrode assembly 520 according to the principles of the present disclosure is shown in simplified form in FIG. 9. The stimulation electrode assembly 520 includes the support 22 described above and a plurality or array of stimulation electrodes 524. The stimulation electrode assembly 520 is optionally provided as part of a stimulation lead 530, which further includes the lead body 32 described above.

[0029] Each of the stimulation electrodes 524 is formed from a conductive material suitable for delivering stimulation energy into the human body. Each of the stimulation electrodes 524 can have an elongated, block-like structure as shown in FIG. 9 . In other embodiments, one, more, or all of the stimulation electrodes 524 can have other shapes (e.g., square, cylindrical, etc.) or structures (e.g., similar to a wire, coil, etc.). The stimulation electrodes 524 are positioned along the support 22 to provide an exposed surface (from which stimulation energy is emitted) at or relative to the upper surface 44 of the support 22. The stimulation electrodes 524 are encapsulated by the support 22 and electrically insulated from one another. In some embodiments, one or more of the stimulation electrodes 524 may be electrically common. Although not visible in the view of FIG. 9 , individual, electrically insulated wires can extend from each of the stimulation electrodes 524 within the thickness of the support 22.

[0030] The overall arrangement of the stimulating electrodes 524 relative to the central minor axis I may be symmetrical and may include one or more stimulating electrodes whose elongated shapes are oriented substantially parallel to the central major axis A and one or more stimulating electrodes whose elongated shapes are oriented substantially perpendicular to the central major axis A. Additionally, the stimulating electrodes 524 may define a pseudo-random array and may include a common large central electrode 524c on both sides of the support 22 (e.g., the central electrode extends along the central minor axis I). In some cases, the central electrode 524c may be utilized as part of a stimulation vector for both the left and right hypoglossal nerves. In either case, the plurality of stimulating electrodes 524 includes a first end electrode 524a and a second end electrode 524b. The first end electrode 524a is the stimulating electrode closest to the first end 40 of the support 22, and the second end electrode 524b is the stimulating electrode closest to the second end 42 of the support 22. Thus, the first end electrode 524a can be viewed as the leading electrode of the plurality of stimulating electrodes 524, and the second end electrode 524b can be viewed as the terminal electrode of the plurality of stimulating electrodes 524. Any number of stimulating electrodes 524 can be positioned intermediate the first end electrode 524a and the second end electrode 524b. Regardless of the number, shape, orientation, and configuration of the stimulating electrodes 524 provided in the stimulating electrode assembly 520, the distance between the opposing first end electrode 524a and second end electrode 524b serves as the effective length EL of the stimulating electrode assembly 520. In accordance with the above description, the stimulation electrode assembly 520 is configured such that its effective length EL corresponds to (e.g., approximates or exceeds) the expected span dimension of the anatomical target site upon final implantation, e.g., the expected span dimension of the bilateral anatomical target sites (e.g., with further reference to FIG. 4 , the span distance S1 between the left and right hypoglossal nerves 130a, 130b within or near the region of innervation corresponding to the left and right genioglossus muscles 114a, 114b, or the span distance S2 between the left and right hypoglossal nerves 130a, 130b within or near the region of innervation corresponding to the left and right hyoglossus muscles 118a, 118b, or the span distance between the nerve endings of the left and right hypoglossal nerves 130a, 130b).

[0031] Although some embodiments show the stimulation electrodes in the stimulation electrode assembly having one or more rectangular stimulation electrodes, other configurations are possible. For example, another stimulation electrode assembly 620 according to the principles of the present disclosure is shown in simplified form in FIG. 10 . The stimulation electrode assembly 620 includes the support 22 described above and a plurality or array of stimulation electrodes 624. The stimulation electrode assembly 620 is optionally provided as part of a stimulation lead 630, which further includes the lead body 32 described above.

[0032] Each of the stimulation electrodes 624 is formed from a conductive material suitable for delivering stimulation energy into the human body. One, more, or all of the stimulation electrodes 624 may have a circular shape, as shown in FIG. 10 . In other embodiments, one or more of the stimulation electrodes 624 may have other shapes (e.g., square, cylindrical, etc.) or structures (e.g., similar to a wire, coil, etc.). The stimulation electrodes 624 are positioned along the support 22 to provide an exposed surface (from which stimulation energy is emitted) at or relative to the upper surface 44 of the support 22. The stimulation electrodes 624 are encapsulated by the support 22 and electrically insulated from one another. In some embodiments, one or more of the stimulation electrodes 624 may be electrically common. Although not visible in the view of FIG. 10 , individual electrically insulated wires may extend from each of the stimulation electrodes 624 within the thickness of the support 22.

[0033] The overall arrangement of the stimulation electrodes 624 relative to the central short axis I may be symmetrical and include a first end electrode 624a and a second end electrode 624b. The first end electrode 624a is the stimulation electrode closest to the first end 40 of the support 22, and the second end electrode 624b is the stimulation electrode closest to the second end 42 of the support 22. Thus, the first end electrode 624a may be viewed as the leading electrode of the plurality of electrodes 624, and the second end electrode 624b may be viewed as the terminal electrode of the plurality of stimulation electrodes 624. In some embodiments (e.g., similar to the embodiment of FIG. 10 ), there may be two (or more) aligned first or leading electrodes 624a and / or two (or more) aligned second or terminal electrodes 624b. Any number of stimulation electrodes 624 may be positioned intermediate the first end electrode 624a and the second end electrode 624b. Regardless of the number, shape, orientation, and configuration of the stimulating electrodes 624 provided in the stimulating electrode assembly 620, the distance between opposing first and second end electrodes 624 a, 624 b serves as the effective length EL of the stimulating electrode assembly 620. In accordance with the above description, the stimulating electrode assembly 620 is configured such that the effective length EL corresponds to (e.g., approximates or exceeds) the expected span dimension of the anatomical target site upon final implantation, for example, the expected span dimension of the bilateral anatomical target sites (e.g., with further reference to FIG. 4 , the span distance S1 between the left and right hypoglossal nerves 130 a, 130 b within or near the region of innervation corresponding to the left and right genioglossus muscles 114 a, 114 b, or the span distance S2 between the left and right hypoglossal nerves 130 a, 130 b within or near the region of innervation corresponding to the left and right hyoglossus muscles 118 a, 118 b, or the span distance between the nerve endings of the left and right hypoglossal nerves 130 a, 130 b, etc.).

[0034] Although some embodiments show the stimulation electrodes in the stimulation electrode assembly having a solid or block-like structure, other configurations are possible. For example, another stimulation electrode assembly 720 according to the principles of the present disclosure is shown in simplified form in FIG. 11 . The stimulation electrode assembly 720 includes the support 22 described above and a plurality or array of stimulation electrodes 724. The stimulation electrode assembly 720 is optionally provided as part of a stimulation lead 730, which further includes the lead body 32 described above.

[0035] Each of the stimulation electrodes 724 is formed from a conductive material suitable for delivering stimulation energy into the human body. One, more, or all of the stimulation electrodes 724 may be a coiled wire, as shown in FIG. 11 . In other embodiments, one or more of the stimulation electrodes 724 may have other shapes or configurations. The stimulation electrodes 724 are positioned along the support 22 to provide an exposed surface (from which stimulation energy is emitted) at or relative to the upper surface 44 of the support 22. The stimulation electrodes 724 are encapsulated by the support 22 and electrically insulated from one another. In some embodiments, one or more of the stimulation electrodes 724 may be electrically common. Although not visible in the view of FIG. 11 , individual electrically insulated wires may extend from each of the stimulation electrodes 724 within the thickness of the support 22.

[0036] The overall arrangement of the stimulating electrodes 724 relative to the central short axis I may be symmetrical and include a first end electrode 724a and a second end electrode 724b. The first end electrode 724a is the stimulating electrode closest to the first end 40 of the support 22, and the second end electrode 724b is the stimulating electrode closest to the second end 42 of the support 22. Thus, the first end electrode 724a may be viewed as the leading electrode of the plurality of stimulating electrodes 724, and the second end electrode 724b may be viewed as the terminal electrode of the plurality of stimulating electrodes 724. Any number of stimulating electrodes 724 may be positioned intermediate the first end electrode 724a and the second end electrode 724b. Regardless of the number, shape, orientation, and configuration of the stimulating electrodes 724 provided in the stimulating electrode assembly 720, the distance between the opposing first end electrode 724a and second end electrode 724b serves as the effective length EL of the stimulating electrode assembly 720. In accordance with the above description, the stimulation electrode assembly 720 is configured such that its effective length EL corresponds to (e.g., approximates or exceeds) the expected span dimension of the anatomical target site upon final implantation, e.g., the expected span dimension of the bilateral anatomical target sites (e.g., with further reference to FIG. 4 , the span distance S1 between the left and right hypoglossal nerves 130a, 130b within or near the region of innervation corresponding to the left and right genioglossus muscles 114a, 114b, or the span distance S2 between the left and right hypoglossal nerves 130a, 130b within or near the region of innervation corresponding to the left and right hyoglossus muscles 118a, 118b, or the span distance between the nerve endings of the left and right hypoglossal nerves 130a, 130b, etc.).

