Patient neck cuff arrangements

Abstract

A patient neck cuff arrangement includes an object or garment configured to be worn or positioned in close contact with a neck of a patient. A wireless transmitter may be arranged within the object or garment to transmit power to a medical device implanted within a head-and-neck region of the patient.

Description

PATIENT NECK CUFF ARRANGEMENTSBackground

[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] FIG. 1 A is a diagram schematically representing an example method and / or example device in relation to a target tissue.

[0003] FIG. 1 B 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.

[0004] FIG. 1 C is a block diagram of a control portion.

[0005] FIGS. 2A-2C are block diagrams schematically representing example systems including an implantable medical device (IMD) and a patient neck cuff.

[0006] FIGS. 3A-3D are diagrams schematically representing example IMDs including a wireless communication portion.

[0007] FIG. 3E is a diagram schematically representing an example IMD including a lead.

[0008] FIG. 4A is a diagram schematically representing an example antenna including three orthogonal coils that may be configured to receive and / or transmit wireless power.

[0009] FIG. 4B is a top view schematically representing an example array of coil structures that may be configured to wirelessly transmit power to an IMD.

[0010] FIG. 4C is a top view schematically representing an example coil structure that may be configured to wirelessly transmit power to an IMD.

[0011] FIGS. 4D-4G are diagrams schematically representing example coil structures that may be configured to wirelessly transmit power to an IMD.

[0012] FIG. 5 is a block diagram illustrating example IMDs and a patient neck cuff.

[0013] FIGS. 6A-6D are diagrams illustrating example patient neck cuffs.

[0014] FIGS. 7A and 7B are diagrams illustrating example patient neck cuff pillows.

[0015] FIG. 8A is a block diagram illustrating example electronic components of a patient neck cuff.

[0016] FIG. 8B is a block diagram illustrating example components accessible on an exterior of a patient neck cuff.

[0017] FIGS. 9A and 9B are block diagrams illustrating example sensing portions, respectively.

[0018] FIGS. 10A and 10B are diagrams including front and side views schematically representing a neck region and an example device and / or example method for sensing impedance.

[0019] FIG. 10C is a diagram including a side view schematically representing a neck region and an example patient neck cuff and / or example method for sensing impedance and / or relating to delivering stimulation.

[0020] FIG. 10D is a diagram schematically representing an external power / control element in wireless communication with an implantable neural interface.

[0021] FIG. 11A is a diagram including a side view schematically representing a neck region and an example patient neck cuff and / or example method to support sleep disordered breathing (SDB) care including multi-target stimulation.

[0022] FIGS. 11 B and 11 C are diagrams including a plan view and a side view, respectively, schematically representing an electrode array of a stimulation element.

[0023] FIG. 11 D is a block diagram including a side view schematically representing a power / control element.

[0024] FIG. 11 E is a block diagram including a side view schematically representing a power / control element in combination with a stimulation portion in stimulating relation to a muscle.

[0025] FIG. 11 F is a cross-sectional view schematically representing a neck region and an example patient neck sleeve.

[0026] FIGS. 12A-12D are diagrams including a top view illustrating example upper airway collapse patterns.

[0027] FIG. 12E is a diagram illustrating a side sectional view of example patient anatomy including an upper airway and related tissues.

[0028] FIGS. 12F and 12G are diagrams illustrating example patient anatomy including example upper airway collapse patterns and locations.

[0029] FIGS. 13A-13E are flow diagrams schematically representing example methods for wirelessly charging a power element of an IMD.

[0030] FIGS. 14A and 14B are block diagrams schematically representing example control portions.

[0031] FIG. 15 is a block diagram schematically representing an example user interface.

[0032] FIG. 16 is a block diagram schematically representing example communication arrangements between an IMD and external devices.

[0033] FIG. 17 is a block diagram schematically representing an example patient management system.

[0034] FIGS. 18A-18K are diagrams illustrating example patient neck cuff arrangements.Detailed Description

[0035] 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 understoodthat features of the various examples described herein may be combined, in part or whole, with each other, unless specifically noted otherwise.

[0036] At least some examples of the present disclosure are directed to devices for diagnosis, therapy, and / or other care of medical conditions. At least some examples may comprise implantable devices and / or methods comprising use of implantable devices. However, in some examples, the methods and / or devices may comprise at least some external components. In some examples, a therapeutic medical device may comprise a combination of implantable components and external components.

[0037] At least some of the example devices and / or example methods may relate to sleep disordered breathing (SDB) care, which may comprise monitoring, diagnosis, evaluation, and / or treatment, which may comprise stimulation in some examples. At least some examples include a patient neck cuff or patient neck cuff arrangement for sensing, stimulation, and / or communication (e.g., for diagnosis, evaluation, and / or treatment of SDB) which may be performed in combination with or independently from an associated implantable medical device. Among other target tissues for stimulation and / or sensing, at least some target tissues comprise tissues of the head and / or neck regions which include nerves, muscles, and / or other tissues (e.g., tendons, bones, cartilage, etc.) related to treating sleep disordered breathing such as, but not limited to, obstructive sleep apnea. These target tissues may directly or indirectly relate to promoting upper airway patency. In some examples, the target tissues for promoting upper airway patency (e.g., upper airway patency-related tissues) may comprise a hypoglossal nerve, a genioglossus muscle, an infrahyoid muscle (IHM)-innervating nerve, and / or infrahyoid muscles. In some examples, other non-upper airway respiratory-related tissues comprise a phrenic nerve and / or diaphragm muscle, which may be sensed and / or stimulated separately from, and / or in conjunction with, sensing and / or stimulation of upper airway patency- related tissues as part of treating sleep disordered breathing (including obstructive sleep apnea).

[0038] In some examples, the external patient neck cuff or patient neck cuff arrangement may be used to charge a power element of an implantable medicaldevice. In some such examples, the charging may be implemented via inductive wireless power transfer (e.g., 50-1000 KHz) or radio frequency (RF) wireless power transfer (e.g., near-field 1-50 MHz).

[0039] In some examples, the external patient neck cuff, patient neck cuff arrangement, and / or other example medical devices, components, etc. may be used in monitoring, evaluation, diagnosis, treatment, etc. of other patient conditions, at least some of which may be treatable via nerve stimulation (and / or innervated muscles).

[0040] These examples, and additional examples, are further described in association with at least FIGS. 1A-18K.

[0041] FIG. 1A is a block diagram schematically representing an example arrangement 50 (an example device and / or example method) including an implantable medical device (IMD) 52 in operable relation to target tissue(s) 60. In some examples, the IMD 52 may comprise a sensing element 54, a stimulation element 56, and / or other element 58 (or function) such that the IMD 52 may be in sensing relation, stimulating relation, and / or other relation with the target tissue(s) 60.

[0042] FIG. 1 B is a block diagram schematically representing a patient’s body 100, including example target portions 110-134 at which at least some example sensing element(s), stimulation element(s), and / or other elements may be employed to implement at least some examples of the present disclosure.

[0043] As shown in FIG. 1 B, patient’s body 100 comprises a head-and-neck portion 110, including head 112 and neck 114. Head-and-neck portion 110 comprises cranial tissue, nerves, etc., and upper airway 116 (e.g., nerves, muscles, tissues), etc. As further shown in FIG. 1 B, the patient’s body 100 comprises a torso 120, which comprises various organs, muscles, nerves, other tissues, such as but not limited to those in pectoral region 122 (e.g., lungs 126, cardiac 127), abdomen 124, and / or pelvic region 129 (e.g., urinary / bladder, anal, reproductive, etc.). As further shown in FIG. 1 B, the patient’s body 100 comprises limbs 130, such as arms 132 and legs 134.

[0044] It will be understood that various sensing elements (and / or stimulation elements) as described throughout the various examples of the present disclosure may be deployed within the various regions of the patient’s body 100 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. 2A-18K. In some such examples, a stimulation element 117 may be located in or near the upper airway 116 for treating sleep disordered breathing (and / or near other nerves / muscles for treating other conditions) and / or a sensing element 128 may be located anywhere within the neck 114, head 112, and / or torso 120 (or other body regions) to sense physiologic information for providing patient care (e.g., SDB, other) and / or for other purposes.

[0045] In some examples, at least a portion of the stimulation element 117 may comprise part of an implantable component / device, such as an implantable pulse generator (IPG) whether full sized or sized as a microstimulator. The implantable components (e.g., IPG, other) may comprise a stimulation / control circuit, a power supply (e.g., non-rechargeable, rechargeable), communication elements, and / or other components. In some examples, the stimulation element 117 also may comprise a stimulation electrode and / or stimulation lead connected to the implantable pulse generator.

[0046] Further details regarding the location, structure, operation, and / or use of the sensing element 128, external element(s) 150, and / or stimulation element 117 are described below in association with at least FIGS. 1C-18K.

[0047] In some examples, at least a portion of the stimulation element 117 may comprise part of an external component / device such as, but not limited to, the external component comprising a pulse generator (e.g., stimulation / control circuitry), power supply (e.g., rechargeable, non-rechargeable), and / other components. In some examples, a portion of the stimulation element 117 may be implantable and a portion of the stimulation element 117 may be external to the patient.

[0048] Accordingly, as further shown in FIG. 1 B, the various sensing element(s) 128 and / or stimulation element(s) 117 implanted in the patient’s body may be inwireless communication (e.g., connection 137) with at least one external element 150.

[0049] As further shown in FIG. 1 B, in some examples, the external element(s) 150 may be implemented via a wide variety of formats such as, but not limited to, at least one of the formats 151 including a patient support 152 (e.g., bed, chair, sleep mat, other), wearable elements 154 (e.g., finger, wrist, head, neck, shirt), noncontact elements 156 (e.g., watch, camera, mobile device, other), and / or other elements 158. In some examples, as shown in FIG. 1 B, external element 150 is implemented as a patient neck cuff or patient neck cuff arrangement 180 configured to be worn on the neck 114 of the patient 100.

[0050] As further shown in FIG. 1 B, in some examples, the external element(s) 150 may comprise one or more different modalities 170 such as (but not limited to) a sensing portion 171 , stimulation portion 172, power portion 174, communication portion 176, and / or other portion 178. The different portions 171 , 172, 174, 176, 178 may be combined into a single physical structure (e.g., patient neck cuff and / or other package, arrangement, assembly), may be implemented in multiple different physical structures, and / or with just some of the different portions 171 , 172, 174, 176, 178 combined together into a single physical structure.

[0051] In some examples, the external stimulation portion 172 and / or implantable portions of stimulation element 117 may be implemented via, and / or comprise at least some of substantially the same features and attributes of, at least the stimulation arrangements, as further described below in association with at least FIGS. 2A-18K and / or other examples throughout the present disclosure. Similarly, in some examples, the external sensing portion 171 and / or implantable portions of sensing element 128 may be implemented via, and / or comprise at least some of substantially the same features and attributes of, at least the sensing arrangements, as further described below in association with at least FIGS. 2A-18K and / or other examples throughout the present disclosure.

[0052] In some examples, the external power portion 174 and / or power components associated with stimulation element 117 (e.g., implantable portions)may comprise at least some of substantially the same features and attributes of at least the stimulation 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 174 may comprise a power source by which a power component of the stimulation element 117 (e.g., implantable portions) may be recharged.

[0053] In some examples, the wireless communication portion 176 (e.g., connection / link at 137) 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.

[0054] Examples are not so limited as expressed by other portion 178 via which other aspects of implementing medical care may be embodied in external element(s) 150 to relate to the various implanted and / or external components described above.

[0055] FIG. 1 C schematically represents a control portion 190, which may comprise at least some of substantially the same features and attributes as the control portion 4200 in FIG. 14A. The control portion 190 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 190 may form part of, and / or be in communication with, the sensing element 128 and / or the stimulation element 117 in FIG. 1 B, external element(s) 150 (e.g., patient neck cuff 180), and / or other medical device (or portions thereof), as further described later.

[0056] FIG. 2A is a block diagram schematically representing an example system 200a including an implantable medical device (IMD) 202a and a patient neck cuff 220a. In some examples, the IMD 202a may be implanted into a patient fordiagnostic, therapeutic, drug delivery, and / or other suitable purposes. In some examples, the IMD 202a may be used to apply electrical stimulation to respiratory- related tissue, such as to an upper airway patency-related tissue of a patient, to treat sleep disordered breathing (SDB) conditions. In some examples, the IMD 202a may be used to apply electrical stimulation to other tissues (e.g., spinal) of a patient to treat other conditions. In some examples, the IMD 202a may provide the stimulation element 117 and / or the sensing element 128 in FIG. 1 B, and the patient neck cuff 220a may provide the patient neck cuff 180 in FIG. 1 B.

[0057] The IMD 202a includes a power element 204 and a wireless receiver 206. The patient neck cuff 220a includes a wireless transmitter 222 to transmit power to the wireless receiver 206 of the IMD 202a over a wireless path 223. The wireless receiver 206 receives power transmitted from the wireless transmitter 222 to charge (or recharge) the power element 204. In some examples, the wireless receiver 206 also receives communications from the patient neck cuff 220a over the wireless path 223. The wireless transmitter 222 may separately transmit power and communication signals to the wireless receiver 206 at different times or may combine (e.g., multiplex) power and communication signals such that power and communications are transmitted simultaneously. The power element 204 may be a liquid electrolyte battery (e.g., lithium-ion battery), a solid-state battery, a supercapacitor, or other suitable component configured to store energy that may be used to power the IMD 202a. In some examples, the solid-state battery may comprise a thin-film solid-state electrolyte, such as (but not limited to) a lithium phosphorus oxynitride (LiPON) material.

[0058] The time required to recharge the power element 204 of the IMD 202a is based upon the power element technology. For example, given a supercapacitor, a solid-state battery, and a liquid electrolyte battery each having the same energy capacity, in some examples the supercapacitor may be recharged from a 10 percent charge to a 90 percent charge faster than the solid-state battery, and the solid-state battery may be recharged from a 10 percent charge to a 90 percent charge faster than the liquid electrolyte battery. For example, when a supercapacitor is used asthe power element 204, the IMD 202a may be rapidly recharged from a 10 percent charge to a 90 percent charge by the patient neck cuff 220a in under 90 seconds for example. When a solid-state battery is used as the power element 204, the IMD 202a may be quickly recharged from a 10 percent charge to a 90 percent charge by the patient neck cuff 220a in under 10 minutes for example. When a liquid electrolyte battery is used as the power element 204, the IMD 202a may be recharged from a 10 percent charge to a 90 percent charge by the patient neck cuff 220a in 20 to 30 minutes for example.

