Multiple implantable medical devices (IMDS) and / or multiple target tissues for sleep disordered breathing (SDB) care

Abstract

A method of treating sleep disordered breathing (SDB) includes selectively operating a first implantable medical device (IMD) in relation to a first target tissue and / or selectively operating a second implantable medical device (IMD) in relation to a second target tissue. A device comprising a first implantable medical device (IMD) arranged in relation to a first target tissue and configured to be selectively operated; and / or a second IMD arranged in relation to a second target tissue and configured to be selectively operation; the device comprising a control portion configured to: selectively operate the first IMD relative to at least one of the first target tissue or the second target tissue; or selectively operate of the second IMD relative to at least one of the first target tissue or the second target tissue.

Description

MULTIPLE IMPLANTABLE MEDICAL DEVICES (IMDs) AND / OR MULTIPLE TARGET TISSUES FOR SLEEP DISORDERED BREATHING (SDB) CAREBackground

[0001] A significant portion of the population suffers from various forms of sleep- related issues, some of which may involve sleep disordered breathing (SDB) and / or other conditions. In some patients, external breathing therapy devices and / or mere surgical interventions may fail to treat the sleep disordered breathing behavior.Brief Description of the Drawings

[0002] FIGS. 1 -2 are diagrams illustrating an example arrangement, including an example method and / or device, for operating implantable medical devices (IMDs) in relation to target tissues.

[0003] FIG. 3 is a block diagram illustrating an example IMD.

[0004] FIG. 4 is a diagram including a front view schematically representing a patient’s body including example implantable components and example external elements of example methods and / or example devices.

[0005] FIG. 5 is a block diagram illustrating an example control portion.

[0006] FIG. 6 is a diagram illustrating example arrangement of IMDs in a neck region.

[0007] FIG. 7 is a block diagram illustrating an example framework for operational relation of multiple IMDs relative to multiple bodily tissues, including various activation and / or sensing modalities.

[0008] FIG. 8 is a diagram illustrating example patient anatomy including infrahyoid- related tissues.

[0009] FIGS. 9, 1 1 -13, 14B-14C are diagrams illustrating example patient anatomy including various target tissues for sensing, activation, and / or fixation.

[0010] FIGS. 10, 14A, and 15 are block diagrams illustrating an example framework like FIG. 7 except regarding different target tissues, as well as different sensing and / or activation modalities.

[0011] FIGS. 14D-14M are diagrams illustrating example arrangements for implanting different combinations of IMDs relative to different combinations of target tissues for activation and / or sensing.

[0012] FIG. 16 is a diagram illustrating an example deployment of an IMD in a neck region.

[0013] FIGS. 17A-17D are diagrams, including side views, illustrating example IMDs for sensing and / or activation.

[0014] FIGS. 18A-18E are block diagrams illustrating example arrangements in which IMDs are in communication with each other and various aspects of implementing activation.

[0015] FIGS. 19A-19D are diagrams illustrating example arrangements in which closed loop activation of an IMD is based on a parameter.

[0016] FIGS. 20A and 22B are diagram illustrating example arrangements (method and / or device) for IMDs to activate target tissues based on sensed information.

[0017] FIGS. 20B and 22A are block diagram illustrating example methods comprising operating IMDs and updating activation and / or sensing settings.

[0018] FIGS. 20C-20D are diagrams illustrating operation of IMDs based on comparison of a disease burden parameter relative to a criteria.

[0019] FIGS. 21 and 23A-23B are diagrams illustrating example arrangements (e.g., example methods and / or devices) in which IMDs operate independently from each other and / or such IMDs communicate with other devices.

[0020] FIG. 22C is a diagram illustrating an example method of activating IMDs implanted in different time frames.

[0021] FIGS. 24A-24B are block diagrams illustrating example methods including various aspects of implementing activation for multiple phase physiologic cycles.

[0022] FIG. 25 is a block diagram illustrating an example arrangement in which IMDs in different body systems operate independently from each other and / or such IMDs communicate with other devices.

[0023] FIGS. 26A-26B are block diagrams illustrating example sensing portions, respectively.

[0024] FIGS. 27A-27D are diagrams including a top view illustrating example upper airway collapse patterns.

[0025] FIG. 27E is a diagram illustrating a side sectional view of example patient anatomy including an upper airway and related tissues.

[0026] FIGS. 27F-27G are diagrams illustrating example patient anatomy including example upper airway collapse patterns and locations.

[0027] FIGS. 28A-28B are block diagrams illustrating example activation portions.

[0028] FIG. 29 is a block diagram illustrating example target selection portion.

[0029] FIGS. 30A-31 D are diagrams illustrating example methods for selecting target tissues.

[0030] FIGS. 32A-32O are diagrams illustrating example sensing protocols and / or stimulating protocols.

[0031] FIGS. 33A-33E are flow diagrams illustrating example methods for sensing and / or applying stimulation.

[0032] FIG. 34A is a diagram illustrating one example method of activating diaphragm-related tissue to modulate a respiratory parameter.

[0033] FIG. 34B is a block diagram illustrating some example respiratory parameters.

[0034] FIG. 34C is a diagram including a graph illustrating example respiratory parameters.

[0035] FIG. 34D is a block diagram illustrating an example stimulation engine.

[0036] FIGS. 35A-35F are diagrams illustrating example breathing patterns and / or stimulation protocols.

[0037] FIGS. 36A-36B are diagrams of example methods, which may be an example implementation of the method of FIG. 34A.

[0038] FIGS. 37A-37C are example timing diagrams illustrating respiratory cycles and example stimulation methods (e.g., protocols) including a series of stimulation cycles.

[0039] FIG. 38A is a block diagram schematically representing an example method based on a ventilation control model.

[0040] FIGS. 38B-38D are block diagrams schematically representing example devices for stimulating a glossopharyngeal nerve and example glossopharyngeal- related tissue.

[0041] FIGS. 39A-39F are diagrams illustrating example upper airway of a patient and target locations for stimulating a glossopharyngeal nerve.

[0042] FIGS. 40A-41 E are diagrams illustrating various aspects associated with example breathing patterns and / or example stimulation protocols in association with an example ventilation control method based on an example ventilation control model.

[0043] FIGS. 42A-42B are block diagrams illustrating example control portions.

[0044] FIG. 42C is a block diagram illustrating an example user interface.

[0045] FIG. 43 is a block diagram illustrating an example arrangement including various devices in communication with a medical device.Detailed Description

[0046] 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 examples may be utilized, and structural or logical changes may be made without departing from the scope of the present disclosure. The following detailed description, therefore, is not to be taken in a limiting sense. It is to be understood that features of the various examples described herein may be combined, in part or whole, with each other, unless specifically noted otherwise.

[0047] At least some examples of the present disclosure are directed to arrangements in which multiple IMDs are in operational relation (e.g., sensing and / or activation therapy) to various target tissues. In some examples, the sensing and activation therapy (e.g., stimulation) may be performed via multiple different IMDs relative to a common target tissue such as the same nerve, same muscle, combination thereof, and / or other types of body tissues in proximity to such nerves, muscles, etc. However, in some examples, the sensing and activation may be implemented on different target tissues, e.g., not the same target tissue, in which each IMD is in operational relation to a different target tissue. In some examples, the IMDs may be in communication with each other and / or in a communication with other devices, which may be external to the patient in some examples. However, in some examples, multiple IMDs may operate independently of each other with some such examples in which at least some of the multiple IMDs do not communicate with each other.

[0048] Via such multiple IMDs, selective operation of the various IMDs may be used among a wide variety of target tissues (e.g., nerves, muscles, other tissues) to treat various conditions. For examples, this highly flexible arrangement may be used to treat sleep disordered breathing (SDB) such as (but not limited to) obstructive sleep apnea. Among other things, such example arrangements enable leveraging favorable aspects of activating tissues and / or sensing tissues in different portions of a body region (e.g., neck) which may not otherwise be reasonably achievable via implantation of a single IMD.

[0049] In some examples, the selective operation of the first IMD may be implemented relative to at least one of the first target tissue or the second target tissue while selective operation of the second IMD may be implemented relative to at least one of the first target tissue or the second target tissue. Moreover, in some examples, in employing multiple IMDs, the method may comprise selectively operating a plurality of implantable medical devices (IMDs), including the first implantable medical device and the second implantable medical device, in relationto a plurality of target tissues, including the first target tissue and / or the second target tissue.

[0050] In some example arrangements, sensing may be implemented via a first IMD at a first tissue, such as in a first location while activation therapy (e.g., electrical stimulation) may be implemented via a second IMD at a second tissue, such as a second location different from the first location. In some examples, the first location is in a same body region as the second location, while in some examples, the first location is in a first body region different from a second body region at which the second location is present. Among other aspects, this arrangement enables an IMD for sensing to be implanted among tissues well suited to achieve highly effective sensing (and / or anchoring, etc.) without being limited by anatomical constraints, goals, etc. of the placement of the IMD used for activation therapy. Similarly, this arrangement enables an IMD for activation therapy to be implanted among tissues well suited to achieve highly effective activation therapy (and anchoring, etc.) without being limited by anatomical constraints, goals, etc. of the placement of the IMD used for sensing. In this way, the anatomical criteria for implementing both sensing and activation therapy via a single non-example IMD (e.g., single implant location) have been decoupled in at least some example of the present disclosure which provide sensing via a first IMD separate from providing activation therapy via a second IMD and therefore are not limited by such narrow anatomical constraints.

[0051] In some such examples, at least some aspects of the activation therapy via the second IMD may be based on the sensing via the first IMD. Accordingly, while this arrangement may comprise two different IMD locations, the overall arrangement may provide more efficacious sensing and more efficacious therapy because each modality (e.g., sensing, activation) was implemented in preferred locations rather than in a single location which might otherwise compromise preferred objectives in sensing and / or activation therapy. In some examples, the two different IMD locations may comprise two different anatomical locations which are spaced apart within a body region (e.g., neck region or portion of neck region) while in some examples, thetwo different IMD locations may comprise a general single anatomical location at which the two different IMDs are located.

[0052] With this in mind, generally speaking at least some IMDs (e.g., those with power sources having a limited life) may place constraints on power expenditures to implement sensing and / or activation therapy in order to ensure a device has an implanted lifetime amenable to the burden associated with device implantation / extraction (which can be dependent on implantation site) and benefit of therapy. Accordingly, some non-example IMDs (e.g., single IMDs) which are to perform biosensing and deliver therapy might make compromises to ensure a suitable device lifetime and therapy efficacy. Some such compromises with nonexample IMDs might involve limiting the frequency with which data from biosensing is analyzed, which therefore may limit which sensing parameters and / or sensing modalities are used, which in turn may forego desirable physiologic information which could be used for more efficacious sensing and / or more efficacious activation therapy.

[0053] In sharp contrast, in at least some examples of the present disclosure, the first IMD and second IMD may avoid at least some of such compromises by separating the sensing and activation therapy to different devices, locations, etc. (in some examples).

[0054] Moreover, when an IMD is to be removed per a surgical revision due to power source depletion or other reasons, re-implantation at a preferred single location for both sensing and therapy may be challenging because of scar tissue and complications with surgical access due to the prior implant. Accordingly, re-acquiring the same implant location(s) to optimize effectiveness of sensing and / or effectiveness of activation therapy may be difficult. At least some examples of the present disclosure may overcome at least some of these challenges, or at least lessen their impact, via provision of a first IMD and a second IMD implanted at different locations to provide sensing and / or activation therapy, whereby impact on each respective location may be lessened at initial implant. Alternatively, in the event that the implantation of the first IMD and second IMD may occur pursuant to asurgical revision of a prior single IMD implant, in some examples of the present disclosure which include separation of the sensing (first IMD) and the activation therapy (second IMD), new implant locations may be used at least because of the sensing and activation therapy being implemented separately from each other, in some examples.

[0055] In view of these challenges, in at least some examples of the present disclosure, implementing sensing and / or activation therapy via the first IMD and second IMD enables greater therapeutic benefit without proportionally increasing the potential burden associated with device implantation / extraction. Moreover, the overall power demand can be better managed at least because each IMD (e.g., first and second IMD) is not responsible for the totality of sensing and / or therapy. Moreover, a broader range of sensing modalities, sensing parameters, activation therapy targets, implant locations, etc. may be implemented.

[0056] These examples, and additional examples, are described below in association with FIGS. 1 -43.

[0057] FIG. 1 is a diagram illustrating an example method 200. As shown at 210 the method may comprise selectively operating a first implantable medical device (IMD) in relation to target tissue within a body region, and / or as shown at 212, may comprise selectively operating a second implantable medical device (IMD) in relation to target tissue within a body region. The operational relation may comprise sensing and / or activation (e.g., stimulation) in relation to a target tissue. In some examples, the target tissue being sensed is the same target tissue being activated, while in some examples, the target tissue being sensed is different from the target tissue being activated. In some examples, the phenomenon being sensed relates directly to the target tissue at which the respective IMD (e.g., first IMD or second IMD) is located, while in some examples, the phenomenon being sensed (e.g., respiration) may involve tissues, bodily functions, etc. including more than the tissues at which a particular sensor is located.

[0058] Moreover, in some examples, the body region in which a target tissue is being sensed is the same body region in which a target tissue is activated, regardless ofwhether the target tissue being sensed is different from, or the same as, the target tissue being activated. On the other hand, in some examples, the body region (e.g., torso) in which a target tissue is being sensed is different from the body region (e.g., neck region) in which a target tissue is activated, where the target tissue being sensed is therefore different from the target tissue being activated.

[0059] Various example implementations of the method 200 are further described below in association with at least FIGS. 2-43.

[0060] FIG. 2 is a diagram illustrating an example arrangement 250 (e.g., an example method and / or device), which may comprise at least some of substantially the same features as, and / or an example implementation of, the example method 200 in FIG. 1 . As shown in FIG. 2, the example arrangement 250 may comprise first IMD 260 and second IMD 262 located within an environment 267 in which sensing (270) may be performed in relation to a first sensing tissue 272 and / or a second sensing tissue 274, and / or in which activation (280) may be performed in relation to a first activation tissue 282 and / or a second activation tissue 284.

[0061] In some examples, each of the first IMD 260 and second IMD 262 may comprise a sensing element (S) 261 A and / or an activation element (A) 261 B.

[0062] The first sensing tissue may be at location L1 while second sensing tissue may be at location L2, first activation tissue at location L3, and second activation tissue at location L4. In some examples, locations L1 and L2 may in be close proximity to each other or comprise the same location, while in some examples, locations L1 and L2 may be separated by a significant distance from each other. Nonetheless, in some examples, locations L1 and L2 may be in the same body region. However, in some examples, locations L1 and L2 may be in different body regions. Similarly, locations L3 and L4 may in be close proximity to each other or comprise the same location, while in some examples, locations L3 and L4 may be separated by a significant distance. Nonetheless, in some examples, locations L1 and L2 may be in the same body region. However, in some examples, locations L1 and L2 may be in different body regions.

[0063] In some examples, at least one of the sensing locations (e.g., L1 and / or L2) may in close proximity to or be the same location as at least one of the activation locations (e.g., L3 and / or L4). Various example implementations regarding the locations are further described below throughout various examples of the present disclosure.

[0064] It will be understood that sensing is not limited to just two different target tissues 272, 274 and / or that activation is not limited to just two different target tissues 282, 284. Moreover, in some examples, sensing may be performed in relation to just one target tissue and / or activation may be implemented relative to just one target tissue.

[0065] In some examples, the environment 267 may comprise a head-and-neck region, a pectoral region, an abdominal region, any other body region, and / or combinations thereof. In some examples, target tissue 272, 274, 282, 284 may be located within, and / or physiologic phenomenon may occur within, at least some of these example regions. In some such examples, within this example environment 267, the example arrangement 250 may comprise treating sleep disordered breathing such as, but not limited to, obstructive sleep apnea, central sleep apnea, multi-type apneas, etc.

[0066] In some examples, the environment 267 may comprise a pelvic region (e.g., 629 in FIG. 4). In some examples, the target tissue 272, 274, 282, 284 may be located within, and / or the physiologic phenomenon may occur within, at least the pelvic region. In some such examples, the example arrangement (e.g., method) may comprise treating pelvic dysfunctions such as, but not limited to, various forms of incontinence (urinary urgency, urinary stress, fecal, and the like) occurring within this example environment 267.

[0067] In some examples, the sensing element(s) 261 A of the respective first and second IMDs 260, 262 may sense (e.g., detect) physiologic phenomenon associated with the environment 267 (e.g., at tissues 272, 274) while the activation element(s) 261 B may activate (e.g., deliver stimulation to) a target tissue (e.g., 282, 284) of, or within, the environment 267. In some examples, the target tissues (e.g., 282, 284)to be activated may comprise a nerve portion(s), a muscle portion(s), a combination of nerve portion(s) and muscle portion(s), a neuromuscular junction of nerve portion(s) and muscle portion(s), and / or combinations thereof.

[0068] In some examples, both the sensing element 261 A and the activation element 261 B of the respective IMDs 260, 262 are implanted within a patient’s body, which forms part of the environment 267.

[0069] However, in some examples, one or both of the sensing element 261 A and the activation element 261 B of one or both of the respective IMDs 260, 262 may be external to the patient’s body, such that the environment 267 comprises at least both internal portions and external portions of the patient’s body. In some such examples, the environment 267 also may comprise an area which does not comprise the patient’s body, but which is in close proximity to the patient’s body.

[0070] In some examples, the sensing element 261 A may comprise any one or more of a wide variety of sensing modalities according to a wide variety of sensing parameters, at least some of which are further described later in association with at least FIGS. 4-7, 26A-26B. Accordingly, among other examples, the sensing element(s) 261 A may comprise an electrode(s) and / or other elements.

[0071] In some examples, the activation element 261 B may comprise an electrode(s) activating at least a portion of target tissue 282, 284. In some examples, the electrode may be used to apply electrical stimulation and / or other ways of activating tissue. In some examples, the activation element 261 B may comprise any one or more of a wide variety of activation modalities according to a wide variety of activation parameters, at least some of which are further described later in association with at least FIGS. 4-7, 28A-28B.

[0072] In some examples, the electrode(s) used for implementing activation (e.g., applying stimulation) also may be used for sensing, and as such also may comprise electrode(s), as further described later. Similarly, the electrode(s) used for sensing also may be used for implementing activation. However, in some examples, the sensing element (e.g., sensing electrodes) are used solely for sensing and theactivation element (e.g., stimulation electrode(s)) are used solely for implementing activation.

[0073] In some examples, the sensing element (e.g., 261 A) does not comprise, or depend on, an electrode(s) for sensing. For example, as further described later in association with at least FIGS. 4-7, 26A-26B such other sensing elements may comprise a pressure sensor (e.g., differential pressure), an accelerometer, an impedance sensor, and / or other sensing elements not comprising electrodes.

[0074] In some examples of sensing (e.g., 272, 274 and / or activation (e.g., 282, 284), the target tissues may comprise nerve portion(s), muscle portion(s), a combination of nerve portion(s) and muscle portion(s), neuromuscular junction(s) of nerve portion(s) and muscle portion(s), and / or combinations thereof. In some examples, the activation signal may comprise sufficient strength (and / or other characteristics) to cause suprathreshold contraction of the target muscle portion such as (but not limited to) via activation (e.g., electrical stimulation) of the hypoglossal nerve resulting in protrusion of the tongue (e.g., genioglossus muscle), activation (e.g., electrical stimulation) of the IHM-innervating nerve (IHMN) resulting in contraction of other upper airway muscles. In some such examples, such activation may maintain and / or increase upper airway patency to treat at least obstructive sleep apnea.

[0075] FIG. 3 is a block diagram illustrating an example medical device (e.g., IMD) comprising at least some of substantially the same features as, and / or an example implementation of, the IMDs 260, 262 described in association with FIGS. 1 -2 and / or 4-43, with medical device 290 comprising sensing and / or activation element 292 (e.g., 261 A and / or 261 B of IMDs 260, 262), power element 294 and / or communication element 296. In some examples, the power element 294 may comprise a non-rechargeable power source (e.g., battery), a re-chargeable power source, a power storage element to receive power wirelessly from an external source, and / or energy harvesting / storage elements. At least some further aspects of power element 294 are described with reference to power portion 674 in FIG. 4. In some examples, the communication element 296 may comprise a wirelesscommunication element (e.g., receiver, antenna, communication circuitry, etc.) to enable wireless communication between medical device 290 and other devices such as (but not limited to) in the manner of communication in example of FIG. 4 (e.g., communication portion 676), FIGS. 42B-43, etc.

[0076] In some examples, such as example arrangements in which the at least two IMDs 260, 262 may operate independently from each other (e.g., FIGS. 21 , 22A), one or both of the first and second IMDs 260, 262 may omit at least portions of the communication element 296 and / or of power element 294 which are configured to transfer power, implement communications (e.g., data, control), etc. between the first IMD 260 and the second IMD 262. In some such examples, such communication element 296 may configured in a manner to be incapable of communication with another communication element within the body (e.g., a second communication element) but capable of communication with yet another communication element outside the body (e.g., a third communication element), or vice versa.

[0077] By such example IMDs including simpler communication elements and / or power elements, each IMD 260, 262 may be constructed in a smaller volume (e.g., smaller footprint), which may ease implantation and / or strategic positioning of the IMD to be in sensing relation and / or activating relation (e.g., electrical stimulation) to a target tissue (and / or to ease anchoring relative to available tissues). In some such examples, the smaller volume and generally simpler circuitry may reduce cost (e.g., materials, design, etc.) while likely increasing reliability. In addition, with less circuitry, the IMDs 260, 262 may use less power, thereby reducing power constraints.

[0078] Among other examples, the later-described examples of at least FIGS. 18A, 18B, 18C, 18D, and / or FIG. 23A provide for communication between multiple IMDs while at least FIGS. 4, 18B, and / or 23B provide for communication between an IMD and an external device.

[0079] In some examples, the communication element 296 may be implemented via various modalities (e.g., forms) of radiofrequency communication and / or other modalities of wireless communication, such as (but not limited to) magnetic induction telemetry, Bluetooth (BT), Bluetooth Low Energy (BLE), near infrared (NIF), near-field protocols, Wi-Fi, Ultra-Wideband (UWB), intrabody communication (IBC), ultrasonic waves (e.g., 1 to 100 MHz), and / or other short range or long range wireless communication protocols suitable for use in communicating between multiple IMDs (or between implanted components of an IMD) and / or for use in communicating between an IMD and external component(s) of a medical device environment. In some such examples, the UWB and IBC modalities may be implemented as part of a wireless body area network (WBAN) in accordance with various protocols / standards such as (but not limited to) IEEE 802.15.4, IEEE 802.15.6.

[0080] With this in mind, selection of a particular communication modality (or modalities) may be based on at least a type(s) of body portion (e.g., tissue(s), fluid(s), organ(s)), volume of body portion, and / or distance, etc. between the respective IMDs and / or between an IMD and external device. In some examples, the type of tissue comprises an epithelial tissue such as (but not limited to) skin, lining of organs, respiratory tract, urinary tract, and / or simple squamous (e.g., blood vessel lining, lymphatic vessels). In some examples, the type of tissue comprises a connective tissue such as (but not limited to) blood, bone, cartilage, adipose, fibrous connective (e.g., tendon, ligaments), and / or loose connective (e.g., areolar, reticular). In some examples, the tissue comprises a muscle tissue such as (but not limited to) skeletal, smooth, and / or cardiac. In some examples, the type comprises a nervous tissue such as (but not limited to) brain, spinal cord, and / or peripheral. Tissue also may comprise membrane(s) of various above-named types of tissues, organs, etc.

[0081] In some examples, communication between multiple IMDs in which the communication path remains within the body may sometimes be referred to wireless intra-body communication, whereas communication between at least two IMDs in which at least a portion of the communication path may occur external of the patient’s body may sometimes be referred to as a partial intra-body wireless communication and / or a partial extra-body wireless communication. For example, a first IMD and second IMD may wireless communicate by implementing an intra-body communication parameter via at least one body portion interposed between the firstIMD and the second IMD which acts as a communication medium for communication signals between the first and second IMDs.

[0082] For wireless communication within the patient’s body, the body portion between the respective IMD’s (or between an IMD and an external device) comprises the communication medium through which a communication signal will be transmitted and / or received. In some such examples, the communication modality may comprise electromagnetic frequency modalities, which may further comprise high electromagnetic frequencies such as microwaves (e.g., 2-9 GHz), millimeter waves (mmwaves, e.g., 30-300 GHz), Terahertz (e.g., 0.1 -10 THz), and optical (e.g., 400-750 THz). In some example, the electromagnetic frequency modality may further comprise low electromagnetic frequencies such as inductive coupling (IC, e.g., DC to 50 MHz), capacitive coupling (CC, e.g., 100 kHz to 120 MHz), and galvanic coupling (GO, e.g., 10 kHz to 10 MHz).

[0083] It will be understood that in some examples, it may be preferable to limit the volume of body portion (e.g., tissue) between respective IMDs (or portions of IMDs) to certain types of body portions (e.g., types of tissues) and / or directionality of such communication to implement quality intra-body communication. In some such examples, the respective IMDs (or portions of the IMDs) may be positioned such that a line-of-sight is established therebetween by which a selected communication modality (e.g., galvanic coupling) may be implemented via a single type of body portion as the predominant communication medium through which the communication between respective IMDs occurs.

[0084] At least some aspects of wireless communication within and / or near the body may comprise at least some of substantially the same features, parameters, etc. as described in Vizziello, Intra-body communications for nervous system applications: Current technologies and future directions, 17 March 2023, Computer Networks 227 (2023) 109718, available at https: / / doi.Org / 10.1016 / j.comnet.2023.109718; and / or Culjak, Wireless Body Sensor Communication Systems Based on UWB and IBC Technologies: State-of-the-Art and Open Challenges, Sensors 2020, 20, 3587; doi.10.3390 / s20123587.

[0085] In some examples, for at least some of the wireless communication methods, time-selective communication may be implemented for one or more reasons.

[0086] In some such examples, the time-selective communication may be implemented for power optimization. Among other reasons, the available power source (e.g., via power element 294 in FIG. 3) may have a peak output power capacity such that performance may be strained if a method and / or device attempted to implement communication simultaneously or generally concurrently with stimulation and / or sensing. Accordingly, some example implementations may comprise implementing time-selective communication via interleaving different functions (e.g., communication, stimulation, sensing, etc.). Moreover, overall battery capacity (e.g., longevity) also may be increased by limiting communications to occur solely at certain times, events, etc.

[0087] In some example methods, wireless communication may be limited to times and / or durations based on the occurrence of certain events (e.g., during, after apnea events), certain sleep-wake states (e.g., being asleep or being awake), and / or other phenomenon.

[0088] In some examples, time-selective communication is implemented via encoding communications as part of stimulation delivery such that communication occurs during a general stimulation time frame and / or during stimulation periods but not during non-stimulation periods. In some examples, the communication may be timed to occur solely during non-stimulation periods of stimulation cycles during delivery of stimulation.

[0089] In some examples, communication is performed solely when robust, strong coupling is present and therefore communication is not performed in situations in which poor coupling exists. For instance, in some of these examples, communication may be performed generally but time-limited for certain body positions of the patient generally and / or during certain positions of portions (e.g., neck) of the patient’s body. In another instance, in some examples, wireless communication may be implemented only during selectable respiratory phases, selectable cardiac phases. For example, if coupling between IMDs is not as effective during certain respiratoryphases due to motion, or due to other reasons (sensing, stimulation, power optimization etc.), communication may be restricted or tied to certain physiologic events (e.g., respiratory motion or cardiac motion).

[0090] In some examples, as previously noted, at least some wireless communication may be implemented via radiofrequency (RF) communication methods at higher frequencies, such as greater than 100 MHz. In some such examples, at least a portion of the communication path may occur external to the patient, e.g., through the ambient environment (i.e., “over-the-air”). In such examples, a communication signal transmitted from a first IMD moves through at least one body portion, exits the body, travels through the air, and then re-enters the body to move through at least one body portion (e.g., tissues) to reach a second IMD.

[0091] In some examples, selecting and implementing a robust, effective wireless communication modality (e.g., intra-body or partially over-the-air) may depend, at least in part, on the types and volumes of tissues between and surrounding the first IMD (e.g., 260, 5260, etc.) and second IMD (e.g., 260, 5260, etc.). For instance, some anatomical body portions (e.g., bone tissue, adipose tissue (i.e. fat) may cause less signal loss than other anatomical body portions (e.g., muscle, blood, fluids, brain, certain organs, etc.), and therefore the less lossy body portions (e.g., bone, adipose (e.g., fat)) may be more favorable for at least some wireless communication modalities (e.g., RF (e.g., over 100 MHz) in some examples). Moreover, some anatomical body portions adjacent the first IMD and / or second IMD may be positioned, sized, and / or shaped to enhance reflectance of a wireless communication signal. Accordingly, some examples comprise selecting a communication path and / or communication modality based on, in part, the type(s) of tissue and their distribution relative to the expected implant location of each respective IMD (e.g., first IMD, second IMD, etc.).

[0092] In one non-limiting example, a communication path may be selected to predominantly include certain tissues (e.g., adipose) to favor robust, effective communication, with the implant location of the first IMD and / or second IMD beingselected to implement the preferred communication path favoring such tissues and / or communication modality which best exploits conduction through such tissues and / or reflectance related to such tissues. For instance, in examples in which adipose tissue is the tissue predominantly acting as a signal conduction medium, the tissues (e.g., skin, muscle) which typically border adipose tissue are generally higher conductivity / permittivity tissues, and the contrast between the electrical properties of the adipose tissue(s) and these other tissues will result in higher signal reflections. Some example implementations may exploit this physiologic phenomenon such that, in some examples, adipose tissue may be used like a waveguide to funnel the RF / EM communication signal waves from the first IMD to the second IMD, or vice versa. Accordingly, in some such examples, a preferred communication path may not necessarily be a shortest distance between the first IMD and the second IMD such that a direct line-of-sight or shortest distance between the first IMD and second IMD is not necessary for robust, effective communication between the first IMD and the second IMD.

[0093] Additional aspects of such wireless communication between respective IMDs and / or between an IMD and an external device is further described in association with at least FIGS. 4,18A-18E, 23A, and / or 23B.

[0094] FIG. 4 is a block diagram schematically representing an example arrangement 600 including patient’s body 602, including example target portions 610-634 at which at least some example sensing element(s), activation element (s) (e.g., stimulation element(s)), and / or other elements may be employed to implement at least some examples of the present disclosure.

[0095] As shown in FIG. 4, patient’s body 100 comprises a head-and-neck portion 610, including head 612 and neck 614. Head 612 and / neck 614 comprises cranial tissue, nerves, etc., and upper airway 616 (e.g., nerves, muscles, tissues), etc. As further shown in FIG. 4, the patient’s body 602 comprises a torso 620, which comprises various organs, muscles, nerves, other tissues, such as but not limited to those in pectoral region 622 (e.g., lungs 626, cardiac 627), abdomen 624, and / or pelvic region 629 (e.g., urinary / bladder, anal, reproductive, etc.). As further shown inFIG. 4, the patient’s body 602 comprises limbs 630, arms 632 and legs 634. Further details regarding sensing and / or activation of tissues in the pelvic region 629 are provided in later examples in association with at least other parameter other parameter 3407 in sensing portion 3400 of FIG. 26B, and / or at least target tissue parameter 3710 in activation portion 3700 in FIG. 28A.

[0096] It will be understood that various sensing elements (and / or activation elements) as described throughout the various examples of the present disclosure may be deployed within the various regions of the patient’s body 602 to sense and / or otherwise diagnose, monitor, treat various physiologic conditions such as, but not limited to those examples described below in association with FIGS. 1 -3 and 5-30. In some such examples, an activation element 617 may be located in or near the upper airway 616 for treating sleep disordered breathing (and / or near other nerves / muscles for treating other conditions) and / or a sensing element 628 may be located anywhere within the neck 614, head 612, and / or torso 620 (or other body regions) to sense physiologic information for providing patient care (e.g., SDB, other) and / or for other purposes. In some examples, the activation element 617 may be located in body regions other than the neck 614, whether for treating sleep disordered breathing and / or other conditions (whether respiratory-related or not).

[0097] In some examples, at least a portion of the activation element 617 may comprise part of an implantable component / device (e.g., implantable pulse generator, lead, etc. ). In some examples, the implantable component / device may be full sized (e.g., traditionally implanted in a torso region).

[0098] However, in some examples, the implantable component / device (e.g., of which the activation element 617 may form a portion) may be sized and / or shaped for implantation in a neck region 614 and in some such examples, the activation element 617 may be implemented as (or referred to as) a microstimulator.

[0099] In some examples, the implantable components (e.g., IPG, other) may comprise an activation / control circuit, a power element (e.g., non-rechargeable power element or rechargeable power element), communication elements, and / or other components. The activation / control circuit may comprise stimulation signalgenerator circuitry and / or sensing signal circuitry. In some of the examples in which the activation element 617 is sized and / or shaped for implantation in a neck region 614 (and may be referred to as a microstimulator), the implantable components (e.g., including the activation / control circuit, power element, communication elements, and / or other components) are also sized and / or shaped for implantation in a neck region 614 (and may be referred to as a microstimulator), whether arranged separately from each other or arranged together as a single portion (e.g., within a single housing). When arranged separately, at least some of the various implantable components may be grouped in desired combinations and each combination may comprise a housing containing such implantable components. At least one of these implantable components may be in wired connection with at least one other implantable component, whether directly or indirectly. In some examples, at one implantable component may be in wireless connection with at least one other implantable component. In some of the aforementioned examples in which a housing contains at least one implantable component, the housing may sealably encapsulate the at least one implantable component.

[0100] In some examples, the activation element 617 also may comprise a stimulation element, which comprises a stimulation electrode arrangement (e.g., stimulation electrode(s) supported on / by a carrier) and / or stimulation lead connected to the implantable pulse generator. In some examples, the lead and / or pulse generator, etc. may be considered as a stimulation support portion, which supports stimulation applied via the stimulation electrode arrangement.