[0037] Although some embodiments have illustrated the support in the stimulation electrode assembly as having a relatively uniform perimeter, other configurations are possible. For example, another stimulation electrode assembly 820 according to the principles of the present disclosure is shown in simplified form in FIG. 12. The stimulation electrode assembly 820 includes a support 822 and a plurality or array of stimulation electrodes 824. The stimulation electrode assembly 820 is optionally provided as part of a stimulation lead 830, which further includes the lead body 32 described above.

[0038] The support 822 is similar to the support 22 (FIG. 1) described above and is configured to maintain the stimulating electrode 824 (as well as any other electrical components) in an electrically insulated state. The support 822 is formed from a biocompatible material suitable for implantation in the human body. As described in more detail below, the support 822 can form or bear one or more features that facilitate implantation and / or fixation. In any case, the form factor, or footprint, or shape, of the support 822 defines a first end 840 opposite a second end 842, and a top surface 844 opposite a bottom surface (hidden in the figure). In any embodiment in which a lead body 32 is provided, the first end 840 may be considered the tip of the stimulating electrode assembly 820 (e.g., because the first end 840 is opposite the lead body 32), and the second end 842 may be considered the terminus. The shape of the support 822 defines a length between the first end 840 and the second end 842, and a width perpendicular to the length. The length may be greater than the width, and a central major axis A of the shape of the support 822 is defined along or relative to the length. A central minor axis I of the support 822 is defined perpendicular to the central major axis A between the first end 840 and the second end 842.

[0039] In the non-limiting example of FIG. 12 , the support 822 narrows (e.g., the hourglass shape of FIG. 12 ), for example, at or near the central minor axis I. In these and related embodiments, the thinned region of the support 822 can exhibit enhanced flexibility compared to other embodiments, imparting less shear force to the support 822 upon final implantation. The increased flexibility can accommodate relative movement between the left and right muscles during stimulation. Other shapes different from the paddle shape and the hourglass shape described above are also contemplated for the stimulation electrode assemblies of the present disclosure. For example, the support can alternatively have a cylindrical, oval, butterfly shape, etc. The thinned region may be part of the support 822 or may be a separate component joining two separate support sections.

[0040] Each of the stimulation electrodes 824 is formed from a conductive material suitable for delivering stimulation energy into the human body. The stimulation electrodes 824 can assume any of the structures disclosed herein, for example, they can be provided as elongated or rectangular block electrodes. In other embodiments, one or more of the stimulation electrodes 824 can have other shapes (e.g., square, cylindrical, etc.) or structures (e.g., similar to a wire, coil, etc.). The stimulation electrodes 824 are positioned along the support 822 to provide an exposed surface (from which stimulation energy is emitted) at or relative to the upper surface 844 of the support 822. The stimulation electrodes 824 are encapsulated by the support 822 and electrically insulated from one another. In some embodiments, one or more of the stimulation electrodes 824 may be electrically common. Although not visible in the view of FIG. 12 , individual electrically insulated wires can extend from each of the stimulation electrodes 824 within the thickness of the support 822.

[0041] The overall arrangement of the stimulation electrodes 824 relative to the central short axis I may be symmetrical and include a first end electrode 824a and a second end electrode 824b. The first end electrode 824a is the stimulation electrode closest to the first end 840 of the support 822, and the second end electrode 824b is the stimulation electrode closest to the second end 842 of the support 822. Thus, the first end electrode 824a may be viewed as the leading electrode of the plurality of stimulation electrodes 824, and the second end electrode 824b may be viewed as the terminal electrode of the plurality of stimulation electrodes 824. Any number of stimulation electrodes 824 may be positioned intermediate the first end electrode 824a and the second end electrode 824b. Regardless of the number, shape, orientation, and configuration of the stimulation electrodes 824 provided in the stimulation electrode assembly 820, the distance between the opposing first end electrode 824a and second end electrode 824b serves as the effective length EL of the stimulation electrode assembly 820. In accordance with the above description, the stimulation electrode assembly 820 is configured such that its effective length EL corresponds to (e.g., approximates or exceeds) the expected span dimension of the anatomical target site upon final implantation, e.g., the expected span dimension of the bilateral anatomical target sites (e.g., with further reference to FIG. 4 , the span distance S1 between the left and right hypoglossal nerves 130a, 130b within or near the region of innervation corresponding to the left and right genioglossus muscles 114a, 114b, or the span distance S2 between the left and right hypoglossal nerves 130a, 130b within or near the region of innervation corresponding to the left and right hyoglossus muscles 118a, 118b, or the span distance between the nerve endings of the left and right hypoglossal nerves 130a, 130b, etc.).

[0042] Another stimulating electrode assembly 920 according to the principles of the present disclosure is shown in simplified form in Figure 13. The stimulating electrode assembly 920 includes a support 922 (generally referred to as a support) and a plurality or array of stimulating electrodes 924. The stimulating electrode assembly 920 is optionally provided as part of a stimulation lead 930, which further includes the lead body 32 described above.

[0043] The support 922 is similar to the support 22 (FIG. 1) described above and is configured to maintain the stimulating electrode 924 (as well as any other electrical components) in an electrically isolated state. In the non-limiting example of FIG. 13, the support 924 is generally defined by multiple individual sections, such as a first support section 932 and a second support section 934. The support sections 932, 934 are physically connected to one another by a joint element 936. In related embodiments, the support 922 may be generally defined by three (or more) separate support sections. The support sections 932, 934 may be substantially identical in some embodiments and formed from a biocompatible material suitable for implantation in the human body. As described in more detail below, the support 922 may form or bear one or more features that facilitate one or both of implantation and fixation. In any case, the form factor, or footprint, or shape of the support 922 defines a first end 940 opposite a second end 942 and a top surface 944 opposite a bottom surface (hidden in the figure). In any embodiment in which a lead body 32 is provided, the first end 940 may be considered the tip of the stimulating electrode assembly 920 (e.g., because the first end 940 is opposite the lead body 32), and the second end 942 may be considered the terminus. The shape of the support 922 defines a length between the first end 940 and the second end 942 and a width perpendicular to the length. The length may be greater than the width, and a central major axis A of the shape of the support 922 is defined along or relative to the length. A central minor axis I of the support 922 is defined perpendicular to the central major axis A between the first end 940 and the second end 942.

[0044] The junction element 936 can assume a variety of forms and, in some embodiments, is or resembles a cable or ribbon. The junction element 936 encases or carries the wiring (not shown) that leads to and from the stimulation electrodes 924 of the first support section 932. Compared to the configuration of the support sections 932, 934, the junction element 936 can exhibit enhanced flexibility (e.g., due to materials, dimensions, etc.), resulting in less shear force being applied to the support 922 upon final implantation.

[0045] Each of the stimulation electrodes 924 is formed from a conductive material suitable for delivering stimulation energy into the human body. The stimulation electrodes 924 can assume any of the structures disclosed herein, for example, they can be provided as elongated or rectangular block electrodes. In other embodiments, one or more of the stimulation electrodes 924 can have other shapes (e.g., square, cylindrical, etc.) or structures (e.g., similar to a wire, coil, etc.). The stimulation electrodes 924 are positioned on or along the upper surface 944 of the support 922 to provide an exposed surface (from which stimulation energy is emitted) relative to the upper surface 944 of the support 922. The stimulation electrodes 924 are encapsulated by the support 922 and electrically insulated from one another. In some embodiments, one or more of the stimulation electrodes 924 may be electrically common. Although not visible in the view of FIG. 13 , individual electrically insulated wires can extend from each of the stimulation electrodes 924 within the thickness of the support 922.

[0046] The collective arrangement of the stimulation electrodes 924 relative to the central short axis I may be symmetrical and include a first end electrode 924a and a second end electrode 924b. The first end electrode 924a is the stimulation electrode closest to the first end 940 of the support 922, and the second end electrode 924b is the stimulation electrode closest to the second end 942 of the support 922. Thus, the first end electrode 924a may be viewed as the leading electrode of the plurality of stimulation electrodes 924, and the second end electrode 924b may be viewed as the terminal electrode of the plurality of stimulation electrodes 924. Any number of stimulation electrodes 924 may be positioned intermediate the first end electrode 924a and the second end electrode 924b. Regardless of the number, shape, orientation, and configuration of the stimulation electrodes 924 provided in the stimulation electrode assembly 920, the distance between the opposing first end electrode 924a and second end electrode 924b serves as the effective length EL of the stimulation electrode assembly 920. In accordance with the above description, the stimulation electrode assembly 920 is configured such that its effective length EL corresponds to (e.g., approximates or exceeds) the expected span dimension of the anatomical target site upon final implantation, e.g., the expected span dimension of the bilateral anatomical target sites (e.g., with further reference to FIG. 4 , the span distance S1 between the left and right hypoglossal nerves 130a, 130b within or near the region of innervation corresponding to the left and right genioglossus muscles 114a, 114b, or the span distance S2 between the left and right hypoglossal nerves 130a, 130b within or near the region of innervation corresponding to the left and right hyoglossus muscles 118a, 118b, or the span distance between the nerve endings of the left and right hypoglossal nerves 130a, 130b).

[0047] Another stimulation electrode assembly 1020 according to the principles of the present disclosure is shown in simplified form in Figure 14. The stimulation electrode assembly 1020 includes a support 1022 and a plurality or array of stimulation electrodes 1024. The stimulation electrode assembly 1020 is optionally provided as part of a stimulation lead 1030, which further includes the lead body 32 described above.