[0059] In examples in which a solid-state battery is used as the power element 204, the power element 204 and thus the IMD 202a may be made smaller since solid state batteries are more energy dense than supercapacitors and liquid electrolyte batteries. Supercapacitors and solid-state batteries are safer than liquid electrolyte batteries, since there is little risk of a liquid electrolyte leaking and the risk of fire may be reduced. Supercapacitors can withstand more charge and discharge cycles (e.g., hundreds of thousands) than solid state batteries before degrading (e.g., storing less energy), and solid-state batteries can withstand more charge and discharge cycles (e.g., about 5000) than liquid electrolyte batteries (e.g., about 1000) before degrading. Supercapacitors have an additional benefit over both solid-state batteries and liquid electrolyte batteries in that supercapacitors do not contain any toxic metals (e.g., lithium) that may involve more special handling, sealing, etc. to permit use within a patient. In some examples, the power element 204 may include two or more power storage technologies, such as a supercapacitor paired with a solid-state battery.

[0060] In some examples, the wireless transmitter 222 transmits power (and / or communications) to the wireless receiver 206 using inductive coupling or near-field radio frequency (RF) wireless power transfer.

[0061] FIG. 2B is a block diagram schematically representing an example system 200b including an implantable medical device (IMD) 202b and a patient neck cuff 220b. In some examples, the IMD 202b may provide the stimulation element 117 and / or the sensing element 128 in FIG. 1 B, and the patient neck cuff 220b mayprovide the patient neck cuff 180 in FIG. 1 B. The IMD 202b is similar to the IMD 202a of FIG. 2A, except that the IMD 202b further includes a wireless transmitter 208. The wireless transmitter 208 may operate at the same frequency as the wireless receiver 206 or at a different frequency from the wireless receiver 206. In some examples, the wireless receiver 206 and the wireless transmitter 208 may be combined into a wireless transceiver. The patient neck cuff 220b is similar to the patient neck cuff 220a of FIG. 2A, except that the patient neck cuff 220b further includes a wireless receiver 224. The wireless receiver 224 may operate at the same frequency as the wireless transm itter 222 or at a different frequency from the wireless transmitter 222. In some examples, the wireless transmitter 222 and the wireless receiver 224 may be combined into a wireless transceiver.

[0062] The wireless transmitter 208 of the IMD 202b may transmit communications and / or other signals to the wireless receiver 224 of the patient neck cuff 220b through a wireless communication path 209. In some examples, the IMD 202b may transmit communications and / or other signals to the patient neck cuff 220b simultaneously with receiving power from the patient neck cuff 220b for charging the power element 204.

[0063] FIG. 2C is a block diagram schematically representing an example system 200c including an implantable medical device (IMD) 202c and a patient neck cuff 220c. In some examples, the IMD 202c may provide the stimulation element 117 and / or the sensing element 128 in FIG. 1 B, and the patient neck cuff 220c may provide the patient neck cuff 180 in FIG. 1 B. The IMD 202c is similar to the IMD 202a of FIG. 2A, except that the IMD 202c further includes a Bluetooth Low Energy (BLE) transceiver 210. The BLE transceiver 210 may operate at a different frequency (e.g., 2.45 GHz) from the wireless receiver 206. The patient neck cuff 220c is similar to the patient neck cuff 220a of FIG. 2A, except that the patient neck cuff 220c further includes a BLE transceiver 226. The BLE transceiver 226 may operate at a different frequency from the wireless transmitter 222. The BLE transceiver 210 of the IMD 202c may exchange communications with the BLE transceiver 226 of the patient neck cuff 220c through a Bluetooth communicationpath 211. In some examples, the IMD 202c may exchange communications with the patient neck cuff 220c simultaneously with receiving power from the patient neck cuff 220c for charging the power element 204.

[0064] Communications from a patient neck cuff (e.g., 220a-220c of FIGS. 2A-2C) to an IMD (e.g., 202a-202c of FIGS. 2A-2C) may be defined as a downlink. Communications from an IMD to a patient neck cuff may be defined as an uplink. Communications that are at or near the recharge frequency may be defined as in- band communications. Communications that are outside of the recharge frequency may be defined as out-of-band communications. For in-band downlink and uplink, charging may be paused for communications and resumed once the communications are complete. For out-of-band downlink and uplink, charging and communications may occur simultaneously. For in-band downlink and out-of-band uplink, there are at least two options as follows: 1 ) pause charging during downlink; or 2) encode the charging energy for simultaneous charging and downlink. In either case, charging may continue during uplink.

[0065] Uplink may be performed using BLE (e.g., via BLE transceivers 210 and 226 of FIG. 2C). The patient neck cuff and the IMD may exchange security / encryption settings. This exchange may be performed once during pairing or each time a charging session begins. The patient neck cuff and the IMD may maintain an active BLE session or disconnect. If disconnected, the IMD may utilize advertisement or extended advertisement packets for uplink, without the need to stay connected to the patient neck cuff. Advertisement packets may be encrypted such that only the patient neck cuff and other paired devices can decrypt the uplink information.

[0066] In some examples, at least some of substantially the same features of the BLE communication components may be used to communicate with other external devices such as (but not limited to) the devices described in association with at least FIGS. 14B-17.

[0067] FIG. 3A is a diagram schematically representing an example implantable medical device (IMD) 250a. In some examples, the IMD 250a may comprise at least some of substantially the same features as, and / or comprise an exampleimplementation of at least some of the features of, the implantable components (e.g., 117, 128) in the arrangements of FIGS. 1A-1 C and / or of IMDs 202a-202c of FIGS. 2A-2C.

[0068] As shown in FIG. 3A, in some examples, IMD 250a includes a housing 252, a wireless communication portion 253, and a stimulation element 256. In some examples, the wireless communication portion 253 may comprise a wireless receiver 206 and / or a wireless communication element 260 (e.g., antenna). In some examples, the IMD 250a may be implanted into a patient for therapeutic and / or other suitable purposes. In some examples, via the stimulation element 256, the IMD 250a may be used to apply electrical stimulation to respiratory-related tissue, such as to an upper airway patency-related tissue of a patient, to treat sleep disordered breathing (SDB) conditions. In some examples, the IMD 250a may be used to apply electrical stimulation to other tissues (e.g., spinal) of a patient to treat other conditions.

[0069] The wireless receiver 206 of the wireless communication portion 253 may receive power transmitted from an external power source or charger (e.g., 174 / 150 of FIG. 1 B, 220a-220c of FIGS. 2A-2C, 4370 of FIG. 16) to power the IMD 250a including the wireless receiver 206 and the stimulation element 256. In some examples, the wireless receiver 206 also receives communications from the external charger (e.g., patient neck cuff) such as in association with communication portion 176 in FIG. 1 B. In some examples, the wireless receiver 206 receives power (and / or communications) using inductive coupling or near-field radio frequency (RF) wireless power transfer.

[0070] The wireless communication element 260 of the wireless communication portion 253 may include a coil antenna for inductive or near-field RF wireless power transfer (e.g., for frequencies less than or equal to about 50 MHz). In the IMD 250a, the wireless communication element 260 may be arranged on the housing 252 (e.g., on an exterior wall of the housing 252 or on an interior wall of the housing 252) or integrated within (e.g., embedded within, etched into) the housing 252. The wireless communication element 260 is electrically coupled to the wireless receiver 206 andis configured to receive power from a wireless transmitter (e.g., 174 in FIG. 1 B, 222 of FIGS. 2A-2C, 4370 of FIG. 16) to power the wireless receiver 206 and the stimulation element 256. In some examples, the wireless communication element 260 may also receive communication signals and / or control signals from an external charger (e.g., 176 in FIG. 1 B, 220a-220c of FIGS. 2A-2C, 4370 of FIG. 16) or other device (e.g., a mobile device 4320, a remote control 4340, a clinician programmer 4350, and / or a patient management tool 4360 of FIG. 16).

[0071] The simulation element 256 may include stimulation circuitry and / or at least one stimulation electrode to apply electrical stimulation to a patient. The stimulation element 256 receives power and / or control signals from the wireless receiver 206 of wireless communication portion 253. The electrical stimulation may be applied via at least one electrode of the stimulation element 256 or electrically coupled to the stimulation element 256. In some examples, at least one electrode (not shown) may be arranged on the housing 252 or on a lead electrically coupled to the stimulation element 256.

[0072] In some examples, the housing 252 encloses at least a portion of the wireless communication portion 253 (e.g., the wireless receiver 206) and at least a portion (e.g., at least stimulation circuitry) of the stimulation element 256. In some examples, housing 252 may encapsulate (e.g., overmold) the wireless receiver 206 and the stimulation element 256 to hermetically seal at least a portion (e.g., the wireless receiver 206) of the wireless communication portion 253 and at least a portion (e.g., stimulation circuitry) of the stimulation element 256. Housing 252 may include any suitable biocompatible material, such as a metal (e.g., titanium, stainless steel, MP35N), a thermoplastic polymer (e.g., silicone, polysulfone (PSU), liquidcrystal polymer (LCP), polyether ketone (PEK), polypropylene, polycarbonate,), a thermoset material (e.g., epoxy), a blend polymer material (e.g., polyetheretherketone (PEEK)), a ceramic material (e.g., glass, aluminum oxide (AI2O3), zirconium oxide (ZO2)), or a combination thereof. Different portions of the housing 252 may be made of different materials. For example, a first portion of the housing 252 may be made of a metal (e.g., titanium) while a second portion of thehousing where the wireless communication element 260 is arranged may be made of a nonconductive material (e.g., PEEK).

[0073] In some examples, the IMD 250a may include a microstimulator configured to be implanted within a patient, such as within a head-and-neck region of the patient. The microstimulator may include the housing 252 to encapsulate (e.g., hermetically seal) at least a portion (e.g., wireless receiver 206) of the wireless communication portion 253 and at least a portion (e.g., stimulation circuitry) of the stimulation element 256.

[0074] FIG. 3B is a diagram schematically representing an example IMD 250b. In some examples, the IMD 250b may comprise at least some of substantially the same features and attributes as IMD 250a of FIG. 3A. As shown in FIG. 3B, the IMD 250b may include a power element 204 and a wireless receiver 206 for charging the power element 204 as previously described. In addition, the IMD 250b may include a housing 252, a control portion 254, and a wireless communication element 260 (e.g., antenna). Housing 252 encloses the power element 204, the wireless receiver 206, and the control portion 254. In some examples, housing 252 may encapsulate (e.g., overmold) the power element 204, the wireless receiver 206, and the control portion 254 to hermetically seal the power element 204, the wireless receiver 206, and the control portion 254 within the housing 252.

[0075] The control portion 254 may control the wireless receiver 206, the power element 204, and other circuitry (not shown) of the IMD 250b. The control portion 254 may include a central processing unit (CPU), a microcontroller, an application specific integrated circuit (ASIC), and / or other suitable logic circuitry. At least some example implementations of the control portion 254 are further described below with reference to at least FIGS. 14A and 14B.

[0076] It will be further understood that in some examples, at least some aspects or elements of the control portion 254 may form part of, and / or be distributed among, the other components (e.g., power, wireless communication portion 253, other) of the IMD 250b such that control portion 254 does not necessarily form a componentof the IMD 250b separate from those other elements (e.g., power, wireless communication, etc.).

[0077] In some examples, an IMD 250b may comprise a power source for other IMDs in close enough proximity to be in power-exchanging relation to the IMD 250b such that IMD 250b may omit a sensing element, stimulation element, etc. and solely serve as a power resource within the patient’s body to support other IMDs within the patient’s body. In some such examples, such support to help power other IMDs within the patient may comprise the IMD 250b including a wired connection to such other IMDs, such as via a lead or other means.

[0078] Similarly, in some examples, with or without its own power element (and / or with or without elements for sensing, stimulation etc.), an IMD may provide a wireless communication node to support wireless communication with other IMDs within a patient’s body and / or wireless communication with external elements (e.g., 150 in FIG. 1 B), which may support such IMDs acting as intra-body wireless communication nodes.

[0079] FIG. 3C is a diagram schematically representing an example IMD 250c. The IMD 250c is similar to the IMD 250b of FIG. 3B, except that the IMD 250c further includes a stimulation element 256. In this example, the control portion 254 may include a therapy manager arranged to control the stimulation element 256 based on at least control information to apply electrical stimulation to a patient. In some examples, the therapy manager may be arranged to control (e.g., based on control information) the stimulation element 256 to apply electrical stimulation to respiratory- related tissue (e.g., upper airway patency-related tissue) to treat sleep disordered breathing (SBD) conditions or to apply electrical stimulation to other tissues. The electrical stimulation may be applied via at least one electrode electrically coupled to the stimulation element 256. In some examples, at least one electrode (not shown) may be arranged on the housing 252 or on a lead electrically coupled to the stimulation element 256.

[0080] In some examples, the IMD 250c may include a microstimulator configured to be implanted within a patient, such as within a head-and-neck region of the patient.The microstimulator may include the housing 252 to encapsulate (e.g., hermetically seal) at least the power element 204, the wireless communication portion 253 (e.g., wireless receiver 206 and / or wireless communication element 260), the stimulation element 256, and / or the control portion 254.

[0081] FIG. 3D is a diagram schematically representing an example IMD 250d. The IMD 250d is similar to the IMD 250b of FIG. 3B, except that the IMD 250d further includes a sensing element 258 and the wireless communication element 260 is integrated into or on the power element 204. In some examples, the wireless communication element 260 may be wrapped around the power element 204 or arranged on a casing of the power element 204. Alternatively, as previously described above with reference to FIG. 3A, the wireless communication element 260 may be arranged on the housing 252 or integrated within the housing 252.

[0082] In this example, the control portion 254 may include a sensing manager arranged to control the sensing element 258 based on at least control information to obtain sensing information (e.g., physiologic information) for a patient. The sensing element 258 may include at least one sensor (e.g., accelerometer, gyroscope, piezoelectric sensor, acoustic sensor, microphone, temperature sensor, pressure sensor, etc.) and / or other suitable circuitry for obtaining sensing information for a patient. The sensing information (e.g., sensed physiologic information) may include respiratory information, cardiac information, activity information, motion information, posture information, and / or other information about the patient. In some examples, the sensing element 258 of the IMD 250d may be included along with the stimulation element 256 of the IMD 250c within a single IMD. The sensing element 258 may sense sensing information of a patient via at least one electrode electrically coupled to the sensing element 258. In some examples, at least one electrode (not shown) may be arranged on the housing 252 or on a lead electrically coupled to the sensing element 258. In some examples in which a sensing element comprises at least one electrode, the at least one electrode also may, at times, be used for stimulation and / or comprise a portion of the stimulation element 256.

