Multiple Targeted Stimulation Therapy for Sleep-Disordered Breathing

Abstract

Devices and / or methods for treating sleep disordered breathing may include stimulation of mono-nerves, poly-nerves, and other tissues associated with a patent upper airway.

Description

[Background technology]

[0001] Sleep-disordered breathing, such as obstructive sleep apnea, can cause serious health problems and is common in the adult population. Some forms of treatment for sleep-disordered breathing may involve electrical stimulation of the nerves and / or muscles associated with a patent upper airway. [Brief explanation of the drawings]

[0002] [Figure 1] FIG. 1 is a block diagram that schematically illustrates an exemplary device and / or an exemplary method for stimulating airway-associated tissue.

[0003] [Figure 2] FIG. 2 is a schematic diagram illustrating a patient's anatomy and an exemplary device and / or exemplary method for stimulating the cervical-associated nerves and / or the hypoglossal nerve.

[0004] [Figure 3A] FIG. 3A is a diagram illustrating a schematic of an exemplary device and / or exemplary method for stimulating airway-related tissue, including a patient's anatomy and an implantable pulse generator (IPG) and associated stimulation elements.

[0005] [Figure 3B] FIG. 3B is a block diagram illustrating an exemplary device including an IPG and a patient remote control.

[0006] [Figure 3C] FIG. 3C is a schematic representation of a patient's anatomy and an exemplary apparatus and / or an exemplary method such as that of FIG. 3A, explicitly showing the sensing element.

[0007] [Figure 4] FIG. 4 is a schematic diagram illustrating an exemplary device and / or method for implanting a stimulation element in a stimulating relationship to a target neural stimulation location.

[0008] [Figure 5A] 5A-5B include side views that are schematic representations of exemplary stimulation leads with connection mechanisms. [Figure 5B] Same as above.

[0009] [Figure 6A] 6A-6B are diagrams including side views that schematically depict exemplary anchoring elements. [Figure 6B] Same as above.

[0010] [Figure 7A] 7A-7C include side views that schematically depict exemplary stimulation leads having bifurcated features and / or associated delivery tools. [Figure 7B] Same as above. [Figure 8]

[0011] [Figure 9] 9-11A are schematic diagrams illustrating exemplary devices and / or methods for implanting stimulation elements in stimulating relationship to target nerve stimulation locations, such as the hypoglossal nerve and cervical-related nerve traps. [Figure 10A] Same as above. [Figure 10B] Same as above. [Figure 10C] Same as above. [Figure 11A] Same as above.

[0012] [Figure 11B] FIG. 11B is a view like FIGS. 9-11B, including implantation of a microstimulator in the neck region for connected stimulation elements.

[0013] [Figure 12] 12-13 are schematic diagrams illustrating exemplary devices and / or methods for implanting stimulation elements through an implant access incision proximate to a cervical-related nerve trap. [Figure 13] Same as above.

[0014] [Figure 14A] 14A-14G are schematic diagrams illustrating exemplary devices and / or methods for implanting stimulation elements and IPGs through implant access incisions proximal to the cervical-associated nerve traps and / or hypoglossal ring. [Figure 14B] Same as above. [Figure 14BB] Same as above. [Figure 14C] Same as above. [Figure 14D] Same as above. [Figure 14E] Same as above. [Figure 14F] Same as above. [Figure 14G] Same as above.

[0015] [Figure 14H] 14H-14K are schematic diagrams illustrating exemplary devices and / or methods for implanting stimulation elements and microstimulators through an implant access incision proximal to the cervical-associated nerve trap and / or hypoglossal nerve. [Figure 14HH] Same as above. [Figure 14I] Same as above. [Figure 14J] Same as above. [Figure 14K] Same as above.

[0016] [Figure 14L] 14L-14R are schematic diagrams illustrating exemplary devices and / or methods for implanting stimulation elements and associated leads, IPGs, or microstimulators through implant access incisions for at least both stimulation locations of the hypoglossal nerve. [Figure 14M] Same as above. [Figure 14N] Same as above. [Figure 14O] Same as above. [Figure 14P] Same as above. [Figure 14Q] Same as above. [Figure 14R] Same as above.

[0017] [Figure 15A] 15A-15C are schematic diagrams illustrating exemplary devices and / or methods for implanting a stimulation element via intravascular access and delivery. [Figure 15B] Same as above. [Figure 15C] Same as above.

[0018] [Figure 16] FIG. 16 is a diagram that schematically illustrates an exemplary device and / or exemplary method for stimulating the cervical-related nerve trapezius and / or hypoglossal nerve relative to a patient's anatomy.

[0019] [Figure 17] FIG. 17 includes a top view that schematically illustrates an exemplary stimulation element as a paddle electrode in a stimulating relationship to a target nerve stimulation location.

[0020] [Figure 18] FIG. 18 is a diagram including a cross-sectional view that schematically illustrates an exemplary cuff electrode.

[0021] [Figure 19] FIG. 19 is a diagram including a side view that schematically illustrates the exemplary cuff electrode of FIG. [Figure 20] FIG. 20 is a diagram including a cross-sectional view that schematically illustrates an exemplary cuff electrode.

[0022] [Figure 21] FIG. 21 includes a side view that schematically illustrates an exemplary device and / or an exemplary method for implanting a microstimulator in the cervical region with wireless power delivery to an external power element.

[0023] [Figure 22A] 22A-23 are schematic diagrams illustrating an exemplary device and / or exemplary method for stimulating a cervical-related nerve trap, including a patient's anatomy and anchoring elements. [Figure 22B] Same as above. [Figure 23] Same as above.

[0024] [Figure 24A] 24A-25B are diagrams including top and side views that schematically depict an exemplary stimulation element including a linear electrode array. [Figure 24B] Same as above. [Figure 25A] Same as above. [Figure 25B] Same as above.

[0025] [Figure 26A] FIG. 26A is a cross-sectional view of an exemplary cuff electrode taken along line 26B-26B of FIG. 26B.

[0026] [Figure 26B] FIG. 26B is a side view that schematically illustrates an exemplary cuff electrode.

[0027] [Figure 27A] 27A-28 include diagrams, including top views, that schematically depict exemplary paddle electrodes that include anchoring elements. [Figure 27B] Same as above. [Figure 28] Same as above.

[0028] [Figure 29A] 29A-29C include top views that schematically depict an exemplary axial stimulation section including a linear electrode array and anchoring elements. [Figure 29B] Same as above. [Figure 29C] Same as above.

[0029] [Figure 30A] FIG. 30A is a flow diagram that schematically illustrates an exemplary implantation method.

[0030] [Figure 30B]30B-30U include side views that schematically depict an exemplary apparatus and / or an exemplary method for implantation, including access and delivery tools for stimulation elements, some of which include anchoring elements. [Figure 30C] Same as above. [Figure 30D] Same as above. [Figure 30E] Same as above. [Figure 30F] Same as above. [Figure 30G] Same as above. [Figure 30H] Same as above. [Figure 30I] Same as above. [Figure 30J] Same as above. [Figure 30K] Same as above. [Figure 30L] Same as above. [Figure 30M] Same as above. [Figure 30N] Same as above. [Figure 30O] Same as above. [Figure 30P] Same as above. [Figure 30Q] Same as above. [Figure 30R] Same as above. [Figure 30S] Same as above. [Figure 30T] Same as above. [Figure 30U] Same as above.

[0031] [Figure 30V] 30V-30W each include a top view and a side view that schematically illustrate an exemplary anchor structure. [Figure 30W] Same as above.

[0032] [Figure 31A] 31A-31G include side views that schematically depict exemplary axial stimulation elements including exemplary anchoring elements. [Figure 31B] Same as above. [Figure 31C] Same as above. [Figure 31D] Same as above. [Figure 31E] Same as above. [Figure 31F] Same as above. [Figure 31G] Same as above.

[0033] Same as above. [Figure 32A] 32A-32C are schematic diagrams illustrating exemplary devices and / or exemplary methods for stimulating various locations of the cervical-related nerve traps, including the patient's anatomy and some intravascular and other delivery routes. [Figure 32B] Same as above. [Figure 32C] Same as above. [Figure 32D]

[0034] [Figure 33A] 33A-37D are diagrams including graphs that schematically represent an exemplary respiratory cycle and an exemplary method of stimulation of upper airway-related nerves. [Figure 33B] Same as above. [Figure 34] Same as above. [Figure 35] Same as above. [Figure 36A] Same as above. [Figure 36B] Same as above. [Figure 37A] Same as above. [Figure 37B] Same as above. [Figure 37C] Same as above. [Figure 37CC] Same as above. [Figure 37D] Same as above.

[0035] [Figure 37E] 37E-37G include graphs that schematically represent an exemplary respiratory cycle and exemplary stimulation methods for upper airway patency-related tissue, including at least some stimulation methods and devices related to patency hysteresis parameters. [Figure 37F] Same as above. [Figure 37G] Same as above.

[0036] [Figure 38A] FIG. 38A is a flow diagram that schematically represents an exemplary device and / or an exemplary method for stimulation therapy.

[0037] [Figure 38B] 38B, 38C, and 38D are block diagrams that schematically illustrate examples of a sensing engine, a sensing tool, and a stimulus engine, respectively. [Figure 38C] Same as above.

[0038] [Figure 38D] FIG. 38D is a flow diagram that schematically represents an exemplary device and / or an exemplary method for stimulation therapy.

[0039] [Figure 38E] 38E-38F are flow diagrams that generally represent example devices and / or example methods for stimulation therapy related to at least the patency hysteresis parameter, among other parameters, functions, engines, etc. [Figure 38F] Same as above.

[0040] [Figure 38G] 38G-38H include graphs that generally represent exemplary respiratory cycles and exemplary methods of stimulation for upper airway patency-related tissue, including at least some stimulation methods related to patency hysteresis parameters. [Figure 38H] Same as above. [Figure 39]

[0041] [Figure 40A] 40A-51B are block diagrams that schematically illustrate exemplary methods, or portions thereof, of sleep disordered breathing care.

[0042] 52A-52C are diagrams, including front and side views, that schematically illustrate an exemplary device and / or exemplary method for sensing the neck region and impedance. [Figure 40B] Same as above. [Figure 40C] Same as above. [Figure 40D] Same as above. [Figure 41A] Same as above. [Figure 41B] Same as above. [Figure 41B2] Same as above. [Figure 41B3] Same as above. [Figure 41B4] Same as above. [Figure 41C] Same as above. [Figure 41D] Same as above. [Figure 42A] Same as above. [Figure 42B] Same as above. [Figure 42C] Same as above. [Figure 43] Same as above. [Figure 44A] Same as above. [Figure 44B] Same as above. [Figure 44C] Same as above. [Figure 45A] Same as above. [Figure 45B] Same as above. [Figure 46A] Same as above. [Figure 46B] Same as above. [Figure 47] Same as above. [Figure 48] Same as above. [Figure 49A] Same as above. [Figure 49B] Same as above. [Figure 50] Same as above. [Figure 51A] Same as above. [Figure 51B] Same as above. [Figure 52A] Same as above. [Figure 52B] Same as above. [Figure 52C] Same as above.

[0043] [Figure 52BB] 52BB and 52D are side views that schematically represent the neck region, as well as exemplary devices / methods, including wearable garments, for sensing impedance and / or associated with delivering stimulation, and / or exemplary methods. [Figure 52D] Same as above.

[0044] [Figure 52E] FIG. 52E is a block diagram that schematically illustrates external power / control elements that communicate wirelessly with the implantable neural interface.

[0045] [Figure 52F] FIG. 52F includes a side view that schematically represents an exemplary device and / or an exemplary method including a wearable garment for supporting sleep disordered breathing (SDB) care including a neck region and multiple targeted stimulations.

[0046] [Figure 52G] 52G and 52H are block diagrams including top and side views, respectively, that schematically represent an electrode array of a stimulation element. [Figure 52H] Same as above.

[0047] [Figure 52I] FIG. 52I is a block diagram including a side view that schematically represents the power / control elements.

[0048] [Figure 52J] FIG. 52J is a block diagram including a side view that schematically represents the power / control elements in combination with the stimulation portion in a stimulating relationship to the muscle.

[0049] [Figure 52K] FIG. 52K includes a side view that schematically illustrates a stimulation element that can be externally attached to the neck region to provide power / control and / or provide upper airway patency related tissue.

[0050] [Figure 52L] FIG. 52L includes a side view that schematically depicts an externally attachable stimulation element and an implantable combination microstimulator-cuff arrangement.

[0051] [Figure 53A] 53A-53D include front and side views that schematically depict an exemplary method for relating a patient's anatomy and collapse patterns associated with a patent upper airway. [Figure 53B] Same as above. [Figure 53C] Same as above. [Figure 53CC] Same as above. [Figure 53D] Same as above.

[0052] [Figure 53E] 53E-53FF are block diagrams that schematically illustrate exemplary devices and / or exemplary methods relating to collapse patterns associated with a patent upper airway. [Figure 53EE] Same as above. [Figure 53F] Same as above. [Figure 53FF] Same as above.

[0053] [Figure 54A] FIG. 54A is a block diagram that schematically represents an exemplary care engine.

[0054] [Figure 54B] 54B-54E are block diagrams that schematically illustrate example controls, user interfaces, and associated devices. [Figure 54C] Same as above. [Figure 54D] Same as above. [Figure 54E] Same as above.

[0055] [Figure 55]55-59B are schematic diagrams illustrating a patient's anatomy and an exemplary device and / or exemplary method for implanting stimulation elements and applying stimulation therapy to the phrenic nerve and / or cervical-related nerve traps. [Figure 56] Same as above. [Figure 57] Same as above. [Figure 58] Same as above. [Figure 59A] Same as above. [Figure 59B] Same as above.

[0056] [Figure 59C] 59C-59E include side views that schematically depict an exemplary stimulation element incorporating an anchor structure, with FIG. 59F including a cross-sectional view of FIG. 59E. [Figure 59D] Same as above. [Figure 59E] Same as above. [Figure 59F] Same as above.

[0057] [Figure 60] FIG. 60 is a schematic diagram illustrating an exemplary device and / or exemplary method for transvenous stimulation of a target nerve location relative to a patient's anatomy and upper airway patency. DETAILED DESCRIPTION OF THE INVENTION

[0058] In the following detailed description, reference is made to the accompanying drawings, which form a part hereof, and in which is shown, by way of illustration, specific examples in which the disclosure may be practiced. It is to be understood that other embodiments 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 is to 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 stated.

[0059] At least some embodiments of the present disclosure are directed to an exemplary apparatus and / or an exemplary method for sleep-disordered breathing (SDB) therapy. In some embodiments, the sleep-disordered breathing may include obstructive sleep apnea, and in some embodiments, the sleep-disordered breathing may include multiple types of sleep apnea, including obstructive sleep apnea and / or central sleep apnea.

[0060] Furthermore, the general principles associated with the exemplary arrangements of the present disclosure for sleep-disordered breathing may be applied to other areas of a patient's body to treat conditions other than sleep-disordered breathing. For example, at least some aspects of the exemplary arrangements of the present disclosure may be deployed in the pelvic region to treat urinary and / or fecal incontinence or other disorders, such as through stimulation of the pudendal nerve, which may cause contractions of the external urethral sphincter and / or external anal sphincter.

[0061] Additionally, other body regions and / or disorders may be suitable candidates for example arrangements that can stimulate multiple neural targets to treat a type or class of physiological condition. It will be further understood that the example sensing arrangements of the present disclosure (for sensing physiological data for a condition of interest) may be deployed in conjunction with various example arrangements for stimulating a single neural target or multiple neural targets.

[0062] As shown in FIG. 1 , some exemplary methods may include stimulating at least one patent upper airway-related tissue 120, which may include a nerve 130 and / or a muscle 140, via at least one stimulation element 110. In some examples, nerve 130 may include a cervical-related nerve trap and / or a hypoglossal nerve, as further shown in FIG. 2 . Furthermore, as will be further described later through various examples, nerve 130 may include nerves in addition to or instead of the hypoglossal nerve and / or cervical-related nerve trap. Meanwhile, in some examples, muscle 140 may include the genioglossus muscle (innervated by the hypoglossal nerve), and in some examples, muscle 140 may include one or more muscle groups innervated by a cervical-related nerve trap (e.g., omohyoid, sternothyroid, sternohyoid). Furthermore, as will be further described later through various examples, muscle 140 may include muscles in addition to or instead of muscle groups innervated by the genioglossus muscle and / or cervical-related nerve trap.

[0063] In one aspect, stimulation of one or more of these exemplary nerves and / or muscles may serve to increase or maintain a patent upper airway in a patient, and therefore may sometimes be referred to as a patent upper airway-associated tissue.

[0064] Figure 2 is a diagram 300 including a side view that schematically depicts the cervical nerve trap 315 in relation to the hypoglossal nerve 305 and cranial nerves C1, C2, and C3. As shown in Figure 2, portion 329A of the cervical nerve trap 315 extends anteriorly from the first cranial nerve C1, and segment 317 runs alongside (e.g., elongates with) the hypoglossal nerve 305 until the cervical nerve trap 315 branches off from the hypoglossal nerve 305 to form the superior root 325 of the cervical nerve trap 315, where a portion of loop 319 is formed. A portion of the hypoglossal nerve 305 extends distally to innervate the genioglossus muscle 304. As further shown in FIG. 2 , the superior root 325 of the cervical-related nerve trap 315 extends inferiorly (i.e., downward) until it reaches near the base 318 of the loop 319, from which the loop 319 extends superiorly (i.e., upward) to form smaller roots 327 (i.e., inferior roots) that join the second and third cranial nerves, C2 and C3, respectively.

[0065] As further shown in FIG. 2 , several branches 331 extend from cervical nerve trap loop 319, including branch 332 innervating omohyoid muscles 334, branch 342 innervating sternothyroid muscles 344 and sternohyoid muscles 354. Another branch 352 innervates sternohyoid muscles 354 and sternothyroid muscles near the base 318 of cervical nerve trap loop 319. In some embodiments, the entire cervical nerve trap 315 (including loop 319) and its associated branches (e.g., at least 332, 342, 352), when considered together, may sometimes be referred to as cervical-related nerve trap 316. It will be further understood that one such cervical-related nerve trap may exist on each side (e.g., right and left) of the patient's body.

[0066] In one aspect, stimulation of the cervical-related nerve trap 316 may include stimulation of the superior root 325 of the cervical nerve trap 315 (e.g., loop) and / or any one of the branches 331 extending from the loop 319, which may affect upper airway patency. However, in some examples, upper airway patency may be increased by directly stimulating the muscles identified above, such as the omohyoid, sternothyroid, and / or sternohyoid muscles.

[0067] Among other effects, stimulation of these nerves and / or muscles acts to move the larynx downward, which may increase upper airway patency.

[0068] Various exemplary implementations for stimulating different portions of the cervical-related nerve trap 316 to activate different associated muscle groups are described below in connection with various embodiments of the present disclosure. Additionally, some of these figures illustrate various exemplary implementations for stimulating the hypoglossal nerve and / or stimulating other nerves in addition to or instead of the cervical-related nerve trap and the hypoglossal nerve.

[0069] Although stimulation of only the hypoglossal nerve 305 (or some branches thereof) can be effective in increasing upper airway patency sufficient to ameliorate obstructive sleep apnea in at least approximately 70 percent of suitable patients when using certain types of implantable neurostimulator devices, some patients may benefit from stimulation of the cervical-related nerve trap 316 in addition to, or instead of, stimulation of the hypoglossal nerve 305. Furthermore, for a single patient, certain positions of the head and neck and / or body (e.g., supine, lateral, etc.) may be more effectively treated by stimulating the cervical-related nerve trap 316 with or without stimulation of the hypoglossal nerve 305. In some such examples, stimulation of the cervical-related nerve trap 316 may be performed upon detecting that the patient is in a certain body position (e.g., supine).

[0070] Furthermore, because the cervical-related nerve trap 316 stimulates several different muscle groups that may affect upper airway patency, stimulation may be applied at several different locations on the cervical-related nerve trap 316. Such stimulation at each different location may occur simultaneously, sequentially, alternating, etc., depending on which nerve (or muscle) is stimulated, when the stimulation occurs relative to each respiratory phase (or portion of each phase) during the patient's breathing, and / or based on other factors.

[0071] Many different examples of various stimulation locations, timing, patterns, etc. of the cervical-related nerve trap 316 are described below throughout this disclosure. Of these various potential stimulation locations, FIG. 2 (and FIGS. 16, 32A) generally shows three example stimulation locations A, B, and C. In some examples, the potential stimulation locations also include stimulation locations D and E. Stimulation elements may be placed at all or only some (one or two) of these example stimulation locations. At each location, a variety of stimulation elements (e.g., cuff electrodes, axial arrays, paddle electrodes) may be implanted, depending on the particular delivery route, method, etc. In each example stimulation A, B, C, D, E, the stimulation elements may be delivered subcutaneously, intravascularly, etc. At each stimulation location, in some examples, the stimulation elements may include a microstimulator. Various aspects of these example implementations are further described below.

[0072] In some exemplary implementations, stimulation elements can be delivered percutaneously to a location in stimulating relationship to the upper airway muscles. In some such embodiments, percutaneous access points can be formed and located between the hyoid bone and the sternum and laterally to the midline. As with other implantation methods described herein, implantation can include nerve monitoring during percutaneous delivery, and in some embodiments, monitoring via a nerve integrity monitor (NIM).

[0073] In some examples, further exemplary implementations for these stimulation locations are described in connection with at least Figure 16 (at least stimulation location A), Figures 22A, 32B (at least stimulation location B), and Figure 32B (stimulation location C). It will be understood that these exemplary stimulation locations A, B, and C are not limiting, and that other portions of the cervical-related nerve trap may include suitable stimulation locations depending on the particular goals of the stimulation therapy, available access / delivery issues, etc.

[0074] Among the different physiological effects resulting from stimulation of various branches of the cervical-related nerve trap 316, in some examples, stimulation of nerve branches that cause contraction of the sternothyroid and / or sternohyoid muscles can pull the larynx downward, thereby increasing and / or maintaining a patent upper airway in at least some patients. Such stimulation may be applied without stimulation of the hypoglossal nerve or may be applied in coordination with stimulation of the hypoglossal nerve 305.

[0075] Other physiological effects of stimulating the cervical-related nerve trap 316 and / or other nerves may be described later in the context of specific examples of the present disclosure.

[0076] 3A is a diagram 500 including a front view that schematically depicts an example arrangement 501 including one or more stimulation elements forming part of an example device and / or example method for increasing and / or maintaining upper airway patency, or for other purposes. As shown in FIG. 3A , in some examples, a first stimulation element 510A is positioned on the hypoglossal nerve 505R on a first side (e.g., right side) of a head and neck portion 520 of a patient's body, and a second stimulation element 510B is positioned on the hypoglossal nerve 505L on an opposing second side (e.g., left side) of the head and neck portion 520, thus spaced apart from the first stimulation element 510A. As further shown in FIG. 3A , in some embodiments, the third stimulation element 513A is positioned in a cervical-related nerve trap 515R on a first side (e.g., the right side) of the head and neck region 520, and the second stimulation element 513B is positioned in a cervical-related nerve trap 515L on an opposing second side (e.g., the left side) of the head and neck region 520, thus spaced apart from the third stimulation element 513A. As shown in FIG. 3A , the stimulation elements 513A, 513B are shown in stimulating relationship to the first and second cervical-related nerve traps 515L, 515R at a location just superior to the clavicle 522. However, it will be understood that for simplicity of illustration, this depiction, at least in FIGS. 2 , 16 , 22A , 32A-32D , etc., represents the stimulation elements 513A, 513B positioned in any portion, such as a cervical nerve trap loop and / or associated branch, to provide a more detailed view of the cervical-related nerve trap 316.

[0077] As can be seen in FIG. 3A, stimulation element 510A is spaced apart from stimulation element 513A, while stimulation element 510B is spaced apart from stimulation element 513B.

[0078] 3A depicts stimulation elements for both the hypoglossal nerve (e.g., elements 510A, 510B) and the cervical-related nerve traps (e.g., elements 513A, 513B), it will be appreciated that in some examples, stimulation of upper airway-related tissues may include stimulation of only the hypoglossal nerves 505R and / or 505L. In such an arrangement, stimulation of the cervical-related nerve traps 515R, 515L does not occur at all, or at least not during a given period of time, situation, etc.

[0079] Stimulation of only one hypoglossal nerve (e.g., 505R or 505L) may be referred to as monolateral stimulation, while stimulation of both such hypoglossal nerves (e.g., 505R and 505L) may be referred to as bilateral stimulation. It will be further understood that in some instances of monolateral stimulation, only one of each stimulating element 510A, 510B is implanted. However, in other instances of monolateral stimulation, both stimulating elements 510A, 510B may be implanted, but only one of them is stimulated to provide monolateral stimulation.

[0080] In some examples of stimulation of both hypoglossal nerves (eg, 505R, 505L), stimulation may be performed simultaneously, alternating, and / or in other patterns.

[0081] Additionally, in some embodiments where one or both of stimulation elements 510A, 510B are implanted (to stimulate the hypoglossal nerve), neither of stimulation elements 513A, 513B (for stimulation of the cervical-related nerve trap) are implanted.

[0082] However, in some embodiments where one or both of stimulation elements 510A, 510B are implanted (to stimulate the hypoglossal nerve), one or both of stimulation elements 513A, 513B (for stimulation of cervical-related nerve traps) may also be implanted. In some such embodiments, such stimulation elements 513A, 513B may be implanted, but such stimulation elements 513A, 513B may not be activated in some embodiments where stimulation of only one or both of the hypoglossal nerves 505R, 505L is provided.

[0083] 3A depicts stimulation elements for both the hypoglossal nerve (e.g., elements 510A, 510B) and the cervical-related nerve traps (e.g., elements 513A, 513B), it will be understood that in some embodiments, stimulation of upper airway-related tissues may include stimulation of only one or both of the cervical-related nerve traps 515R, 515L. In such an arrangement, stimulation of the hypoglossal nerves 505R, 505L does not occur at all, or at least not during a given period of time, situation, etc.

[0084] Stimulation of only one cervical-related nerve (e.g., 515R or 515L) may be referred to as monostimulation, while stimulation of both such nerves (e.g., 515R and 515L) may be referred to as bilateral stimulation. It will be further understood that in some embodiments of monolateral stimulation, only one of each stimulating element 513A, 513B is implanted. However, in other embodiments of monolateral stimulation, both stimulating elements 513A, 513B may be implanted, but only one of them is stimulated to provide monolateral stimulation.

[0085] In some embodiments of stimulation of both cervical-related nerve traps (e.g., 515R, 515L), stimulation may be performed simultaneously, alternating, and / or in other patterns.

[0086] Additionally, in some embodiments where one or both of stimulation elements 513A, 513B are implanted (to stimulate the cervical-related nerve traps), neither stimulation element 510A, 510B (to stimulate the hypoglossal nerve) is implanted.

[0087] However, in some embodiments where one or both of stimulation elements 513A, 513B are implanted (to stimulate the cervical-related nerve traps), one or both of stimulation elements 510A, 510B (to stimulate the hypoglossal nerve) may also be implanted. In some such embodiments, such stimulation elements 510A, 510B may be implanted, but such stimulation elements 510A, 510B may not be activated in some embodiments where stimulation of only one or both of the cervical-related nerve traps 515R, 515L is provided.

[0088] In some embodiments, stimulation of only the cervical-related nerves 515R and / or 515L may be used to stimulate certain aspects of the upper airway. collapse Pattern, or complete collapse It can be implemented for less than action.

[0089] 3A , in some embodiments, only one stimulation element is implanted on the left side of the head and neck portion 520 to stimulate a first type of nerve (e.g., the hypoglossal nerve, the cervical-related nerve trap, or the like), and only one stimulation element is implanted on the right side of the head and neck portion 520 to stimulate a different second type of nerve (e.g., the hypoglossal nerve, the cervical-related nerve trap, or the like). For example, in some embodiments, only stimulation element 510A is implanted to stimulate the right hypoglossal nerve 505R and only stimulation element 513B is implanted to stimulate the left cervical-related nerve trap 515L, or vice versa.

[0090] Alternatively, all stimulation elements 510A, 510B, 513A, 513B of example configuration 501 may be implanted, but stimulation is performed via only stimulation element 510A to the right hypoglossal nerve 505R and via only stimulation element 513B to the left cervical-related nerve trap 515L, or vice versa. In some such examples, stimulation elements (e.g., a combination of 510A and 513B, or a combination of 510B and 513A) may be activated to deliver stimulation to the respective hypoglossal and cervical-related nerve traps simultaneously. However, in some examples, stimulation elements (e.g., a combination of 510A and 513B, or a combination of 510B and 513A) may be activated to deliver stimulation alternately to the respective hypoglossal and cervical-related nerve traps. In other examples, various stimulation patterns may be implemented in which one stimulation element (e.g., 510A) is activated multiple times within a selectable period of time, followed by activation of the other stimulation element (e.g., 513A) one or more times. In further examples, stimulation applied via each stimulation element 510A, 510B, 513A, 513B may be performed in an interleaved manner.

[0091] It will be further appreciated that the various stimulation elements 510A, 510B, 513A, 513B shown in FIG. 3A may be embodied as part of leads, microstimulators, etc., and may be secured to non-neural tissue or structures within a patient's body via various anchoring elements, as described more fully below in connection with at least FIGs. 6A-6B, 22A-23, and / or 27A-30B. For example, with reference to FIG. 3A, in some examples, such anchoring elements may be secured to non-neural tissue, such as, but not limited to, the illustrated clavicle 522, the manubrium 524 of the sternum, etc.

[0092] Similarly, each stimulation element 510A, 510B, 513A, 513B may be embodied as one of a variety of electrode arrays, cuff electrodes, paddle electrodes, etc., as described more fully below in various exemplary configurations of this disclosure. Each stimulation element may be embodied in a unipolar, bipolar, or multipolar configuration.

[0093] In some embodiments, the various stimulation configurations described in connection with at least FIG. 3A may be implemented, with stimulation performed without any sensing or with limited sensing, such as, but not limited to, simply sensing to assess the effectiveness of stimulation but not using sensing to gauge or trigger stimulation. In either case, in some embodiments, stimulation may be applied simultaneously to both the cervical-associated nerves and the hypoglossal nerve. Further details are provided throughout the various embodiments of this disclosure.

[0094] 3B is a diagram that schematically illustrates an example arrangement 571, including example devices and / or example methods, for communication between an implantable medical device (IMD) 570 and a patient remote control 572. In some embodiments, the implantable medical device 570 may include an implantable pulse generator (IPG) (e.g., 533 of FIG. 3A) and a microstimulator (e.g., 1313A of FIGS. 10A and 10C, 6575 of FIG. 14H). In some embodiments, the implantable medical device 570 (with the patient remote control 527) may include one example implementation of the IPG 533 of FIG. 3A, and thus applies to example implementations throughout this disclosure.