[0048] The support 1022 is similar to the support 22 (FIG. 1) described above and is configured to maintain the stimulating electrode 1024 (as well as any other electrical components) in an electrically insulated state. The support 1022 is formed from a biocompatible material suitable for implantation in the human body. As described in more detail below, the support 1022 can form or carry one or more features that facilitate implantation and / or fixation. In any case, the form factor, or footprint, or shape of the support 1022 defines a first end 1040 opposite a second end 1042, and a top surface 1044 opposite a bottom surface (hidden in the figure). In any embodiment in which a lead body 32 is provided, the first end 1040 may be considered the tip of the stimulating electrode assembly 1020 (e.g., because the first end 1040 is opposite the lead body 32), and the second end 1042 may be considered the terminus. The shape of the support 1022 defines a length between a first end 1040 and a second end 1042 and a width perpendicular to the length. The length may be greater than the width, and a central major axis A of the shape of the support 1022 is defined along or relative to the length. A central minor axis I of the support 1022 is defined perpendicular to the central major axis A between the first end 1040 and the second end 1042.

[0049] 14, the support 1022 can have or define a variable width, as indicated, for example, by a contoured perimeter shape. In these and related embodiments, the thin regions of the support 1022 can exhibit enhanced flexibility. Furthermore, the contoured shape can promote tissue ingrowth along the support 1022, thereby facilitating passive fixation of the stimulation electrode assembly 1020 after implantation. The contoured perimeter shape can be symmetrical about the central major axis A and symmetrical about the central minor axis I, as shown. In other embodiments, a non-uniform contoured perimeter shape can be used.

[0050] Each of the stimulation electrodes 1024 is formed from a conductive material suitable for delivering stimulation energy into the human body. The stimulation electrodes 1024 can assume any of the structures disclosed herein, for example, they can be provided as elongated or rectangular block electrodes. In other embodiments, one or more of the stimulation electrodes 1024 can have other shapes (e.g., square, cylindrical, etc.) or structures (e.g., similar to a wire, coil, etc.). The stimulation electrodes 1024 are positioned along the support 1022 to provide an exposed surface (from which stimulation energy is emitted) at or relative to the upper surface 1044 of the support 1022. The stimulation electrodes 1024 are encapsulated by the support 1022 and electrically insulated from one another. In some embodiments, one or more of the stimulation electrodes 1024 may be electrically common. Although not visible in the view of FIG. 14 , individual electrically insulated wires can extend from each of the stimulation electrodes 1024 within the thickness of the support 1022.

[0051] The overall arrangement of the stimulation electrodes 1024 relative to the central short axis I may be symmetrical and include a first end electrode 1024a and a second end electrode 1024b. The first end electrode 1024a is the stimulation electrode closest to the first end 1040 of the support 1022, and the second end electrode 1024b is the stimulation electrode closest to the second end 1042 of the support 1022. Thus, the first end electrode 1024a may be viewed as the leading electrode of the plurality of stimulation electrodes 1024, and the second end electrode 1024b may be viewed as the terminal electrode of the plurality of stimulation electrodes 1024. Any number of stimulation electrodes 1024 may be positioned intermediate the first end electrode 1024a and the second end electrode 1024b. Regardless of the number, shape, orientation, and configuration of the stimulating electrodes 1024 provided in the stimulating electrode assembly 1020, the distance between opposing first and second end electrodes 1024 a, 1024 b serves as the effective length EL of the stimulating electrode assembly 1020. In accordance with the above description, the stimulating electrode assembly 1020 is configured such that the effective length EL corresponds to (e.g., approximates or exceeds) the expected span dimension of the anatomical target site upon final implantation, for example, the expected span dimension of bilateral anatomical target sites (e.g., with further reference to FIG. 4 , the span distance S1 between the left and right hypoglossal nerves 130 a, 130 b within or near the region of innervation corresponding to the left and right genioglossus muscles 114 a, 114 b, or the span distance S2 between the left and right hypoglossal nerves 130 a, 130 b within or near the region of innervation corresponding to the left and right hyoglossus muscles 118 a, 118 b, or the span distance between the nerve endings of the left and right hypoglossal nerves 130 a, 130 b, etc.).

[0052] Another stimulation electrode assembly 1120 according to the principles of the present disclosure is shown in simplified form in Figure 15. The stimulation electrode assembly 1120 includes a support 1122 and a plurality or array of stimulation electrodes 1124. The stimulation electrode assembly 1120 is optionally provided as part of a stimulation lead 1130, which further includes the lead body 32 described above.

[0053] The support 1122 is similar to the support 22 (FIG. 1) described above and is configured to maintain the stimulating electrode 1124 (as well as any other electrical components) in an electrically insulated state. The support 1122 is formed from a biocompatible material suitable for implantation in the human body. As described in more detail below, the support 1122 can form or carry one or more features that facilitate implantation and / or fixation. In any case, the form factor, or footprint, or shape of the support 1122 defines a first end 1140 opposite a second end 1142, and a top surface (visible in the figures) opposite a bottom surface (hidden in the figures). In any embodiment in which a lead body 32 is provided, the first end 1140 may be considered the tip of the stimulating electrode assembly 1120 (e.g., because the first end 1140 is opposite the lead body 32), and the second end 1142 may be considered the terminus. The shape of the support 1122 defines a length between a first end 1140 and a second end 1142 and a width perpendicular to the length. The length may be greater than the width, and a central major axis A of the shape of the support 1122 is defined along or relative to the length. A central minor axis I of the support 1122 is defined perpendicular to the central major axis A between the first end 1140 and the second end 1142.

[0054] 15, the support 1122 can have or define a reduced or narrower width compared to at least some of the other stimulation electrode assemblies of the present disclosure. For example, the width of the support 1122 can approximate or be slightly larger than the outer dimensions (e.g., diameter) of the lead body 32 so that the support 1122 resembles a ribbon.

[0055] Each of the stimulation electrodes 1124 is formed from a conductive material suitable for delivering stimulation energy into the human body. The stimulation electrodes 1124 can assume any of the structures disclosed herein, for example, they can be provided as elongated or rectangular block electrodes. In other embodiments, one or more of the stimulation electrodes 1124 can have other shapes (e.g., square, cylindrical, etc.) or structures (e.g., similar to a wire, coil, etc.). The stimulation electrodes 1124 are positioned along the support 1122 to provide an exposed surface (from which stimulation energy is emitted) on or relative to the upper surface of the support 1122. The stimulation electrodes 1124 are encapsulated by the support 1122 and electrically insulated from one another. In some embodiments, one or more of the stimulation electrodes 1124 may be electrically common. Although not visible in the view of FIG. 15 , individual electrically insulated wires can extend from each of the stimulation electrodes 1124 within the thickness of the support 1122.

[0056] The overall arrangement of the stimulation electrodes 1124 relative to the central short axis I may be symmetrical and include a first end electrode 1124a and a second end electrode 1124b. The first end electrode 1124a is the stimulation electrode closest to the first end 1140 of the support 1122, and the second end electrode 1124b is the stimulation electrode closest to the second end 1142 of the support 1122. Thus, the first end electrode 1124a may be viewed as the leading electrode of the plurality of stimulation electrodes 1124, and the second end electrode 1124b may be viewed as the terminal electrode of the plurality of stimulation electrodes 1124. Any number of stimulation electrodes 1124 may be positioned intermediate the first end electrode 1124a and the second end electrode 1124b. Regardless of the number, shape, orientation, and configuration of the stimulating electrodes 1124 provided in the stimulating electrode assembly 1120, the distance between opposing first and second end electrodes 1124 a, 1124 b serves as the effective length EL of the stimulating electrode assembly 1120. In accordance with the above description, the stimulating electrode assembly 1120 is configured such that the effective length EL corresponds to (e.g., approximates or exceeds) the expected span dimension of the anatomical target site upon final implantation, for example, the expected span dimension of the bilateral anatomical target sites (e.g., with further reference to FIG. 4 , the span distance S1 between the left and right hypoglossal nerves 130 a, 130 b within or near the region of innervation corresponding to the left and right genioglossus muscles 114 a, 114 b, or the span distance S2 between the left and right hypoglossal nerves 130 a, 130 b within or near the region of innervation corresponding to the left and right hyoglossus muscles 118 a, 118 b, or the span distance between the nerve endings of the left and right hypoglossal nerves 130 a, 130 b, etc.).

[0057] Another related embodiment stimulation electrode assembly 1220 according to the principles of the present disclosure is shown in simplified form in Figures 16A and 16B. The stimulation electrode assembly 1220 includes a support 1222 and a plurality or array of stimulation electrodes 1224. The stimulation electrode assembly 1220 is optionally provided as part of a stimulation lead 1230, which further includes the lead body 32 described above.

[0058] The support 1222 is similar to the support 22 (FIG. 1) described above and is configured to maintain the stimulating electrode 1224 (as well as any other electrical components) in an electrically insulated state. The support 1222 is formed from a biocompatible material suitable for implantation in the human body. As described in more detail below, the support 1222 can form or carry one or more features that facilitate implantation and / or fixation. In any case, the form factor, or footprint, or shape of the support 1222 defines a first end 1240 opposite a second end 1242, and a top surface (visible in the view of FIG. 16A) opposite a bottom surface (hidden in the view). In any embodiment in which a lead body 32 is provided, the first end 1240 may be considered the tip of the stimulating electrode assembly 1220 (e.g., because the first end 1240 is opposite the lead body 32), and the second end 1242 may be considered the terminus. The shape of the support 1222 defines a length between a first end 1240 and a second end 1242 and a minor dimension (e.g., diameter or width) perpendicular to the length. The length may be greater than the minor dimension, and a central major axis A of the shape of the support 1222 is defined along or relative to the length. A central minor axis I of the support 1222 is defined perpendicular to the central major axis A between the first end 1240 and the second end 1242.