[0083] The sensed information may be used to initiate, terminate, pause, synchronize, and / or trigger therapy to be applied via an IMD and / or external therapy elements (e.g., patient neck cuff). In some examples, the sensed information may be used as feedback for controlling therapy (e.g., stimulation therapy). In some such examples, the sensed information may be used in closed loop stimulation therapy in which stimulation (e.g., specific stimulation periods) is synchronized relative to or triggered relative to sensed respiratory phase information, respiratory morphology, etc. so that a stimulation period (of a series of stimulation periods) coincides with a particular portion of the respiratory phase (e.g., at least a portion of the inspiratory phase). The sensed information also may be used for diagnostic purposes and / or for monitoring (and / or evaluation of) a particular physiologic effect, physiologic response, etc. regardless of whether the sensed information is used for other purposes (e.g., therapy). In some such examples, the sensed information may be used to implement open loop stimulation therapy which, in some examples does not synchronize and / or trigger delivery of the stimulation therapy relative to respiratory phase information (e.g., an inspiratory phase), respiratory morphology, etc. Therefore, the open loop stimulation periods may sometimes overlap with a portion of a particular respiratory phase (e.g., inspiratory phase), but each stimulation period (of a series of stimulation periods of a therapy protocol) does not necessarily coincide with a particular respiratory phase (e.g., inspiratory phase) as might otherwise occur in some examples of closed loop stimulation therapy.

[0084] However, in some examples, whether closed loop or open loop, stimulation therapy may be initiated, terminated, paused, and / or triggered based on sensed information other than respiration, such as one or more of posture, activity, cardiac information, disease burden, etc. In one example, disease may comprise a severity of sleep disordered breathing, which may comprise a severity index such as (but not limited to) apnea-hypopnea index (AHI) (e.g., frequency of apnea events per hour).

[0085] For example, if the sensed parameter (e.g., posture, activity, motion, cardiac information, or disease burden, etc.) fails to meet a criteria (e.g., is at or below a threshold), stimulation may remain dormant or the stimulation may be paused orterminated if stimulation had been previously occurring. However, if the sensed parameter meets the criteria (e.g., is above the threshold), the stimulation therapy may be initiated, triggered, or maintained.

[0086] In some examples, an IMD may comprise any one of various combinations of the above-described elements (e.g., stimulation, sensing, power, communication, control) of the respective IMDs described in association with FIGS. 2A-3D and / or FIGS. 1A-1 C. In one example, a sensing element (e.g., 258 in FIG. 3D) may take the place of the stimulation element 256 of the IMD 250a in FIG. 3A, or vice versa. In another example, both the sensing and stimulation elements 258, 256 may be included in the same IMD or all three of the sensing, stimulation, and power elements 258, 256, 204 may be included in the same IMD, along with other elements such as a wireless communication portion 253 and / or a control portion 254. At least some of these various combinations regarding FIGS. 1 A-3D are also applicable to the various later described examples associated with FIGS. 4A-18K.

[0087] FIG. 3E is a diagram schematically representing an example IMD 400. In some examples, IMD 400 may comprise at least some of substantially the same features and attributes as, and / or comprise an example implementation of at least some of the features of, stimulation element 117 in FIG. 1 B, sensing element 128 in FIG. 1 B, IMD 202a-202c in FIGS. 2A-2C, and / or IMD 250a-250d in FIGS. 3A-3D. IMD 400 includes a housing 402, a lead 420, and an electrode-carrier arrangement 440. Housing 402 may include a first housing portion 406, which may enclose a power element (e.g., 204 of FIGS. 2A-2C or 3B-3D). Housing 402 may include a second housing portion 408, which may enclose a wireless receiver (e.g., 206 of FIGS. 2A-3D), a wireless transmitter (e.g., 208 of FIG. 2B), a BLE transceiver (e.g., 210 of FIG. 2C), a wireless communication element (e.g., 260 of FIGS. 3A-3D), a stimulation element (e.g., 256 of FIGS. 3A or 30), a sensing element (e.g., 258 of FIG. 3D), a control portion (e.g., 254 of FIGS. 3B-3D), and / or other circuitry. In some examples, second housing portion 408 may include one or more suture anchors 410 for securing housing 402 within a patient, which may be located on one or more different sides or ends of the housing 402 in a configuration to robustly secure andstabilize the housing 402 relative to patient tissue. Housing 402 may include a third housing portion 412 for connecting lead 420 to housing 402 via a connector 422. In some examples, connector 422 may be removably secured to third housing portion 412 via one or more set screws 414.

[0088] Housing 402 may include any suitable biocompatible material, such as a metal (e.g., titanium, stainless steel, MP35N), a thermoplastic polymer (e.g., silicone, polysulfone (PSU), liquid-crystal polymer (LCP), polyether ketone (PEK), polypropylene, polycarbonate), a thermoset material (e.g., epoxy), a blend polymer material (e.g., polyetheretherketone (PEEK)), a ceramic material (e.g., glass, aluminum oxide (AI2O3), zirconium oxide (ZO2)), or a combination thereof. Different portions of the housing 402 may be made of different materials. For example, first portion 406 and third portion 412 of housing 402 may comprise a metal (e.g., titanium) while second portion 408 of housing 402 where a wireless communication element 260 may be arranged may comprise a nonconductive material (e.g., PEEK).

[0089] Lead 420 may include a plurality of wires electrically coupling circuitry enclosed by housing 402 to electrode-carrier arrangement 440. Electrode-carrier arrangement 440 may include a cuff electrode-carrier 442 supporting a plurality of electrodes 444. In some examples, the electrode-carrier arrangement 440 may include another suitable arrangement, such as a paddle electrode, a flexible circuit, a cylindrical carrier with circumferential electrodes, etc. In some examples, IMD 400 may be sized to be implanted within a neck 114 (e.g., as IMD 117 in FIG. 1 B) of a patient and may communicate with a patient neck cuff 180 (FIG. 1 B) for power transfer and / or transfer of stimulation information and / or sensing information. In some examples, housing 402 and the circuitry enclosed by housing 402 may be considered a pulse generator or microstimulator. In some examples, the pulse generator or microstimulator housing 402 sealingly contains a power source (which may be rechargeable), circuitry for generating stimulation signals and / or for receiving sensing signals, and / or circuitry for communication, etc.

[0090] FIG. 4A is a diagram schematically representing an example antenna 500 including three orthogonal coils 502a, 502b, and 502c that may be configured toreceive and / or transmit wireless power. In some examples, antenna 500 may be part of wireless transmitter 222 of FIGS. 2A-2C. In some examples, antenna 500 may provide wireless communication element 260 of wireless communication portion 253 of FIGS. 3A-3D. In some example, the coils 502a, 502b, and 502c may be wrapped around a power element (e.g., 204 of FIGS. 2A-2C or 3B-3D) or a magnetic core (e.g., ferrite core) along orthogonal axes. The coils 502a, 502b, and 502c may include a single coil element (e.g., wire) with windings across the three axes, or each coil 502a, 502b, and 502c may be separate from each other (e.g., separate windings). By including orthogonal coils 502a, 502b, and 502c within an IMD and / or within a patient neck cuff (e.g., 174 / 176 of FIG. 1 B, 220a-220c of FIGS. 2A-2C, 4370 of FIG. 16), the patient neck cuff may maintain sufficient coupling (e.g., inductive or near-field RF) with the IMD independent of the orientation of the IMD relative to the patient neck cuff. While coils 502a, 502b, and 502c are illustrated as having a rectangular arrangement in FIG. 4A, in some examples, coils 502a, 502b, and 502c may have another suitable geometric arrangement, such as circular, elliptical, triangular, hexagonal, etc., or a non-geometric or asymmetrical arrangement.

[0091] FIG. 4B is a top view schematically representing an example array 510 of coil structures 512 that may be configured to wirelessly transmit power via inductive coupling. In some examples, the array 510 of coil structures 512 is part of wireless transmitter 222 of FIGS. 2A-2C. While the array 510 includes three coil structures 512, the array 510 of coil structures 512 may include any suitable number of coil structures. The coil structures may be arranged in rows and columns where each row and each column includes any suitable number of coil structures 512. The array 510 of coil structures 512 may be selected to be sufficiently large such that the array overlaps one or more IMDs within a patient’s body, such that at least one coil structure 512 will be aligned with each IMD during power transfer to the one or more IMDs. In this example, each coil structure 512 partially overlaps at least one adjacent coil structure 512, such as two, three, four, or more adjacent coil structures. By overlapping the coil structures 512, inductive coupling between adjacent coil structures may be minimized.

[0092] In some examples, a relative amplitude and phase of each coil structure 512 of the array 510 of coil structures may be controlled independently. The relative amplitude and phase of each coil structure 512 may be controlled independently to maximize wireless power transfer to an IMD and / or to minimize a specific absorption rate (SAR) by the patient.

[0093] Each coil structure 512 may include a single coil or a plurality of coils as further described below with reference to at least FIGS. 4C-4G. In some examples, a single coil structure 512 of the array 510 of coil structures is selected at a given time to transfer power to an IMD. In some examples, at least two coil structures 512 (e.g., a subset of adjacent coil structures) of the array 510 of coil structures are selected at a given time to transfer power to an IMD. In some examples, a first coil structure or subset of coil structures may be selected to transfer power to a first IMD, and a second coil structure or subset of coil structures may be selected to transfer power to a second IMD. The coil structure or subset of coil structures selected to transfer power to an IMD may be based on a measurement of power coupling between the wireless receiver of an IMD and the wireless transmitter of the patient neck cuff and / or a sensed location, position and / or orientation of an IMD relative to the patient neck cuff. In some examples, the coil structure or subset of coil structures selected to transfer power to an IMD may be dynamically updated during a recharge session based on measurements of power coupling between the wireless receiver of the IMD and the wireless transmitter of the patient neck cuff and / or based on a change in the sensed location, position and / or orientation of the IMD relative to the patient neck cuff. In some examples, an accelerometer and / or other sensor may be used to the sense the position and / or orientation of the IMD.

[0094] In some examples, each coil structure 512 or a subset of coil structures 512 may be powered simultaneously at the same frequency and at the same power level to transfer power to an IMD. In some examples, each coil structure 512 or a subset of coil structures 512 may be powered simultaneously at the same frequency and at a different power level to transfer power to an IMD. In some examples, each coil structure 512 of the array 510 of coil structures may be powered simultaneously at adifferent frequency and at the same power level for selecting at least one coil structure to transfer power to an IMD. In this example, the wireless receiver may measure and communicate to the wireless transmitter the received power from each coil structure corresponding to the frequency of the coil structure. Based on the received power information, the wireless transmitter may select the coil structure or subset of coil structures having the optimum power coupling with a wireless receiver.

[0095] A patient neck cuff (e.g., 220a-220c of FIGS. 2A-2C) including the array 510 of coil structures 512 may include a single receiver multiplexed to each coil structure 512, a dedicated receiver for each coil structure 512, or multiple receivers multiplexed to multiple coil structures 512. The receiver(s) of the patient neck cuff may be used to implement methods for selecting a coil structure 512 or a subset of coil structures 512 to optimize wireless power transfer to one or more IMDs as further described below with reference to at least FIGS. 13A-13E. In these examples, the receiver(s) may be part of a wireless transmitter (e.g., 222 of FIGS. 2A-2C) of a patient neck cuff.

[0096] FIG. 4C is a top view schematically representing an example coil structure 516. Coil structure 516 is a circular spiral coil, which in some examples may provide each coil structure 512 of array 510 of FIG. 4B. In some examples, spiral coil 516 may have another suitable shape, such as square, hexagonal, octagonal, etc. In some examples, the size of the coil structure within a patient neck cuff (e.g., 220a- 220c of FIGS. 2A-2C) used to transmit power to a coil structure of an IMD (e.g., 202a-202c of FIGS. 2A-2C or 250a-250d of FIGS. 3A-3D) may be selected based on the size of the IMD. For optimum power transmission, the size (e.g., length, width, diameter) of the coil structure within the patient neck cuff should be within a range between about 50% to 500% of the distance between the coil structure of the patient neck cuff and the coil structure of the IMD.

[0097] In some examples, coil structure 516 of FIG. 40, array 510 of coil structures of FIG. 4B, and coil structures 520a-520d described below with reference to FIGS. 4D-4G may be formed via traces on and / or within a printed circuit board (PCB) or another substrate.

[0098] FIG. 4D is a diagram schematically representing an example coil structure 520a that may be part of a patient neck cuff (e.g., 220a-220c of FIGS. 2A-2C). In some examples, the wireless transmitter (e.g., 222 of FIGS. 2A-2C) of a patient neck cuff may include a single coil structure 520a to transmit power to an IMD (e.g., 202a- 202c of FIGS. 2A-2C or 250a-250d of FIGS. 3A-3D). In some examples, the coil structure 520a may provide each coil structure 512 of array 510 of FIG. 4B, such that the wireless transmitter of the patient neck cuff includes an array of coil structures 520a. In this example, the coil structure 520a includes a single loop coil 522. While the single loop coil 522 illustrated in FIG. 4D has a square shape, in some examples, the single loop coil 522 may have another suitable geometric shape, such as circular, elliptical, rectangular, triangular, hexagonal, etc., or a non-geometric or asymmetric shape. The coil structure 520a may maintain sufficient inductive coupling with an antenna (e.g., 260 of FIGS. 3A-3D) of an IMD over a range of orientations of the IMD when the antenna of the IMD includes three orthogonal coils.

[0099] FIG. 4E is a diagram schematically representing an example coil structure 520b that may be part of a patient neck cuff (e.g., 220a-220c of FIGS. 2A-2C). In some examples, the wireless transmitter (e.g., 222 of FIGS. 2A-2C) of a patient neck cuff may include a single coil structure 520b to transmit power to an IMD (e.g., 202a- 202c of FIGS. 2A-2C or 250a-250d of FIGS. 3A-3D). In some examples, the coil structure 520b may provide each coil structure 512 of array 510 of FIG. 4B, such that the wireless transmitter of the patient neck cuff includes an array of coil structures 520b. In this example, the coil structure 520b includes a single loop coil 522 and a single figure-eight coil 524. While single loop coil 522 and single figure-eight coil 524 illustrated in FIG. 4E have an overall square shape, in some examples, single loop coil 522 and single figure-eight coil 524 may have another suitable geometric shape, such as circular, elliptical, rectangular, triangular, hexagonal, etc., or a nongeometric or asymmetric shape. By combining a single loop coil 522 with a single figure-eight coil 524 generating two orthogonal fields (rather than the single magnetic field generated by coil structure 520a of FIG. 4D), coil structure 520b may maintainsufficient inductive coupling with an antenna (e.g., 260 of FIGS. 3A-3D) of an IMD over a range of orientations of the IMD.