[0101] Further details regarding the location, structure, operation, and / or use of the sensing element 628, external element(s) 650, and / or activation element 617 are described below and / or later in association with at least FIGS. 5-43.

[0102] In some examples, at least a portion of the activation element 617 may comprise part of an external component / device such as, but not limited to, the external component comprising a pulse generator (e.g., activation / control circuitry), power element (e.g., rechargeable or non-rechargeable power element), and / other components. In some examples, a portion of the activation element 617 may beimplantable and a portion of the activation element 617 may be external to the patient.

[0103] Accordingly, as further shown in FIG. 4, the various sensing element(s) 628 and / or activation element(s) 617 implanted in the patient’s body may be in wireless communication (e.g., connection 637) with at least one external element 650.

[0104] As further shown in FIG. 4, in some examples, the external element(s) 650 may be implemented via a wide variety of formats such as, but not limited to, at least one of the formats 651 including a patient support 652 (e.g., bed, chair, sleep mat, other), wearable elements 654 (e.g., finger, wrist (e.g., watch), head, neck, torso (e.g., belt), shirt), noncontact elements 656 (e.g., camera, mobile device, other), and / or other elements 658. In some such examples, the noncontact elements 656 may sometimes be referred to as a nearable element at least because the noncontact elements are in reasonably close proximity (i.e. near) the IMD to permit wireless communication between the IMD and the noncontact element and / or to permit the noncontact element to perform some operation (e.g., noncontact sensing) relative to the patient’s body. Such noncontact sensing may comprise Doppler, light and distance ranging (LIDAR), radiofrequency, etc.

[0105] In some examples in which the wearable element and / or noncontact element may comprise at least a sensing element, the respective wearable element and / or noncontact element may comprise at least some of substantially the same features described in association with the sensing portions 3300, 3400 of FIGS. 26A, 26B, respectively.

[0106] As further shown in FIG. 4, in some examples, the external element(s) 650 may comprise one or more different modalities 670 such as (but not limited to) a sensing portion 671 , activation portion 672 (which may comprise stimulation circuitry and / or control circuitry), power portion 674, communication portion 676, and / or other portion 678. The different portions 671 , 672, 674, 676, 678 may be combined into a single physical structure (e.g., package, arrangement, assembly), may be implemented in multiple different physical structures, and / or with just some of thedifferent portions 671 , 672, 674, 676, 678 combined together in a single physical structure.

[0107] Among other such details, in some examples the external sensing portion 671 and / or implanted sensing element 628 may comprise at least some of substantially the same features and attributes of at least sensing portions 3300 (FIG. 26A), 3400 (FIG. 26B).

[0108] In some examples, the external activation portion 672 and / or implantable portions of activation element 617 may comprise at least some of substantially the same features and attributes of at least the activation arrangements, as further described below in association with at least FIGS. 28A-28B, generally throughout the examples of FIGS. 5-43, and / or other examples throughout the present disclosure.

[0109] In some examples, the external power portion 674 and / or power components associated with activation element 617 (e.g., implantable portions) may comprise at least some of substantially the same features and attributes of at least the activation arrangements, as further described throughout the examples of the present disclosure. In some such examples, the respective power portion, components, etc. may comprise a rechargeable power element (e.g., supply, battery, circuitry elements) and / or non-rechargeable power elements (e.g., battery). In some examples, the external power portion 674 may comprise a power source by which a power component of the activation element 617 (e.g., implantable portions) may be recharged.

[0110] In some examples, the wireless communication portion 676 (e.g., connection / link at 637) may be implemented via various forms of radiofrequency communication and / or other forms of wireless communication, such as (but not limited to) magnetic induction telemetry, Bluetooth (BT), Bluetooth Low Energy (BLE), near infrared (NIF), near-field protocols, Wi-Fi, Ultra-Wideband (UWB), ultrasonic waves, and / or other short range or long range wireless communication protocols suitable for use in communicating between implanted components and external components in a medical device environment.

[0111] Examples are not so limited as expressed by other portion 678 via which other aspects of implementing medical care may be embodied in external element(s) 650 to relate to the various implanted and / or external components described above.

[0112] FIG. 5 schematically represents a control portion 680, which may comprise at least some of substantially the same features and attributes as the control portion 14500 in FIG. 42A. The control portion 680 may be used to implement at least some of the various example devices and / or example methods of the present disclosure as described herein. In some examples, the control portion 680 may form part of, and / or be in communication with, the sensing element 628 and / or the activation element 617 in FIG. 4, external element(s) 650, and / or other medical device (or portions thereof), as further described later.

[0113] Prior to embarking on a fuller discussion of various examples in association with FIGS. 7-43, FIG. 6 provides a simplified illustration of a neck region and example arrangement 685 comprising a first IMD 687 (e.g., 260 in FIG. 2) and a second IMD 688 (e.g., 262 in FIG. 2) to sense and / or activate target tissues. In this example, the first IMD 687 is implanted at upper part of the neck region 614 to be in activating relation and / or sensing relation to a first upper airway patency related tissue (UAPRT), which may comprise a hypoglossal nerve in some examples. In some examples, the first IMD 687 also may be anchored in a location and manner to be in sensing relation to tissues (e.g., mandible or non-bony structures) other than the hypoglossal nerve to sense respiration, whether or not the first IMD 687 is in activating relation to the hypoglossal nerve.

[0114] The second IMD 688 is implanted at a lower part of the neck region 614 to be in activating relation and / or sensing relation to a second upper airway patency related tissue (UAPRT), which may comprise an infrahyoid-muscle (IHM)-innervating nerve (IHMN) and / or IHM (e.g., sternothyroid muscle (STM)) in some examples. In some examples, the second IMD 688 also may be anchored in a location and manner to be in sensing relation to tissues (e.g., manubrium, phrenic nerve, or other tissue) other than the IHMN to sense respiration, whether or not the second IMD 688 is inactivating relation to the IHMN. In some examples, the second IMD 688 may be in close proximity to, but superior of, a clavicle 692R or manubrium 693.

[0115] In some examples, the two IMDs 687, 688 may be in communication with each other, while in some examples, the two IMDs 687, 688 may operate independently. In either case, the two IMDs 687, 688 work toward a single goal of increasing or maintaining upper airway patency to treat sleep disordered breathing (SDB) such as (but not limited to) obstructive sleep apnea.

[0116] While just two IMDs 687, 688 are shown, it will be understood that the example arrangement 685 may comprise more than two IMDs and in some examples, even a single IMD may be used as further described below.

[0117] These examples, and further examples, are described in association with at least FIGS. 7-43.

[0118] FIG. 7 is a diagram 801 illustrating an example arrangement 800 (e.g., example device and / or method) for sleep disordered breathing (SDB) care. In some examples, the example arrangement may comprise an example implementation of, and / or at least some of substantially the same features as, the examples in association with FIGS. 1 -6 and 8-43. As shown in diagram 801 of FIG. 7, the example arrangement 800 includes a column 820 illustrating an array 821 of anatomical elements which may refer to body regions and tissues for sensing, activation, and / or anchoring as part of example methods of treating sleep disordered breathing such as (but not limited to) obstructive sleep apnea. It will be understood that in any given example method (or device), just some of the nerves, muscles, tissues listed in column 820 will be engaged (e.g., sensed, activated, and / or anchored) versus engaging / involving all of the listed nerves, muscle, tissues, etc.

[0119] The example arrangement 800 in FIG. 7 also includes columns 811 , 812, 813 and 814 which correspond to an array 810 of tissues comprising a first sensing tissue 272, second sensing tissue 274, first activation tissue 282, and second activation tissue 284, respectively. With this in mind, populating one of the data fields in the respective columns 81 1 -814 of diagram 801 represents sensing, activating, and / or anchoring of a particular tissue listed in Column 820, as represented by thevarious alphanumeric indicators described below. As previously noted, example methods are not limited to just two sensing tissues and / or two activation tissues, and may include greater or fewer than two sensing tissues and / or activation tissues.

[0120] As further shown in FIG. 7, Column 811 in diagram 801 illustrates a broad range of potential sensing modalities and / or sensing parameters which may be used in performing sensing for tissue 272 and / or 274, even though in particular examples, just one or a few (e.g., 2 or 3) such sensing modalities and / or sensing parameters may be used in performing a particular example method of treating sleep disordered breathing. It will be further understood that example methods may comprise additional and / or other sensing modalities and / or sensing parameters, at least some of which are described later in association with at least FIGS. 26A-26B and / or other examples throughout the present disclosure.

[0121] With this general framework in mind, as shown in FIG. 7, among other tissues (for sensing, activation, and / or anchoring) array 821 includes a hypoglossal nerve (HGN) 822, a genioglossus muscle (GGM) 824, an infrahyoid (strap) muscle (IHM)-innervating nerve (IHMN) 826, and / or an infrahyoid muscle (IHM) 828. The infrahyoid muscle(s) 828 may comprise an omohyoid muscle (OM), sternohyoid muscle (SHM), and / or a sternothyroid muscle (STM). Further details regarding the IHMN 826 and / or infrahyoid muscle(s) 828 are described in association with at least FIG. 8.

[0122] As further shown in FIG. 7, the array 821 of tissues also may comprise phrenic nerve (PRN) 840 and diaphragm muscle (DPM) 842, which are further described in association with at least FIGS. 14A-14C, and the array 821 of tissues also may comprise glossopharyngeal nerve 844 and / or interior superior laryngeal nerve (iSLN) 846, which are further described in association with at least FIG. 15. While later examples throughout the present disclosure address sensing the phrenic nerve (PRN 840) and / or diaphragm muscle (DPM) 842, it also will be understood that in some examples stimulating these target tissues may be used to treat central sleep apnea (CSA), obstructive sleep apnea (OSA), and / or mixed sleep apnea including both CSA and OSA.

[0123] In some examples, activation (e.g., electrical stimulation) of the phrenic nerve (PRN 840) via an activation element (e.g., 261 B of an IMD in FIG. 2) to cause contraction of the diaphragm may be implemented as part of preventing or treating at least central sleep apnea. As described in association with at least FIGS. 1 -37C (e.g., particularly FIGS. 32A-32J), in some examples sensing and / or stimulation of the phrenic nerve (and / or diaphragm muscle) may be used to facilitate stimulation therapy regarding respiration, including treating various forms of sleep disordered breathing. It will be further understood that some example methods may comprise treating both obstructive sleep apnea and central sleep apnea, such as but not limited to, instances of multiple-type sleep apnea in which both types of sleep apnea may be present at least some of the time. In some such instances, separate stimulation leads may be provided, or a single stimulation lead may be provided but with a bifurcated distal portion with each separate distal portion extending to a respective one of the upper airway patency-related nerve (e.g., hypoglossal nerve, IHMN) and the phrenic nerve. In some examples, one of the stimulation leads may be used to stimulate other nerves such as (but not limited to) the iSLN, afferent nerve fibers / branches of the glossopharyngeal nerve, and / or other sensory nerves, which when stimulated, may elicit (via the CNS) a reflex opening response which activates at least some of the above-identified nerves and / or muscles to facilitate respiration to prevent and / or overcome sleep disordered breathing, as described in association with at least some aspects of the various example associated with at least FIGS. 1 - 43.

[0124] As further shown in FIG. 7, the array 821 of tissues also may comprise carotid sinus tissue (e.g., nerve) 847 and / or other tissues. In some examples, the carotid sinus tissue (e.g., nerve) 847 may be understood as a portion of the glossopharyngeal nerve (GPN) 844, and may be activated and / or sensed directly at the carotid sinus tissue (e.g., nerve) 847 or may be activated and / or sensed more generally via a more proximal portion of the glossopharyngeal nerve 844. Various aspects of activating (e.g., electrically stimulating) and / or sensing a carotid sinus tissue (e.g., nerve 847, etc.) are further described later in various examplesthroughout the present disclosure such as (but not limited to) at least FIGS. 14L, 14M, 29-31 D, 38A-41 E.

[0125] The carotid sinus nerve may be activated and / or sensed directly at the carotid sinus tissue (e.g., nerve) 847 or a more proximal portion of the glossopharyngeal nerve 844, and as further described in association with at least FIGS. 39A-39E.

[0126] Examples are not limited to the tissues illustrated and may comprise other tissue 848.

[0127] As further shown in FIG. 7, instead of or in addition to the tissues 822-846, in some examples tissues at which sensing, activation, and / or anchoring may be implemented may comprise neck region 850 (e.g., 614 in FIG. 3) and / or torso tissues870. In some examples, some neck-torso transition tissues may be considered neck tissues, particularly when a target tissue for sensing and / or activation is located in the neck region 850, and / or some head-neck transition tissues may be considered neck tissues particularly when a target tissue for sensing and / or activation is located in the neck region 850. It will be understood that at least some of the previously mentioned nerves and / or muscles may comprise tissues in neck region 850. In some examples, neck tissue 850 may comprise a broad range of non-nerve and / or nonmuscle tissues such as (but not limited to) mandible (MAND) 851 , hyoid bone 852, thyroid tissues (e.g., cartilage) 853, digastric tissues 854, clavicle tissues 692R, 692L (e.g., tissues including the clavicle and / or just superior to the clavicles), non-bony tissues (e.g., various tendons, cartilages, etc.) 858, and / or other tissues 859. In some examples, at least some tissues of torso region 870 may comprise a chest871 , manubrium 693 (and / or remainder of the sternum), lungs 875, abdomen 877, non-bony tissues 878, and / or other tissues 879. It will be understood that the torso tissues 870 include the pectoral region, as shown in FIG. 2.

[0128] As further shown in FIG. 7, the example arrangement 800 also comprises various sensing modalities and / or sensing parameters by which the various tissues may be sensed, and which are represented in columns 811 , 812 via boxed parameters described below. Some example sensing modalities and / or parametersmay comprise direct (D) sensing, electroneurography (ENG), electromyography (EMG), impedance (I), temperature (T), accelerometer (XL), activity (AC), electroencephalography (EEG), electrocardiogram (ECG), respiration (R), disease burden (DB), activation effect (AE), activation parameter (AP), snoring (SN) (e.g., acoustic 3439 in FIG. 26B), arterial (ART), activity (ACT), oxygen desaturation (02), blood pressure (BP), cardiac (CA), pulse oximetry (PO), among other sensing modalities and / or parameters at least some of which are described further in association with at least sensing portions 3300, 3400 of FIGS. 26A, 26B. As further shown later in association with at least FIGS. 27A-27G, in some examples the sensing modalities and / or sensing parameters of example arrangement 800 may comprise modalities and / or parameters relating to upper airway collapse patterns, various anatomical features, etc.

[0129] Moreover, Columns 813, 814 in diagram 801 of FIG. 7 depict a small range of potential activation (A) modalities (electrical stimulation (ES) which may be used in activating tissues 282, 284. For example, However, it will be further understood that example methods may comprise additional and / or other activation modalities and / or activation parameters, at least some of which are described later in association with at least FIGS. 28A-28B and / or other examples throughout the present disclosure.

[0130] With this in mind, further attention is drawn to Column 811 of FIG. 7 regarding additional sensing modalities and / or sensing parameters. In some examples, the activation effect (AE) comprises physiologic effects resulting from activation of tissue (e.g., 282, 284 in FIG. 2) implemented by first IMD (e.g., 260 in FIG. 2) and / or second IMD (e.g., 262 in FIG. 2) on a target nerve and / or muscle. In some examples, the activation parameter (AP) comprises one or more parameters of the activation implemented by a first IMD 260 and / or by second IMD 262. At least some of the activation effects and / or activation parameters are described later throughout various examples of the present disclosure such as (but not limited to) FIGS. 19A-19D, 26B (e.g., 3472, 3470, respectively), and 28A-28B. Among other aspects, as later illustrated by at least FIG. 26B, it will be understood that theactivation effect parameter 3472 may comprise a physiologic parameter 3474 to track physiologic effects (e.g., parameter 3474) from activation of the IMD(s) (e.g., 260, 262 in FIG. 2). In some examples, either or both of the activation effect (AE) parameter 3472 and activation parameter (AP) 3470 may comprise a nonphysiologic parameter 3480, which corresponds to non-physiologic phenomenon detectable via sensing such as (but not limited to) aspects of (and / or associated with) generating, delivering, etc. an activation signal (e.g., electrical stimulation signal).

[0131] For instance, activation of the infrahyoid muscle-innervating nerve (IHMN) 826 causes activation of the IHM 828, which itself is one physiologic effect (e.g., an activation effect). Activation of the IHM 828, may cause additional physiologic effects such as (but not limited to) increasing pharyngeal wall stiffness to increase or maintain upper airway patency. A change in upper airway patency may be determined via sensing impedance or via other sensing modalities, as further described later.

[0132] In some examples, the activation parameter (AP) comprises a parameter associated with implementing activation of a nerve and / or muscle, and which can be sensed. For instance, instead of sensing a physiologic effect of activation, an activation pulse may be detected via electrodes of a sensing element or an activation element.

[0133] In some examples, the activation effect (AE) and / or activation parameter (AP) may provide an input to determining / implementing further activation of one of the target tissues 282, 284, at least some aspects of which are further described below. For instance, implementing activation of one IMD (e.g., first IMD) may be triggered upon this IMD (e.g., first IMD) sensing physiologic phenomenon which is an effect of activation of target tissue by another IMD (e.g., second IMD). In another instance, implementing activation of one IMD (e.g., first IMD) may be triggered upon this IMD (e.g., first IMD) sensing a parameter of activation (i.e., activation parameter (AP)) of target tissue by another IMD (e.g., second IMD).

[0134] As further shown in FIG. 7, columns 813, 814 in diagram 801 provide data fields to identify potential activation modalities and / or activation parameters whichmay be used in activating tissues 282, 284 corresponding to one or more of the tissues listed in column 820. As one example, as shown in FIG. 7, columns 813 and 814 list electrical stimulation (ES) as one modality for activating (A) a hypoglossal nerve 822 and / or an IHM-innervating nerve (IHMN) 826, respectively, as listed in Column 820. The electrical stimulation (ES) modality is further described throughout examples of the present disclosure and / or in association with at least FIG. 28A and 28B (e.g., 3812). Furthermore, additional or other activation modalities are further described later in association with at least FIGS. 28A-28B. It will be understood that in particular examples, just one or a few (e.g., 2 or 3) such activation modalities and / or activation parameters may be used in performing a particular example method of treating sleep disordered breathing.

[0135] As further shown in FIG. 7, in some examples the example arrangement 800 may comprise activation of the genioglossus muscles 824 (e.g., tongue), as represented via activation (A) of first activation tissue 282 as shown in Column 813. In some such examples, the tissues 282 in Column 813 may be activated via a first IMD 260. In some examples, this activation results from activation (e.g., electrical stimulation) of at least some nerve fibers / branches of the hypoglossal nerve 822, whereby at least some protrusors of the genioglossus muscles 824 become activated (A), resulting in protrusion of the tongue which thereby may maintain and / or increase upper airway patency. Instead of, or in addition to, activating the hypoglossal nerve 822, some example implementations may comprise also directly activating (A) at least protrusors of the genioglossus muscle 824 and / or neuromuscular junctions of the nerve 822 and muscle 824.

[0136] As further shown in FIG. 7, in some examples the example arrangement 800 may comprise activation of the infrahyoid muscle(s) 828 (e.g., sternothyroid in some examples), as represented via block (A) in column 814 of FIG. 7. In some such examples, the tissues 284 in Column 814 may be activated via a second IMD 262. In some such examples, this activation may comprise electrical stimulation (ES in block A) in some examples whereby activation of at least some nerve fibers / branches of the IHM-innervating nerve (IHMN) 826 causes at least someinfrahyoid strap muscles 828 to become activated, resulting in maintaining and / or increasing upper airway stiffness, which contributes to maintaining and / or increasing upper airway patency. Instead of, or in addition to, activating the IHMN 826, some example implementations may comprise also directly activating (e.g., not via nerve 826) at least some IHMs 828 such as (but not limited to) the sternothyroid muscle (STM), and / or neuromuscular junctions of the nerve 822 and muscle 824.

[0137] It will be understood that some nerves / muscles may be considered to be upper airway patency-related tissue (e.g., nerves / muscles) such that direct sensing and / or direct activation of such nerves / muscles may have a direct effect on upper airway patency. For instance, activation of the hypoglossal nerve 822 may cause protrusion of the tongue (via activation of the genioglossus muscle), which may directly maintain and / or increases patency of the upper airway. Similarly, activation of the IHMN 826 may cause (via activation of the sternothyroid muscle and / or other infrahyoid strap muscles), which may directly maintain and / or increase patency of the upper airway.

[0138] The example arrangement of activating tissues 282, 284 may comprise activating other nerves and / or muscles (e.g., 840-846) instead of, or in addition, to activating at least one of the nerves and / or muscles 822-828. At least some such examples are described further below in association with at least FIGS. 9-28B.

[0139] As an introduction to various further examples, in some examples a first IMD 260 may activate a first tissue 282 during a first portion of a first phase of a physiologic cycle and a second IMD 260 may activate the same tissue (e.g., 282) or a different tissue (e.g., 284) during a second portion of a first phase of a physiologic cycle. In such examples, the activation may be implemented via a relationship parameter 3738 as described later in association with at least FIG. 28A.

[0140] In some such examples, a first IMD 260 may activate (e.g., electrically stimulate) a first nerve innervating an upper airway patency-related muscle (e.g., 282) during a first portion (and optionally just preceding) of an inspiratory phase of a respiratory cycle and a second IMD 260 may activate the first nerve (or a second nerve innervating an upper airway patency-related (UAPR) muscle (e.g., 284) duringa second portion of the inspiratory phase of the respiratory cycle. Among other aspects, this example arrangement may promote overall device longevity at least because the general power requirements for implementing such activation is spread among multiple IMDs instead of being borne by just a single IMD. In another aspect, the first nerve (e.g., 272) may innervate LIAPR muscle(s) which ensure upper airway patency at a beginning of an inspiratory phase better than those UAPR muscle(s) innervated by the second nerve (e.g., 274), which may help ensure upper airway patency prior to the beginning of the inspiratory phase. However, once the inspiratory phase has commenced, activation of the second nerve (innervating UAPR muscle(s)) may ensure upper airway patency during a remainder of the inspiratory phase of the respiratory cycle better than activation of the first nerve (innervating UAPR muscle(s)). The respiratory cycle may be sensed via the first IMD and / or the second IMD (or even a third IMD or an external medical device) and this sensed respiratory information used to implement the above-described examples of using both the first IMD and second IMD to activate different portions of a first phase of a physiologic cycle.

[0141] In some examples, at least one of the target tissues 272, 274 (e.g., FIG. 2, 7) may be used to sense a signal that generally corresponds to respiration (R in circle in Column 811 ) to thereby provide information about a respiration parameter (e.g., 3305 in FIG. 26A and / or 3405 in FIG. 26B). The signal may be sensed from one of the target tissues 272, 274 on one or both lateral sides of the patient, and / or using a combination of the target tissues 272, 274. In some examples, one of the target tissues 272, 274 may be the first target tissue used to sense a first neural signal (and / or muscle signal), and a second target tissue nerve may be used if the first neural signal (and / or muscle signal) cannot be used (e.g., is no longer sensed, is noisy or other issues) or for other reasons to enhance therapy.

[0142] Similarly, at least one of the target tissues 272, 274 (e.g., FIG. 2) may be used to sense a signal that generally corresponds to, or from which it may be determined, a disordered breathing (DB) parameter (e.g., “DB” in circle in Column 81 1 of FIG. 7) such as (but not limited to) example disease burden parameter 3308in FIG. 26A. In some examples, the signal may be sensed from one of the target tissues 272, 274 on one or both lateral sides of the patient, and / or using a combination of the target tissues 272, 274. However, in some examples, the disordered breathing parameter may be obtained via information obtained via additional and / or other tissues, sensing modalities, etc. In some examples, the disease burden parameter 3308 may be determined from a single sensing modality and / or single sensing parameter (e.g., general respiration). However, in some examples, the disease burden parameter 3308 may be determined from multiple sensing modalities and / or multiple sensing parameters. For instance, in some such examples, the disease burden parameter may be determined from combining information from a cardiac parameter (e.g., ECG 3426 in FIG. 26B; cardiac 3406 / 3423 in FIG. 26B), a respiration parameter (e.g., 3305 in FIG. 26A; 3405 in FIG. 26B), a collapse parameter (e.g., 3310 in FIG. 26A) and / or other parameters identified in sensing portion of FIG. 26B. In a similar manner, other parameters such as respiration may be determined from multiple sensing modalities and / or from multiple sensing parameters sensed via a single modality (e.g., accelerometer XL), as further described in various examples of the present disclosure such as (but not limited to) in association with at least FIGS. 7 and 10.

[0143] In some examples, at least one of the target tissues in Column 820 may be activated (e.g., stimulated). As previously described, any one of the respective target tissues listed in Column 820 may additionally serve as the target tissue(s) 282, 284 to be activated. In some examples, multiple (e.g., at least two) target tissues 282, 284 may be activated. The activation of the multiple target tissues may occur simultaneously and / or sequentially. In some examples, such as those described above, the activation and sensing of the target tissues may be timed, such that sensing occurs at different times than activation.

[0144] The timing, duration, amplitude, and / or selection of the target tissues 282, 284 to be activated may be set based on the signal (e.g., neural or muscle) sensed from at least one of the target tissues 272,274.

[0145] Among many other example implementations of sensing via example arrangement or framework 800, in some examples the multiple IMDs can be used to track, determine, or compare sensed information (via sensing parameters, modalities, etc.), and / or activation information (via activation parameters, modalities, etc.) according to different target tissues, different body regions, or different parts of a single body region. For instance, one example implementation may use a first IMD 260 to determine a first respiration information within a first part of the neck region 850 (e.g., near mandible 851 in proximity to hypoglossal nerve), while a second IMD 262 determines a second respiration information within a second part of the neck region 850 (e.g., accelerometer (XL) at thyroid cartilage 853) or within a torso region 870. For instance, the respective first and second respiration information may be compared to determine additional information regarding respiration that may not otherwise be obtainable via determining just one of the respective first and second respiration information. Alternatively, this comparison may be used to determine which IMD 260, 262 may be preferable to act as a sole respiration sensing source or primary respiration sensing source. In some examples, the same sensing modality (e.g., accelerometer XL) may be deployed in the two different parts of the same body region (e.g., neck) to sense the same type of tissue (e.g., respiratory) and / or to determine the same sensing parameter (e.g., respiration).

[0146] However, in some examples, using a single sensing modality (e.g., accelerometer (XL)), the first IMD at a first location within the body region may sense a first type of information (e.g., acoustic breathing sounds) while the second IMD at a second location within the same body region may sense a different second type of information (e.g., respiratory-related movement of an organ, bone, or portions of a body region). In some such examples, the two different types of information may relate to the same / single type of physiologic behavior such respiration, which may include respiratory phase information. In some such examples, the first type of information may correspond to a first frequency range (e.g., high frequency, such as when the acoustic information comprises snoring sounds) while the second type of information may correspond to a second frequency range (e.g., low frequency, suchas cyclical chest movement during breathing). Among other aspects, the first type of information in the higher first frequency range may capture apnea events better than the second type of information in the lower second frequency range.

[0147] Among other information which may be sensed via an accelerometer, in some examples the accelerometer may capture changes in amplitude and / or direction such that the accelerometer may be used to sense (at least) frequency of vibrations such as (but not limited to) related to sensing snoring in the neck region (e.g., 614 in FIG. 4, 6). This snoring information may at least partially provide information regarding collapse, obstruction, disease burden, and / or respiration, etc. In some such examples, this snoring-related information may be used as at least one criteria by which stimulation therapy may be initiated on an as-needed (e.g., on- demand) basis in response to disease burden and / or by which an intensity (e.g., amplitude) may be adjusted in response to disease burden.

[0148] As noted elsewhere, this same example arrangement may be implemented via two different sensing modalities instead of a single sensing modality (e.g., accelerometer). For instance, in some examples acoustic-based respiration information (e.g., in the neck region) may be sensed via a piezoelectric element of an IMD (e.g., 260) while the body motion-based respiration information may be sensed via an accelerometer (XL) of an IMD (e.g., 262) in the neck region or in the chest region.

[0149] However, in some such examples, the two different types of information (e.g., acoustic, movement) may relate to different types of physiologic behavior such as the acoustic mode of accelerometer (XL) being used to sense respiration (e.g., breathing sounds) while the body movement mode of accelerometer sensing being used to sense posture or body position.

[0150] In some examples, the same / single sensing modality may be used to sense the same parameter (e.g., respiration) in the same way (e.g., respiratory-related body motion) in two different locations (e.g., two different parts of a single body region (e.g., neck) or a first location in a first body region and a second location in a different second body region). In some such examples, the sensing at the twodifferent locations may produce at least slightly different respiration information, with such differences providing higher fidelity to the actual physiologic respiratory behavior which is occurring. This increased fidelity provides better information on which to base timing, initiation, termination, etc. of activating (e.g., electrically stimulating) target tissues and / or on which to evaluate efficacy of activation therapy.

[0151] In another example, first respiration information may be sensed via an accelerometer (XL) within torso region (e.g., implanted in pectoral region as part of an implantable pulse generator) and second respiration information may be determined via an EMG of diaphragm muscle within the torso region and / or via neural sensing of the phrenic nerve (in the neck region 850 or the torso region 870). In one aspect, the same general sensing parameter of respiration is being sensed at first location within a first body region independently from a second location within the same first body region. In some examples a first sensing modality (e.g., XL) is used at the first location within a first body region while a different, second sensing modality (e.g., EMG) is used at the second location within the same first body region. Among other differences between these sensing modalities in sensing physiologic phenomenon, the EMG sensing of / at the diaphragm muscle may better capture a tidal volume of respiration such that in at least this aspect, the EMG sensing (e.g., at the diaphragm muscle) may exhibit greater fidelity to the actual physiologic respiratory behavior.

[0152] In some such examples of using two different sensing modalities at two different locations to sense the same general parameter (e.g., respiration), each of the first and second sensing modalities are respectively implemented at the target tissue (e.g., first 272 or second 274) best suited for the particular type of sensing modality. Thereafter, comparison and / or combining the sensing information from the two different locations may provide an overall more robust and / or accurate profile of the sensed parameter (e.g., respiration) than if just one sensing modality and / or just one sensing location were used to obtain the information about the particular sensing parameter (e.g., respiration).

[0153] In some examples, the same sensing modality can be used independently at the two different locations within the same body region (e.g., neck region), as noted above.

[0154] In some examples, using EMG and / or other sensing modalities, sensing respiration and / or upper airway patency may be determined via use of EMG (and / or other sensing modalities) to sense different position(s), magnitude of contraction, etc. of respiratory-related muscles / muscle groups and / or upper airway patency- related muscles (UAPRTs). At least some aspects of this type of sensing is described later in association with the EMG sensing modality and / or other examples.

[0155] As noted elsewhere, the same sensing modality can be used independently at two different body regions, whether the same sensing modality is used for the same type of information (e.g., body movement) in both body regions or for different types of information in the different body regions (e.g., acoustic (breathing sounds) in neck, movement in chest).

[0156] At some further details regarding these examples is further described later in association with at least FIGS. 10-140, 26A-26B.

[0157] Among other aspects, each different sensing tissue may offer different reliability (and / or fidelity) for respiration (or other physio parameters) because of an intrinsic nature of the particular sensing tissue, because of different body positions / postures / activities, or for other reasons. Accordingly, some particular sensing modalities may obtain better physiologic information relative to a particular sensing tissue than other sensing modalities, but not necessarily under all circumstances. Moreover, by combining sensed physiologic information from multiple sensing modalities (which may be applied to different target tissues or the same / single tissue), some example methods obtain better overall sensed information for a particular physiologic phenomenon such as (but not limited to) respiration.

[0158] In some examples, when a particular sensing modality exhibits different fidelity (relative to the actual physiologic behavior) because of posture changes (without sensing being performed to detect posture), this sensing modality may be used to provide a closed loop therapy which is posture-responsive without detectingposture by monitoring a change (e.g., amplitude, frequency, noise, etc.) in the sensing signal for the particular sensing modality. At least some example sensing modalities which may be used for at least this purpose comprise at least accelerometry, pressure transduction, bioimpedance, and / or electromechanical sensing.

[0159] In examples in which the same parameter such as respiration is being sensed via different sensing modalities and / or at different sensing locations, in some examples a method may use the strongest available signal to determine respiration. However, in some examples, a method may take both of the differently sensed measures of respiration and combine them into a composite respiration signal, which may provide a more complete representation of the actual physiologic respiratory behavior and / or provide a more robust representation of the actual physiologic behavior.

[0160] With at least some of these principles in mind, in some examples two different sensing modalities can be used to sense the same sensing tissue or different sensing tissue.

[0161] Another example method comprises sensing both of a first sensing tissue and a second sensing tissue via a single sensing modality such as (but not limited to) both of the first and second target tissues being located in the same body region (e.g., a neck region).

[0162] In some examples, whether or not in the same body region, a method comprises implementing the sensing via a first component of a sensing signal from the single sensing modality and via a second component of a sensing signal from the single sensing modality. In some such examples, the method comprises sensing, as the first component, breathing sounds via at least one of the respective first and second IMDs in the neck region, and sensing, as the second component, respiratory- related body motion via at least one of the respective first and second IMDs in the neck region. In some examples, the first sensing modality comprises an accelerometer.

[0163] In some examples, sensing via an accelerometer signal includes separating the accelerometer signal to determine multiple signal components with the different signal components comprising at least one of respiratory-related tissue motion, acoustic-based breathing sounds, acoustic-based snoring, posture, acoustic-based heart sounds, or non-respiratory gross body motion. In some examples, this separation may also comprise determining (e.g., identifying) sleep-related tissue motion, which may comprise identifying posture, snoring, etc. In some examples, this separation may also comprise determining (e.g., identifying) motion indicative of an efficacy of therapy for sleep disordered breathing (SDB), which may comprise identifying respiratory-related motion (e.g., chest, abdomen, etc.) such as breathing, tongue motion, etc.