[0059] 16A, the support 1222 can have or define a reduced or narrower width compared to at least some of the other stimulation electrode assemblies of the present disclosure. For example, the minor outer dimension of the support 1222 can approximate the dimension of the lead body 32 such that the support 1222 resembles a ribbon or an extension of the lead body 32.

[0060] Each of the stimulation electrodes 1224 is formed from a conductive material suitable for delivering stimulation energy into the human body. The stimulation electrodes 1224 can assume any of the structures disclosed herein. The stimulation electrodes 1224 are positioned along the support 1222 to provide an exposed surface (from which stimulation energy is emitted) on or relative to the upper surface of the support 1222. The stimulation electrodes 1224 are encapsulated by the support 1222 and electrically insulated from each other. In some embodiments, and as best shown in FIG. 16B , one, more, or all of the stimulation electrodes 1224 may be split-ring electrodes or similar to split-ring electrodes. In some embodiments, one or more of the stimulation electrodes 1224 may be electrically common. Although not shown, individual electrically insulated wires may extend from each of the stimulation electrodes 1224 within the thickness of the support 1222.

[0061] In other embodiments, one, more than one, or all of the stimulating electrodes 1224 may have an axisymmetric shape. For example, FIG. 16C shows an alternative stimulating electrode 1224′ useful in the stimulating electrode assembly 1220. The stimulating electrode 1224′ extends along the entire circumference of the support 1222, similar to a conventional stimulating lead electrode. Returning to FIG. 16A , some or all of the stimulating electrodes 1224 may each have a split-ring shape (as in FIG. 16B ), and some or all of the stimulating electrodes 1224 may each be circumferential (as in FIG. 16C , similar to a conventional stimulating lead). Thus, some stimulating electrode assemblies and corresponding stimulating leads of the present disclosure may resemble conventional axially symmetric stimulating leads.

[0062] The overall arrangement of the stimulation electrodes 1224 relative to the central short axis I may be symmetrical and include a first end electrode 1224a and a second end electrode 1224b. The first end electrode 1224a is the stimulation electrode closest to the first end 1240 of the support 1222, and the second end electrode 1224b is the stimulation electrode closest to the second end 1242 of the support 1222. Thus, the first end electrode 1224a may be viewed as the leading electrode of the plurality of stimulation electrodes 1224, and the second end electrode 1224b may be viewed as the terminal electrode of the plurality of stimulation electrodes 1224. Any number of stimulation electrodes 1224 may be positioned intermediate the first end electrode 1224a and the second end electrode 1224b. Regardless of the number, shape, orientation, and configuration of the stimulating electrodes 1224 provided in the stimulating electrode assembly 1220, the distance between opposing first and second end electrodes 1224 a, 1224 b serves as the effective length EL of the stimulating electrode assembly 1220. In accordance with the above description, the stimulating electrode assembly 1220 is configured such that the effective length EL corresponds to (e.g., approximates or exceeds) the expected span dimension of the anatomical target site upon final implantation, for example, the expected span dimension of the bilateral anatomical target sites (e.g., with further reference to FIG. 4 , the span distance S1 between the left and right hypoglossal nerves 130 a, 130 b within or near the region of innervation corresponding to the left and right genioglossus muscles 114 a, 114 b, or the span distance S2 between the left and right hypoglossal nerves 130 a, 130 b within or near the region of innervation corresponding to the left and right hyoglossus muscles 118 a, 118 b, or the span distance between the nerve endings of the left and right hypoglossal nerves 130 a, 130 b, etc.).

[0063] Any of the stimulation electrode assemblies of the present disclosure can include or be provided with features that facilitate fixation during or after implantation. The fixation provided can be active fixation. For example, FIG. 17A illustrates another stimulation electrode assembly 1320 that is very similar to stimulation electrode assembly 20 (FIGS. 1A and 1B), further including one or more retractable tines 1340 (e.g., similar to the metal tines used in micropacemakers) carried by support 22. Other active fixation device formats similar to tines (e.g., helices) can be utilized. The mechanism for activating or deploying the active fixation device is carried by support 22 and connected to an actuator (e.g., a wire extending from support 22) accessible to a clinician from outside the patient's body during the implantation procedure. In these and related embodiments, the active fixation device can be in a contracted state or position (e.g., retracted into support 22) during initial implantation of stimulation electrode device 1320 (with support 22 providing a low profile to aid implantation). Once the stimulation electrode assembly 1320 is positioned at the desired target site, the active fixation device deploys against the support 22 to provide fixation to the tissue surrounding the target site.

[0064] Alternatively or additionally, the stimulation electrode assemblies of the present disclosure can incorporate features that provide passive fixation. For example, a mesh material configured to promote tissue ingrowth (e.g., a material similar to hernia mesh) may be formed on or incorporated into the support 22. Other texturing, such as texturing similar to Velcro®-style loops, can be provided on the surface to interact with / promote tissue ingrowth. Similarly, and as shown with respect to the stimulation electrode assembly 1420 of FIG. 17B (which is otherwise very similar to the stimulation electrode assembly 20 (FIGS. 1A and 1B)), one or more through-holes 1440 can be formed through the support 22 to allow fibrous tissue to grow through. The one or more through-holes 1440 can alternatively function to accept sutures that provide active fixation at the implantation site. The configuration of the one or more stimulation electrodes 24 can be selected to promote tissue ingrowth (e.g., the coil electrodes described above). One or more dissolvable suture barbs can be carried by the support 22. Similarly, and as shown with respect to the stimulation electrode assembly 1520 of FIG. 17C (which is otherwise very similar to the stimulation electrode assembly 20 (FIGS. 1A and 1B)), one or more passive tines 1540 (e.g., made from a material such as silicone or polyurethane) can be carried by the support 22. Mechanical protrusions can be provided along the lead body 32 and can be sized, shaped, and positioned relative to the stimulation electrode assembly 1520 so as not to "fit" into either the tunnels created at the target site (where the stimulation electrode assembly 1520 will reside upon final implantation) or the tunnels created at the location of the stimulation device (e.g., an IPG) to which the lead body 32 will subsequently be connected. Similarly, the periphery of the support 22 can be contoured or implement protrusions such that fibrous encapsulation occurs therearound (e.g., the non-limiting example of FIG. 14). In these and similar embodiments, the mechanical protrusions can effectively act to "anchor" the lead body 32, and thus the stimulation electrode assembly 20, in both directions.

[0065] Any of the stimulation electrode assemblies of the present disclosure (e.g., the stimulation electrode assemblies of FIGS. 1 and 6-17C and variations thereof) can be implanted in various manners at bilateral target sites, such as the left and right hypoglossal nerves 130a, 130b (e.g., the second branch 150a of the third medial nerve trunk of the left hypoglossal nerve 130a and the second branch 150b of the third medial nerve trunk of the right hypoglossal nerve 130b, or the nerve endings associated with the left hypoglossal nerve 130a and the right hypoglossal nerve 130b). In some embodiments, a method of the present disclosure provides for delivering the bilateral stimulation electrode assemblies near the left and right hypoglossal nerves 130a, 130b via a small incision on one side of the patient's jaw and tunneling across the midline M of the jaw to the target site (e.g., making an incision on the left lateral side of the patient's jaw and tunneling across the midline M from the left lateral side to the right lateral side of the patient's jaw, or vice versa). For reference, Figure 18 shows the anatomy of the connection of the mandible 100, tongue 104, and hypoglossal nerve 130. The hyoglossus muscle 118 extends to the tongue 104 as described above. Additionally, Figure 18 shows the mylohyoid muscle 1600, which runs from the connection of the mandible 100 (general reference) to the hyoid bone, as well as the superior pharyngeal constrictor muscle 1604 and the middle pharyngeal constrictor muscle 1606.

[0066] With the above anatomical structures in mind, one exemplary method of the present disclosure suitable for achieving implantation of a stimulation electrode assembly at the target site 200 of FIG. 5A may include making an incision through the patient's skin at a location generally indicated at 1610 in FIG. 18. With cross-reference between FIGS. 5A and 18, the incision is sufficient to access the mylohyoid muscle 1600. The clinician can then retract the mylohyoid muscle 1600 in the direction of arrow 1612 to access tissue behind the mylohyoid muscle 1600 and form a tunnel to the target site 200 ( FIG. 5A ), including a tunnel across the midline M. In other embodiments, a puncture is made through the patient's skin and mylohyoid muscle 1600 at a location generally indicated at 1614. In a related embodiment, the puncture may be made through the hyoglossus muscle 118 or the genioglossus muscle 114 at approximately location 1614 (i.e., on either the left or right side of the patient). A surgical punch (not shown), for example, can be used, which has a predetermined blade width on its distal end. Instead of cutting like a scalpel, the tool presses against the patient's skin and makes an incision of a defined width (e.g., proportional to the width of the stimulating electrode assembly to be implanted). Alternatively, a conventional surgical tool (e.g., a scalpel, cautery, etc.) can be used to make the incision. A tunnel extending across the midline M is then formed through the puncture. Using these and similar techniques, a tunnel can be formed so that the target site 200 is located "under" the hyoglossus muscle 118 (e.g., one or both of the left and right hyoglossus muscles 118a, 118b) and the genioglossus muscle 114 (e.g., one or both of the left and right genioglossus muscles 114a, 114b). The target location of the tunnel is adjacent to the hypoglossal nerve on the left and right sides of the anatomy. In other embodiments, the target location of the tunnel is within the base of the genioglossus muscle. As is known in the art, additional tunnels, such as those for placement of lead body 32 (FIG. 1), can be formed by incision or puncture.