[0100] FIG. 4F is a diagram schematically representing an example coil structure 520c that may be part of a patient neck cuff (e.g., 220a-220c of FIGS. 2A-2C). In some examples, the wireless transmitter (e.g., 222 of FIGS. 2A-2C) of a patient neck cuff may include a single coil structure 520c to transmit power to an IMD (e.g., 202a- 202c of FIGS. 2A-2C or 250a-250d of FIGS. 3A-3D). In some examples, the coil structure 520c may provide each coil structure 512 of array 510 of FIG. 4B, such that the wireless transmitter of the patient neck cuff includes an array of coil structures 520c. In this example, the coil structure 520c includes two figure-eight coils 524 and 526. The figure-eight coil 526 is arranged orthogonal to the figure-eight coil 524. While each figure-eight coil 524 and 526 illustrated in FIG. 4F have an overall square shape, in some examples, each figure-eight coil 524 and 526 may have another suitable geometric shape, such as circular, elliptical, rectangular, triangular, hexagonal, etc., or a non-geometric or asymmetric shape. By combining the figureeight coil 524 with the figure-eight coil 526 generating two orthogonal fields (rather than the single magnetic field generated by coil structure 520a of FIG. 4D), the coil structure 520c may maintain sufficient inductive coupling with an antenna (e.g., 260 of FIGS. 3A-3D) of an IMD over a range of orientations of the IMD. In addition, the dominant magnetic field directions of coil structure 520c are different from the dominant magnetic field directions of coil structures 520a and 520b, such that coil structure 520c may be more appropriate for some orientations of an IMD.

[0101] FIG. 4G is a diagram schematically representing an example coil structure 520d that may be part of a patient neck cuff (e.g., 220a-220c of FIGS. 2A-2C). In some examples, the wireless transmitter (e.g., 222 of FIGS. 2A-2C) of a patient neck cuff may include a single coil structure 520d to transmit power to an IMD (e.g., 202a- 202c of FIGS. 2A-2C or 250a-250d of FIGS. 3A-3D). In some examples, the coil structure 520d may provide each coil structure 512 of array 510 of FIG. 4B, such that the wireless transmitter of the patient neck cuff includes an array of coil structures 520d. In this example, the coil structure 520d includes a single loop coil 522 and twofigure-eight coils 524 and 526. While the single loop coil 522 and each figure-eight coil 524 and 526 illustrated in FIG. 4G have an overall square shape, in some examples, the single loop coil 522 and each figure-eight coil 524 and 526 may have another suitable geometric shape, such as circular, elliptical, rectangular, triangular, hexagonal, etc., or a non-geometric or asymmetric shape. By combining a single loop coil 522 with two figure-eight coils 524 and 526 generating three orthogonal fields (rather than the single magnetic field generated by coil structure 520a of FIG. 4D or the two orthogonal magnetic fields generated by the coil structures 520b and 520c of FIGS. 4E and 4F), coil structure 520d may maintain good inductive coupling with an antenna (e.g., 260 of FIGS. 3A-3D) of an IMD over a range of orientations of the IMD.

[0102] FIG. 5 provides a simplified illustration of a neck region and example arrangement 600 comprising a patient neck cuff 650 and a first IMD 687 (e.g., a first 117, 128 of FIG. 1 , 202a-202c of FIGS. 2A-2C, 250a-250d of FIGS. 3A-3D, or 400 of FIG. 3E) and a second IMD 688 (e.g., a second 117, 128 of FIG. 1 , 202a-202c of FIGS. 2A-2C, 250a-250d of FIGS. 3A-3D, or 400 of FIG. 3E) to sense and / or stimulate target tissues. As shown in FIG. 5, arrangement 600 comprises a head- and-neck portion 610, including head 612 and neck 614, and a torso 620. In this example, the first IMD 687 is implanted at an upper part of the neck region 614 to be in stimulating relation and / or sensing relation to a first upper airway 616 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 stimulating relation to the hypoglossal nerve. In some such examples, the first IMD 687 may comprise an accelerometer configured to sense movement of such tissues indicative of respiration and / or an acoustic sensor configured to sense upper airway airflow indicative of respiration.

[0103] In some examples, the second IMD 688 is implanted at a lower part of the neck region 614 to be in stimulating relation and / or sensing relation to a secondupper airway 616 patency related tissue (UAPRT), which may comprise an infrahyoid-muscle (IHM)-innervating nerve and / or IHM (e.g., sternothyroid muscle (STM)) in some examples. In some examples, the second IMD 687 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 IHM-innervating nerve to sense respiration, whether or not the second IMD 688 is in stimulating relation to the IHM-innervating nerve. For example, an IMD 688 may comprise an accelerometer, which is mounted at a manubrium, clavicle, other bony structure, or non-nerve structure to sense movement indicative of respiration. In some examples, the second IMD 688 may be in close proximity to, but superior of, a clavicle 692R or manubrium 693. In some examples, either one of the first IMD 687 and second IMD 688 may be implanted at other locations within the neck region.

[0104] 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.

[0105] In some examples, neck cuff 650 (e.g., 180 of FIG. 1 B, 220a-220c of FIGS. 2A-2C) may be worn on the neck region 614 to transmit power to IMD 687 and / or 688 to power IMD 687 and / or 688 (e.g., during a treatment period, such as during stimulation and / or sensing) and / or to recharge a power element (e.g., 204 of FIGS. 2A-2C and 3B-3D) of IMD 687 and / or 688 (e.g., outside a treatment period and / or during a treatment period). Neck cuff 650 may include one coil structure (e.g., 500 of FIG. 4A, 516 of FIG. 4C, or 520a-520d of FIGS. 4D-4G) large enough to simultaneously transmit power to both IMDs 687 and 688, at least two coil structures (e.g., separate coil structures or array 510 of FIG. 4B) to simultaneously transmit power to both IMDs 687 and 688, or one coil structure to alternately transmit power to IMDs 687 and 688 one at a time. In examples where IMDs 687 and 688 are alternately powered one at a time, a first duty cycle of the power transmission signal to IMD 687 and a second duty cycle of the power transmission signal to IMD 688may be based on a power consumption of IMDs 687 and 688, respectively. For example, if IMD 688 consumes two times as much power as IMD 687, the second duty cycle for IMD 688 may be two times the first duty cycle for IMD 687.

[0106] In some examples, neck cuff 650 may be worn on the neck region 614 to sense physiologic information for providing patient care as previously described with reference to FIG. 1 B and further described below with reference to FIGS. 9A-12G. Neck cuff 650 may communicate with IMD 687 and / or 688 and / or other components (e.g., mobile device 4320, remote control 4340, clinician programmer 4350, patient management tool 4360 of FIG. 16) to transmit and / or receive control information and / or sensing information for providing patient care.

[0107] While two IMDs 687, 688 are shown in FIG. 5, it will be understood that the example arrangement 600 may comprise more than two IMDs and in some examples, a single IMD may be used. Moreover, the placement of such IMDs is not limited to the particular portions of the neck region 614 shown in FIG. 5. In addition, while IMDs 687, 688 are shown on just a right side of the neck region 614, it will be understood that one or both of IMDs 687, 688 may be located on the left side of the neck region 614 instead of, or in addition to, being present on the right side of the neck region 614. Furthermore, in some examples, just two IMDs 687 may be present on opposite sides of the neck region 614, or just two IMDs 688 may be present on opposite sides of the neck region 614.

[0108] As shown in FIG. 5, in some examples the neck cuff 650 may comprise two paddles 651 R, 651 L which are sized, shaped, oriented, and / or locatable to generally overlie an anterior portion of the neck region 614 with one paddle 651 R generally overlying a right anterior portion of neck region 614 and the other paddle 651 L generally overlying a left anterior portion of neck region 614. In some such examples, one of the paddles (e.g., 651 R) may comprise a size, shape, orientation, and / or location different from a size, shape, orientation, and / or location of the other respective paddle (e.g., 651 L) such that the one paddle 651 R is configured to overlie a right anterior portion of neck region 614 having a location, size, and / or shapedifferent from a size, shape, orientation, and / or location of a left anterior portion of neck region 614 which the other paddle 651 L overlies.

[0109] Alternatively, each respective paddle 651 R, 651 L may comprise a size, a shape, an orientation, and / or a location configured to generally overlie any location of an IMD within the respective right and left anterior portions of the neck region 614 so that regardless of the size, shape, orientation, and / or location of a particular IMD (or multiple IMDs), the paddles 651 R, 651 L overlie the particular IMD (or multiple IMDs) to communicate power, control, and / or data between the IMD and the respective paddle 651 R, 651 L.

[0110] In some examples, the paddle 651 R, 651 L may overlie solely or primarily just one of a submental triangular region, a submandibular triangular region, or a carotid triangular region of the anterior portion of the neck region 614. In such examples, each paddle 651 R, 651 L overlies one of these regions (e.g., submental triangular, a submandibular triangular, a carotid triangular, etc.) without overlying other respective adjacent region (e.g., submental triangular, a submandibular triangular, a carotid triangular, etc.). In some examples, the submental triangular region comprises an area bounded by a sagittal midline, the hyoid bone, and an anterior digastric muscle. In some examples, the carotid triangular region is bounded by the sternocleidomastoid (SCM) muscle, omohyoid muscle, and the posterior digastric muscle. In some examples, the submandibular triangular region is bounded by the anterior digastric muscle, the posterior digastric muscle, and a base of the mandible. In some examples, the anterior portion of the neck region 614 in which the various triangular regions reside comprise an area extending bounded by sagittal midline, base of mandible, and sternocleidomastoid (SCM) muscle.

[0111] It will be understood that the IMDs (e.g., 687, 688), or portions thereof, may be located within one of the aforementioned triangular regions, located outside of such regions, or in locations in between such regions. Moreover, at least because IMDs may be configured in a wide variety of shapes, sizes, etc., may be configured as multiple, spaced-apart, connected components, and / or may be implanted in a wide variety of orientations, locations, etc., it will be apparent that any particular IMDmay not be susceptible of being characterized as being in just one portion of the neck region 614.

[0112] In some such examples, the paddles 651 R, 651 L may comprise a generally triangular shape, a generally elliptical shape, a generally rectangular shape (e.g., FIG. 5), a generally circular shape, etc., with each shape corresponding to a particular size, shape, and / or location of an IMD which the paddle 651 , 651 L is to overlie. In some such examples, the size, shape, and / or location of the IMD may correspond to one of the submental triangular region, a submandibular triangular region, a carotid triangular region, or other subregion of the anterior portion of the neck region 614.

[0113] A wide variety of structures may be used to engage the head 612 and / or neck 614 to removably position, orient, and maintain the paddles 651 R, 651 L in place relative to targeted portions of an anterior portion of neck region 614. In some examples, as shown via dashed lines in FIG. 5, the neck cuff 650 may comprise a band 652 having ends connected to and extending from respective paddles 651 R, 651 L with the band 652 to wrap around the back of the patient’s neck to help releasably secure the entire neck cuff 650 about the neck region 614 and to removably position the paddles to overlie the anterior portions of the neck region 614.

[0114] In some examples, each paddle 651 R, 651 L is sized and / or shaped to generally overlie a substantial majority of the anterior portion of the neck region 614 but with operative components (e.g., power transfer, communication, sensing, and / or stimulation) being sized and shaped within paddles 651 R, 651 L to overlie an IMD within the anterior portion of the neck region but without overlying the rest of the anterior portion of neck region when the IMD will be in a specific anatomical location. Patient neck cuff 650 may include flexible and / or slidably adjustable / extendable portions to mechanically adjust the patient neck cuff 650 such that each paddle 651 R, 651 L may be positioned relative to the neck region 614.

[0115] Alternatively, the operative components may be sized, shaped, oriented, and / or located within paddle 651 R, 651 L to be in operative relation with a particularIMD (or IMDs) regardless of size, shape, location, and / or orientation of a particular IMD (or IMDs) within the anterior portion of the neck region so that neck cuff 650 is able to support, direct, etc. the IMDs regardless of their size, shape, orientation, and / or location and so that just one neck cuff 650 may be suitable for a wide range of types, placements, etc. of IMD(s). In some examples, the operative components may be arranged only within paddle 651 R, only within paddle 651 L, or within both paddles 651 R, 651 L. In some examples, where neck cuff 650 includes operative components only within one paddle, the neck cuff 650 may be symmetrical such that the neck cuff may be reversed, thereby positioning the operative components on either the right side or the left side of the neck region 614. In examples where the operative components are arranged within both paddles 651 R, 651 L, in some examples the operative components arranged within the paddle closer to an IMD are enabled while the operative components arranged within the paddle farther away from the IMD are disabled. In some examples, the patient neck cuff 650 may automatically identify the operative components arranged within the paddle closer to the IMD.

[0116] In some examples, one or both paddles 651 R, 651 L comprise components for different types of therapy. For example, one paddle (e.g., one of 651 R, 651 L) is configured for a first therapy type while the other paddle (e.g., other of 651 R, 651 L) is configured for a second therapy type different from the first therapy type. In some examples, each paddle 651 R, 651 L may be configured to deliver at least two different types of therapy.

[0117] In some examples, the neck cuff 650 and IMDs (e.g., 687, 688) may comprise wireless communication modalities such that the paddles 651 R, 651 L need not directly overlie the IMDs with which the paddles 651 R, 651 L are communicating.

[0118] FIG. 6A is a diagram illustrating an example patient neck cuff 1000a. In some examples, patient neck cuff 1000a comprises an example implementation of, and / or includes at least some of the features of, patient neck cuff 180 of FIG. 1 B, 220a-220c of FIGS. 2A-2C, and / or 650 of FIG. 5. Neck cuff 1000a includes a housing 1002 including a band portion 1004 connecting a right side portion 1006Rand a left side portion 1006L. The right side portion 1006R and left side portion 1006L may comprise one example implementation of the paddle 651 R and 651 L, respectively. Inside housing 1002, electrical components (e.g., sensing, stimulation, power, communication, other) may be arranged, for example, in dashed areas 1010, 1012R, and / or 1012L, which may sometimes be referred to as housing portion (e.g., right side housing portion 1012R, left side housing portion 1012L, neck band housing portion 1010). The inner side 1014 of the band portion 1004 may include a padded and / or conformable material. The inner side 1014 may include sensors and / or electrodes for contacting the skin of the patient. The right side portion 1006R and the left side portion 1006L may include inner side portions 1016R, 1016L, which in some examples comprise a padded and / or conformable material, and in some examples, upon which sensors and / or electrodes for contacting the skin of the patient may be arranged as further described below with reference to FIGS. 8A-11 E.