[0095] The patient remote control 572 includes inputs for changing stimulation intensity settings, starting or stopping therapy, etc. The patient remote control 572 may receive control data, sensing data, therapy data, and / or other data from the IMD 570. The patient remote control 572 may communicate wirelessly with the IMD 570 via telemetry or other wireless communication protocols. At least some aspects of starting, stopping, adjusting stimulation settings, and / or other configuration of the IMD 570 are further described below in connection with various embodiments throughout this disclosure.

[0096] In some embodiments, example arrangement 571 may include one example implementation of care engine 10000 ( FIG. 54A ), control portions 10500, 10528, 10600 ( FIG. 54B, 54C ), and / or user interface 10520 ( FIG. 54D ), described below. With this in mind, patient remote control 572 can include one example implementation of patient remote control 10530 of FIG. 54C and / or patient remote control 10640 of FIG. 54E .

[0097] FIG. 3C is a diagram of an example arrangement 575 that includes at least some of substantially the same features and attributes as the example arrangement 500 of FIG. 3C , except that it includes various examples of sensors that may form part of the IPG 533 and / or may be separate from the IPG 533. In general, the sensors associated with FIG. 3C may include any one or more of the sensing types, modalities, parameters, etc., as described below in connection with at least FIGS. 38B-38C and at least FIGS. 40A-51B, 54A (care engine 10000). In some examples, the example arrangement 575 may include one example implementation of the care engine 10000 ( FIG. 54A ), control portions 10500, 10528, 10600 ( FIGS. 54B, 54C ), and / or user interface 10520 ( FIG. 54D ), described below.

[0098] In some examples, the IPG 533 may include an on-board sensor 560 integrated into the housing of the IPG 533 and / or exposed on an exterior surface of the housing of the IPG 533. In some examples, the sensor 560 may include an accelerometer (e.g., 8754 in FIG. 38C ), which may include a single-axis accelerometer or a multi-axis (e.g., three-axis) accelerometer. As described in connection with at least FIGS. 38C-38D , the accelerometer may be used to sense various physiological information, such as, but not limited to, body position (e.g., 8722 in FIG. 38B ), respiration (e.g., 8274 in FIG. 38B ), sleep (e.g., 8728 in FIG. 38B ), disease burden (e.g., 8726 in FIG. 38B ), etc. In some examples, the sensed respiration may be used to time the application of stimulation to treat sleep-disordered breathing, assess the severity of sleep-disordered breathing or other disease burden, the effectiveness of stimulation therapy, and / or other physiological information.

[0099] In a manner similar to sensing body position, accelerometers can be used to sense posture and / or activity based on whole-body movement. Accelerometers can be used to sense at least ballistocardiograms (8762 in FIG. 38C), psychocardiograms (8764 in FIG. 38C), heart rate (HR) (8766 in FIG. 38C), sleep (8728 in FIG. 38C), and disease burden (8726 in FIG. 38C), as further described below in connection with FIG. 38. In some examples, via at least such accelerometer sensing, disease burden may include cardiovascular strain and / or may be determined via cardiac output and / or cardiac waveform morphology.

[0100] In some examples, the on-board sensor 560 may include electrodes formed on an outer surface of the housing of the IPG 533 and may be used to sense impedance (e.g., 8752 in FIG. 38C ) in combination with other implanted sensors, such as, but not limited to, sensors 568A, 568B, which may be located on the patient's torso. As described further below, the sensor 560 may be used in combination with sensing elements, such as electrodes implanted in the head and neck region 520. In some examples, the stimulation elements (e.g., 510A, 510B, 513A, 513B) may include electrodes that function in combination with the sensor 560 (as electrodes) to sense impedance. In some such examples, the sensed impedance may be used to determine respiration, which may be used for at least some of the purposes identified above and / or other purposes.

[0101] In some examples, the sensed impedance may indicate the degree of upper airway patency. For example, an upper airway with a smaller cross-section may be sensed as a lower impedance, reflecting a smaller upper airway patency. Conversely, an upper airway with a larger cross-sectional area may be sensed as a higher impedance, reflecting a larger upper airway patency. Thus, maximum patency (measured as a higher impedance) may generally correspond to the stimulation period (HGN and / or ACN) or the peak expiration of the respiratory cycle. Meanwhile, minimum patency (measured as a lower impedance) generally corresponds to inspiration just prior to or before the onset of stimulation (e.g., HGN and / or ACN).

[0102] In some examples, the onboard sensor 560 may include an ECG sensor or may include electrodes that, when used in combination with other electrodes (e.g., 568A, 568B), can be used to sense electrocardiogram (ECG) information, such as by the ECG parameters 8760 of FIG. 38C.

[0103] 3C , in some example implementations, example arrangement 575 may include sensor leads 564 supporting a sensor 566, which in some examples may include a pressure sensor (e.g., differential pressure) (e.g., 8756 of FIG. 38B ). Among other physiological parameters, the pressure sensor may be used to sense respiration, which may be used for at least some of the purposes identified above and / or other purposes. In some examples, sensor 566 may sense physiological parameters other than pressure.

[0104] In some examples, the example arrangement 575 may be implemented via at least some external sensors associated with at least some of the sensing types, modalities, physiological parameters, etc., described above as being implemented via implantable sensors.

[0105] 1-3C in mind, in some embodiments, an exemplary method (and / or exemplary device) includes applying electrical stimulation to a patent upper airway-related tissue via at least one stimulation element and according to at least one stimulation protocol based on a patent upper airway hysteresis parameter. At least some aspects of the exemplary method (and / or exemplary device) are further described below in connection with at least FIGS. 37E-37G, 38E-38H, and / or 52D-52L.

[0106] In some embodiments of the method relating to the patency hysteresis parameter, the upper airway patency-related tissue comprises a cervical-related nerve trap, and in some embodiments, the cervical-related nerve trap comprises a superior root portion, hi some embodiments, the superior root portion stimulates at least one of the sternothyroid, sternohyoid, and omohyoid muscles.

[0107] In some embodiments, the patent upper airway-associated tissue includes at least one nerve portion extending distally from the superior root portion and innervating at least one of the sternothyroid, sternohyoid, and omohyoid muscles.

[0108] In some embodiments, the patent upper airway-associated tissue includes at least one of a plurality of infrahyoid muscles, including at least one of the sternothyroid, sternohyoid, and omohyoid muscles, hi some such embodiments, the method includes applying electrical stimulation to the at least one infrahyoid muscle.

[0109] In some of these embodiments, the method includes applying electrical stimulation percutaneously to at least one infrahyoid muscle. In some such embodiments, the percutaneous application may include removably securing a stimulation element external to and relative to the neck region.

[0110] However, in some embodiments, applying electrical stimulation may include implanting a stimulation element subcutaneously in the neck region and in stimulating relationship with at least one infrahyoid muscle.

[0111] In some embodiments, the upper airway patency hysteresis parameter represents the degree and duration of upper airway patency for upper airway patency-related tissue after at least one stimulation period of at least one stimulation protocol.

[0112] In some embodiments, the upper airway patency hysteresis parameter comprises an upper airway patency hysteresis criterion, hi some such embodiments, the upper airway patency hysteresis criterion is based on at least one of a historical patient-specific mean patency hysteresis effect and a mean patency hysteresis effect of multiple patents.

[0113] In some embodiments, the patent upper airway-related tissue includes subhyoid-based patent upper airway tissue, and in some such embodiments, the subhyoid-based patent tissue includes at least one of a cervical-related nerve trap and at least one infrahyoid muscle innervated by the cervical-related nerve trap.

[0114] In some embodiments, the patent upper airway-related tissue comprises genioglossus-based patent tissue, and in some such embodiments, the genioglossus-based patent tissue comprises at least one of the hypoglossal nerve and the genioglossus muscle innervated by the hypoglossal nerve.

[0115] In some examples, the patent upper airway-associated tissue includes at least one of subhyoid-based patent upper airway tissue and genioglossus-based patent tissue. In some such examples, the at least one stimulation element includes a first stimulation element, and applying stimulation via a first stimulation protocol includes stimulating the subhyoid-based patent tissue via the first stimulation element without stimulating the genioglossus-based patent tissue.

[0116] In some examples, the at least one stimulation protocol includes a first stimulation protocol including a series of stimulation cycles, each stimulation cycle including alternating stimulation periods and non-stimulation periods, and applying electrical stimulation via the first stimulation protocol and the first stimulation element to the patent tissue of the subhyoid base via at least one of a first closed-loop mode including adjusting the stimulation period in relation to sensed respiratory phase information and based on a hysteresis patency parameter, and a first open-loop mode including adjusting the stimulation period without reference to the respiratory phase information and based on a hysteresis patency parameter.

[0117] In some examples, the at least one stimulation element includes a second stimulation element, and applying stimulation via the first stimulation protocol includes applying stimulation via the second stimulation element to the genioglossus-based patent tissue via at least one of a second closed-loop mode that includes adjusting a stimulation period of the first stimulation protocol in relation to the sensed respiratory information and based on the hysteresis patency parameter, and a second open-loop mode that includes adjusting a stimulation period without reference to the respiratory phase information and based on the hysteresis patency parameter.

[0118] In some examples, in the first closed-loop mode, based on the hysteresis patency parameter, the method includes setting a duration of the non-stimulation period between stimulation periods, the duration comprising a minimum duration corresponding to at least one respiratory cycle based on the sensed respiratory information, or a maximum duration of a selectable number of respiratory cycles based on the sensed respiratory information.

[0119] In some examples, in the first open-loop mode, based on the hysteresis patency parameter, the method includes setting the duration of the non-stimulation period between stimulation periods, including a minimum duration corresponding to at least one reference respiratory cycle or a maximum duration of a selectable number of reference respiratory cycles.

[0120] In some embodiments, in the first open-loop mode, the non-stimulation periods between stimulation periods have a duration equal to at least one reference respiratory cycle or the sum of at least one of a selectable number of reference respiratory cycles.

[0121] In some embodiments, one method of applying electrical stimulation (to upper airway patency-related tissue via at least one stimulation element according to at least one stimulation protocol based on an upper airway patency hysteresis parameter) includes performing stimulation adjustment without a sensing element for adjusting the stimulation.

[0122] In some examples, a method of applying electrical stimulation (via at least one stimulation element to a patent upper airway-related tissue according to at least one stimulation protocol based on a patent upper airway hysteresis parameter) includes sensing respiratory information and adjusting the stimulation based on the sensed respiratory information. In some such examples, the sensed respiratory information includes sensed respiratory phase information including at least one of an inspiratory phase and an expiratory phase.

[0123] In some examples, the first stimulation protocol includes applying a selectable number of consecutive stimulation periods.

[0124] In some embodiments, a method of applying electrical stimulation (via at least one stimulation element to upper airway-related tissue in accordance with at least one stimulation protocol based on the upper airway hysteresis parameter) includes at least one of applying stimulation via the at least one stimulation protocol at a first duty cycle that is less than a first selectable percentage of a duration of a reference or sensed respiratory cycle when the breath sensing sensitivity parameter is below a threshold, and applying stimulation via the at least one stimulation protocol at a second duty cycle that is greater than or equal to the first selectable percentage of a duration of a reference or sensed respiratory cycle when the breath sensing sensitivity parameter is equal to or greater than the threshold. In some such embodiments, the first selectable percentage comprises 50 percent.

[0125] In some embodiments, a method of applying electrical stimulation (via at least one stimulation element to a patent upper airway-related tissue in accordance with at least one stimulation protocol based on a patent upper airway hysteresis parameter) includes determining to adjust the application of the stimulation in accordance with the at least one stimulation protocol based on the patency hysteresis parameter and in accordance with at least one of a body position parameter, a nighttime parameter, a sleep disordered breathing (SDB) event frequency parameter, a patient stimulation pause parameter, a patient stimulation intensity adjustment parameter, and a swallowing parameter. In some such embodiments, determining to adjust the application of the stimulation (in accordance with the at least one stimulation protocol) is related to at least one of the SDB event frequency parameter and the body position parameter. collapse In some of these embodiments, the patent upper airway tissue comprises patent subhyoid-based tissue; collapse via initiating or increasing intensity of stimulation of patent subhyoid base tissue when the parameter value meets or exceeds a threshold value; collapse and performing modulation of the stimulation via terminating stimulation of or reducing the intensity of stimulation of the patent subhyoid-based tissue when the value of the parameter is less than a threshold value.

[0126] In some examples, the at least one stimulation protocol includes an open-loop stimulation mode, a closed-loop stimulation mode, and a selective continuous stimulation mode, and includes applying stimulation by selectively switching between the respective modes based on at least one of a value of the hysteresis patency parameter and a value of the breath sensing sensitivity parameter. In some examples, the selective continuous stimulation mode may implement tonal level stimulation for suprathreshold contraction levels of stimulation.

[0127] 4 is a diagram 600 including a front view that generally depicts an example arrangement 601 including one or more stimulation elements forming part of an example device and / or example method for increasing and / or maintaining upper airway patency, and / or for other purposes. In some embodiments, example arrangement 601 can include at least some of the substantially same features as the examples described above in connection with at least FIGS. 1-3C or one example implementation thereof.

[0128] In some examples, the exemplary method may include implanting a stimulation element (e.g., 510A and / or 510B) in the hypoglossal nerve (e.g., 505R and / or 505L). As shown in FIG. 4 , in some examples, this implantation involves a tunnel (T3) between a first incision 609C and a second incision 609A, where an implantable pulse generator (IPG) 533 is implanted through the first incision 609C and a stimulation element (e.g., 510A) is implanted through the second incision 609A. In some examples, this portion of the exemplary configuration 601 may be operated to treat sleep-disordered breathing (SDB) without modification or supplementation, either indefinitely or for at least as long as treatment is deemed satisfactory.

[0129] However, in some embodiments, the exemplary configuration 601 can be supplemented to enhance treatment of sleep-disordered breathing. In such embodiments, a second implantation procedure is performed with the first stimulation element (e.g., 510A) implanted relative to the hypoglossal nerve (e.g., 505R), such as after a period following implantation of the first stimulation element (e.g., 510A). In a separate second implantation procedure, a second stimulation element (e.g., 513A) is implanted in a stimulating relationship to a cervical-related nerve trap (e.g., 515R). In some embodiments, the method includes implanting a second stimulation element (e.g., 513A) upon determining that the patient exhibits sleep-disordered breathing (SDB) despite treatment via the first stimulation element (e.g., 510A and / or 510B) of the hypoglossal nerve (e.g., 505R and / or 505L). In some such embodiments, the patient may exhibit symptomatic AHI despite stimulation of the hypoglossal nerve. In some embodiments, the baseline stimulation regimen involving the hypoglossal nerve is collapse However, stimulation of the cervical nerves simultaneously with stimulation of the hypoglossal nerve may, in some embodiments, reduce the pressure of the upper airway by 5 cm of water. collapse changes to only 8cm of water pressure or so.

[0130] There are some example ways in which a first stimulation element 510A and a second stimulation element 513A may be implanted to supplement an already implanted stimulation element 510A.

[0131] It will be appreciated that the first stimulation element 510A may be implanted via a first stimulation lead on which the first stimulation element 510A is supported, at a location extending between the implanted pulse generator 533 (at or near the access incision 609C) and the location of the first stimulation element on the hypoglossal nerve (at or near the access incision 609A), as shown in Figure 4. One exemplary arrangement 700 for doing this is shown in Figure 5A.

[0132] FIG. 5A is a diagram, including a side view, that schematically illustrates an exemplary device 700 including a stimulation lead 740 including a body 741 extending between a proximal portion 744 and an opposing distal portion 742 that supports a first stimulation element 710. In some embodiments, the first stimulation element 710 may include one exemplary implementation of the stimulation element 510A of FIG. 4. With further reference to FIG. 5A, the first stimulation element 710 may include a linear array of electrodes 716 adapted to stimulate the hypoglossal nerve 505R (or 505L). However, it will be understood that the first stimulation element 710 may include other types of electrode configurations (e.g., cuffs, paddles, etc.). Meanwhile, the proximal portion 744 of the lead 740 is connectable to a port on a header 735 of an implantable pulse generator (IPG) 533. As further represented by the dashed line in FIG. 5A, the IPG 533 is implanted through an implant access incision 609C, which may be in the pectoral muscle region 532 as shown in FIG.

[0133] With this in mind, a first stimulation lead 740 may be implanted subcutaneously through the implant access incisions 609A, 609C, and through appropriate tunneling, the stimulation element 710 may be positioned in a stimulating relationship to the hypoglossal nerve 505R, with the body 741 of the lead 740 extending between the hypoglossal nerve 505R and the IPG 533 in the pectoral region 532.

[0134] As previously mentioned, the first stimulation lead 740 may be operated to treat sleep disordered breathing via stimulation of the hypoglossal nerve 505R.

[0135] However, when it is determined that the patient exhibits an unsatisfactory level of sleep-disordered breathing despite stimulation at the hypoglossal nerve 505R via the stimulation lead 740, an exemplary method illustrated generally by 5A (in the context of FIG. 4) includes implanting a second stimulation lead 760 carrying a second stimulation element 713 positioned in a stimulating relationship to the cervical-related nerve trap 515R. In some embodiments, the second stimulation element 713 may include one exemplary implementation of the stimulation element 513A of FIG. 4, and in some embodiments, may include a linear array of electrodes 716 shown in FIG. 5A.

[0136] 5A , the second stimulation lead 760 includes a proximal portion 764 for connecting to the intermediate portion 745 of the first stimulation lead 740. In particular, in some embodiments, the intermediate portion 745 of the lead 740 includes a port interface 750 including an extension arm 752 including a connection port for receiving the proximal portion 764 of the second stimulation lead 760 to establish an electrical connection (and mechanical connection) of the lead 760 to the IPG 533.

[0137] As further shown in FIG. 4 (in the context of FIG. 5A ), in some examples, tunneling T1 may be performed between implant access incision 609C and new implant access incision 609B, through which second stimulation element 713 ( FIG. 5A ) is positioned, with tunnel T1 providing a pathway for implanting second stimulation lead 760. As shown via FIG. 5A , second stimulation lead 760 may be substantially shorter than first stimulation lead 740. While second stimulation lead 760 is shown as being relatively short, it will be understood that second stimulation lead 760 may have a greater relative length than shown in FIG. 5A , and that length may depend on the location of port interface 750 along stimulation lead 740.

[0138] Via this arrangement, if stimulation of the cervical-related nerve trap 515R is determined to be desirable in terms of inadequate treatment of sleep-disordered breathing, at a period after implantation of the first stimulation lead 740, a second stimulation lead 760 may be implanted for connection to the IPG 533 via releasable connection of the second stimulation lead 760 to the port interface 750 of the stimulation lead 740.

[0139] In some embodiments, the implantation sequence described in connection with the device 601, 700 embodiments of FIGS. 4, 5A may be reversed such that a first stimulation lead is implanted to stimulate the cervical-related nerve trap 515R, and then, at a later point in time, a second stimulation lead is implanted to stimulate the hypoglossal nerve with the second stimulation lead electrically connectable to the first stimulation lead.

[0140] With this in mind, Figure 5B includes a side view that schematically depicts an exemplary device 771. In some embodiments, device 770 may include some of the same features and attributes as device 700 of Figure 5A, except that device 771 provides a first stimulation lead 770 that is adapted to be in a stimulating relationship to the cervical-related nerve trap 515R and that is adapted to be implanted in an initial implant procedure instead of first implanting a stimulation lead for the hypoglossal nerve.

[0141] As shown in FIG. 5B , the first stimulation lead 770 includes a distal portion 772 supporting the stimulation element 713 (including a linear array of electrodes 716) and a proximal portion 774 electrically connected to the IPG 533 via a header 735. The first stimulation lead 770 includes an intermediate portion 773 including a port interface 750 (similar to FIG. 5A ) to receive the proximal portion 784 of the second stimulation lead 780 in a stimulating relationship to the hypoglossal nerve 505R. The second stimulation lead 780 includes a distal portion 782 supporting the stimulation element 710 (including a linear array of electrodes 716). As with other example stimulation leads throughout this disclosure, each stimulation element 710, 713 of the exemplary device 771 of FIG. 5B can include a variety of types of electrode configurations (e.g., cuffs, paddles, axial arrays, etc.).

[0142] In operation, a first stimulation lead 770 is implanted to treat sleep-disordered breathing via stimulation of the cervical-related nerve trap 515R. After a period of time, such as a determination that the neurostimulation therapy is unsatisfactory, a second implant procedure can be performed to implant a second stimulation lead 780 for neurostimulation of the hypoglossal nerve 505R (or 505L). As part of this second implant procedure, a proximal portion 784 of the second stimulation lead 780 is electrically (and mechanically) connected to the port 752 of the port interface 750, as represented by directional arrow C in FIG. 5B .

[0143] As further presented in FIG. 4 (in the context of FIG. 5B ), to add a second stimulation lead 780, tunneling T2 can be performed from the location of the port interface 750 of the lead 770 (at or near the implant access incision 609B in FIG. 5B ) to the intended implant location of the stimulation element 710 on the second stimulation lead 780 at the implant access incision 609A ( FIG. 4 ).

[0144] Through the exemplary arrangement provided via exemplary device 771 of FIG. 5B, neurostimulation therapy can be conveniently expanded to include additional nerves as desired to enhance therapy, address changes in the patient's underlying condition, or both.

[0145] Additional exemplary implementations of implanting multiple stimulation elements for a second nerve / type or a second side of the body are described below in at least (but not limited to) FIGS. 10A-10C.

[0146] It will be appreciated, of course, that the various leads, stimulation elements, port interfaces, etc., can be secured with sutures and / or a wide variety of anchors, as described in connection with at least FIGS. 3-5B. While FIGS. 6A-6B provide exemplary implementations of only some such anchors, other types of anchors are described in connection with at least FIGS. 22A-23 and 27A-30B. It will be further appreciated that the exemplary anchors of FIGS. 6A-6B (e.g., wings, holes for tissue ingrowth, tines, barbs, etc.) may be used with any of the various stimulation elements, leads, etc., as desired. Furthermore, in some embodiments, some of the anchor features (e.g., suture-friendly surfaces, wings, holes for sutures, holes for tissue ingrowth, tines, barbs, etc.) may be incorporated into implantable structures, such as port interfaces (e.g., 750 in FIGS. 5A-5B, 1070 in FIG. 7, etc.), to facilitate anchoring of the respective elements to non-neural tissues and structures to stabilize them within the patient's body. In this regard, it will be appreciated that such fixation may occur through at least some of the non-neural tissues and structures detailed below in connection with at least Figures 22A-23.

[0147] 6A is a side view that schematically depicts an elongated suture anchor element 800 that includes a body 811 and a linear array of protrusions 812 to facilitate anchoring the anchor element to non-neural tissue via sutures. As further shown in FIG. 6A, anchor element 800 may be fixed onto a portion of lead 814 or may be slidable so as to be movable along the portion of lead 814 that is to be fixed.

[0148] 6B is a side view that schematically illustrates anchor element 830 including a body 831 and a pair of wings 832 that extend perpendicularly outward from body 831 to facilitate securing anchor element 830 to non-neural tissue via sutures. As further shown in FIG. 6B, anchor element 830 may be fixed onto a portion of lead 814 or may be slidable so as to be movable along the portion of lead 814 that is to be secured.

[0149] Anchoring the anchoring element 800 or 830 secures the lead 814 relative to non-neural tissue within the patient's body. It will be appreciated that similar types of anchoring features may be incorporated into portions of the lead, such as the various exemplary port interfaces (e.g., FIGS. 5A, 5B, 7A, etc.) described in several embodiments of the present disclosure.

[0150] 7A includes a diagram that includes a top view that schematically illustrates an example arrangement 1000 including an IPG 533, a bifurcated port interface 1070, and removably insertable stimulation leads 1080, 1081. In some examples, the example arrangement 1000 includes at least some of the substantially same features and attributes as the example arrangements described in connection with FIGS. 1-6B , at least with respect to providing flexibility in the order or timing of implanting the respective stimulation leads 1080, 1081 according to the patient's condition, the anatomy encountered during implantation, changes in health over time, etc.

[0151] As shown in FIG. 7A , the lead support portion 1060 includes a proximal portion 1064 electrically connectable to the IPG 533 via the header 735 and a distal portion 1062 supporting a bifurcated port interface 1070. The port interface 1070 includes two spaced apart prongs 1072A, 1072B that branch off from one another, with each prong 1072A, 1072B including a connection port 1075 and removably receiving an electrical (and mechanical) connection from a proximal portion 1084 of a stimulation lead 1080, 1081. Each stimulation lead 1080, 1081 includes a distal portion 1082 supporting a respective stimulation element 710, 713, each of which includes a linear array of electrodes 716. As in other embodiments, the stimulation elements 710, 713 can take on a wide variety of electrode configurations (e.g., cuffs, paddles, etc.) other than the axial array shown in FIG. 7A . In some embodiments, the IPG 533 and lead support portion 1060 (including the port interface 1070) may be implanted to support the simultaneous implantation of both stimulation leads 1080, 1081. However, in some embodiments, in a manner similar to that described above in connection with at least FIGS. 5A and 5B, in some embodiments, only one of the stimulation leads 1080, 1081 may be implanted in an initial implant procedure in stimulating relationship to a first nerve (e.g., the hypoglossal nerve or a cervical-related nerve trap). At a later point in time, the other one of the stimulation leads 1080, 1081 may be implanted in stimulating relationship to a second nerve (e.g., the hypoglossal nerve or a cervical-related nerve trap). In such an arrangement, the port interface 1070 conveniently allows for the selective addition of a second stimulation lead (e.g., 1080 or 1081) during a second implant procedure by insertion of the proximal portion 1084 of the respective stimulation lead.

[0152] In some embodiments, in a manner similar to the port interface described in Figures 5A-5B, the port interface 1070 can be implanted and / or accessed through an implant access incision, such as implant access incision 609B in the head and neck portion 520 of Figures 4-5B.

[0153] In some examples, implantation of the port interface 1070 and / or stimulation leads 1080, 1081 may be facilitated through the use of a tunneling tool 1100, which is schematically represented in FIG. 7B. As shown in FIG. 7B, the tunneling tool 1110 includes a proximal main portion 1102 supporting bifurcated portions 1104A, 1104B from which extend spaced apart prongs 1106A, 1106B. The prongs 1106A are insertable into the subcutaneous tissue and can be advanced through the subcutaneous tissue to form a tunnel for implantation of the stimulation lead and associated structures.

[0154] In some embodiments, the tunneling tool 1090 can be used in exemplary lead placements other than that shown in Figure 7A, where two different tunnels are formed subcutaneously to provide pathways for implantation of leads, stimulation elements, etc. It will be further appreciated that the prongs 1106A, 1106B can have different lengths from one another and, in some embodiments, can have steerable tips.

[0155] 8 is a diagram including a top view that schematically depicts an example arrangement 1130 including a stimulation lead 1140. In some examples, the stimulation lead 1140 may include at least some of the substantially same features and attributes as, include, and / or be usable with, the example arrangements described in connection with at least FIGS. 1-7B.

[0156] 8 , in some embodiments, the stimulation lead 1140 includes a proximal support portion 1144 electrically (and mechanically) connectable to the IPG 533 via the header 735, and the distal portion 1142 includes a bifurcated pair of distal stimulation portions 1164A, 1164B. Only a portion of the distal stimulation portions 1164A, 1164B are illustratively shown for simplicity, but it will be understood that each distal stimulation portion 1164A, 1164B may support a stimulation element, such as stimulation element 510A, 510B, 513A, 513B, 710, or 713, such as a portion of the stimulation elements described throughout the preceding embodiments or below.

[0157] 9 is a diagram including a front view that schematically depicts an example arrangement 1150, including an example apparatus and / or example method for implantation of stimulation elements 510A and / or 513A. In some examples, example arrangement 1150 may include at least some of the substantially same features and attributes as, include example implementations of, and / or be usable with, at least the example arrangements described in connection with FIGS. 1-8.

[0158] It will be further appreciated that in some embodiments, stimulation elements 510A, 513A may be supported by respective separate stimulation leads, which are not shown in FIG. 9 for illustrative simplicity.

[0159] 9, tunnel T4 is formed between implant access incisions 609C and 609B to implant stimulation element 513A, and tunnel T5 is formed between implant access incisions 609C and 609A to implant stimulation element 510A. In some examples, both tunnels T4, T5 may be created at the time of the initial implant procedure when both stimulation elements 510A, 513A (and their respective stimulation leads) are implanted.

[0160] However, in some embodiments, each representative stimulation element 510A, 513A is implanted at a different time, with one stimulation element being implanted in an initial implant procedure and the other being implanted in a separate, later implant procedure. In some such embodiments, each stimulation lead (e.g., supporting a stimulation element 510A, 513A) may be electrically connected directly to the IPG 533, as shown in the example arrangement of FIG. 10A, while in some embodiments, a proximal portion of such a stimulation lead may be connected indirectly to the IPG 533 via a port interface (e.g., 750 in FIGS. 5A-5B).

[0161] 10A is a diagram including a front view that schematically depicts an example arrangement 1200 relative to a patient's body, including an example apparatus and / or example method for implantation of stimulation elements 510A and / or 513A. In some examples, example arrangement 1200 may include at least some of the substantially same features and attributes as, include example implementations of, and / or be usable with, at least the example arrangements described in connection with FIGS. 1-9.

[0162] 10A, two separate stimulation leads 1235, 1237 may be implanted to position the respective stimulation elements 513A, 510A for implantation at the target neural location. In a manner similar to at least some of the previously described embodiments, in some embodiments, both stimulation leads 1235, 1237 may be implanted as part of the same initial implant procedure, and in some embodiments, one of the respective stimulation leads (e.g., 1235, 1237) is implanted in a first implant procedure, while the other lead is implanted in a second, separate implant procedure at a later time.

[0163] 10A, in this embodiment, the proximal portion of each stimulation lead is directly connected to the IPG 533. However, in some embodiments, a port interface with a bifurcated feature (e.g., 1070 in FIG. 7A) near the IPG 533 may be employed to connect the proximal end of each lead 1235, 1237 to the header 735 of the IPG 533.

[0164] In some embodiments, the stimulation lead 1235 may support multiple stimulation elements 513A, as shown in FIG. 10B , where a distal portion of the stimulation lead 1235 includes a bifurcation resulting in two distinct distal prongs 1236A, 1236B, each supporting a respective stimulation element 513B, 513C. Each prong 1236A, 1236B has a length suitable for positioning a different respective stimulation element 513B, 513C at a different target nerve location. For example, one simulation element 513B may be located at a first target nerve location (e.g., 316 in FIG. 2 ) of a cervical-related nerve trap, and the other simulation element 513C may be located at a second target nerve location (e.g., 316 in FIG. 2 ) of a different cervical-related nerve trap.

[0165] 10C is a diagram including a front view that schematically depicts an example arrangement 1300 relative to a patient's body, including an example apparatus and / or example method for implantation of stimulation elements 510A and / or 1313A. In some examples, example arrangement 1300 may include at least some of the substantially same features and attributes as, include example implementations of, and / or be usable with, at least the example arrangements described in connection with FIGS. 1-9.