[0067] Regardless of how the tunnel to the target site 200 is created, the stimulation electrode assembly is then delivered to the target site 200 through the tunnel. Some embodiments of the present disclosure relate to tools for introducing or delivering a stimulation electrode assembly. An example of an introducer 1700 of the present disclosure is shown in simplified form in FIG. 19 along with a stimulation electrode assembly 20. It should be understood that the introducer 1700 can be used with any of the stimulation electrode assemblies of the present disclosure and is not limited to the stimulation electrode assembly 20. The introducer 1700 includes a head 1702 carried at the distal end of a shaft (not shown). The head 1702 includes a base 1704 and sidewalls 1706 that combine to define a channel or pocket sized and shaped to receive the support 22. A gap or spacing 1710 is defined between the sidewalls 1706 opposite the base 1704. The gap 1710 has a size and shape according to the size and shape of the stimulation electrode 24 (one of which is seen in the diagram of FIG. 19). For example, a lip 1712 may extend inward from each of the side walls 1706 to partially close the channel (e.g., the support 22 is captured between the base 1704 and the lip 1712), with a gap 1710 defined between the lips 1712. In either case, the side of the head 1702 opposite the base 1704 is open enough to expose the stimulation electrode 24. During a delivery procedure, the stimulation electrode assembly 20 is loaded into the introducer 1700 as shown, and the introducer 1700 is manipulated to advance the stimulation electrode assembly 20 to a target site within the patient (e.g., the stimulation electrode assembly 20 is advanced into the patient from one side of the jaw and through a pre-made tunnel to a target site extending across the midline of the patient's jaw). With the stimulation electrode assembly 20 still held by the introducer 1700, electrical tests can be performed to verify or confirm the position of the various stimulation electrodes 24 relative to the anatomical structure of interest (e.g., the left and right hypoglossal nerves). For example, stimulation energy can be selectively delivered to one, more than one, or all of the stimulation electrodes 24, which can then deliver or impart energy to the patient through the gap 1710.Once the clinician is satisfied with the position of the stimulation electrode assembly 20 within the patient, the introducer 1700 can be removed.

[0068] Another example of an introducer 1720 of the present disclosure is shown in simplified form in FIG. 20 together with a stimulation electrode assembly 20. It should be understood that the introducer 1720 can be used with any of the stimulation electrode assemblies of the present disclosure and is not limited to the stimulation electrode assembly 20. The introducer 1720 includes a head 1722 carried at the distal end of a shaft (not shown). The head 1722 defines a closed channel or pocket sized and shaped to receive the stimulation electrode assembly 20. Unlike the introducer 1700 of FIG. 19 , the head 1722 includes an upper wall 1726 that extends over the stimulation electrode assembly 20 when the stimulation electrode assembly 20 is loaded into the channel. In some embodiments, the introducer 1720 can further include one or more test electrodes 1728 carried by or embedded within the thickness of the upper wall 1726, with wiring (not shown) extending along the shaft from corresponding test electrodes 1728. In some embodiments, the number of test electrodes 1728 provided on the introducer 1720 can match the number of stimulating electrodes 24 provided on the stimulating electrode assembly 20, with the test electrodes 1728 arranged on or along the top wall 1726 according to the pattern of the stimulating electrodes 24 carried by the support 22. The introducer 1720 may further include an alignment feature (e.g., a protrusion, etc.) that facilitates positioning the stimulating electrode assembly 20 within the channel such that, in the final loaded state of the stimulating electrode assembly 20, each of the stimulating electrodes 24 is aligned with a corresponding one of the test electrodes 1728. In other embodiments, the number of test electrodes 1728 provided on the introducer 1720 is less than the number of stimulating electrodes 24 and may include only one test electrode 1728.

[0069] During the delivery procedure, the stimulation electrode assembly 22 is loaded into the introducer 1720 as shown, and the introducer 1720 is manipulated to advance the stimulation electrode assembly 20 to the target site within the patient (e.g., the stimulation electrode assembly 20 is advanced into the patient from one side of the jaw and through a pre-created tunnel to the target site extending across the midline of the patient's jaw). With the stimulation electrode assembly 20 still held by the introducer 1720, electrical tests can be performed to verify or confirm the position of the various stimulation electrodes 24 relative to the anatomical structure of interest (e.g., the left and right hypoglossal nerves), for example, by selectively delivering stimulation energy to one, more than one, or all of the stimulation electrodes 24, which can then deliver or impart energy to the patient. Once the clinician is satisfied with the position of the stimulation electrode assembly 20 within the patient, the introducer 1720 can be removed. In some embodiments, the introducer 1720 may be a peel-away introducer or sheath, or the like, to facilitate disassembly from the stimulation electrode assembly 20 (e.g., perforations or slit lines may be formed through the thickness of the head 1722). In other embodiments, the introducer 1720 may be inserted into the patient first, with the head 1722 oriented toward the target site, prior to final loading of the stimulation electrode assembly 20. Testing may be performed using a test electrode 1728. Once the clinician is satisfied with the position of the head 1722 relative to the target site, the stimulation electrode assembly 20 may be delivered through the introducer 1720 into position within the head 1722.

[0070] In some embodiments, the stimulating electrode assembly of the present disclosure can include or incorporate one or more features that facilitate delivery to a target site. For example, another stimulating electrode assembly 1820 according to the principles of the present disclosure is shown in simplified form in FIGS. 21A and 21B. The stimulating electrode assembly 1820 may be similar to any of the stimulating electrode assemblies described above, for example, it may include a support 22 and stimulating electrodes 24 as described above (or the support and stimulating electrode arrangement of any other embodiment of the present disclosure). Additionally, the stimulating electrode assembly 1820 includes a guide body 1822 attached to or integrally formed with the support 22. The guide body 1822 defines an internal lumen 1824 sized to slidably receive a delivery tool or device, e.g., a guidewire, catheter, stylet, suitable for guiding the stimulating electrode assembly 1820 to a target site. The stimulating electrode assembly 1820 is optionally provided as part of a stimulation lead 1830, which further includes the lead body 32 described above.

[0071] Although the lumen 1824 is shown as extending along a length that approximates the length of the support 22, other shapes or configurations are possible. For example, in other embodiments, the length of the guide body 1822, and thus the length of the lumen 1824, may be substantially less than the length of the support 22 (e.g., about 50% or less of the length of the support 22). Alternatively, the stimulation lead 1830 may be configured or constructed such that the lumen 1824 extends from (e.g., within) the support 22 along at least a portion of the lead body 32, for example, along the entire length of the lead body 32. In any event, in some non-limiting methods of the present disclosure, a distal region of a guide device (e.g., a guidewire, catheter, or stylet) is first advanced to the target site. The guide device is slidably disposed within the lumen 1824. The stimulation electrode assembly 1820 is then advanced over the guide device to the target site. Once the clinician is satisfied with the position of the stimulation electrode assembly 1820 relative to the target site (e.g., after testing), the guide device can be withdrawn from the lumen and the patient. Alternatively, if the lumen terminates near the proximal end of the support 22 but does not pass entirely through the support 22, a stylet can be used to effectively push the support 22 into a pre-made delivery channel.

[0072] Regardless of the method of delivery and implantation, the stimulation electrode assembly of the present disclosure can be manipulated in various ways (e.g., supplying electrical stimulation energy via an implantable pulse generator (IPG)) to deliver stimulation therapy to a patient, for example, on a bilateral basis. For reference, FIG. 22 illustrates a simplified final implantation position of a stimulation electrode assembly 1900 relative to a first nerve 2000 and a second nerve 2002 of a patient. In the non-limiting example of FIG. 22, the simulation electrode assembly 1900 is provided as part of a stimulation system 1910 that further includes an implantable pulse generator (IPG) assembly 1912, as described in more detail below. The stimulation electrode assembly 1900 may have any of the structures of the present disclosure and generally includes a support 1920 carrying a plurality of stimulation electrodes 1922. Consistent with the above description, the support 1920 has an elongated shape and defines a length that is greater than its width. A central longitudinal axis A is defined by the support 1920 in the direction of the length. A central minor axis I is defined between opposing ends 1924, 1926 of the support 1920, perpendicular to the central major axis A. The stimulating electrodes 1922 may have any of the structures, shapes, patterns, etc. disclosed herein. More generally, the plurality of stimulating electrodes 1922 can be viewed as providing first subgroup electrodes 1930 on one side of the central minor axis I (e.g., between the central minor axis I and the first end 1924) and second subgroup electrodes 1932 on the other side of the central minor axis I (e.g., between the central minor axis I and the second end 1926). The configuration of the first subgroup electrodes 1930 may be identical to the configuration of the second subgroup electrodes 1932 (i.e., the first subgroup electrodes 1930 and the second subgroup electrodes 1932 are symmetrical about the central minor axis I). In other embodiments, the first subgroup electrodes 1930 and the second subgroup electrodes 1932 may differ from one another with respect to one or more of the number of stimulating electrodes, the type of stimulating electrodes, the shape of the stimulating electrodes, the location of the stimulating electrodes, etc. Although Figure 22 shows the first subgroup electrodes 1930 and the second subgroup electrodes 1932 as each including four stimulating electrodes 1922, other numbers, either greater or less, are possible (including a single stimulating electrode 1922).