[0119] The type, size, and / or shape of housing 1002, padded and / or conformable material regions of inner portions 1014, 1016R, 1016L, etc. facilitates comfort while ensuring a snug enough fit to place and maintain patient neck cuff 1000a relative to the skin surface and tissues of the neck region of the patient. In some examples, the inner portions 1016R and 1016L may have different shapes. The snug fit facilitates accurate power transfer to an IMD for operating and / or recharging the IMD. The snug fit also facilitates stimulation, sensing and / or other measurements during movement (or in a rest state) of specific tissue portions (e.g., underlying muscles, muscle groups, airway, etc.) within the neck region of the patient relating to upper airway patency, which may relate to infrahyoid-based patency and / or genioglossus- based patency. In some examples, the snug fit may sometimes be referred to as conformably fitting to the particular topography of the neck region for each patient. In some examples, at least portions of the housing 1002 may be constructed from a material that is easily cleaned using a disinfecting wipe or cloth, such as polymethylpentene (PMP), polypropylene (PP), or polyethylene (HDPE or LDPE).

[0120] As noted elsewhere, in some examples the neck band 1004 may be omitted and other elements may be used to maintain the left and right side portions 1006R,1006L (including conformable inner side portions 1016R, 1016L) removably securely against the neck region 614 and in operative relation (e.g., sensing, stimulation, power transfer, communication, etc.) relative to IMD(s) within the neck region 614.

[0121] In some examples, the neck band 1004 may provide a wired communication pathway between components within the left and right side housing portions 1006L, 1006R, while in some examples, the components within the left and right side housing portions 1006L, 1006R may be in wireless communication with each other regardless of whether the neck band 1004 is present or absent.

[0122] FIG. 6B is a diagram illustrating an example patient neck cuff 1000b. Patient neck cuff 1000b is similar to patient neck cuff 1000a of FIG. 6A, except that patient neck cuff 1000b includes a separate power source 1015a or 1015b. In this example, patient neck cuff 1000b may not include a battery (e.g., rechargeable battery), such that the components (e.g., sensing, stimulation, power transfer, communication, etc.) of patient neck cuff 1000b are powered by power source 1015a or 1015b. Power source 1015a may be a wired power source to transfer power to the patient neck cuff 1000b for operating the patient neck cuff. For example, power source 1015a may be placed on a belt of the patient or in a pocket of the patient and a power cord 1013 may extend between the power source 1015a and the patient neck cuff 1000b. Power source 1015a may include a battery pack 1017 (e.g., rechargeable and / or replaceable battery pack) and / or be connected to an AC outlet 1018 to receive AC power, which may be transformed by power source 1015a to charge the battery pack 1017 and / or to power patient neck cuff 1000b.

[0123] Power source 1015b may be a wireless power source to transfer power to the patient neck cuff 1000b for operating the patient neck cuff. For example, power source 1015b may be placed under or within a pillow of the patient or in close proximity to the patient neck cuff 1000b. Power source 1015b may include a battery pack 1017 (e.g., rechargeable and / or replaceable battery pack) and / or be connected to an AC outlet 1018 to receive AC power, which may be transformed by power source 1015b to charge battery pack 1017 and / or to power patient neck cuff 1000b. Power source 1015b also includes a wireless transmitter 1019 to wirelessly transmitpower from battery pack 1017 and / or AC outlet 1018 to patient neck cuff 1000b. For example, to wirelessly transfer power from the power source 1015b to the patient neck cuff 1000b, wireless transmitter 1019 may comprise substantially the same features as wireless transmitter 222 of FIGS. 2A-2C, and patient neck cuff 1000b may include a wireless receiver comprising substantially the same features as wireless receiver 206 of FIGS. 2A-2C.

[0124] FIG. 6C is a diagram illustrating an example patient neck cuff 1000c. Patient neck cuff 1000c is similar to patient neck cuff 1000a of FIG. 6A, except that patient neck cuff 1000c may include electrical components (e.g., sensing, stimulation, power, communication, other) in dashed areas 1009R and 1009L adjacent (e.g., directly adjacent) the inner portions 1016R and 1016L, respectively. Thus, in this example, the electrical components may be placed closer to the specific tissue portions (e.g., underlying muscles, muscle groups, airway, etc.) within the neck region, which may improve sensing, stimulation, and / or power transfer between the patient neck cuff 1000c and an IMD within the patient.

[0125] In addition, patient neck cuff 1000c may include a remote control 1008 attached (e.g., removably attached) to the left side portion 1006L. In some examples, the remote control 1008 may be attached (e.g., removably attached) to the right side portion 1006R instead of to the left side portion 1006L. Remote control 1008 may be used to control at least some functions of the patient neck cuff 1000c and / or an implantable medical device as further described below in association with at least patient remote 4232 of FIG. 14B and / or remote control 4340 of FIG. 16. For example, remote control 1008 may control charging functions of patient neck cuff 1000c and / or may provide visual and / or audio feedback to the patient. The visual and / or audio feedback may include, for example, proper charging coil placement during charging, charging complete, time duration to complete charge, percent IMD battery charged, percent patient neck cuff 1000c battery charged, low battery warning for patient neck cuff 1000c, and / or low battery warning for remote control 1008. For patient neck cuffs (e.g., 1000a of FIG. 6A) not including a remote control 1008, these charging control functions and / or patient feedback functions describedwith reference to remote control 1008 may be provided by (e.g., integral to) the patient neck cuffs.

[0126] FIG. 6D is a diagram illustrating an example patient neck cuff 10OOd. Patient neck cuff 1000d is similar to patient neck cuff 1000a of FIG. 6A, except that patient neck cuff 1000d may include first electrical components (e.g., first sensing, stimulation, power, communication, other) in dashed areas 1005R and / or 1005L and second electrical components (e.g., second sensing, stimulation, power, communication, other) in dashed areas 1007R and / or 1007L adjacent (e.g., directly adjacent) the inner portions 1016R and 1016L, respectively. In some examples, the first electrical components 1005R and / or 1005L may be configured to transfer power and / or communicate with a first IMD (e.g., 687 of FIG. 5) within the neck region 614 of the patient, and the second electrical components 1007R and / or 1007L may be configured to transfer power and / or communicate with a second IMD (e.g., 688 of FIG. 5) within the neck region 614 of the patient. In some examples, the first electrical components 1005R and / or 1005L may have a first function (e.g., power transfer to an IMD), and the second electrical components 1007R and / or 1007L may have a second function (e.g., sensing, stimulation, other).

[0127] FIG. 7A is a diagram illustrating an example patient neck cuff pillow 1020a. Patient neck cuff pillow 1020a may comprise at least some of substantially the same features as patient neck cuff 1000a-1000d of FIGS. 6A-6D except that patient neck cuff pillow 1020a includes the form of a pillow, which rests on the shoulders of the patient to position the neck cuff pillow around the neck region 614 of the patient. Patient neck cuff pillow 1020a includes a pillow body 1022 and electrical components 1023. Pillow body 1022 may be made of memory foam and / or another suitable material and / or may be inflatable. In some examples where the pillow body 1022 is inflatable, the patient neck cuff pillow 1020a may further include a pressure regulator to protect against over-inflation for safety and / or for patient comfort. The pressure regulator may be integrated into an inflation valve or may be a separate valve in a separate location that is rated to a pre-set or configurable pressure rating. The regulator may automatically deflate the patient neck cuff pillow 1020a once thepressure rating is reached. In some examples, patient neck cuff pillow 1020a may include a cinch cord 1021. Electrical components 1023 may include a coil structure or coil structures (e.g., 500 of FIG. 4A, array 510 of FIG. 4B, 516 of FIG. 4C, or 520a- 520d of FIGS. 4D-4G) placed on one side or both sides of the pillow body 1022 for transmitting power to an IMD. The coil structure or coil structures may be arranged obliquely or vertically within the pillow body 1022 and may be padded with memory foam or another suitable material for patient comfort where the pillow body 1022 contacts the neck region 614 of the patient.

[0128] FIG. 7B is a diagram illustrating another example patient neck cuff pillow 1020b. Patient neck cuff pillow 1020b is similar to patient neck cuff pillow 1020a, except that patient neck cuff pillow 1020b includes components 1024. Components 1024 may include electronics (e.g., sensing, stimulation, power, communication, other) and coil structure(s) housed in a rigid enclosure (e.g. , cylinder) within the pillow body 1022. In some examples, the rigid enclosure may be manually rotated as indicated at 1025 and / or moved back and forth as indicated at 1026 to optimize coupling with an IMD within the patient and / orfor patient comfort. In some examples, a counterweight 1027 may be arranged within the pillow body 1022 on the opposite side of the patient neck cuff pillow 1020b from components 1024 to balance out the weight of the components 1024. In these examples, the counterweight 1027 and the components 1024 may be interchangeable to accommodate patients with an IMD implanted on either the left side or right side of the neck region. In some examples, the patient neck cuff pillow 1020a or 1020b may include a removable, washable sleeve.

[0129] FIG. 8A is a block diagram illustrating example electronic components 1028 of the patient neck cuff 1000a-1000d of FIGS. 6A-6D or patient neck cuff pillow 1020a-1020b of FIGS. 7A-7B. Within housing 1002 (e.g., within 1010, 1012R, and / or 1012L in FIGS. 6A-6D) and / or on housing 1002 or within pillow body 1022 of FIGS. 7A-7B, electronic components 1028 may include one or more sensors 1030, a stimulation element 1032, a control portion 1034, a rechargeable battery 1036, one or more receivers 1038, one or more transmitters 1040, and / or an antenna (e.g.,charging coil) 1042. In some examples, electronic components 1028 may exclude stimulation element 1032 and / or sensor(s) 1030.

[0130] Sensor(s) 1030 may include one or more of an accelerometer, gyroscope, piezoelectric sensor, acoustic sensor, microphone, temperature sensor, pressure sensor, impedance sensor, inertial measurement unit (IMU), etc. and / or other suitable circuitry for obtaining sensing information for a patient as further described below with reference to at least FIGS. 9A-9B. The sensed information (e.g., sensed physiologic information) may include respiratory information, cardiac information, activity information, motion information, posture information, and / or other information about the patient. The sensor(s) 1030 may sense the sensed information of a patient via at least one electrode electrically coupled to the sensor(s) 1030. In some examples, at least one electrode (not shown) may be arranged on 1014, 1016R, and / or 1016L (FIGS. 6A-6D) of the patient neck cuff 1000a-1000d or on pillow body 1022 (FIGS. 7A-7B) of patient neck cuff pillow 1020a-1020b. In some examples in which a sensor comprises at least one electrode, the at least one electrode also may, at times, be used for stimulation and / or comprise a portion of the stimulation element 1032. In some examples, such sensing electrodes may be arranged (e g., on 1014, 1016R, and / or 1016L or on 1022) according to at least some of the features of the example implementations of FIGS. 10A-11A in which an array of such sensing electrodes may be used to sense bio-impedance, as further described later.

[0131] In some examples, the sensed information may be used to initiate, terminate, pause, synchronize, and / or trigger recharging of an IMD. In some examples, the sensed information may be used to initiate, terminate, pause, synchronize, and / or trigger therapy to be applied via an IMD and / or via the patient neck cuff 1000a-1 OOOd or patient neck cuff pillow 1020a-1020b. In some examples, the sensed information may be used as feedback for controlling therapy (e.g., stimulation therapy) in a synchronized manner, such as in closed loop stimulation therapy as previously described. The sensed information also may be used for diagnostic purposes and / or for monitoring (and / or evaluation of) a particular physiologic effect, physiologic response, etc. regardless of whether the sensedinformation is used for other purposes (e.g., therapy). In some such examples, the sensed information may be used to implement open loop stimulation therapy, which, in some examples does not synchronize and / or trigger delivery of specific stimulation periods of a therapy protocol relative (e.g., to respiratory phase information) as previously described.

[0132] In some examples, electronic components 1028 may include stimulation element 1032. Stimulation element 1032 may be used to apply electrical stimulation to respiratory-related tissue, such as to an upper airway patency-related tissue of a patient, to treat sleep disordered breathing (SDB) conditions. In some examples, the stimulation element 1032 may be used to apply electrical stimulation to other tissues (e.g., spinal) of a patient to treat other conditions. In some examples, at least a portion of the stimulation element 1032 may comprise a pulse generator and related circuitry. In some such examples, the pulse generator (and related circuitry) may correspond to a stimulation portion, such as stimulation portion 172 of external element 150 in FIG. 1 B, which supports a stimulation element (e.g., 117 in FIG. 1 B) of an IMD via the stimulation element 1032 (e.g., pulse generator) controlling, sending, etc. stimulation signals to the implantable stimulation element.

[0133] The stimulation element 1032 also may comprise at least one stimulation electrode, which may be exposed on inner side portions 1014, 1016R, and / or 1016L (FIGS. 6A-6D) of the patient neck cuff 1000a-1 OOOd or on inner side portions of pillow body 1022 (FIGS. 7A-7B) of the patient neck cuff pillow 1020a-1020b.

[0134] The control portion 1034 may control the sensor(s) 1030, stimulation element 1032, receiver(s) 1038, transmitter(s) 1040, rechargeable battery 1036, antenna 1042, and other circuitry (not shown) of the patient neck cuff 1000a-1000d or the patient neck cuff pillow 1020a-1020b. The control portion 1034 may include a central processing unit (CPU), a microcontroller, an application specific integrated circuit (ASIC), and / or other suitable logic circuitry. At least some example implementations of the control portion 1034 are further described below with reference to at least FIGS. 14A and 14B.

[0135] It will be further understood that in some examples, at least some aspects or elements of the control portion 1034 may form part of, and / or be distributed among, the other components (e.g., sensor(s), receiver(s), transmitter(s), other) of the patient neck cuff 1000a-1000d or patient neck cuff pillow 1020a-1020b such that control portion 1034 does not necessarily form a component of the patient neck cuff or patient neck cuff pillow separate from those other elements.