[0164] In some examples in which a respiratory signal sensed via an accelerometer (or other sensing modality) has been separated into multiple different signal components, a method comprises forming a composite respiratory profile from at least two of the different signal components. Moreover, in some examples, such methods may comprise augmenting the composite respiratory profile via adding additional parameters. For instance, in some examples least one of the following parameters may be added to the composite respiratory profile such as (but not limited to) respiratory-indicative temperature information, respiratory-indicative electrocardiograph information, and / or respiratory-indicative heart rate information.

[0165] In some examples, a parameter may be determined by combining sensed information from two different sensing modalities or two different signal components of a single sensing modality. For instance, one example method may comprise determining a disease burden parameter via combining respiratory-indicative electrocardiography information with sensed respiration waveform information.

[0166] With this foundation in mind, more specific details regarding various target tissues, sensing modalities / parameters, activation modalities / parameters, and / or anchoring modalities / parameters are further described below.

[0167] FIG. 8 illustrates a simplified patient anatomy 1200 including nerves and / or muscles that may comprise target tissues in some examples. Among other nerves,FIG. 8 illustrates an infrahyoid muscle (IHM)-innervating nerve (IHMN) and associated muscles. In some examples, an IHMN may comprise a nerve or nerve branch which innervates (directly or indirectly) at least one infrahyoid muscle, which may sometimes be referred to as an infrahyoid strap muscle. In some examples, IHMNs / nerve branches extend from (e.g., originates) from a nerve loop called the ansa cervicalis (AC) or the “AC nerve loop,” which stems from the cervical plexus, e.g., extending from cranial nerves C1 -C3. Accordingly, in some examples, at least some IHMNs may correspond to an ansa cervicalis (AC)-related nerve in the sense that such nerves / nerve branches (e.g., IHMNs) do not form the AC nerve loop but extend from the AC nerve loop. At least because the AC nerve loop is the origin for some nerves which innervate muscles other than the infrahyoid muscles (IHMs), some AC-related nerves do not comprise IHMNs. Moreover, it will be understood that in some examples, stimulation applied to a portion (e.g., superior root) of the AC nerve loop (and / or to nerves from which the AC nerve loop originates) may activate IHMNs / nerve branches, which extend from the AC nerve loop. However, implementing stimulation (e.g., to influence upper airway patency) occurring at more proximal locations, such as along the superior root of the AC nerve loop may be more complex because of the number / type of different nerves and number / type of different muscles innervated via a superior root of the AC nerve loop such that selective activation of a particular IHM (via stimulation along the superior root) may be quite challenging in some circumstances.

[0168] For example, stimulation can be applied at target location A, target location B, and / or target location C. Portion 1229A of the AC-main nerve 1215 (e.g., a portion or trunk connecting to the AC nerve loop 1219) extends anteriorly from a first cranial nerve C1 with a segment 1217 running alongside the hypoglossal nerve 1235 (target location A) until the AC-main nerve 1215 diverges from the hypoglossal nerve 1235 to form a superior root 1225, which forms part of an AC nerve loop 1219. Target location B may be located at superior root 1225. A portion of the hypoglossal nerve 1235 extends distally to innervate the genioglossus muscle 1204. The superior root 1225 extends inferiorly until reaching near bottom portion 1218 of the AC nerve loop1219, from which the AC nerve loop 1219 further extends superiorly to form a lesser root 1227 (i.e. the inferior root of loop 1219) to complete the AC nerve loop 1219, and with portions 1229B and 1229C joining the second and third cranial nerves, C2 and C3, respectively.

[0169] Several branches 1231 extend off the AC nerve loop 1219, including branch 1242 (which includes target location C) which innervates the sternothyroid muscle (STM) 644 and a portion of the sternohyoid muscle (SHM), e.g., SHM inferior. Another branch 1252, near bottom portion 1218 of the AC nerve loop 1219, innervates another portion of the SHM, e.g., SHM superior 1254. The branches 1231 further include branch 1232 which innervates the omohyoid muscle (OM) 1234. The AC-related nerve 1214 may include additional branches (beyond those illustrated and described) extending from the AC nerve loop 1219. In some examples, the collective arrangement of the AC-main nerve 1215 (including at least superior root 1225 of the AC nerve loop 1219) and its related branches (e.g., at least 1232, 1242, 1252) when considered together, or any of those elements individually, may sometimes be referred to as an IHMN 1216. It will be further understood that at least one such IHMN 1216 is present on both sides (e.g., right and left) of the patient’s body.

[0170] In some examples, target location A is located where segment 1217 runs alongside the hypoglossal nerve 1235 and innervates at least the genioglossus muscle 1204. In some such examples, these more proximal portions of the hypoglossal nerve 635 and the AC-main nerve 1215 may be activated, such as via selective stimulating at least the nerve fibers (e.g., fascicles) of the hypoglossal nerve 1235 responsible for protrusion of the tongue (via activation of the genioglossus muscle) and of the AC-main nerve 1215 responsible for activation of at least the sternothyroid muscle, in some examples.

[0171] In some examples, target location B is located along the superior root 1225 and provides a more proximal location from which at least some branches (e.g., 1242, 1252) may be activated, such as via selective stimulation of nerve fibers within the superior root 1225. In some examples, target location C is located along branch1242, which extends distally from a superior root 1225 of the AC nerve loop 1219 and innervates at least the sternothyroid muscle (STM) 1244. Accordingly, at least branch 1242 may sometimes be referred to as an IHM-innervating nerve (IHMN). Stimulating at the target location C may be used to completely capture and / or fully activate the STM 1244 and / or to promote upper airway patency. In some examples, target location C of the IHMN 1216 may innervate the STM 1244 and the SHM inferior. Stimulation at target location C may thereby fully activate the STM 1244 to pull the thyroid cartilage inferiorly, via branch 1245A, and, optionally activate the SHM inferiorly to pull the hyoid bone inferiorly, via branch 1245B. Activating the SHM superior 1254 alone or activating a combination of the SHM superior 1254 and SHM inferior (STM 1244) may have greater impact on hyoid bone movement (inferiorly) than activation of the SHM inferior without activating the SHM superior 1254. As such, in some examples, activating the SHM inferior may have minimal (or below a threshold) impact on the movement of the hyoid bone. While stimulation of just the hypoglossal nerve 1235 (or some branches thereof) may be effective in increasing upper airway patency to a sufficient degree to ameliorate OSA in high percentage of qualified patients (e.g., least about 70 to 80 % in some examples) when using certain types of implantable neurostimulation devices, some patients may benefit from stimulation of the an IHM-innervating nerve (IHMN) (e.g., 1242, 1219) in addition to, or instead of, stimulation of the hypoglossal nerve 1235. Moreover, for a particular patient, certain positions of the head-and-neck and / or of their body (e.g., supine, lateral decubitus, etc.) may be treated more effectively by stimulating an IHMN (e.g., more direct via branch 1242 or less directly via AC nerve loop 1219), with or without stimulation of the hypoglossal nerve 1235.

[0172] While noted elsewhere, in some examples stimulation may be applied at locations more distal than location C, such as applying stimulation in close proximity to the particular target IHM (e.g., STM 1244). In some such examples, stimulation may be applied at the IHM itself and / or at a neuromuscular junction of the target IHM and the nerve branch directly innervating the target IHM.

[0173] FIG. 9 is diagram schematically representing an example arrangement 1300 including example locations for implanting devices for sensing and / or activation, as well as example anchoring tissue(s) for each example implant location. The devices represented in FIG. 9 may comprise an example implementation of, and / or include, at least some of substantially the same features of any device of FIGS. 1 -8 and I Q- 43.

[0174] More specifically, FIG. 9 is a diagram including a front view schematically representing example arrangement 1300 of example elements (e.g., electrode arrangements) 1310R, 1310L, 1313R, 1313L, 1314R, 1314L, 1316R, 1316L deployed for sensing from and / or activating a plurality of target tissues. In some examples, each of the respective elements 131 OR, 1310L, 1313R, 1313L, 1314R, 1314L, 1316R, 1316L may be implanted within each of the respective locations A, C, E, G and B, D, F, H of the patient, which are located respectively on right and left sides 1312R, 1312L in the head-and-neck 1305 region (e.g., 614 in FIG. 6) of the patient 1301 , as shown with respect to the sagittal midline 1317. These electrode arrangements may be supported on a lead extending from a housing of an IMD (e.g., 260, 262), or may be exposed on an exterior surface of a housing of an IMD. A housing of an IMD (which may provide for sensing, activation (e.g., stimulation), and / or other functions) may be chronically implanted in a pectoral region of the patient and the electrode arrangements 131 OR, 1310L, 1313R, 1313L, 1314R, 1314L, 1316R, 1316L may be chronically implanted in a head-and-neck region 1305 of the patient. However, in some examples, the housing of the IMD may be formed on a smaller scale and / or different shape to be amenable for implantation in the head-and-neck region 1305 instead of a pectoral region. Accordingly, in some such examples, the housing of the IMD and associated electrode arrangements may be implemented on a scale in which both the housing and electrode arrangements (e.g., including a lead in some examples), such that the entire IMD, may be implanted at or near the example target locations A-H in FIG. 9. In some examples, the target tissues include hypoglossal nerves 1320R, 1320L (e.g., 822 in FIG. 7), IHM- innervating nerves (IHMN) 1324R, 1324L (e.g., 826 in FIG. 7) (and / or infrahyoidmuscles), reflex-inducing nerves 1322R, 1322L (e.g., afferent fibers of iSLN 846, afferent fibers of a glossopharyngeal nerve 844 in FIG. 7), and / or phrenic nerves 1326R, 1326L (e.g., 840 in FIG. 7). In some examples, the target tissues may additionally and / or alternatively include muscles innervated by or elicited as part of reflex response driven by at least some of such nerves, including but not limited to genioglossus muscle, IHMs, and diaphragm muscles. As apparent from at least the later-described sensing portion 3400 in FIG. 26B (and / or sensing portions 3300, 3400 in FIGS. 26A, 26B) and / or activation portion (e.g., 3800 in FIG. 28B; 3700 in FIG. 28A), the example target tissues illustrated in FIG. 9 do not comprise the full range of available target tissues available for sensing and / or activation.

[0175] In some examples, the elements 1310R, 1310L, 1313R, 1313L, 1314R, 1314L, 1316R, 1316L of FIG. 9, as well as those further illustrated throughout the figures including FIGS. 14B-14M, may be implemented as or form part of an electrode arrangement and / or an IMD. Accordingly, the elements are sometimes herein referred to as activation elements, electrode arrangements, and / or IMDs.

[0176] It will be understood that the particular locations of the activation elements (e.g., electrode arrangements) 131 OR, 1310L, 1313R, 1313L, 1314R, 1314L, 1316R, 1316L provide just one example and that such locations are also representative of many different target tissues and locations at which the respective electrode arrangement may be located consistent with accessibility of the respective nerves, muscles, other tissues, etc.

[0177] As further shown in FIG. 9, at each of the respective locations B, D, F, H, a housing of an IMD (and / or lead) may be securely fixed at or relative to an anchoring tissue as represented via the dashed boxes at each respective location. In some examples, the anchoring tissues comprise non-bony tissue (e.g., 858 in FIG. 7) of the neck 850. In some such examples, the anchoring tissue may comprise a muscle such as (but not limited to) the mylohyoid (MHM), digastric (DGM), sternothyroid muscle (STM), sternohyoid muscle (SHM), omohyoid muscle (OM), sternocleidomastoid (SOM), and / or other muscles. In some examples, the anchoring tissue may comprise non-nerve and / or non-muscle tissues such as bony structures,tendons, etc., which may include a mandible (851 in FIG. 7), hyoid bone (e.g., 852 in FIG. 7), clavicle (e.g., 692R / 692L in FIG. 6, 692 in FIG. 7, etc.), thyroid cartilage (e.g., 853 in FIG. 7), digastric tendon (e.g., 854 in FIG. 7), etc., at least some of which are further described in association with FIGS. 1 1 -13 and / or other figures throughout examples of the present disclosure.

[0178] FIG. 10 is a diagram illustrating an example arrangement 1500 for implementing sleep disordered breathing (SDB) care. In some examples, the example arrangement 1500 may comprise at least some of substantially the same features as example arrangement (e.g., framework) 800 of FIG. 7, with example arrangement 1500 (FIG. 10) providing a more specific example method comprising sensing physiologic information via one or multiple (e.g., at least two) different sensing modalities via separate IMDs in the neck region and / or torso region. In some examples, the physiologic information may comprise respiration information and / or other types of information obtainable via the particular sensing modalities.

[0179] In one example implementation, as indicated via dashed boxes “1 ”, comprises sensing at least respiration via a first IMD including an accelerometer (XL) at / on a first sensing tissue 272 (in column 811 ) and via a second IMD implementing neural (N) sensing at / on a second sensing tissue 274. For example, as indicated by dashed box 1 including “XL” in column 81 1 , the accelerometer (XL) of the first IMD may be mounted on (or relative to) any one of the enumerated tissues 851 -859 of the neck region 850 to sense movements indicative of respiration. Meanwhile, as indicated by dashed box 1 (two instances) including “N” in column 812, neural (N) sensing via a second IMD may be performed on a second tissue 274, such as at / on a phrenic nerve 840 (first instance of dashed box 1 in Column 812) within the neck region 850 (second instance of dashed box 1 in Column 812).

[0180] In another example, as indicated by dashed box 2 including “XL” in column 81 1 , an accelerometer (XL) of a first IMD may be mounted on (or relative to) any one of the enumerated tissues 871 -879 of the torso region 870 to sense movements indicative of respiration. Meanwhile, as indicated by two instances of dashed box 2 in Column 812, which include “EMG”, EMG sensing via a second IMD may beperformed on a second tissue 274, such as at / on a diaphragm muscle 842 (first instance of dashed box 2) within the torso region 870 (second instance of dashed box 3) to sense respiration. Accordingly, in this example method (or example device) the first IMD comprises a first sensing modality (e.g., XL) and the second IMD comprises a second sensing modality (e.g., EMG) different from the first sensing modality. In some examples, instead of (or in addition to) the EMG sensing at the diaphragm muscle 842, the second IMD may be located in sensing relation to a phrenic nerve 840 and the second sensing modality may comprise direct electrical sensing or ENG sensing of the phrenic nerve. At least some aspects of this example are further described in association with at least FIG. 14A-14B.

[0181] In one example, as indicated by dashed box 3 including “XL” in column 811 , an accelerometer (XL) of a first IMD may be mounted on (or relative to) any one of the enumerated tissues 871 -879 of the torso region 870 to sense movements indicative of respiration. Meanwhile, as indicated by two dashed boxes 3 including “N” in column 812, neural (N) sensing via a second IMD may be performed on a second tissue 274, such as at / on a phrenic nerve 840 (first instance of dashed box 3) within the neck region 850 (second instance of dashed box 3) to sense respiration. At least some further examples of neural sensing of the phrenic nerve 840 are further described later in association with at least FIG. 14A-14C. In this example, instead of sensing the phrenic nerve 840, the method may comprise EMG sensing of the diaphragm muscle 842 to sense respiration.

[0182] In at least these specific examples, at least respiration information is obtained via two different sensing modalities, which then may be compared to refine or further define the respiration information to enhance accuracy, robustness, etc. of the sensed respiration information. For instance, in the second example of sensing first respiration information via an accelerometer in the torso (or an accelerometer in the neck) and sensing second respiration information via EMG in the torso, a comparison of these two sensing signals may be used to determine occurrence of a single extended breath, whereas the accelerometer signal alone may be indicative of an extended breath while the EMG-diaphragm signal may indicate two short,separate breaths. By looking at both signals and / or forming a composite respiration signal from the two different signals, an example method may determine that a single attempted breath.

[0183] Whether considered to be mounted in the neck 850, mounted in the torso 870, or mounted in a transition between the neck 850 and torso 870, in some examples an accelerometer (XL) may be implanted at or in close proximity to a sternal notch (e.g., 694 in FIG. 6), which is a small “soft tissue” region just superior to the manubrium (e.g., 693 in FIG. 6) and adjacent (and between) the inner ends of the clavicles 692 (e.g., 692R, 692L in FIG. 6,). In some such examples, the accelerometer (XL) may be supported in this implanted position via an anchor at the manubrium (e.g., 693 in FIG. 6), clavicles 692 (e.g., 692R, 692L in FIG. 6), and / or other nearby non-nerve tissues. In some examples, the sternal notch (e.g., 694 in FIG. 6) may be represented in FIGS. 7, 10, etc. via other parameter 859 or other parameter 879.

[0184] The accelerometer (XL), which is at or in close proximity to the sternal notch, may be used to sense respiration via sensing movement and / or acoustic phenomena. In some examples, other types of sensors (e.g., piezoelectric) may be implanted instead of the accelerometer. Via these example arrangements of sensing at (or in close proximity to) the sternal notch, respiration may be determined, tracked, etc. In some examples, sensing (e.g., via an accelerometer) at or in close proximity to the sternal notch also may be used to sense effort / activity of infrahyoid strap muscles, which may be indicative of respiratory effort.

[0185] In some examples, instead of being fully implanted, an external first element may be in operative relation to a second element implanted at or in close proximity to the sternal notch to provide sensing of respiration via sensing motion of the sternal notch. In some such examples, the implanted second element may comprise a magnet, coil, antenna, etc. such that movement of the implanted second element may be sensed by, and relative to, the external first element. In some examples, the external first element also may comprise a magnet, coil, antenna, etc. by which relative movement of the respective first and second elements (e.g., movement ofthe second element relative to the first element) indicates motion of (and at) the sternal notch. In some examples, this indicated motion corresponds to respiration information as the sternal notch 694 moves dynamically in a rhythm corresponding to inspiration and expiration. In some examples, the external first element also may comprise at least a portion of control portion (e.g., 680 in FIG. 5; 4500 in FIG. 42A; and / or 14520 in FIG. 42B) to provide for operating the sensing via the first, second elements, as well as storing sensed information, etc.

[0186] In some examples, respiration and / or respiratory effort (associated with an infrahyoid muscle (IHM)-innervating nerve (IHMN)) may be sensed via EMG sensing of infrahyoid strap muscles and / or via electroneurographic (ENG) sensing of the IHMN.

[0187] Moreover, in some such examples, it will be understood that sensing of respiration via an accelerometer, ENG, EMG is not limited to placement of sensors at or in close proximity to the sternal notch. Rather, a wide variety of sensor placements in the neck (e.g., 614 in FIG. 4; 850 in FIG. 7), transition between a neck (e.g., 614, 850) and a torso (e.g., 620 in FIG. 4; 870 in FIG. 7), and / or torso (e.g., 620, 870) may be used to sense respiration.

[0188] In another example, a method comprises sensing respiration in first body region (neck) via an acoustic sensing modality (e.g., such as via a microphone, piezoelectric element, or accelerometer) and / or sensing respiration in a second body region (e.g., chest) via another sensing modality such as an accelerometer (XL).

[0189] For at least the sensing implemented via an accelerometer (XL), sensed physiologic information also may comprise activity, body position, cardiac information (e.g., hear rate, heart rate variability, etc.), etc.

[0190] Regardless of the particular sensing modality, in some examples, the sensed respiration information (e.g., respiratory phase) may be used for triggering and / or timing (e.g., synchronization) the activation (e.g., electrical stimulation) of first and / or second activation tissues 282, 284 as represented in columns 813, 814, which may sometimes be referred to as closed loop activation (e.g., 3720 in FIG. 28A). In addition to, or instead of, this type of respiration information, the sensed physiologicinformation may comprise disease burden information (e.g., apnea severity index) which also may sometimes be used as part of a closed loop activation method in which initiation, intensity, and / or termination of activation (e.g., electrical stimulation) may be based on sensed disease burden information.

[0191] Further example implementations of specific target tissues, sensing modalities, activation modalities, and / or anchoring modalities of the general framework 1500 in FIG. 10 are described below.

[0192] While the example arrangement 1330 in FIG. 9 illustrates several muscles as potential tissues to which a IMD (or portion of an IMD) may be anchored (and / or at which sensing, activation may occur), FIG. 11 further illustrates various non-nerve anatomical features which may serve as a tissue at which (or relative to) an example IMD may be anchored and / or anatomical features corresponding to example target tissues to be sensed and / or stimulated. More particularly, FIG. 11 illustrates a front view of the head-and-neck region of the patient, which includes the right mandible 851 R (including lower edge portion 1833R), left mandible 851 L (including lower edge portion 1833L), chin 1315, hyoid bone 852, thyroid cartilage 853, clavicle 692L, 692R, and manubrium 693, each of which may comprise tissues (e.g., anchoring tissue) to which a portion of an IMD may be fixed. As apparent from these examples, these tissue may comprise bony structures and / or non-nerve soft tissues (e.g., tendon, cartilage, etc.). In some such examples, as represented via 1844 in FIG. 11 , the portion of the IMD may be directly secured at / onto the particular tissue (e.g., hyoid bone 852), while in some examples, the portion of the IMD may be indirectly secured to the particular tissue, such as via a tether extending between the particular tissue and the portion of the IMD (e.g., housing).

[0193] In addition, in some examples, with an IMD 1844 mounted at (or relative to) at particular tissue / structure (e.g., hyoid bone 852), sensing may be performed regarding a position or change in position (or lack thereof) of the particular tissue / structure (e.g., hyoid bone 852), which may be indicative of upper airway patency and / or indirectly indicative of upper airway patency to the extent that position or change in position of tissues (associated with upper airway patency) connectedto the particular tissue / structure (e.g., hyoid bone 852) may affect a position or change in position (or lack thereof) of the particular tissue / structure (e.g., hyoid bone 852). In some such examples, the change in position may sometimes be referred to as movement. Similarly, such position or change in position may be used to determine respiratory parameters (e.g., phase, transition between respiratory phases, rate, duration, etc.) in addition to or instead of upper airway patency information.

[0194] In some of these examples regarding the hyoid bone 852 (or other tissues / structures enumerated in association with at least FIG. 1 1 ), some example methods may compare a timing of the sensed position or sensed change in position of the hyoid bone 852 (and / or other enumerated tissues) with timing of a sensed respiratory cycle (or portion thereof) or other sensed physiologic parameters (e.g., other respiratory parameters, cardiac parameters, and / or other parameters) in order to determine a pertinence of the particular position or change in position in the hyoid bone 852 (and / or other enumerated tissues) regarding upper airway patency and / or respiratory parameters (e.g., phase, transition between respiratory phases, rate, duration, etc.).

[0195] Among other sensing modalities, in some example the IMD (or portion thereof) being fixed relative to a tissue may comprise an accelerometer (XL). Among other physiologic information which may be sensed, placement of an accelerometer at least some of these example locations (e.g., right mandible 851 R (including lower edge portion 1833R), left mandible 851 L (including lower edge portion 1833L), chin 1315, hyoid bone 852, thyroid cartilage 853) may be used to sense respiration such as (but not limited to) via sensing movements associated with respiration. In one aspect, respiratory sensing at these locations in the neck region may be distinguished from more general sensing (e.g., general chest movement) in that respiratory sensing in the neck region takes place close or closer to sites at which tissues may to activated to increase or maintain upper airway patency, and thereby enable simpler, faster implantation of respective sensing elements and activation elements. Among other potential respiratory-indicative movements, at leastvibrations may comprise one type of such movement, which may be obtained via sensing snoring and / or airway obstructions.

[0196] As further shown in FIG. 11 , several infrahyoid muscles (IHMs) are located in the neck region, with such muscles being innervated by an IHM-innervating nerve (IHMN), as previously described in association with FIG. 8. The IHMs include the omohyoid muscle 1234 which overlies at least a portion of the sternohyoid muscle (SHM) 1254 and the sternothyroid muscle (STM) 1244. The omohyoid muscle 1234 comprises a superior belly portion 1234A, an inferior belly portion 1234C, and a tendon 1234B therebetween. While an IMD may be mounted relative to any of these portions (1243A, 1243B, 1243C), as shown in FIG. 1 1 in some examples, as represented via 1847, an IMD may be mounted at omohyoid tendon 1234B or an anchor associated with an may be mounted at omohyoid tendon 1234B. Such mounting at the omohyoid tendon 1234B (or omohyoid muscle portion 1234A, 12340) may position the IMD to deliver stimulation at STM 1244, sternohyoid muscle 1254, the omohyoid muscle 1234, and / or other infrahyoid muscles.

[0197] While the thyrohyoid muscle 1243 is generally considered not to be innervated by the IHMN (e.g., 826 in FIG. 7, 1216 in FIG. 8), the thyrohyoid muscle 1243 may sometimes be referred to as an infrahyoid muscle. In some such examples, the thyrohyoid muscle 1243 may form a superior-ward continuation of the STM 1244, such that contraction of the thyrohyoid muscle 1243 (e.g., via stimulation of the thyrohyoid muscle 1243 and / or stimulation of a nerve (e.g., first cervical spinal nerve (e.g., runs parallel with the hypoglossal nerve) innervating the thyrohyoid muscle 1243) may contribute to the stiffening of the pharyngeal walls via a similar mechanism as modulated by contraction of the STM 1244 (caused by stimulation of the STM 1244 and / or of the infrahyoid-muscle (IHM)-innervating nerve (IHMN) (e.g., 826 in FIG. 7, 1216 in FIG. 8).

[0198] In some examples, as shown in FIG. 11 , in some examples, as represented via 1848, an IMD 1848 may be mounted at or on STM 1244 or an anchor associated with an IMD may be mounted at STM 1244. Such IMD may be used to stimulate the STM 1244 and / or another IHM.

[0199] In some examples, the tissues to which an IMD may be fixed may comprise various other muscles within the neck region 850 such as the mylohyoid muscle 1264. Further, IMD(s) may be implanted at other locations, such as illustrated by the IMDS 1840, 1842, 1846, 1849.

[0200] With this in mind, FIGS. 12 and 13 are diagrams schematically representing patient anatomy, which may be used as target tissue by an example device and / or in an example method for fixation, sensing, and / or activation. Among other aspects of this patient anatomy, the side view of FIG. 12, and / or front view of FIG. 13, illustrate various aspects of the hyoid bone 852, thyroid cartilage 853, and / or other non-nerve structures to which an IMD (or portion thereof) may be fixed, such as to enable sensing (and / or activation) of target tissues, including phenomenon ( e.g., movement) associated with functions (e.g., respiration). In addition, FIGS. 12-13 illustrate different example target tissue including, but not limited to, upper airway patency-related motor nerves and muscles innervated by, and upper airway reflex- related sensory nerves.

[0201] As further shown in FIGS. 12-13, the hyoid bone 852 comprises a central portion 852C and two arms 852R, 852L extending in an orientation to form a general U-shaped member with each arm 852R, 852L extending on opposite sides of the body (e.g., opposite sides from a sagittal midline (e.g., 1317 in FIG. 9)). In some examples, an IMD (e.g., including an accelerometer and / or other sensing modalities) may be fixed on the central portion 852C or may be fixed on one of the two arms 852R, 852L of hyoid bone 852.

[0202] In some examples, locating a sensor (e.g., accelerometer) at or along central portion 852C of hyoid bone 852 may enhance sensing respiration at least because the central portion 852C may be in close proximity to an insertion point of muscles (e.g., middle pharyngeal constrictor muscle and / or stylopharyngeus muscle) that cause movement of the hyoid bone 852C during respiration (and / or move in a manner to promote upper airway patency), because the central portion 852C may be a location closer to an external surface, which may ease implantation, and / or because the central portion 852C may provide a more robust mounting site.On the other hand, the two arms 852R, 852L of hyoid bone 852C may be preferred in some instances because they would provide a relatively deeper implantation location and thereby be preferable cosmetically and / or the two arms 852R, 852L may in close proximity to other target tissues.

[0203] As further shown in FIGS. 12-13, the thyroid cartilage 853 comprises a central portion 853C and two wing portions 853R, 853L extending in an orientation to form a general U-shaped member (e.g., in an anterior-posterior orientation of the body) with each arm 853R, 853L extending on opposite sides of the body (e.g., opposite sides from a sagittal midline (e.g.,1317 in FIG. 9)). The thyroid cartilage 853 also may comprise an upper portion 853U and lower portion 853LWR. In some examples, an IMD (e.g., including an accelerometer and / or other sensing modalities) may be fixed on the central portion 853C or may be fixed on one of the two wing portions 853R, 853L of the thyroid cartilage 853, whether on upper portion 853U or lower portion 853L. In some examples, locating a sensor (e.g., accelerometer) at or along central portion 853C of thyroid cartilage 853 may enhance sensing respiration at least because the central portion 8530 is directly connected to the trachea, because the central portion 853C may be a location closer to an external surface, which thereby eases implantation, and / or because the central portion 8530 may provide a more robust mounting site. On the other hand, the two arms 853R, 853L of thyroid cartilage 853 may be preferred in some instances because they would provide a relatively deeper implantation location and / or permit an implant accessincision site which is offset from a sagittal midline (e.g., 1317 in FIG. 9), and thereby be preferable cosmetically or easier surgically. In some examples, the two arms 853R, 853L may be in close proximity to other target tissues such as (but not limited to) non-respiratory tissues. In some examples, either (or both) arm 853R, 853L may provide a surface area sized, shaped, and / or oriented to permit affixation of a stimulation lead to target tissues adjacent the cartilage 853, as well as a location placed to enhance such stimulation lead to be in sufficient proximity to be in stimulating relation to target tissues (e.g., nerves, muscles which may promote upper airway patency).

[0204] FIGS. 12-13 also illustrate a superior laryngeal nerve (SLN) 1806 such as an internal branch of the superior laryngeal nerve (iSLN) 846R, 846L (e.g., 846 in FIG. 7). As shown by the diagram 1800 in FIG. 12, the SLN 1806 extends from the inferior ganglion 1813 of the vagus nerve 1811 and with a portion (e.g., the 1810) running alongside the vagus nerve 1811 and the pharynx. The SLN 1806 has two branches, the iSLN 846 and the external SL nerve (eSLN) 1810 (primarily including efferent nerve fibers). Among other aspects, the eSL nerve 1810 includes efferent nerve fibers (e.g., motor nerve fibers) which innervate the cricothyroid muscle 1822 (shown on both sides of the patient in FIG. 13. FIG. 12 also illustrates cricoid cartilage 1814 and the trachea 1816 of the patient. The level of the vocal folds 1020 is shown in FIG. 13 as a dashed line.

[0205] Meanwhile, the iSLN 846 includes (e.g., carries) afferent nerve fibers which extend from the laryngeal mucosa, and ultimately to the central nervous system (CNS). As shown in FIGS. 12-13, a proximal portion of the iSLN 846 may be viewed as being inferior to the hyoid bone 852 and arising out of and through the thyrohyoid membrane 1803 (superior to the thyroid cartilage 853) from the more distal portions of the iSLN 1808. As further schematically represented in FIG. 13, the more distal branches of the iSLN 846 extend from the epiglottis (1818 in FIG. 13), the base of the tongue (e.g., genioglossus muscle), the epiglottis glands, and from a posterior origin in the aryepiglottic fold, from the laryngeal mucosa. Among other aspects, the laryngeal mucosa comprises mucous membrane(s) surrounding the entrance of the larynx, and the mucous lining of the larynx as far down as the vocal folds 1812.

[0206] The afferent nerve fibers of the iSLN 846 may receive sensory information (which is indicative of or includes the respiratory information) from mechanoreceptors located at or near the upper airway. For example, the mechanoreceptors may form part of the tissue that at least some of the more distal branches of the iSLN 846 extend from including a region commensurate with a posterior oropharyngeal wall, among other tissues.

[0207] Among other physiologic influences, in some examples, the sensed neural activity of the iSLN 846 which corresponds to, and which reveals, upper airwayobstruction may be associated with (and result from) activity of mechanoreceptors located at or near the upper airway. The mechanoreceptors may provide general respiratory information based on their behavior during the respiratory cycle. In particular, during inspiration, a contraction of the diaphragm causes negative pressure in the lungs, which induces (e.g., causes) air to enter the lungs while cells of the mechanoreceptors are stretched (and / or otherwise mechanically affected) during this inspiration. Accordingly, during regular respiration there is a baseline phasic neural activity of the mechanoreceptors which may be sensed. When an upper airway obstruction is present, an increased pressure differential is exhibited because the diaphragm may contract harder / longer in an effort to induce an adequate volume of air into the lungs, with the increased pressure differential increasing the amount of stretch on the mechanoreceptors. This increased pressure differential, in turn, causes a change in the sensory signal sent along the afferent / sensor fibers of an affected nerve (e.g., iSL nerve 846) to the CNS, which then directs an upper airway reflex opening response to occur to overcome the obstruction. In some examples, the signal sent via afferent nerve fibers (associated with the mechanoreceptors) may convey a magnitude and / or duration of the obstruction. In some such examples, these mechanoreceptors may be in communication with and / or comprise a portion of (and / or be associated with) the iSL nerve, afferent nerve fibers / branch of the glossopharyngeal nerve, and / or other nerves.

[0208] Even without sensing the afferent fibers of the iSLN 846, in some examples activation of the afferent fibers of the iSLN 846 may be used to evoke the upper airway reflex response to thereby increase or maintain upper airway patency as a way to treat sleep disordered breathing (SDB) including obstructive sleep apnea.

[0209] In a manner similar to the upper airway reflex opening response elicited via activation of the afferent fibers of the iSLN 846, in some examples one target tissue may comprise at least some afferent nerve fibers / branches of the glossopharyngeal nerve (e.g., 844 in FIG. 7), whereby activation of these afferent nerve fibers may elicit an upper airway reflex opening response.