[0166] 10C , the example arrangement 1300 may include at least some of the same features and attributes as the example arrangement 1200 of FIG. 10A and / or 1250 of FIG. 10B , except that the stimulation element 513A is implemented as a microstimulator 1313A such that no stimulation leads extend between the microstimulator 1313A and the IPG 533. However, in some examples, the microstimulator 1313A may wirelessly communicate with the IPG 533 to share at least control and / or data signals. In some examples, the microstimulator 1313A wirelessly communicates with the stimulation element 510A (or a communication element formed as part of the stimulation lead 1237) to share at least control and / or data signals to coordinate the action of the respective microstimulator 1313A and stimulation element 510A relative to each other or other therapy elements (e.g., the IPG 533, sensing, tracking, etc.). In some examples, the microstimulator 1313A may communicate wirelessly with a control portion, programmer, and / or user interface external to the patient's body in addition to or instead of communicating with the IPG 533.

[0167] In a manner similar to that described in connection with the exemplary arrangement of FIG. 10A , both the stimulation element 510A (and stimulation lead 1237) and the microstimulator 1313A can both be implanted in the same initial implant procedure. However, in some embodiments, one of the respective stimulation element 510A (and lead 1237) and microstimulator 1313A may be implanted in the initial implant procedure, after which the other element (e.g., element 510A or microstimulator 1313A) may be later implanted in a separate, second implant procedure. The second implanted element may be used to augment the neural stimulation therapy already established via the initial implant procedure. As noted elsewhere, in some embodiments, the exemplary arrangement 1300 may be understood as representative of implantation on the left and / or right lateral sides of a patient's body, and of implantation providing stimulation in connection with any of the nerves identified in this disclosure for increasing or maintaining upper airway patency or for other recognized purposes.

[0168] In some embodiments, a microstimulator 1313A is implanted in stimulating relationship to the hypoglossal nerve 505R, and a stimulator element 513A (FIG. 10A) is implanted in stimulating relationship to the cervical-related nerve trap 515R.

[0169] Generally speaking, the microstimulator 1313A includes power and circuitry in a compact package to enable stimulation of upper airway-related tissue (e.g., nerve 515R) via at least one stimulation element on or extending from the microstimulator housing. The microstimulator 1313A may also include a sensing element. In some examples, the microstimulator 1313A may include at least some of the substantially same features and attributes as those described in "Microstimulation Sleep-Disordered Breathing (SDB) Therapy Device" by Rondoni et al., published May 26, 2017 as WO 2017 / 087681, and published August 13, 2020 as U.S. Patent Application Publication No. 2020-0254249, which is incorporated herein by reference.

[0170] 11A includes a front view that schematically depicts an example arrangement 1350 relative to a patient's body, including an example device and / or example method for implantation of microstimulators 1360A and / or 1313A relative to respective target nerves 505R, 515R. In some examples, the example arrangement 1350 may include at least some of the substantially same features and attributes as, include example implementations of, and / or be usable with, the example arrangements described in connection with at least FIGS. 1-9. Thus, in some examples, the target nerves 505R, 515R may include the hypoglossal nerve 505R and the cervical-related nerve 515R, respectively.

[0171] 11A , the example arrangement 1350 may include at least some of the same features and attributes as the example arrangement 1300 of FIG. 10B , except that the stimulation element 510A is implemented as a microstimulator 1360A such that an IPG is not present and no stimulation leads extend between the microstimulator 1360A and the IPG 533. In some examples, the microstimulator 1360A wirelessly communicates with the microstimulator 1313A to share at least control and / or data signals to coordinate the action of each microstimulator 1313A, 1360A relative to each other or other therapy elements (e.g., sensing, tracking, etc.). In some examples, both the microstimulators 1360A, 1313A may wirelessly communicate with a control portion, programmer, and / or user interface external to the patient's body.

[0172] In a manner similar to that described in connection with the exemplary arrangement of FIG. 10B , both microstimulator 1360A and microstimulator 1313A may be implanted in the same initial implant procedure, such as through the respective implant access incisions 609A, 609B shown in some previously described embodiments. However, in some embodiments, one of each microstimulator 1360A, 1313A may be implanted in the initial implant procedure, after which the other microstimulator (e.g., 1360A or 1313A) may be later implanted in a separate, second implant procedure. The second implanted element may be used to enhance the neurostimulation therapy already established via the initial implant procedure.

[0173] In some embodiments, each microstimulator 1313A, 1360A may be implanted through a single implant access incision of the type shown in FIG. 13, where several operations (for a single access incision) may be used to position each microstimulator 1313A, 1360A adjacent to each target nerve 515R, 505R.

[0174] 11B is a diagram, including a front view, that schematically depicts an example arrangement 1400 relative to a patient's body 510, including an example apparatus and / or an example method for implantation of a single microstimulator 1413A in the head and neck region 520. In some examples, the example arrangement 1400 may include at least some of the substantially same features and attributes as, include example implementations of, and / or be usable with, at least the example arrangements described in connection with FIGS.

[0175] 11B, the microstimulator 1413A includes a power / control element 1417 and a pair of stimulation elements 1414A, 1416A positioned in a stimulating relationship with a respective nerve 505R, 515R. Each stimulation element 1414A, 1416A extends from the power / control element 1417 via a respective lead 1414B, 1416B. The power / control element 1417 may operate in a similar manner to the IPG 533, but miniaturized on a smaller scale within a significantly smaller housing.

[0176] 11B shows each stimulation element 1414A, 1416A as an array of electrodes (e.g., 716 in FIGS. 5A, 5B, 7A), which may take the form of small paddles, an axial array of ring electrodes, or other electrode configurations. In some examples, a cuff or partial cuff configuration may be employed, as well as a pigtail configuration. Each stimulation element 1414A, 1416A may include its own anchoring element (e.g., tines, barbs, suture holes, etc.), or separate anchoring elements may be used to secure the stimulation element 1414A, 1416A to the respective nerve 505R, 515R and / or adjacent non-neural structures.

[0177] In some embodiments, the microstimulator 1413A (and associated stimulation elements 1414A, 1416A) may be implanted through a single implant access incision of the type shown in Figure 13. In some such embodiments, some minor tunneling and / or manipulation is used to position each stimulation element 1414A, 1416A adjacent to a respective target nerve 505R, 515R.

[0178] In some embodiments, the microstimulator 1413A can be deployed at a location within the head and neck region 520 where first and second target nerve locations are proximate to one another. For example, the microstimulator 1413A (including stimulation elements 1414A, 1416A) can be implanted as one of the example configurations 2101 or 2401 in the example method of FIGS. 16-17 (or FIGS. 16, 18-20) such that a single device (e.g., 1413A) within the head and neck region 520 can function to stimulate two different nerves (e.g., 505R, 515R), such as portion 307 of the hypoglossal nerve 305 (FIGS. 16-17) and portion 329A of the cervical-related nerve snares 315 (FIGS. 16-17).

[0179] 1-11B, it will be understood that such exemplary arrangements, methods of implantation, etc., can be used to implement sensing elements, which may be in place of the respective stimulation elements and / or which may act as or carry sensing elements. At least some additional aspects of sensing are described further below through various embodiments of the present disclosure.

[0180] Additionally, with respect to at least the various exemplary arrangements depicted in Figures 3-11B, the stimulation elements are shown in stimulating relationship to the right side of the patient's body, such as the hypoglossal nerve 505R and / or the cervical-related nerve trap 515R. However, it will be understood that such examples are intended to represent implantation, therapy, etc. on the left side of the patient's body, and / or for bilateral implantation of such stimulation elements, leads, etc. It will be further understood that the exemplary arrangements of Figures 3-11B may be implemented in accordance with various exemplary implementations depicted in connection with the exemplary arrangement of Figure 2.

[0181] Furthermore, with respect to at least the exemplary arrangements of Figures 10A-11B, it will be further understood that various stimulation elements, leads, and / or microstimulators may be secured within a patient's body relative to non-neural structures or tissue via at least some of the various exemplary anchor elements provided throughout the embodiments of the present disclosure, such as at least Figures 6A-6B, 22A-23, and / or 27A-30B.

[0182] 12 is a diagram including a front view that schematically depicts an example arrangement 1600 relative to a patient's body 510, including an example apparatus and / or an example method for implantation of a stimulation element 513A in stimulating relationship to a cervical-related nerve trap 515R. In some embodiments, the example arrangement 1600 may include at least some of the substantially same features and attributes as, include example implementations of, and / or be usable with, the example arrangements described in connection with at least some of FIGS. 1-11B.

[0183] In some embodiments, the exemplary arrangement 1600 includes implantation of the stimulation element 513A and the IPG 533 through a single implant access incision 609B. The stimulation element 513A is implanted in a stimulating relationship to the neck-related nerve trap 515R and is electrically (and mechanically) connected to the IPG 533 via a stimulation lead, illustratively omitted for clarity. In some embodiments, the IPG 533 may be implanted and positioned relatively close to the stimulation element 513A in an area such as the upper pectoral region 532 or the head and neck portion 520. This arrangement may allow for the use of shorter stimulation leads, a reduced amount of subcutaneous infiltration, etc. By utilizing a single implant access incision 609B to implant all elements of the exemplary arrangement 1600, the implant procedure may be completed in a quicker and less invasive manner for the patient.

[0184] 13 is a diagram including a front view that schematically depicts an example arrangement 1700 relative to a patient's body 510, including an example apparatus and / or an example method for implantation of a stimulation element 1313A in a stimulating relationship to a cervical-related nerve trap 515R. In some examples, the example arrangement 1700 may include at least some of the substantially same features and attributes as, include example implementations of, and / or be usable with, the example arrangements described in connection with at least some of FIGS. 1-11B.

[0185] In one particular example, the exemplary arrangement 1700 may include at least some of the same features and attributes as the exemplary arrangement 1600 of FIG. 12 , except that the stimulation element 513A is replaced with a microstimulator 1313A (e.g., 10A) and the IPG 533 is omitted. In one aspect, this exemplary arrangement 1700 significantly simplifies the implant procedure by using a single implant access incision and a single stimulation element, which, while embodied as a microstimulator 1313A, includes its own power elements, control circuitry, etc. In some examples, the microstimulator 1313A may include a linear array of electrodes 716 on its external housing to provide stimulation and / or sensing capabilities. However, it will be understood that the microstimulator 1313A may provide other electrode configurations.

[0186] 12, 13, it will be understood that such exemplary arrangements may be performed on only one side or both sides of the patient's body 510. Furthermore, it will be understood that such a single implant procedure via a single implant access incision 609B may be later supplemented with an additional implant access incision for implanting a second stimulation element (including a stimulation lead) or microstimulator in a second, separate implant procedure, such as in the exemplary implementations described in connection with at least some of FIGS.

[0187] With respect to both of the exemplary arrangements shown in Figures 12-13, it will be understood that at least some aspects of these exemplary arrangements may be applied to implantation of stimulation elements in other nerves, such as, but not limited to, the hypoglossal nerve or other nerves.

[0188] 14A includes a front view that schematically depicts an example arrangement 1800 relative to a patient's body 510, including an example device and / or example method for implantation of a stimulation element 1810A in stimulating relationship to a hypoglossal nerve 505R and a stimulation element 1813A in stimulating relationship to a cervical-related nerve trap 515RR. In some examples, the example arrangement 1800 may include at least some of the substantially same features and attributes as, include example implementations of, and / or be usable with, the example arrangements described in connection with at least some of FIGS. 1-13.

[0189] 14A , in some embodiments, example arrangement 1800 may be implanted in a single implant procedure via a single implant access incision 609C in a manner similar to that described for example example arrangement 1600 of FIG. 12 , except that example arrangement 1800 includes an additional stimulation element 1810A for stimulating the hypoglossal nerve 505R, and both stimulation elements 1810A, 1813A are carried on a single stimulation lead 1837. In some embodiments, the single implant access incision may be in the pectoral region 532, as indicated by indicator 609C in FIG. 14 , or may be in the head and neck region 520, such as via implant access incision 609B shown in some other embodiment figures.

[0190] As shown in FIG. 14A, tunneling (T6) may be performed through a single implant access incision 609C between the implant access incision 609C and the target stimulation location of each stimulation element 1810A (in stimulating relationship to the hypoglossal nerve 505R) and / or stimulation element 1813A in stimulating relationship to the cervical-related nerve trap 515R.

[0191] As further shown in FIG. 14A, the IPG 533 is implanted subcutaneously through the implant access incision 609C and the stimulation leads 1837 are inserted and advanced through tunnel T6 until the respective stimulation elements 1810A, 1813A are positioned in stimulating relationship to the respective hypoglossal nerve 505R and cervical-related nerve trap 515R, as shown in FIG. 14A.

[0192] 14A shows that each stimulation element 1810A, 1813A may be implemented as a linear array of electrodes 716, which may facilitate proper neural capture by adjusting the linear position of the array relative to the neural target. In some instances, this exemplary arrangement of electrodes 716 may sometimes be referred to as an axially arranged electrode array, an axial array, an axial lead, and similar terms. However, it will be understood that in some embodiments, one or both stimulation elements 1810A, 1813A may include different electrode configurations, such as (but not limited to) some of the exemplary electrode configurations described in connection with at least FIGS. 24A-30B.

[0193] 14B includes a diagram including a front view that schematically depicts an example arrangement 6300 relative to a patient's body 510, including an example apparatus and / or example method for implantation of a lead 6337A including a stimulation element 6310A in stimulating relationship to the hypoglossal nerve 505R and a stimulation element 6313A in stimulating relationship to the cervical-related nerve trap 515R. In some examples, the example arrangement 6300 may include at least some of the substantially same features and attributes as, include example implementations of, and / or be usable with, the example arrangements described in connection with FIGS. 14A and / or at least some of 1-13.

[0194] As shown in FIG. 14B , various components of the exemplary arrangement 6300 can be implanted through implant access incision 609C (in a manner similar to the arrangement of FIG. 14A ) and through implant access incision 609D. In some embodiments that form implant access incision 609C, the IPG 533 may be implanted subcutaneously, such as in a subcutaneous pocket within the pectoral muscle region 532. In some embodiments, implant access incision 609F is formed to allow implantation of components of the exemplary arrangement 6300, such as, but not limited to, stimulation element 6313A. In some such embodiments, stimulation element 6313A may include a cuff electrode. Such a third access incision may be implemented in at least any one of the exemplary arrangements of each of FIGS. 14A-14R to facilitate implantation of multiple stimulation elements, lead portions, etc., as desired.

[0195] 14A-14R may include at least some stimulation elements configured as one or more axial-style electrode arrays (e.g., a series of ring electrodes), and in some embodiments, the example stimulation elements shown in each one of FIGS. 14A-14R may include cuff electrodes in place of the illustrated axial-style electrode arrays, at least some such embodiments being described above throughout various embodiments of the present disclosure.

[0196] For various examples of the present disclosure, an implant access incision includes an incision of a type, size, and / or shape adapted to allow for subcutaneous implantation of an implantable medical element, such as a stimulation element, a sensing element, etc. An implant access incision is in contrast to a non-implant access incision, which may be an incision for purposes other than implanting an implantable medical element, such as a stimulation element and / or a sensing element.

[0197] Upon forming the implant access incision 609D, the distal portion of the lead 6337A may be subcutaneously implanted, which may include several embodiments. As further shown in FIG. 14B , the lead 6337A may include a proximal portion 6339A, a body portion 6338A, and first and second distal portions 6346, 6344A extending from the body portion 6338A via a junction 6340. In some instances, the lead 6337A may be referred to as including a bifurcated lead to the extent that the junction 6340 extending from the lead body portion 6338A is shaped to result in bifurcation of the respective first and second distal portions 6346, 6344A from the lead body portion 6338A.

[0198] However, in some embodiments, the first distal lead portion 6346 of the lead 6337A may be considered a continuation of the body portion 6338A, and the second distal lead portion 6344A may be considered an extension from the body portion 6338A via the junction 6340. Further, in some embodiments, the junction 6340 may be formed to cause the second distal portion 6344A to extend in an opposite orientation from the first distal portion 6346 (and the stimulation portion 6310A). In some such embodiments, the junction 6340 and portions of the first distal portion 6346 and second distal portion 6344A that meet at the junction 6340 may be formed as a resilient structure and / or material to bias the second distal portion 6344A to extend in an opposite (or reverse) orientation from the first distal portion 6346. In some examples, the second distal portion 6344A can be considered to extend in generally the same orientation as the body portion 6338A of the lead 6337A, relative to the orientation of at least the first distal portion 6346 (including the stimulation portion 6310A). As shown in FIG. 14B , each of the stimulation portions 6310A, 6313A includes a linear array of spaced apart electrodes 716 (e.g., ring electrodes or split ring electrodes), which can be considered an axial arrangement of the electrodes 716. It will be further understood that the electrodes 716 may include shapes other than rings, and the stimulation portions 6310A, 6313A may include other arrangements, such as paddle electrodes. In some examples, the specific arrangement (e.g., number, shape, spacing, orientation, etc.) of the electrodes on the stimulation portion 6310A may differ from the specific arrangement of the electrodes on the stimulation portion 6313A.

[0199] In one aspect, the first distal portion 6346 of the lead 6337A may be subcutaneously implanted through the implant access incision 609D and advanced until the stimulation portion 6310A is in stimulating relationship to the nerve 505R. In particular, the first distal portion 6346 (including the stimulation portion 6310A) may have a length that is sufficiently short so that the first distal portion 6346 (including the stimulation portion 6310A) may be implanted with little or no tunneling from the implant access incision 609D. Stated another way, the location of the implant access incision 609D may be selected sufficiently proximate to a target stimulation location along the nerve 505R so that little or no tunneling is required (from the implant access incision 609D to the target stimulation site) to implant the first distal portion 6346 (including the stimulation portion 6310A) in stimulating relationship to the nerve 505R (target stimulation location). In some embodiments, implant access incision 609D may include a different location than implant access incision 609A (e.g., FIGS. 4, 9), such that implant access incision 609D is closer to a more distal portion of nerve 505R. However, in some embodiments, implant access incision 609D may correspond to the location of implant access incision 609A (e.g., FIGS. 4, 9, etc.).

[0200] In some embodiments of the first distal portion 6346, the stimulation portion 6310A can have a length that includes at least about 50 percent, 60 percent, 70 percent, or 80 percent of the length of the entire first distal portion 6346 extending from the junction 6340. In some embodiments, this length relationship can sometimes be expressed as the stimulation portion 6310A having a length that includes a substantially majority of the entire length of the first distal portion 6346.

[0201] In another embodiment, prior to implanting the second distal portion 6344A of the lead 6337A, tunneling (represented by arrow T7) can be performed from the implant access incision 609D toward the nerve 515R. The second distal portion 6344A (including the stimulation portion 6313A) can then be advanced through the tunnel to position the stimulation portion in a stimulating relationship to the nerve 515R. In some embodiments of the second distal portion 6366, the stimulation portion 6313A can have a length that comprises approximately 10, 15, 20, 25, or 30 percent of the entire length of the second distal portion 6366 extending from the junction 6340. Stated another way, the entire length of the second distal portion 6366 extending from the junction 6340 can include some of the length of the stimulation portion 6313A of the second distal portion.

[0202] In one aspect, the proximal end of the body portion 6338 of the lead 6337A is implanted to extend toward and in connection with the IPG 533. However, in some examples, tunneling is first performed between the implant access incision 609D and the implant access incision 609C to establish a tunnel (i.e., pathway), as represented by arrow T8. It will be understood that tunneling can be performed starting from either the implant access incision 609C, 609D. With the tunnel in place, the proximal portion 6339 of the lead 6337A is inserted and advanced through the implant access incision 609D toward the IPG 533 until the body portion 6338 extends from the implant access incision 609D to the implant access incision 609C, where it can be further manipulated to electrically and mechanically connect to the IPG 533. It will be further understood that in some embodiments, the particular arrangement in which various aspects of implantation (e.g., first distal portion 6346, second distal branch 6344A, main body portion 6338A, IPG 533) are performed may vary depending on circumstances, preferences, etc.

[0203] In some embodiments, such as those shown in at least Figures 14E, 14F, where a particular distal portion 6346 or 6344A of lead 6337A (including its stimulation portion) is relatively short and little or no tunneling occurs, the stimulation portion (e.g., 6310A, 6313A) may include a cuff electrode.

[0204] In some embodiments, as shown in FIG. 14C , an implant access incision 609D ( FIG. 14B ) is formed between the mandible 6330 and the hyoid bone 6332 to position the first distal portion 6346 of the lead 6337A (including the stimulation portion 6310A) in proximity to at least some portion of the hypoglossal nerve 505R. In some such embodiments, the particular implant access incision 609D is selected to position the stimulation portion 6310A at or near a more distal portion of the hypoglossal nerve 505R, such as a portion less likely to nerve-stimulate a retractor muscle (e.g., nasal constrictor) such as the tongue in order to stimulate a protrusive muscle of the tongue / airway (e.g., the genioglossus). In some embodiments of these more distal locations, the target stimulation location of the hypoglossal nerve 505R may be in proximity to muscle portions innervated by the hypoglossal nerve 505R, such as in proximity to nerve endings of the hypoglossal nerve's precursor-related fibers, fascicles, etc., which are more diffusely distributed (compared to clearly defined nerve branches) within portions of the genioglossus muscle.

[0205] Among other features, the exemplary arrangement 6300 of FIG. 14B may include a convenient delivery path from the implant access incision 609D to the implant site for the stimulation portion 6313A relative to the nerve 515R, while simplifying and facilitating the surgical implant procedure, at least to the extent that the implant access incision 609D conveniently allows for relatively simple implantation of the stimulation portion 6310A relative to the nerve 505R.

[0206] Some of the example arrangements in Figures 14A-14R show multiple stimulation elements on a single, first side of the patient's body, as shown in at least Figure 14B, where both a first stimulation element for stimulating the hypoglossal nerve and a second stimulation element for stimulating the cervical-related nerve trap are implanted on the same side of the patient's body (e.g., the right or left side). However, consistent with at least Figure 3A, in some examples, one of the respective stimulation elements (e.g., for the hypoglossal nerve) may be located on one side of the patient's body, while another stimulation element (e.g., for the cervical-related nerve trap) may be located on an opposing, second side of the patient's body. Furthermore, consistent with the example of Figure 3A, at least some of example arrangements 14A-14R may be implemented such that both the left and right hypoglossal nerves and the left and right cervical-related nerve traps have their own stimulation elements (e.g., in four different locations), such that stimulation can be applied in any desired combination from among the right hypoglossal nerve, the left hypoglossal nerve, the right cervical-related nerve trap, and the left cervical-related nerve trap. With these examples in mind, Figure 36A provides one example stimulation protocol 5510 when stimulation elements are implanted in each of four different locations (e.g., Figure 3A, etc.). However, it should be understood that the fact that each of the four different locations may have a stimulation element implanted does not require stimulation to occur at any one of a given location, as at least some of the various example stimulation protocols, methods, etc., throughout various embodiments of the present disclosure may involve selective stimulation between multiple implanted stimulation elements to achieve various goals in treating sleep disordered breathing.

[0207] 14BB is a schematic representation of an example arrangement 6347 that includes at least some of the substantially same features and attributes as the example arrangement 6300 of FIG. 14B , except that at least some portions of the body portion 6338B and / or distal lead portion 6344B include a variable length feature (e.g., a sigmoidal shape, a sinusoidal shape, etc.) that may provide strain relief, among other characteristics. Thus, as shown in FIG. 14BB, the body portion 6338B of the lead 6337B extending between the IPG 533 and the junction 6340 (near the implant access incision 609D) includes at least one segment that includes a variable length feature (e.g., a sigmoidal shape, a sinusoidal shape, etc.) that is incorporated into the flexible, resilient structure of the body portion 6338B.

[0208] 14BB, in some embodiments, the distal portion of the lead body portion 6338B and / or the joint 6340 of the lead 6337B are anchored relative to non-neural tissue, as represented by indicator Z1. In some such embodiments, this anchoring (Z1) is achieved via anchoring, such as (but not limited to) the example anchors 800, 830 of FIGS. 6A, 6B, or other applicable types of anchoring disclosed in this disclosure. In some embodiments,

[0209] In some examples, the lead body portion 6338B may comprise the only portion of the lead 6337B that includes a variable length feature (eg, a sigmoidal shape, a sinusoidal shape, etc.).

[0210] As further shown in FIG. 14BB, the distal lead portion 6344B of lead 6337B, extending between junction 6340 (near implant access incision 609D) and stimulation portion 6313A, includes at least one segment including a variable length feature (e.g., a sigmoidal shape, a sinusoidal shape, etc.) incorporated into the flexible, resilient structure of the distal portion 6344B. In some embodiments, the distal end (near stimulation portion 6313A) or other portion of distal portion 6344B is anchored relative to non-neural tissue, as represented by second indicator Z2. In some embodiments, this anchoring (Z2) may be the only anchoring of lead 6337B, or in some embodiments, may include anchoring in addition to anchoring (Z1) near or at junction 6340. The second anchoring (Z2) may be implemented via anchoring elements including at least some of substantially the same features and attributes as the anchoring elements used to implement the first anchoring (Z2), or may include anchoring elements with different features.

[0211] In some examples, the lead 6337B can be considered to have a stimulation element (e.g., a stimulation portion 6310A, such as an axial electrode array) inserted between a distal variable length lead portion (e.g., 6344B) and a proximal variable length lead portion (e.g., 6338B).

[0212] In some embodiments, fixations (eg, Z1, Z2) can be implemented at other locations along the length of lead 6337B in addition to or instead of the fixations shown in FIG. 14BB.

[0213] The variable length characteristics (e.g., sigmoidal, sinusoidal, etc.) of the lead body portion 6338B and distal lead portion 6344B may be implemented in any one of the embodiments of the present disclosure as desired, with or without fixed Z1, Z2 (e.g., anchor element 800 of FIG. 6A, anchor element 830 of FIG. 6B, or other types of anchors), or in one or more of at least some of the leads, lead portions, etc. of the various exemplary anchor mechanisms disclosed throughout the present disclosure.

[0214] 14D includes a front view that schematically depicts an example arrangement 6350 relative to a patient's body 510, including an example apparatus and / or example method for implantation of a lead 6357 including a stimulation element 6310A in stimulating relationship to the hypoglossal nerve 505R and a stimulation element 6313A in stimulating relationship to a cervical-related nerve trap 515R. In some examples, the example arrangement 6350 can include at least some of the substantially same features and attributes as the example arrangement 6300 associated with FIGS. 14B-14C , except for a differently positioned implant access incision 609E and variations in the configuration of the first and second distal portions 6364, 6366 of the lead 6357 (relative to the configuration of the first and second distal portions 6346, 6344A of the lead 6337A in FIG. 14B ).

[0215] As shown in Figure 14D, the various components of the exemplary arrangement can be implanted through implant access incision 609C (in a manner similar to the arrangement of Figure 14A) and through implant access incision 609E. In some examples that form implant access incision 609C, the IPG 533 may be implanted subcutaneously, such as in a subcutaneous pocket in the pectoral muscle region 532. Upon forming implant access incision 609E, a distal portion of lead 6357 may be implanted subcutaneously, which can include several embodiments.

[0216] 14D , the lead 6357 can include a proximal portion 6339, a body portion 6358, and first and second distal portions 6364, 6366 extending from the body portion 6358 via a junction 6355. In some examples, the junction 6355, and at least a portion of the first distal portion 6364, and the second distal portion 6366 that meet at the junction 6355 can be formed as a resilient structure and / or material to bias the second distal portion 6366 to generally extend in an opposite (or reverse) orientation to the first distal portion 6364.

[0217] In one aspect, the second distal portion 6366 of the lead 6357 may be implanted subcutaneously through the implant access incision 609E and advanced until the stimulation portion 6313A is in stimulating relationship with the nerve 515R. Notably, like the first distal portion 6346 of the lead 6337 in FIG. 14B , the second distal portion 6366 (including the stimulation portion 6313A) of the lead 6357 in FIG. 14D has a length that is sufficiently short so that the second distal portion 6366 (including the stimulation portion 6313A) may be implanted with little or no tunneling from the implant access incision 609E. In other words, the location of the implant access incision 609E can be selected sufficiently close to the target stimulation location along the nerve 515R so that little or no tunneling is required (from the implant access incision 609E to the target stimulation site) to implant the second distal portion 6366 (including the stimulation portion 6313A) in a stimulating relationship to the nerve 515R (the target stimulation location).

[0218] In some embodiments of the second distal portion 6366, the stimulation portion 6313A can have a length that includes at least about 50 percent, 60 percent, 70 percent, or 80 percent of the entire length of the second distal portion 6366 extending from the junction 6355. In some embodiments, this length relationship can sometimes be expressed as the stimulation portion 6313A having a length that includes a substantially majority of the entire length of the second distal portion 6366.

[0219] In another embodiment, prior to implanting the first distal portion 6364 of the lead 6337, tunneling (represented by arrow T9) can be performed from the implant access incision 609E toward the nerve 505R. The first distal portion 6364 (including the stimulation portion 6310A) is then advanced through tunnel T9 to position the stimulation portion 6310A in a stimulating relationship to the nerve 505R. In some embodiments of the first distal portion 6364, the stimulation portion 6310A can have a length that comprises approximately 10 percent, 15 percent, 20 percent, 25 percent, or 30 percent of the entire length of the first distal portion 6364 extending from the junction 6355. In other words, the entire length of the first distal portion 6364 extending from the junction 6355 can include some of the length of the stimulation portion 6310A of the first distal portion 6364.

[0220] In one aspect, the body portion 6358 of the lead 6357 is implanted to extend toward and in connection with the IPG 533. However, in some examples, tunneling is first performed between the implant access incision 609E and the implant access incision 609C to establish a tunnel (i.e., pathway), as represented by arrow T10. It will be understood that tunneling can be performed starting from either the implant access incision 609C, 609E. With the tunnel in place, the proximal portion 6339 of the lead 6357 is inserted and advanced through the implant access incision 609E toward the IPG 533 until the body portion 6358 extends from the implant access incision 609E to the implant access incision 609C, where the proximal portion 6339 of the lead 6357 can be further manipulated to electrically and mechanically connect to the IPG 533. It will be further understood that in some embodiments, the particular sequence in which various aspects of implantation (e.g., first distal portion 6364, second distal branch 6366, main body portion 6358, IPG 533) are performed may vary in some embodiments.

[0221] In some embodiments, the particular location of the implant access incision 609E may correspond to a location within the head and neck region that provides direct access to a portion of the cervical-related nerve trap corresponding to a desired stimulation location. In some such embodiments, the implant access incision 609E may allow direct access for implantation of a stimulation element (e.g., a cuff electrode, a stimulation portion, etc.) for positioning the stimulation element in a stimulating relationship to one or more of exemplary stimulation locations A, B, C, D, or E, as generally described in connection with at least FIGS. 2, 32A, and 32C, and more specifically described in connection with FIG. 16 (stimulation location A), 22A, 32B (stimulation location B), and 32D (stimulation location C). It will be understood that other stimulation locations (e.g., D, E) at / along the cervical-related nerve trap 316 may be accessed via the implant access incision 609E. Additionally, in some embodiments, these aspects related to implant access incision 609E are applicable to implant access incision 609B shown in some other exemplary configurations of the present disclosure (eg, FIG. 4).