[0136] Rechargeable battery 1036 may power the components of patient neck cuff 1000a-1000d or patient neck cuff pillow 1020a-1020b including sensor(s) 1030, stimulation element 1032, control portion 1034, receiver(s) 1038, transmitter(s) 1040, and antenna 1042. In addition, rechargeable battery 1036 may power an IMD (e.g., 117 of FIG. 1 B, 202a-202c of FIGS. 2A-2C, 250a-250d of FIGS. 3A-3D, 400 of FIG. 3E, 687 and / or 688 of FIG. 5) via antenna (e.g., charging coil) 1042 using inductive or near-field RF power transmission to the IMD. In some examples, patient neck cuff 1000a-1000d or patient neck cuff pillow 1020a-1020b provides an external power source to power an IMD that does not include its own power element (e.g., IMD 250a of FIG. 3A). In some examples, patient neck cuff 1000a-1000d or patient neck cuff pillow 1020a-1020b may be used to recharge an internal power element of an IMD (e.g., 204 of FIGS. 2A-2C and 3B-3D). In some examples, rechargeable battery 1036 may be sized such that the battery is capable of recharging an IMD multiples times (e.g., 2, 3, 4, 5, or more times) before rechargeable battery 1036 needs to be recharged.

[0137] In some examples, patient neck cuff 1000a-1 OOOd or patient neck cuff pillow 1020a-1020b may recharge a power element of an IMD (e.g., 204 of an IMD 202a- 202c of FIGS. 2A-2C or 250b-250d of FIGS. 3B-3D) based upon the power element technology. For example, given a power element comprising a supercapacitor, a solid-state battery, or a liquid electrolyte battery each having the same energy capacity, in some examples the patient neck cuff or patient neck cuff pillow may recharge the supercapacitor from a 10 percent charge to a 90 percent charge faster than the solid-state battery, and may recharge the solid-state battery from a 10 percent charge to a 90 percent charge faster than the liquid electrolyte battery. Forexample, when a supercapacitor is used as the power element, the patient neck cuff or patient neck cuff pillow may rapidly recharge the power element from a 10 percent charge to a 90 percent charge in under 90 seconds for example. When a solid-state battery is used as the power element, the patient neck cuff or patient neck cuff pillow may quickly recharge the power element from a 10 percent charge to a 90 percent charge in under 10 minutes for example. When a liquid electrolyte battery is used as the power element, the patient neck cuff or patient neck cuff pillow may recharge the power element from a 10 percent charge to a 90 percent charge in 20 to 30 minutes for example.

[0138] Transmitter(s) 1040 may transmit power and / or communications via antenna 1042 to an IMD as previously described and illustrated with reference to FIGS. 2A-2C. Transmitter(s) 1040 may separately transmit power and communication signals to the IMD at different times or may combine (e.g., multiplex) power and communication signals such that power and communications are transmitted simultaneously. In some examples, the communication signals may comprise stimulation generation signals, including stimulation settings, related therapy parameters (e.g., usage, disease burden, etc.), etc. Transmitter(s) 1040 may also transmit such communications and / or other signals to other devices (e.g., mobile device 4320, remote control 4340, clinician programmer 4350, patient management tool 4360 in FIG. 16). Receiver(s) 1038 may receive communications from an IMD as previously described and illustrated with reference to FIGS. 2B-2C. In some examples, receiver(s) 1038 may receive communications and / or other signals from an IMD simultaneously with powering / charging the IMD. Receiver(s) 1038 may also receive communications and / or other signals from other devices (e.g., mobile device 4320, remote control 4340, clinician programmer 4350, patient management tool 4360 in FIG. 16).

[0139] FIG. 8B is a block diagram illustrating example components 1028 that may be accessible on an exterior of the patient neck cuff 1000a-1000d or patient neck cuff pillow 1020a-1020b and / or on a remote control for the patient neck cuff 1000a- 1000d or patient neck cuff pillow 1020a-1020b (e.g., 1008 of FIG. 6C). Components1028 may include a power button 1060, a charge indicator 1062, a charging and / or data port 1064, a microphone 1066, an IMD link indicator 1068, a speaker 1070, and / or control buttons 1072a-1072c. In some examples, power button 1060, charge indicator 1062, charging and / or data port 1064, microphone 1066, IMD link indicator 1068, speaker 1070, and / or control buttons 1072a-1072c may be electrically coupled to control portion 1034. Microphone 1066 may provide one of sensor(s) 1030. Charging and / or data port 1064 may also be electrically coupled to rechargeable battery 1036, a receiver 1038, and / or a transmitter 1040. In some examples, power button 1060, charge indicator 1062, charging and / or data port 1064, microphone 1066, IMD link indicator 1068, speaker 1070, and / or control buttons 1072a-1072c may be accessible on an outer portion of the housing 1002 of band 1004, right side portion 1006R, and / or left side portion 1006L (FIGS. 6A-6D) of patient neck cuff 1000a-1000d or on an outer portion of pillow body 1022 (FIGS. 7A-7B) of patient neck cuff pillow 1020a-1020b. In some examples, one or more of power button 1060, charge indicator 1062, charging and / or data port 1064, microphone 1066, IMD link indicator 1068, speaker 1070, and / or control buttons 1072a-1072c may be excluded and / or patient neck cuff 1000a-1000d or patient neck cuff pillow 1020a-1020b may include other components accessible on the exterior of the patient neck cuff or patient neck cuff pillow (e.g., display, touch screen, switch(es), other sensor(s), other indicator(s), etc.).

[0140] Power button 1060 may be used turn patient neck cuff 1000a-1000d or patient neck cuff pillow 1020a-1020b on and off. Charge indicator 1062 may provide a visual indication of the amount of charge remaining for rechargeable battery 1036 (FIG. 8A) and / or for a power element of an IMD (e.g., 204 of FIGS. 3B-3D). Charging and / or data port 1064 may receive a charging / data cable to recharge rechargeable battery 1036 and / or to pass communications between the patient neck cuff 1000a- 1000d or patient neck cuff pillow 1020a-1020b and another device (e.g., mobile device 4320, remote control 4340, clinician programmer 4350, patient management tool 4360 in FIG. 16). In some examples, charging and / or data port 1064 may includea USB port (e.g., USB-A port, USB-C port) or another suitable charging and / or data port.

[0141] Microphone 1066 may be used to sense acoustic information, such as but not limited to respiratory information, snoring, noise signals in the patient’s environment, etc. In some examples, the microphone 1066 may permit voice- operated control of the functions of neck cuff 1000a-1 OOOd or patient neck cuff pillow 1020a-1020b and / or of the functions of IMD(s) in communication with the neck cuff or neck cuff pillow. Such functions may comprise power on, power off, pausing stimulation therapy, and / or adjusting amplitudes (and / or other stimulation energy parameters), etc.

[0142] IMD link indicator 1068 may provide a visual indication that patient neck cuff 1000a-1 OOOd or patient neck cuff pillow 1020a-1020b is linked with an IMD to charge the IMD and / or for transmission of communications between the patient neck cuff or patient neck cuff pillow and the IMD. Speaker 1070 may provide audible indicators (e.g., sounds, alerts, tones, speech, etc.) relating to the operation of the patient neck cuff or patient neck cuff pillow. Some non-limiting examples of audible indicators may include a low charge alert (e.g., for rechargeable battery 1036 of FIG. 8A and / or for power element 204 of FIGS. 3B-3D), an IMD link established tone, an IMD link lost alert, an error alert (e.g., the patient neck cuff or patient neck cuff pillow is not positioned on the patient’s neck correctly or is malfunctioning), a power on tone and / or a power off tone (e.g., in response to pressing power button 1060 to turn on or turn off the patient neck cuff or patient neck cuff pillow), a button tone (e.g., in response to pressing a button 1072a-1072c), a communication link established spoken message (e.g., in response to establishing a Bluetooth or other communication link with another device, such as mobile device 4320, remote control 4340, clinician programmer 4350, patient management tool 4360 in FIG. 16), etc. In some examples, audible indicators also may comprise voice communicated words, sentences, etc. of such information (e.g., low charge, power on / off, etc.) and / or spoken messages reporting therapy settings, therapy perform ance / outcomes (e.g., nightly report, weekly report, etc.), usage, therapy goals, etc.

[0143] In some examples, components 1028 may include buttons 1072a-1072c. While three buttons are illustrated in FIG. 8B, in some examples, components 1028 may include 0, 1 , 2, or more than 3 buttons. Buttons 1072a-1072c may be used for a variety of purposes. Some non-limiting examples for buttons 1072a-1072c include volume control buttons for speaker 1070, therapy control buttons to control stimulation therapy, such as turning the stimulation therapy on / off, pause, and / or increasing or decreasing the amplitude of stimulation within a lower and upper limit set by a clinician (and / or device manufacturer, supplier, etc.), initiating recharging of an IMD via the patient neck cuff 1000a-1000d or patient neck cuff pillow 1020a- 1020b, initiating a communication link with an IMD or another device (e.g., mobile device 4320, remote control 4340, clinician programmer 4350, patient management tool 4360 in FIG. 16), etc. In some examples, patient neck cuff 1000a-1000d or patient neck cuff pillow 1020a-1020b may include some or all of the functionality of patient remote 4232 described below with reference to FIG. 14B and / or user interface 4240 described below with reference to FIG. 15. Accordingly, in at least some examples, at least some of the various functions of a patient neck cuff or patient neck cuff pillow described in association with at least FIGS. 8A-8B may be implemented via a graphical user interface (GUI) on an exterior portion of the neck cuff or neck cuff pillow, such as an exterior portion of side portions (1006R, 1006L in FIG. 6A-6D) facing away from the patient’s neck region 614), or may be implemented via a graphical user interface (GUI) on one of the other devices (e.g., mobile device 4320, remote control 4340, clinician programmer 4350, patient management tool 4360 in FIG. 16).

[0144] FIGS. 9A and 9B are block diagrams schematically representing an example sensing portion 1300 and sensing portion 1400, respectively, including a plurality of different physiologic parameters which may be sensed and / or a plurality of different sensing modalities, in association with various examples of the present disclosure. With respect to at least FIG. 9A, in some examples, at least some of these parameters are sensed data and / or determinable from sensed data as part of a sensing portion 171 (FIG. 1 B) of an external element 150 (e.g., sensor(s) 1030 ofcomponents 1028 (FIG. 8A)) and / or a sensing element of an IMD, such as sensing element 258 of IMD 250d in FIG. 3D. In some examples, at least some of the parameters represented via at least FIG. 9A correspond to, and / or are example implementations of, the sensed physiologic parameters described later in further detail in association with at least FIGS. 12A-12G.

[0145] In some examples, at least some of the sensors and / or sensor modalities described in association with FIGS. 9A-9B may be incorporated within or on an IMD (e.g., 117 in FIG. 1 B, 202a-202c in FIGS. 2A-2C, 250a-250d in FIGS. 3A-3D, 400 in FIG. 3E, or 687 or 688 in FIG. 5) and / or external element (e.g., patient neck cuff 180 in FIG. 1 B, 220a-220c in FIGS. 2A-2C, 650 in FIG. 5, 1000a-1000d in FIGS. 6A-6D, or 1020a-1020b in FIGS. 7A-7B).

[0146] As shown in FIG. 9A, in some examples, physiologic parameters determinable from sensed data may comprise parameters regarding collapse 1310, position 1309, respiration 1305, disease burden 1308, sleep 1316, and other 1330. In some examples, the collapse parameter 1310 (e.g., collapsibility parameter) may comprise further parameters regarding a level 1311 , a pattern 1312, and / or a degree 1314 of collapse of the upper airway in the patient’s body. In some such examples, the sensing of data regarding a collapse pattern parameter 1312 and / or a degree parameter 1314 may be implemented via at least some of substantially the same features and attributes as later described in association with at least FIGS. 12A-12G by which a pattern, location, and degree of collapse may be determined and characterized.

[0147] In some examples, per collapse parameter 1310, if an antero-posterior collapse is detected (of a sufficient degree), then in some examples stimulation may be delivered via an IMD (e.g., 117 in FIG. 1 B, 202a-202c in FIGS. 2A-2C, 250a-250d in FIGS. 3A-3D, 400 in FIG. 3E, or 687 or 688 in FIG. 5). In some examples, per collapse parameter 1310, if a lateral and / or concentric collapse pattern (of a sufficient degree) is detected, then in some examples stimulation may be delivered via an IMD (e.g., 117 in FIG. 1 B, 202a-202c in FIGS. 2A-2C, 250a-250d in FIGS. 3A-3D, 400 in FIG. 3E, or 687 or 688 in FIG. 5).

[0148] In some examples, collapse information may be determined via sensing impedance, such as via sensing element 128 (FIG. 1 B) or 258 (FIG. 3D) of an IMD or via an external element (e.g., sensor(s) 1030 of components 1028 (FIG. 8A)), either of which may comprise electrodes or other sensor input. In some such examples, the external element incorporated on a patient neck cuff (e.g., 650 in FIG. 5; 1000a-1000d in FIGS. 6A-6D, 1020a-1020b in FIGS. 7A-7B) to sense impedance (e.g., for determining collapse information and / or other physiologic information (e.g., respiratory parameters) may be implemented via, and / or may comprise at least some of substantially the same features as, the impedance sensing arrangements described in association with at least FIGS. 9B, 10A-11A.

[0149] In some examples, one or more of other sensor tools (e.g., sensing portion 1400 in FIG. 9B) may be used to determine collapse, such as but not limited to sensed accelerometer data (per 1 26 in FIG. 9B), which may be used alone or with sensed impedance. Similarly, sensed acoustic data (1439 in FIG. 9B) from an accelerometer or other sources may reveal collapse information, snoring information, 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.

[0150] In some examples, a typical collapse pattern for a given patient may be known prior to implanting a tissue stimulation system (e.g., nerve stimulation system) such that the sensing portion 1300 (as supported by memory of the control portion 4200 in FIG. 14A) may retrieve stored data regarding such collapse pattern(s) for use in initial or ongoing programming of stimulation therapy, adapting the stimulation 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 4240 (FIG. 15), clinician programmer 4350 (FIG. 16), and / or a patient management tool 4360 (FIG. 16) such as (but not limited to) a cloud portal resource 4362 (FIG. 16).

[0151] Moreover, to the extent that the stimulation 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 stimulation therapy and potentially determine what, if any, adjustments to stimulation 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 IHM-N, right IHM-N, and combinations thereof) is to be stimulated in cooperation with other data from sensing portion (1300 in FIG. 9A; 1400 in FIG. 9B) or other parameters, factors, engines, methods, as described throughout various examples of the present disclosure.

[0152] In some examples, the position parameter 1309 of sensing portion 1300 in FIG. 9A 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 stimulation 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 stimulation to both a first target tissue (e.g., left HGN and / or right HGN) and a second target tissue (e.g., left IHM-N and / or IHM-N), such as via an IMD (117 in FIG. 1 B, 202a-202c in FIGS. 2A-2C, 250a-250d in FIGS. 3A-3D, 400 in FIG. 3E, or 687 or 688 in FIG. 5). As previously mentioned, posture and / or activity sensed via an accelerometer may be used with sensed body position for making the preceding determination.