[0210] In addition to the activation of upper airway dilator nerves / muscles, the above-noted upper airway reflex opening response also may include heightened activation of the phrenic nerve, causing increased contraction of the diaphragm muscle to enhance inspiration of air into the lungs.

[0211] FIG. 14A is a diagram illustrating an example arrangement 2000 like that of example arrangement 800 of FIG. 7, with particular focus on example implementations for sensing of the phrenic nerve 840 and / or diaphragm muscle 842, as well as activation of target tissues (e.g., hypoglossal nerve 822, IHMN 826, in some examples). In some examples, the example arrangement may comprise an example implementation of, and / or at least some of substantially the same features as, the example arrangement 1500 in association with FIG. 10 and / or other various examples in the present disclosure.

[0212] As shown in column 81 1 of FIG. 14A, in some examples a first IMD may perform neural (N) sensing (or ENG sensing) of physiologic information (e.g., respiration (R), disease burden (DB)) at or via a phrenic nerve 840, which may be accessible in a neck region 850 and / or a torso region 870. Alternatively, as shown in column 812 of FIG. 14A, in some examples a first IMD (or other IMD) may perform EMG sensing of physiologic information (e.g., respiration (R), disease burden (DB)) at or via a diaphragm muscle 842 (e.g., EMG sensing), which may be accessible in a torso region 870.

[0213] In some examples, a single IMD may be used to implement both of the different sensing modalities (e.g., neural (N) sensing of phrenic nerve 840 and EMG sensing of diaphragm muscle 842), such as when the single IMD is located in torso region 870. In some such examples, the single IMD may comprise at least one lead (e.g., a single lead or two leads) extending from a housing (e.g., as in FIGS. 16-17D) wherein one of the sensing modalities is located at an end (or along a body) of the lead and the other sensing modality is located at the housing of the IMD. In some examples, such as when the single IMD comprises a pair of leads (e.g., as shown in FIGS. 17B, 17C), a first lead (e.g., 2274A in FIGS. 17A0-17B) may implement the first sensing modality (e.g., direct electrical or ENG) and a second lead (e.g., 2274Bin FIGS. 17A-17B) may implement the second sensing modality (e.g., EMG). In some such examples of a two lead arrangement, a housing of the IMD (e.g., 2222 / 2250, 2222 / 2275 in FIGS. 16-17D) also may comprise an electrode (e.g., 2295 in FIG. 17D) or electrode array (e.g., 2294 in FIG. 17D) on its surface which facilitates implementation of the first and / or second sensing modality.

[0214] However, in some examples, a first IMD may be used to implement the neural (N) sensing of the phrenic nerve 840 separate from a second IMD implementing the EMG sensing of the diaphragm muscle 842.

[0215] In some examples, the physiologic information (e.g., respiration information) sensed via the phrenic nerve 840 and / or diaphragm muscle 842 may be used to trigger, implement timing of, initiate, terminate, etc. activation of activation tissues such as (but not limited to) a hypoglossal nerve 822 (and / or genioglossus muscle 824) and / or an IHM-innervating nerve (IHMN) 826 (and / or infrahyoid muscle 828), as represented in columns 813, 814 of FIG. 14A. In some examples, this activation may be implemented via an IMD separate from the IMD(s) used to implement the sensing of the phrenic nerve 840 and / or of the diaphragm muscle 842.

[0216] Among other aspects, sensing respiration at the phrenic nerve provides a robust respiration signal with high fidelity to the physiologic respiration, whereas some other sensing modalities and / or target tissue may provide less robust respiration signals, lower fidelity, and / or be harder to implant.

[0217] In some examples, at least examples herein which are associated with sensing and stimulating a phrenic nerve (and / or a diaphragm muscle) to treat sleep disordered breathing (including obstructive sleep apnea) and / or at least examples herein which are associated with stimulating a phrenic nerve (or diaphragm muscle) and an IHMN may comprise at least some of substantially the same features as described in PCT application PCT / US2024 / 031051 filed 5 / 24 / 2024 published as WO 2024 / 243537 on November 28, 2024, titled “Sensing and / or Stimulating Target Tissue Including Diaphragm-related Tissue and / or Upper Airway Patency- Related Tissue”, claiming benefit from U.S. Provisional Serial Number 63 / 468,621 filed May 24, 2023, and filed as U.S. National Stage application Serial Number on> , published as US Patent Application Publication > on , as described in PCT application PCT / US2025 / 030831 , filed 5 / 23 / 2025, published as on , titled “Stimulating Target Tissue Among A Set of Target Tissues Including Diaphragm-Related Tissue And / or Upper Airway Patency-Related Tissue”, claiming benefit from U.S. Provisional Serial Number 63 / 782,316 filed April 2, 2025, and filed as U.S. National Stage application Serial Number on , published as US Patent Application Publicationboth of which are hereby incorporated by reference.

[0218] FIG. 14B schematically represents an example arrangement 2100 including an example implant access-incision 21 10A as part of example methods and / or example devices for delivering sensing elements and / or stimulation elements for use in methods / devices of treatment.

[0219] As shown in FIG. 14B, in order to access at least some of the target tissues (e.g., 840, 1242) and / or other target tissues, one example arrangement 2100 includes an example method (and / or example devices) forming and / or using an implant-access incision 21 10A in a neck region 850 (614 in FIG. 4) of the patient. In some examples, the implant-access incision 2110A may comprise a location about 3 to about 5 centimeters (as represented via arrow IA 1 ) superior to a clavicle 692. In some examples, the implant-access incision 2110A is sized, shaped, oriented and / or located to provide access to a portion of a phrenic nerve 840 (FIG. 7) for sensing and / or stimulating the phrenic nerve 840 while simultaneously providing access to an IHMN 826 (e.g., nerve portion or branch 1242 innervating the sternothyroid muscle (STM) 1244). In some examples, the same implant-access incision 2110A also may be used to access an IHM, such as the sternothyroid muscle (STM in FIG. 7; 1244 in FIG. 8), as just one example.

[0220] Among other aspects, the implant-access incision 21 10A may comprise a single implant-access incision through which all of the implantable elements of an example device and / or for an example method may be delivered into a chronically implanted position (e.g., subcutaneously) within the patient’s body, such as head- and-neck region in some examples. For instance, both a sensing element (e.g.,261 A in FIG. 2) and an activation element (e.g., 261 B in FIG. 2) may be delivered and secured within the body via the single implant-access incision 2110A. In some such examples, it will be understood that the sensing element and / or activation element may comprise power elements, control elements, communication elements, or combinations thereof such that the implanted system may include all components suitable for operation independently from external devices for at least certain periods of time. In some such examples, some or all of these implanted components when viewed collectively may comprise a microstimulator or may comprise an IPG sized / shaped for implantation in a neck region in some examples or sized / shaped for implantation in a head-and-neck region in some examples.

[0221] Among other aspects, the superior-of-clavicle, implant-access incision 21 10A enables quick, convenient, and effective access to a portion of the phrenic nerve 840 (FIG. 7) which is remote from (e.g., having an inferior orientation and spaced apart from) to the more complex nesting of nerves, muscles, tissues, bones, ligaments, etc. in more superior anatomical locations (e.g., near mandible 851 ) at which the phrenic nerve also may be accessed such as proximate the mandible (and / or similar locations) at which other nerves (e.g., hypoglossal nerve) are often accessed for implantation of stimulation elements. Similarly, the superior-of-clavicle, single implant-access incision 2110A enables quick, convenient, and effective access to select IHMN (e.g., 826 in FIG. 7, branch 1242 in FIG. 8) which is closer to an innervated muscle (e.g., sternothyroid muscle (STM) 1244) which may be of more particular therapeutic interest, and which is remote from (e.g., inferior) to the more complex nesting of nerves, muscles, tissues, bones, ligaments, etc. in more superior anatomical locations at which the ansa cervicalis nerve loop (e.g., 1219 in FIG. 8) may be generally accessed and at which other nerves (e.g., hypoglossal nerve) also may accessed for implantation of stimulation elements.

[0222] Moreover, the example implant-access incision 2110A also may offer quick, convenient access to non-nerve anatomical structures in a less crowded environment and / or which are easier to visualize, which may aid in locating desirednerves, muscles as well as aid in locating / employing structures to which the sensing element(s), stimulation element(s), and / or other elements may be anchored.

[0223] Among other recognizable anatomical landmarks / structures, the implantaccess incision 2110A may enable visualizing the internal jugular vein (IJV) 2120 and the position or orientation of the phrenic nerve 840 being dorsal to the IJV 2120 and the IHMN (e.g., branch 1242 innervating the STM 1244) being ventral (e.g., anterior) to the IJV 2120. In some such examples, after gaining initial access via implant-access incision 21 10A, a sensing element (e.g., sensing lead) and / or activation element (e.g., stimulation lead) may be delivered intravascularly to better position the respective sensing element in sensing relation to the target tissue (e.g., phrenic nerve 840 in FIG. 14A) and / or the activation element in activating relation to the target tissue (e.g., IHMN 826 in FIG. 14A). As noted further herein, in some examples such intravascular delivery as well as associated sensing, stimulation, and anchoring (of sensing elements and / or stimulation elements) may comprise at least some of the substantially the same features as described in U.S. Patent Application Publication , published on , titled “Transvenous Stimulation to Promote Upper Airway Patency” corresponding to U.S. application Serial Number filed on > , which claims priority to PCT application PCT / US2024 / 055172, filed November 8, 2024 and published as WO on , which claims the benefit of Provisional application Serial Number 63 / 547,742, filed on November 8, 2023, all of which is hereby incorporated by reference.

[0224] It will be further understood that at least some of the other target tissues of array 821 (in column 820) of FIG. 14A may be additionally or alternatively accessed via the implant-access incision 2110A.

[0225] In addition to the afore-mentioned features associated with the single implant-access incision 21 10A in FIG. 14B, in some examples, via the implantaccess incision 2110A various non-nerve structures (and / or non-muscle structures in some examples) may be accessed for anchoring the first IMD and / or second IMD.For example, among other locations, the first IMD and / or second IMD may be anchored relative to clavicle 692 and / or other nearby bony structures.

[0226] With this in mind, in some examples the implant-access incision 2110A (or similar type of implant-access incision) may be used to implant an accelerometer (see also XL in FIGS. 7, 12, 14A, 26B) consistent with the examples in FIGS. 10-13 and / or various examples throughout the present disclosure.

[0227] In some examples, the aforementioned anchoring (e.g., via single implantaccess incision 2110A) may be implemented relative to various tissues (e.g., bones, muscles, other) via at least some of substantially the same features as described in: (1 ) U.S. Patent Application Publication 2023-0172479, titled “Single or Multiple Nerve Stimulation to Treat Sleep Disordered Breathing” and filed on November 17, 2022 as Serial Number 17 / 926,010; (2) U.S. Patent Application Publication US 2024- 0252824, titled “Multiple Target Stimulation Therapy for Sleep Disordered Breathing” for application Serial Number 18 / 560,886, filed November 14, 2023; (3) PCT application PCT / US2023 / 085822, filed 12 / 22 / 2023, published as WO 2024-145251 on July 4, 2024, titled “Targeting Stimulation Locations of An Infrahyoid Muscle (IHM)-lnnervating Nerve”, and filed as U.S. National Stage application Serial Number 19 / 143,305, filed on June 25, 2025, and published as U.S Patent Application Publication on > ; (4) PCT application PCT / US2023 / 012105, filed 2 / 1 / 2023, published as WO 2023 / 150158 on August 10, 2023, titled “Implantable Stimulation Elements and Methods for Sleep Disordered Breathing (SDB) Care”, and filed as U.S. National Stage application Serial Number 18 / 834,549, filed July 30, 2024 and published as U.S. Patent Application Publication US 2025 / 0108218; (5) PCT application PCT / US2024 / 022047 filed 3 / 28 / 2024, published as WO 2024 / 206680 on October 3, 2024, titled “Target Tissue Engagement”, and filed as U.S. National Stage application Serial Number , on , and published as U.S Patent Application Publication on > ; and (6) PCT application PCT / US2024 / 055635 filed November 13, 2024, published as WO 2024 / 144516 on July 3, 2025, titled “Implantable Medical Device and Methods for Sleep Disordered Breathing (SDB) Care”, which claims priority to U.S. Provisionalpatent application Serial Number 63 / 615,638, filed December 28, 2023 and filed as U.S. National Stage application Serial Number , on , and published as U.S Patent Application Publication on > ; (7) PCT application PCT / US2024 / 055172, filed November s, 2024 and published on May 15, 2025, as WO 2025 / 101932, titled “Transvenous Stimulation to Promote Upper Airway Patency”, which claims the benefit of Provisional application Serial Number 63 / 547,742, filed on November 8, 2023, and filed as U.S. National Stage application Serial Number , on , and published as U.S Patent Application Publication on , all of which are hereby incorporated by reference in their entirety.

[0228] FIG. 14C schematically represents chronic implantation 2150 of an accelerometer 2170 (e.g., three-axis accelerometer) at or near the hypopharynx region 2160, such as along or near walls 21 12 of the hypopharynx region 2160. Among other uses, the accelerometer 2170 may comprise one example implementation of sensing element 261 A in FIG. 2. In some examples, the accelerometer 2170 may enable sensing respiration information, among other physiologic information (e.g., body position, activity, etc.) at least because at least some portions of the hypopharynx region 2160 exhibit motion / behavior during respiration and which is indicative of phasic respiratory information.

[0229] However, in some examples, the accelerometer (XL) 2170 may be delivered to a desired target tissue (e.g., hypopharynx 2160) via incisions, pathways (e.g., intravascular), etc. independent of (e.g., without) using the implant-access incision 21 10A.

[0230] FIG. 14D is a diagram schematically representing an example arrangement 31 10 (e.g., method and / or system) in which an IMD 1314R (e.g., 260, 262 in FIG. 2) is implanted in stimulating relation (and / or sensing relation) to IHM-innervating nerve (IHMN) 1324R (826 in FIG. 14A) and an IMD 1316R (e.g., 260, 262 in FIG. 2) is implanted in stimulating relation (and / or sensing relation) to phrenic nerve 1326R (e.g., 840 in FIG. 14A). In some examples, the IMD 1314R and IMD 1316R are located on opposite sides of the internal jugular vein 1220. Accordingly, the examplearrangement 1350 comprises at least some of substantially the same features as the example arrangement in at least FIG. 14B in which a branch 1242 of the IHMN is located medial to, and on an opposite side of, the IJV 2120 in comparison to the phrenic nerve 840, which is lateral to the IJV 2120.

[0231] FIG. 14E is a diagram schematically illustrating an example arrangement 3120 like example arrangement 3110 (FIG. 14D), except further comprising implanting an IMD 131 OR to be in stimulating relation (and / or sensing relation) to hypoglossal nerve 1320R, such as via implant-access incision 2110B. Among other implementations, the example arrangement 3120 may be used to perform stimulation (and / or sensing) of the hypoglossal nerve 1320R, the IHMN 1324R and / or the phrenic nerve 1326R. In some such examples, such stimulation (and / or sensing) may be implemented via at least some of substantially the same features of the later-described target selection portion 9500 of FIG. 29, method 10500 of FIGS. 30A-30G, and / or method 11000 of FIGS. 31 A-31 D.

[0232] FIG. 14F is a diagram schematically illustrating an example arrangement 3130 like example arrangement 3120 (FIG. 14E), except further comprising implanting an IMD 1317R to be in stimulating relation (and / or sensing relation) to glossopharyngeal nerve 844. In some examples, the implantation may be executed via implant-access incision 2110B used to access the hypoglossal nerve 1320R. In some such examples, implantation of the IMD 1317R may be performed via the implant-access incision 21 10B used to implant IMD 131 OR in relation to the hypoglossal nerve 1320R. In doing so, some examples may comprise performing tunneling, blunt dissection, etc. from the location of the implant-access incision 21 10B to place the IMD 1317R into stimulating (and / or sensing) relation to the glossopharyngeal nerve 844. It will be understood that the location of implantation of IMD 1317R may comprise any one or more of the various portions of the glossopharyngeal nerve 844, as further described in association with at least FIGS. 38A-39F, 40A-41 E.

[0233] Among other implementations, the example arrangement 3130 may be used to perform stimulation (and / or sensing) of the hypoglossal nerve 1320R, the IHMN1324R, the phrenic nerve 1326R, and / or the glossopharyngeal nerve 844 (e.g., including select portions thereof). In some such examples, such stimulation (and / or sensing) may be implemented via at least some of substantially the same features of the later-described target selection portion 9500 of FIG. 29, method 10500 of FIGS. 30A-30G, and / or method 11000 of FIGS. 31 A-31 D.

[0234] FIG. 14G is a diagram schematically illustrating an example arrangement 3140 like example arrangement 3130 (FIG. 14F), except omitting the implantation of IMD 1314R (in relation to IHMN 1324R) and IMD 1316R (in relation to phrenic nerve 1326R). In example arrangement 3140, implant-access incision 2110B is used to implant IMD 131 OR to be in stimulating relation (and / or sensing relation) to hypoglossal nerve 1320R and to implant IMD 1317R to be in stimulating relation (and / or sensing relation) to glossopharyngeal nerve 844 as previously described.

[0235] FIG. 14H is a diagram schematically illustrating an example arrangement 3160 like example arrangement 3140 (FIG. 14G), except in which implant-access incision 21 10C is implemented instead of (and / or in addition to) implant-access incision 2110B (in close proximity to hypoglossal nerve 1320R). In some examples, implant-access incision 2110C is used to implant IMD 1317R in stimulating relation (and / or sensing relation) to glossopharyngeal nerve 844. In situations in which a separate implant-access incision 21 10B (FIGS. 14D-14G) is not made for accessing hypoglossal nerve 1320R, then implant-access incision 2110C may be used to also implant IMD 131 OR in stimulating relation (and / or sensing relation) to hypoglossal nerve 1320R.

[0236] In some examples, example arrangement 3160 may further comprise implant-access incision 2110C being formed within an oral cavity 3172, as further shown in FIG. 141, instead of forming implant-access incision 2110C from an externally-originated incision into and through the skin, tissue, etc. overlaying the glossopharyngeal nerve 844. With this context in mind, FIG. 141 is a diagram schematically illustrating an example arrangement 3170 in which implant-access incision 21 10C may be formed at some portion within oral cavity 3172 of mouth region 3544, such as (but not limited to) forming implant-access incision 2110C at ornear tonsils 3174, which may overlie or nearly overlie glossopharyngeal nerve 844. As shown in FIG. 141, this location may be in close proximity to a soft palate region 3546, which may comprise a tip portion 3548 of soft palate region 3546. In some examples, using implant-access incision 21 10CC may simplify and expedite implanting an IMD (e.g., IMD 1317R) in stimulating relation (and / or sensing relation) to at least a portion of glossopharyngeal nerve 844 (and / or other target tissue) at least because a fewer number of tissues are present between the surface 3173 of the oral cavity 3172 and the underlying target tissue (e.g., glossopharyngeal nerve 844) as compared to the number and complexity of tissues which otherwise would be navigated to access the glossopharyngeal nerve 844 using an external implantaccess incision, such as an implant-access incision originating on an external surface of the neck region 614.

[0237] As further shown in FIG. 141, in some examples the implant-access incision 21 10GG is located within or just above an oropharynx portion 3562 of upper airway portion 3550, which is posterior to a base 3549 of tongue 3547 (i.e., genioglossus muscle(s)). However, in some examples, the implant-access incision 2110GG may be formed at other locations within the oral cavity 3172 to provide access for implanting an IMD to be in stimulating relation (and / or sensing relation) to various target tissues employed to treat sleep disordered breathing.

[0238] FIG. 14J is a diagram schematically illustrating an example arrangement 3200 which may comprise at least some of substantially the same features as the various example arrangements of FIGS. 14D-14I, 14K-14M, except further comprising an IPG 3202 to support the various IMDs (e.g., 131 OR, 1314R, 1316R, 1317R). In some examples, such support may comprise the IPG 3202 providing power, control, communication, and / or sensing information to and / or from the various implanted IMDs. In some examples, the IPG 3202 comprises a stand-alone IMD, which is self-powered via a non-rechargeable power source within the IPG 3202 or which is powered via a power source external to the patient in wireless communication with the IPG. In some such examples, the IPG 3202 and any related power sources (and / or other external portions) may comprise at least some ofsubstantially the same features as the IMDS 260, 262 of FIG. 2 and / or 290 of FIG. 3, and / or the components of any of FIGS. 4-6. In some such examples, the various IMDs (e.g., 131 OR, 1317R, 1314R, and / or 1316R) and / or IPG 3202 may be implanted via a single implant-access incision 211 OB (e.g., near one of the target tissues, e.g., 1320R) or via multiple-access incisions, in some examples.

[0239] FIG. 14K is a diagram schematically illustrating an example arrangement 3230 in which multiple access-incisions (e.g., 2110A, 2110B, 21 10C) are used to implant multiple IMDs. In some examples, the example arrangement 3230 may comprise at least some of substantially the same features as example arrangements of FIGS. 14D-14I with the additional feature that for each of a plurality of implantaccess incisions (e.g., 2110A, 21 10B, and 2110C), multiple IMDs may be implanted at each respective implant-access incision 2110A, 2110B, 2110C. In some such examples, for each different implant-access incision, at least a pair of IMDs are implanted. For instance, in some examples, 1314R and 1316R are implanted via a first implant-access incision 2110A, with IMD 1314R being in stimulating relation (and / or sensing relation) relative to IHM-innervating nerve (IHMN) 1324R and IMD 1316R being in stimulating relation (and / or sensing relation) relative to phrenic nerve 1326R. Meanwhile, in some examples, IMDs 131 OR, 1318R are implanted via a second implant-access incision 21 10B, with IMD 131 OR being in stimulating relation (and / or sensing relation) relative to hypoglossal nerve 1320R and IMD 1318R being in stimulating relation (and / or sensing relation) relative to internal superior laryngeal nerve (iSLN) (846 in FIGS. 7, 8, 10, 14A, etc. and 51 16A, 5116B in FIG. 32C). In some examples, IMDs 1317R, 1319R are implanted via a third implant-access incision 21 10C, with IMD 1317R being in stimulating relation (and / or sensing relation) relative to glossopharyngeal nerve (e.g., 844 in FIGS. 7, 10, 14A, 14F-14H) and IMD 1319R being in stimulating relation (and / or sensing relation) relative to carotid sinus nerve (e.g., 847 in FIGS. 7, 8, 10, 14A, etc. and nerve branch 9212, carotid body 9216, and / or carotid sinus 9214 in FIGS. 39A-39E). It will be understood that while the carotid sinus nerve (CSN) (e.g., 847) is considered a branch of the glossopharyngeal nerve (e.g., 844), the CSN (e.g., 847) may bestimulated (and / or sensed) specifically without stimulating (and / or sensing) other branches of the glossopharyngeal nerve (e.g., 844).

[0240] In some examples, just one or just two of the IMD pairs are implanted. For instance, in some examples, just the pair of IMDs 1317R, 1319R associated with implant-access incision 2110C are implanted, just the pair of IMDs 131 OR, 1318R associated with implant-access incision 2110B are implanted, or just the pair of IMDs 1314R, 1316R associated with implant-access incision 2110A are implanted. In some examples, IMD pairs may be implanted via (e.g., at) just two of three implantaccess incisions 21 10A, 21 10B, 2110C. In some examples, a pair of IMDs may be implanted at each of two implant-access incisions and just one IMD at a third implantaccess incision may be implanted. In some examples, a pair of IMDs may be implanted at one implant-access incisions and then just one IMD implanted at the two other respective implant-access incisions.

[0241] With reference to FIG. 14K in context with the example arrangements of FIGS. 14D-14J, 14L-14M, it will be understood that in some examples, more implantaccess incisions may be used than shown in the respective FIGS. 14D-14M in order to implant a desired number of IMDs at various locations.

[0242] Moreover, while FIGS. 14D-14K illustrate a right side of a patient’s neck region 614, it will be understood that in some examples, similar arrangements may be implemented for a left side (e.g., 1312L in FIG. 9) of a patient’s neck region 614 whether in addition to, or instead of, such implantations on a right side (e.g., 1312L in FIG. 9) of a patient’s neck region 614.

[0243] In addition to the physical simplicity of implanting two IMDs (or more than two IMDs) via a single implant-access incision, the example arrangement 3230 (e.g., method and / or system) may comprise strategic therapeutic benefits in that activation of (e.g., stimulation of) a particular pair (or higher number combination) of target tissues accessible via a single implant-access incision may results in physiologic effects which are complementary in treating sleep disordered breathing. Moreover, as described in various examples throughout the present disclosure, one or both of such IMDs also may perform (or receive) sensing of target tissues, which may beused as an input to initiate, manage, adjust, evaluate, etc. stimulation of the same IMD, the other respective IMD associated with the same implant-access incision, and / or IMDs associated with different implant-access incisions for treating sleep disordered breathing and / or externally located medical devices associated with treatment via such IMDs.

[0244] However, with respect to at least some of the various examples associated with at least FIGS. 14D-14J, it will be understood that in some examples at least two implant-access incisions may be used to implant the at least two IMDs such as (but not limited to) in at least two different locations in the neck region 614. For instance, in example arrangement 3130 of FIG. 14F, a second implant-access incision may be implemented at (or in close proximity to) IMD 1317R and / or a third implant-access incision may be implemented at (in close proximity to) IMDs 1314R, 1316R. In some examples, in example arrangement 3140 of FIG. 14G, a second implant-access incision may be implemented at (or in close proximity to) IMD 1317R. In some examples, in example arrangement 3160 of FIGS. 14H-14I, a second implant-access incision may be implemented at (or in close proximity to) IMD 131 OR. For instance, in example arrangement 3200 of FIG. 14J, a second implant-access incision may be implemented at (or in close proximity to) IMD 1317R, a third implant-access incision may be implemented at (or in close proximity to) IMDs 1314R, 1316R, and / or a fourth implant-access incision may be implemented at (or in close proximity to) IPG 3202.

[0245] FIG. 14L is a diagram schematically illustrating an example arrangement 3250 further illustrating example implantation locations of multiple IMDs relative to multiple target tissues, and related methods / systems for such IMDs to be in stimulating relation and / or sensing relation to such target tissues. In some examples, the example arrangement 3250 may comprise at least some of substantially the same features as at least the example arrangements associated at least with FIGS. 14D-14K.

[0246] In particular, as just one example, a single implant-access incision 211 OF enables implantation of IMD 1316R for a phrenic nerve and of IMD 1314R for an IHM-innervating nerve (IHMN), in a manner similar to the previously describedexamples of FIGS. 14B, 14D 14K, etc., on a right side 1312R of the head-and-neck region 1305 Similarly, in some examples, a separate implant-access incision 21 10G may be implemented to enable implantation of IMD 1316L for a phrenic nerve and of IMD 1314L for an IHMN, in a manner similar to the previously described examples of FIGS. 14B, 14D 14K, etc., except for a left side 1312L of the head-and-neck region 1305. In some examples, both implant-access incisions 21 1 OF, 21 10G may be implemented in order to enable bilateral engagement (e.g., stimulation and / or sensing) of the respective target tissues.

[0247] In some examples, example arrangement 3250 additionally comprises implementing one or both of implant-access incisions 21 10D, 2110E such as (but not strictly limited to) along the jawline to enable implanting IMDs for multiple target tissues. In some such examples, each respective implant-access incisions enables implanting IMD 131 OR (for hypoglossal nerve), IMD 1318R (for iSLN), IMD 1317R (for glossopharyngeal nerve), and / or IMD 1319R for carotid sinus nerve (CSN) (e.g., nerve branch 9212, carotid body 9216, and / or carotid sinus 9214 in FIGS. 39A-39E). In some examples, both implant-access incisions 2110D, 21 10E may be implemented in order to enable bilateral engagement (e.g., stimulation and / or sensing) of the respective target tissues, while in some examples, just one of the respective implant-access incisions 2110D, 21 10E are implemented for unilateral stimulation of such target tissues.

[0248] In some examples, the implantation of IMDs for any particular group of target tissues via one of the implant-access incisions 21 10D, 2110E, 2110F, 21 10G may be implemented on a case-by-case basis.

[0249] In some examples, all four implant-access incisions 2110D, 2110E, 21 10F, 21 10G may be implemented at one time, i.e. in a single surgical procedure. In some such examples, this arrangement may be implemented for patients having at least one demographic parameter (e.g., values of such parameters) indicating a likelihood of being non-responsive (e.g., not achieving therapeutically effective treatment) to activation (e.g., stimulation) of a single target tissue (e.g., hypoglossal nerve such as via IMD 131 OR and / or 1310L).

[0250] In some examples, instead of exhibiting a single demographic parameter (e.g., FIGS. 30B-30G), a given patient may exhibit multiple demographic parameters, which together may increase a likelihood of being non-responsive to SDB treatment via activation (e.g., stimulation) of a single target tissue.

[0251] In some such examples, by implanting multiple IMDs in a single surgical procedure, the example arrangement may significantly increase a likelihood of achieving a clinically efficacious SDB treatment at least because the various IMDs may address the various demographic parameters without follow-up diagnosis, separate / additional surgical procedures, etc.

[0252] Moreover, in some examples, by using a single implant procedure at the outset of a SDB neurostimulation treatment plan for a given patient, and particularly for those who exhibit demographic parameters associated with a higher likelihood of being non-responders to neurostimulation of a single target tissue (e.g., hypoglossal nerve), implanting a plurality of IMDs for multiple different target tissues (e.g., FIGS. 14K, 14L, 14M, etc.) may enable foregoing one or more sleep studies, enable achieving clinically efficacious therapy sooner, and / or enable a reduction in a number of surgical procedures over the patient’s lifetime. In some such examples, a treatment plan may comprise promptly implementing example arrangements such as (but not limited to) the at least some aspects of the example implementations in association with at least FIGS. 29-31 D (which may, in turn, implement aspects of various examples throughout the present disclosure) to implement activation (e.g., stimulation) and / or sensing of the most effective combination of target tissues for particular demographic parameters.

[0253] For instance, in some examples, a given patient may exhibit obstruction via a demographic parameter (e.g., 10521 in FIG. 30C) associated with significant partial concentric collapse or a complete concentric collapse (CCC) for which solely activating the hypoglossal nerve (e.g., to activate at least protrusor muscles) may not adequately ameliorate or prevent such clinically significant obstructions of the upper airway, in at least some patients. In such instances, the activation of one or more target tissues in addition to activating (e.g., stimulating) the hypoglossal nervemay prevent or mitigate such obstructions. In some such examples, the one or more target tissues may comprise an IHM-innervating nerve (IHMN) (e.g., 826 in FIG. 14A), a phrenic nerve (e.g., 840 in FIG. 14A), a glossopharyngeal nerve (e.g., 844 in FIG. 14A), an internal superior laryngeal nerve (iSLN) (e.g., 846 in FIG. 14A), and / or a carotid sinus nerve (CSN) (e.g., 847 in FIG. 14A; nerve branch 9212, carotid body 9216, and / or carotid sinus 9214 in FIGS. 39A-39E). It will be understood that each of the aforementioned target tissues (in association with example arrangement 3250) may invoke different physiologic mechanisms, pathways, etc., in order to prevent or mitigate the concentric collapse (e.g., partial significant or complete). For instance, in some examples, activation of at least the IHMN (e.g., 826), of portions of the glossopharyngeal nerve (e.g., 844), and / or of the phrenic nerve (e.g., 840 in FIG. 14A) may cause or contribute to increasing dilation of and / or stiffening lateral walls (e.g., pharyngeal lateral wall) in at least the oropharynx portion (e.g., 3562 in FIG. 27E) of the upper airway (e.g., upper airway portion 3550 in FIG. 27E). The particular physiologic mechanisms of doing so are further described in various examples of the present disclosure which are germane to those respective target tissues (including muscles innervated by such nerves).

[0254] However, in some examples, the order of implantation (and / or deployment) of the various IMDs (via the respective implant-access incisions 21 10D, 21 10E, 21 1 OF, and / or 21 10G) may be implemented according to at least some of substantially the same features as the example arrangements of FIGS. 29-31 D.

[0255] FIG. 14M is a diagram schematically illustrating an example arrangement 3270 which comprises at least some of substantially the same features as the example arrangement 3250 of FIG. 14L, except for comprising fewer implant access incisions (e.g., 211 OH, 21101) and / or locating the implant-access incisions (e.g., 21 1 OH, 21 101) along or near a sagittal midline 1317. In some examples, this arrangement 3270 may comprise implementing implant-access incision 211 OH to implant IMDs 1310R, 1310L, 1318R, 1318L, 1317R, 1317L, 1319R, and / or 1319L relative to their respective target tissues (e.g., hypoglossal nerve, iSLN, glossopharyngeal nerve, and carotid sinus nerve). Meanwhile, in some examples,this arrangement may comprising implementing implant-access incision 21101 to implant IMDs 1314R, 1314L, 1316R, and / or 1316L relative to their respective target tissues (e.g., IHMN (e.g., branches thereof), phrenic nerve, etc.).

[0256] FIG. 15 is a diagram illustrating an example arrangement 2175 like that of example arrangement 800 of FIG. 7, with particular focus on example implementations for sensing via an accelerometer (XL), as well as activation of an iSLN 846 or glossopharyngeal nerve 844 as a target tissue, without or with activation of other target tissues such as a hypoglossal nerve 822, IHM-innervating nerve (IHMN) 826, in some examples. The example arrangement may comprise an example implementation of, and / or at least some of substantially the same features as, the example arrangement 1500 in association with FIG. 10, FIGS. 11 -13, and / or other various examples in the present disclosure.

[0257] As a specific, and non-limiting example, as represented by “A (ES)” in Column 282 the afferent fibers of the iSLN 846 may be activated (e.g., electrically stimulated) via a first IMD (e.g., 260 in FIG. 2) to elicit (via the CNS) the previously described upper airway reflex opening response that activates at least some of the target tissues, such as (but not limited to) the hypoglossal nerve 822, the IHMN 826, which in turn causes activation (e.g., contraction) of their innervated muscles (e.g., upper airway dilators, such as the genioglossus muscle 824 and IHMs 828).