[0222] 14E includes a front view that schematically depicts an example arrangement 6400 relative to a patient's body 510, including an example device and / or an example method for implantation of a lead 6437 including a stimulation element 6411A in stimulating relationship to the hypoglossal nerve 505R and a stimulation element 6313A in stimulating relationship to the cervical-related nerve trap 515R. In some examples, the example arrangement 6400 can include at least some of the same features and attributes as the example arrangement 6300 related to FIGS. 14B-14C , except that the first distal portion 6346 includes the cuff electrode 6411A of FIG. 14E instead of the stimulation portion 6310A (e.g., the axial-style array of electrodes 716) of FIG. 14B . In substantially all other respects, the example arrangement 6400 includes substantially the same features and attributes as the arrangement 6300 of FIG. 14B . As shown in FIG. 14E, the lead 6437 may include a proximal portion 6339, a body portion 6438, and first and second distal portions 6346, 6344 extending from the body portion 6438 via a junction 6340.

[0223] 14B , in the example arrangement 6400 of FIG. 14E , the relatively short length of the first distal portion 6346 may be particularly beneficial for implanting the cuff electrode 6411A relative to the nerve 505R proximate the implant access incision 609D, at least because such a cuff electrode 6411A is typically not suitable for introduction, advancement, etc., via a tunneled pathway in a manner similar to that of an axial lead (e.g., stimulation portion 6313A). As noted elsewhere, while FIG. 14A depicts the stimulation element 6411A (for the right hypoglossal nerve 505R) and the stimulation element 6313A (for the right cervical-related nerve trap 515R) on the same side of the body, it will be understood that the exemplary arrangement 6300 can be implemented such that one of the stimulation elements (6411A, 6313A) is implanted on a first side (e.g., the right or left side) of the patient's body and the other of the stimulation elements (6411A, 6313A) is implanted on an opposing second side (e.g., the right or left side) of the patient's body. In some such examples, at least one of the tunnels T7 and / or T8 (or other tunnels) and lead portions (e.g., 6344 and / or 6438) can extend across the sagittal midline of the patient's body, such as along the neck below the patient's chin. This arrangement can be implemented between and through at least some of the other exemplary arrangements of FIGS. 14A-14R, as desired.

[0224] 14B (including the stimulation portion 6310A), in some embodiments, the cuff electrode 6411A of FIG. 14E can have a length that comprises at least about 50, 60, 70, or 80 percent of the length of the entire first distal portion 6346 extending from the junction 6340. In some embodiments, this length relationship can sometimes be expressed as the cuff electrode 6411A (e.g., one type of stimulation portion) having a length that comprises substantially a majority of the entire length of the first distal portion 6346. Conversely, in some embodiments of the second distal portion 6344, the stimulation portion 6313A can have a length that comprises about 10, 15, 20, 25, or 30 percent of the length of the entire second distal portion 6344 extending from the junction 6340. Stated another way, the entire length of the second distal portion 6344 extending from the junction 6340 may include some of the length of the stimulation portion 6313A of the second distal portion 6344.

[0225] 14F is a diagram, including a front view, that schematically depicts an example arrangement 6450 relative to a patient's body 510, including an example device and / or an example method for implantation of a lead 6457 including a cuff electrode 6414A in stimulating relationship to the hypoglossal nerve 505R and a stimulating portion 6313A in stimulating relationship to the cervical-related nerve trap 505R. In some examples, the example arrangement 6450 can include at least some of the same features and attributes as the example arrangement 6350 associated with FIG. 14D, except that the second distal portion 6366 of the lead 6457 of FIG. 14F includes a cuff electrode 6414A instead of the stimulating portion 6313A (e.g., including an axial-style array of electrodes 716) as in the example arrangement 6350 of FIG. 14D. In substantially all other respects, the example arrangement 6450 includes substantially the same features and attributes as the arrangement 6350 of FIG. 14D. As shown in FIG. 14F, the lead 6457 may include a proximal portion 6339, a body portion 6358, and first and second distal portions 6364, 6366 extending from the body portion 6358 via a junction 6355.

[0226] 14D , the relatively short length of the second distal portion 6366 in the example arrangement 6450 of FIG. 14F can be particularly beneficial for implanting the cuff electrode 6414A proximal to the implant access incision 609E and relative to the nerve 515R, at least because such cuff electrodes 6414A are typically not suitable for introduction, advancement, etc., via a tunneled pathway in a manner similar to that of an axial lead (e.g., the stimulation portion 6313A). In a similar manner for the second distal portion 6366 of FIG. 14D (including the stimulation portion 6313A), in some embodiments, the cuff electrode 6414A of FIG. 14F can have a length that comprises at least about 50, 60, 70, or 80 percent of the entire length of the second distal portion 6366 extending from the junction 6355. In some embodiments, this length relationship may sometimes be expressed as the cuff electrode 6414A (e.g., one type of stimulation portion) having a length that includes substantially a majority of the overall length of the first distal portion 6346. Conversely, in some embodiments of the first distal portion 6364, the stimulation portion 6310A may have a length that includes approximately 10 percent, 15 percent, 20 percent, 25 percent, or 30 percent of the entire length of the first distal portion 6364 extending from the junction 6355. In other words, the entire length of the first distal portion 6364 extending from the junction 6355 may include some of the length of the stimulation portion 6310A of the first distal portion 6364.

[0227] 14G includes a front view that schematically depicts an example arrangement 6500 relative to a patient's body 510, including an example apparatus and / or example method for implantation of a lead 6537 including a stimulation element 6310A in stimulating relationship to the hypoglossal nerve 505R and a stimulation element 6313A in stimulating relationship to the cervical-related nerve trap 515R. In some examples, the example arrangement 6500 may include at least some of the substantially same features and attributes as, include example implementations of, and / or be usable with, the example arrangements described in connection with at least some of FIGS.

[0228] As shown in FIG. 14G , the various components of the exemplary arrangement are implantable through a single implant access incision 609C (in a manner similar to the arrangement of FIG. 14A ). In some embodiments, upon forming the single implant access incision 609C, the IPG 533 may be implanted subcutaneously, such as in a subcutaneous pocket within the pectoral muscle region 532. As further shown in FIG. 14G , the lead 6537 may include a proximal portion 6539 and first and second lead body portions 6533, 6549 extending from a junction 6534 extending distally from the proximal portion 6539. In some embodiments, each lead body portion 6533, 6549 may sometimes be referred to as bifurcated. In some embodiments, the lead body portion 6533 includes a distal portion 6547 including the stimulation portion 6310A, while the lead body portion 6549 includes a distal portion 6548 including the stimulation portion 6313A.

[0229] In another embodiment, prior to implanting the lead body portions 6533, 6549 of the lead 6537, tunneling can be performed from the implant access incision 609C toward the nerve 515R and nerve 505R, as represented by sequence T11. The first lead body portion 6533 (including the stimulation portion 6310A) and the second lead body portion 6549 (including the stimulation portion 6313A) are then advanced through the tunnel (T11) to position the stimulation portion 6310A in a stimulating relationship to the nerve 505R and the stimulation portion 6313A in a stimulating relationship to the nerve 515R.

[0230] In one aspect, the proximal portion 6539 of the lead 6537 is inserted and advanced through the implant access incision 609C toward the already implanted IPG 533 such that the proximal portion 6539 can be electrically and mechanically connected to the IPG 533. It will be further understood that in some embodiments, the particular sequence in which various aspects of implantation (e.g., lead body portions 6533, 6549, 6539, IPG 533) are performed can vary depending on the circumstances, preferences, etc.

[0231] Among other features, the exemplary arrangement 6500 provides a single implant access incision and a single tunnel, thereby simplifying and speeding the surgical implant procedure.

[0232] 14H includes a front view that schematically depicts an example arrangement 6550 relative to a patient's body 510, including an example stimulation device (e.g., 6552) for implantation, and / or an associated example method, the arrangement 6550 including a stimulation portion 6310A in stimulating relationship to the hypoglossal nerve 505R and a stimulation portion 6313A in stimulating relationship to the cervical-related nerve trap 515R. In some examples, the example arrangement 6550 may include at least some of the substantially same features and attributes as the lead 6337 of FIG. 14B, except for omitting the lead body portion 6338 and omitting the IPG 533 in the pectoral region 532. In particular, instead of the IPG 533, in some embodiments, the stimulation device 6552 includes a microstimulator 6575 to which the first lead portion 6546 (including the stimulation portion 6310A) and the second lead portion 6566 (including the stimulation portion 6313A) are directly connected such that no intermediate or body portion (of the implantable medical device) is interposed between the microstimulator 6575 (which provides wireless communication to the recharging element 6576 for stimulation circuitry, power, and / or recharging and / or other control / sensing communications, etc.) and the lead portions 6566, 6564 (each including an array of stimulation electrodes). In some embodiments, the microstimulator 6575 may constitute, or an example implementation in wireless communication with, at least a portion of the control portion (e.g., FIGS. 54A-54E ) and may communicate wirelessly with a remote patient (e.g., FIG. 3B ), as further described elsewhere in connection with embodiments of the present disclosure.

[0233] As shown in FIG. 14H , in some embodiments, the various components of the exemplary stimulator 6552 can be implanted through a single implant access incision 609D (in a manner similar to the arrangement of FIG. 14A ) and without creating a second implant access incision, such as incision 609C of FIG. 14B , that would otherwise be used to implant the now-omitted IPG 533. As further shown in FIG. 14H , in some embodiments, the stimulator 6552 can include a microstimulator 6575 and first and second lead body portions 6566, 6564 extending from the microstimulator 6575 and including stimulation elements 6313A, 6310A, respectively. As described above, all of these elements can be implanted through the single implant access incision 609D.

[0234] 14C above, the implant access incision 609D of FIG. 14H is formed between the mandible 6330 and the hyoid bone 6332 to position the first lead portion 6566 (including the stimulation portion 6310A) in proximity to at least some portion of the hypoglossal nerve 505R. In some such embodiments, the particular implant access incision 609D is selected to place the stimulation portion 6310A at or near a more distal portion of the hypoglossal nerve 505R, as previously described.

[0235] As further shown in FIG. 14H , in some embodiments, the stimulator 6552 can be formed, assembled, etc., such that each lead portion 6566, 6546 extends outward from the periphery of the housing 6577 of the microstimulator 6575, spaced apart by an angle (α). As further shown in FIG. 14HH , the angle (α) at ​​which these lead portions (as represented by solid lines L1, L2) extend outward in their spaced apart configuration can be between 0 and 360 degrees. Moreover, FIG. 14HH merely depicts an example in which each lead portion 6566, 6564 can extend from opposite portions (e.g., ends, sides, etc.) of the periphery of the microstimulator housing 6577, with the two lead portions (L1, L2) spaced 180 degrees apart. It will be understood that the housing of such an exemplary microstimulator 6575 can include a wide variety of shapes, sizes, etc., and the particular shape shown in FIG. 14HH is merely an example shape.

[0236] 14HH , in some embodiments, the particular angle (α) at ​​which the lead portions L1, L2 are spaced around the circumference of the microstimulator housing 6577 can be fixed. In some such embodiments, this fixation occurs because the lead portions (e.g., 6546, 6566 in FIG. 14H ) are formed as a single piece with the microstimulator housing 6577. However, in some embodiments, the lead portions (e.g., 6564, 6566 in FIG. 14H ) are detachable from the microstimulator housing 6577 (at or near the time of implant) via separate connection ports (e.g., P1, P2 shown in FIG. 14HH ) formed in the microstimulator housing 6577 at spaced locations corresponding to the angle (α) at ​​which the lead portions 6566, 6564 are intended to extend outward from the microstimulator housing 6577.

[0237] In some embodiments, multiple connection ports (e.g., P1, P2) may be adjacent to each other on the same side of the microstimulator housing, such as, but not limited to, both near line A in FIG. 14HH.

[0238] 14H and 14HH depict only two lead portions 6566, 6546 (or L1, L2) extending from the microstimulator housing 6577, it will be understood that in some embodiments, more than two lead portions 6566, 6546 can extend from the microstimulator housing 6577. It will be further understood that in some embodiments, some additional lead portions can include sensing lead portions versus stimulation lead portions. Furthermore, in some embodiments, at least some of the electrodes of a stimulation lead portion can sometimes be used for sensing.

[0239] Among other aspects, the lead portions (e.g., 6566, 6546) extend outwardly from the microstimulator housing 6577 from different spaced locations around the periphery of the housing 6577 (as shown in FIGS. 14H, 14HH); this exemplary arrangement can simplify implantation of a multiple-lead stimulator (e.g., 6552) because each lead portion (e.g., 6566, 6564) is already biased to extend in an orientation (relative to the microstimulator housing 6577) to align and position the stimulation portion 6313A, 6310A with the target nerve 515R, 505R. Furthermore, this exemplary arrangement 6550 facilitates practicality of the implant procedure ( FIG. 14H ) using a single implant access incision, because at least a single implant access incision 609D is generally interposed (at least in some embodiments) between each target nerve location (e.g., 515R, 505R). Thus, when a single implant access incision (e.g., 609D) is made at the midpoint between the respective target stimulation locations (505R, 515R), implantation of the stimulator 6552 involves positioning the microstimulator 6575 at a midpoint between the two target stimulation locations (505R, 515R) such that the lead portions can extend outward toward the target stimulation locations in a natural manner to simplify advancement of each lead portion toward its target stimulation location. Furthermore, such placement can steer the multiple lead portions extending from the microstimulator 6575 to their desired orientation within the body, reducing strain on the lead portions to an extent that may induce strain under some circumstances.

[0240] In some embodiments, a kit of several different stimulators (each including a microstimulator and at least two pre-connected lead portions L1, L2) may be provided, with each different stimulator in the kit including lead portions (L1, L2) extending from the microstimulator at a different angle (α in FIG. 14HH ) from each other. For example, one stimulator in the kit may have lead portions (e.g., L1, L2 in FIG. 14HH ) extending from each other at an angle (α) of approximately 130 degrees, while a different stimulator in the kit may have lead portions (e.g., L1, L2) extending from each other at an angle (α) of approximately 170 degrees. Thus, when beginning a stimulator implantation procedure, a surgeon may select a stimulator from the kit having an angle (α) suitable for facilitating implantation of the stimulator (including the microstimulator and lead portions) given the particular target stimulation location of the nerve where the stimulator portion (e.g., electrode array, cuff electrode, etc.) will be implanted.

[0241] As previously noted in connection with at least the exemplary arrangement of FIG. 14B, the implant access incision 609D can be selected such that at least one lead portion (e.g., 6546) can be implanted through the implant access incision 609D without tunneling.

[0242] Conversely, as further shown in FIG. 14H, in a manner similar to that described in connection with at least FIGS. 14B and 14E, a tunnel (T7) can be formed through the implant access incision 609D to form a pathway for advancing the lead portion 6566 subcutaneously until the stimulation portion 6313A is aligned and positioned relative to the cervical-related nerve trap 515R, as shown in FIG. 14H.

[0243] Further, with respect to at least Figures 14F, 14H-14K, it will be appreciated that in some embodiments, tunneling can be performed in two separate orientations, with a first tunnel established for a first lead (including a stimulation portion) for stimulating the hypoglossal nerve 505R, and a second tunnel for a second lead (including a stimulation portion).

[0244] 14H , in some examples, the example arrangement 6550 may include a recharging element 6576 for recharging a power source for the microstimulator 6575. In some such examples, the recharging element 6576 and / or the microstimulator 6575 may include at least some of substantially the same features and attributes as the example arrangement 2700, as described below in connection with at least FIG.

[0245] 14H , in some embodiments, the stimulation portion 6310A of FIG. 14H can have a length that includes at least about 50, 60, 70, or 80 percent of the length of the entire first lead portion 6546 extending from the microstimulator 6575. In some embodiments, this length relationship can sometimes be expressed as the stimulation portion 6310A having a length that includes substantially a majority of the entire length of the first lead portion 6546. Conversely, in some embodiments of the second lead portion 6566, the stimulation portion 6313A can have a length that includes about 10, 15, 20, 25, or 30 percent of the length of the entire second lead portion 6566 extending from the microstimulator 6575. Stated another way, the length of the entire second lead portion 6566 extending from the microstimulator 6575 can include some of the length of the stimulation portion 6313A of the second lead portion 6566. It will be understood that these same "relative length" relationships are shown in the example configurations described below in connection with at least Figures 14I-14K ​​with respect to similar lead portions and stimulation portions of each example configuration.

[0246] 14I includes a front view that schematically depicts an example arrangement 6600 relative to a patient's body 510, including an example stimulation device 6602 for implantation and / or an associated example method, the arrangement 6600 including a stimulation portion 6310A in stimulating relationship to the hypoglossal nerve 505R and a stimulation portion 6313A in stimulating relationship to the cervical-related nerve trap 515R. In some examples, the example arrangement 6600 can include at least some of the same features and attributes as the example arrangement 6550 of FIGS. 14H, 14HH, except that the single implant access incision 609E has a different location than the implant access incision 609D (FIG. 14H), and the roles of the respective lead portions 6666 and 6664 of FIG. 14I are reversed relative to the lead portions 6564 and 6566 of FIG. 14H.

[0247] In particular, the implant access incision 609E is formed in a location reasonably close to the cervical-related nerve trap 515R into which the microstimulator 6575 may be implanted so that the lead portion 6666 (including the stimulation portion 6313A) can be properly aligned and positioned in stimulating relationship to the cervical-related nerve trap 515R, while after and through tunneling (as at T9 in FIG. 14D ), the lead portion 6664 can be advanced subcutaneously through the tunnel until the stimulation portion 6310A is properly aligned and positioned in stimulating relationship to the hypoglossal nerve 505R.

[0248] 14J includes a front view that schematically depicts an example arrangement 6620 relative to a patient's body 510, including an example stimulation device 6622 for implantation and / or an associated example method, the arrangement 6620 including a stimulation portion 6310A in stimulating relationship to the hypoglossal nerve 505R and a stimulation portion provided as a cuff electrode 6414A in stimulating relationship to the cervical-related nerve trap 515R. As shown similarly to FIGS. 14H, 14HH, and 14I, the stimulation device 6622 includes at least a microstimulator 6575, a lead 6666 having a stimulation element 6414A, and a lead 6664 having a stimulation element 6410A.

[0249] In some examples, the example arrangement 6620 can include at least some of the substantially same features and attributes as the example arrangement 6600 of Figure 14I, except that the cuff electrode 6414A of Figure 14J replaces the stimulating portion 6313A of Figure 14I. For example, the example arrangement 6620 of Figure 14J (including the stimulator 6622) includes a recharging element 6576 and a microstimulator 6575, each of which includes at least some of the substantially same features and attributes described above in connection with Figures 14H, 14HH, 14I, and with reference to the features and attributes of Figure 21.

[0250] Because at least a single implant access incision 609E is formed at a location reasonably close to the cervical-related nerve trap 515R, implanting the cuff electrode 6414A (on the lead portion 6666) in stimulating relationship to the cervical-related nerve trap 515R can be performed in a relatively simple manner without tunneling. Furthermore, this relatively direct access can greatly facilitate implantation of the cuff electrode 6414A, which may involve more manipulation into, around, and between tissue within the surgical work area than simply pushing an axial cylindrical stimulation portion. Implantation of the cuff electrode 6414A may be preferred in some embodiments, including but not limited to, to reliably establish a stimulating relationship of the stimulation element (e.g., a carrier with an electrode) to the nerve, which can be difficult (in some patients) to ensure stable positioning of a non-cuff electrode type stimulation element. For example, direct visualization of the cervical-related nerve trap 316 may better enable probing to / among different branches of the cervical-related nerve trap 316 to identify the stimulation location (e.g., A, B, C, or other locations in FIG. 2) with the best muscle response to test stimulation. Once such identification is made, the cuff electrode 6414A may then be placed at the identified location and fixed in place to establish reliable chronic implantation and a robust stimulation relationship to the target stimulation location of the nerve. Among other aspects, using a "direct access" implant access incision may enhance visualization and probing, which may allow for greater flexibility and success in performing implants that account for anatomical variations between different patients.

[0251] 14K includes a front view that schematically depicts an example arrangement 6650 relative to a patient's body 510, including an example stimulation device 6652 for implantation and / or an associated example method, the arrangement 6650 including a stimulation portion (provided as a cuff electrode 6411A) in stimulating relationship to the hypoglossal nerve 505R and a stimulation portion 6413A in stimulating relationship to the cervical-related nerve trap 515R. In some examples, the example arrangement 6650 can include at least some of the substantially same features and attributes as the example arrangement 6550 of FIG. 14H, except that the cuff electrode 6411A of FIG. 14K replaces the stimulation portion 6310A of FIG. 14H. For example, via the example arrangement (and method), the entire stimulation device 6652 (including the microstimulator 6575, the lead 6666 having the stimulation element 6431A, and the lead 6664 having the stimulation element 6411A) can be implanted through a single implant access incision 609D.

[0252] Because at least a single implant access incision 609D is made in a location reasonably close to the hypoglossal nerve (e.g., its more distal portion), implanting the cuff electrode 6411A (on the lead portion 6666) in stimulating relationship to the hypoglossal nerve 515R can be performed in a relatively simple manner without tunneling. Furthermore, this relatively direct access can greatly facilitate implantation of the cuff electrode 6411A, which may involve more manipulation into, around, and between tissue within the surgical work field than simply pushing an axial cylindrical stimulation portion. Implantation of the cuff electrode 6411A may be preferred in some embodiments, including but not limited to, to reliably establish a stimulating relationship of the stimulation element (e.g., a carrier with an electrode) to the nerve, which can be difficult (at least in some patients) to ensure stable positioning of a non-cuff electrode type stimulation element. For example, direct visualization of the hypoglossal nerve 505R may better enable probing to / between different branches (and / or distal nerve endings) of the hypoglossal nerve 505R to identify a stimulation location with optimal muscle response to test stimulation. Once such identification is made, the cuff electrode 6411A may then be placed at the identified location and fixed in place to establish reliable chronic implantation and a robust stimulation relationship to the target stimulation location of the nerve. Among other aspects, using a "direct access" implant access incision may enhance visualization and probing, which may allow for greater flexibility and success in performing implants that account for anatomical variations between different patients.

[0253] Through at least some of these features and attributes, such as, but not limited to, a single implant access incision 609D and a compact stimulation device 6652, surgeons may implant the stimulation device in a more efficient and effective manner while potentially increasing patient comfort.

[0254] 14L-14R illustrate at least some exemplary methods of implantation and / or stimulation therapy. For example, various examples of stimulation therapy are described in connection with at least FIG. 3A, which may include administering electrical stimulation to the left hypoglossal nerve, the right hypoglossal nerve, the left cervical-related nerve trap, and / or the right cervical-related nerve trap. In some such examples, therapy may be applied to one or both of the same type of nerve (e.g., only the hypoglossal nerve or only the cervical-related nerve trap), to one or both of different types of nerve (e.g., stimulating nerves on only the right side of the body or only the left side of the body), or to both of different types of nerve (e.g., stimulating the left hypoglossal nerve and the right cervical-related nerve trap, or vice versa). With this in mind, FIGS. 14L-14R include several exemplary implementations of the exemplary arrangement of FIG. 3A directed to stimulation of both the left and right hypoglossal nerves, and stimulation of one of a single cervical-related nerve trap (e.g., left or right). In particular, Figures 14L-14R relate to at least some embodiments of implantation methods and exemplary stimulation devices for implementing stimulation of both the left and right hypoglossal nerves and stimulation of one of a single cervical-related nerve tract (e.g., left or right). Various exemplary methods of stimulation therapy, including whether (and how) different nerves (e.g., left HGN, right HGN, left AC, and right AC) are stimulated simultaneously, alternating, staggered, sequentially, synchronously, asynchronously, and similarly, are provided in at least Figures 1-3C, 16, and 32A-50, and / or various other therapy examples throughout this disclosure. Furthermore, implantation of various elements of the exemplary stimulation devices in connection with at least Figures 14L-14R may further be implemented via at least some of the exemplary arrangements (e.g., devices and methods) described in connection with the delivery tools, anchor elements, lead connectivity features, etc. of at least Figures 1-32C, 49B-51B.

[0255] 14L-14R illustrate examples in which stimulation may be applied to the right cervical-related nerve trap in combination with stimulation including both the left and right hypoglossal nerves, it will be understood that these examples are equally applicable to exemplary implementations of applying stimulation to the left cervical-related nerve trap in combination with stimulation including both the left and right hypoglossal nerves. Furthermore, in some embodiments, using similar elements, methods, etc., some exemplary methods of implantation and / or exemplary stimulation devices include stimulation of both the left cervical-related nerve trap (e.g., 515L) and the right cervical-related nerve trap (e.g., 515R), as described in connection with at least FIGS.

[0256] FIG. 14L includes a front view that schematically depicts an example arrangement 3400, including an example device and / or example method for implantation of a stimulation device 3405. The stimulation device 3405 is adapted to provide stimulation of both the left and right hypoglossal nerves 505R, 505L and one of the cervical-related nerves 515R (e.g., 316 in FIG. 2A) to maintain and / or restore upper airway patency, such as for treating obstructive sleep apnea and / or other sleep-disordered breathing. Accordingly, FIG. 14L depicts the head and neck region 520 of a patient's body 510, while indicating at least some anatomical landmarks, such as the chin 509, and provides a dotted line 3401 to distinguish between the right and left sides of the patient's body 510.

[0257] As shown in FIG. 14L , the stimulation device 3405 may include a stimulation lead 3410 for delivering a therapeutic stimulation signal generated via an implantable pulse generator (IPG) 533 and applied through at least one of a stimulation portion 6310A, a stimulation portion 6310B, and / or a cuff electrode 6414A. In some embodiments, the stimulation portion 6310A, 6310B may include a linear array of spaced apart electrodes (e.g., rings, split rings, etc.), which may sometimes be referred to as an axial lead or axial stimulation portion. In some embodiments, the stimulation lead 3410 may include a proximal portion 3412, a body portion 3414, a joint 3418, a lead portion 3416, and distal lead portions 3420, 3422. The proximal portion 3412 of the lead 3410 is connectable to the IPG 533, and the body portion 3414 extends distally from the proximal portion 3412. The junction 3418 connects the distal lead portions 3420, 3422 and the lead portion 3416 to each other and to the body portion 3414 of the lead 3410. In some embodiments, the junction 3418 may sometimes be referred to as including or defining the bifurcation of the distal lead portions 3420, 3422 and the lead portion 3416 to each other and / or to the body portion 3414 of the lead 3410.

[0258] In some embodiments, these elements may be implanted through an implant access incision 609E, which in some embodiments may include the only implant access incision through which the elements of the stimulation device 3405 are implanted. As noted elsewhere, using a single implant access incision may, at least in some embodiments, reduce surgical complexity, increase patient comfort, and shorten procedure time. As shown in FIG. 14L, the implant access incision 609E is located proximal to the cervical-related nerve trap 515R.

[0259] It will be appreciated that in some embodiments, multiple implant access incisions may be used.

[0260] In one aspect, an implantation method may include forming an implant access incision 609E, followed by introducing and advancing a lead portion 3416 to place the cuff electrode 6414A in stimulating relationship to a neck-related nerve trap 515R, such as on one side of the body (e.g., the right side). From a single implant access incision 609E, a tunnel T8 may be formed subcutaneously toward the relevant portion of the right hypoglossal nerve 505R, followed by introducing and advancing a distal lead portion 3420 to place the stimulation portion 6310A in stimulating relationship to a target stimulation portion on the right hypoglossal nerve 505R. Similarly, through the implant access incision 609E, a tunnel T9 is formed for the left hypoglossal nerve 505L, followed by introducing and advancing a distal lead portion 3422 to place the stimulation portion 6310B in stimulating relationship to a target stimulation portion on the left hypoglossal nerve 505R. Through this arrangement, the respective distal lead portions 3420, 3422 provide a mechanism by which stimulation of both the left and right hypoglossal nerves may be delivered. As previously described elsewhere, in some embodiments, the stimulation portion 6310A, 6310B may include an axial lead type of stimulation portion including a linear array of spaced apart electrodes (e.g., ring electrodes, split ring electrodes, etc.). As further noted elsewhere, each stimulation portion 6310A, 6310B and supporting distal lead portion 3420, 3422 (respectively) may include anchoring elements as described in various examples of this disclosure, such as (but not limited to) FIGS.

[0261] Among other aspects, a cuff-type electrode 6414A secured to the cervical-related nerve trap 515R can help ensure robust engagement of the stimulation electrode in stimulating relationship to the nerve 515R, given the nerve's small size, given the type and location of the nerve 515, and / or given the type, size, etc. of surrounding non-neural tissue. In other aspects, the axial-type stimulation portions 6310A, 6310B may better facilitate introduction and advancement through tunnels (e.g., T8, T9) than cuff electrodes and may also avoid the need for separate implant access incisions near the nerves 505R, 505L, thereby facilitating implant procedures using fewer implant access incisions. Doing so reduces surgical time and complexity and increases patient comfort.

[0262] In a further aspect of the implantation method, from a single implant access incision 609E, a tunnel T10 can be formed subcutaneously at a suitable location where the IPG 533 can be implanted, such as in the pectoral region 532 of the patient's body. In some examples, additional implant access incisions can be formed proximate to where the IPG 533 is to be implanted. With the tunnel T10 formed, through the implant access incision 609E, the body portion 3414 of the lead 3410 can be introduced and advanced to the implant location of the IPG 533 to allow the proximal portion 3412 of the stimulation lead 3410 to be connected (electrically and mechanically) to the IPG 533.

[0263] The exemplary arrangement shown in FIG. 14L provides a branch point near the implant access incision 609E, and in some embodiments, the stimulation lead can include a branch point near the IPG 533, such as (but not limited to) the exemplary implementation of FIG. 14N described below.

[0264] Figure 14M is a diagram including a front view that schematically depicts an example arrangement 3440, including an example device and / or example method for implantation of a stimulation device 3450. In some examples, the stimulation device 3450 may include at least some of substantially the same features and attributes as the stimulation device, method, etc., as described above in connection with at least Figure 14L, except that the stimulation device 3450 of Figure 14M includes a microstimulator 6575 (e.g., Figure 14H) instead of the IPG 533 of Figure 14L (and omits the body portion 3414 of the lead 3410 associated with the IPG 533).

[0265] As shown in FIG. 14M, in some embodiments, the microstimulator 6575 is implanted at or near the target stimulation location of the cervical-related nerve trap 515R.

[0266] Thus, further in comparison to Figure 14L and with further reference to Figure 14M, the stimulator 3450 of Figure 14M includes the same distal lead portions 3420, 3422 and respective stimulation portions 6310A, 6310B for delivering stimulation to both the right and left hypoglossal nerves 505R, 505L, respectively. Additionally, the stimulator 3450 of Figure 14M includes the same lead portion 3416 and cuff electrode 6414A in stimulating relationship to the cervical-related nerve trap 515R.