[0153] 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 stimulation solely to a second target tissue (e.g., left or right IHM-N). In some examples, upon sensing the patient is lying prone, then an example method may comprise not delivering stimulation via an IMD. At least because some patients may exhibit atypical position-dependent sleep disordered breathing, it will be understood that other stimulation settings may be generated than described above. In someexamples, a sensed position (e.g., 1309 in FIG. 9A) may be used to determine or adjust timing of when stimulation is to be applied and / or to adjust which nerve targets (left HGN, right HGN, left IHM-N, right IHM-N) are to be stimulated.

[0154] With further reference to FIGS. 9A, 9B, in some examples, a respiration parameter (e.g., 1305 in FIG. 9A; 1405 in FIG. 9B) may comprise the sensed data which is evaluated and on which stimulation settings may be generated to determine which target tissues (and at which strength settings, etc.) are to be stimulated. In some examples, the respiration parameter (e.g., 1305 in FIG. 9A; 1405 in FIG. 9B) may comprise the sensed data which is evaluated and on which stimulation settings may be generated to determine which nerves (and at which strength settings, etc.) are to be stimulated. In some such examples, a sleep parameter 1316 may comprise a sleep state, such as whether the patient is awake or asleep and / or such as the sleep stage of the patient.

[0155] With further reference to FIG. 9A and FIG. 9B, in some examples, a disease burden parameter (1308 in FIG. 9A) may comprise the sensed data which is evaluated and on which stimulation settings may be generated to determine which target tissues (e.g., nerves) are to be stimulated and at which strength, settings, etc. In some such examples, the disease burden parameter 1308 may comprise an indication of a severity (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). It will be understood that in some examples, the disease burden parameter 1308 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.

[0156] It will be understood that at least some of the various parameters in the sensing portion 1300 in FIG. 9A may be used in a complementary manner in various combinations in methods of stimulation therapy for treating sleep disordered breathing according to examples of the present disclosure.

[0157] In some examples, the other parameters 1330 relate to care of sleep disordered breathing other than those specifically described in association with FIG. 9A.

[0158] FIG. 9B illustrates a block diagram schematically representing an example sensing portion 1400. In some examples, an example method may employ and / or an example care device may comprise the sensing portion 1400 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, among other uses. In some examples, one sensing modality within sensing portion 1400 may be at least partially implemented via another sensing modality within sensing portion 1400.

[0159] 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. 1A-9A and / or FIGS. 10A-18K. In some examples, at least some of these parameters are sensed data and / or are determinable from sensed data, and may be used in various ways such as (but not limited to) for determining a stimulation therapy according to example methods and / or example devices of the present disclosure.

[0160] It will be understood that the sensing portion 1400 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. 9B may correspond to a sensor and / or a sensing modality.

[0161] 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 1405 in FIG. 9B), 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. Therespiration information may be sensed via one or more sensing modalities described below (and / or other sensing modalities) such as, but not limited to, accelerometer 1426, electrocardiogram (ECG) 1416, electroneurography (ENG) 1420, impedance 1430, pressure 1432, temperature 1434, acoustic 1439, and / or other sensing modalities, 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 stimulation therapy (e.g., electrical stimulation therapy), as well as sensing settings.

[0162] In some examples, the sensed physiologic information may comprise cardiac information (1406) obtained from a cardiac signal and from which various metrics 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 1423 in FIG. 9B. 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 1423, accelerometer 1426, ECG 1416, electromyogram (EMG) 1418, impedance 1430, pressure 1432, temperature 1434, and / or acoustic 1439. In some examples, the sensed physiologic information (e.g., via sensing portion 1400) may comprise a wide variety of physiologic information other (1407) than respiration and / or cardiac information, with at least some examples further described below in association with FIG. 9B, and other examples throughout the present disclosure.

[0163] The sensed physiologic signals and / or information (e.g., respiration 1405, cardiac 1406, and / or other information 1407) 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, determiningdisease 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.

[0164] For instance, in one non-limiting example, an electrocardiogram (ECG) sensor 1416 in FIG. 9B 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 cardiac information, including but not limited to, heart rate 1425A (HR), heart rate variability 1425B (HRV) and other cardiac parameters 1425C, 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. However, in some instances, the ECG sensor 1416 may represent ECG sensing element(s) in general terms without regard to a particular manner in which sensing ECG information may be implemented.

[0165] 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.

[0166] 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 1423 shown in FIG. 9B, which may comprise one or more of a ballistocardiogram sensor(s), seismocardiogram sensor(s), and / oraccelerocardiogram 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 1426.

[0167] In one aspect, in some examples in which the cardiac sensor 1423 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) 1425A, heart rate variability (HRV) 1425B, and / or additional cardiac morphology 1425C. In some examples, such ballistocardiogram-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.

[0168] In some examples in which the cardiac sensor 1423 comprises a seismocardiogram sensor, the sensor 1423 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 1423 may be placed in the chest wall. In some such examples of sensing per sensor 1423, such methods and / or devices also may comprise sensing a respiratory rate and / or other respiratory information.

[0169] In some examples the sensing portion 1400 may comprise an electroencephalography (EEG) sensor 1412 to obtain and track EEG information. In some examples, the EEG sensor 1412 may also sense and / or track central nervous system (CNS) information in addition to sensing EEG information. In some examples, the EEG sensor(s) 1412 may be implanted subdermally under the scalp or may be implanted in a head-neck region otherwise suitable to sense EEGinformation. Accordingly, the EEG sensor(s) 1412 are located near the brain and may detect frequencies associated with electrical brain activity.

[0170] 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 used in 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 to avoid exacerbating the obstructive sleep apnea.

[0171] 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.

[0172] 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.

[0173] 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 tostimulation solution settings (e.g., values of stimulation energy parameters) to minimize arousals.

[0174] 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.

[0175] In some examples, the sensing portion 1400 may comprise an electromyogram (EMG) sensor 1418 to obtain and track EMG information. 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, respiratory-related muscles in the upper airway, and / or other respiratory-related muscles. 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.

[0176] 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 1418 also can be placed at other locations within (or on) the body to detect muscle activity which may be indicative of a 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 EMGinformation 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. to maintain and / or improve those patient metrics according to various examples of the present disclosure.

[0177] In some examples, the sensing portion 1400 may comprise an accelerometer 1426. In some examples, the accelerometer 1426 may be used to sense respiration 1405 and related parameters. In some examples, the accelerometer 1426 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. 11 ,324,950 issued on May 10, 2022, titled ACCELEROMETER-BASED SENSING FOR SLEEP DISORDERED BREATHING (SDB) CARE, filed October 9, 2018 under Serial Number 16 / 092,384; U.S. 2023-0119173, 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 U.S. published on > , titled RESPIRATORY PHASE DETERMINATION and filed May 5, 2023 under Serial Number 63 / 464,382; U.S. Patent Publication 2023-0277121 , 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.

[0178] In some examples, the accelerometer may comprise a single axis accelerometer while in some examples, the accelerometer may comprise a multiple axis accelerometer.

[0179] Among other types and / or ways of sensing information, the accelerometer sensor(s) 1426 may be employed to sense or obtain a ballistocardiogram, a seismocardiogram, and / or an accelerocardiogram (see cardiac sensor 1423 and related disclosure), which may be used to sense (at least) heart rate 1425A and / or heart rate variability 1425B (among other information such as respiratory rate in some 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.

[0180] In some examples, the accelerometer 1426 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.

[0181] In some examples, the sensing portion 1400 may comprise an impedance sensor 1430, which may sense transthoracic impedance or other bioimpedance of the patient such as (but not limited to) bioimpedance at, within, and / or across neck region (e.g., 614 in FIG. 5). In some examples, the impedance sensor 1430 may comprise a plurality of sensing elements (e.g., electrodes) spaced apart from each other across a portion of the patient’s body (e.g., a neck region 614). 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 or other implantable sensing monitor, while other sensing elements may be located (e.g., on a lead) at a spaced distance from the sensing element of the IMD 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.

[0182] In some examples in which the sensing electrodes are located external to the patient’s body, the sensing electrodes may be incorporated on a patient neck cuff (e.g., 650 in FIG. 5; 1000a-1000d in FIGS. 6A-6D; 1020a-1020b in FIGS. 7A- 7B) to sense impedance (e.g., for determining collapse information) and / or other physiologic information (e.g., respiratory parameters), and may be implemented via, and / or may comprise at least some of substantially the same features as, the impedance sensing arrangements described in association with at least FIGS. 10A- 11 A. In some such examples, the sensing electrodes are provided on just one of or on both of the right side portion (e.g., 651 R in FIG. 5, 1006R in FIGS. 6A-6D) and left side portion (e.g., 651 L in FIG. 5, 1006L in FIGS. 6A-6D) of a patient neck cuff. In addition, or as an alternative, at least some sensing electrodes may be provided on neck band 1004 for sensing impedance and / or for other purposes.

[0183] Among other uses, the impedance sensor 1430 may be used to determine collapse information as one example implementation of the collapse parameter 1310 of sensing portion 1300 of FIG. 9A and / or in association with the collapse determination framework described in at least FIGS. 12A-12G.

[0184] In some examples, the sensing portion 1400 may comprise a pressure sensor 1432, which senses respiratory information, such as but not limited to respiratory cyclical information. In some examples, the pressure sensor 1432 may be located in direct or indirect continuity with respiratory organs or airway or tissues supporting the respiratory organs or airway to sense respiratory information.

[0185] In some examples, sensing portion 1400 may comprise an acoustic sensor 1439 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.

[0186] In some examples, sensing portion 1400 may comprise body motion parameter 1440 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 viaaccelerometer 1426 and in some examples, body motion may be sensed via EMG 1418 and / or other sensing modalities, as described throughout various examples of the present disclosure.

[0187] In some examples, the sensing portion 1400 in FIG. 9B may comprise a body position / posture parameter 1436 and / or body motion parameter 1440 to sense and / or track sensed information regarding posture, which also may comprise sensing of body position, activity, etc. of the patient. This sensed information may be indicative of an awake or sleep state of the patient in some examples. In some such examples, such information may be sensed via accelerometer 1426 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. 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 within a nightly treatment period.

[0188] In addition or alternatively, sensing activity, motion, and / or body position (e.g., posture) may be used to track a relative degree to which a patient is more active or less active during daytime hours, which may comprise one objective measure of therapy outcome because if the patient is sleeping better at night due to a desirable stimulation solution settings (e.g., values of stimulation energy parameters) which better control sleep disordered breathing, the patient may be much more active during daytime (non-sleep) hours as compared to a baseline in which their sleep disordered breathing was poorly controlled (corresponding to inferior stimulation energy settings) or not controlled at all. Similarly, sensing activity and / or motion as described herein also may be used to detect if the patient tends to fall asleep during daytime (e.g., non-sleep) hours, which may be an objective therapy outcome parameter by which stimulation energy parameters (and associated usage, and other therapy outcome parameters) may be evaluated and potentially adjusted according to at least some examples of the present disclosure.

[0189] As further shown in FIG. 9B, in some examples the sensing portion 1400 may comprise a temperature sensor 1434. In some examples, the sensed temperature may be used as part of determining respiration generally, obstructions, and related parameters. In some example methods, sensing a change in temperature (such as via sensor 1434) during a treatment period may be used to identify sleep disordered breathing behavior. In some such examples, additional sensed information (as described in examples of the present disclosure) may be used in addition to sensed temperature to identify sleep disordered breathing (SDB) behavior. In some examples, small yet detectable temperature changes within a treatment period may be used to at least partially determine a disease burden parameter. For instance, a detectable temperature change may be sensed as a result of patient exertion to breathe in response to an apnea event, given the greater muscular effort in attempting to breathe. In making this determination, in some examples, such sensed temperature fluctuation information may provide a more distinctive or characteristic indication of a sleep or wake period when compared with heart rate or body position, which may exhibit more changes, some of which are not necessarily indicative of a sleep period or wake period, at least in some instances.

[0190] Referring now to FIG. 10A-10C, a patient’s body comprises a head-and- neck including head 2010 and neck region 2002. The neck region 2002 comprises an upper airway 2006 (represented by dashed lines) and a nasal airway passage. FIGS. 10A and 10B are diagrams including a front view and side view, respectively, schematically representing an example arrangement 2000 including an example device and / or example method to identify an upper airway collapse pattern. In one aspect, the example arrangement 2000 comprises a patient neck cuff (e.g., 1000a- 1000d in FIGS. 6A-6D, 1020a-1020b in FIGS. 7A-7B, 2052 of FIG. 10C) which is externally, releasably mountable to the neck region 2002 of a patient’s body. As shown in FIGS. 10A, 10B, the example arrangement 2000 comprises an array 2020 of spaced apart electrodes 2022 to be located across and around the external surface between a front 2004A and sides 2004B of the patient’s neck 2002. In some examples, the electrodes 2022 are arranged in rows 2021 , such that the array 2020may form a grid (e.g., 3x4, 3x6, 4x5, and so on) via the spaced apart electrodes 2022. The electrodes 2022 of the array 2020 are spaced apart by a distance suitable to provide the desired level of detail regarding the function, structure, collapse, opening, etc. of the patient’s upper airway.

[0191] As further shown in FIG. 10A, the electrodes 2022 may be interconnected via wires 2024 or other electrically conductive elements. While not shown for illustrative simplicity, in some examples the example arrangement 2000 may comprise a material, such as a fabric, mesh, etc. of 1014, 1016R, and / or 1016L of patient neck cuff 1000a-1000d (FIGS. 6A-6D) or of pillow body 1022 of patient neck cuff pillow 1020a-1020b (FIGS. 7A-7B) which acts as a body to provide stability and ease of handling of the array 2020 of electrodes 2022.

[0192] The electrode array 2020 comprises one example implementation of providing impedance sensing electrodes on the example patient neck cuffs of FIGS. 5-7B, in which one or more of the example patient neck cuffs of FIGS. 5-7B may comprise at least some of substantially the same features as electrode array 2020 in association with at least FIGS. 10A-11A.

[0193] In some examples, the array 2020 of electrodes 2022 is sized and shaped to cover an external portion of the patient’s neck to provide sensing information regarding anatomical structures, such as muscles, bones, connective tissues, etc. which define the upper airway of the patient. In some examples, one method may comprise sensing an impedance between at least some of the example electrodes 2022, which may be indicative of the opening, closing, collapse patterns, etc. of the patient’s upper airway. In some such examples, this sensing may be performed while the patient is sleeping to identify their particular collapse pattern when the patient experiences sleep disordered breathing (SDB) events, such as obstructive sleep apnea events. In some such examples, the sensed impedance information may provide a type of collapse, a site of collapse, and / or a degree of collapse with details regarding the type, site and / or degree of collapse.