[0258] In some such examples, such activation may be triggered by or timed in relation to respiration sensed via an accelerometer (XL), as represented in Column 81 1 of FIG. 15, and consistent with previously described example (e.g., FIGS. 10- 1 1 ) and / or later described examples (e.g., FIGS. 26A-26B). The accelerometer may form part of the first IMD, be part of a second IMD, or even comprise a third IMD.

[0259] However, instead of or in addition to the accelerometer-based sensing, in some examples, as represented via “N” in Column 811 of FIG. 15, a neural signal may be sensed from the iSLN 846 and / or glossopharyngeal nerve 844 may indicate an upper airway obstruction is occurring and act as a trigger to activate target tissues to alleviate the obstruction. In some examples, this sensing may be performed viathe same IMD (e.g., a first IMD) by which the afferent fibers of the iSLN 846 (and / or glossopharyngeal nerve 844) are activated.

[0260] For some patients, activating afferent fibers of the iSLN 846 (and / or glossopharyngeal nerve 844) to cause the reflex opening response may not be effective in increasing upper airway patency to a sufficient degree to ameliorate obstructive sleep apnea. In response, additional target tissue (e.g., 282, 284) may be activated via a second IMD (e.g., 262) such as activating the IHMN 826 or IHM 828 or such as activating the hypoglossal nerve 822. In some such examples, other information indicative of a disease burden (e.g., AHI) (e.g., DB in FIG. 7; 3308 in FIG. 26A) may additionally or alternatively indicate to activate the additional target tissue(s).

[0261] These arrangements associated with FIG. 15 provide additional examples by which at least two different IMDs (e.g., 260, 262) may work in a complementary manner toward achieving the same general physiologic effect (e.g., increasing upper airway patency) but via activating significantly different neural pathways.

[0262] FIG. 16 is a diagram 2200 schematically representing an example IMD 2220 within a patient. The IMD 2220 includes a first element 2222 and a second element 2224 implanted in a patient. In some examples, the IMD 2220 may comprise at least some of substantially the same features as, and / or an example implementation of at least some features of, the examples described in association with FIGS. 1 -15 and 17A-43. In some examples, the IMD 2220 may comprise an activation element (e.g., electrical stimulation element) which may be implanted in a head 612 or neck region 614 of the patient. In some such examples, the first element 2222 may comprise a power / control element such as (but not limited to) an implantable pulse generator (IPG). In some examples, the IMD 2220 may comprise an implementation and / or at least some of substantially the same features as, and / or an example implementation of at least some features of, the example microstimulator as further described herein in association with at least FIGS. 38B-38D.

[0263] In some examples, the entire IMD 2220 is sized and / or shaped to be implanted within the neck region 614, and in some examples, the entire IMD 2220may be sized and shaped for non-muscular, extra-vascular implantation. In some such examples, a non-muscular implantation location may comprise a location in which the entire IMD 2220 (or a least a portion thereof) is located adjacent to a muscle, between muscles, and the like but in which the entire IMD 2220 (or at least a portion thereof) is external to the muscle (e.g., a belly of the muscle) such that the IMD 2220 is not embedded within the muscle. This arrangement stands in sharp contrast with at least some non-example IMDs which may be injectable via a hypodermic needle into muscular tissue (e.g., embedded within the muscular tissue) and / or which may be sized / shaped for intravascular delivery. However, it will be understood that IMD 2220 is merely an example and that at least some example IMDs described throughout various example of the present disclosure may be sized and shaped for intravascular delivery and / or for delivery via an introducer or needle (e.g., into a muscle).

[0264] In some example, at least a portion of the IMD 2220 (e.g., an IPG) is located in a body region that is different from the body region than the activation element is implanted. For example, the IMD may be located in a pectoral region of the patient, which is not in the neck region 614, as further described herein.

[0265] In some examples, as later shown in FIG. 17D, the first element 2222 may comprise the entire IMD 2220 such that IMD 2220 is lead-less.

[0266] In some examples, as shown in FIG. 16, the second element 2224 of IMD 2220 includes a lead body 2227, which may extend perpendicular to the longitudinal axis of a housing 2225 of the first element 2222, in some examples. In some instances, the entire second element 2224 may sometimes be referred to as a lead. Via this configuration, the lead body 2227 may be placed in the neck region 614 without making sharp turns (e.g., 90 degree turn) along a length of lead body 2227 relative to a longitudinal axis of a housing 2225 of the first element 2222. Accordingly, surgical implantation of the lead 2224 including lead body 2227 (and IMD 2220 generally) may be simplified and / or less stress may be applied to the lead body 2227. Moreover, this generally perpendicular configuration may enhance theability to anchor the first and second elements 2222, 2224 relative to non-nerve tissues within the head-and-neck region (612, 614).

[0267] In some examples, such as shown in FIG. 16, a conductive element 2230 (e.g., electrode portion) of the second element 2224 (e.g., lead) may be aligned / positioned for stimulation of a target tissue (e.g., infrahyoid-muscle (IHM)- innervating nerve and / or IHM) such as (but not limited to) those listed in Column 820 of FIG. 7. However, it will be understood that the first and second elements 2222, 2224 may be implanted in a wide variety of positions, orientations, etc. within the head-and-neck region (612, 614) to be placed in stimulating relation to a wide variety of nerves, nerve branches, muscles, and / or combinations thereof.

[0268] As one example implementation of the examples of at least FIGS. 1 -4, the IMD 2220 of FIG. 16 may comprise an activation element (e.g., 261 B in FIG. 2; 292 in FIG. 3; 617 in FIG. 4) for delivering therapy and / or sensing element (261 A in FIG. 2; 292 in FIG. 3; 628 in FIG. 4) to sense information pertinent to the therapy. The IMD 2220 also may comprise a power element and communication element (e.g., 294, 296 in FIG. 3). The first element 2222 may include an electrical connector to which an electrical connector 2226 at a proximal portion of the lead body 2227 is connected. The second element 2224 (e.g., lead) may include a wire (e.g., electrical conductor) extending through its length, and at least one conductive element (e.g., electrode) 2230 (e.g., stimulation electrode and / or sensing electrode) on a distal portion of the lead body 2227. In some examples, the second element 2224 may also include an antenna (e.g., coil antenna or RF antenna). The at least one conductive element (e.g., electrode) 2230 (e.g., cuff electrode, axial electrode, etc.) is electrically connected, via the at least one wire within lead body 2227 and the electrical connector 2226, to circuitry (e.g., stimulation circuitry, sensing circuitry), which resides within housing 2225 of first element 2222. In some examples, the second element 2224 may support independent addressability of a plurality of electrodes 2930 (e.g., 2, 3, 4, 5, 6, 7, 8, or more) that are electrically connected to circuitry of first element 2222 through a plurality of wires (e.g., extending through the lead body 2227) and the electrical connector 2226.

[0269] FIG. 17A illustrates an example device 2250 including a first element 2222 and second elements (e.g., leads) 2274A, 2274B. In some examples, device 2250 includes at least some of substantially the same features as IMD 2220 of FIG. 16, except that device 2250 comprises includes two second elements 2274A, 2274B (each including a lead body 2227A, 2227B, respectively) and associated respective conductive elements 2230A, 2230B) instead of just one second element 2224 (and lead body 2227) and one conductive element 2230. Each second element 2274A, 2274B may include a first portion (e.g., proximal portion) including an electrical connector 2226, at least one first wire, and at least one first conductive element 2230A, 2230B on an opposite second portion (e.g., first distal portion) of the second element 2274A, 2274B. As shown in FIG. 17A, in some examples the respective second elements 2274A, 2274B extend outward from opposite sides of the housing 2225 of first element 2222. The second elements 2274A, 2274B may comprise at least some of substantially the same features as the second element 2224 in FIG. 16 such as (but not limited to) at least one wire extending through a length of the lead body 2227A, 2227B (respectively) and the at least one conductive element 2230 described with reference to FIG. 16.

[0270] In some examples, using at least two second elements 2274A, 2274B (and two corresponding at least one conductive elements 2230A, 2230B) extending from opposite sides of first element 2222 enables reaching target tissues in different directions (e.g., opposite) from housing 2225 of first element 2222.

[0271] For instance, in some examples, the device 2250 may be implanted in a lower portion of neck region 614, such as superior to the clavicle 692 or the manubrium 693 (e.g., FIG. 5), at which one lead (e.g., 2274A) may extend to be in stimulating relation to an IHM (e.g., 828 in FIG. 7; e.g., STM 1244 in FIG. 8) and / or an IHMN (e.g., 826 in FIG. 7; e.g., 1242 in FIG. 8) distal to the ansa cervicalis nerve loop (e.g., 1219 in FIG. 8). The other lead (e.g., 2274B) may extend to be in operational relation to other target tissues related to treating sleep disordered breathing (SDB) including obstructive sleep apnea. However, in some examples, the other lead 2274B is positioned to be in sensing relation to other target tissues(e.g., respiratory tissues) to facilitate stimulation therapy for treating sleep disordered breathing (e.g., obstructive sleep apnea). In some examples, the other target tissues may comprise a phrenic nerve and / or diaphragm muscle to sense respiration and / or other physiologic parameters suitable to facilitate stimulation therapy for treating sleep disordered breathing (e.g., obstructive sleep apnea).

[0272] In some examples, the sensed respiration may be used for providing closed loop stimulation in which a timing of the stimulation is based on the sensed respiratory information. However, in some examples, the stimulation may be an open loop stimulation (e.g., in which stimulation timing is not based on sensed respiration) and the sensed respiratory information may be used for other purposes to facilitate SDB treatment. Of course, the two lead arrangement is not limited to use with the above-mentioned stimulation and sensing targets.

[0273] FIG. 17B illustrates an example device 2275 comprising at least some of substantially the same features as example device 2250 (FIG. 17A) except that the respective second elements 2274A, 2274A of device 2275 are connected to opposite ends 2223A, 2223B of the housing 2225 of first element 2222 which may provide greater flexibility in positioning the respective leads 2274A, 2274B relative to target tissues which are located in opposite directions from a location at which the housing 2225 of the first element 2222 may be anchored within the patient’s body.

[0274] While the leads 2274A, 2274B in FIG. 17A are illustrated as extending from opposite ends of the electrical connector 2226, in some examples, the leads may extend from the same sidewall of electrical connector 2226, from adjacent sidewalls (e.g., perpendicular sidewalls) of electrical connector 2226, and / or from the end wall of the electrical connector 2226. This principle similarly applies to the example of FIG. 17B.

[0275] In addition, while two leads are illustrated in either FIG. 17A or FIG. 17B as extending from the first element 2222, in some examples, more than two leads 2274A, 2274B may extending from the first element 2222.

[0276] FIG. 17C illustrates an example device 2280 including a first element 2222 and a second element 2284. In some examples, device 2280 includes at least someof substantially the same features as IMD 2220 of FIG. 16 (or FIGS. 17A-17B), except that instead of the lead body 2227 of second element 2284 (lead) extending perpendicular (e.g., 90°) to the longitudinal axis 2253 of the housing 2225 of the first element 2222, in device 2280 the lead body 2227 extends at an angle theta (0) relative to the longitudinal axis 2253. In some examples, the angle theta (6) may be within a range between 0° and 90° (e.g., 10°, 20°, 30°, 45°, 60°, 80°). While device 2280 illustrated in FIG. 17C includes one lead 2284, in some examples, device 2280 may include more than one lead (as in FIGS. 17B or 17C) and at least one of the multiple leads may be connected at a non-perpendicular angle relative to the longitudinal axis 2253 of the housing 2225 of the first element 2222. In some such examples, the angle theta (0) for each lead may be the same or different and each lead may extend from the same sidewall of electrical connector 2226, from adjacent sidewalls (e.g., perpendicular sidewalls) of electrical connector 2226, and / or from the end wall of the electrical connector 2226.

[0277] FIG. 17D is a diagram illustrating an example IMD 2290, which may comprise at least some of substantially the same features as the examples of FIGS. 16-17C, except comprising a leadless implementation omitting a lead (e.g., second element 2224, 2274A, 2274B, 2284). As shown in FIG. 17D, the IMD 2290 comprises a first element 2292 (like 2222 in FIGS. 16-17C) and an array 2294 of electrodes 2295, which may be used for activating (e.g., electrical stimulation) target tissue and / or for sensing physiologic phenomenon. It will be understood that the electrodes 2295 may be located on a single surface or multiple different surfaces (e.g., ends, sides, top, bottom, etc.) of a housing 2225 of the first element 2292, that array 2292 may comprise a greater or fewer number of electrodes 2295. In some such examples, the first element 2292 also may comprise additional or other sensing elements contained within a housing 2225 of the first element 2292. At least some such sensing elements may be implemented according to the example sensing portions 3300, 3400 of FIGS. 26A, 26B, and / or sensing examples throughout the present disclosure.

[0278] At least FIGS. 16-17D support further example implementations. For instance, in some examples a method may comprise providing at least one electrical stimulation element on an external surface of a housing of each respective first and second IMD and / or as at least one lead extending from the housing. In some examples, the at least one lead comprises a first lead and a second lead, with each respective first and second lead comprising at least one stimulation electrode.

[0279] In some examples, an example method and / or device may comprise at least one of: implementing the selective operation of the first IMD via stimulating the first target tissue via the at least one stimulation electrode of the first lead of the first IMD and stimulating the second target tissue via the at least one stimulation electrode of the second lead of the first IMD; or implementing the selective operation of the second IMD via stimulating the first target tissue via the at least one stimulation electrode of the second lead of the second IMD and stimulating the second target tissue via the at least one stimulation electrode of the second lead of the second IMD. In some such examples, the example method may comprises at least one of: (A) implementing the selective operation of the first IMD via sensing the first target tissue via the first lead of the first IMD and / or sensing the second target tissue via the second lead of the first IMD; or (B) implementing the selective operation of the second IMD via sensing the first target tissue via the second lead of the second IMD and / or sensing the second target tissue via the second lead of the second IMD.

[0280] In some examples, a method may comprise at least one of: (A) implementing the selective operation of the first IMD via stimulating a first site of the first target tissue via the at least one stimulation electrode of the first lead of the first IMD and stimulating a second site of the first target tissue via the at least one stimulation electrode of the second lead of the first IMD; or (B) implementing the selective operation of the second IMD via stimulating a first site of the second target tissue via the at least one stimulation electrode of the second lead of the second IMD and stimulating a second site of the second target tissue via the at least one stimulation electrode of the second lead of the second IMD.

[0281] It will be further understood that similar example arrangements of first and second leads, electrodes, housings, etc. may be implemented relative to target tissue (e.g., a single target tissue or multiple, different target tissues) solely for sensing, i.e. without applying stimulation. For example, an IMD may comprise an IPG implanted in a pectoral region with elements (e.g., activation and / or sensing elements) implanted in the head-and-neck region of the patient, and with lead(s) extending between and connecting the IPG and the elements.

[0282] It will be further understood that the present disclosure is not limited to the examples of FIGS. 16-17D and that a wide variety of differently configured first elements (e.g., 2222, 2292) and second elements (e.g., 2224, 2227A, 2227B, 2284) may be employed to achieve activation and / or sensing of target tissue.

[0283] FIGS. 18A and 18B are diagrams illustrating an example arrangement 2500 and 2550, respectively, in which multiple IMDs such as first IMD 260 and a second IMD 262 are in communication (e.g., wireless) with each other directly (e.g., FIG. 18A) or indirectly via a third device 2553 (e.g., FIG. 18B), respectively.

[0284] In some examples, the first IMD 260 and / or second IMD 262 of FIGS. 18A- 18B may comprise at least some of substantially the same features as the IMDs (and related methods, components, associated target tissues for sensing, stimulation) of the examples of at least FIGS. 1 -17D and FIGS. 18C-43.

[0285] FIG. 18C illustrates one example arrangement 5200 implementing at least some aspects of the arrangements 2500 and / or 2550 of FIGS. 18A-18B. In particular, example arrangement 5200 comprises a first IMD 5260 (like 260 in FIG.2) and a second IMD 5262 (like 262 in FIG. 2) in wireless communication (e.g., intrabody) with each other as represented via arrow 5210. The first and second IMDs 5260, 5262 may be implanted within a single body region 5205 (e.g., neck 614 in FIGS. 4, 6). At least one body portion 5207 is interposed between the first and second IMDs 5260, 5262 as each IMD 5260, 5262 is positioned to be in operable relation (e.g., sensing and / or stimulating relation) with a different respective target tissue (e.g., 272, 274, 282, 284 in FIG. 2) which may be spaced apart from each other within the body region 5205 (or multiple body regions in other examples). Aspreviously described in association with at least FIG. 3 regarding communication element 296, the at least one body portion may comprise one or more types of tissues, organs, etc. with the first IMD 260 and second IMD 262 separated by a distance D10 through which conductive communication may be implemented via one of the previously described intra-body wireless communication modalities. In some such examples, the at least one body portion 5207 may sometimes be referred to as a conductive medium through which the wireless communication signal may be transmitted and / or received.

[0286] In some examples, in order for the intra-body wireless communication to be reasonably robust and effective, one example method may determine a selectable maximum distance (predetermined distance) D10 of separation (between first IMD 5260 and second IMD 5262) as a function (at least) of the selected communication signal modality as well as the type(s) and / or volume of anatomy forming the at least one body portion 5207 between the first IMD 5260 and second IMD 5262.

[0287] For at least some examples employing the arrangement of FIGS. 18A or 18B, each of the first IMD 260 and second IMD 262 may comprise one or more electrodes (e.g., electrically conductive elements) in a manner similar to that described for conductive elements 2230A, 2230B, 2295 of FIGS. 17A-17D. In some such examples, as shown in FIG. 18C, at least one of the first IMD 5260 and the second IMD 5262 may comprise a housing 5270 comprise a plurality of electrodes 5274 distributed on one or more different surfaces (e.g., 5272F, 5272X, 5272L, 5272R, 5272T, 5272B). The housing 5270 may sealingly encapsulate components configured for sensing, stimulation, monitoring, power, and / or communication, with such components cooperating to comprise an implantable pulse generator (IPG) in some examples.

[0288] As further shown in FIG. 18C, in some examples multiple electrodes 5274 may be located on at least some of the different surfaces 5272F-5272B of housing 5270. In some such examples, at least one of the electrodes 5274 on each of the first and second IMDs 5260, 5262 may be used for communication whether thatparticular electrode is also used for sensing and / or stimulation or that particular electrode is used solely for communication.

[0289] With these aspects in mind, in some examples conductive wireless communication within the body (e.g., entirely through the body) may be implemented between an electrode 5274 of the first IMD 5260 and an electrode 5274 of the second IMD 262.

[0290] Given the available multiple electrodes 5274 of first IMD 5260 and multiple electrodes 5274 of second IMD 5262 in the body region 5205, one example method comprises selecting a pair of electrodes (including one electrode 5274 from the first IMD 5260 and one electrode from the second IMD 5262) by which robust and stable intra-body wireless communication may be implemented between the respective IMDs 5260, 5262. The determination of which electrodes (of the first IMD 5260, second IMD 5262) form the preferred electrode pair may be based on at least a relative location within the body region 5205 (e.g., neck 614) and / or orientation of the first and second IMDs 5260, 5260 relative to each other according to which electrode pair provides the best signal strength upon applying a test signal using the various combinations of electrode pairs from the first IMD 5260 and second IMD 5262. In some examples, determining the preferred electrode pair also may be based on other factors such as (but not limited to): (1 ) which intra-body wireless communication modality is used for such testing and communication; (2) which types and / or volumes of tissues, organs, etc. form the at least one body portion 5207; (3) a distance between the respective IMDs 5260, 5262.

[0291] In some examples, a control portion (e.g., 680 in FIG. 5; 14500 in FIG. 42A) and / or other features of the examples of the present disclosure may be used to support and implement the determination of the preferred electrode pair, operating the communication modality, implementing the communications to support uses of the IMDs for SDB care.

[0292] It will be further understood that at least some of the electrodes 5274 and / or other electrodes on housing 5270 (or otherwise associated with the respective IMD 5260, 5262) may be used for sensing and / or stimulation in order to implement amethod of sleep disordered breathing (SDB) care (e.g., sensing, monitoring, and / or therapy, etc.).

[0293] While the examples of FIGS. 18A-18C correspond to at least some examples which may be implemented via intra-body communication methods, in some examples communication between first IMD 5260 and second IMD (5262 or 5362) may alternatively (or additionally) be implemented at least partially outside (e.g., external to) the body through the ambient environment with such communication occurring via higher RF frequencies (e.g., at / greater than 100 MHz), as previously described.

[0294] FIG. 18D illustrates another example arrangement 5300 (e.g., method and / or device) by which intra-body communication between a first IMD 5260 and a second IMD 5362 may be implemented. In some examples, arrangement 5300 (including first IMD 5260 and / or second IMD 5362) of FIG. 18D may comprise at least some of substantially the same features as the arrangements and IMDs (and related methods, components, associated target tissues for sensing, stimulation) of the examples of at least FIGS. 1 -18C and FIGS. 18E-43. In the example arrangement 5300, one of the first and second IMDs (e.g., first IMD 5260) in FIG. 18D may comprise generally the same features as first IMD 5260 in FIG. 18C. However, one of the first and second IMDs (e.g., second IMD 5360) in FIG. 18D may have at least some features different from example arrangement 5200 in FIG. 18C.

[0295] In particular, as shown in FIG. 18D, the second IMD 5362 may comprise a lead 5376 including a lead body 5377 having a proximal end connected to, and extending from, housing 5370 to support an electrode-carrier combination 5380 at distal end of lead body 5377. The electrode-carrier combination 5380 may comprise a non-conductive carrier 5382 to support and carry electrodes 5385 therein for stimulation and / or sensing. In some such examples, the electrode-carrier combination 5380 may comprise a cuff electrode or other arrangement which may be releasably secured relative to a target tissue (e.g., nerve). In some examples, at least one electrode 5384 may be provided on an external surface of the non- conductive carrier 5382 for implementing conductive communication (as in FIG. 18C)with another IMD (e.g., electrode(s) 5274 of first IMD 5260). In some such examples, the electrode(s) 5384 may sometimes alternatively (or additionally) be used for sensing and / or stimulation.

[0296] In some examples, in addition to or instead of providing electrode 5384 for communication, the second IMD 5362 may comprise one or more “communication” electrodes 5275 distributed along at least a portion of the length of the lead body 5377. In some such examples, the electrode(s) 5275 may sometimes alternatively (or additionally) be used for sensing and / or stimulation relative to target tissue(s).

[0297] In a manner similar to the example arrangement 5200 of FIG. 18C, one example method comprises selecting an electrode from the electrodes 5274 of first IMD 5260 and an electrode from the electrodes (e.g., 5275, 5384) of second IMD 5362 to determine a preferred electrode pair for conductive communication between the first and second IMDs 5260, 5362.

[0298] In some examples, the housing 5370 of second IMD 5362 may contain components similar to housing 5270 (FIGS. 18C, 18D), and in some examples, housing 5370 may omit any “communication” electrodes on its exterior surface. However, in some examples, an exterior surface of the housing 5370 of second IMD 5362 may support or carrier sensing electrodes and / or stimulation electrodes.

[0299] In some further examples, an exterior surface of the housing 5370 may include “communication” electrodes (e.g., 5274, as in FIG. 18C) which, together with electrodes 5275 and / or 5384 of second IMD 5362 in FIG. 18D, may be selectable in the above-described example method of determining a preferred electrode pair for intra-body wireless communication between the respective IMDs 5260, 5362.

[0300] In some examples, an electrode carrier combination 5400 as shown in FIG. 18E (or a paddle electrode, etc.) may be used instead of the electrode carrier combination 5380 in FIG. 18D. The electrode carrier combination 5400 may comprise a non-conductive carrier 5403 supporting axially spaced apart ring electrodes 5402.

[0301] While the examples of FIGS. 18A-18C correspond to at least some examples which may be implemented via intra-body communication methods, insome examples communication between first IMD 5260 and second IMD (5262 or 5362) may alternatively (or additionally) be implemented at least partially outside (e.g., external to) the body through the ambient environment with such communication occurring via higher RF frequencies (e.g., at / greater than 100 MHz), as previously described.

[0302] In some examples, such extra-body wireless communication methods may be more likely to be implemented when the first IMD is spaced apart from the second IMD by a large distance such that intra-body wireless communication may not be feasible in some examples.

[0303] In at least some of the foregoing examples relating to communication paths and modalities, it will be understood that the communication element (e.g., 296 in FIG. 3) of an IMD (e.g., 260, 262, 5260, 5262, 5362 in FIGS. 2, 18A-18D) may comprise an antenna, coils, and / or electrically conductive arrangement by which higher frequency RF waves may be communicated. Accordingly, with regard to the examples of at least FIGS. 18C-18D, an antenna or similar arrangement may be located in at least some of the locations shown for communication electrodes on an external surface of a housing, along a lead body, and / or on / at an electrode-carrier arrangement. Moreover, in some examples, an antenna or similar arrangement may be located within a housing of an IMD and / or forming a portion of a wall of the housing. Furthermore, in some examples, communication element 296 of an IMD may be implemented via both an antenna (or similar arrangement) and communication electrode(s).

[0304] In some examples, at least some of substantially the same features of these example communication methods and modalities of FIGS. 18A-18E may be implemented as applicable to the later-described example arrangement 2970 of FIG. 23A and / or 2980 of FIG. 23B.

[0305] With further reference to at least FIGS. 18A, 18B, these example arrangements provide a foundation from which a wide range of examples may be implemented, as further described below. For instance, in some examples, the first IMD 260 and / or the second IMD 262 may be used to activate target tissue (e.g., 282,284 in FIG. 2) according to a closed loop operation (e.g., activation method), while in some examples, each of the first IMD 260 and / or the second IMD 262 may be operated individually to activate target tissue (e.g., 282, 284 in FIG. 2) according to an open loop operation (e.g., activation method). In some examples, such closed loop operation is implemented based on communication between the first IMD 260 and the second IMD 262. However, in some examples, such closed loop operation via the first IMD 260 is not based on communication or interaction with the second IMD 262, and vice versa. In some examples, the closed loop operation comprises implementing one or more parameters of the activation based on receiving sensed information or other information related to the therapy, while in some examples, the open loop operation comprises implementing one or more parameters of the activation independent of (e.g., not based on) receiving sensed information related to the therapy.

[0306] As further shown at 2560 in FIG. 19A, some example methods comprise activating (e.g., electrical stimulation or other) a first upper airway patency-related (UAPRT) via a first activation element of a first IMD (e.g., 260) and / or activating a second UAPRT via a second activation element of a second IMD (e.g., 262), including implementing the activation as a closed loop activation based on a first parameter.

[0307] As shown in at 2570 in FIG. 19B, some example methods comprise determining the first parameter via: receiving a physiologic state indicator; and / or receiving sensed physiologic information by sensing the first sensing tissue (e.g., 272 in FIG. 2), second sensing tissue (e.g., 274 in FIG. 2), and / or other physiologic phenomenon. Some such example methods may comprise implementing sensing of a first sensing tissue via the first IMD 260 independently of sensing the second sensing tissue via the second IMD 262. In some example methods, the activation (e.g., delivered stimulation) is synchronized and / or triggered relative to the first parameter, which may comprise a respiratory parameter, in some examples. The respiratory parameter may further comprise respiratory phase information.

[0308] Whether with regard to the example associated with FIG. 19B and / or other examples associated with at least FIGS. 19A, 19C-19D, in some examples the physiologic phenomenon to be sensed may comprise a physiologic phenomenon sensed via any one or more of the various sensors, sensing modalities, sensing elements, etc. described throughout examples of the present disclosure including (but not limited to) those enumerated in association with at least the sensing portions 3300, 3400 in FIGS. 26A, 26B, respectively.

[0309] In some examples associated with at least FIGS. 19A-19D, at least some of the same sensing portions 3300, 3400 in FIGS. 26A, 26B may be used to sense nonphysiologic phenomenon (e.g., 3480 in FIG. 26B, activation parameter, (e.g., 3470 in FIG. 26B, AP in FIG. 7, in some examples) resulting from the activation implemented by a first or second IMD (260, 262). In some examples, such nonphysiologic phenomenon (e.g., parameter 3480 in FIG. 26B) may include or relate to an electrical phenomenon (e.g., energy, signal, etc.) which comprises part of the activation (e.g., stimulation) and / or which comprises a non-physiologic effect of the activation.

[0310] As just one of many examples, some example methods may further comprise sensing, via the second IMD (e.g., 262 in FIGS. 2, 18A), the respiratory phase information at the phrenic nerve (e.g., 840 in FIGS. 7, 10, 14A, 15) as the second sensing tissue, and activating, via the first IMD (e.g., 260 in in FIGS. 2, 18A), the target tissue (e.g., 282 in FIG. 2) as an upper airway patency-related tissue (LIAPRT). In some examples, the LIAPRT comprises the hypoglossal nerve (e.g., 822 in FIGS. 7, 10, 14A, 15) and / or IHM-innervating nerve (IHMN) (e.g., 826 in FIGS. 7, 10, 14A, 15, STM (1244 in FIG. 8), SHM (1254 in FIG. 8)). In some examples, the sensed respiratory phase information may be used to implement closed loop activation in which timing of the activation is based on (e.g., coincides with, triggered by, etc.) the sensed respiratory phase information (e.g., inspiratory phase, in some examples). In some of these examples, the second IMD (e.g., 262 in FIGS. 2, 18A) may be implanted in a location superior, and in proximity, to a clavicle (e.g., 692R / 692L in FIG. 6, 692 in FIG.7) so that the second IMD (e.g., 262) is in closeproximity to an IHMN (e.g., 826 in FIGS. 7, 10, 14A, 15; 1242 in FIG. 8) and / or sternothyroid muscle (e.g., 828 / STM in FIGS. 7, 10, 14A, 15; 1244 in FIG. 8) in order to also activate (e.g., electrically stimulate) the IHMN (e.g., 826 in FIGS. 7, 10, 14A, 15) and / or sternothyroid muscle (e.g., 828 / STM in FIGS. 7, 10, 14A, 15). Meanwhile, in this example, the first IMD (e.g., 260 in FIGS. 2, 18A) is positionable to be in sensing relation to the phrenic nerve (e.g., 840 in FIGS. 7, 10, 14A, 15) to sense physiologic information, which may comprise respiratory phase information, in some examples.

[0311] Some such examples may be implemented via a single IMD instead of using two separate IMDs. For instance, in some examples, the sensing element (e.g., 261 A in FIG. 2) of the second IMD (e.g., 262 in FIGS. 2, 18A) may comprise at least one lead extending from a housing of the second IMD (e.g., 262), with the sensing element comprising a first element disposed on the lead and a second element located on an exterior of the housing of the second IMD (e.g., 262). In some of these examples, the second IMD 262 may be implanted in a location superior, and in proximity, to a clavicle (e.g., 692 in FIGS. 6,7, etc.) so that the second element (e.g., comprising stimulation electrodes) on the housing of second IMD (e.g., 262) is in close proximity to an IHMN (e.g., 826 in FIGS. 7, 10, 14A, 15) and / or sternothyroid muscle (e.g., 828 / STM in FIGS. 7, 10, 14A, 15) in order to activate (e.g., electrically stimulate) the IHMN (e.g., 826) and / or sternothyroid muscle (e.g., 828 / STM). Meanwhile, in this example, the first element (e.g., sensing electrodes) of the lead of the second IMD (e.g., 262 in FIGS. 2, 18A) is positionable to be at or in close proximity to the phrenic nerve (e.g., 840 in FIGS. 7, 10, 14A, 15) to sense physiologic information, which may comprise respiratory phase information, in some examples.

[0312] In some examples, the configuration may be reversed such that a housing of the second IMD (e.g., 262) is located at or in close proximity to the phrenic nerve (e.g., 840 in FIGS. 7, 10, 14A, 15) to position the second element on the housing for sensing the phrenic nerve (e.g., 840), and to position the first element on the lead of the second IMD (e.g., 262) is located at or in close proximity to the IHMN (e.g.,826) and / or sternothyroid muscle (e.g., 828 / STM) to use the first element to activate those tissues.

[0313] Some example methods may comprise, via the first IMD (e.g., 260 in FIGs. 2, 18A), activating the hypoglossal nerve (e.g., 822 in FIGS. 7, 10, 14A, 15) and sensing respiration (and / or other information) at the hypoglossal nerve (e.g., 822), and via the second IMD (e.g., 262 in FIGS. 2, 18A), based on the sensed respiration information at the first IMD (e.g., 260), activating the IHMN (e.g., 826 in FIGS. 7, 10, 14A, 15) and / or sternothyroid muscle (e.g., 828 / STM in FIGS. 7, 10, 14A, 15). Via this example arrangement, obtaining sensing information is simplified in that it is obtained from the first IMD (e.g., 260) which is already in sufficiently close proximity to the hypoglossal nerve (e.g., 822 in FIGS. 7, 10, 14A, 15) to be in activating relation to the hypoglossal nerve (e.g., 822) such that the same (first) IMD (e.g., 260) can be used to obtain a respiratory sensing signal. In this way, access, delivery, and implantation of the entire device is simplified.

[0314] In association with at least the example of FIG. 19A, as shown at 2580 in FIG. 19C, in some examples a method comprises determining the first parameter (see FIGS. 19A, 19B) via sensing, via at least one of the first IMD (e.g., 260 in FIGS. 2, 18A) and second IMD (e.g., 262 in FIGS. 2, 18A), a second parameter associated with activation of tissue implemented by a respective one of the first and second IMDs (e.g., 260, 262). The method also comprises implementing, based on the second parameter, the activation of target tissue by a respective other one of first and second IMDs (e.g., 260, 262).