[0267] As further shown in FIGURE 14M, the microstimulator 6575 is directly connected to respective lead portions 3420, 3422, 3416, each having a distal lead portion 3420, 3422 with a branch point 3425 at or near the housing of the microstimulator 6575. In some embodiments, the lead portion 3416 may extend directly from the microstimulator 6575 shown in FIGURE 14M, or in some embodiments, may extend from the same branch point 3425 (or junction) as the distal lead portions 3420, 3422. As mentioned elsewhere with respect to some embodiments of the present disclosure, the microstimulator 6575 may include stimulation / control circuitry, a power source (e.g., rechargeable), and may communicate with an external power recharging device, element, etc.

[0268] It will be further understood that in some embodiments, at least a portion of the stimulation portion (e.g., 6310A, 6310B), cuff electrode (e.g., 6414A), may communicate wirelessly with the microstimulator 6575, such that one or more of the associated lead portions (e.g., supporting the respective stimulation portion or cuff electrode) may be omitted in some embodiments.

[0269] 14N is a diagram including a front view that schematically depicts an example arrangement 3460, including an example device and / or example method for implantation of a stimulation device 3469. In some examples, the stimulation device 3469 may include at least some of the substantially same features and attributes as the stimulation device, method, etc., as described above in connection with at least FIG. 14L, except that the stimulation device 3469 includes a stimulation lead array 3470 having bifurcated leads 3464, 3476 extending from the IPG 533 and distal lead portions 3466, 3468 of the leads 3464 originating at a bifurcation point 3467 much closer to the target stimulation location of the hypoglossal nerves 505R, 505L. As further shown in FIG. 14N, the stimulation device 3469 includes a cuff electrode 6414A supported on a distal portion of the lead 3476 for stimulating the cervical-related nerve trap 515R. The stimulator 3469 includes stimulation portions 6310A, 6310B (e.g., axial / linear electrode arrays) on respective distal lead portions 3466, 3468 for stimulating the hypoglossal nerves 505R, 505L on either side (right, left) of the patient's neck, respectively.

[0270] 14N, one embodiment of an exemplary method of implantation may include forming an implant access incision 609E and implanting a cuff electrode 6414A (through the incision 609E) in stimulating relationship to the cervical-related nerve trap 515R. Through the implant access incision 690E, a tunnel (T13) may be formed to the implant location of the IPG 533, and a lead 3476 may be introduced and advanced through the tunnel T13 to connect a proximal portion 3474 of the lead 3476 (electrically and mechanically) to the IPG 533.

[0271] In some embodiments, additional implant access incisions can be formed near the IPG 533 to facilitate implantation of the IPG 533, the lead 3476, and / or the lead 3464.

[0272] In another aspect of the implantation method, in some embodiments, an implant access incision 609D may be formed adjacent to the anticipated target stimulation location of the hypoglossal nerve 505R on the same side (right) of the neck as the implant access incision 609E. From the implant access incision 609D, a tunnel T11 is formed to the target stimulation location of the left hypoglossal nerve 505L. Through the implant access incision 609D, the distal lead portion 3466 (including the stimulation portion 6310A) and the distal lead portion 3468 (including the stimulation portion 6310B) are introduced and advanced subcutaneously to their respective target stimulation locations of the right and left hypoglossal nerves 505R, 505L, resulting in the chronically implanted configuration of the stimulation portions 6310A, 6310B shown in FIG. 14N.

[0273] In some embodiments, the implant access incision 609D is close to the target stimulation location of the right hypoglossal nerve 505R such that little or no tunneling can be used to position the distal lead portion 3466 in stimulating relationship to the right hypoglossal nerve 505R.

[0274] Through implant access incisions 609D and / or 609E, tunnel T12 is formed to allow introduction and advancement of lead 3464 between implant access incisions 606D and 6009E. Using previously formed tunnel T13, lead 3464 may be advanced further subcutaneously for electrical and mechanical connection of the proximal portion 3462 with the IPG 533 in the pectoral muscle region 532.

[0275] 14O is a diagram including a front view that schematically depicts an example arrangement 3500, including an example device and / or example method for implantation of a stimulation device 3505. In some examples, the stimulation device 3505 may include at least some of the substantially same features and attributes of the stimulation device, method, etc., as described above in connection with at least FIGS. 14L-14N, except that the stimulation device 3500 includes a single stimulation lead 3510 extending from the IPG 533 and bifurcated distal lead portions 3520, 3522 originating at a junction 3523 (i.e., bifurcation point) that may be positioned proximate a target stimulation location in the hypoglossal nerve 505R, 505L. In some examples, the stimulation portion 6310B (e.g., an axial / linear electrode array) is supported on (and by) the distal lead portion 3522 to stimulate the left hypoglossal nerve 505L, while the cuff electrode 6411A is supported on and by the distal lead portion 3520 to stimulate the right hypoglossal nerve 505R. As further shown in FIG. 14O, the stimulation device 3550 includes a cuff electrode 6414A supported on a lead portion 3516 that extends from the main portion 3514 of the lead 3510 via a junction 3517 (i.e., bifurcation point) and configured to stimulate the cervical-related nerve trap 515R.

[0276] With this framework in mind, as shown in FIG. 14O, one embodiment of an exemplary method of implantation may include forming an implant access incision 609E and implanting (through the incision 609E) a cuff electrode 6414A (supported on a lead portion 3516) in stimulating relationship to a cervical-related nerve trap 515R. Through the implant access incision 690E, a tunnel (T13) may be formed to an implant location relative to the IPG 533, and the lead portion 3514 of the lead 3510 can be introduced and advanced through the tunnel T13 to connect (electrically and mechanically) the proximal portion 3512 of the lead 3510 to the IPG 533, such as within the pectoral muscle region 532. In some examples, additional implant access incisions may be formed near the IPG 533 to facilitate implantation of the IPG 533, lead 3476, and / or lead 3464.

[0277] In another aspect of the implantation method, in some embodiments, an implant access incision 609D can be formed adjacent to the anticipated target stimulation location of the hypoglossal nerve 505R on the same side (right) of the neck as the implant access incision 609E. From the implant access incision 609D, a tunnel T11 is formed to the target stimulation location of the left hypoglossal nerve 505L. Through the implant access incision 609D, the distal lead portion 3520 (including the cuff electrode 6411A) and the distal lead portion 3522 (including the stimulation portion 6310B) are introduced and advanced subcutaneously to their respective target stimulation locations of the right and left hypoglossal nerves 505R, 505L, resulting in the chronically implanted configuration of the stimulation portions 6411A, 6310B shown in FIG.

[0278] In some examples, the implant access incision 609D is close to the target stimulation location of the right hypoglossal nerve 505R such that little or no tunneling is used to position the distal lead portion 3520. Through this placement, sufficient space is available to implant a cuff electrode 6411A on the nerve 505R. However, as described above, a non-cuff stimulation portion 6310B is provided for the left hypoglossal nerve 505L so that the distal lead portion 3522 (including the stimulation portion 6310B) can be delivered to the target stimulation location via tunneling (T11) without an additional implant access incision on the left side of the patient's neck.

[0279] Through implant access incisions 609D, 609E, a tunnel T12 is formed to allow introduction and advancement of lead portion 3518 between implant access incision 606D and implant access incision 609E.

[0280] Via the exemplary arrangement, the cuff electrode 6414A is anchored relative to the cervical-associated nerve trap 515R, and the cuff electrode 6411A is anchored relative to the right hypoglossal nerve 505R via the associated implant access incisions 609E, 609D, while the ability to stimulate both the left and right hypoglossal nerves 505L, 505R is achieved via tunneling (T11) from the implant access incision 609D. In this manner, robust, fixed implantation of stimulation elements for multi-target therapy may be performed with generally reduced surgical complexity.

[0281] In some embodiments, the IPG 533 may be omitted, and instead a microstimulator (e.g., 6575 in FIG. 14M ) may be implanted through the implant access incision 609D proximate to a target stimulation location of the right hypoglossal nerve 505R, such as, but not limited to, at the junction 3523 of the lead 3550. Similarly, instead of implanting the IPG 533, a microstimulator (e.g., 6575 in FIG. 14M ) may be implanted through the implant access incision 609E proximate to a target stimulation location of the cervical-related nerve trap 515R, such as, but not limited to, at the junction 3517 of the lead 3550. Of course, it will be understood that in these embodiments, appropriate modifications are made to connect the various lead portions to the microstimulator. As noted elsewhere, in some embodiments, the implanted microstimulator may communicate wirelessly with at least a portion of the stimulation portion, cuff electrode, etc.

[0282] 14P is a diagram including a front view that schematically depicts an example arrangement 3540, including an example device and / or example method for implantation of a stimulator 3545. In some examples, the stimulator 3545 may include at least some of substantially the same features and attributes as the stimulator, method, etc., as described above in connection with at least FIG. 14O, except that the stimulator 3545 of FIG. 14P includes a single distal portion 3519 of the lead 3510 that includes the paddle electrodes 3560 of FIG. 14P (to achieve both hypoglossal nerve stimulation) instead of the bifurcated distal lead portions 3520, 3522 of FIG. 14O.

[0283] With this framework in mind, as shown in FIG. 14P, one embodiment of an exemplary method of implantation may include forming a tunnel T14 from the aforementioned implant access incision 609D, and introducing and subcutaneously advancing a paddle electrode 3560 through tunnel T14 to establish the paddle electrode 3560 at a position extending between and overlapping both of the target stimulation locations of the left and right hypoglossal nerves 505L, 505R, as shown in FIG. 14P. In some examples, the paddle electrode 3560 may include a carrier 3562 (e.g., body) 3562 supporting a linear array 3566 of electrodes 3568 on a first portion 3564R of the carrier 3562 and a linear array 3566 of electrodes 3568 on a second portion 3564L of the carrier 3562. Providing these linear arrays may ensure that at least some of the electrodes 3568 are juxtaposed in a stimulating relationship to the target stimulation locations of the respective left and right hypoglossal nerves 505L, 505R. In a related aspect, by establishing multiple electrodes 3568 in juxtaposed positions in a potentially stimulating relationship to each nerve 505L, 505R, some exemplary methods of stimulation therapy may include selective stimulation of different fiber bundles within a nerve, nerve branch, etc., to optimize the intended therapeutic effect, manage fatigue, etc.

[0284] In some embodiments, the arrays 3566 on the left and right portions 3564L, 3564R of the paddle electrode 3560 may be sized to join to form a single array of electrodes 3568 extending along / transversely to substantially the entire length of the carrier 3562 of the paddle electrode 3560.

[0285] In some examples, the array 3566 of electrodes 3568 may include electrodes 3568 that are sized, shaped, and / or arranged to include a two-dimensional array of electrodes 3568 having rows / columns of spaced apart electrodes 3568.

[0286] In some embodiments, certain features of the paddle electrode 3560 and related implantation methods, therapy methods, etc. may include at least some of the substantially same features and attributes as those described in PCT application PCT / US21 / 17754, filed on February 12, 2021, having serial number ___________, as a U.S. 371 national stage application, entitled "STIMULATION ELECTRODE ASSEMBLIES, SYSTEMS AND METHODS FOR TREATING SLEEP DISORDERED BREATHING," which is incorporated herein by reference in its entirety.

[0287] Figure 14Q is a diagram including a front view that schematically depicts an example arrangement 3570, including an example device and / or example method for implantation of a stimulation device 3575. In some examples, the stimulation device 3575 may include at least some of the substantially same features and attributes as the stimulation device, method, etc., as described above in connection with at least Figure 14O, except that the stimulation device 3575 of Figure 14Q includes an axial stimulation portion 6310C for stimulating the cervical-related nerve trap 515R instead of the cuff electrode 6414A of Figure 14O, and the axial stimulation portion 6310C of Figure 14Q is supported by a different lead portion 3573, among other differences. However, similar to the exemplary arrangement of Figure 14, the stimulator 3575 of Figure 14Q includes a stimulation portion 6310B (e.g., an axial / linear electrode array) supported on and by a distal lead portion 3577 for stimulating the left hypoglossal nerve 505L, while a cuff electrode 6411A is supported on and by a distal lead portion 3578 for stimulating the right hypoglossal nerve 505R. As further shown in Figure 14Q, the stimulator 3550 includes a lead portion 3573 extending from a main portion 3574 of the lead 3571, through a junction 3576 (i.e., bifurcation point) of the lead 3571 near the implant access incision 690D, to a nerve stimulation location of the cervical-related nerve trap 515R, to support an axial stimulation portion 6310C in stimulating relationship to the cervical-related nerve trap 515R.

[0288] With this framework in mind, as shown in FIG. 14Q, one embodiment of an exemplary method of implantation may include forming an implant access incision 609D and implanting a cuff electrode 6411A and a stimulation portion 6310B (through the incision 609D) in a manner similar to at least that described in connection with FIG. 14O. Further, through the implant access incision 609D, a tunnel T16 may be formed toward the annular cervical-related nerve trap 515R, and the lead portion 3573 of the lead 3571 may be introduced through the tunnel T16 and advanced to extend toward a target stimulation location in the annular cervical-related nerve trap 515R to place the stimulation portion 6310C (similar to 6310B) in a stimulating relationship relative to the annular cervical-related nerve trap 515R.

[0289] 14Q, the main lead portion 3574 of the lead 3571 extends proximally from the junction 3576. Through the implant access incision 609D, a tunnel (T15) can be formed to the implant location of the IPG 533, where an additional implant access incision 609C can be formed near the IPG 533 to facilitate implantation of the IPG 533 and the lead portion 3574. In this framework, in some examples, the lead portion 3574 of the lead 3571 can be introduced and advanced through the tunnel T15 to connect (electrically and mechanically) the proximal portion 3572 of the lead 3571 to the IPG 533, such as within the thoracic region 532.

[0290] In some embodiments, the junction 3576 can be configured to allow releasable connectability of the various lead portions 3573, 3577, 3578 to the main lead portion 3574 and / or to each other. Further, in some embodiments, the junction 3576 can be configured to allow releasable connection of the main lead portion 3574 to the junction 3576.

[0291] Among other aspects, in conjunction with the implant access incision 609D, the exemplary arrangement 3570 may reduce surgical complexity while providing a method for establishing a cuff electrode 6411A on the right hypoglossal nerve 505R, an axial stimulation portion 6310B on the left hypoglossal nerve, and an axial stimulation portion 6310C on the cervical-related nerve trap 515R.

[0292] 14R is a diagram including a front view that schematically depicts an example arrangement 3580, including an example device and / or an example method for implantation of a stimulator 3582. In some examples, the stimulator 3582 can include at least some of substantially the same features and attributes as the stimulator, method, etc., as described above in connection with at least FIG. 14Q, except that the stimulator 3580 of FIG. 14R includes a microstimulator 6575 instead of the IPG 533 of FIG. 14Q, and the main lead portion 3574 is omitted in addition to the IPG 533.

[0293]

[00103] Accordingly, with further reference to Figure 14R in comparison to Figure 14Q, the stimulator 3582 of Figure 14R includes the same distal lead portions 3578, 3577 and their respective stimulation elements (e.g., cuff electrode 6411A, stimulation portion 6310B) for delivering stimulation to both the right and left hypoglossal nerves 505R, 505L, respectively. Additionally, like the stimulator of Figure 14Q, the stimulator 3582 of Figure 14R retains the same lead portion 3573 and axial stimulation portion 6310C in stimulating relationship to the cervical-related nerve trap 515R.

[0294] As further shown in FIG. 14R, the microstimulator 6575 is directly connected to each lead portion 3578, 3577, with the distal lead portion 3578, 3577, 3573 having a branch point (formed by a junction 3585) at or near the housing of the microstimulator 6575. In some embodiments, the lead portion 3573 (of the stimulation portion 6310C) may extend directly from the microstimulator 6575, as shown in FIG. 14R, or in some embodiments, may extend from the same junction 3585 as the distal lead portions 3578, 3577. As mentioned elsewhere with respect to some embodiments of the present disclosure, the microstimulator 6575 may include stimulation / control circuitry, a power source (e.g., rechargeable), and may communicate with an external power recharging device, element, etc.

[0295] Among other aspects, the exemplary arrangement 3580 may include an exemplary method of implantation that significantly reduces surgical complexity, shortens implantation time, and increases patient comfort. In some such examples, these features may be achieved, at least in part, due to a single (i.e., only one) implant access incision 609D made at or near the target stimulation location of the right hypoglossal nerve 505R, which simultaneously allows for convenient implantation of a cuff electrode 6411A on the right side of the patient's neck, implantation of an axial stimulation portion 6310B on the left side of the patient's neck, implantation of an axial stimulation portion 6310C on the right side of the patient's neck, and implantation of a microstimulator 6575 to support the respective cuff electrodes and stimulation portions of the stimulation device 3582. In a manner similar to that described in connection with FIG. 14Q, the joints 3585 may allow for various forms of permanent or releasable connections between the various lead portions 3578, 3577, 3573 to the microstimulator 6575 and / or to each other. This aspect may enhance reduced surgical complexity, shorter procedure times, and the like.

[0296] 15A includes a front view that schematically depicts an example arrangement 1830 relative to a patient's body 510, including an example device and / or example method for implantation of a stimulation element 1810A in stimulating relationship to a hypoglossal nerve 505R and a stimulation element 1813A in stimulating relationship to a cervical-related nerve trap 515R. In some examples, the example arrangement 1850 may include at least some of the substantially same features and attributes as, include example implementations of, and / or be usable with, the example arrangements described in connection with at least some of FIGS.

[0297] In particular, as shown in Figure 15A, in some embodiments, the arrangement 1830 can be implanted in a single implant procedure through a single implant access incision 609C, for example, in a manner similar to that described for the example arrangement 1800 of Figure 14A. However, instead of tunneling, as in the example of Figure 14A, in the example of Figure 15A, the stimulation lead 1838 is delivered through an access point 1842 and implanted within the vasculature to position the stimulation element 1810A within the vein 1832, shown in dashed line, (so as to be in a stimulating relationship to the hypoglossal nerve 505R).

[0298] Similarly, stimulation lead 1837 is delivered through access point 1843 and implanted within the vasculature to position stimulation element 1813A within vein 1833 (shown in dashed lines) in a stimulating relationship to neck-related nerve trap 515R. As described below in connection with at least Figures 32A-32B, in some embodiments, applicable vasculature 1855 can include veins such as the anterior jugular vein, inferior thyroid vein, superior thyroid vein, external jugular vein, etc.

[0299] In some embodiments, both stimulation elements 1810A, 1813A may include an axial array of electrodes 716 that facilitates linear positioning and adjustment to ensure a desired co-extension position of the electrodes 716 relative to the desired portion of the respective nerve being stimulated. In some embodiments, each stimulation element 1810A, 1813A may include one of the electrode configurations, such as one of the stimulation elements described below in connection with at least Figures 25-26 and 29-30B, which in some embodiments may include an anchoring element. Additionally, one example implementation of stimulation leads 1838 and / or 1837 is described in connection with Figure 15C.

[0300] As further shown in FIG. 15A, the IPG 533 can be implanted subcutaneously through the implant access incision 609C and electrically connected to the proximal portions of the respective stimulation leads 1838, 1837.

[0301] FIG. 15B is a schematic diagram of an example arrangement 1850 that may include at least some of the same features and attributes as the example arrangement 1800 of FIG. 15A , except that the two stimulation elements 1810A, 1813A are disposed on a single stimulation lead 1867 rather than separate stimulation leads 1838, 1837, as in FIG. 15A . As further shown in FIG. 15B , through a single implant access incision 609C, a portion of the stimulation lead 1867 is inserted into the vasculature 1855 at an access point 1856 and advanced through the vasculature 1855 until a stimulation element 1810A at a distal portion of the stimulation lead 1867 is positioned adjacent to a first target nerve 505R. In some embodiments, the first target nerve 1805R may include the hypoglossal nerve (e.g., 505R), while in some embodiments, the first target nerve 1805R may include a portion of the cervical-related nerve snares 315 ( FIG. 2 ) or yet another nerve. With such positioning, a second stimulation element 1813A located more proximally on the same stimulation lead 1867 is positioned within the vasculature 1855 adjacent to and in a stimulating relationship to a second neural target 1815R. In some embodiments, the second target nerve may include a portion of a ganglion-associated nerve 515R or other nerve.

[0302] Figure 15C is a side view that schematically depicts an example arrangement 1870 including an example stimulation lead 1872, which may include one example implementation of the stimulation leads 1837, 1838 of Figure 15A or the stimulation lead 1867 of Figure 15B. As shown in Figure 15C, the stimulation lead 1872 includes an array (e.g., axial) of electrodes 716 and includes a stimulation element 1880A supported by a distal portion 1874 of a lead body 1875, a proximal portion (not shown) of which is adapted for electrical and mechanical connection to the IPG 533 (e.g., via the header 735).

[0303] As further shown in FIG. 15C , the lead body 1875 defines an internal lumen 1877 that extends through the length of the lead body 1875 and the stimulation element 1880A. The lumen 1877 is sized and shaped to allow the stimulation lead body 1875 and the stimulation element 1880A to be slidably advanced and steerable over a guidewire 1879, or stylet or other guiding element. With this arrangement, to implant the stimulation lead 1872 in the manner shown in FIG. 15A or 15B , the guidewire 1879 is first inserted into the vasculature (e.g., 1832, 1833 in FIG. 15A ) and advanced through the vasculature until a distal portion of the guidewire 1879 is positioned just beyond the most distal target stimulation location, such as the hypoglossal nerve 505R in FIG. 15A . Next, the open end of lumen 1877 at distal portion 1881 of stimulation lead 1872 (including stimulation element 1880A) is slidably seated over the proximal end of guidewire 1879 in the region of implant access incision 609C (e.g., FIGS. 15A, 15B). Stimulation lead 1872 is then slidably advanced through the vasculature (e.g., 1832, 1833 in FIG. 15A or 1855 in FIG. 15B) until distal portion 1881 of stimulation lead 1872 is positioned such that stimulation element 1880A (e.g., an exemplary implementation of element 1810A in FIG. 15A) is in a stimulating relationship to a target nerve, such as hypoglossal nerve 505R for stimulation lead 1838 in FIG. 15A. It will be appreciated that the example arrangement 1870 is equally applicable to the stimulation lead 1837 of FIG. 15A and / or the stimulation lead 1867 of FIG. 15B.

[0304] Additionally, in some embodiments, multiple transvascular (e.g., transvenous) stimulation leads and / or multiple branches of such transvascular stimulation leads may be implanted to provide stimulation of multiple stimulation targets in the cervical-related nerve traps and / or other upper airway patency-related tissues.

[0305] 16 is a diagram, including a side view, that schematically illustrates an example arrangement 2000, including an example device and / or example method, for stimulating a portion of the cervical-related nerve trap 316 (FIG. 2) and / or a portion of the hypoglossal nerve 305. In one example embodiment, an example stimulation arrangement 2101 is deployed as further described in connection with at least FIGS. 17-19. In one example implementation, a stimulation arrangement 2401 includes separate stimulation elements 2410, 2420, as further described in connection with at least FIG. 20.

[0306] Figure 17 is a diagram, including a side view, that schematically depicts an example arrangement 2100 that may include one example implementation of the example stimulation element 2101 of Figure 16. In some examples, the example arrangement 2100 of Figure 17 includes a stimulation element 2109 in a stimulating relationship to both the hypoglossal nerve 305 and a portion 317 of the cervical-related nerve trap 316 to implement an example method for treating sleep-disordered breathing, such as through increasing and / or maintaining a patent upper airway. In some examples, the example arrangement 2100 may include at least some of the substantially same features and attributes as, include example implementations of, and / or be usable with, the example arrangements described in connection with at least some of Figures 1-16.

[0307] 17, the stimulation element 2101 shown in FIG. 16 may include a paddle electrode 2109 including an array 2125 of spaced electrodes 2126 disposed on a body 2120. While not shown for clarity of illustration, it will be understood that in some embodiments, the paddle electrode 2109 may be supported on a distal portion of a stimulation lead, or in some embodiments, may form part of a microstimulator that omits a stimulation lead of the type that is connected to an IPG (e.g., 533). With this in mind, a microstimulator that may include one exemplary implementation of the stimulation element 2101 may include at least some of substantially the same features and attributes as the microstimulator 1413A, as described above in connection with at least FIG. 11B.

[0308] With further reference to the paddle electrode 2109, the body 2120 and array 2125 of the electrode 2126 are sized and shaped so that when the paddle electrode 2109 is apposed to a pair of nerves, one or both of the respective nerves may be stimulated as desired. In some such examples, the nerves may include the hypoglossal nerve 305 and a portion 317 of the cervical-related nerve trap 316. In particular, in the exemplary implementation shown in FIG. 17 , the stimulation element 2109 is positioned proximal to the junction 311 ( FIG. 16 ) where the superior root 325 of the cervical-related nerve trap 315 branches off from the proximal portion 307 of the hypoglossal nerve 305. It will be understood that in this context, the term “proximal portion” of the hypoglossal nerve 305 is specific to the junction 311.

[0309] 17, an exemplary method of treating sleep-disordered breathing may include stimulating one or both of the respective hypoglossal nerve 305 and the cervical-related nerve trap 316 to increase and / or maintain upper airway patency. In one aspect, this configuration may include the use of selective steering of stimulation signals to capture specific fiber fascicles (e.g., motor) within each respective nerve fascicle of the nerves 305, 316. At least because, in this particular location, both the hypoglossal nerve 305 and the portion 329A of the cervical-related nerve trap 316 include some non-target fibers (e.g., nerve stimulation of the tongue retractor muscles of the HGN) among the targeted nerve fibers, such as nerve fibers innervating the tongue protrusive muscles (of the HGN) and / or nerve fibers innervating the sternothyroid and / or sternohyoid muscles (of the ACN) (for example).

[0310] In certain stimulation locations of example placement 2000 in FIG. 16 (including example placements 2101 or 2401), stimulation is applied to the main trunk of the hypoglossal nerve 305 and portion 329A of the cervical-associated nerve trap 316. In some examples, this stimulation location may provide sufficient space and anatomy to allow placement of a paddle electrode ( FIG. 17 ) or a cuff electrode ( FIGS. 18-20 ), such as, but not limited to, a single implant access incision adjacent to the hypoglossal nerve 305 (e.g., main trunk). Through such a placement, similar to FIGS. 17 , 18-19 , and / or 20 , a single electrode placement can provide stimulation to both the hypoglossal nerve 305 and the cervical-associated nerve trap 316 (via portion 329A). Furthermore, this stimulation location may allow for the use of larger-sized (e.g., diameter) cuff electrodes or larger paddle electrodes, which are easier to handle and may provide more robust chronic implantation than when such cuff or paddle electrodes are implanted in association with small-diameter nerves.

[0311] FIG. 18 is a diagram including cross-sectional views that schematically depict an example arrangement 2200, including an example device and / or an example method, for providing stimulation to two different types of nerves to increase and / or maintain upper airway patency. In some embodiments, the example arrangement 2200 includes one example implementation of the example arrangement 2101 of FIG. 16 to provide stimulation to one or both of the hypoglossal nerve 305 and the cervical-related nerve trap 316 (FIG. 16). As shown in FIG. 18 , in some embodiments, the example arrangement 2200 may include a cuff electrode 2230 including a cylindrically shaped body 2231 defining a lumen 2233 to at least partially surround or encircle the respective nerves 305, 316. As shown in FIG. 18 , the body 2231 may include a slit or reclosable opening 2235, which allows for positioning of the cuff electrode 2230 around the nerves 305, 315 and reclosing the wall of the body 2231 around the nerves. Although not shown for illustrative simplicity, in some embodiments, the cuff electrode 2230 may include overlapping flange members to enhance releasable fixation of the cuff electrode around the nerves 305, 316. Additionally, in some embodiments, the cuff electrode 2230 includes an array of circumferentially spaced electrodes 2236 exposed on an inner surface 2237 in a stimulating relationship to the respective nerves 305, 316. Through various combinations of electrodes 2236 and selectable parameters of the stimulation signals (e.g., amplitude, pulse width, current, frequency, duty cycle, activation sequence, etc.), various fiber bundles 309 within the hypoglossal nerve 305 and / or various fiber bundles 313 within the cervical-associated nerve bundle 316 may be targeted to effect desired stimulation of at least motor fibers to increase and / or maintain upper airway patency. In some such embodiments, the various nerves 305, 316 (and their various fiber bundles) may be stimulated according to at least some of the stimulation patterns described in connection with at least FIGS. 33A-37D .

[0312] Figure 19 is a side view schematic representation of the cuff electrode 2230 of Figure 18 further illustrating various features and attributes of the cuff electrode 2230. For example, Figure 19 shows one example configuration of the electrodes 2236 when arranged in an array in which the electrodes 2236 extend in an axially spaced manner along the length of the body 2231 of the cuff electrode 2230 and in a circumferentially spaced manner around the inner surface 2237 (Figure 18) of the body 2231 of the cuff electrode 2230.

[0313] FIG. 20 is a cross-sectional view that schematically illustrates an example arrangement 2413 that includes one example implementation of example arrangement 2401 of FIG. 16. As shown in FIG. 20, in some embodiments, example arrangement 2413 may include a first cuff electrode 2411 that may include one example implementation of stimulation element 2410 of FIG. 16 and a second cuff electrode 2421 that may include one example implementation of stimulation element 2420 of FIG. 16. As shown in FIG. 20, each cuff electrode 2411, 2421 includes at least some of the same features and attributes as cuff electrode 2230 of FIG. 18, except that each cuff electrode 2411, 2421 is sized to at least partially surround one nerve, such as nerves 305, 316, instead of two nerves, as in FIG. 18. Accordingly, the features of cuff electrodes 2411, 2421 are identified via reference elements, as in FIG. 18.

[0314] Through this exemplary arrangement 2411, stimulation of each nerve 305, 316 is applied in a parallel arrangement via separate cuff electrodes 2411, 2421, which may simplify at least some aspects of selectively stimulating specific fiber bundles within each nerve 305, 316 associated with controlling upper airway patency and related physiological functions.

[0315] In some example implementations, cuff electrodes 2230, 2411, and / or 2421 may include at least some of the substantially same features and attributes as described in Bonde et al., "Self-Expanding Electrode Cuff," issued January 5, 2016 as U.S. Patent 9,227,053; Bonde et al., "Self-Expanding Electrode Cuff," issued December 25, 2012 as U.S. Patent 8,340,785; Johnson et al., "Nerve Cuff," issued January 13, 2015 as U.S. Patent 8,934,992; and Rondoni et al., "Cuff Electrode," published February 14, 2019 as WO2019 / 032890 and subsequently published July 23, 2020 as US2020 / 0230412, all of which are incorporated herein by reference in their entireties.

[0316] In some embodiments, the cuff electrodes of Figures 18-20 may be used in other exemplary configurations of the present disclosure and are not limited to use only in the anatomical and physiological contexts presented in connection with Figures 18-20. Thus, in any embodiment of the present disclosure calling for a stimulation element in which a cuff electrode may be a suitable exemplary implementation, such stimulation element may include one of the cuff electrodes of Figures 18-20 or Figures 26A-26B described below.