[0073] The IPG assembly 1912 may include a housing 1960 containing circuitry 1962 and a power source 1964 (e.g., a battery), and an interface block or header-connector 1966 carried or formed by the housing 1960. The housing 1960 is configured to make the IPG assembly 1912 suitable for implantation in a human body and may incorporate biocompatible materials and hermetic seals. The circuitry 1962 may include circuit components and wiring apparent to those skilled in the art suitable for generating a desired stimulation signal (e.g., converting energy provided by the power source 1964 into a desired stimulation signal), for example, in the form of a stimulation engine. In some embodiments, the circuitry 1962 may include telemetry components for communicating with an external device, as known in the art. The interface block 1966 is configured to facilitate coupling between the IPG assembly 1916 and the stimulation electrode assembly 1900, for example, via a lead body 1970 coupled to the stimulation electrode assembly 1900 as described above. Once generated via circuitry 1962 (e.g., as controlled or facilitated by an algorithm or a therapy manager programmed or operated by circuitry 1962), the stimulation signals are selectively transmitted to interface block 1966 for delivery to selected ones of the stimulation electrodes 1922. In other embodiments, the stimulation electrode assembly 1900 may be more directly connected to or carried by a power source (e.g., a microstimulator configuration, etc.).

[0074] In some embodiments, the nerves 2000, 2002 are a bilateral nerve pair extending from either side of the patient's midline M, e.g., the left and right hypoglossal nerves. In some embodiments, the first nerve 2000 may be the second branch of the third medial nerve trunk of the left hypoglossal nerve, and the second nerve 2002 may be the second branch of the third medial nerve trunk of the right hypoglossal nerve. Numerous other nerves or nerve segments (including, but not limited to, nerve endings or nerve fiber endings) can be involved by the devices, systems, and methods of the present disclosure. In any case, the stimulation electrode assembly 1900 is positioned such that, upon final implantation, for example, the stimulation electrode assembly 1900 extends across the midline M, such that the first subgroup electrode 1930 is adjacent to or positioned to affect the first nerve 2000 and the second subgroup electrode 1932 is adjacent to or positioned to affect the second nerve 2002.

[0075] 22 , upon final implantation, the plurality of stimulating electrodes 1922 of the first subgroup of electrodes 1930 need not be in direct physical contact with the first nerve 2000 (although one or more of the stimulating electrodes 1922 of the first subgroup of electrodes 1930 may be in direct physical contact with the first nerve 2000). Similarly, the plurality of stimulating electrodes 1922 of the second subgroup of electrodes 1932 need not be in direct physical contact with the second nerve 2002 (although one or more of the stimulating electrodes 1922 of the second subgroup of electrodes 1932 may be in direct physical contact with the second nerve 2002). In some methods of the present disclosure, the stimulating electrode assembly 1900 is placed or implanted in the patient's muscle and / or fatty tissue in proximity to, but not in physical contact with, the nerves 2000, 2002. The distance between each of the stimulating electrodes 1922 and the corresponding target nerve 2000, 2002 may vary (e.g., the distance between each of the stimulating electrodes 1922 of the first subgroup electrodes 1930 and the first nerve 2000 at the time of final implantation may or may not be the same).

[0076] The stimulation electrode assembly 1900 operates as part of a stimulation system 1910 (which further includes an energy source (e.g., IPG assembly 1912) electrically connected to the stimulation electrodes 1922) to deliver stimulation energy to one or both of the nerves 2000, 2002 in various ways, for example, via programming or algorithms provided with or operated on an energy source according to the present disclosure. In some examples, stimulation is delivered to the nerve to cause a response in the corresponding innervated muscle. In some examples, the nerve (e.g., nerve 2000, 2002) may be associated with restoring upper airway patency, such as for use in methods of treating sleep-disordered breathing. In some embodiments, the stimulation electrode assembly 1900 operates to deliver stimulation energy (via one or more of the stimulation electrodes 1922) at a level high enough to stimulate the nerve, but low enough so as not to overtly directly activate muscle tissue. For example, in embodiments in which the stimulation electrodes 1922 do not make direct physical contact with the corresponding most proximal nerves 2000, 2002, the stimulation electrode assembly 1900 can be operated to essentially "spray" an electrical signal in the direction of the corresponding nerves 2000, 2002 at a level sufficient to stimulate the nerves 2000, 2002, but not overtly stimulate muscle or other tissue in the path of the sprayed electrical signal.

[0077] In some embodiments, the disclosed methods include providing stimulation energy to only one of the first subgroup electrodes 1930 and the second subgroup electrodes 1932. In other embodiments, the disclosed methods include selectively providing stimulation energy to one or more stimulating electrodes 1922 of the first subgroup electrodes 1930 and one or more stimulating electrodes 1922 of the second subgroup electrodes 1932. In these and related embodiments, the stimulation electrode assembly 1900 can operate to provide synchronous stimulation at or from the first subgroup electrodes 1930 and the second subgroup electrodes 1932. For example, interleaved pulse trains can be delivered to the stimulating electrodes 1922 of the first subgroup electrodes 1930 and the second subgroup electrodes 1932. In either case, simultaneous stimulation of the nerves 2000, 2002 (e.g., bilateral stimulation) can be performed at a lower energy level threshold than that used for unilateral nerve stimulation when treating the same disorder (e.g., SDB). The stimulation at the first subgroup electrodes 1930 and the second subgroup electrodes 1932 may be interloped and not perfectly synchronized.

[0078] The specific type of energy delivered to and emitted from the stimulating electrodes 1922 of the first subgroup of electrodes 1930 may differ from that delivered to the stimulating electrodes 1922 of the second subgroup of electrodes 1932. Additionally, the type of energy provided to the plurality of stimulating electrodes 1922 in one or both of the subgroup electrodes 1930, 1932 may differ. For example, the level of energy provided to individual ones of the stimulating electrodes 1922 within each of the subgroup electrodes 1930, 1932 may vary based on the distance between the individual electrode 1922 and the corresponding nerve 2000, 2002. Positive or negative energy may be delivered to certain ones of the stimulating electrodes 1922 in each subgroup of electrodes 1930, 1932. Certain ones of the stimulating electrodes 1922 of one or both of the first subgroup of electrodes 1930 and the second subgroup of electrodes 1932 may be manipulated to hyperpolarize specific nerve segments. For example, upon final implantation, a first one of the stimulating electrodes 1922 may be positioned proximate a segment of the nerve 2000, 2002 whose stimulation causes a desired response in a first muscle, and a second one of the stimulating electrodes 1922 may be positioned proximate a segment of the nerve 2000, 2002 whose stimulation causes an undesired response in a second muscle (e.g., the first muscle may be the anterior tongue retractor and the second muscle may be the retractor tongue). Using these and related scenarios, methods of the present disclosure may include simultaneously providing energy to the first stimulating electrode 1922 and the second stimulating electrode 1922. The energy provided to the first stimulating electrode 1922 is energy appropriate to stimulate the first nerve segment and promote activation of the corresponding first muscle, and the energy provided to the second stimulating electrode 1922 is energy appropriate to “stun” the second nerve segment and limit or prevent activation of the corresponding second muscle. A voltage or current source may be utilized in the IPG assembly 1912. In some examples, one or more of the stimulation electrodes 1922 may be operated to provide monopolar stimulation to selected nerve branches.

[0079] As further shown in FIG. 22 , the lead body 1970 can extend to a location adjacent to a nerve (e.g., the hypoglossal nerve and / or the phrenic nerve) for chronic subcutaneous implantation (e.g., via tunneling). The stimulation electrode assembly 1900 can include stimulation electrodes 1922 that interface with one or more nerves to stimulate the nerves to treat physiological conditions such as sleep-disordered breathing, such as obstructive sleep apnea, central sleep apnea, and multiple types of sleep apnea. The IPG assembly 1912 or similar device can include circuitry, power elements, etc. to support control and operation (via the lead body 1970) of both the sensor and the stimulation electrodes 1922. In some examples, such control, operation, etc. may be implemented at least in part via a control portion (and associated functions, portions, elements, engines, parameters, etc.).

[0080] With regard to various examples of the present disclosure, in some instances, delivering stimulation to an upper airway patency nerve (e.g., the hypoglossal nerve) via the stimulation electrode 1922 causes contraction of upper airway patency-associated muscles, which can cause or maintain an open upper airway to prevent and / or treat obstructive sleep apnea. Similarly, such electrical stimulation can be applied to the phrenic nerve via the stimulation electrode 1922 to cause contraction of the diaphragm, at least as part of preventing or treating central sleep apnea. It will be further understood that some exemplary methods may include treating both obstructive sleep apnea and central sleep apnea, such as, but not limited to, cases of multi-type sleep apnea in which both types of sleep apnea may be present at least sometimes. In some such instances, separate stimulation leads may be provided, or a single stimulation lead may be provided but with bifurcated distal portions, each extending to one of the hypoglossal nerve and the phrenic nerve.