[0315] More specifically, as shown at 2590 in FIG. 19D, in some examples, the second parameter comprises a physiologic phenomenon (e.g., 3474 in FIG. 26B) which is an effect of the activation (of target tissue) (e.g., 3472 in FIG. 26B) implemented by the second IMD (e.g., 262), while in some examples, the second parameter comprises an activation parameter (e.g., stimulation parameter) (e.g., 3470 in FIG. 26B) of the activation being implemented by the second IMD (e.g., 262). Moreover, as shown in FIG. 19D, in some examples, the second parameter comprises a physiologic phenomenon (e.g., 3474 in FIG. 26B) which is an effect ofthe activation (e.g., electrical stimulation) (e.g., 3472 in FIG. 26B) implemented by the first IMD (e.g., 260), while in some examples, the second parameter comprises an activation parameter (e.g., stimulation parameter) (e.g., 3470 in FIG. 26B) of the activation implemented by the first IMD (e.g., 260).

[0316] Some example implementations may employ a similar arrangement except without explicit or specific reference to a first parameter and / or a second parameter. For instance, in some examples, a method may comprise implementing activation of a target tissue (e.g., delivery of electrical stimulation) by a first IMD (e.g., 260) based on the first IMD (e.g., 260) sensing a first phenomenon (which may be a nonphysiologic phenomenon in some examples and / or a physiologic phenomenon in some examples) resulting from activation implemented via the second IMD (e.g., 262). Conversely, in some examples, a method may comprise implementing activation of a target tissue (e.g., delivery of electrical stimulation) by a second IMD (e.g., 262) based on the second IMD (e.g., 262) sensing a second phenomenon (which may be a non-physiologic phenomenon in some examples and / or a physiologic phenomenon in some examples) resulting from activation of target tissue implemented by the first IMD (e.g., 260).

[0317] In some examples, a method comprises implementing activation (of target tissue) by first IMD (e.g., 260 in FIGS. 2, 18A) based on the first IMD (e.g., 260) sensing physiologic phenomenon (e.g., 3474 in FIG. 26B) which is an effect of activation (of target tissue) (e.g., 3472 in FIG. 26B) implemented by the second IMD (e.g., 262 in FIGS 2, 18A). In some examples, a method comprises implementing activation (of target tissue) by the second IMD (e.g., 262) based on the second IMD (e.g., 262) sensing physiologic phenomenon (e.g., 3474 in FIG. 26B) which is an effect of activation (e.g., 3472 in FIG. 26B) implemented by the first IMD (e.g., 260).

[0318] While the previous examples involved two separate IMDs, in some examples a similar method may be implemented using just one IMD. Accordingly, in some examples a method comprises implementing activation (of target tissue) by the first IMD (e.g., 260) based on the first IMD (e.g., 260) sensing (a parameter of) activation (e.g., 3470 in FIG. 26B) being implemented by the first IMD (e.g., 260) orbased on the first IMD (e.g., 260) sensing a physiologic phenomenon (e.g., 3474 in FIG. 26B) which is an effect of activation implemented by the first IMD (e.g., 260). In some examples, a method comprises implementing activation (of target tissue) by the second IMD (e.g., 262) based on the second IMD (e.g., 262) sensing a parameter of activation (e.g., 3470 in FIG. 26B) being implemented by the second IMD (e.g., 262) or based on the second IMD (e.g., 262) sensing a physiologic phenomenon (e.g., 3474 in FIG. 26B) which is an effect of activation implemented by the second IMD (e.g., 262). In some such examples, an initial implementation of activation by the IMD (e.g., first IMD 260 or second IMD 262, respectively) may be occur without being based on the same IMD sensing a parameter of activation (e.g., 3470 in FIG. 26B) or sensing an effect (e.g., 3472 in FIG. 26B) of of such initial activation.

[0319] Via at least some of substantially the same features as, and / or as an example implementation of, at least the various examples associated with at least FIGS. 19A-19D and 20A-20D in some examples a method may comprise delivering therapy via a first IMD (e.g., one of IMDs 260, 262) which varies as a function of the first IMD detecting therapy (e.g., initiation, on-going delivery, etc.) delivered by a second IMD (e.g., one the other respective IMDs 260, 262). In some such examples, at least some aspects of this example method may comprise a first IMD 260 detecting or otherwise receiving information about an operational parameter by the second IMD 262 and the first IMD 260 then uses that detected (or received) operational parameter (from the second IMD 262) in order to execute an operational parameter of the first IMD, or vice versa. One example implementation of an operation parameter is represented as operational parameter 3740 in activation portion 3700 in FIG. 28A, which in some examples, comprises an auto-control parameter 3742, which controls a start, stop, and / or pause of activation (e.g., stimulation therapy) and / or controls some other operational function of an IMD (e.g., 260, 262).

[0320] In some examples, at least some aspects of this operational parameter may comprise (and / or be associated with, complementary of, etc.) an activation parameter (AP) and / or an activation effect (AE), as described elsewhere in variousexamples throughout the present disclosure. One example implementation of an activation parameter (AP) is represented by indicator 3750 in FIG. 28A as some aspect associated with an IMD implementing activation (e.g., stimulation therapy) of a target tissue, such as generating an activation signal, implementing an operation parameter (e.g., 3740 in FIG. 28A), and / or otherwise embodying characteristics of at least some of the various examples of an activation parameter as described throughout the present disclosure. In some examples, at least some aspects of the operational parameter may be represented via the second parameter in association with at least some of the example methods associated with at least FIGS. 19C, 19D, 20A. In some examples, such an activation parameter may be sensed, which is represented by indicator 3470 of sensing portion 3400 in FIG. 26A. In some examples, an activation effect (AE) may be sensed, which is represented by indicator 3472 of sensing portion 3400 in FIG. 26A, with the activation effect (AE) embodying characteristics of at least some of the various examples of an activation effect as described throughout the present disclosure.

[0321] In some such examples, the afore-mentioned operational parameter may comprise an auto-control parameter in which automatic control of the particular IMD (e.g.. 260, 262 in FIG. 2) is at least partially driven (e.g., determined) according to a sleep-wake status, determined via at least some sensing parameters (e.g., FIGS. 26A-26B) determined and / or received by the respective IMD(s). In some examples, the automatic control may comprise automatic starting (e.g., initial start or resuming after a pause), pausing, and / or stopping activation therapy (e.g., electrical stimulation therapy). At least some features associated with implementing operational control of one IMD based on sensing performed via another IMD, such as (but not limited to) sensing and determining sleep-wake status, is further described in association with at least some of the parameters of FIGS. 26A-26B and / or at least some of the sleep-related parameters of FIGS. 32J-32O.

[0322] In some instances, a patient may be confirmed to be a good candidate for implantable activation therapy (e.g., electrical stimulation) which maintains or increases upper airway patency. However, it may not be known which activatabletarget tissue (e.g., hypoglossal nerve, IHMN, other) to which the particular patient may be the most responsive under a particular set of conditions and / or a wide variety of circumstances, at least due to inherent limits of the screening process. Moreover, this situation may change over time (e.g., change in weight, health, etc.) such that initial determinations may be revisited at a later time and appropriate adjustments implemented.

[0323] With this situation in mind, in some examples at least two IMDs may be implanted at the same time, and then operate IMDs in different manners to determine, for a particular set of conditions among a wide range of conditions, which manner of operation of the two IMDs (and therefore which target tissues) produce the most efficacious response in maintaining or increase upper airway patency to prevent or counteract sleep disordered breathing (e.g., obstructive sleep apnea). Thereafter, an activation therapy protocol may be implemented in which a respective one (or both) of the at least two IMDs activate target tissues (e.g., 282, 284 in FIG. 2) and / or sense tissue (e.g., 272, 274 in FIG. 2) according to any particular set of conditions within a range of conditions.

[0324] With this in mind, FIG. 20A is a flow diagram schematically representing an example arrangement 2700 including an example device for, and / or example method of, using sensed data as feedback to adjust an intensity (e.g., strength) of, or other parameters, aspects, etc. regarding, activation of various target tissues such as, but not limited to, upper airway patency-related tissue (UAPRT). In some examples, as shown at 2760 in FIG. 20B, the example arrangement 2700 of FIG. 20A may be implemented at a post-implant initial therapy period, at selectable intervals after the “post-implant initial therapy period”, and / or on an ongoing basis (e.g., during life of the implanted device) in which each IMD of multiple IMDs is operated to vary at least some of the activation parameters and / or sensing parameters of each IMD to evaluate and potentially update activation parameters and / or sensing parameters in order to provide efficacious activation therapy for treating sleep disordered breathing. In some examples, adjusting an intensity of the activation (e.g., stimulation) of various target tissues may sometimes be referred to a titrating the activation therapy.Accordingly, in some examples the arrangement 2700 (e.g., method and / or device) in FIG. 20A may comprise one example implementation of, and / or may be implemented according to, titration parameter 3724 in FIG. 28A.

[0325] In some examples, such methods of the example arrangement 2700, may be performed via example arrangements 2500, 2550 of FIGS. 18A, 18B in which first IMD 260 and second IMD 262 may be in communication with each other, so as to operate in a manner based on information / operation of other respective IMD. For instance, as noted above, when first IMD 260 and second IMD 262 communicate with each other, each respective IMD may obtain sensed information from the other respective IMD. Accordingly, some such example methods may be implemented according to titration cooperation parameter 3725 in FIG. 28A.

[0326] However, in some examples, the example method described in association with at least FIG. 20A, 20B may be implemented according to the example arrangement of FIG. 21 while operating the first IMD and second IMD independently from each other, as further described later in association with at least FIG. 21. In these examples, a respective IMD does not determine its operation based on receiving sensed information (or other information) from the other respective IMD. Accordingly, some such example methods may be implemented according to titration independent parameter 3726 in FIG. 28A.

[0327] With further reference to example of FIG. 20A, in some such examples, the target tissue (e.g., 282, 284 in FIG. 2) may comprise an upper airway patency-related tissue (LIAPRT) (e.g., hypoglossal nerve, IHMN, etc.) and / or other airway patency- related tissues which may contribute to treating sleep disordered breathing. In some examples, the example arrangement 2700 may comprise at least some of substantially the same features and attributes as the example activation devices and / or methods previously described examples of the present disclosure (e.g., in association with at least FIGS. 1 -19D), including activation protocols, activation arrangements, etc. as described in association with at least FIGS. 28A-28B. In some examples, the sensing may comprise at least some of the same features andattributes as at least the later described sensing / control examples, such as but not limited to FIGS. 26A-26B.

[0328] As shown in FIG. 20A, example arrangement 2700 comprises a first IMD 260 and a second IMD 260, each of which include an activation element 261 B and / or sensing element 261 A, as in FIG. 2. An activation element 261 B of the respective IMDs 260, 262 activates (e.g., electrically stimulates) target tissues 282, 284, as previously shown in at least FIG. 2. It will be understood that the example arrangement is not limited to two IMDs, and that up to “N” IMDs may be utilized as part of example arrangement (method and / or device), wherein “N” is greater than 2. As noted later, in some examples even a single IMD may implement at least aspects of the example arrangement.

[0329] During and / or after such activation, sensed data may be used to evaluate the effectiveness of the activation, such as (but not limited to) in relation to a disease burden parameter (e.g., upper airway patency, apnea severity index, etc.). In some examples, the sensed data may comprise data 2722, 2732 sensed from the IMDs 260, 262 such as (but not limited to) the activation element(s) 261 B and / or sensing elements 261 A of the respective IMDs 260, 262 or other sensors on-board (e.g., in / on housing, on lead extending from housing, etc.) the IMDs 260, 262. In some examples, other sensors 2734 which are not part of the IMDs 260, 262 may provide sensed data 2733. The sensing elements 261 A and / or the other sensor(s) 2734 may comprise at least one of a plurality of sensing modalities, types, etc. such as (but not limited to) the sensing modalities, parameters, etc. of sensing portions 3300, 3400 of FIGS. 26A, 26B.

[0330] With further reference to FIG. 20A, at 2735, the sensed data is evaluated (e.g., checked) such as a sensed data evaluator and the value 2737 of the measured parameter(s) is fed to the generator (at 2740), which in turn generates activation signals (e.g., instructions) 2712, 2714, which may include updated (or maintained) activation settings (and / or sensing settings) which are fed as inputs to the first IMD 260 and second IMD 262 for implementing activation via an activation element 261 B (and / or implementing sensing via sensing element 261 A).

[0331] As shown in FIG. 20A, the example arrangement 2700 may comprise a control portion 2730 to implement the sensed data evaluator 2735 and / or generator 2740. As represented via dotted boxes 2730A, 2730B, 2730C, the control portion 2730 may be implemented as part of first IMD 260, second IMD 262, and / or other devices. The control portion 2730 may comprise at least some of substantially the same features as, and / or an example implementation of, the control portion 14500 of FIG. 42A. As apparent from the example of FIG. 20A and other examples (e.g., FIGS. 18A-18B, 19A-19D, 20B-20D, 26A, 26B, etc.) and in view of the at least some examples of the control portion (e.g., 2730, 2730A, 2730B, 2730C), in some examples one IMD (e.g., one of IMD 260 or IMD 262) may evaluate the effectiveness of another IMD (e.g., other respective IMD 260, 262), while in some examples, each IMD 260, 262 may evaluate effectiveness of its own operation, or even a third device (e.g., FIGS. 23A, 23B) may evaluate the effectiveness of IMD 260 and / or IMD 262. As later described in association with at least FIGS. 20B, 20C, 20D, 26A, 26B, etc., in some examples this evaluation may comprise evaluating a disease burden relative to a criteria. In some examples, this evaluation may result in one IMD (e.g., 260, 262) adjusting its settings or causing adjustment of settings of the other respective IMD (e.g., 260, 262) to modify (e.g., increase) an effectiveness of the respective IMDs in delivering SDB treatment. In some such examples, such adjustment may comprise utilizing at least some features of activation portion 3700 (FIG. 28A), prioritized order / deployment of IMDs relative to target tissues (e.g., FIGS. 29-31 D), etc. so as to adjust settings (e.g., timing, energy, duration, etc.) of activation (e.g., electrical stimulation), to adjust sensing settings (e.g., which sensing modalities, which target tissues to sense, which IMD(s) to use for sensing), and / or whether the IMDs would best work cooperatively or best work independently, etc.

[0332] In some examples, the above-described evaluation and / or adjustment also may be communicated to stakeholders such as (but not limited to) a clinician, patient, and / or third party (e.g., device manufacturer) such as via communication implemented via the example arrangement described in association with at least FIG. 42C-43 (e.g., generally FIGS. 41 A-43).

[0333] Among a broad range of various sensing data which may be used in the example arrangement 2700 in FIG. 20A, in some examples, the sensed data 2722, 2732, 2733 may comprise, and / or be used to determine, a disease burden parameter. In some examples, based on the sensed data per the operation of the first IMD 260 and / or second IMD 262, the example arrangement may implement a method (e.g., via generator 2740) such as shown at 2800 in FIG. 20C comprising operating the first IMD 260 and / or second IMD 262 (e.g., either or both IMDs 260, 262), and for each IMD (e.g., 260, 262) performing a comparison of a disease burden parameter relative to a criteria. In some such examples, this method may comprise sensing physiologic information to determine a disease burden (DB) parameter and adapt operation of the IMDs 260, 262 (e.g., independently or cooperatively) based on a comparison of the determined disease burden information relative to the criteria.

[0334] In some examples, the comparison of the disease burden parameter may be performed with respect to just one of the first and second target tissues. For instance, it may be understood that stimulation of a first target tissue (e.g., hypoglossal nerve or genioglossus muscle to cause tongue protrusion) is generally effective for most patients in treating obstructive sleep apnea. However, for some patients, despite such stimulation of the first target tissue, they still may experience obstructive sleep apnea regularly or perhaps just when they are sleeping in certain postures (e.g., supine) or for other reasons.

[0335] With this in mind and as illustrated by FIG. 20D, one example method 2850 comprises: (A) at 2852, activating, via a first IMD (e.g., 260), a first LIAPRT; and (B) at 2854, selectively activating, via a second IMD 262, a second UAPRT based upon comparison of a disease burden parameter relative to a criteria. In some such examples, the example method may further comprise implementing the activation of the first and second IMDs to include: (A) delivering electrical stimulation, via a first IMD 260, the first target tissue (e.g., a first UAPRT such as a hypoglossal nerve and / or genioglossus muscle) throughout a nightly treatment period; and (B) selectively delivering electrical stimulation via the second IMD to the second targettissue (e.g., a second LIAPRT such as IHMN and / or IHM) during the nightly treatment period based upon comparison of a disease burden parameter relative to a criteria.

[0336] In some such examples, the term “throughout a nightly treatment period” may comprise the stimulation being applied continuously within (e.g., occurring an entirety of) a time period according to a duty cycle. The continuous stimulation may comprise continuous pulsed stimulation synchronous with inspiration or may comprise continuous pulsed stimulation which is asynchronous relative to a respiratory cycle. In some examples, the time period may comprise a selectable time period, such as 10pm to 6am or other time frame, while in some examples, the time period may be implemented according to an automatic on / off feature based on detecting a sleep-wake status in which the time period begins when the treatment period is initiated upon detecting sleep and terminated upon detecting wake. In some such examples, such methods may permit temporary interruptions (e.g., pauses) during the time period to enable a patient to go to the bathroom or for other short term interruptions in their normal sleep pattern.

[0337] In some examples, the term “during the nightly treatment period” corresponds to the selective activation (e.g., stimulation) occurring at at least one period within the nightly treatment period instead of occurring during an entirety of the nightly treatment period in the manner defined above regarding “throughout the nightly treatment period.” For instance, in some such examples, this selective activation may be applied sparingly such as on an “on-needed” basis just when there is a temporary increase in the disease burden. However, it will be understood that for some patients, the selective activation based on the level of disease burden may sometimes comprise maintaining (e.g., implementing) the activation throughout the nightly treatment period because the particular patient exhibits a disease burden which requires on-going stimulation of the second target tissue in addition to the stimulation of the first target tissue.

[0338] As background, it will be understood that some patients which exhibit non- favorable therapeutic outcomes from stimulation solely of the first target tissue (e.g., stimulation causing tongue protrusion) may sometimes be referred as non-responders. However, via implementation of method 2850 (FIG. 20D) in which stimulation is selectively applied to a second target tissue (e.g., IHM-innervating nerve), the patient may become a responder in which they experience a successful therapeutic outcome.

[0339] It will be further understood that the example method 2850 in FIG. 20D also may be implemented conversely, such as comprising implementing the activation of the first and second IMDs to include: (A) delivering electrical stimulation via a first IMD 260 to the second target tissue (e.g., a second UAPRT such as IHM-innervating nerve (IHMN) and / or infrahyoid muscle (IHM) throughout a nightly treatment period; and (B) selectively delivering electrical stimulation via the second IMD to the second target tissue (e.g., a first UAPRT such as a hypoglossal nerve and / or genioglossus muscle) during the nightly treatment period based upon comparison of a disease burden parameter relative to a criteria.

[0340] In some examples, the target tissue (e.g., first and second UAPRT) may comprise nerves and / or muscles other than the hypoglossal nerve, genioglossus muscle, IHMN and / or IHM.

[0341] Moreover, in some examples a third UAPRT or other tissue (e.g., phrenic nerve, iSLN, etc.) may be generally activated (e.g., 2852) or selectively activated (e.g., 2854) in addition to, or instead of, the activation of a first UAPRT and / or selective activation of a second UAPRT.

[0342] In some examples, the disease burden parameter may comprise an apnea severity index (e.g., apnea-hypopnea index (AHI)) and / or an upper airway patency parameter, either of which may be based on more specific sensed information. The disease burden parameter also may be expressed with respect to sleep disruptions, arousals, and / or other parameters, etc. at least some of which are further described in association with at least sensing portion 3300 of FIG. 26A and / or sensing portion 3400 of FIG. 26B.

[0343] In some examples, when evaluating an apnea severity index, the criteria may comprise a threshold such as a quantitative value (e.g., selectable number of apnea events per hour (e.g., 5)). Upon the comparison yielding a conclusion thatthe apnea severity index exceeds a selectable threshold, the operation of the IMD (260 and / or 262) may be adapted to reduce the apnea severity index. For instance, if the apnea severity index for the patient (at a snapshot in time) is too high (e.g., equal to or exceeding 5 or some other selectable quantity per hour), via generator 2740, the operation of either (or both) IMD 260, 262 is adapted in an effort to reduce the disease burden. Among other adjustments, in some examples adapting the operation may comprise adjusting an amplitude energy of activation (e.g., electrical stimulation) and / or initiating activation of a target tissue (e.g., UAPRT) via the respective IMD in instances in which the respective IMD was inactive, etc.

[0344] In some examples in which the disease burden parameter comprises upper airway patency, as just one example, via activation elements and / or sensing elements of the IMDs (e.g., electrodes in some examples), a bio-impedance may be determined based on the location and spacing between such respective elements, and using the sensed impedance to determine a degree of upper airway patency. For example, a smaller cross-sectional area of the upper airway, which reflects less upper airway patency, may be sensed as a lower impedance. In some instances, the lower impedance may correspond to obstruction or partial obstruction of the upper airway, and hence, increased disease burden such as obstructive sleep apnea. Conversely, a larger cross-sectional area in the upper airway, which reflects more upper airway patency, may be sensed as a higher impedance. In some instances, the higher impedance may correspond to a lack of obstruction (or less obstruction) of the upper airway, and hence, decreased disease burden.

[0345] In some other examples, a large or larger degree of patency (measured as a higher impedance) may generally correspond to periods of activation of upper airway patency-related tissues (HGN, IHMN, and / or other tissues) or correspond to peak expiration of a respiratory cycle. Meanwhile, a small or smaller degree of patency (measured as a lower impedance) generally corresponds to inspiration, just prior to inspiration, or the onset of activation (e.g., HGN and / or IHMN).

[0346] In some examples, in addition to, or instead of, attempting to determine a degree of the upper airway patency, a disease burden parameter may comprise aposition of the tongue relative to a posterior pharyngeal wall, a contraction of the tongue (sensed via EMG), as well as a contraction, tone, or position of the posterior or lateral pharyngeal wall. In some such examples, these parameters may be determined before, during, or after specific respiratory phases such as (but not limited to) an inspiratory phase. Moreover, additional disease burden parameters or parameters contributing to determining a disease burden parameter may comprise an upper airway collapse pattern (e.g., FIGS. 27A-27G). Moreover, in some examples, the percentage of patency (e.g., openness) of the upper airway also can be expressed for different vertical levels (e.g., along a superior-inferior orientation) within the upper airway and the criteria (e.g., threshold) may be selectively adjusted for each different identified vertical level of the upper airway, either with or without regard to a specific collapse pattern.

[0347] In some examples, just one of multiple IMDs (i.e. not both IMDs) is configured to adapt its operation based on a disease burden parameter while other IMD maintains on-going activation therapy to treat sleep disordered breathing. For instance, as shown in example arrangement 2850 in FIG. 20D, at 2852 a method comprises activating, via a first IMD (e.g., 260 in FIGS. 2, 18A, 20A), a first tissue (e.g., 282 in FIG. 2). At 2854, the method comprises selectively activating, via a second IMD (e.g., 262 in FIGS. 2, 18A, 20A), a second tissue (e.g., 284 in FIG. 2) based on a comparison of a disease burden parameter relative to a criteria. In some such examples, the first tissue may comprise a first upper airway patency related tissue (UAPRT), and the second tissue may comprise a second UAPRT.

[0348] It will be understood that the comparison of the determined disease burden information relative to a criteria in FIG. 20A may be just one example method of determining an efficacy of operation of an IMD, such as (but not limited to) an effectiveness of sensing pertinent physiologic parameters and / or effectiveness of stimulating target tissue to treat sleep disordered breathing. Accordingly, the efficacy of operation of the first IMD 260 and / or second IMD 262 relative to target tissues may be determined via parameters other than a disease burden parameter. With regard to either of the examples of FIGS. 20C-20D, in some such examples, the firstIMD 260 and / or the second IMD 262 may operate in an open loop mode (e.g., activation is not synched or timed relative to respiratory phase information) or in a closed loop mode (e.g., activation is synchronized or timed relative to respiratory phase information).

[0349] With regard to either of the example arrangements of FIGS. 20C-20D, in some examples the determination of the disease burden and comparison relative to a criteria may be performed without posture information and / or without body position information. Accordingly, it will be understood that in some such examples this example method may sometimes be referred to as being not “posture-responsive therapy” in at least the sense that the method does not determine posture or body position in order to control the activation (other than sleep detection). In some examples, other parameters by which it may be determined whether to implement the second activation (upon comparison of a disease burden parameter relative to a criteria) may comprise tongue position, or pharyngeal wall tone, which may be used instead of AHI, absolute UAP, and / or posture.

[0350] In some examples, the disease burden parameter meeting the criteria (to justify selective activation of the second IMD 262) corresponds to the patient lying in a supine position during the nightly treatment session.

[0351] With further reference to the general framework of the example arrangement 2700 of FIG. 20A, among other adjustments, the determination made at 2735 in FIG. 20A may be used to balance a relative amount of activation to be applied via the first IMD 260 and / or the second IMD 262. For example, per some example determinations at 2735, balancing the activation comprises implementing activation solely via the first IMD 260, while per some example determinations at 2735, balancing the activation may comprise implementing activation solely via the second IMD 262. Moreover, per some example determinations at 2735, balancing the activation may comprise implementing the activation as some activation via the first IMD 260 and some activation via the second IMD 262 while controlling a relative proportion of the activation between the respective target tissues (e.g., hypoglossal nerve, IHM-innervating nerve (IHMN) (822, 826 in FIGS. 7, 10, 14A, 15)). In addition,to the extent that bilateral activation may be applied among example target tissues (e.g., a left HGN nerve, a right HGN nerve, a left IHMN, and / or a right IHMN (and / or other nerves)), the above-described adjustments may be made among those four nerves (or greater or a smaller number of nerve targets).

[0352] In some examples, generating the activation settings at generator 2740 (e.g., activation setting generator) may comprise considering other parameters in addition to, or other than, adjusting which target tissues (e.g., LIAPRT) are activated (and by how much). Such other parameters may comprise adjusting an intensity or strength of the activation at any given target tissue (e.g., HGN and / or IHMN)), whereby the strength adjustment may comprise adjustments in amplitude, pulse width, pulse frequency, duty cycle, pulse duration, and the like, at least some of which are described in association with and / or implemented via the activation portion 3700 in FIG. 28A. In some examples, additional adjustments may comprise whether activation of the nerves (e.g., left HGN, right HGN, left IHMN, and / or right IHMN, in some examples) are implemented simultaneously, alternately, in a particular sequence, randomly, and the like, such as described regarding parameters 3734, 3732, etc. in activation portion 3700 of FIG. 28A.

[0353] With further reference to FIG. 20A, in some examples, generating settings at 2740 may comprise setting whether IMD 260 and / or 262 operate (e.g., apply stimulation of target tissue(s)) in an open loop mode or a closed loop mode. In some such examples, implementing these settings may comprise evaluating for each IMD 260, 262 whether it is more effective to operate in an open loop mode or a closed loop mode. In some such examples, the evaluation may comprise evaluating which sensing modalities and / or sensing parameter(s) are most effective for each location of the respective IMDs 260, 262, respectively. As just one example, the evaluation may be based on the effectiveness of respiration sensing for each location of the respective IMDs 260, 262. In some such examples, a closed loop mode may implement a timing of stimulation based on sensed respiratory phase information whereas an open loop mode may include stimulating timing not being based on sensed respiratory phase information.

[0354] For instance, in making an evaluation of sensing modalities and / or sensing parameters, it may be determined that the second IMD 262 (at its particular location) provides more robust and / or accurate sensing than the first IMD 260, and the first IMD 260 (at its particular location) provides more robust and / or effective activation therapy activation (than at the location of the second IMD), or vice versa (e.g., best activation at second IMD 262, best sensing at first IMD 260). However, reaching such a conclusion does not necessarily exclude performing sensing and / or activation at the less robust or less effective locations because such locations can provide backup activation and / or backup sensing. Moreover, in some example methods, generator 2740 (and / or via control portion) may determine that a particular permutation (e.g., performing primary sensing via first IMD 260) functions best at home (e.g., as part of a suite of sensing modalities) but this particular permutation does not function as well during travel (e.g., when not at home), such that during travel the example method may switch to using second IMD 262 for primary sensing, or vice versa.

[0355] In some implementations of the example arrangement 2850 of FIG. 20D, a method comprises, outside of a nightly treatment session, switching the role of the respective first and second IMDs. In some such examples, via such switching, a method may comprise activating target tissue via the second IMD in an open loop mode (not synchronized relative to respiratory phase information) or in a closed loop mode in which stimulation is synchronized relative to respiratory phase information; and selectively implement activation via the first IMD based upon comparison of a disease burden parameter relative to a criteria, according to at least some of substantially the same features described above (e.g., AHI, quantitative UAP, tongue position, tongue tone, posture / body position, etc.). Among other reasons, switching the role of the first and second IMDs may enhance therapy when a patient changes position (e.g., supine to lateral or vice versa), experiences health changes (e.g., increase or reduction in BMI), and / or other reasons.

[0356] As shown in the example arrangement 2900 of FIG. 21 , a method comprises operating a first IMD 260 and a second IMD 262 independently from each other. Insome such examples, such methods comprise operating each respective first IMD 260 and second IMD 262 without communication between the first IMD 260 and the second IMD 262 directly or via an intermediary, as shown at 2910 FIG. 22A. In some of these examples, the first and second IMDs 260, 262 operating independently comprises the first IMD 260 and the second IMD 262 being “not electrically connected” (e.g., not having an electrically conductive lead extending between the first IMD 260 and the second IMD 262) and / or “not being mechanically connected”, such as not having a housing and / or other structure extending between the respective first IMD 260 and second IMD 262, or not having lead extending between the first IMD 260 and second IMD 262.

[0357] In some examples, the first IMD 260 and the second IMD 262 are spaced apart from each other by a first distance which exceeds a maximum distance of effective wireless intra-body communication. Accordingly, at least some examples of independent operation of the first IMD and second IMD address situations in which multiple IMDs are to operate in a same body region (or different body regions) with an objective of treating a single condition or related conditions but the anatomy, distance, etc. precludes intra-body communication between the multiple IMDs. In some such examples, the first distance may comprise about 30 centimeters.

[0358] However, in some examples the first IMD and second IMD may be located close enough to each other such that wireless intra-body communication may be feasible, but the example method (and / or example device) still implements operation of a first IMD and a second IMD independently from each other for other reasons. For example, in some instances, lower power consumption, reducing cost and / or achieving lower size, certain shape, by omitting communication elements by which such intra-body comms would be accomplished. In other instances, one of the implanted first and second IMDs may lack a communication element for intra-body communication such that even with later implantation of a respective IMD, first IMD and second IMD would still operate independently from each other. In some such examples, even if the first and second IMDs comprise an intra-body communicationelement, in some examples such intra-body communication element might not be compatible with a communication element of a later-implanted IMD).

[0359] However, as noted elsewhere, there are examples in which wireless communication may be implemented between two IMDs located in the same body region (e.g., neck) which does not occur solely on an intra-body basis. In some such examples, a wireless communication signal may be implemented via a higher radio frequency (RF) (e.g., over 100 MHz) in which the wireless communication signal emitted from a first IMD passes outside of the body and re-enters the body to be received at a second IMD. In some instances, such communication may sometimes be referred to as partial extra-body communication or partial intra-body communication.

[0360] In some examples associated with at least FIG. 21 , 22A, one or both of the first and second IMDs 260, 262 may omit at least portions of the communication element 296 and / or of power element 294 (FIG. 3) which are configured to transfer power, implement communications (e.g., data, control), etc. between the first IMD 260 and the second IMD 262. By doing so, each IMD 260, 262 may be constructed in a smaller volume (e.g., smaller footprint), which may ease implantation and / or strategic positioning of the IMD to be in sensing relation and / or activating relation (e.g., electrical stimulation) to a target tissue (and / or to ease anchoring relative to available tissues). In some such examples, the smaller volume and generally simpler circuitry may reduce cost (e.g., materials, design, etc.) while likely increasing reliability. In addition, with less circuitry, the IMDs 260, 262 may use less power, thereby reducing power constraints. As noted throughout various examples of the present disclosure, the example of independent operation in FIG. 21 of multiple IMDs (260, 262) provides additional benefits.

[0361] While at least some of the example arrangements in FIGS. 18A-25 comprise wireless connections and communication between respective IMDs (and / or portions thereof), in some examples a wired connection and / or communication extends between respective IMDs (or portions thereof). Even in the example arrangement 2900 of FIG. 21 in which a first IMD and second IMD operate independently fromeach other, in some examples a wired connection may extend between the respective first IMD and second IMD. In some such examples, this wired connection may provide for fixation, power sharing, and / or other functions.

[0362] Diagram 2920 in FIG. 22B illustrates an example arrangement 2922, which may comprise one example implementation of the example method 2900 in FIG. 21 in which a first IMD 260 and a second IMD 262 may operate independently of each other. This example arrangement 2922 may comprise and / or operate according to at least some of the principles of operation of example arrangement 2700 of FIG. 20A (and related examples. With this in mind, some such example methods of arrangement 2922 may comprise an example implementation of, and / or be implemented according to, titration independent parameter 3726 in FIG. 28A.

[0363] In some example implementations of the example arrangement 2922 of FIG. 22B, each respective first and second IMD 260, 262 performs its own evaluation (per evaluator 2735) of sensed data 2722 and generation (per generator 2737) of activation signals 2712 (including any adjustment of activation settings and / or sensing settings), according to their own respective control portion 2930A, 2930B, respectively. In other words, via this arrangement, independent from each other, the respective first and second IMDs 260, 262 automatically titrate their own sensing settings and / or activation (e.g., stimulation) settings in order to achieve a target therapeutic effect on upper airway patency. The titration may be based on sensed data 2722 and / or information provided via generator 2740.