[0317] In some examples, the stimulation location for the example stimulation electrode arrangements 2101, 2401 of Figure 16 may correspond to at least stimulation location "A" in the example arrangement described below in connection with Figure 32C. Stimulation at location "A" may be performed, in some examples, via an intravascular approach (e.g., intravenous) through the internal jugular vein 4250.

[0318] 21 is a side view diagram that schematically illustrates an example arrangement 2700 including a stimulation element 513A and a passive receiver 2725 that receives and provides power and control signals to the stimulation element 513A. In this arrangement, the stimulation element 513A is a standalone element without a stimulation lead (connected to the IPG 533) and is positioned in a stimulating relationship to the cervical-related nerve trap 316. However, in other respects, the stimulation element 513A may include at least some of the substantially same features and attributes as the stimulation elements (and associated arrangements) described in connection with the various example stimulation elements described throughout this disclosure. Furthermore, it will be further understood that the same example arrangement may be implemented for the hypoglossal nerve 505R in addition to, or instead of, being implemented for the cervical-related nerve trap 316.

[0319] 21 , the passive receiver 2725 may be connected to the stimulation element 513A (e.g., via wire 2727) and positioned adjacent an external surface 2732 of the patient's body, such as in the head and neck region 520. In some such examples, the example arrangement 2700 may include an externally located power control element 2735 to provide power and / or control signals to the stimulation element 513A via wireless communication with the passive receiver 2725. In some examples, the power control element 2735, whether embodied as a sensing element or not, may receive sensed data from the stimulation element 513A via the passive receiver 2725.

[0320] 22A includes a side view that schematically depicts an example arrangement 2900 including a stimulation element 513A in a stimulating relationship to a cervical-related nerve trap 316 (e.g., at the superior root 325) and a supporting stimulation lead 2917 fixed relative to a non-neural structure 2929 (e.g., tissue). In some embodiments, the stimulation element 513A and / or the stimulation lead 2917 may include at least some of substantially the same features and attributes as the stimulation element (and associated arrangements) described in connection with the various embodiments described in connection with at least FIGS. 1-21.

[0321] It will be understood that the particular location of the stimulation element 513A in FIG. 22A is merely representative of the many different locations in the neck-related nerve trap 316 in which the stimulation element 513A may be positioned.

[0322] 22A , the stimulation lead 2917 may be formed in a strain relief loop or portion extending between the stimulation element 513A and the anchor element 2927, and includes a distal portion 2919 at which the anchor element 2927 is secured to a non-neural structure 2929 to anchor the stimulation lead 2917. A lead body 2921 of the stimulation lead 2917 extends proximally from the anchor element 2927.

[0323] As further shown in FIG. 22B , box 2950 schematically represents at least some of the non-neural structures 2929 ( FIG. 22A ) to which anchor element 2927 can secure a portion of stimulation lead 2917. In some examples, such non-neural structures may include the omohyoid tendon, hyoid bone, clavicle, sternum (including manubrium), trachea, digastric tendon, and / or other non-neural structures. Furthermore, such non-neural structures may be used to secure stimulation leads, port interfaces (e.g., FIGS. 5A, 5B, 7A, etc.), stimulation elements, etc., with respect to upper airway patency-related tissues with respect to the examples of FIGS. 22A , 23 and / or other examples throughout this disclosure.

[0324] 23 is a diagram, including a side view, that schematically depicts an example arrangement 3100 that includes at least some of the substantially same features and attributes as the example arrangement 2900 of FIGS. 22A-22B, except that the distal portion of the stimulation lead 3117 includes a pre-formed strain relief segment 3119 between the anchor element 2927 and the stimulation element 513A. The pre-formed strain relief segment 3119, shown within dashed lines, may include any flexible, resilient shape (e.g., sigmoidal, etc.) that helps to relieve strain on the stimulation element 513A at its fixed position relative to the stimulated nerve or muscle, such as strain that occurs during neck movement and / or other body movements.

[0325] It will be understood that the fixation arrangements (e.g., anchor elements, non-neural structures, strain relief segments, etc.) described in connection with at least Figures 22A-23 may be implemented in various forms using any of the stimulation elements, stimulation leads, port interfaces, sensing leads, etc., as described throughout the various embodiments of the present disclosure.

[0326] 24A-26B provide a series of illustrations of various exemplary stimulation elements. In some examples, the various stimulation elements depicted in FIGS. 24-26B may include at least some of the substantially same features and attributes that may be exemplary implementations of, and / or be consistent with, the stimulation elements (and related arrangements) described in connection with the various stimulation elements described throughout this disclosure.

[0327] 24A is a top plan view that schematically illustrates an exemplary stimulation element 3200. As shown in FIG. 24A, the exemplary stimulation element 3200 includes a paddle electrode 3210 that includes a paddle-style body 3212 on which a linear array 3214 of electrodes 3216 is located. In some embodiments, the array 3214 may include a two-dimensional array of electrodes 3216. The paddle electrode 3210 is supported by and extends from a distal portion 3220 of a stimulation lead 3222.

[0328] 24B, the paddle electrode 3210 may be positioned to be in a stimulating relationship to a nerve 3228, such as the hypoglossal nerve (e.g., 505R) or the cervical-related nerve fascicle (e.g., 513R), or other nerve associated with increasing and / or maintaining a patent upper airway. The paddle electrode 3210 may be secured in press contact with the nerve 3228, or secured in close proximity to but spaced from the nerve 3228.

[0329] 25A is a side view that schematically depicts an example arrangement 3241 in which stimulation element 3240 is in a stimulating relationship to nerve 3228 (as in FIG. 24B ). In some examples, stimulation element 3240 may include at least some of the substantially same features and attributes as stimulation element 3210, except that electrodes 3216 are arranged in a linear array 3245 of spaced ring electrodes 3246.

[0330] 25B is a side view that schematically depicts an example arrangement 3261 in which a stimulation element 3260 is adapted to be in a stimulating relationship to a nerve (such as nerve 3228 in FIGS. 24B, 25A ). In some examples, the stimulation element 3260 may include at least some of substantially the same features and attributes as the stimulation element 3240 of FIG. 25A , except that the stimulation element 3260 includes a linear array 3265 of spaced-apart split ring electrodes 3266 instead of the ring electrode 3246 of FIG. 25A , and the body 3242 includes a generally cylindrical shape.

[0331] Figure 26A is a side view and Figure 26B is a side view that schematically depicts an example arrangement 3300 including a cuff electrode 3330. In some embodiments, the cuff electrode 3330 of Figures 26A-26B can include at least some of the substantially same features and attributes as the cuff electrode 2230 of Figures 18-19, except that the cuff electrode 3330 includes fewer electrodes as shown in Figures 26A-26B. In particular, the cuff electrode 3330 includes a bottom row of axially spaced electrodes 3336D and a middle row of circumferentially spaced electrodes 3336A, 3336B, 3336D, 3336C. By utilizing various combinations of the respective electrodes 3336A, 3336B, 3336C, 3336D, and variations in the stimulation signal as described above, this electrode configuration can be used to provide selective stimulation and / or stimulation steering of the stimulation signal to different fiber bundles, nerve fibers, etc. within the nerve around which the cuff electrode 3310 is secured.

[0332] 27A-31G are a series of illustrations of various exemplary configurations of stimulation elements, each of which includes some form of anchoring element to provide an exemplary apparatus and / or exemplary method for anchoring the stimulation element within a patient's body relative to non-neural tissue. Through such anchoring, the stimulation element can be secured in a stimulating relationship to a target nerve associated with controlling upper airway patency. In some examples, the various stimulation elements described in FIGS. 27A-31G can include at least some of the substantially same features and attributes that may be exemplary implementations of, and / or be consistent with, the stimulation elements (and associated configurations) described in association with the various stimulation elements described throughout this disclosure. Furthermore, the various anchoring elements described in association with FIGS. 27A-31G can be used with at least some of the various previously described (and later described) exemplary stimulation elements, depending on the context in which they are implanted.

[0333] 27A is a top plan view that schematically illustrates an example arrangement 3600 including a paddle electrode 3610 supported on a distal portion 3220 of a stimulation lead 3222. The paddle electrode 3610 includes an array 3614 of electrodes 3616 disposed on a body 3612, with a proximal portion 3619 connected to the stimulation lead 3222. The distal portion 3618 of the paddle electrode 3610 supports an anchoring element 3630 that includes a pair of curved, pointed fingers 3632, 3633 that diverge from each other and outward relative to a side 3611 of the body 3612 of the paddle electrode 3610. In some embodiments, the curved fingers 3632, 3633 are formed from a resilient and flexible material. As shown in FIG. 27A, the curved, pointed fingers 3632, 3633 are configured to engage non-neural tissue adjacent to the location where the paddle electrode 3610 is positioned in a stimulating relationship to the nerve (shown in dashed lines), thereby securing the paddle electrode 3610 in the desired treatment position.

[0334] 27B , in some example arrangements 3650, an introducer needle 3660 (or guide catheter) defining an internal lumen 3662 is provided to facilitate advancement and positioning of a paddle electrode 3610 having curved fingers 3632, 3633. The lumen 3662 of the introducer needle 3660 can maintain the curved fingers 3632, 3633 in a folded position against the sides 3611 of the paddle electrode 3610 until the paddle electrode 3610 is in a desired location. The introducer needle 3660 is then slidably withdrawn, allowing the curved fingers 3632, 3633 to expand outwardly to the deployed position and configuration shown in FIG. 27A , whereby the fingers 3632, 3633 engage surrounding non-neural tissue.

[0335] As shown in FIG. 27B, the introducer needle 3660 can include a wall 3663 defining a lumen 3662 through which the paddle electrode 3610 can be slidably and releasably inserted in the manner previously described.

[0336] FIG. 28 is a top plan view that schematically illustrates an example arrangement 3800 that includes a paddle electrode 3810, such as the paddle electrode 3610 of FIG. 27A , except that it omits the fingers 3633, 3632 and instead includes holes 3840 around the periphery of the body 3812 of the paddle electrode 3810 to promote tissue in-growth and help secure the body 3812 of the paddle electrode 3810 relative to non-neural tissue / structures. However, in some embodiments, the holes 3840 can be used to secure the paddle electrode 3810 via sutures to surrounding non-neural structures / tissues. As shown in FIG. 28 , the paddle electrode 3810 includes a two-dimensional array 3814 of electrodes 3816 and can be attached to a stimulation lead 3222 similar to the arrangement of FIG. 27A .

[0337] 29A is a side view schematic representation of an example stimulation element 3910 including a linear array 3914 of spaced ring electrodes 3916 and an anchoring element including an array 3926 of flexible, resilient tines 3927 extending outward from opposite sides of a body 3911 of the stimulation element 3910. In one embodiment, the stimulation element 3910 includes a distal portion 3918 and an opposing proximal portion 3919 that may be supported via a distal portion 3220 of a stimulation lead 3222, as further shown in FIG. 29B . When deployed at a desired location, the tines 3927 engage non-neural tissue to secure the stimulation element in a stimulating relationship to a target nerve to increase and / or maintain upper airway patency.

[0338] 29B includes a side view that schematically depicts an example arrangement 3950 including the example stimulation element 3910 of FIG. 29A in association with an example introducer needle 3960 (or guide catheter) for delivering the stimulation element 3910 to a target location. In some examples, the introducer needle 3960 includes a wall 3963 that defines a lumen 3962 through which the stimulation element 3910 is slidably inserted such that the tines 3927 fold against the side of the body 3911 of the stimulation element 3910 to prevent engagement with surrounding non-neural tissue during delivery of the stimulation element 3910 to the target neural location. Once the stimulation element 3910 reaches the target neural location, the introducer needle 3960 is slidably withdrawn, releasing the tines 3927 and folding them outward to their deployed position, as shown in FIG. 29A , engaging surrounding non-neural tissue, thereby securing the stimulation element 3910 in a stimulating relationship with the target neural location.

[0339] 29C includes a side view that schematically depicts an example arrangement 3980 in which the introducer needle 3960 includes a window 3982 formed in the wall 3963. In some examples, the window 3982 can allow at least some electrodes 3916 of the stimulation element 3910 to be exposed to a potential target nerve location such that a test stimulation signal can be applied while manipulating the stimulation element 3910 with the tines 3927 in an undeployed position during such a test manipulation. In this manner, the introducer needle 3960 allows selective positioning of the anchor tines 3927 while allowing application of a test stimulation signal through the window 3982.

[0340] It will be further understood that a similar style introducer 3960 including a window 3982 may be used as or with at least some of the other exemplary configurations (e.g., introducer 3660 of FIG. 27B ) in association with stimulation elements of other exemplary configurations of the present disclosure to facilitate application of test stimulation signals in identifying a target nerve location.

[0341] At least the example implementations of Figures 30A-31G relate to delivery tools, anchors, and related elements that may be used as part of an example method of implantation and / or an example device for implantation, therapy, etc. Among other attributes, using a delivery tool as part of an example method of implantation for multi-target therapy may minimize the size of an incision in the patient's skin, tissue, etc., which may minimize the amount of tissue dissection (e.g., on the path to and / or near the intended target stimulation site) while providing access to multiple target stimulation sites. In some examples, at least some of these features may be performed or achieved through a single implant access incision (i.e., in some examples, a single implant access incision within the patient's body), such as, but not limited to, at least some of the aforementioned examples of a single implant access incision. In a related aspect, these features may reduce surgical implantation time.

[0342] 30A is a flow diagram that schematically illustrates an exemplary method 2500 of implantation. In some embodiments, method 2500 may include exemplary implementations of various embodiments of implanting at least some of the stimulation leads in at least some of the embodiments of the present disclosure. For example, at least some aspects of method 2500 may include one exemplary implementation of various embodiments of implanting a stimulation element (e.g., device, lead, stimulation device, stimulation portion, etc.) described in connection with at least FIGS. 3-29C and 30B-32C and / or one exemplary implementation of various embodiments of identifying a target stimulation site in connection with at least FIGS. 51A-51B.

[0343] As shown at 2512 in Figure 30A, method 2500 includes inserting a probe needle into a patient's body in a region where a target stimulation location (e.g., a nerve) is generally located. The probe needle may include at least some conductive elements supported by stimulation control circuitry for applying a test stimulation signal through the probe needle to tissue into which the probe needle is inserted. Through application of the test stimulation signal, as shown at 2514 in Figure 30A, a location at which the stimulation portion of the lead is delivered into the relevant tissue of the patient's body can be determined.

[0344] While applying the test stimulus signal through the probe needle, the clinician can observe a muscle response, such as the response of upper airway-related muscles, to the test stimulus signal. In some examples, the observed response may include contraction of the lingual process (e.g., contraction of the genioglossus muscle, which is innervated by the hypoglossal nerve) and / or contraction of muscles (e.g., sternohyoid, sternothyroid) innervated by the cervical-related nerve trap 316 (e.g., at least FIGS. 2A, 32A, etc.). Thus, to the extent that no muscle response is observed upon application of the test stimulus signal, the user can continue to advance and manipulate the probe needle until an appropriate response is observed.

[0345] It will be appreciated that the probe needle may be inserted into multiple locations and / or carefully manipulated within a given area to determine a desired target stimulation location, with test stimulation signals applied to various locations where the probe needle is manipulated. Additionally, in some examples, the probe needle may include an elongated, flexible needle that can be bent in a desired orientation relative to the relevant anatomy, tissue, etc. to reach the desired target location.

[0346] FIG. 30B is a side view that schematically illustrates an exemplary probe needle 2550, which may include one exemplary implementation of a probe needle used in the exemplary method of FIG. 30A. As shown in FIG. 30B, in some embodiments, the probe needle includes an elongated tubular member 2552 (i.e., a sleeve) that defines a lumen 2556 via a sidewall 2555. The tubular member 2552 may comprise a semi-rigid or flexible, resilient material and extends between a distal end 2554 and a proximal end 2556. In some embodiments, a handle portion 2558 may be formed on or attached to or near the proximal end 2556 of the probe needle 2550 to facilitate handling, maneuverability, etc. of the probe needle 2550.

[0347] In some embodiments, the probe needle 2550 may include at least one stimulation test electrode 2560 for applying a test stimulation signal. In some embodiments, the test electrode 2560 may be spaced proximally from the distal end 2554 of the probe needle 2550 by a distance X1, such that the test electrode 2560 may sometimes be referred to as being set back from the distal tip 2554 of the probe needle 2550. In some such embodiments, the setback distance X1 may generally correspond to the setback distance on the stimulation lead, i.e., the distance between the distal tip of the stimulation lead and the distal end of the electrode array of the stimulation portion on the stimulation lead. In one aspect, the retracted position of the test electrode 2560 on the probe needle 2550 may increase the likelihood that upon full implantation of a stimulation lead based on an implantation method including the use of a probe needle (e.g., 2512, 2514, 2516 in FIG. 30A ; 2550 in FIG. 30B ), all or most of the electrodes of the stimulation electrode array will be positionally coincident with (or proximate to) a target stimulation location identified via the probe needle (e.g., 2550) from or during application of test stimulation signals via the probe needle at various potential stimulation locations. In some such examples, the fortuitous location may sometimes be referred to as the stimulation electrode array being generally centered on or generally co-located with the target stimulation site of the target nerve.

[0348] In some embodiments, the test electrode 2560 of the probe needle 2550 may be positioned at the distal end 2554 of the probe needle 2550, for example, at the distal tip of the probe needle 2550, as shown in FIG. 30B, so as not to retract from the distal end 2554.

[0349] In some examples, in one exemplary implementation of an implantation method, determining the location and manner of insertion and advancement of a probe needle (e.g., 2550) may be performed via visualization methods, including palpation, such as with respect to known observable anatomical landmarks and / or user experience. In some examples, in addition to or instead of such palpation, an exemplary method may include using external image-based monitoring where visualization is provided via ultrasound, fluoroscopy, x-ray, etc. In some examples, one exemplary implementation of visualization and / or other forms for guiding probe needles and other delivery tools, stimulation leads, etc., within a patient's body during an implantation method may include at least some of the substantially same features and attributes as those described in U.S. Patent No. 9,888,864, issued February 13, 2018, entitled "METHOD AND SYSTEM FOR IDENTIFYING A LOCATION FOR NERVE STIMULATION," which is incorporated herein by reference in its entirety.

[0350] In some examples, instead of using a probe needle (e.g., 2512, 2514 of FIG. 30A , 2550 of FIG. 30B ) to identify a target stimulation site along a nerve, some example implementations of method 2500 of FIG. 30A include the use of a stimulation electrode on a stimulation lead to be implanted to provide the role or function of a probe needle, such as, but not limited to, embodiments 2512, 2514 in method 2500 ( FIG. 30A ). In some such examples, application of a test stimulation signal may be applied via a stimulation portion of the stimulation lead while the stimulation lead is within a delivery tool (e.g., a cannula, hollow insertion needle, etc.) and during insertion and advancement of the delivery tool within or near the relevant tissue where the target stimulation location is expected to be identified. In some such examples, instead of using a stimulation electrode on the stimulation lead, there may be a dedicated test electrode on the stimulation lead in addition to the stimulation electrode. In some examples, another alternative to the use of a probe needle may include a delivery tool (e.g., a cannula, hollow insertion needle, etc.) carrying one or more test stimulation electrodes that allows for the application of a test stimulation signal to identify and / or confirm the location of the target stimulation site before the delivery tool (which may complete implantation of the stimulation lead) is withdrawn.

[0351] Once the target location has been identified according to 2512, 2514 of method 2500, method 2500 includes inserting a guidewire into the patient's body and into and through the probe needle already positioned at the target stimulation location, as shown in FIG. 30A at 2516. With the guidewire in place at the desired location at the target stimulation location, the probe needle is withdrawn from the body (over the guidewire).

[0352] With this in mind, Figure 30B provides a schematic illustration of an exemplary guidewire 2570 extending through the lumen 2556 of the probe needle 2550. It will be appreciated that the guidewire 2570 may include an elongated, flexible, resilient element that may, in some examples, include a metallic material, and may include a biocompatible outer coating, or the like.

[0353] As further shown in Figure 30A at 2518, a dilator is advanced over the guidewire to the target stimulation location, and at 2520 a hollow sheath (e.g., an introducer needle, etc.) is advanced over the dilator to the target stimulation location, after which the dilator is removed, leaving the hollow sheath in place at the target stimulation location. At 2522, a stimulation lead (or other type of lead) is inserted into and advanced through the hollow sheath (with or without a guidewire) until the stimulation portion of the lead reaches the target stimulation location.

[0354] In some examples, after the stimulation portion of the lead has been delivered to its location for chronic implantation, the hollow sheath may be removed from the patient's body, which may include peeling or breaking the hollow sheath to release it from the stimulation lead and from its implant location within the patient's body.

[0355] In some examples, removal of the hollow sheath from the stimulation lead may automatically activate any anchoring elements (tines, threads, coils, filaments, etc.) on the stimulation lead that were held in an undeployed state (folded, covered, etc.) within the delivery tool (e.g., hollow sheath, sleeve, etc.) during delivery of the stimulation lead's stimulation element (e.g., electrode array, etc.) to guide it to a target stimulation location, as per method 2500 of FIG. 30A . With this in mind, various exemplary implementations of delivering the stimulation lead while holding the anchoring elements in an undeployed state and then deploying the anchoring elements upon removal of the delivery tool are described in association with at least FIGs. 30B-31G .

[0356] While the details of the exemplary method of implantation may vary depending on the size, length, and shape of the element (e.g., stimulation lead) being implanted, it will be understood that the exemplary method 2500 of FIG. 30A provides one exemplary implementation in which at least some of the exemplary leads, exemplary stimulation devices, etc. of the present disclosure may be implanted, including but not limited to at least some of the example leads, stimulation devices described in connection with at least FIGS. 1-29C, 30C-30W, and / or 31A-32D.

[0357] FIG. 30C includes a front view that schematically depicts an example arrangement 6700 including an example stimulation device 6710 that may be used in an example method of implantation, with or without additional tools. In some examples, the stimulation device 6710 may include at least some of substantially the same features and attributes of at least some of the example arrangements described in connection with at least FIGS. 1-29C and described below in connection with at least FIGS. 30D-32C. As shown in FIG. 30C, the stimulation device 6710 may include a body 6713 extending between a distal end 6719 and a proximal end 6718. In some such examples, the proximal end 6718 may be connected to or extend from a lead body that is connectable to a pulse generator or microstimulator, in a manner similar to various example stimulation portions, leads, etc. of the present disclosure.

[0358] 30C , the stimulation device 6710 includes an array 6714 of electrodes 6716, such as ring electrodes or split ring electrodes, spaced apart from one another axially along a portion of the length of the body 6713 of the device 6710. In some embodiments, the stimulation device 6710 includes an anchor structure 6725, which in some embodiments may include an array of tines (or similar elements) 6727A, 6727B, 6727C, 6729.

[0359] While shown in two-dimensional format in FIG. 30C, it will be understood that multiple tines (e.g., 6727A, etc.) at specific locations along the body 6713 of the stimulation device 6710 may be arranged around the circumference of the body (e.g., cylindrical).

[0360] 30C , tines 6727A and tines 6727B are located distal to array 6714 of electrodes 6716 and are between array 6714 and a distal end 6719 of body 6713 of stimulator 6710, while in some embodiments tines 6727C and 6729 are located proximal to array 6714 of electrodes 716 and are between array 6714 and a proximal end 6718 of body 6713 of stimulator 6710. Each of the respective tines (6727A, 6727B, 6727C, 6729) is connected to (and extends from) a side surface 6711 of body 6713 and extends outward from side surface 6711 at an angle (Ω). 30C , the ends 6728 of the tines 6727A, 6727B, 6727C extend in a first orientation (F) with the ends 6728 pointed posteriorly toward the proximal end 6718 of the body 6713 of the device 6710. In contrast, the tines 6279 extend in an opposite second orientation (arrow S) with the ends 6728 pointed toward the distal end 6719 of the body 6713 of the device 6710. Thus, the tines 6729 have an orientation opposite to the orientation of the tines 6727A, 6727B, 6727C. As described further below, this orientation can promote robust and stable fixation of the stimulation device 6710 within the patient's body via the respective tines 6727A, 6727B, 6727C, 6729 engaging non-neural structures.

[0361] In some embodiments, the tines 6727A, 6727B, 6727C, 6729 are made from a flexible, resilient material and are formed relative to the side 6711 of the body 6713 such that the tines are biased to extend outward (at an angle Ω) from the side 6711 in the manner shown in FIG. 30C. From this outward angle, the tines (e.g., 6727A, 6727B, 6727C, 6729) are foldable (e.g., flexibly bend, fold) toward and / or against the side 6711 of the body 6713 when some external force or structure causes such folding (i.e., bending toward the side 6711), as subsequently shown at least in FIGS. 30E-30G. In some embodiments, at least some of the tines may comprise elongated cylindrical members having a circular or similar cross-sectional shape. Of course, while retaining a generally elongated shape, in some embodiments the tines may include different / other cross-sectional shapes, such as rectangular, triangular, etc.

[0362] In some examples, the stimulator 6710 may be implanted using a variety of different tools for delivery, implantation, etc. With this in mind, Figures 30D-30G schematically illustrate an exemplary method of preparing for and / or performing implantation of the stimulator 6710.

[0363] FIG. 30D includes a side view that schematically depicts an example arrangement 6750 including an example stimulation device 6710 for use with a hollow insertion needle 6760 and a sleeve 6751 as part of a method of implanting the stimulation device 6710. In some examples, the stimulation device 6710 can include at least some of the same features and attributes as the stimulation device 6710 of FIG. 30. As further shown in FIG. 30D , the sleeve 6751 can include a body defined by side walls 6753 that are spaced apart a distance and slidably fit together to temporarily collapse (i.e., bend, fold, flex, etc.) the tines 6729 against the side 6711 of the body 6713 of the stimulation device 6710, as shown in FIG. 30D . In some examples, the sleeve 6751 can include a slit or other feature along its side that allows the sleeve 6751 to be removably attached onto the stimulation device 6710 in the region of the “reverse-oriented” tines 6729, resulting in the collapsed configuration shown in FIG. 30D . In some such embodiments, this removably attaching may include a sliding motion, as represented via the directional arrow at identifier A, to facilitate folding of the tines 6729.

[0364] 30D , in one embodiment, preparation for implanting the stimulation device 6710 begins with inserting the distal end 6719 of the stimulation device 6710 into the proximal end 6764 of a hollow insertion needle 6760, as represented by directional arrow “B,” and further includes slidably inserting the stimulation device 6710 into and within the hollow insertion needle 6760. In some examples, the hollow insertion needle 6760 includes a lumen 6768 defined by a sidewall 6765, the lumen 6768 extending between the proximal end 6764 and the opposing distal end 6762. The needle 6760 may include a bevel portion 6763 at the distal end 6762 to facilitate penetration of the needle 6760 into and through the associated tissue in which the stimulation device 6710 is to be implanted. In at least some embodiments, the relevant tissues may include tissues such as, but not limited to, subcutaneous tissue, including, but not limited to, muscles such as the sternocleidomastoid (SCM), squamosal, omohyoid, sternohyoid, and sternothyroid muscles.

[0365] 30E includes a side view that schematically depicts the example arrangement 6750 of FIGS. 30C, 30D , including the example stimulation device 6710 being fully inserted into the hollow insertion needle 6760, resulting in folding (e.g., bending) of the tines 6727A, 6727B, 6727C relative to (e.g., toward, away from, etc.) the side 6711 of the stimulation device 6710. Additionally, in FIG. 30E , the lumen 6768 of the needle 6710 is sized to slidably receive the sleeve 6751, with the sleeve 6751 already mounted over the tines 6729 of the stimulation device 6710 within the hollow insertion needle 6760. Finally, as represented by directional arrow C in FIG. 30E, the sleeve 6751 can be slidably removed out from the proximal end 6764 of the needle 6760 and off the “reverse-oriented” tines 6729 of the stimulation device 6710, resulting in the configuration shown in FIG. 30F, in which the tines 6729 expand slightly outward to contact the sidewalls 6765 of the needle 6760.

[0366] Thus, in this ready-to-implant configuration, the hollow insertion needle 6760 is inserted into the relevant tissue, as represented via directional arrow D.

[0367] As further shown in FIG. 30G, once the distal end 6719 of the stimulator 6710 is positioned in its desired position relative to the target stimulation site (e.g., in stimulating relationship to the target location along the nerve), the needle 6760 may be slidably removed from the stimulator 6710, as represented by directional arrow E. This action releases the tines 6727A, 6727B (from a collapsed position similar to FIGS. 30E, 30F) to an extended position for engaging surrounding non-neural tissue to secure the stimulator 6710 (including the array 6714 of electrodes 6716) in stimulating relationship to the target nerve or tissue (e.g., muscle). Further proximal sliding movement of the needle 6760 relative to the stimulation device 6710 results in the release of the tines 6727C and the "reverse-oriented" tines 6729, engaging the surrounding tissue such that the stimulation device 6170 is in the configuration shown in FIG. 30C with all of the tines 6727A, 6727B, 6727C, 6729 engaging the surrounding tissue. In one aspect, by including at least one set of "reverse-oriented" tines 6729 axially spaced and juxtaposed relative to the tines 6727A, 6727B, 6727C, the combination of the tines 6727A, 6727B, 6727C and the "reverse-oriented" tines 6729 can act to prevent or minimize "tacking," which can sometimes occur with some implanted medical elements. In some instances, tacking can occur in areas of high motion, such as with medical elements implanted in the cervical region where repeated rotations, tilts, flexions, etc. of the head repeatedly flex the neck in various directions. To the extent that the implanted medical element has tines or other protrusions that engage surrounding non-neural tissue, these repetitive neck movements may result in the implanted medical element moving or migrating from its original implanted position because the tines (or other protrusions) may move or "walk" slightly during or as such repetitive neck movements, thereby resulting in movement of the implanted medical element.

[0368] However, the juxtaposition of the tines 6729 with the tines 6727A, 6727B, 6727C may prevent or minimize such clogging, as such repetitive neck movements would tend to cause potential movement of the stimulation device 6170 in a direction or orientation opposite to that which would otherwise result from the orientation of the tines 6727A, 6727B, 6727C in the presence of the "reverse-oriented" tines 6729.

[0369] FIG. 30H includes a front view that schematically depicts an example arrangement 6771, including an example stimulation device 6770, that may be used in an exemplary method of implantation, with or without additional tools. In some embodiments, the stimulation device 6770 may include at least some of the same features and attributes as the stimulation device 6710 described in connection with FIG. 30, except that all of the tines are positioned proximal to the electrode array 6714 and a few tines (e.g., 6727C) have a first orientation. However, like the stimulation device 6710, the stimulation device 6770 of FIGS. 30H-30J includes at least one set of tines 6729 of an opposing second orientation (i.e., “reverse orientation”) that, when juxtaposed with the first orientation tines 6727C, can prevent or minimize ratchet-type movement of the stimulation device 6770 from its original or intended implant position.