[0081] In some such instances, contraction of the hypoglossal nerve and / or contraction of the phrenic nerve caused by electrical stimulation comprises suprathreshold stimulation as opposed to subthreshold stimulation (e.g., mere tone) of such muscles. In one aspect, suprathreshold intensity levels correspond to stimulation energies greater than the excitation threshold of the nerves, whereby suprathreshold stimulation may provide a greater (e.g., maximal, etc.) upper airway clearance (i.e., patency) and efficacy of sleep apnea therapy.

[0082] In some examples, the target intensity level of the stimulation energy is selected, determined, implemented, etc. without regard to intentionally establishing a patient's discomfort threshold (e.g., in response to such stimulation). Stated differently, in at least some examples, the target intensity level of the stimulation may be implemented to provide a desired effective therapeutic effect of reducing sleep-disordered breathing (SDB) without attempting to adjust or increase the target intensity level according to (or in relation to) a discomfort threshold.

[0083] In some examples, a treatment period (during which stimulation may be applied at least part of the time) may include a period beginning with the patient turning on a treatment device and ending with the patient turning the device off. In some examples, a treatment period may include a selectable predetermined start time (e.g., 10:00 PM) and a selectable predetermined stop time (e.g., 6:00 AM). In some examples, a treatment period may include a period between automatically detected sleep onset and awakening from automatically detected sleep. With this in mind, a treatment period corresponds to a period during which the patient is asleep such that stimulation of upper airway patency-related nerves and / or central sleep apnea-related nerves is generally not perceived by the patient, and thus the stimulation is consistent with patient behavior (e.g., sleep) during which sleep-disordered breathing behavior (e.g., central or obstructive sleep apnea) is expected to occur.

[0084] In some examples, the initiation or termination of a treatment period may be performed automatically based on sensed sleep state information, which may also include sleep stage information.

[0085] To avoid activating stimulation before the patient falls asleep, in some examples, stimulation may be activated after expiration of a timer initiated by the patient (to allow for therapy via remote control) or automatically activated via sleep stage detection. To avoid continuation of stimulation after the patient wakes up, stimulation may be disabled by the patient using remote control or automatically via sleep stage detection. Thus, in at least some examples, these periods are considered to be outside of the therapeutic period, or the activation and quiescence portions of the therapeutic period, respectively.

[0086] In some examples, stimulation of upper airway patency-related nerves may be performed via open-loop stimulation, which may refer to performing the stimulation without the use of any sensory feedback of any kind to the stimulation.

[0087] In some examples, open-loop stimulation refers to stimulation performed without the use of sensory feedback, whereby the timing (e.g., synchronization) of stimulation can be determined separately in relation to respiratory information (e.g., respiratory cycle). However, in some such examples, some sensory feedback can be utilized to generally determine whether a patient should receive stimulation based on the severity of their sleep apnea behavior.

[0088] Conversely, in some examples, and as previously described in connection with at least some examples, stimulation of upper airway patency-associated nerves may be performed via closed-loop stimulation, which may refer to performing stimulation based at least in part on sensory feedback regarding parameters and / or effects of the stimulation.

[0089] In some examples, closed-loop stimulation may refer to stimulation performed through the use of sensory feedback in which the timing (e.g., synchronization) of stimulation is determined with respect to respiratory information, such as, but not limited to, respiratory cycle information, which may include the onset, offset, duration, magnitude, morphology, etc. of various features of the respiratory cycle, including, but not limited to, inspiratory phase, expiratory activity phase, etc. In some examples, the respiratory information excludes (i.e., does not include) tracking respiratory volume and / or respiratory rate. In some examples, such synchronization-based stimulation may be delivered throughout the entire treatment period or substantially throughout the entire treatment period. In some examples, such stimulation may be delivered only during a portion or portions of the treatment period.

[0090] In some examples of "synchronization," synchronization of stimulation to the inspiratory phase can extend over the pre-inspiratory period and / or the post-inspiratory period. For example, in some such examples, the onset of synchronization can occur at a point in each respiratory cycle just before the onset of the inspiratory phase. In some examples, this point can be approximately 200 milliseconds or 300 milliseconds before the onset of the inspiratory phase.

[0091] In some instances where the stimulation is synchronized with at least a portion of the inspiratory phase, the upper airway muscles are contracted via the stimulation to ensure that they are open at the time that the respiratory drive controlled by the central nervous system initiates inspiration (inhalation). In some such instances, the exemplary implementation of the pre-inspiratory stimulation described above, in combination with stimulation occurring during the inspiratory phase, helps ensure that the upper airway is open before negative inspiratory pressure within the respiratory system is applied via the diaphragm of the patient's body. In one aspect, this exemplary arrangement can minimize the possibility of upper airway contraction or collapse, which could otherwise occur if upper airway flow becomes too restricted before full inspiratory force is generated.

[0092] In some such instances, stimulation of upper airway patency-related nerves can occur synchronously with at least a portion of the exhalation period.

[0093] With respect to at least the methods of treating sleep apnea described above in connection with at least Figures 1-22, at least some such methods may include performing delivery of stimulation to a first nerve associated with upper airway patency without synchronizing such stimulation to a portion of the respiratory cycle. In some instances, such methods may be referred to as open-loop stimulation as described above.

[0094] In some examples, the term "without synchronization" may refer to performing stimulation without regard to the timing of the respiratory cycle. In some examples, the term "without synchronization" may refer to performing stimulation while being aware of respiratory information, but without necessarily triggering the onset of stimulation in relation to a particular portion of the respiratory cycle or aligning the stimulation with a particular portion of the respiratory cycle (e.g., the inspiratory phase).

[0095] In some examples, the term "unsynchronized" in this context may refer to stimulation administered upon detection of a sleep-disordered breathing (e.g., an obstructive sleep apnea event), but without necessarily triggering the onset of stimulation in relation to a particular portion of the respiratory cycle or aligning the stimulation with the inspiratory phase. At least some such examples are described in International Patent Application WO2016 / 149344, entitled "STIMULATION FOR TREATING SLEEP DISORDERED BREATHING," published September 22, 2016, to Wagner et al., which is incorporated herein by reference in its entirety.

[0096] In some examples, open-loop stimulation may be performed continuously regardless of the timing of respiratory information (e.g., inspiratory phase, expiratory phase, etc.), but such exemplary methods and / or systems may still include respiratory information for diagnostic data and / or to determine whether (and to what extent) the continuous stimulation should be adjusted. For example, such respiratory sensing may determine that the number of sleep-disordered breathing (SDB) events is too high (e.g., elevated AHI) and therefore the intensity (e.g., amplitude, frequency, pulse width, etc.) of the continuous stimulation should be increased, or that the number of SDB events is relatively low and therefore therapeutic stimulation can still be provided but the intensity of the continuous stimulation can be reduced. It will be appreciated that other SDB-related information may be determined via such respiratory sensing, which may be used for diagnostic purposes and / or to determine adjustments to the intensity of stimulation, the initiation of stimulation, and / or the termination of stimulation to treat sleep-disordered breathing. It will further be appreciated that such “continuous” stimulation may be performed with selectable duty cycles, trains of stimulation pulses, selective activation of different combinations of electrodes, etc.

[0097] In some examples of open-loop or closed-loop stimulation, some sensory feedback may be utilized to generally determine whether a patient should receive stimulation based on the severity of their sleep apnea behavior, in other words, the device may deliver stimulation upon sensing that a predetermined number of sleep apnea events have occurred.

[0098] Some non-limiting examples of such devices and methods for recognizing and detecting various features and patterns associated with respiratory effort and flow limitation include, but are not limited to, PCT International Application WO / 2010 / 059839, published May 27, 2010, and entitled "A METHOD OF TREATING SLEEP APNEA," U.S. Patent No. 5,944,680 to Christopherson, entitled "RESPIRATORY EFFORT DETECTION METHOD AND APPARATUS," and U.S. Patent No. 5,522,862 to Testerman, entitled "METHOD AND APPARATUS FOR TREATING OBSTRUCTIVE SLEEP APNEA."

[0099] Additionally, in some instances, various stimulation methods may be applied to treat obstructive sleep apnea, including, but not limited to, International Patent Application WO2013 / 023218 to Ni et al., entitled "SYSTEM FOR SELECTING A STIMULATION PROTOCOL BASED ON SENSED RESPIRATORY EFFORT," U.S. Patent No. 8,938,299 to Christopherson et al., entitled "SYSTEM FOR TREATING SLEEP DISORDERED BREATHING," published January 20, 2015, and International Patent Application WO2016 / 149344 to Wagner et al., entitled "STIMULATION FOR TREATING SLEEP DISORDERED BREATHING," published September 22, 2016, each of which is incorporated herein by reference in its entirety.

[0100] As can be seen from the above description, the stimulation system 1910 includes a controller, control unit, or control portion that facilitates the execution of specified operations. FIG. 23A is a block diagram that schematically represents a control portion 2100 according to an example of the present disclosure. In some examples, the control portion 2100 includes a controller 2102 and a memory 2104. In some examples, the control portion 2100 provides an example implementation of a control portion that forms, implements, and / or manages part of any one of the devices, systems, assemblies, circuits, managers, engines, functions, parameters, sensors, electrodes, modules, and / or methods as represented throughout this disclosure.