[0364] It will be understood that in some examples the example arrangement 2922 of FIG. 22B also can be adapted to enable communication between the IMDs 260, 262 even if each respective control portion 2930A, 2930B retains control over its own respective IMD, 260, 262.

[0365] In some examples in which multiple IMDs which operate independently of each other (e.g., 2900 in FIG. 21 ), some such examples comprise implementing activation of later-implanted second IMD at a time period after implementation of activation therapy via an initially implanted first IMD, as shown at 2960 in FIG. 22C. Among other aspects, this example arrangement may enhance therapyimplementation such as when the patient’s sleep disordered breathing (SDB) is not satisfactorily alleviated via implantation and operation of the first IMD. More specifically, after implantation and stabilization, the first IMD may be operated for a period of time (e.g., weeks, months, etc.) after which full expression of a therapeutic response would be expected. However, in the event that the patient does not exhibit the expected therapeutic response, sometimes the patient may be referred to as being a non-responder or partial responder, and in some examples, upon later implantation / operation of the second IMD 262, the patient may exhibit a more favorable therapeutic response. In some such examples, the first IMD may remain implanted at least because the later addition of the second IMD 262 may help the first IMD 260 to become more therapeutically effective. In some examples, the second IMD 262 may be located to cause activation of a target tissue different from the target tissue at which the first IMD 260 is located. For instance, in some examples, the first IMD 260 may be in activating relation (e.g., stimulating relation) to a first UAPRT such as the hypoglossal nerve (e.g., 822 in FIGS. 7, 10, 14A, 15), and by which the patient was deemed a non-responder for relatively ineffective therapy, and the second IMD 262 is later implanted in activating relation (e.g., stimulating relation) to a different UAPRT such as an IHMN 826 or other nerve, muscle which may contribute to treating sleep disordered breathing (SDB). It will be understood that in some examples the first IMD 260 may be implanted at an UAPRT other than the hypoglossal nerve and the second IMD 262 is implanted at some target tissue (e.g., UAPRT) other than the UAPRT at which the first IMD 260 is implanted.

[0366] Moreover, in some examples, the addition of the later-implanted IMD at a location different from the initially-implanted IMD may contribute to more robust or effective sensing (via a sensing modality, location, etc. different from sensing by the already-implanted IMD), which may then enable the initially-implanted IMD or the later-implanted IMD to provide more efficacious activation therapy for at least some conditions under which the initially-implanted IMD was lacking performance.

[0367] Among other advantages, the example arrangement 2900 of FIG. 21 (e.g., IMDs 260, 262 operating independently) and example arrangement 2960 in FIG. 22C may permit later implanting an IMD (e.g., second IMD 262) without having to adjust programming the initially-implanted IMD (e.g., first IMD 260) in view of the later- implanted second IMD. For instance, the initially-implanted IMD (e.g., first IMD 260) may operate as originally intended and the later-implanted IMD (e.g., second IMD 262) may operate just when needed but without having to synchronize operation of the later-implanted IMD (e.g., second IMD 262) with operation of the initially- implanted IMD (e.g., 260). In some such examples, the initially-implanted IMD (e.g., 260) may provide more efficacious therapy in a first set of conditions but less efficacious therapy in a second set of conditions, such that the patient potentially may be deemed a partial responder or non-responder. However, the later-implanted IMD (e.g., 262) may be located, operated, etc. in a manner to provide the desired therapeutic efficacy for the second set of conditions, such that the combination of the initially-implanted IMD and later-implanted IMD provides desired efficacious therapy for both of the first and second set of conditions such that the patient may then be deemed a full responder or otherwise to be receiving more efficacious therapy.

[0368] It will be understood that in some examples, at least some aspects of the method of example arrangement 2960 in FIG. 22C may be implemented using the example arrangement of FIG. 20A and in which communication between the initially- implanted IMD and the later-implanted IMD may be established directly or indirectly, such as via an external device or third IMD. Either of this external device or third IMD may be represented by third device 2553 in FIG. 18B.

[0369] In some examples, a method comprises implanting a second IMD 262 at or near the time that a first IMD 260 is implanted such that the second IMD 262 is not being implanted because the patient is a non-responder or partial responder as in the prior example. Instead, the multiple IMDs are implanted in the same general procedure to provide a dynamic arrangement by which either or both IMDs 260, 262 (and / or additional IMDs) may implement sensing and / or activation based on dynamic conditions experienced by the patient regarding their environment, sleep habits,changes in physiology, available sensing modalities or parameters, etc. In such example arrangements, each IMD may operate independently based on information available to that particular IMD without receiving information from another IMD. In one aspect, a particular IMD may determine its sensing and / or activation based on physiologic conditions, environmental conditions, etc. which may change based on sensing and / or activation via another IMD but without the first IMD and second IMD communicating with each other about such conditions, state of operation, etc. In some instances, these example arrangements may sometimes be referred to as operating according to initiative based tactics (IBT) in which each IMD comprises full autonomy to act or re-act to sensed conditions based on the data available to the respective IMD. In some such examples, any given IMD may operate (by itself) in a closed loop mode, or in some examples, may operate in an open loop mode, and any given IMD may convert its operation between a closed loop mode and an open loop mode as conditions warrant.

[0370] It will be understood from the foregoing that various examples provide an option between whether multiple IMDs are implanted in a single surgical procedure (e.g., one point in time) or implanting one (or more) IMDs in a first surgical procedure followed by implanting one or more IMDs in a second surgical procedure at a later point in time. This option is not based strictly on whether the IMDs would operate independently of each other. In other words, multiple IMDs which operate in cooperation (e.g., direct) with each other may be implanted in a single surgical procedure or different IMDs (which cooperate with each other in some manner) may be implanted in different surgical procedures occurring at different points in time. At least some aspects of prioritizing an order of implantation (e.g., in different surgical procedures) or prioritizing an order of deployment of already-implanted multiple IMDs (whether implanted all at once or in different surgical procedures) is further described later in association with at least FIGS. 29-31 D.

[0371] In some examples, such as shown in the example arrangement 2970 of FIG. 23A and / or the example arrangement 2980 of FIG. 23B, the first IMD 260 and second IMD 262, which operate independently of each other may be in communication (e.g.,selectively) with a third IMD 2972 (FIG. 23A) and / or an external device 2974 (FIG. 23B) and by which operation of either the first IMD 260 and / or the second IMD 262 may be adjusted, modified, etc. In some examples, the external device 2974 may comprise a dedicated device (e.g., patient remote control 14640, clinician programmer 14650 in FIG. 43) or a non-dedicated device (e.g., app 14630 on mobile device 14620, cloud portal 14662 in FIG. 43). In some examples including the example arrangements 2970, 2980 of FIGS. 23A, 23B, a method comprises communicating information (e.g., sensing data, activation information, etc.) from both or either one of the respective first and second IMDs 260, 262 to the third IMD 2972 (FIG. 23A) or to an external device 2974 (FIG. 23B); and evaluating the information, which may comprise evaluating information regarding efficacy of operation of the respective first and second IMDs. From this evaluation, the third IMD 2972 or external device 2974 can send adjustment instructions to the first IMD 260 and / or the second IMD 262, which still maintain operations independent of each other.

[0372] In some implementations of the example arrangement 2900 of FIG. 21 , a method comprises implementing the independent operation of first IMD 260 and second IMD 262 within a nightly treatment / therapy session. However, outside of the nightly treatment / therapy session, first information from a previous night’s treatment / therapy session (or from multiple night’s treatment) from each of the first and second IMDs 260,262 may be communicated between the respective first and second IMDs. The first information may comprise sensing information and / or therapy information. Among other uses, in some examples this communicated (e.g., transferred) information may enable making adjustments in activation therapy and / or sensing between / among the first and second IMDs 260, 262 which continue to operate independently within the nightly treatment sessions.

[0373] As shown at 3050 of FIG. 24A, some example methods comprise activation via a first IMD of a first tissue and activation via a second IMD of a second tissue to augment performance of (at least a portion of) a first phase of an automatically repeating physiologic two-phase cycle, wherein the second phase of the two-phase cycle occurs naturally without activation of the first IMD (e.g., 260) and / or secondIMD (e.g., 262). In some such examples, neither the first IMD nor the second IMD (or any other IMD) is used to augment the second phase of the two-phase cycle. In some aspects, this example arrangement stands in contrast to non-example arrangements which activate target tissues to treat maladies for which physiologic cycles do not automatically repeat.

[0374] In some examples of the present disclosure, the two-phase cycle automatically repeats between about 5 to 30 times per minute, while in some examples the cycle repeats between about 10 to about 20 times per minute. In some such examples, the two-phase cycle comprises a human respiratory cycle (e.g., breathing cycle), which comprises an inspiratory phase immediately followed by an expiratory phase. In particular, the inspiratory phase is at least partially caused by downward (e.g., inferior) movement of the diaphragm muscle (during its contraction), which in turn permits the lungs to fill with air entering via the upper airway, followed by a nearly instantaneous transition from an end of the inspiratory phase to a beginning of the expiratory phase corresponding to rapid upward (e.g., superior) movement of the diaphragm muscle (e.g., during its relaxation), which in turn forces air out of the lungs. At the end of the expiratory phase, the next inspiratory phase immediately begins, and so on. While the natural activation of certain other tissues (e.g., phrenic nerve via central nervous system) are involved in initiating and sustaining the repeating respiratory cycle, it will be understood that once the inspiratory phase occurs (e.g., is completed), activation of the phrenic nerve or another nerve is not required to induce expulsion of air out of the lungs. Rather, cessation of activation of the phrenic nerve (at the end of the inspiratory phase) causes and enables relaxation of the diaphragm muscle, which in turn permits (e.g., causes) expulsion of air from the lungs in the expiratory phase. In one aspect, the expiratory phase may comprise an active expiratory phase and an expiratory pause phase.

[0375] The frequency of the automatically repeating human respiratory cycle is significantly higher than some other physiologic progression events, such as a sexual event which may comprise arousal progressing to orgasm, in some examples.In comparison, the respiratory cycle may repeat at a frequency at least an order of magnitude or several orders of magnitude greater than which the sexual progression event can be repeated. Moreover, several conditions and affirmative actions must be taken by participants (or must be simulated via activating particular nerves / muscles using artificial stimulators to attempt restoration of such functions) to initiate and maintain even a single sexual event. In sharp contrast, assuming that a particular patient’s sleep disordered breathing involves primarily or solely obstructive sleep apnea, the respiratory cycle occurs automatically and repeats without the patient having to take any affirmative steps in order for the respiratory cycle to initiate and be maintained.

[0376] The above-noted frequency of the respiratory cycle is also significantly higher than some other physiologic cycles, such as a urinary retention-voiding progression event, which may comprise retention of fluids within a bladder for a desired amount of time, typically on the order of several hours and then, at a later time, a release of the retained fluids via a urethra to exit the body. A similar progression event is applicable for fecal retention-voiding events, which may take an even longer time span, such as days in some cases. In comparison, the respiratory cycle may repeat a frequency at least an order of magnitude or several orders of magnitude greater than a frequency by which a urinary or fecal retention-voiding progression event can be repeated. Moreover, several conditions and affirmative actions must be taken by participants (or must be simulated via activating nerves / muscles using artificial stimulators to attempt restoration of such functions) to initiate and maintain even a single progression of retention-voiding body fluids (e.g., urinary or fecal). In sharp contrast, the respiratory cycle occurs automatically and repeats without the patient having to take any affirmative steps in order for the respiratory cycle to initiate and be maintained.

[0377] Some example methods of the present disclosure comprise a treatment period of at least 5 hours, 6 hours, at least 7 hours, at least 8 hours, and so on, such as the treatment period having a duration corresponding to a sleeping period (e.g., nightly for most patients vs. some daytime sleepers) which occurs once in every 24hour period. In some examples, the treatment period corresponds to the activation therapy being performed continuously throughout the treatment period. It will be understood that the “continuous” activation therapy may comprise a cyclical activation signal and may comprise occasional brief pauses. In sharp contrast, some non-example arrangements (such as some pelvic stimulators to treat sexual dysfunction) may comprise a treatment period of a significantly shorter time frame on the order of minutes, quarter-hour, half-hour, and the like. Some non-example arrangements (such as some pelvic stimulators to treat urinary or fecal incontinence) other than the examples of the present disclosure may comprise treatment lasting for just several minutes a few times a day. Moreover, at least some aspects of the treatment periods for these non-example arrangements are not performed during a sleeping period in which the patient is sleeping, and the bodily functions being addressed would not occur.

[0378] With these differences in mind, one implementation of the example arrangement (3050) of FIG. 24A may be implemented as shown at 3055 in FIG. 24B, in which activation via a first IMD of a first upper airway patency-related tissue (UAPRT) and activation via a second IMD of a second UAPRT augments performance of (at least a portion of) an inspiratory phase of a respiratory cycle. Performance of the expiratory phase (e.g., second phase) of the two-phase cycle occurs naturally at the end of the inspiratory phase without activation of the first IMD (e.g., 260) and / or second IMD (e.g., 262.) Provided generally normal function of the central nervous system and / or phrenic nerve is occurring, even in the case of obstructive sleep apnea such as caused by collapse of the upper airway (i.e. loss of patency), the expiratory phase will occur naturally (without any activation of the phrenic nerve and / or diaphragm muscle). This stands in sharp contrast to the much lower frequency progression events (e.g., arousal-orgasm sexual event or retentionvoiding urinary / fecal events) in which some affirmative activation (naturally or artificially) must occur in order for the second part (e.g., orgasm, voiding, respectively) of the progression to occur.

[0379] In some such examples, neither the first IMD nor the second IMD (or any other IMD) is used to augment the expiratory phase of the two-phase cycle.

[0380] FIG. 25 is a diagram illustrating an example arrangement 3070 comprising a first IMD 260 for treatment of a first body system 3072 and a second IMD 262 for treatment of a second body system 3074, which comprises different body functions than the first body system 3072. In some examples, the first body system 3072 (e.g., upper respiratory function) is located in a body region (e.g., neck region) different from a body region (e.g., pelvic region) in which the second body system 2074 (e.g., urinary or fecal function) is located.

[0381] In some of these examples, sensing a function (or dysfunction) in one body system (e.g., 3072) via first IMD 262 may be used to trigger or inform operation of second IMD 260 regarding the other body system (e.g., 3074), or vice versa. For instance, in view of a nexus for some patients between urinary dysfunction (e.g., incontinence, such a nocturia) in the pelvic region (body system 3074) and sleep disorders (e.g., obstructive sleep apnea), some example methods may communicate information between the first IMD 260 and second IMD 262 in order to enhance treatment of dysfunction (and / or distinguish which body system may be a primary cause or secondary cause of behaviors in the respective body systems) in either of the respective first and second body systems 3072, 3074. Such communication may occur directly, such as via communication pathway 3078 (e.g., wireless or wired) and / or via a third device 3076 (e.g., external device or third IMD) communicating wirelessly with each of the respective first and second IMDs 260, 262, as shown in FIG. 25.

[0382] As part of this example arrangement, some example methods may evaluate whether activation of target tissue by the first IMD 260 for one body system (e.g., upper respiratory) to treat a condition (e.g., obstructive sleep apnea) may cause a decrease in symptoms in the other body system (e.g., pelvic) sensed via the second IMD 262, and / or vice versa.

[0383] In some examples, both the first and second body systems 3072, 3074 may be located in the same / single body region.

[0384] FIG. 26A is a block diagram schematically representing an example sensing portion 3300 including a plurality of different physiologic parameters which may be sensed in association with various examples of the present disclosure. In some examples, at least some of these parameters are sensed data and / or determinable from sensed data and may be used in various ways such as (but not limited to) sensing evaluator 2735 as part of the example arrangement in FIG. 20A.

[0385] As shown in FIG. 26A, in some example physiologic parameters determinable from sensed data may comprise parameters regarding collapse 3310, position 3309, respiration 3305, disease burden 3308, sleep 3316, and other 3330.

[0386] In some examples, the collapse parameter 3310 (e.g., collapsibility parameter) may comprise further parameters regarding a pattern 3312 and / or a degree 3314 of collapse of the upper airway in the patient’s body. In some such examples, the sensing of data regarding a collapse pattern parameter 3312 and / or a degree parameter 3314 may be implemented via at least some of substantially the same features and attributes as later described in association with at least FIGS. 27A-27G by which a pattern, location, and degree of collapse may be determined and characterized so as to use this information as part of the sensed data check.

[0387] In some examples, per collapse parameter 3310, if an antero-posterior collapse is detected (of a sufficient degree), then in some examples the activation settings are generated (e.g., 2740 in FIG. 20A) to implement activation therapy via implementing activation of the first IMD 260 solely, initially, or primarily (but not solely). In some examples, implementing the activation initially may sometimes be referred to as implementing activation first, i.e. prior to implementing activation of the second IMD 262 (e.g., which may comprise activating an IHMN in some examples).

[0388] In some examples, per collapse parameter 3310, if a lateral and / or concentric collapse pattern (of a sufficient degree) is detected, then in some examples the activation settings are generated (e.g., 2740 in FIG. 20A) to implement activation therapy via applying activation solely, initially, or primarily (i.e. not solely) to the second IMD. In some examples, implementing the activation initially maysometimes be referred to as implementing activation first, i.e. prior to implementing activation via the first IMD.

[0389] In some examples, via the collapse parameter 3310 in FIG. 26A, one example implementation of the example arrangement 2700 in FIG. 20A may comprise generating activation settings (e.g., 2740 in FIG. 20A) using the sensing evaluator (e.g., 2735 in FIG. 20A) based on sensor inputs 2722, 2732, 2733 to assess the pattern, location, and / or degree of collapse and then select which target tissues (e.g., HGN, IHMN, etc.) are to be activated via the first and second IMDs 260, 262, and if different types of target tissues (e.g., different types of nerves) are to be activated, then select a sequence of activation, simultaneous implementation, proportion, etc. In some examples, such selection may be implemented in cooperation with the relationship parameter 3738 of the activation portion (e.g., engine 3700 in FIG. 28A), as further described below.

[0390] In some examples, collapse information may be determined via sensing impedance (e.g., 3430 in FIG. 26B), such as via sensor inputs 2722, 2732 (via the first IMDs 260, 262 (e.g., which may comprise electrodes) or other sensor input 2733 in FIG. 20A. As previously noted, impedance sensing may be performed via measuring the bioimpedance between two or more electrodes (e.g., sensing and / or stimulation elements) which are spaced apart from each other within the patient’s body, such as the elements being positioned at different points along and / or across the upper airway. In some examples, one or more of the other sensor tools (e.g., sensing portion 3400 in FIG. 26B) may be used to determine collapse, such as but not limited to sensed accelerometer data (per 3426 in FIG. 26B), which may be used alone or with sensed impedance. Similarly, sensed acoustic data (3439 in FIG. 26B) from an accelerometer or other sources may reveal collapse information, snoring information (e.g., SN in Column 811 of FIG. 7), etc. One non-limiting example includes sensing snoring information (e.g., via snoring partner, other) In some examples, the snoring information may comprise signature frequencies indicative of sleep disordered breathing such as (but not limited to) obstructions, obstructive sleep apnea, etc.

[0391] In some examples, a typical collapse pattern for a given patient may be known prior to implanting a tissue activation system (e.g., nerve stimulation system) such that the sensing portion 3300 (as supported by memory of the control portion 4500 in FIG. 42A) may retrieve stored data regarding such collapse pattern(s) for use in initial or ongoing programming of activation therapy, adapting the activation therapy and / or use in confirming sensing of such collapse patterns. In some such examples, a clinician / other may enter such known collapse information as part of the programming, whether initially or later. This information may be entered via user interface 14540 (FIG. 42C), clinician programmer 14650 (FIG. 43), and / or a patient management tool 14660 (FIG. 43) such as (but not limited to) a cloud portal resource 14662 (FIG. 43).

[0392] Moreover, to the extent that the activation therapy may be effective in lessening or preventing the known collapse pattern, then example devices / methods may compare a degree, type, etc. of the stored, known collapse pattern with the currently sensed collapse pattern (or lack thereof) as one way to evaluate the activation therapy and potentially determine what, if any, adjustments to activation therapy may be warranted. For example, one may evaluate the sensed collapse (e.g., pattern, degree) and adjust how each target tissue (e.g., left HGN, right HGN, left IHMN, right IHMN, and combinations thereof) is to be activated (e.g., stimulated) such as via various aspects of the relationship parameter (e.g., 3738 in FIG. 28A) and / or other parameters of the activation portion (e.g., engine 3700 in FIG. 28A), relative to available activation therapy protocols as well as in cooperation with other data from sensing portion (e.g., 3300 in FIG. 26A; 3400 in FIG. 26B) or other parameters, factors, engines, methods, as described throughout various examples of the present disclosure.

[0393] In some examples, whether with regard to the collapse parameter 3310 or independent of the collapse parameter 3310, a stimulation therapy protocol may deliver stimulation to multiple different nerves (e.g., left HGN, right HGN, left IHMN, right IHMN, and combinations thereof) in a pattern in which the various nerves are stimulated simultaneously or in an offset manner such as interleaving. In some suchexamples, individual pulses within a stimulation period (e.g., a train of pulses) for the different target tissues may be delivered simultaneously or at least some of the individual pulses for the different target tissues may be offset from each other such as (but not limited to) interleaving. In some such examples, individual stimulation periods (e.g., a train of pulses) for different target tissues may be delivered simultaneously or at least some of the stimulation periods for different target tissues may be offset from each other such as (but not limited to) being interleaving.

[0394] In some examples, some of the stimulation therapy protocols also may apply stimulation in a pattern in which a stimulation period (or just some pulses within a stimulation period (i.e. pulse train)) for a given target tissue are omitted periodically (e.g., a stimulation period need not be delivered in each respiratory cycle) because prior instance(s) of stimulating the target tissue may yield the desired effect (e.g., increased upper airway patency) despite the omitted stimulation period. In some examples, such stimulation therapy protocols (e.g., involving simultaneous application, offset application (including but not limited to interleaving), periodic omissions in delivery, etc.) may comprise at least some of substantially the same features and attributes as described in: (1 ) U.S. Patent Publication US 2023- 01661 13T, filed December 1 , 2021 under Serial Number 17 / 539,916, filed December 1 , 2021 , titled “Implantable Medical Devices”; (2) U.S. Patent Publication US 2023 / 0172479C, November 17, 2022 under Serial Number 17 / 926,010, titled “Single or Multiple Nerve Stimulation to Treat Sleep Disordered Breathing”; (3) PCT Application PCT / US2022 / 030543, filed on May 23,2022, published as WO 2022 / 246320 on November 24, 2022, titled “Multiple Target Stimulation Therapy for Sleep Disordered Breathing”, and filed as U.S. National Stage application under Serial Number 18 / 560,886, filed on November 14, 2023, published as US Patent Application Publication US 2024 / 0252824 on August 1 , 2024; (4) PCT Application PCT / US2023 / 023361 , filed 5 / 23 / 2022, published as WO 2023 / 230131 , titled “Devices for Sensing and Stimulating in Timed Relationship”, and filed as U.S. National Stage application under Serial Number 18 / 867,857 on November 21 , 2024 and published as US Patent Application Publication on ; and(5) PCT Application PCT / US2024 / 031051 filed 5 / 24 / 2024, published as WO 2024 / 243537 on November 28, 2024, titled “Sensing and / or Stimulating Target Tissue Including Diaphragm-Related Tissue and / or Upper Airway Patency- Related Tissue ”, and filed as U.S. National Stage application under Serial Number on and published as US Patent Application Publication on , all of which are hereby incorporated by reference in their entireties for their teachings.

[0395] In some examples, the position parameter 3309 of sensing portion 3300 in FIG. 26A may be used for a wide variety of purposes. In some examples, sensed data regarding body position (or posture) may be used to initiate, terminate, and / or adjust therapy activation settings, patterns, etc. For instance, in some examples, upon sensing the patient being in a supine position, such as when one may expect a highest likelihood of obstructive sleep apnea for at least some patients, then an example method may comprise delivering activation to both a first target tissue (e.g., left HGN and / or right HGN) and a second target tissue (e.g., left IHMN and / or IHMN), such as via first and second IMDs 260, 262. As previously mentioned, posture and / or activity sensed via an accelerometer may be used with sensed body position for making the preceding determination.

[0396] In some examples, upon sensing the patient is lying on their side (e.g., a lateral decubitis position), then an example method may comprise implementing activation solely to a second target tissue (e.g., left or right IHMN), such as solely via second IMD 262 in FIG. 20A.

[0397] In some examples, upon sensing the patient is lying prone, then an example method may comprise delivering activation to neither the first IMD (e.g., to activate left and / or right HGN) nor the second IMD (e.g., to activate an IHMN) per 260, 262 in FIG. 20A.

[0398] At least because some patients may exhibit atypical position-dependent sleep disordered breathing, it will be understood that other activation settings may be generated than described above.

[0399] In some examples, a sensed position (e.g., 3309 in FIG. 26A for 2735 in FIG. 20A) may be used to determine or adjust timing of when activation is to be applied and / or to adjust which nerve targets (left HGN, right HGN, left IHMN, right IHMN) are to be stimulated.

[0400] With further reference to FIGS. 26A, 26B, and 20A, in some examples, a respiration parameter (e.g., 3305 in FIG. 26A; 3405 in FIG. 26B) may comprise the sensed data which is evaluated (e.g., 2735 in FIG. 20A) and on which activation settings may be generated (e.g., 2740 in FIG. 20A) to determine which target tissues (and at which strength settings, etc.) are to be activated via signals 2712, 2714 to IMDs 260, 262 in FIG. 20A. In some such examples, the sleep parameter (e.g., 3316 in FIG. 26B) may comprise a sleep state, such as whether the patient is awake or asleep (e.g., a sleep-wake status) and / or such as the sleep stage of the patient. In some examples, the sleep parameter 3316 also may comprise at least some of substantially the same features of (and / or be an example implementation of) the sleep-related features, parameters, etc. associated with at least FIGS. 32J-32O and / or of other sleep-related examples throughout the present disclosure.

[0401] With further reference to FIG. 26A-26B and FIG. 20A, in some examples, a respiration parameter (e.g., 3305 in FIG. 26A; 3405 in FIG. 26B) may comprise the sensed data which is evaluated (2735 in FIG. 20A) and on which activation settings may be generated (e.g., 2740 in FIG. 20A) to determine which nerves (and at which strength settings, etc.) are to be stimulated (e.g., 260, 262 in FIG. 20A). At least some example implementations of the respiration parameter 3305, 3405 as sensed data (e.g., 2735 in FIG. 20A) and / or for other uses are described in association with at least FIGS. 1 -25 and / or FIGS. 26B-30.

[0402] With further reference to FIG. 26A and FIG. 20A, in some examples, a disease burden parameter (e.g., 3308 in FIG. 26A) may comprise the sensed data which is evaluated (e.g., 2735 in FIG. 20A) and on which activation settings may be generated (e.g., 2740 in FIG. 20A) to determine which target tissues (e.g., nerves) and at which strength settings, etc., are to be activated (e.g., via IMDs 260, 262 in FIG. 20A). In some such examples, the disease burden parameter 3308 maycomprise an indication of a seventy (e.g., apnea-hypopnea index - AHI) (e.g., burden) on the patient imposed by the disease (e.g., sleep disordered breathing, such as but not limited to obstructive sleep apnea), arousals, sleep disruption (e.g., sensed via non-respiratory gross body motion). It will be understood that in some examples, the disease burden parameter 3308 may comprise burden indications of other diseases, such as cardiac disorders, etc. which may be related to the disease burden imposed by sleep disordered breathing. At least some example implementations of the disease burden parameter 3308 as sensed data (e.g., 2735 in FIG. 20A) and / or for other uses are previously described in association with at least FIGS. 1 -25 and / or FIGS. 26B-43.

[0403] It will be understood that at least some of the various parameters in the sensing portion 3300 in FIG. 26A (and / or 3400 in FIG. 26B) may be used in a complementary manner in various combinations in methods of activation therapy for treating sleep disordered breathing according to examples of the present disclosure.

[0404] In some examples, the other parameters relating to care of sleep disordered breathing other than those specifically described in association with FIG. 26A.

[0405] FIG. 26B illustrates a block diagram schematically representing an example sensing portion 3400. In some examples, an example method may employ and / or an example care device may comprise the sensing portion 3400 to sense physiologic information via different physiologic parameters, sensing modalities, and / or other information, with such sensed information relating to care of a wide variety of physical conditions such as, but not limited to, sleep disordered breathing care, pelvic care, cardiac care, among other uses. Regarding SDB care, the sensed information may be used to determine disease burden information such as (but not limited to) severity of apnea-related behavior (e.g., apnea-hypopnea index (AHI)), arousals, sleep disruptions, etc.

[0406] The sensed information may be used to implement, and / or may be obtained, via at least some aspects of the example methods and / or examples devices described in association with at least FIGS. 1 A-26A and / or FIGS. 25B-43. In some examples, at least some of these parameters are sensed data and / or aredeterminable from sensed data, and may be used in various ways such as (but not limited to) via sensing evaluator 2735 as part of the example arrangement in FIG. 20A for determining an activation therapy according to example methods and / or example devices of the present disclosure.

[0407] It will be understood that the sensing portion 3400 may be implemented as a single sensor or multiple sensors, and may comprise a single type of sensing or multiple types of sensing. In addition, it will be further understood that the various types of sensing schematically represented in FIG. 26B may correspond to a sensor and / or a sensing modality.

[0408] In some examples, the sensed information may refer to physiologic signals (e.g., biosignals) and / or metrics which may be derived from such physiologic signals. For example, among other sensed physiologic signals, one physiologic signal may comprise respiration (parameter 3405 in FIG. 26B), from which various metrics may be derived such as, but not limited to, respiratory rate, respiratory rate variability, respiratory phase, rate times volume, waveform morphology, and more. The respiration information may be sensed via one or more sensing modalities described below (and / or other sensing modalities) such as, but not limited to, accelerometer 3426, electrocardiogram (ECG) 3416, electroneurography (ENG) 3420, impedance 3430, pressure 3432, temperature 3434, acoustic 3439, moisture 3459, and / or other sensing modalities (e.g., electrooculography (EOG)), at least some of which are further described below. The respiration information may be used for a wide variety of purposes such as, but not limited to, timing stimulation relative to respiration, disease burden, sleep-wake status, arousals, etc. In some such examples, the detection of disease burden may comprise detection of sleep disordered breathing events, which may be used in determining, assessing, etc. therapy outcomes such as, but not limited to, AHI. This information, in turn, may be used to evaluate and / or adjust settings of activation therapy (e.g., electrical stimulation therapy), as well as sensing settings.

[0409] In some examples, the sensed physiologic information may comprise cardiac information (3406) obtained from a cardiac signal and from which variousmetrics may be derived such as, but not limited to, heart rate (HR), heart rate variability (HRV), P-R intervals, waveform morphology, and more. One example of a cardiac signal may comprise an ECG signal, as represented at 3423 in FIG. 26B. Accordingly, the cardiac information and / or signal may be sensed via one or more sensing modalities further described below (and / or other sensing modalities) such as, but not limited to, cardiac sensor 3423, accelerometer 3426, ECG 3416, electromyogram (EMG) 3418, impedance 3430, pressure 3432, temperature 3434, and / or acoustic 3439. In some examples, the sensed physiologic information (e.g., via sensing portion 3400) may comprise a wide variety of physiologic information other (3407) than respiration and / or cardiac information, with at least some examples further described below in association with FIG. 26B, and other examples throughout the present disclosure. For example, in some examples the other parameter may comprise pelvic-related parameters sensed in association with the activation of pelvic-related tissues as further described later in association with target tissue parameter 3710 of activation portion 3700 of FIG. 28B and / or as previously described in association with FIG. 4.

[0410] The sensed physiologic signals and / or information (e.g., respiration 3405, cardiac 3406, and / or other information 3407) may be used for a wide variety of purposes such as, but not limited to, determining sleep-wake status (e.g., various sleep onset determinations), timing stimulation relative to respiration, determining disease burden, determining arousals, etc. In some such examples, the determination of disease burden may comprise detection of sleep disordered breathing events, which may be used in determining, assessing, etc. therapy outcomes such as, but not limited to, AHI, as well as titrating stimulation parameters, adjusting sensitivity of sensing the physiologic information, etc.

[0411] For instance, in one non-limiting example, an electrocardiogram (ECG) sensor 3416 in FIG. 26B may comprise a sensing element (e.g., electrode) or multiple sensing elements arranged relative to a patient’s body (e.g., implanted in the transthoracic region) to obtain ECG information. In some examples, the ECG information may comprise one example implementation to obtain cardiacinformation, including but not limited to, heart rate 3425A (HR), heart rate variability 3425B (HRV) and other cardiac parameters 34250, which may be used (with or without other information) in determining delivering stimulation therapy and associated sensing (e.g., inputs) for determining effectiveness of the therapy and / or implementing the therapy, as described throughout the examples of the present disclosure.

[0412] However, in some instances, the ECG sensor 3416 may represent ECG sensing element(s) in general terms without regard to a particular manner in which sensing ECG information may be implemented.

[0413] In some examples in which multiple electrodes are employed to obtain an ECG signal, an ECG electrode may be mounted on or form at least part of a case (e.g., outer housing) of an IMD (e.g., housing of an implantable pulse generator (IPG)). In such instances, other ECG electrodes are spaced apart from the ECG electrode associated with the IPG. In some examples, at least some ECG sensing electrodes also may be employed to deliver stimulation to a nerve or muscle, such as but not limited to, an upper airway patency-related nerve (e.g., hypoglossal nerve) or other nerves or muscles.