[0370] 30H , in addition to the features common to the stimulator 6710, in some embodiments, the stimulator 6770 does not include tines distal to the electrode array 6714, but rather includes at least one set of tines 6727C in a first orientation adjacent to the electrode array 6714, and at least one set of tines 6729 in an opposing second orientation (i.e., “reverse orientation”) sandwiched between the first orientation tines 6727C and the proximal end 6718 of the stimulator 6770. In embodiments in which the at least one set of first orientation tines 6727C may include multiple sets of tines, the tines may be configured similar to the configuration shown in FIG. 30 , where at least two sets of tines 6727A, 6727B are present but are spaced apart from one another along a portion of the length of the body 6713. Further, in some embodiments, to the extent that no tines are present distal to the electrode array 6714, the distal portion 6722 of the body 6713 may be reduced to the length shown in FIG. 30H compared to such distal portion 6722 having a greater length when tines (e.g., 6727A, 6727B) are present.

[0371] 30C-30G, and with further reference to FIG. 30H, a method of implanting the stimulation device 6770 includes first folding (e.g., bending) the "reverse-orientation" tines 6829 against the sides 6711 of the body 6713 of the stimulation device 6770 to allow the stimulation device 6770 to be loaded into and within a hollow insertion needle 6760. Thus, in some embodiments, an example arrangement 6771 uses a sleeve, such as sleeve 6751 of FIG. 30D, that engages and causes the folding (e.g., bending) of the "reverse-orientation" tines 6729 into the folded configuration. When such a sleeve is slidably removed proximally in a manner similar to that shown in Figures 30E-30F, the configuration of only the stimulation device 6770 within the lumen 6768 of the needle 6760 is shown in Figure 30I, with the "reverse orientation" tines 6729 in a partially collapsed state so as to be restrained by the sidewall 6765 of the hollow insertion needle 6760.

[0372] In the configuration shown in FIG. 30I, the stimulator 6770 is releasably held within a hollow insertion needle 6760, and the needle 6760 is inserted into and through the relevant tissue to deliver the stimulator 6770 (which may include a stimulation portion of a longer lead (illustratively not shown for simplicity)) into a stimulating relationship to a target tissue, such as a target location along a nerve represented by directional arrow D.

[0373] Once the stimulation device 6770 has been delivered and is positioned at a desired location relative to the target tissue, the needle 6760 is slidably withdrawn from the stimulation device 6770, as represented by directional arrow E in FIG. 30J. This action results in the tines 6727C, 6729 releasing from a collapsed state (FIG. 301) to an expanded state (FIG. 30K) so that the tines 6727C, 6729 may engage surrounding non-neural tissue to secure the stimulation device 6770 in a rigid and stable position in stimulating relationship to the target tissue (e.g., a nerve).

[0374] 30J , however, when the hollow insertion needle 6760 is in a position just before the tines 6727C, 6729 are released, in some embodiments, the electrode array 6714 may protrude significantly from the distal end 6762 of the hollow needle 6760 so that further manipulation of the needle 6760 and stimulator 6770 combination can occur while applying test stimulation signals via the electrode array 6714 to further identify or confirm the location of a desired target stimulation site. In one aspect, the absence of tines distal to the electrode array 6714 and between the electrodes 6716 of the array 6714 may facilitate further positioning of the stimulator 6770 (by the support of the needle 6760) without interference from more distal tines (similar to FIGS. 30C, 30D , etc.) relative to the target stimulation location.

[0375] Thus, after further refinement of the identification or confirmation of the target stimulation location, and when the needle 6760 is further slidably removed from the now-implanted stimulator 6770 (and from the relevant portion of the patient's body), the tines 6727C, 6729 of the stimulator 6770 may fully expand to an unconstrained state as shown in FIG. 30H and then engage surrounding non-neural tissue to anchor the stimulator 6770 within the patient's body at the desired stimulation site.

[0376] 30K includes a front view that schematically depicts an example arrangement including an example stimulation device 6790 that may be used in an exemplary method of implantation, with or without additional tools. In some embodiments, the stimulation device 6790 may include at least some of the same features and attributes as the stimulation device 6770 described in connection with at least FIGS. 30H-30J, except that at least one set of first orienting tines 6727C are positioned between the electrodes 6716 of the electrode array 6714, such as interposed between adjacent electrodes 6716. Through this arrangement, the generally more proximal location of the tines 6727C, 6729 relative to the electrode array 6714 (e.g., no distal tines of the electrode array) may allow some maneuverability of the stimulation device 6790 (in a manner similar to that described for the stimulation device 6770) while further identifying and / or confirming the target stimulation site immediately prior to finalizing the chronic implant location. Additionally, similar to the stimulator 6770, the stimulator 6790 of FIG. 30K includes at least one set of opposing, second-orientation (i.e., "reverse-orientation") tines 6729 that, when juxtaposed with the first-orientation tines 6727C, can prevent or minimize ratchet-type movement of the stimulator 6810 from its original or intended implant position as a result of flexion and movement of the neck and upper body. Finally, as noted elsewhere with respect to several other exemplary implementations, interposing some of the tines 6727C between some of the electrodes 6716 of the array 6716 can enhance firm fixation of the electrode array 6714 in proximity to and in stimulating relationship with the target stimulation site.

[0377] FIG. 30L includes a front view that schematically depicts an example arrangement 6800 including an example stimulation device 6810 that may be used in an exemplary method of implantation, with or without additional tools. In some embodiments, the stimulation device 6810 may include at least some of the same features and attributes as the stimulation device 6710 described in connection with FIG. 30C , except that all tines are disposed distal to the electrode array 6714 and fewer tines 6727A having a first orientation. However, like the stimulation device 6710, the stimulation device 6810 of FIGS. 30L-30R includes at least one set of opposing, second-orientation (i.e., “reverse-orientation”) tines 6829 that, when juxtaposed with the first-orientation tines 6727A, may prevent or minimize ratchet-type movement of the stimulation device 6810 from its original or intended implant position. However, in some embodiments, all tines distal to the electrode array 6714 may have the same orientation.

[0378] 30L , in addition to the features common to the stimulator 6710, in some embodiments, the stimulator 6810 may not include tines proximal to the electrode array 6714, but may include at least one set of first orientation tines 6727A adjacent the distal end 6719, and at least one set of opposing second orientation (i.e., “reverse orientation”) tines 6829 sandwiched between the electrode array 6714 and the first orientation tines 6727A. In embodiments in which the at least one set of first orientation tines 6727A may include multiple sets of tines, the tines may be configured similar to the configuration shown in FIG. 30C , where there are at least two sets of tines 6727A, 6727B, but they are spaced apart from each other along a portion of the length of the body 6713.

[0379] As with the stimulation device 6710 of Figures 30C-30G, and with further reference to Figure 30L, a method of implanting the stimulation device 6810 includes first folding (e.g., bending) the "reverse orientation" tines 6829 against the sides 6711 of the body 6713 of the stimulation device 6810 to allow the stimulation device 6810 to be loaded into and within the hollow insertion needle 6760. Thus, in some embodiments, the exemplary arrangement 6800 may include a sleeve 6830 that is removably attached to the body 6713 of the stimulator 6810 near its proximal end 6718 (which may be connected to the lead body or extend distally from the lead body) and then slidably advanced, as represented by directional arrow F, above and along the body 6713 of the stimulator 6810 until the distal end 6831 of the sleeve 6830 engages and causes the "reverse-oriented" tines 6829 to fold (e.g., bend) into a folded configuration within the lumen 6833 of the sleeve 6830, as shown in FIG. 30M.

[0380] With the stimulator 6810 and sleeve 6830 in the configuration shown in FIG. 30M, this combination of elements is slidably inserted via the proximal end 6764 of the hollow insertion needle 6760 into and within the lumen 6768 of the needle 6760, as indicated by directional arrow G ( FIG. 30M), causing folding (e.g., bending, rotation, etc.) of the first orienting tine 6727A against the side 6711 of the body 6713 of the stimulator 6810 and insertion and advancement of the already removably attached sleeve 6830 within the lumen 6768 of the needle 6760. The resulting configuration is shown as example arrangement 6850 in FIG. 30N.

[0381] Thereafter, as represented by directional arrow H in FIG. 30O , the sleeve 6830 is slidably withdrawn proximally from the needle 6760 via the proximal end 6764 of the needle 6760, while the stimulator 6810 is retained within the lumen 6768 of the needle 6810. Among other factors, the releasable engagement of the tines 6727A with the sidewall 6765 of the needle 6760 serves to retain the stimulator 6810 within the lumen 6768 of the needle 6760 during and after slidable removal of the sleeve 6830 from the stimulator 6810 and needle 6760. When the sleeve 6830 is slidably removed proximally just past the tines 6829 in the opposing second orientation (i.e., the "reverse orientation"), the tines 6829 are released to extend slightly outward while still being constrained by the sidewall 6765 of the needle 6760, as shown in FIG. 30O . When the sleeve 6830 is fully withdrawn from the stimulator 6810 and needle 6760, the resulting configuration of only the stimulator 6810 within the lumen 6768 of the needle 6760 is shown in FIG. 30P.

[0382] In the configuration shown in FIG. 30P, the stimulator 6810 is releasably retained within the needle 6760, which is inserted into and through the relevant tissue to deliver the stimulator 6810 (which may include a stimulation portion of a longer lead (not shown for ease of illustration)) into a stimulating relationship to the target tissue, such as a target location along a nerve, as represented by directional arrow I.

[0383] Once the stimulation device 6810 has been delivered and is positioned at a desired location relative to the target tissue, the needle 6760 is slidably withdrawn from the stimulation device 6810, as represented by directional arrow J in FIG. 30Q. This action results in the tines 6727A, 6829 releasing from a collapsed state ( FIG. 30P ) to an expanded state ( FIG. 30Q ) so that the tines 6727A, 6829 may engage surrounding non-neural tissue to secure the stimulation device 6810 in a rigid and stable position in stimulating relationship to the target tissue (e.g., a nerve).

[0384] When the needle 6760 (FIG. 30Q) is further slidably removed from the implanted stimulation device 6810 (and from the relevant portion of the patient's body), the stimulation device 6810 remains chronically implanted (in the configuration shown in FIG. 30R) at the desired stimulation site within the patient's body.

[0385] FIG. 30S is a diagram 6900 including a side view that schematically depicts an example stimulator 6910. In some embodiments, the stimulator 6910 includes at least some of the substantially same features and attributes as the stimulator 6810 described in connection with at least FIGS. 30L-30R, except that the stimulator 6910 includes an anchor structure 6920 instead of the fixed arrangement of tines 6727A, 6829 in the stimulator 6810 of FIGS. 30L-30R. Like the stimulator 6710, 6810 embodiments, the stimulator 6910 may include a distal portion of a stimulation lead body extending proximally from a proximal end 6718 of the stimulator 6910.

[0386] 30S, in some embodiments, the anchor structure 6920 includes multiple anchor elements 6924 protruding from a side 6711 of the body 6713 of the stimulator 6910. In some embodiments, the anchor elements 6924 may be grouped into different arrays 6922A, 6922B, and in some embodiments, the anchor structure 6920 may include a single cluster of elements 6924.

[0387] It will be appreciated that in some embodiments, the element 6924 can extend around the entire periphery (eg, the periphery of the body 6713).

[0388] As shown in FIG. 30S, the anchor structure 6920 is located distal to the electrode array 6716 and is between the electrode array 6714 and the distal end 6719 of the body 6713 of the stimulator 6910.

[0389] In this configuration, the location of the anchor structure 6920 on one end (e.g., the distal end) of the electrode array 6714 can prevent or minimize "lead elongation," i.e., elongation of the lead body 6713 that can potentially be caused by muscle movement when anchor elements (e.g., tines) are present on the opposite end of the electrode array 6714.

[0390] In some examples, the element 6924 may include a filament (e.g., a fine screw) that is flexible and resilient and biased to extend outward from the side 6711 of the body 6713. The filament may be formed of a polymeric material such as, but not limited to, nylon, propylene, silk, polyester, trimethylene carbonate, etc. In some examples, such filament may be resorbable or non-absorbable.

[0391] In some embodiments, each element 6924 may include a diameter (or maximum cross-sectional dimension) of about 0.05 to about 0.40 millimeters. In some embodiments, each element 6924 may include a length of about 0.2 to about 2 millimeters. In some embodiments, each element 6924 may include a length of about 0.5 percent to about 50 percent of the diameter of the lead body 6710 in the region of the electrode array 6714 and / or at the distal end 6719. In some embodiments, the anchor structure 6920 may be embodied as a matrix of heterogeneous elements via filaments having pseudo-random sizes, shapes, orientations, and / or positions that exhibit more variation than a plurality of identical, distinct elements (e.g., 6927 in FIG. 30T) that may be visually discernible. Meanwhile, not all of the various features of the matrix of heterogeneous elements may be readily visually discernible. Among other features, this heterogeneous matrix may enable fixation in both (e.g., opposing) directions (along the length of the stimulation portion / lead) and facilitate deliverability of the lead / lead portion. At least some example implementations of anchor structures 7000, 7100 that include a matrix of heterogeneous elements are described below in connection with at least Figures 30V-30W. In some embodiments, the heterogeneous elements may sometimes be referred to as heterogeneous anchoring elements.

[0392] In some examples, anchor structure 6920 may include multiple clearly defined, distinct elements, at least some of the distinct elements having a size, shape, orientation, and / or position that is different from the size, shape, orientation, and / or position of each of the other distinct elements of anchor structure 6920.

[0393] In some examples, the anchor structure 6920 can enhance some exemplary methods of implantation of the stimulation device, at least because each element 6924 exhibits a low profile relative to the outer diameter of the body 6713 of the stimulation device 6910, such that the stimulation device 6910 (FIGS. 30S-30) can be delivered through a hollow insertion needle 6760 without a sleeve (e.g., 6751 in FIG. 30D, 6830 in FIG. 30O, etc.) or similar element while firmly securing the stimulation device 6910.

[0394] As further shown in the enlarged side view of a single element 6924 in FIG. 30T, in some embodiments, at least some (or all) of the elements 6924 may include protrusions 6927 on their surfaces, which in some embodiments may include barbs, hooks, or other sharp pointed structures. In some embodiments, the protrusions 6927 may be present on only a portion of the element 6924, such as, but not limited to, the distal portion 6929 of the element 6924. However, in some embodiments, the protrusions 6927 may be present on the entire or substantially the entire surface of the element 6924. In still other embodiments, groups of protrusions 6927 may be positioned in spaced-apart clusters that are spaced apart from one another along and around the surface of the element 6924.

[0395] It will be further understood that the protrusions 6927 are not strictly limited to structures having sharp tips or hooks, but may include structures including adhesive surface coatings or rounded edges while being formed as blunt tip members that can firmly engage surrounding non-neural tissue in proximity to the target stimulation site.

[0396] With respect to the exemplary stimulation device 6910 of Figures 30S-30W, it will be understood that in some embodiments, the anchor structures 6920 may be located only proximal to the electrode array 6714, such that similar anchor structures 6920 are not located distal to the electrode array 6714.

[0397] However, in some embodiments, a first anchor structure 6920 may be present distal to the electrode array 6714, as shown in Figures 30O-30Q, and a second anchor structure similar to anchor structure 6920 may be present proximal to the electrode array 6714, such that the stimulation device 6910 resembles the stimulation device 6710 of Figure 30C, at least to the extent that some anchor structures or elements are present on both sides of the electrode array 6714.

[0398] 30U is a diagram, including a side view, that schematically illustrates an example arrangement 6950 of an example device and / or example method of implantation that includes a stimulation device 6910 slidably and removably inserted within a hollow insertion needle 6760. In some examples, the needle 6760 can include at least some of substantially the same features and attributes as the needle 6760 and associated example method, as described above in connection with at least FIGS.

[0399] 30U, upon insertion of the stimulation device 6910 into the lumen 6768 of the hollow insertion needle 6760, the elements 6924 of the anchor structure 6920 at least partially fold against the side 6711 of the stimulation device 6910. In a manner similar to the above-described embodiments, the stimulation device 6910 is conveyed into the hollow insertion needle 6760 until the combination of these elements is ultimately positioned near the target stimulation location. The needle 6760 is then withdrawn (represented by directional arrow Q), placing the stimulation device 6910 in a stimulating relationship with the target stimulation location and allowing the elements 6924 of the anchor structure 6924 to engage surrounding non-neural tissue to firmly secure the stimulation portion (e.g., the electrode array 7614) in the stimulating relationship position.

[0400] 30V is a diagram including an expanded top view that schematically illustrates an example anchor structure 7000 formed on and included as part of an anchor structure, a base 7002. In some embodiments, anchor structure 7000 may include similar example implementations of anchor structure 6920 of FIGS. 30S-30U and may include at least substantially the same features and attributes as anchor structure 6920, particularly with respect to providing a matrix of heterogeneous elements. However, in some embodiments, anchor structure 7000 may have broad applicability acting as an anchor or position-affecting element.

[0401] As shown in Figure 30V, anchor structure 7000 may include an array 7010 of illustrative heterogeneous elements 7012, 7013, 7016, which may form a matrix, network, or the like, which may overlap or otherwise be juxtaposed with one another to generally generate a preferred surface profile of traction. It will be appreciated that in some examples, the various heterogeneous elements of array 7010 may be positioned much closer to one another than shown in Figure 30V, such as to contact, overlap, partially interlock, or interfere with one another to increase the frictional properties (e.g., sliding resistance) of the anchor structure or to decrease the frictional properties (e.g., slideability) of the anchor structure, depending on the type, size, orientation, coating, etc., of the particular arrangement of the elements of array 7010.

[0402] Generally speaking, the various elements of the array 7010 may comprise a flexible, elastic material, however, some elements may be stiffer or softer depending on the goals for slidability or resistance to sliding.

[0403] In some examples, the particular type, spacing, orientation, position, relative flexibility, etc. of the heterogeneous elements of array 7010 can be selected and configured to correspond to a selectable coefficient of kinetic friction that allows a desired bias for controlled slidable movement against tissue within a patient's body and / or against a lumen within a patient's body, and / or to correspond to a selectable coefficient of static friction that allows a desired bias for static positioning against tissue or at a selected location within a lumen.

[0404] In some examples, whether formally expressed as a coefficient of kinetic or static friction, the various disparate elements of array 7010 are selected and shaped according to their shape, position, spacing, orientation relative to one another, relative flexibility, etc. to produce a desired fixation effect while allowing some degree of slidable advancement.

[0405] As shown in FIG. 30V , at least some example shapes (as seen in cross section from a top view) can include elements having shapes such as triangular 7012, circular 7013, rectangular 7016, etc. The elements can have different sizes (e.g., S2) and spacings (e.g., S1) relative to each other or relative to the edge 7031 (e.g., S2) of the base 7002. In some examples, at least some of the elements of the array 7010 can include a hook shape, a J shape, a U shape, etc. In some examples, at least some of such elements, or the juxtaposed pattern of such elements, can promote tissue in-growth and long-term fixation, such as, but not limited to, apertures formed in such elements or by the juxtaposition of some of the respective elements.

[0406] The various elements may be organized into directional patterns, such as rows aligned in a first orientation (K), or a second orientation (L), or other non-orthogonal orientations, which may be used to implement selectable biases to permit or prevent slidable movement in various directions, which may enhance the positioning and / or fixation of the medical element in which the anchor structures 7000 are located.

[0407] In some examples, at least some elements of array 7010 can be arranged along perimeter 7030 of base 7002 in rows or other organizational patterns. Elements 7034 can have the same size, shape, location, etc., or can differ from one another in size, shape, location, etc. By providing this configuration along one or more edges 7031 of base 7002, anchor structures 7010 can affect slidability or sliding resistance in a particular direction. In related aspects, the presence or absence of elements of array 7010 in interior portion 7040 can provide a similar effect, with or without edge-type rows of such elements, etc.

[0408] In some examples, surface 7040 of base 7002 and / or elements of array 7010 may include a coating having desired lubricity and / or frictional properties that may be selected to act synergistically with various shapes, sizes, positions, spacing, orientations, etc. of elements of array 7010.

[0409] 30W is a diagram, including an enlarged side view, that schematically illustrates an example anchor structure 7100 formed on and included as part of an anchor structure on a base 7002. In some embodiments, anchor structure 7100 may include similar example implementations to anchor structure 6920 of FIGS. 30S-30U and may include at least substantially the same features and attributes as anchor structure 6920, particularly with respect to providing a matrix or network of heterogeneous elements. However, in some embodiments, anchor structure 7100 may have broad applicability acting as an anchor or position-affecting element.

[0410] In some embodiments, anchor structure 7100 of FIG. 30W can include at least some of the substantially same features and attributes as anchor structure 7000 of FIG. 30V.

[0411] 30V, the array 7110 of elements includes different shapes, sizes, positions, spacing, orientations, etc. For example, rectangular elements 7130A, 7130B, 7130C, 7130D exhibit different angular orientations (e.g., relative to the horizontal plane in which base 7002 extends), which may sometimes be referred to as bidirectional or multidirectional. Other elements may include spherical elements 7120A, 7120B, pyramidal elements 7122, etc. Each element of array 7110 may be formed according to a selectable height (per height arrow H) that may vary from one another as part of the desired effect of promoting slidability or sliding resistance, depending on the intended use of the anchor structure and the medical element being formed / attached. It will be further appreciated that some shapes, such as spherical elements 7120A, 7120B, are likely to enhance sliding due to their smooth convex surfaces, while some shapes, such as pyramidal elements 7122 or rectangular elements (7130A-7130D), may enhance sliding resistance depending on their orientation. In some examples, directional arrow S4 may represent the relative horizontal spacing between elements of array 7010.

[0412] In some examples, the base 7002 may be formed in a two-dimensional plate shape so that the anchor structures 7000 or 7100 can be easily formed or attached to a rear surface of the carrier opposite an electrode side of a stimulation portion, such as a paddle electrode. However, in some examples, the base may include a cylindrical shape so that the elements of the array 7010 (FIG. 30V) and / or array 7110 (FIG. 30W) may extend circumferentially outward from a cylindrically shaped lead on which the array 7010 or 7110 is formed or attached.

[0413] 31A includes a side view that schematically depicts an example arrangement 8600 including a stimulation element 6710 including a linear array 6714 of spaced apart electrodes 6716 (e.g., ring electrodes, split ring electrodes, or other electrodes). The stimulation device 6710 may include a distal end 6719 and an opposing proximal end 6718 supportable on (or extending from) a stimulation lead body 3222. In some embodiments, the example arrangement 8600 (including the stimulation element 6710) includes at least some of substantially the same features and attributes as at least some of the stimulation devices in embodiments of the present disclosure, as described in connection with at least FIGS. 1-30W.

[0414] Additionally, the example arrangement 8600 includes a spiral or helix shaped anchoring element 8638 that can be used to secure the distal end 6719 of the stimulation device 6710 relative to non-neural tissue, thereby securing the stimulation element in a stimulating relationship relative to the target neural location. In some examples, the anchoring element 8638 can be formed as a flexible, resilient member having its tip 8623 configured to at least partially wrap around a non-neural structure (e.g., tendon) and / or puncture or penetrate the non-neural structure near the target neural location.

[0415] FIG. 31B is a diagram including a side view that schematically depicts an example arrangement 8640 that includes a stimulation device 6710 and includes at least some of substantially the same features and attributes as the example arrangement 8600 of FIG. 31A , except that the example arrangement 8640 further includes a dissolvable capsule 8642. In some examples, the dissolvable capsule 8642 encapsulates the anchoring element 8638 at its target stimulation location before and during delivery of the stimulation device 6710 (e.g., through an implant access incision, via a delivery tool, etc.). In one aspect, the capsule 8642 includes a dissolvable material that dissolves when exposed to fluids and / or temperatures within the patient's body during implantation, within a suitable time frame during which at least the stimulation lead is delivered to the target stimulation location and the capsule 8642 remains intact until a relatively short time thereafter. Through this arrangement, the capsule 8642 can prevent the anchoring element 8638 (including the tip 8623) from engaging tissue before the stimulation portion (e.g., the electrode array 6714) reaches its target stimulation location. However, after the stimulation device 6710 is delivered to the intended location, after a short period of time, the capsule 8642 dissolves, exposing the anchor elements 8638, at which time the clinician can rotate the stimulation device 6710 (represented by directional arrow R1) to rotatably engage the exposed anchor elements 8638 with surrounding non-neural tissue and firmly secure the electrode array 6714 in a stimulating relationship to the target neural stimulation location.

[0416] In some examples, the materials forming dissolvable capsule 8642 may include sugar-based or other materials that dissolve reasonably quickly (but not instantly) within the patient's body when exposed to bodily fluids, body temperature, etc. The particular composition of the materials may be selected to control or influence the period of time before capsule 8642 begins and / or completes dissolution within the patient's body.

[0417] 31C-31D include side views that schematically represent an example arrangement 8660 that includes a stimulation device 6710 and includes at least some of the substantially same features and attributes as the example arrangement 8600 of FIG. 31A, except that the anchor element 8638 is selectively movable from a retracted position shown in FIG. 31C to an extended position shown in FIG. 31D.

[0418] 31C , the stimulator 6710 may include an array 6714 of spaced apart electrodes 6716 and an anchor structure 8662 positioned distally to the electrode array 6714 and defining a distal portion of the stimulator 6710. In some examples, the anchor structure 8662 may include a hollow tubular frame portion 8664 including a sidewall 8665 defining a lumen 8667. The anchor structure 8662 includes an anchor element 8638 (e.g., a helix, a coil, etc.) releasably retained (e.g., temporarily housed) within the lumen 8667 of the tubular frame portion 8664. In this configuration, the stimulator 6710 is adapted for insertion into and within a delivery tool and / or advancement into and between tissues of a patient's body while the anchor elements 8638 prevent engagement with such tissue until at least the stimulation portion of the stimulator 6710 (of the stimulation lead) (e.g., the electrode array 6714) is delivered to its target stimulation location where it will be chronically implanted. Once in its chronic implant location, the anchor elements 8638 are released to extend outwardly from (e.g., protrude relative to) the distal end 8624 of the stimulator 6710 such that the anchor elements 8638 may engage surrounding non-neural tissue, thereby firmly and securely fixing at least the stimulation portion (e.g., the electrode array 6714) in a stimulating relationship with the identified target stimulation location. In some examples, as shown in FIGS. 31C-31D , the anchor element 8638 can be supported by a rod 8669 or other element such that translational movement (as represented by directional arrow F1) and / or rotational movement (as represented by directional arrow R1) of the rod 8669 (or other element) causes extension of the anchor element 8638 to the position shown in FIG. 31D . In some examples, the rod 8669 can extend through and into a lumen in the body 6713 of the stimulation device 6710 (and support lead). In some examples, a mechanism other than the rod 8669 can be used to actuate and / or move the anchor element 8638 from its retracted position ( FIG. 31C ) to its extended position ( FIG. 31D ). In some such examples, the rod 8669 and / or other mechanism can be detachable from the anchor element 8638.

[0419] With the anchor element 8638 in its extended position, the user may rotate (e.g., twist) the body 6713 of the stimulator 6710 (as part of twisting the entire lead supporting the body of the stimulator 6710) to securely engage the anchor element 8638 with surrounding non-neural tissue, as described above, which in turn fixes the electrode array 6714 in a stimulating relationship to the identified target stimulation location of the nerve.

[0420] In some embodiments, the tubular frame portion 8662 may include a length (LA1) that is approximately the same as or slightly longer than the length of the anchor element 8638, such that when the anchor element 8638 is in its retracted position (FIG. 31C), the anchor element 8638 is prevented from engaging surrounding non-neural tissue until the anchor element 8638 is moved to its extended position as described above.

[0421] FIG. 31E is a diagram including a side view that schematically depicts an example arrangement 8670 including an example device and / or example method for implantation of a stimulation device 6710. In some examples, the stimulation device 6710 may include at least some of substantially the same features and attributes as the stimulation device of the example arrangement 8600 of FIG. 31A , except that the stimulation device 6710 includes a helical anchor element 8672 formed on or attached to the body 6713 of the stimulation device 6710 ( FIG. 31E ) instead of the end-mounted anchor element 8638 of FIG. 31A . In some examples, the anchor element 8672 includes a helical thread extending outward from the side 6711 of the body 6713 of the stimulation device 6710, with a gap 8675 extending between successive threads 8674 of the anchor element 8672. In some examples, a maximum distal thread 8676 of the thread 8672 terminates proximal to the electrode array 6714. In some such embodiments, the distal most threads 8676 may terminate proximal to the electrode array 6714, which may in some embodiments further ensure that the electrode array 6714 is robustly maintained in stimulating relationship to the target stimulation location. The threads 8672 are sized and shaped to engage surrounding non-neural tissue when a clinician rotates (e.g., twists) the body 6713 of the stimulator 6710 (and its supporting stimulation lead body) during implantation, as represented by directional arrow R1.

[0422] In a manner similar to that described with respect to at least some of the example tines above, in some embodiments, the electrodes 6716 of the array 6714 may be spaced apart a sufficient distance such that at least some of the threads 8676 may be disposed between adjacent electrodes 6716 of the array 6714. This arrangement may help to further co-locate the fixation force (created by the gripping action of the threads 8676 against surrounding non-neural tissue) with the element (e.g., the electrode 6716) desired to be firmly fixed in a stimulating relationship to the target stimulation location. Although not explicitly shown in FIG. 31E , at least some of the threads 8674 may be located distal to the electrode array 6714, regardless of whether some of the threads 8674 are proximal to the electrode array 6714 and / or interposed between the electrodes 6716 of the electrode array 6714.

[0423] 31F-31G are diagrams, including side views, that schematically depict an example arrangement 8680, including an example device and / or an example method for implantation of a stimulation device 6710. In some examples, the stimulation device 6710 can include at least some of the substantially same features and attributes as the stimulation device of FIG. 31A, except that the end-mounted anchor structure 8682 takes the form of a non-helical structure. FIG. 31F shows the anchor structure 8682 in a folded, first state prior to deployment, and FIG. 31G shows the same anchor structure 8682 in an expanded, second state when deployed within a patient's body proximate a target stimulation location of the electrode array 6714.