[0101] Generally, the controller 2102 of the control portion 2100 includes an electronics assembly 2106 (e.g., at least one processor, microprocessor, integrated circuit, logic, etc.) and associated memory or storage. The controller 2102 is electrically coupled to and in communication with the memory 2104 to generate control signals that direct the operation of at least some devices, systems, assemblies, circuits, managers, modules, engines, functions, parameters, sensors, electrodes, and / or methods as described throughout this disclosure. The control signals may be software programs stored in storage and loaded into the memory 2104 and executed by the electronics assembly 2106. In some examples, these generated control signals also include, but are not limited to, using a therapy manager 2108 stored in the memory 2104 to at least manage a therapy delivered to the patient, e.g., a therapy for sleep-disordered breathing, and / or manage and operate designated detections in a manner described in at least some examples of the present disclosure. It should further be appreciated that the control portion 2100 (or another control portion) may also be used to operate the general functions of the various treatment devices / systems described throughout this disclosure.

[0102] In response to or based on commands received via a user interface (e.g., user interface 2110 of FIG. 23C ) and / or via machine-readable instructions, controller 2102 generates control signals to perform therapy administration, therapy monitoring, therapy management, and / or management and control according to at least some of the foregoing examples of this disclosure. In some examples, controller 2102 is embodied in a general-purpose computing device, while in some examples, controller 2102 is incorporated into or associated with at least some of the related devices, systems, assemblies, circuits, sensors, electrodes, device components, and / or managers, engines, parameters, functions, etc. described throughout this disclosure.

[0103] For purposes of this disclosure, when referring to the controller 2102, in embodiments in which the electronics assembly 2106 comprises or includes at least one processor, the term “processor” shall mean a now-developed or future-developed processor (or processing resource) or microprocessor that executes sequences of machine-readable instructions contained in a memory. In some examples, execution of sequences of machine-readable instructions, such as instructions provided via the memory 2104 of the control portion 2100, causes the processor to perform operations, such as operating the controller 2102 to implement sleep-disordered breathing (SDB) therapy and related management, as generally described in (or consistent with) at least some examples of the present disclosure. The machine-readable instructions, as represented in the memory 2104, may be loaded into a random access memory (RAM) for execution by the processor from a stored location in a read-only memory (ROM), mass storage device, or some other persistent storage (e.g., a non-transitory or non-volatile tangible medium). In some examples, memory 2104 comprises a computer-readable tangible medium that provides non-volatile storage of machine-readable instructions executable by a process of controller 2102. In other examples, hardwired circuitry may be used in place of or in combination with machine-readable instructions to implement the described functions. For example, electronics assembly 2106 may be embodied as part of at least one application-specific integrated circuit (ASIC), at least one integrated circuit, a microprocessor and an ASIC, or the like. In at least some examples, controller 2102 is not limited to any particular combination of hardware circuitry and machine-readable instructions, nor is it limited to any particular source of the machine-readable instructions executed by controller 2102.

[0104] FIG. 23B is a diagram 2120 that schematically illustrates at least some ways in which the control portion 2100 may be implemented, according to one example of the present disclosure. In some examples, the control portion 2100 is implemented entirely within or by an IPG assembly 2122, as described above in connection with at least FIG. 22, which has at least some of the substantially same features and attributes as the IPG assembly 1912. In some examples, the control portion 2100 is implemented entirely within or by a remote control 2130 (e.g., a programmer) outside the patient's body, such as a patient control 2132 and / or a physician control 2134. In some examples, the control portion 2100 is implemented partially in the IPG assembly 2122 and partially in the remote control 2130 (at least one of the patient control 2132 and the physician control 2134). In some examples, the control portion 2100 may be implemented via a server accessible via the cloud and / or other network paths. In some examples, the control portion 2100 may be distributed or allocated among multiple devices or resources, such as a server, an IMD, and / or a user interface.

[0105] In some examples, in connection with the control portion 2100, the user interface (2110 in FIG. 23C) is implemented in a remote control 2130. FIG. 23C is a block diagram that schematically represents the user interface 2110, according to one example of the present disclosure. In some examples, the user interface 2110 forms part of and / or is accessible via a patient external device, by which the treatment system can be at least partially controlled and / or monitored. The external device hosting the user interface 2110 can be a patient remote portion (e.g., 2132 in FIG. 22C, e.g., a smartphone running a custom software application), a physician remote portion (e.g., 2134 in FIG. 23B), and / or a clinician portal portion. In some examples, the user interface 2110 includes a user interface or other display that provides simultaneous display, activation, and / or manipulation of at least some of the various systems, assemblies, circuits, engines, sensors, components, modules, functions, and parameters as described herein. In some examples, at least some portions or aspects of the user interface 2110 may be provided via a graphical user interface (GUI) and may include a display and input.

[0106] While specific examples have been illustrated and described herein, various alternative and / or equivalent implementations may be substituted for the specific examples shown and described without departing from the scope of the present disclosure. This application is intended to cover any adaptations or variations of the specific examples discussed herein.

Claims

1. 1. A system for treating sleep-disordered breathing (SDB) in an adult patient, comprising an implantable stimulating electrode assembly, the implantable stimulating electrode assembly comprising: a support defining opposing first and second ends, a central major axis, and a central minor axis perpendicular to the central major axis and intermediate the first and second opposing ends, the support defining a length along the central major axis and a width along the central minor axis, the length being greater than the width such that the support has an elongated shape; a first stimulation electrode carried by the support and positioned between the central minor axis and the first end; a second stimulation electrode carried by the support and positioned between the central minor axis and the second end; Equipped with a distance between the first stimulating electrode and the second stimulating electrode defines an effective length of the stimulating electrode assembly; the first stimulation electrode is provided as one of a plurality of electrodes in a first subgroup of electrodes located between the central short axis and the first end, and the second stimulation electrode is provided as one of a plurality of electrodes in a second subgroup of electrodes located between the central short axis and the second end; and final implantation of the stimulation electrode assembly into an adult patient, the support is positioned such that the central longitudinal axis extends across the midline of the patient's jaw, the first stimulating electrode and the second stimulating electrode are positioned on opposite sides of the midline of the patient's jaw, and the effective length is selected according to a span distance between the right and left hypoglossal nerves of an adult patient such that all of the electrodes in the first subgroup of electrodes are closer to the patient's right hypoglossal nerve than any of the electrodes in the second subgroup of electrodes, and all of the electrodes in the second subgroup of electrodes are closer to the patient's left hypoglossal nerve than any of the electrodes in the first subgroup of electrodes. system.

2. The system of claim 1 , wherein the first stimulating electrode and the second stimulating electrode each have an axisymmetric shape.

3. Upon final implantation into the adult patient, at least one electrode in the first subgroup of electrodes is positioned to deliver stimulation energy to the right hypoglossal nerve and at least one electrode in the second subgroup of electrodes is positioned to deliver stimulation energy to the left hypoglossal nerve. The system of claim 1 .

4. In the final transplantation into the adult patient, at least one electrode in the first sub-group of electrodes is positioned to deliver stimulation energy to the medial branch of the right hypoglossal nerve, and at least one electrode in the second sub-group of electrodes is positioned to deliver stimulation energy to the medial branch of the left hypoglossal nerve; The system of claim 3.

5. further comprising an implantable pulse generator (IPG); the pulse generator (IPG) is programmed to deliver stimulation energy to at least one electrode in the first subgroup of electrodes and at least one electrode in the second subgroup of electrodes at a level sufficient to stimulate each of the medial branches of the right hypoglossal nerve based on a distance between at least one electrode in the first subgroup of electrodes and a medial branch of the left hypoglossal nerve and a distance between at least one electrode in the second subgroup of electrodes and a medial branch of the left hypoglossal nerve; The system of claim 4.

6. further comprising an implantable pulse generator (IPG); the pulse generator (IPG) is programmed to deliver stimulation energy to at least one of the first subgroup electrodes and the second subgroup electrodes; The system of claim 3.

7. the pulse generator (IPG) is programmed to deliver stimulation energy to only one of the first subgroup electrodes and the second subgroup electrodes to stimulate only one of the right hypoglossal nerve and the left hypoglossal nerve; The system of claim 6.

8. the pulse generator (IPG) is programmed to deliver stimulation energy to at least one electrode in the first subgroup of electrodes and at least one electrode in the second subgroup of electrodes to stimulate both the right hypoglossal nerve and the left hypoglossal nerve; The system of claim 6.

9. The pulse generator (IPG) in at least one of amplitude, pulse width, and speed, programmed to deliver a stimulation signal to at least one electrode in the first sub-group of electrodes that is different from a stimulation signal delivered to at least one electrode in the second sub-group of electrodes; The system of claim 8.

10. The pulse generator (IPG) programmed to deliver a synchronization pulse train to at least one electrode in the first subgroup of electrodes and to at least one electrode in the second subgroup of electrodes; The system of claim 8.

11. further comprising an introducer for guiding the stimulation electrode assembly through an incision in the patient's skin. The system of claim 1 .

12. The system comprises: a test electrode carried by the introducer; at least one of the first stimulating electrode and the second stimulating electrode of the stimulation electrode assembly that emits stimulation energy through a channel having an opening defined in the introducer; configured to apply stimulation energy by at least one of The system of claim 11.

13. the support defines a curved shape in extension between the first end and the second end; The system of claim 1 .

14. the support has a predetermined shape in extension between the first end and the second end; the predetermined shape is one of a U-shape and a W-shape; The system of claim 1 .

Images