[0414] In some examples, other types of sensing may be employed to obtain cardiac information (including but not limited to heart rate and / or heart rate variability), such as a cardiac sensor 3423 shown in FIG. 26B, which may comprise one or more of a ballistocardiogram sensor(s), seismocardiogram sensor(s), and / or accelerocardiogram sensor(s). In some examples, such sensing is based on and / or implemented via accelerometer-based sensing such as further described below in association with accelerometer 3426.

[0415] In one aspect, in some examples in which the cardiac sensor 3423 comprises a ballistocardiogram sensor, the sensor senses cardiac information caused by cardiac output, such as the forceful ejection of blood from the heart into the great arteries that occurs with each heartbeat. The sensed ballistocardiogram information may comprise heart rate (HR) 3425A, heart rate variability (HRV) 3425B, and / or additional cardiac morphology 3425C. In some examples suchballistocardiogram-type information may be sensed from within a blood vessel in which the sensor (e.g., accelerometer) senses the movement of the vessel wall caused by pulsations of blood moving through the vessel with each heartbeat. This phenomenon may sometimes be referred to as arterial motion.

[0416] In some examples in which the cardiac sensor 3423 comprises a seismocardiogram sensor, the sensor 3423 may provide cardiac information which is similar to that described for ballistocardiogram sensor, except for being obtained via sensing vibrations, per an accelerometer (e.g., single or multi-axis), in or along the chest wall caused by cardiac output. In particular, the seismocardiogram measures the compression waves generated by the heart (e.g., per heart wall motion and / or blood flow) during its movement and transmitted to the chest wall. Accordingly, the sensor 3423 may be placed in the chest wall.

[0417] In some such examples of sensing per sensor 3423, such methods and / or devices also may comprise sensing a respiratory rate and / or other respiratory information.

[0418] In some examples the sensing portion 3400 may comprise an electroencephalography (EEG) sensor 3412 to obtain and track EEG information. In some examples, the EEG sensor 3412 may also sense and / or track central nervous system (CNS) information in addition to sensing EEG information. In some examples, the EEG sensor(s) 3412 may be implanted subdermally under the scalp or may be implanted in a head-neck region otherwise suitable to sense EEG information. Accordingly, the EEG sensor(s) 3412 are located near the brain and may detect frequencies associated with electrical brain activity.

[0419] In some examples, a sensing element used to sense EEG information is chronically implantable, such as in a subdermal location (e.g., subcutaneous location external to the cranium skull), rather than an intracranial position (e.g., interior to the cranium skull). In some examples, the EEG sensing element is placed and / or designed to sense EEG information without stimulating a vagus nerve at least because stimulating the vagus nerve may exacerbate sleep apnea, particularly with regard to obstructive sleep apnea. Similarly, the EEG sensing element may be usedin a device in which a stimulation element delivers stimulation to a hypoglossal nerve or other upper airway patency-related nerve without stimulating the vagus nerve in order to avoid exacerbating the obstructive sleep apnea.

[0420] In some examples, sensed EEG information may be used as part of (or solely in) making a sleep-wake determination, such as sleep onset, and wake onset. Among other uses, this sleep-wake information may help provide overall sleep hours, which may comprise part of therapy outcome, in some examples.

[0421] In some examples, sensed EEG information may be used to detect sleep stages during sleep. Among other uses, this sensed sleep stage may help determine an absolute amount or relative amount of deep sleep, REM sleep per night, and / or other sleep metrics. For instance, such information may be used to evaluate whether a particular stimulation solution setting corresponds to a patient's most therapeutic stimulation energy settings / parameters based on (at least or in part) the recognition of more deep sleep typically corresponds to the most or more therapeutic stimulation energy settings whereas less deep sleep typically corresponds to lesser therapeutic stimulation energy settings.

[0422] In some examples, sensed EEG information may be used to detect arousals, which may comprise one aspect of determining therapy outcome. Among other uses, the detection of more arousals may provide an indication of the patient exhibiting more daytime sleepiness, which in turn may lead to adjustments to stimulation solution settings (e.g., values of stimulation energy parameters) in order to minimize arousals.

[0423] In some examples, the above-described aspects regarding the use of sensed EEG information may be combined in whole, or part, to provide an overall sleep efficiency parameter. In some such examples, the sleep efficiency parameter may be based on: 1 ) sleep duration; 2) sleep depth; and / or 3) events (e.g., number of arousals). In some examples, the sleep efficiency parameter may be compared to a reference sleep efficiency parameter such as (but not limited to): 1 ) a reference sleep duration (e.g., 8-9 hours); 2) a reference sleep depth (e.g., a minimum duration of deep sleep and REM sleep; and / or 3) few or no arousals.

[0424] In some examples the sensing portion 3400 may comprise an electromyogram (EMG) sensor 3418 to obtain and track EMG information.

[0425] In some examples, the EMG sensor may be used to sense respiration such as via sensing a respiratory-related muscle. Among other examples, the EMG sensor may sense respiration from a diaphragm muscle (e.g., 842 in FIGS. 7, 10, 14A, 15), respiratory-related muscles in the upper airway, and / or other respiratory- related muscles.

[0426] In some examples, the EMG sensor may be used to determine obstructions, upper airway patency, and related parameters based on sensing a position or degree of contraction of muscles in the upper airway including the tongue (e.g., genioglossus muscle), pharyngeal walls, and / or based on sensing other respiratory-related muscles such as the diaphragm muscle (e.g., 842 in FIGS. 7, 10, 14A, 15).

[0427] In some examples, the EMG sensor may comprise an electrode positioned near the tongue to detect signals indicative of voluntary control of the tongue, which in turn may be indicative of wakefulness. In some examples, the sensed EMG signals may be used to identify sleep and / or obstructive events. In some examples, the EMG sensor also can be placed at other locations within (or on) the body to detect muscle activity which may be indicative of sleep parameter such as, but not limited to, sleep depth. In some such examples, one sleep depth parameter may comprise REM sleep, which may be used to determine whether a target amount (e.g., minimum) of REM sleep occurred. In some examples, the detected EMG information may be used to detect arousals and / or overall patient movement. These examples of determining and / or using sensed EMG information may be used as part of determining patient metrics (e.g., therapy outcome, usage, other) by which stimulation energy parameters may be determined, adjusted, etc. in order to maintain and / or improve those patient metrics according to various examples of the present disclosure.

[0428] In some examples, the sensing portion 3400 may comprise an accelerometer 3426 which may comprise at least some of substantially the same features as, and / or an example implementation of, the accelerometer (XL) in FIG.7, 2170 in FIG. 14C, etc.

[0429] In some examples, the accelerometer 3426 may be used to sense respiration 3405 and related parameters. In some examples, the accelerometer 3426 and associated sensing (e.g., motion at (or of) the chest, neck, and / or head, respiratory, cardiac, posture, etc.) may be implemented according to at least some of substantially the same features and attributes as described in: U.S. 1 1 ,324,950 issued on May 10, 2022, titled ACCELEROMETER-BASED SENSING FOR SLEEP DISORDERED BREATHING (SDB) CARE, filed October 19, 2018 under Serial Number 16 / 092,384; U.S. Publication Number 2023 / 01 19173, published on April 20,2023, titled RESPIRATION DETECTION, and filed September 2, 2020 under Serial Number 16 / 977,664; U.S. 2023-0095780 published on March 30, 2023, titled SLEEP DETECTION FOR SLEEP DISORDERED BREATHING (SDB) CARE, and filed September 4, 2020 under Serial Number 16 / 978,470; and WO 2022-261311 published on December 15, 2022, titled RESPIRATION SENSING, and filed June 9,2022 under Serial Number PCT / US2022 / 032821 , which was filed on October 17,2023 as U.S. National Phase application under Serial Number 18 / 287,205 and published as U.S. 2024 / 0197200; and WO 2024 / 233290 published on November 14,2024, titled RESPIRATORY PHASE DETERMINATION, and filed May 3, 2024 under Serial Number PCT / US2024 / 0275279, and filed on > as U.S. National Phase application under Serial Number and published as US ; U.S. Patent Publication 2023-0177121 , published on September 7, 2023, titled “DISEASE BURDEN INDICATION” and filed under Serial Number 18 / 017,797, and which are incorporated by reference herein in their entirety.

[0430] In some examples, the accelerometer may comprise a single axis accelerometer while in some examples, the accelerometer may comprise a multiple axis accelerometer.

[0431] Among other types and / or ways of sensing information, the accelerometer sensor(s) 3426 may be employed to sense or obtain a ballistocardiogram, a seismocardiogram, and / or an accelerocardiogram (see cardiac sensor 3423 and related disclosure), which may be used to sense (at least) heart rate 3425A and / or heart rate variability 3425B (among other information such as respiratory rate in insome instances), which may be used as part of determining respiratory information, cardiac information, as described throughout the examples of the present disclosure. In some examples, this sensed information also may be used in determining sleepwake status.

[0432] In some examples, the accelerometer 3426 may be used to sense respiration, activity, posture, and / or body position as part of determining a disease burden parameter, and / or the sensed activity, posture, and / or body position may sometimes be at least partially indicative of a sleep-wake status, which may be used as part of automatically initiating, pausing, and / or terminating stimulation therapy.

[0433] In some examples, the sensing portion 3400 may comprise an impedance sensor 3536, which may sense transthoracic impedance or other bioimpedance of the patient. In some examples, the impedance sensor 3430 may comprise a plurality of sensing elements (e.g., electrodes) spaced apart from each other across a portion of the patient’s body. In some such examples, one of the sensing elements may be mounted on or form part of an outer surface (e.g., case) of an IMD (e.g., 260, 262 in FIGS. 2, 20A, 23A, 25) or other implantable sensing monitor, while other sensing elements may be located (e.g., on a lead as in FIGS. 16-17B) at a spaced distance from the sensing element of the IMD (e.g., 260, 262) or sensing monitor. In at least some such examples, the impedance sensing arrangement integrates all the motion / change of the body (e.g., such as respiratory effort, cardiac motion, etc.) between the sense electrodes (including the case of the IMD when present). Some example implementations of the impedance measurement circuit will include separate drive and measure electrodes to control for electrode to tissue access impedance at the driving nodes.

[0434] In some examples, the sensed impedance may provide respiratory information such as (but not limited to) respiratory phase information including respiratory waveform / morphology, inspiratory phase information and / or expiratory phase information (including expiratory pause information). Among other uses, this sensed respiratory information may be used to trigger delivery stimulation therapy. In some examples, stimulation therapy may be synchronized relative to sensedrespiratory phase information such as (but not limited to) inspiratory phase information and / or expiratory phase information. In some examples, the sensed respiratory information may at least partially provide information regarding upper airway collapse, obstructions, and the like.

[0435] In some example methods, sensing bioimpedance may comprise selectively operating both of a first IMD (e.g., 260) and a second IMD (e.g., 262) via sensing a bio-impedance of a third target tissue between the first IMD (e.g., 260) and the second IMD (e.g., 262). In one aspect, some such arrangements provide just one example of implementing the selective operation of the first IMD (e.g., 260) and the second IMD (e.g., 262) to include performing sensing according to a single sensing modality which includes receiving information sensed via the first IMD (e.g., 260) and via the second IMD (e.g., 262).

[0436] In some examples, the sensing portion 3400 may comprise a pressure sensor 3432, which senses respiratory information, such as but not limited to respiratory cyclical information. In some examples, the pressure sensor 3432 may be located in direct or indirect continuity with respiratory organs or airway or tissues supporting the respiratory organs or airway in order to sense respiratory information.

[0437] In some examples, one sensing modality within sensing portion 3400 may be at least partially implemented via another sensing modality within sensing portion 3400.

[0438] In some examples, sensing portion 3400 may comprise an acoustic sensor 3439 to sense acoustic information, such as but not limited to cardiac information (including heart sounds), respiratory information, snoring, etc. In some examples, acoustic sensing may be implemented via an accelerometer, a microphone, a piezoelectric transducer, etc.

[0439] In some examples, sensing portion 3400 may comprise body motion parameter 3440 by which patient body motion may be detected, tracked, etc. The body motion may be detected, tracked, etc. via a single type of sensor or via multiple types of sensing. For instance, in some examples, body motion may be sensed via accelerometer 3426 and in some examples, body motion may be sensed via EMG3418 and / or other sensing modalities, as described throughout various examples of the present disclosure.

[0440] In some examples, the sensing portion 3400 in FIG. 26B may comprise a body position / posture parameter 3436 and / or body motion parameter 3440 to sense and / or track sensed information regarding posture, which also may comprise sensing of body position, activity, etc. of the patient. In some examples, body motion parameter 3440 includes sensing and / or tracking patient ambulatory motion (e.g., walking), which may be considered a gross body motion. This sensed information may be indicative of an awake or sleep state of the patient in some examples, and therefore may be used to initiate, pause, and / or terminate therapy. In some such examples, such information may be sensed via accelerometer 3426 as mentioned above, and / or other sensing modalities. In some examples, such posture information (and / or body position, activity) may be used sometimes alone and / or in combination with other sensing information to determine a patient metric. As described elsewhere herein, in some examples posture may be considered as one of several parameters when determining a probability of sleep (or awake). In some such examples, the sleep-wake status may be used to initiate, pause, and / or terminate stimulation therapy wi...

Claims

CLAIMS1 . A method of treating sleep disordered breathing (SDB) comprising: selectively operating a first implantable medical device (IMD) in relation to a first target tissue; and / or selectively operating a second IMD in relation to a second target tissue.

2. The method of claim 1 , comprising at least one of: implementing the selective operation of the first IMD relative to at least one of the first target tissue or the second target tissue; or implementing the selective operation of the second IMD relative to at least one of the first target tissue or the second target tissue.

3. The method of claim 1 , comprising: selectively operating a plurality of implantable medical devices (IMDs), including the first IMD and the second IMD, in relation to a plurality of target tissues, including the first target tissue and / or the second target tissue.

4. The method of claim 1 , comprising: implanting the first IMD to be in close proximity to the first target tissue and the second IMD to be in close proximity to the second target tissue.

5. The method of claim 1 , wherein the SDB comprises at least obstructive sleep apnea and / or central sleep apnea.

6. The method of claim 1 , comprising at least one of: implanting the first IMD and the second IMD in a first body region; implanting the first IMD in a first part of the first body region and implanting the second IMD in a second part of the first body region; orimplanting the first IMD in the first body region and implanting the second IMD in a different second body region.

7. The method of claim 6, wherein the first body region comprises a neck region.

8. The method of claim 7, wherein the second body region comprises a torso region.

9. The method of claim 7, comprising: implanting the first IMD to be spaced apart from the second IMD by a distance less than a first predetermined distance within which the first IMD and the second IMD are to communicate wirelessly with each other within and through a single body region in which both the first and second IMD are located.

10. The method of claim 9, wherein the implanting comprises: positioning the first IMD and second IMD among surrounding tissues within the patient’s body to be aligned with respect to each other to permit the wireless communication according to an intra-body communication parameter.1 1 . The method of claim 10, wherein the positioning comprises: implementing the intra-body communication parameter via at least one body portion interposed between the first IMD and the second IMD which acts as a communication medium for communication signals between the first and second IMDs.

12. The method of claim 11 , wherein the at least one body portion comprises at least one bodily fluid, at least one organ portion, and / or at least one tissue, wherein the at least one tissue comprises epithelial tissue, connective tissue, muscle tissue, and / or nervous tissue.

13. The method of claim 11 , wherein the implementing comprises: implementing the wireless communication according to a first communication modality including at least one of: ultrasound; microwave; millimeterwave; inductive coupling; capacitive coupling; or galvanic coupling.

14. The method of claim 7, wherein the positioning comprises: implementing the wireless communication between the first IMD and the second IMD independent of a type, and / or a volume, of at least one body portion interposed between the first IMD and the second IMD.

15. The method of claim 14, wherein the implementing comprises: implementing the wireless communication according to a second communication modality which optionally comprises radiofrequency (RF) waves comprising at least 100 MHz.

16. The method of claim 14, wherein at least a portion of a path of the wireless communication occurs external to the patient’s body.

17. The method of claim 7, wherein the implanting comprises: providing each of the first IMD and second IMD with a size and shape to be implanted within a submandibular region between a mandible and a clavicle.

18. The method of claim 17, each of the respective first and second IMDs comprise a microstimulator.

19. The method of claim 17, wherein each of the respective first and second IMDs comprise a housing sealably encapsulating at least one of: a power element; a control portion to control circuitry to generate an activation signal and / or to receive a sensing signal; or a communication element.

20. The method of claim 19, wherein the power element is rechargeable.21 . The method of claim 19, comprising: providing at least one sensing element: on an external surface of the housing; internally within the housing; and / or on at least one lead extending from the housing.

22. The method of claim 21 , comprising: operating the circuitry to generate the activation signal based, at least in part, on physiologic information received from the sensing signal.

23. The method of claim 19, wherein the communication element comprises a wireless communication element to communicate at least one of power, data, and control with an external device.

24. The method of claim 1 , comprising: providing at least one of the first IMD and second IMD to include an activation element.

25. The method of claim 24, wherein the activation element comprises at least one electrical stimulation element.

26. The method of claim 25, comprising: providing the at least one electrical stimulation element: on an external surface of a housing of each respective first and second IMD; and / or as at least one lead extending from the housing.

27. The method of claim 26, wherein the at least one lead comprises a first lead and a second lead, with each respective first and second lead comprising at least one stimulation electrode.

28. The method of claim 27, comprising at least one of: implementing the selective operation of the first IMD via stimulating the first target tissue via the at least one stimulation electrode of the first lead of the first IMD and stimulating the second target tissue via the at least one stimulation electrode of the second lead of the first IMD; or implementing the selective operation of the second IMD via stimulating the first target tissue via the at least one stimulation electrode of the second lead of the second IMD and stimulating the second target tissue via the at least one stimulation electrode of the second lead of the second IMD.

29. The method of claim 28, comprising at least one of: implementing the selective operation of the first IMD via sensing the first target tissue via the first lead of the first IMD and / or sensing the second target tissue via the second lead of the first IMD; or implementing the selective operation of the second IMD via sensing the first target tissue via the second lead of the second IMD and / or sensing the second target tissue via the second lead of the second IMD.

30. The method of claim 27, comprising at least one of:implementing the selective operation of the first IMD via stimulating a first site of the first target tissue via the at least one stimulation electrode of the first lead of the first IMD and stimulating a second site of the first target tissue via the at least one stimulation electrode of the second lead of the first IMD; or implementing the selective operation of the second IMD via stimulating a first site of the second target tissue via the at least one stimulation electrode of the second lead of the second IMD and stimulating a second site of the second target tissue via the at least one stimulation electrode of the second lead of the second IMD.31 . The method of claim 1 , comprising implementing the implanting of the second IMD after a selectable time period from the implanting of the first IMD.

32. The method of claim 31 , wherein the selectable time period comprises at least 90 days.

33. The method of claim 1 , comprising implanting: the first IMD on a first side of the body and locating the second IMD on an opposite second side of the body; or both the first IMD and the second IMD on a single, same side of the body.

34. The method of claim 1 , comprising implementing the operation of the first IMD as sensing and the operation of the second IMD as activating target tissue.

35. The method of claim 1 , comprising: providing a first single housing in which all components of the first IMD are encapsulated within the housing and / or on the housing; and / or providing a second single housing in which all components of the second IMD are encapsulated within the housing and / or on the housing.

36. The method of claim 1 , comprising implementing the operation of the first IMD and / or of the second IMD to include sensing.

37. The method of claim 36, comprising implementing the sensing via a first type of sensing modality.

38. The method of claim 36, implementing the sensing via the first IMD independently of the sensing via the second IMD.

39. The method of claim 36, wherein the first target tissue sensed via the first IMD is a different type of tissue than the second target tissue sensed via the second IMD.

40. The method of claim 36, wherein the first target tissue is located in a neck region and the second target tissue is located in a torso region.41 . The method of claim 40, comprises implementing the sensing of the first target tissue via a first type of sensing modality; and implementing the sensing of the second target tissue via a second type of sensing modality different from the first type of sensing modality.

42. The method of claim 41 , comprising implementing the sensing to comprise: sensing breathing sounds via the first target tissue in the neck region via the first type of sensing modality comprising at least one of microphone or a piezoelectric element; and sensing respiratory-related motion via the second target tissue in the torso region via the second type of sensing modality comprising at least one of an accelerometer or an impedance.

43. The method of claim 41 , implementing the sensing to comprise at least one of: sensing respiratory-related motion via the first target tissue in the neck region via the first type sensing modality comprising an accelerometer; or sensing respiratory-related motion in the torso region via the second type sensing modality comprising at least one of: sensing via electroneurography at the second target tissue comprising at least one of a phrenic nerve or an infrahyoid muscle (IHM)- innervating nerve; sensing via electromyography at the second target tissue comprising at least one of a diaphragm muscle or an infrahyoid muscle.

44. The method of claim 36, comprising implementing the sensing of both of the first target tissue and the second target tissue via a single sensing modality.

45. The method of claim 36, comprising selectively operating both of the first IMD and the second IMD via sensing a bio-impedance of a third target tissue between the first IMD and the second IMD.

46. The method of claim 36, comprising implementing the selective operation of the first IMD and the second IMD to include performing sensing according to a single sensing modality which includes receiving information sensed via the first IMD and via the second IMD.

47. The method of claim 44, both of the first and second target tissues are located in a neck region.

48. The method of claim 47, comprising implementing the sensing via a first component of a sensing signal from the single sensing modality and via a second component of a sensing signal from the single sensing modality.

49. The method of claim 48, comprising implementing the sensing to comprise: sensing, as the first component, breathing sounds via at least one of the respective first and second IMDs in the neck region; and sensing, as the second component, respiratory-related body motion via at least one of the respective first and second IMDs in the neck region.

50. The method of claim 49, wherein the single sensing modality comprises an accelerometer.51 . The method of claim 36, comprising implementing the sensing via an accelerometer signal including: separating the accelerometer signal to determine multiple signal components with different signal components comprising at least one of: respiratory-related tissue motion; sleep-related tissue motion; sleep-disordered breathing therapy efficacy motion; acoustic-based breathing sounds; acoustic-based snoring; posture; acoustic-based heart sounds; or non-respiratory gross body motion.

52. The method of claim 51 , comprising: forming a composite respiratory profile from at least two of the different signal components.

53. The method of claim 52, comprising augmenting the composite respiratory profile via adding at least one of the following parameters to the composite respiratory profile:respiratory-indicative temperature information; respiratory-indicative electrocardiograph information; or respiratory-indicative heart rate information.

54. The method of claim 36, wherein the sensing comprises: determining a disease burden parameter via combining respiratory- indicative electrocardiography information with sensed respiration waveform information.

55. The method of claim 36, comprising implementing the sensing via at least one of the following modalities: electromyography; electroneurography; accelerometer; impedance; acoustic; piezoelectric optical sensing ; electrochemical; electromechanical; moisture; electrocardiogram (ECG); and / or electrooculography (EOG).

56. The method of claim 36, comprising: anchoring a first IMD relative to a mandible to enable the first IMD to sense the first target tissue and anchoring the second IMD relative to a clavicle or hypopharynx to sense the second target tissue.

57. The method of claim 1 , implementing the operating comprising:activating the first target tissue via the first IMD; and / or activating the second target tissue via the second IMD.

58. The method of claim 57, comprising at least one of: implementing the activation via the first IMD to activate at least one of the first target tissue or the second target tissue; or implementing the activation via the second IMD to activate at least one of the first target tissue or the second target tissue.

59. The method of claim 57, wherein activating the first target tissue comprises: activating the first target tissue via the second IMD in addition to, or instead of, activating the first target tissue via the first IMD.

60. The method of claim 57, wherein activating the second target tissue comprises: activating the second target tissue via the first IMD in addition to, or instead of, activating the second target tissue via the second IMD.61 . The method of claim 57, comprising implementing the activating via: the first IMD comprising a first activation element comprising a first activation modality and the second IMD comprising a second activation element including a second activation modality.

62. The method of claim 61 , comprising the first activation modality and / or the second activation modalities comprise at least one of: electrical stimulation; optical; magnetic; chemical;electrochemical; biologic; or electromechanical .

63. The method of claim 61 , wherein the first and second activation modalities are the same modality, which comprises electrical stimulation.

64. The method of claim 57, wherein the first target tissue comprises a first upper airway patency-related tissue (LIAPRT) and the second target tissue comprises a second upper airway patency-related tissue (UAPRT), wherein each of the respective first and second UAPRTs comprise an upper airway patency- related nerve and / or an upper airway patency-related muscle.

65. The method of claim 64, wherein at least one of the respective first and second UAPRTs comprising a hypoglossal nerve and / or an infrahyoid muscle (IHM)- innervating nerve.

66. The method of claim 65, comprising implementing the activation of the first target tissue via the first IMD based on sensing a respiratory parameter.

67. The method of claim 66, comprising implementing the sensing via sensing the respiratory parameter via the first IMD.

68. The method of claim 66, comprising implementing the sensing via sensing the respiratory parameter via the second IMD.

69. The method of claim 68, comprising implementing the sensing the respiratory parameter via the second IMD comprising at least one of: sensing a phrenic nerve via electroneurography;sensing a diaphragm muscle via electromyography; or sensing respiratory-related body movement via an accelerometer.

70. The method of claim 68, comprising implementing the activating comprising: activating the first target tissue via the first IMD, wherein the first target tissue comprises a hypoglossal nerve; and activating the second target tissue via the second IMD, wherein the second target tissue comprises at least one of an infrahyoid muscle (IHM)-innervating nerve or an infrahyoid muscle.71 . The method of claim 57, comprising implementing the activating via at least one of the first IMD and second IMD as open loop activation.

72. The method of claim 71 , comprising implementing the open loop activation without use of a sensing element for timing the activation.

73. The method of claim 57, comprising implementing the activating comprising: activating the second target tissue via the second IMD, wherein the second target tissue comprises at least one of an infrahyoid muscle (IHM)-innervating nerve or an infrahyoid muscle.

74. The method of claim 73, comprising implementing the activating comprising: activating the first target tissue via the first IMD, wherein the first target tissue comprises a hypoglossal nerve.

75. The method of claim 73, wherein the second IMD comprises a first element and a second element.

76. The method of claim 75, comprising: implanting the second IMD in a location superior of a clavicle to:position the first element of the second IMD as a stimulation element to be in stimulating relation to the second target tissue to affect upper airway patency.

77. The method of claim 76, wherein the implanting of the second IMD in the location superior to the clavicle is to position the second element of the second IMD as a stimulation element to be in stimulating relation to a phrenic nerve.

78. The method of claim 77, comprising: applying stimulation via the second element to the phrenic nerve to treat obstructive sleep apnea.

79. The method of claim 77, comprising: applying stimulation via the second element to the phrenic nerve to treat multiple-type sleep apnea including central sleep apnea and obstructive sleep apnea.

80. The method of claim 77, comprising: applying stimulation via the second element to the phrenic nerve to treat central sleep apnea.81 . The method of claim 76, wherein the second element comprises a sensing element and comprising: implementing the operative relation of the second element of the second IMD as being in sensing relation to a phrenic nerve to sense a respiratory parameter; applying stimulation to the first target tissue via the first element and / or to the phrenic nerve based on the respiratory parameter sensed via the phrenic nerve.

82. The method of claim 76, wherein the first element is carried by a housing of the second IMD and wherein the second element is supported on a first lead extending from a housing of the second IMD.

83. The method of claim 76, wherein the first element is supported on a first lead extending from a housing of the second IMD and wherein the second element is carried by a housing of the second IMD.

84. The method of claim 76, wherein the first element is supported on a first lead extending from a housing of the second IMD and wherein the second element is supported on a second lead extending from a housing of the second IMD.

85. The method of claim 75, comprising: implanting the second IMD in a location superior of a clavicle to: position the second element; and position the first element as an activation element on a lead in activating relation to the IHM-innervating nerve to affect upper airway patency.

86. The method of claim 76, wherein the implanting of the second IMD in the location superior to the clavicle is to position the second element of the second IMD as an accelerometer to be in sensing relation to respiratory-indicative tissue.

87. The method of claim 86, wherein the second element is contained within a housing of the second IMD or supported on a lead extending from the housing of the second IMD.

88. The method of claim 57, comprising implementing the activation of the first and second IMDs to include:delivering electrical stimulation via the first IMD to the first target tissue throughout a nightly treatment period; and delivering electrical stimulation via the second IMD to the second target tissue selectively during the nightly treatment period based upon comparison of a disease burden parameter relative to a criteria.

89. The method of claim 88, wherein the comparison of the disease burden parameter relative to the criteria comprises at least one of: a sensed apnea severity index exceeding a selectable first threshold; or a sensed upper airway patency being less than a selectable second threshold.

90. The method of claim 88, comprising implementing the electrical stimulation of the first IMD and / or the second IMD: in an open loop mode in which the electrical stimulation is not based on respiratory phase information; or in a closed loop mode in which a timing of the electrical stimulation is based on respiratory phase information.91 . The method of claim 88, comprising performing the comparison during a nightly treatment session.

92. The method of claim 88, comprising: outside of a nightly treatment session, switching the role of the respective first and second IMDs to: delivering the electrical stimulation to the second target tissue via the second IMD throughout a nightly treatment period; and selectively delivering stimulation to the first target tissue via the first IMD during the nightly treatment period based upon comparison of a disease burden parameter relative to a criteria.

93. The method of claim 57, comprising the first IMD and second IMD selectively communicating with each other, and comprising: implementing the selective operation of the respective first and second IMDs within a nightly therapy session; and communicating first information about the nightly therapy session between each of the first and second IMDs, wherein the first information comprises sensing information and / or therapy information.

94. The method of claim 93, comprising implementing the communication during the nightly therapy session and evaluating the first information regarding efficacy of operation of the respective first and second IMDs, and adjusting, based on the evaluation, the selective operation of the first IMD and / or second IMD.

95. The method of claim 94, comprising implementing the evaluating and the adjusting within the nightly therapy session.

96. The method of claim 94, comprising implementing, via the first IMD, the adjusting of the selective operation of the first IMD independent of implementing, via the second IMD, the adjusting of the selective operation of the second IMD.

97. The method of claim 94, wherein the efficacy of operation comprises an efficacy of sensing and / or an efficacy of stimulation.

98. The method of claim 94, wherein the adjusting comprises, via communication between the respective first and second IMDs, coordinating adjusting of the selective operation of the first IMD and the second IMD relative to each other.

99. The method of claim 98, wherein the efficacy of operation comprises an efficacy of sensing and / or an efficacy of stimulation.

100. The method of claim 93, wherein the first information comprises information obtained from both of the first IMD and the second IMD during the night’s therapy session regarding the night’s therapy session.101 . The method of claim 93, wherein the first information comprises information obtained from both of the first IMD and the second IMD after the night’s therapy session regarding the night’s therapy session.

102. The method of claim 101 , comprising implementing the communication between the first and second IMDs after the night’s therapy session.

103. The method of claim 57, comprising operating the first IMD and the second IMD independently from each other.

104. The method of claim 103, wherein the first IMD and the second IMD operate without communicating with each other.

105. The method of claim 104, wherein the first IMD and the second IMD are spaced apart from each other by a first distance which exceeds a maximum distance of effective wireless intra-body communication.

106. The method of claim 103, comprising: implementing the independent operation within a nightly therapy session; and communicating, outside of the nightly therapy session, first information from a previous night’s therapy session from each of the first and second IMDs, wherein the first information comprises sensing information and / or therapy information.

107. The method of claim 106, comprising: communicating the first information from each of the respective first and second IMDs to a third device; and evaluating the first information regarding efficacy of operation of the respective first and second IMDs.

108. The method of claim 107, wherein the third device comprises a third IMD or an external device.

109. The method of claim 107, adjusting, based on the evaluation, the selective operation of the first IMD and / or second IMD.1 10. The method of claim 109, wherein the adjusting of the selective operation of the first IMD is independent of the adjusting of the selective operation of the second IMD.1 1 1. The method of claim 110, wherein the adjusting comprises, via the third IMD, coordinating adjusting of the selective operation of the first IMD and the second IMD relative to each other.1 12. The method of claim 107, wherein the efficacy of operation comprises an efficacy of sensing and / or an efficacy of stimulation.1 13. The method of claim 103, wherein operating the first IMD comprises: retrieving first information from the first IMD regarding efficacy of operation of the first IMD during a night’s therapy session; andevaluating the efficacy of operation of the first IMD independently of the efficacy of operation of the second IMD; and wherein operating the second IMD comprises: retrieving second information from the second IMD regarding efficacy of operation of the second IMD during a night’s therapy session; and evaluating the efficacy of operation of the second IMD independently of the efficacy of operation of the first IMD.1 14. The method of claim 113, wherein the efficacy of operation comprises an efficacy of sensing and / or an efficacy of stimulation.1 15. The method of claim 113, wherein each of the respective first and second information comprises sensing information and / or therapy information.1 16. The method of claim 113, wherein at least one of the respective first and second information comprises information from a previous night’s treatment / therapy session.1 17. The method of claim 113, wherein at least one of the respective first and second information comprises information obtained during a night’s therapy session regarding the night’s therapy session.1 18. A device comprising: a first implantable medical device (IMD) arranged in relation to a first target tissue and configured to be selectively operated; and / or a second IMD arranged in relation to a second target tissue and configured to be selectively operation.1 19. The device of claim 118, comprising a control portion configured to:selectively operate the first IMD relative to at least one of the first target tissue or the second target tissue; or selectively operate of the second IMD relative to at least one of the first target tissue or the second target tissue.

120. The device of claim 118, comprising a control portion configured to selectively operate a plurality of IMDs, including the first IMD and the second IMD, in relation to a plurality of target tissues, including the first target tissue and / or the second target tissue.

121. A device comprising: a plurality of implantable medical devices (IMD) arranged in relation to a plurality of target tissues; and a control portion configured with the plurality of IMDs to select respective ones of the plurality of target tissues and associated ones of the plurality of IMDs arranged in relation to the selected target tissues, and to activate the selected target tissues using the associated ones of the plurality of IMDs.

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