[0424] As further shown in FIGS. 31F-31G, in some embodiments, the anchor element structure 8682 may include multiple elements 8684, each of which may include a base portion 8686, an arm 8688, and an extension 8689. The base portion 8686 of each element 8684 is attached to the distal portion 6722 of the stimulation device 6710, and in some embodiments, the base portions 8686 of multiple elements 8684 may be connected together or form a common element. In some embodiments, the arm 8688 may extend in a generally opposite orientation to the base portion 8686, and the extension 8689 may extend at an angle relative to the arm 8688. Generally speaking, the size, shape, and relative orientation of the base portion 8686, arm 8688, and extension 8689 are arranged together such that in the retracted / folded state shown in FIG. 31F, each element 8682 exhibits a compressed volume that can expand to a much larger volume as shown in FIG. 31G. In some examples, each element 8684 may include a shape memory material (e.g., nitinol, etc.) that allows the anchor structure 8682 to remain in its collapsed / reduced volume state ( FIG. 31F ) until the anchor structure 8682 is placed within another tool (e.g., a cannula, hollow sheath, sleeve, etc.) and / or a desired environment (e.g., a desired location within a patient's body) where expansion of the anchor structure 8682 to its expanded volume ( FIG. 31G ) is appropriate. In particular, once within the patient's body, the shape memory material responds to elevated temperatures and transitions from the collapsed state ( FIG. 31F ) to the expanded state ( FIG. 31G ).However, using a delivery tool, such as (but not limited to) at least some of the exemplary delivery tools in various examples of the present disclosure, the anchor structure 8682 may be prevented from fully expanding by the walls (or other elements) of the delivery tool until the delivery tool reaches the desired location within the patient's body and the delivery tool is withdrawn, thereby allowing the elements 8684 of the anchor structure 8682 (together) to fully expand through a slight divergence of the base portion 8686, and deploying the arms 8688 relative to the base portion 8686 and the extensions 8689 relative to the arms 8688 due to automatic, natural activation of the shape memory features of each element 8684 of the anchor structure 8682.

[0425] In other embodiments, in its expanded state (FIG. 31G), the arm 8688 and extension 8689 of each element 8684 have a second orientation (i.e., a posterior orientation) that is opposite to the first orientation (i.e., an anterior orientation) of the base portion 8686, such that the arm / extension 8688 / 8689 effectively forms a hook or catch that can further facilitate secure fixation of the stimulation device 6710 to surrounding non-neural tissue.

[0426] It will be understood that the shape, size, number, etc. of the elements 8684 of the anchor structure 8682 can take a wide variety of forms, and that the particular arrangement of the base portion 8686, arms 8688, and extensions 8689 of the elements 8684 shown in Figures 31F-31G is merely one exemplary implementation.

[0427] Among other aspects, the use of shape memory material to form the element 8684 may enable the anchor structure 8682 to achieve a significantly smaller collapsed volume and a significantly larger expanded volume than could be achieved in the absence of the shape memory material, which facilitates both delivery and deployment of the anchor structure 8682. As shown in FIG. 31G, in its fully expanded state, the anchor structure 8682 may extend significantly further outward from the side 6711 of the stimulator 6710 than could be achieved through at least some other anchors present on the body of the stimulator, which may enhance robust fixation of the electrode array 6714 in a stimulating relationship to the target stimulation location.

[0428] However, in some embodiments, the anchor structure 8682 may be formed of a material other than a shape memory material and relied upon to hold the expandable anchor structure 8682 in a primarily collapsed state within the delivery tool until the stimulation device 6710 is in a suitable position for deployment to a fully expanded state within and relative to the surrounding non-neural tissue of the anchor structure 8682.

[0429] With respect to various exemplary arrangements (e.g., devices, methods, etc.) throughout this disclosure that may include implanting multiple leads, such as (but not limited to) bifurcated leads, it will be understood that at least some of the various exemplary anchors (e.g., tines, filaments, elements, etc.) for securing the stimulation leads may be included on each lead of the bifurcated lead. In one aspect, doing so secures each lead independently with respect to the other leads. Among other features, this independent fixation of multiple leads (e.g., bifurcated leads, etc.) may allow relative movement of the leads with respect to one another while maintaining robust fixation of the stimulation portion of each lead at its respective target stimulation location. This arrangement, in turn, may enhance patient comfort.

[0430] It will be understood that the various anchors, delivery tools, elements and associated delivery methods described throughout the various embodiments of the present disclosure with respect to stimulation devices and the like may be used to deliver, implant, etc., sensing leads and / or other types of leads, implantable medical elements of appropriate shapes / sizes, etc.

[0431] 32A is a diagram including a side view that schematically depicts an example arrangement 4000 including an intravascular pathway and / or other access for delivering stimulation elements to a target stimulation location of the cervical-related nerve trap 316 and / or the hypoglossal nerve 305. In some examples, the example arrangement 4000 may include stimulation elements (and associated methods) that include substantially the same features and attributes or at least some of the example implementations of the previously described example arrangements of this disclosure.

[0432] Figure 32A depicts the cervical spine-associated neurites 316 in at least the same general manner as in Figure 2, and further depicts the anterior jugular vein 4031, the thyroid vein 4021 (inferior layer 4025 and superior layer 4023), and the sternohyoid muscle 4060 overlying the sternothyroid muscle 4062 (e.g., anterior to it). It will be understood that in Figure 32A, for simplicity and clarity of illustration, only a portion of the anatomical features identified above are shown.

[0433] 32A , in at least some patients, one or both of the anterior jugular vein 4031 and the inferior thyroid vein 4025 pass near at least a portion of a portion of the sternothyroid branch (e.g., 342) of the cervical nerve trap 319. Thus, via an exemplary device and / or exemplary method, a stimulation element may be delivered intravascularly via one or both of such veins 4031, 4025 in transvascular stimulation relationship to a portion of the cervical-related nerve trap 316 to increase and / or maintain upper airway patency by causing contraction of the sternothyroid muscle 4062 and / or the sternohyoid muscle 4060.

[0434] 32A , the superior thyroid vein 4023 may pass near the superior root 325 or other portions of the cervical-related nerve trap 316. Thus, in an exemplary device and / or exemplary method, a stimulation element may be delivered intravascularly via the superior thyroid vein 4023 to be positioned adjacent to and in transvascular stimulatory relationship to the superior root 325 of the cervical-related nerve trap 316 to increase and / or maintain a patent upper airway by causing contraction of at least some muscles (e.g., sternothyroid, sternohyoid) that are innervated by the superior root 4023 of the cervical-related nerve trap 316. As previously mentioned, contraction of such muscles may cause downward movement of the larynx, which may increase and / or maintain a patent upper airway and thereby prevent or ameliorate sleep-disordered breathing, such as obstructive sleep apnea, among other effects.

[0435] In some examples, such intravascular delivery (for transvenous stimulation) via the anterior jugular vein 4031 and / or the thyroid vein 4021 may be implemented via at least some of the substantially same features and attributes of the stimulation elements of the embodiments described above, at least in connection with Figures 1-31 , and particularly with respect to at least some of the substantially same features and attributes of the intravascular delivery embodiments, at least in connection with Figures 15A-15C . For example, one or both of stimulation elements 1810A, 1813A may be provided for intravascular delivery and transvenous stimulation via veins 4031, 4021 in the example arrangement 4000 of Figure 32A . Furthermore, multiple transvascular (e.g., transvenous) stimulation leads and / or multiple branches of such transvascular stimulation leads may be implanted to provide stimulation of multiple stimulation targets in the neck-related neural traps and / or other upper airway-related tissues.

[0436] In some examples, other portions of the vasculature may be used to deliver stimulation elements intravascularly in a stimulating relationship to target nerve locations, including, but not limited to, the cervical-related nerve traps 316 and / or other upper airway patency-related tissues.

[0437] 32B is a view similar to FIG. 32A , except that it further schematically depicts an example arrangement 4100 in which at least two microstimulators 4113A, 4113B are implanted within the head and neck region 520 (e.g., FIG. 11A ). In some examples, the example arrangement 4100 may include stimulation elements (and associated methods) that include at least some of the substantially same features and attributes and / or include example implementations of the previously described example arrangements of this disclosure.

[0438] As shown in FIG. 32B , a first microstimulator 4113A is delivered within and through the vasculature (i.e., intravascularly) so as to be adjacent to and in a transvascular stimulating relationship to the target nerve. In the example shown in FIG. 32B , the blood vessel includes the superior thyroid vein 4023, and the target nerve includes the superior root 325 of the cervical-related nerve trap 316. However, it will be understood that this depiction is merely representative, and the microstimulator 4113A may be delivered intravascularly within and through other blood vessels, such as, but not limited to, the anterior jugular vein 4031, the external jugular vein, and / or other blood vessels (e.g., superior laryngeal vein). With this in mind, the microstimulator 4113A may be positioned in a transvascular (e.g., transvenous) stimulating relationship to nerve branches of the cervical-related nerve trap 316 other than the superior root 325.

[0439] Meanwhile, as further shown in FIG. 32B , a second microstimulator 4113B is implanted subcutaneously (or percutaneously) in stimulating relationship to a target nerve location and is secured in place relative to non-neural tissue 2929 via anchoring element 2927. In the example shown in FIG. 32B , the second microstimulator 4113B is positioned in stimulating relationship to nerve branches 342A, 342B (of the cervical-related nerve trap 316) associated with at least the sternothyroid and sternohyoid muscles. However, it will be understood that this depiction is merely representative, and that the microstimulator 4113B may be implanted relative to other nerve branches, roots, etc. of the cervical-related nerve trap 316. With this in mind, the microstimulator 4113A may be positioned in stimulating relationship to nerve branches of the cervical-related nerve trap 316 other than branches 342A, 342B.

[0440] Additionally, in some embodiments, the microstimulator 4113B can be anchored relative to non-neural tissue 2929 and relative to its target nerve location via at least some of the anchor elements generally described in connection with at least Figures 6A-6B, 22A-22B, and / or 27A-31. As further shown in Figure 32B, depending on the particular nerve branch to be stimulated, the anchor elements 2927 can include at least one anchor element (or similar element) identified in legend 2950 "Anchor Location" in Figure 32B.

[0441] Via the exemplary arrangement 4100, multiple different neural locations of the cervical-related neural trap 316 may be coordinately stimulated to more fully utilize physiological processes associated with a particular goal, such as increasing and / or maintaining upper airway patency. In some such embodiments, and as mentioned in connection with other embodiments of the present disclosure, the respective microstimulators 4113A, 4113B may communicate (e.g., wirelessly) with each other and / or with a third device, implanted or external, to facilitate control, therapy, etc.

[0442] Of course, depending on the particular patient's anatomy or other purposes / goals, only one of several implanted stimulation elements (e.g., microstimulators 4113A, 4113B) may be activated to apply stimulation, sensing, etc.

[0443] In some examples, one or both of the stimulation elements 4113A, 4113B may include cuff electrodes (supported by the IPG 533), paddle electrodes, axial arrays, etc., which may be implanted in place of one or both of the stimulation elements 4113, 4113B that include a microstimulator. Thus, one exemplary arrangement may include a microstimulator 4113A delivered intravascularly and implanted relative to a portion of the cervical-related nerve trap 316 (whether at the superior root 325 or elsewhere), and other stimulation elements 4113B that include something other than a microstimulator.

[0444] As noted elsewhere, it will be further understood that in some embodiments, the general principles associated with exemplary arrangement 4100 (and other example stimulation arrangements of the present disclosure) can be used to implement exemplary arrangements in other regions of a patient's body to treat conditions other than sleep-disordered breathing. For example, arrangement 4100 of stimulation elements (e.g., microstimulators 4113A, 4113B), anchors, etc., can be deployed in the pelvic region to treat other disorders, such as urinary and / or fecal incontinence, or through stimulation of the pudendal nerve, which can cause contractions of the external urethral sphincter and / or external anal sphincter. While not explicitly shown in connection with FIG. 32B , it will be understood that the associated sensing elements described in this disclosure (for sensing physiological data for conditions of interest) can be deployed in connection with various exemplary arrangements for stimulating multiple neural targets. However, other body regions and / or disorders may be suitable candidates for exemplary arrangements (e.g., 4100) that can stimulate multiple neural targets (of a single nerve or entirely different nerves) to treat one type of physiological behavior.

[0445] FIG. 32C includes a front view of patient anatomy 4201 associated with the hypoglossal nerve 305 and cervical-related nerve traps 316, and schematically depicts example placements 4200 of various potential stimulation locations (e.g., at least A, B, C, D, or E of FIG. 2) and exemplary intravascular delivery of stimulation elements for transvascular (e.g., transvenous) stimulation. As shown in FIG. 32C, the associated patient anatomy includes the cervical-related nerve traps 316 associated with the hypoglossal nerve 305 and in relation to the cranial nerves C1, C2, and C3. Due to well-documented differences in patient anatomy (among different patients) with respect to at least the cervical-related nerve traps and / or tasks of graphically depicting such structures and their relationships, the schematic representation of patient anatomy 4201 in FIG. 32C (and FIG. 32D) illustrates some differences relative to the schematic representations of the cervical-related nerve traps 316 in FIGS. 2, 16, 32A, and 32B. Nevertheless, as shown in FIG. 32C, the general locations of exemplary stimulation locations A, B, and C (and D, E in FIG. 2) remain consistent with respect to at least the specific muscle groups innervated by portions of nerve 316 at exemplary stimulation locations A, B, and C, as reproduced in FIGS. 32C-32D (relative to their depictions in FIGS. 2, 16, 32A-32B).

[0446] As shown in FIG. 32C, portion 4229A of cervical-related nerve trap 316 extends anteriorly from first cranial nerve C1, with segment 317 running alongside (e.g., extending concurrently with) hypoglossal nerve 305 (indicated by "305, 317") along its length, until cervical-related nerve trap 3165 branches off from hypoglossal nerve 305 to form the superior root of cervical-related nerve trap 316 (e.g., 325 in FIG. 2A).

[0447] As further shown in FIG. 32C , the patient's anatomy 4201 includes an internal jugular vein 4250, which extends along a superior-inferior orientation and within the context of the cervical-related nerve trap 316 and may include an upper portion 4252 and an opposite lower portion 4254. Approximately parallel to this portion of the internal jugular vein 4250, a common carotid artery 4240 extends superiorly toward a junction 4243, from which the internal carotid artery 4242 and the external carotid artery 4244 branch off from one another. As shown, an exemplary first stimulation location (dashed line A and indicators 305, 317) generally corresponds to target stimulation location A, as previously described in at least FIGS. 2A , 16 , 32A, and 32B. Furthermore, in some embodiments, stimulation at location A may be performed via an exemplary stimulation location 2101, 2401, which (in some embodiments) corresponds to the exemplary stimulation locations of FIGS. 17-20. Various aspects relating to this stimulation location (A, "305, 317") have been previously described in connection with at least Figures 16-20, at least some of which are equally applicable with respect to the example arrangement 4200 of Figure 32.

[0448] Portions 4229B, 4229C of Figure 32C generally correspond to portions 329B, 329C of Figures 2A, 16, 32A, etc.

[0449] 32C , in some embodiments, the exemplary arrangement 4200 may include a stimulation lead 4270 that can be advanced into and through the internal jugular vein 4250 to position a stimulation portion 4213B in stimulating relationship to the hypoglossal nerve 304 and portion 317 of the cervical-related nerve trap 316 at location “A” (“305, 317”). In some embodiments, the stimulation lead 4270, and its delivery, fixation, etc., can include at least some of the substantially same features and attributes as described in connection with at least FIGS. 15A-15C, 25A-25B, 29A-29B, 30A-31G, and / or 30A, 32A-32B. In just one example, stimulation portion 4213B may include a linear array of spaced apart electrodes 4216 (e.g., ring electrodes, split ring electrodes, etc.) sized, shaped, and / or distributed such that stimulation can be selectively applied to each hypoglossal nerve 305 (e.g., main trunk portion) and various fibers, fiber bundles, etc. of portion 317 of cervical-associated nerve trap 316 to treat sleep-disordered breathing (such as at least OSA). As noted elsewhere, applying stimulation at this location A activates at least some nerve fibers of the cervical-associated nerve trap that stimulate the sternothyroid muscle to increase upper airway patency, and at least some nerve fibers of the hypoglossal nerve that stimulate at least the protrusor muscle of the tongue to maintain or increase upper airway patency.

[0450] In some embodiments, the stimulation portion 4213B can be supported on the lead body 4271. While FIG. 32C depicts two stimulation portions (e.g., 4213A, 4213B) on the lead body 4271, it will be understood that in some embodiments, the lead 4270 includes one stimulation portion 4213B for stimulating at location A, or only one stimulation portion for stimulating at location B, as described further below. In some embodiments, the stimulation lead 4271 can include both stimulation portions 4213A, 4213B on the lead 4271, regardless of whether one or both of stimulation locations A and B are stimulated.

[0451] In some examples, prior to chronic intravascular implantation of at least the stimulation portion 4213B, the position of the lead body 4271 and the stimulation portion 4213B may be optimized for desired effective selective stimulation, and / or various combinations of electrodes may be selected to determine which combination of electrodes, stimulation protocols (e.g., timing, sequence, etc.) at portion 317 provides desired effective selective stimulation of the hypoglossal nerve 305 and / or cervical-related nerve trap 316.

[0452] 32C, the exemplary arrangement 4200 may include an embodiment of a second target stimulation location (dashed line "B") along the cervical-related nerve trap 316, similar to that shown in FIGS. 2 and 16. In some embodiments, a cuff or paddle electrode may be implanted at stimulation location B, in accordance with many embodiments in this disclosure that implant such electrodes in a stimulating relationship to the cervical-related nerve trap 316. As shown in FIG. 32C, in some embodiments, a stimulation lead 4270 may be delivered intravascularly in and through the internal jugular vein 4250, as also described above, to position a stimulation portion 4213A proximate to stimulation location B.

[0453] In some examples, if both stimulation portions 4213B and 4213A are provided on lead 4270, then stimulation is provided to stimulation location A only, stimulation location B only, or both stimulation locations A and B. Also, as further described elsewhere, if both stimulation locations A and B can be stimulated, such stimulation can be simultaneous, alternating, staggered, etc., or stimulation of each location can be collapse This may depend on other parameters such as pattern, body position, and whether the hypoglossal nerve is also stimulated.

[0454] In some embodiments, the stimulation lead 4270 may be configured to include only one stimulation portion (either 4213B or 4213A), and such single stimulation portion is positioned within the internal jugular vein 4250 at location B in a stimulating relationship to the associated portion of the cervical-associated nerve trap 316.

[0455] 32C , this portion of the cervical-related nerve trap 316 may include a significant number of motor nerve fibers (e.g., most or all of them) that innervate the sternothyroid muscle, such that delivering stimulation at site B results in a robust response and contraction of the sternothyroid muscle that contributes to a patent upper airway. Thus, in some such examples, non-selective stimulation may be applied to at least the nerve fibers at site B that innervate the sternothyroid muscle.

[0456] 32C, the exemplary configuration 4200 may include an exemplary third target stimulation location (dashed line "C") at portion 324 along the cervical-related nerve trap 316. In some embodiments, a cuff or paddle electrode may be implanted at stimulation location C in accordance with many embodiments in the present disclosure that implant an electrode in a stimulating relationship to the cervical-related nerve trap 316, such as portion 324.

[0457] As further shown in FIG. 32D , the example placement 4300 may include a stimulation lead 4280 that is delivered intravascularly in and through the internal jugular vein 4250 and then delivered in and through the middle thyroid vein 4260, which branches off (at 4251) from the internal jugular vein 425. Via such intravascular delivery, the example placement results in positioning a stimulation portion 4213A of the stimulation lead 4280 along portion 324 of the cervical-related nerve trap 316, adjacent to and in a stimulating relationship to a stimulation location C. As further shown in FIG. 32D , a body portion 4282 of the lead 4280 may extend in and through the internal jugular vein 4250, while a distal portion 4283 of the lead 4280 extends in and through the middle thyroid vein 4260.

[0458] At this stimulation location C, portion 324 of the cervical-related nerve trap 316 may include a significant number of motor nerve fibers (e.g., most or all) that innervate the sternothyroid muscle, such that delivering stimulation at location C results in a robust response and contraction of the sternothyroid muscle that may contribute to a patent upper airway. Thus, in some such examples, non-selective stimulation may be applied to at least the nerve fibers at location C that innervate the sternothyroid muscle.

[0459] In some embodiments, a single / same type of electrode arrangement (e.g., a cuff electrode, etc.) may be implanted at each of stimulation locations A, B, and C, or at each of one or two of such locations. However, in some embodiments, different types of electrode arrangements may be implanted between each of stimulation locations A, B, and C. In one non-limiting example, a cuff electrode may be implanted at location A, while an axial style stimulation portion may be delivered intravascularly to apply stimulation to location B. Other combinations will be apparent.

[0460] 32A-32D (e.g., cuff electrodes, paddle electrodes, axial electrode array, etc.) may be embodied as part of a microstimulator instead of being connected to, supported by, etc., a lead associated with an IPG (e.g., 533). In some such embodiments, the microstimulator may be implanted subcutaneously or intravascularly, such as, but not limited to, the exemplary methods and devices described throughout various embodiments of the present disclosure.

[0461] 33A-37D are a series of diagrams including diagrams that schematically represent various stimulation protocols, including closed-loop and / or open-loop stimulation patterns, that include stimulation of at least the hypoglossal nerve and / or cervical-related nerve trap 316. In some examples, stimulation implemented via the various stimulation protocols may be implemented via at least some of the substantially same features and attributes of the various exemplary stimulation arrangements described above in connection with at least FIGS. 1-32D and / or various subsequently described exemplary arrangements, including sensing, control, etc. Thus, unless otherwise specified, the various exemplary stimulation protocols may be applied to one or both of the respective target nerves. Furthermore, in some examples, for a given nerve (e.g., HGN), one stimulation pattern of the exemplary stimulation protocols (FIGS. 33A-37D) may be switched and applied to another nerve (e.g., ACN), or vice versa.

[0462] FIG. 33A is a diagram 5000 that schematically illustrates an exemplary respiratory waveform 5010 and a series of stimulation protocols 5030, 5050, 5070, each of which includes a stimulation pattern for the hypoglossal nerve (HGN) and the cervical associated nerve (ACN) 316. In particular, FIG. 33A provides an exemplary respiratory waveform 5010 that includes an inspiratory phase 5012 with a sustained INP, an active expiratory phase 5014 with a sustained EA, and an expiratory pause 5016 with a sustained EP. Together, these phases comprise an overall respiratory cycle 5011 having a duration (e.g., respiratory period) of R. This respiratory cycle 5011 is repeated as represented in successive frames A, B, C, D, E, etc. Although the respiratory cycle 5011 shown in each frame A-E of FIG. 33A is shown to be identical, it will be understood that in reality there is variation in the respiratory cycle from breath to breath, and each patient may exhibit some differences in the respiratory waveform from other patients. Additionally, for ease of illustration, the respiratory waveforms shown in FIGS. 33A-37D do not depict interruptions in the respiratory waveform corresponding to sleep-disordered breathing, signal imperfections, and the like.

[0463] As shown in FIG. 33A, an exemplary stimulation protocol 5030 includes an exemplary first stimulation pattern 5031 for stimulating the hypoglossal nerve (HGN) and an exemplary second stimulation pattern 5041 for stimulating the cervical associated nerve (ACN).

[0464] A first stimulation pattern 5031 for stimulating the hypoglossal nerve (HGN) includes a stimulation cycle 5035 including a stimulation period 5032 and a non-stimulation period 5034, where the stimulation cycle 5035 is repeated through successive frames A, B, C, D, E, etc. As shown in the first stimulation cycle 5035, the stimulation pattern 5031 includes a stimulation period 5032 including an N1 amplitude during an inspiratory phase 5012, followed by a non-stimulation period 5034 having zero amplitude during exhalation phases 5014, 5016. In one aspect, this stimulation pattern 5031 may be referred to as being synchronized with the inspiratory phase (5012) of the patient's respiratory cycle (e.g., breathing pattern). In another aspect, this stimulation pattern 5031 may sometimes be referred to as a closed-loop stimulation pattern in that sensed respiratory information (i.e., sensed feedback) is used to time the stimulation period 5032 to coincide with the inspiratory phase (5012) of the patient's respiratory cycle (e.g., breathing pattern).

[0465] 33A, the second stimulation pattern 5041 includes a stimulation cycle 5046 that lasts for two respiratory cycles 5011 (e.g., two frames) and includes a stimulation period 5043 and a non-stimulation period 5045. This stimulation cycle 5046 is repeated through pairs of frames A and B, C and D, etc.

[0466] As shown in the first stimulation cycle 5046, the second stimulation pattern 5041 (for the ACN) includes a stimulation period 5043 including an amplitude of P1 during the inspiratory phase 5012, and a subsequent non-stimulation period 5045 having an amplitude of zero during the expiratory phases 5014, 5016, and the entire subsequent respiratory cycle (e.g., frame B). It is noted that the amplitude P1 for stimulation of the ACN 315 may include a different value than the amplitude N1 for stimulation of the hypoglossal nerve. In one aspect, this stimulation pattern 5046 may sometimes be referred to as being periodically synchronized with the inspiratory phase (5012) of the patient's respiratory cycle (e.g., breathing pattern) when stimulation is applied for a portion of the respiratory cycle (e.g., periodically in frames A, C, E) to the extent that the stimulation coincides with the inspiratory phase 5012 of the patient's respiratory cycle 5011. It may further be observed that when stimulation is applied to the ACN 316 per stimulation pattern 5041, it is applied in synchronization with the stimulation of the hypoglossal nerve.

[0467] Stimulation of the cervical-associated nerve trap (e.g., 316 in FIG. 2 ) according to a second stimulation pattern 5041 supplements stimulation of the hypoglossal nerve (via first stimulation pattern 5031) to increase and / or maintain a patent upper airway, while stimulating the ACN 316 every other breath (i.e., respiratory cycle) prevents or minimizes fatigue of the cervical-associated nerve trap (ACN) 316 and / or associated target muscles. As previously mentioned, for at least some patients, for some patient positions, etc., providing stimulation to the cervical-associated nerve trap 316 (in addition to stimulating the hypoglossal nerve) may be useful in increasing and / or maintaining a patent upper airway, as certain patients may have particular anatomical characteristics, particular comorbidities, etc.

[0468] FIG. 33A depicts an example stimulation protocol 5050 in which a second stimulation pattern 5061 of the ACN 316 is substantially the same as the example stimulation pattern 5041 of protocol 5030, but a first stimulation pattern 5051 of the hypoglossal nerve provides stimulation every other respiratory cycle, illustrated as occurring in frames A, C, E, etc. In one aspect, this stimulation pattern may act to prevent or minimize fatigue of the hypoglossal nerve and / or genioglossus muscle. In some examples, the alternating stimulation periods (for HGN) of pattern 5051 are offset from the stimulation periods (for ACN 316) of pattern 5061. However, in some examples, the alternating HGN stimulation periods (e.g., frames A, C, E) in pattern 5051 may be shifted so that they are applied to coincide with (i.e., synchronize) with the alternating stimulation periods (e.g., frames B, D, etc.) in the stimulation pattern 5061 of the ACN 316.

[0469] FIG. 33A also illustrates an example stimulation protocol 5070 in which a second stimulation pattern 5041 of the ACN 316 is substantially the same as the example stimulation pattern 5041 of protocol 5030, but in a first stimulation pattern 5071 (for the hypoglossal nerve), the amplitude of stimulation varies every other respiratory cycle. As shown in FIG. 33A , in the first stimulation pattern 5071 of the stimulation protocol 5070, the amplitude of the stimulation period 5032 in frames B, D, etc. of the hypoglossal nerve includes N1. Meanwhile, the amplitude of the stimulation period 5072 of the hypoglossal nerve in frames A, C, E, etc. includes N2, which is less than amplitude N1. In some examples, N2 may be substantially less (e.g., 50% less, 25% less, etc.) than amplitude N1. In one aspect, this stimulation pattern may act to prevent or minimize fatigue of the hypoglossal nerve and / or genioglossus muscle.

[0470] 33A , in this example stimulation protocol 5070, respiratory cycles (e.g., frames A, C, E) during which lower amplitude N2 stimulation is applied to the hypoglossal nerve are timed to coincide with stimulation periods 5043 during which stimulation is applied to the cervical-related nerve fascicles. In one embodiment, this arrangement times stimulation of the ACN 316 to complement stimulation of the hypoglossal nerve during lower amplitude HGN stimulation, such that stimulation of the ACN 316 can help increase and / or maintain upper airway patency during such respiratory cycles. Furthermore, this stimulation protocol 5070 provides alternating stimulation periods of the ACN 316 that also help minimize or manage potential fatigue of the ACN 316 and / or associated target muscles. Furthermore, although not shown in FIG. 33A, it will be appreciated that in some embodiments, the amplitude P1 of the stimulation period 5043 for stimulating the ACN 316 may be re...

Claims

1. a first stimulation element positionable in stimulating relationship to a cervical-related nerve trap; a control portion configured to selectively deliver a first stimulation signal via a first stimulation element according to a selectable first stimulation intensity setting based on a disease burden parameter to promote upper airway patency; 1. An apparatus for treating obstructive sleep apnea, comprising:

2. The apparatus of claim 1 , wherein the disease burden parameter comprises a sleep apnea index (AHI) parameter.

3. the device includes a sensing element that senses physiological information corresponding to a disease burden parameter; The control part is increasing the first stimulation intensity setting if the sensed physiological information indicates that the disease burden parameter is equal to or exceeds a selectable threshold; maintaining or decreasing the first stimulation intensity setting if the sensed physiological information indicates that the disease burden parameter is below a selectable threshold; The device of claim 1 , configured to:

4. the device includes a second stimulation element positionable in stimulating relationship to the hypoglossal nerve; 4. The device of claim 3, wherein the control portion is configured to selectively deliver a second stimulation signal via a second stimulation element according to a selectable second stimulation intensity setting based on the disease burden parameter to promote upper airway patency.

5. The control part is increasing the second stimulation intensity setting if the sensed physiological information indicates that the disease burden parameter is equal to or exceeds a selectable threshold; maintaining or decreasing the second stimulation intensity setting if the sensed physiological information indicates that the disease burden parameter is below a selectable threshold; 5. The apparatus of claim 4, wherein the apparatus is configured to:

6. The control part is 5. The device of claim 4, wherein the device is configured to omit selective delivery of at least one of the first stimulation signal or the second stimulation signal when the sensed physiological information indicates that the disease burden parameter is below a selectable threshold.

7. 4. The apparatus of claim 3, wherein the disease burden parameters include upper airway collapse parameters including a collapse site parameter, a collapse type parameter and / or a collapse extent parameter.

8. The device of claim 7 , wherein the collapse type parameter comprises a concentric collapse pattern.

9. 8. The device of claim 7, wherein the degree of collapse parameters include a complete collapse parameter corresponding to at least 75% collapse of the upper airway.

10. 8. The device of claim 7, wherein the device includes a wearable element configured for releasable contact with the patient's neck, the wearable element including a sensing element for performing sensing of physiological information at the neck to at least partially determine the upper airway collapse parameter.

11. 11. The device of claim 10, wherein the sensing element comprises an array of spaced electrodes for measuring impedance indicative of upper airway patency.

12. The device of claim 10 , wherein the sensing of physiological information includes airflow.

13. The device of claim 10 , wherein the sensing element comprises an accelerometer and / or an acoustic sensor.

14. The device of claim 1 , wherein the wearable element includes a stimulation signal generating element associated with a control portion for generating the first stimulation signal and / or the second stimulation signal.

15. The device of claim 14 , wherein the wearable element comprises a power element.

16. 2. The device of claim 1, wherein the control portion is configured to selectively deliver the first stimulation signal based on a patency hysteresis parameter, the patency hysteresis parameter causing at least a portion of a stimulation period of the first stimulation signal to be omitted over one or more respiratory cycles.

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