[0194] In some examples, sensing the impedance (and / or delivering stimulation in response thereto) regarding the collapse pattern may be performed in associationwith at least the example arrangements within FIGS. 9A, 9B including impedance sensor 1430 (FIG. 9B), collapse parameter 1310 (FIG. 9A), disease burden parameter 1308 (FIG. 9A), and / or the collapse determination framework in FIGS. 12A-12G, etc.

[0195] In some examples, the device and / or method comprises performing such impedance sensing during application of a stimulation signal to the hypoglossal nerve and / or the infrahyoid muscle (IHM)-innervating nerve (and / or other upper airway patency-related tissue) to determine how, when, and / or where the patient may respond to such stimulation in terms of the upper airway collapse pattern being affected by the stimulation. In some examples, such determinations may be used to identify which single portion or which multiple portions (and a pattern of stimulation among those portions) of the IHM-innervating should be stimulated for a particular patient, or some patients in general, to increase and / or maintain upper airway patency. Moreover, some examples methods also comprise performing the stimulation of the IHM-innervating nerve without or with stimulation of the hypoglossal nerve, and vice versa, to better understand how combinations of stimulating different types of nerves (or different nerve branches) affect increasing and / or maintaining upper airway patency during sleep to thereby treat sleep disordered breathing. In some such examples, other upper airway patency-related nerves (and their innervated muscles) may be included in such determinations regarding which tissues (e.g., nerves, muscles) and / or portions thereof may promote upper airway patency. Moreover, in some examples, other non-upper airway respiratory-related tissues such as the phrenic nerve and / or diaphragm muscle may be included in such determinations regarding ameliorating sleep disordered breathing.

[0196] With regard to the example arrangement 2000 in at least FIG. 10B, an example arrangement 2300 in FIG. 10C schematically represents one example implementation of a patient neck cuff 2052 supporting the array 2020 of electrodes 2022 in the manner described with respect to FIG. 10B. In some examples, the electrodes 2022 may be embedded between adjacent layers (e.g., material, fabric)of the patient neck cuff 2052, and the electrodes 2022 may be exposed on an inner surface of the patient neck cuff 2052 facing the skin surface of the neck region 2002. As shown in FIG. 10C, the patient neck cuff 2052 may comprise a cuff-like body 2055 which conformably fits about a neck region 2002. The cuff-like body 2055 may comprise an upper edge portion 2054A and opposite lower edge portion 2054B, as well as two front portions 2055A (only one front portion 2055A is visible in FIG. 10C) and opposite rear portion 2055B. The rear portion 2055B (and / or side portions) may comprise a slightly flexible material (e.g., polymer) and / or the like to facilitate removable securing about the neck region 2002. The type, size, and / or shape of a housing material, padded portions, etc. of patient neck cuff 2052 facilitates comfort while ensuring a snug enough fit to place and maintain the electrodes 2022 coupled relative to the skin surface and tissues of the neck region 2002 to facilitate accurate impedance or other measurements during movement (or in a rest state) of specific tissue portions (e.g., underlying muscles, muscle groups, airway, etc.) within the neck region 2002 relating to upper airway patency, which may relate to infrahyoidbased patency and / or genioglossus-based patency. In some examples, the snug fit may sometimes be referred to as conformably fitting to the particular topography of the neck region 2002 for each patient.

[0197] In some examples, via the array 2020 of electrodes 2022 in example arrangements 2000, 2300, impedance measurement may be indicative of motion of a pharynx (and / or other tissues) upward upon application of electrical stimulation to infrahyoid-based patency tissue, such as an IHM-innervating nerve or infrahyoid strap muscle innervated by the IHM-innervating nerve. Among other purposes, identifying this upward motion during stimulation may confirm capture of the target upper airway patency tissue (e.g., nerve and / or muscle) to which a stimulation element(s) is placed into stimulating relation.

[0198] As further shown in FIG. 100, example arrangement 2300 comprising a patient neck cuff 2052 and impedance sensing arrangement like that in FIG. 10A- 10B, may further comprise a power / control element 2310 which may be carried within, and / or otherwise supported by, patient neck cuff 2052. The power / controlelement 2310 may take a wide variety of forms and may comprise an on-board power source, which may or may not be wirelessly chargeable from an external source. In some examples, the power / control element 2310 also may comprise control circuitry, communication circuitry, and / or wireless communication circuitry (e.g., transceiver, antenna, etc.), such as the components 1034, 1036, 1038, 1040, and 1042 in FIG. 8A. In some examples, the control circuitry may comprise stimulation circuitry (e.g., 1032 in FIG. 8A) to generate stimulation signals. The power / control element 2310 may wirelessly communicate with an implanted stimulation element, such as any one of the implanted stimulation elements (e.g., a microstimulator or other) as previously described in association with at least FIGS. 1A-3E and 5 for stimulation of a hypoglossal nerve, an IHM-innervating nerve, and / or an infrahyoid strap muscle innervated by the IHM-innervating nerve, as will be described in association with at least FIG. 11 A, in some examples.

[0199] In some examples, the power / control element 2310 may comprise at least some of substantially the same features and attributes as, and / or an example implementation of, sensing 171 , stimulation 172, power 174, and / or communication 176 of external element 150 of FIG. 1 B, wireless transmitter 222 of FIGS. 2A-2C, wireless receiver 224 of FIG. 2B, BLE transceiver 226 of FIG. 2C, and / or sensor(s) 1030, stimulation element 1032, control portion 1034, receiver(s) 1038, and transmitter(s) 1040 of FIG. 8A.

[0200] FIG. 10D is a diagram schematically representing an example arrangement 2400 which may comprise one example implementation of the power / control element 2310 of FIG. 10C as well as comprising an implantable neural interface 2454 and passive receiver 2450 for wireless communicating (e.g., via inductive telemetry or other wireless protocols) with the externally located power / control element 2310. The neural interface 2454 may be implanted to be in stimulating relation to nerves, muscles, or combinations thereof within a head-and-neck region of a patient. For example, the neural interface 2454 may be implanted to be in stimulating relation to nerves, muscles, or combinations thereof of upper airway patency tissue, which may comprise infrahyoid-based patency tissue and / or genioglossus-based patencytissue, and / or other non-upper airway respiratory-related tissues (e.g., phrenic nerve). It will be understood that the neural interface 2454 may be in stimulating relation to other tissues (e.g., muscles / nerves) that alleviate sleep disordered breathing and / or in stimulating relation to tissues (e.g., cranial nerves, innervated muscles) within the neck region related to physiologic conditions other than sleep disordered breathing.

[0201] In some examples, the power / control element 2310 may comprise a power element 2426, a control element 2430, a first transceiver element 2424 and a second transceiver element 2420. In some examples, the control element 2430 may comprise at least some of substantially the same features and attributes as (or an example implementation of) the control portion in FIGS. 14A-14B.

[0202] In some examples, the power element 2426 may comprise a rechargeable power source or other type of power source. The first transceiver element 2424 is configured to wirelessly communicate through skin 2440 and tissue 2442 with implanted receiver 2450 to send / receive data, commands, etc. to and from the neural interface 2454 (e.g., stimulation element) via connection 2453. In some examples, the first transceiver element 2424 may comprise inductive telemetry (e.g., magnetic induction) antenna / elements or electronic components for other types of wireless communication. In some examples, the second transceiver element 2420 may communicate with a patient remote control, external recharging station, or other externally located device. The second transceiver element 2420 may comprise an antenna and circuitry to wirelessly communicate with the external devices via any one of many wireless communication protocols (e.g., Bluetooth or any one of several short range RF-based protocols).

[0203] The power / control element 2310 may comprise a housing 2410 (e.g., can) to contain the control element 2430, power element 2426 (which may be removable), and the first and second transceiver elements 2424, 2420. The housing 2410 may comprise opposite ends 2412A, 2412B, and opposite first and second surfaces 2411 A, 2411 B.

[0204] With regard to at least the example arrangements in FIGS. 10C, 10D and the below-described example of FIG. 11 A, in some examples, the impedancesensing electrode array may be omitted from the patient neck cuff 2052. However, with regard to FIG. 11A below, it will be understood that the electrode array 2020 may be included and supported by patient neck cuff 2052 (as in FIG. 10C) in some examples, but is merely omitted from FIG. 11 A for illustrative clarity.

[0205] FIG. 11 A is a diagram schematically representing an example arrangement 2500 like that in FIG. 10C, except further comprising a stimulation element 2330 and / or a power / control element 2510, both of which may be within a portion of patient neck cuff 2052. The stimulation element 2330 may communicate with element 2510 via wired connection 2339 or wirelessly. In some examples, the stimulation element 2330 is sized, shaped, positionable, and securable via patient neck cuff 2052 to be in stimulating relation to an infrahyoid strap muscle for stimulation to increase and / or maintain upper airway patency, which in some examples may further comprise leveraging a patency hysteresis effect, as previously described. In such examples, the stimulation element 2330 may comprise one example implementation of stimulation element 172 in FIG. 1 B or 1032 in FIG. 8A.

[0206] As further shown in FIGS. 11 B, 11 C, one example implementation of the stimulation element 2330 comprises a carrier 2530 comprising opposite ends 2532A, 2532B, opposite sides 2531 A, 2531 B, and opposite faces 2536A, 2536B with an array 2534 of electrodes 2535 on face 2536A for presentation to a tissue to be stimulated and / or a skin surface / tissue through which a stimulation signal will be delivered to a target tissue (e.g., muscle) such as an infrahyoid strap muscle.

[0207] In some examples, the stimulation element 2330 may be supported by a power / control element or recharge element 2510, as shown in FIG. 11 A. In some examples, the element 2510 may comprise a power / control element as shown in the diagram 2550 of FIG. 11 D, and which may comprise a power element 2426, a control element 2580, and / or a transceiver element 2560. These power, control, and transceiver elements may comprise at least some of substantially the same features and attributes as previously described for corresponding elements in FIG. 10C-10D.

[0208] However, in some examples, the stimulation element 2330 may incorporate the components of the element 2510 as shown in FIG. 11 E as schematically represented as stimulation element 2570. As shown in FIG. 11 E, in this example, the stimulation element 2570 comprises a power element 2426, a transceiver element 2560, and a control element 2582 which incorporates with (or is co-located with) array 2534 of electrodes 2535.

[0209] As further shown in FIG. 11 E, the stimulation element 2570 may be externally mounted relative to a skin surface, such as via patient neck cuff 2052 in FIG. 11 A, to be in stimulating relation to a target muscle 2554, which may comprise an upper airway patency-related tissue such as (but not limited to) an infrahyoid strap muscle.

[0210] It will be understood that in some examples, a portion of or the entire control portion or a portion of (or the entire) power portion of the example power / control element 2510 (e.g., FIG. 11A, 11 D) can be incorporated into the stimulation element 2330 (e.g., FIGS 11 A, 11 B, 11 C).

[0211] FIG. 11 F is a cross-sectional view schematically representing a neck region 2002 and an example patient neck sleeve 2600. Patient neck sleeve 2600 may comprise at least some of substantially the same features as patient neck cuff 2052 of FIGS. 10C and 11 A except that patient neck sleeve 2600 fully encircles the neck region 2002. In some examples, at least a portion of the patient neck sleeve 2600 may include a stretchy material such that patient neck sleeve 2600 may be pulled over the head of the patient and secured around the neck region 2002 of the patient. In some examples, patient neck sleeve 2600 may include at least one fastener (e.g., button, snap, zipper, clasp, buckle, hook and loop, etc.) to removably secure the patient neck sleeve 2600 around the neck region 2002. Patient neck sleeve 2600 may comprises at least some of substantially the same features (e.g., sensing, stimulation, power, communication, other) as patient neck cuff 220a-220c of FIGS. 2A-2C, 650 of FIG. 5, and / or 1000a-1 OOOd of FIGS. 6A-6D or patient neck cuff pillow 1020a-1020b of FIGS. 7A-7B.

[0212] FIGS. 12A-12D are diagrams including front and side views schematically representing patient anatomy and example methods relating to collapse patterns associated with upper airway patency. More specifically, FIGS. 12A-12D are a series of diagrams schematically representing at least some different upper airway collapse patterns, including an anterior-posterior (AP) collapse pattern (FIG. 12A), a concentric collapse pattern (FIG. 12B), a lateral collapse pattern (FIG. 12C), and an anterior-posterior (AP) - lateral collapse pattern (FIG. 12D). In addition to observing such collapse patterns and / or other collapse patterns, at least some aspects of such collapse patterns may be measured, such as via impedance sensing using implanted electrodes (e.g., sensing elements and / or stimulation elements) or using externally applied arrays of electrodes, etc., such as described and illustrated in association with at least FIGS. 10A-10C. By determining an upper airway collapse pattern, some example arrangements may determine whether to apply stimulation via a hypoglossal nerve and / or via an IHM-innervating nerve (including which single or multiple portions thereof to stimulate), via other non-hypoglossal nerves related to upper airway patency, and / or combinations of these nerves including unilateral and bilateral options. At least some more specific details regarding FIGS. 12A-12D are further described below in relation to at least FIGS. 12E-12G.

[0213] FIGS. 12E-12G are diagrams schematically representing example devices and / or example methods relating to collapse patterns associated with upper airway patency. FIG. 12E is a side view of example patient anatomy of a head-and-neck portion, which schematically represents an upper airway and related tissues. FIG. 12F is a block diagram schematically representing an example sorting tool 3660 by which to sort and weigh a location, pattern, and degree of obstruction or patency. As shown in FIG. 12F, obstruction sorting tool 3660 includes functions for location detection 3662, pattern detection 3670, and degree detection 3680. In general terms, the location detection function 3662 operates to identify a site along the upper airway at which an obstruction occurs and which is believed to cause sleep disordered breathing. In one example, the location detection function 3662 includes a velum (soft palate) parameter 3664, an oropharynx-tongue base parameter 3666,and an epiglottis / larynx parameter 3668. Each respective parameter denotes an obstruction identified in the respective physiologic territories of the velum (soft palate), oropharnyx-tongue base, and epiglottis which are generally illustrated for an example patient in FIG. 12E. In one aspect, these distinct physiologic territories define an array of vertical strata within the upper airway. Moreover, each separate physiologic territory (e.g., vertical portion along the upper airway) exhibits a distinct characteristic behavior regarding obstructions and associated impact on breathing during sleep. Accordingly, each physiologic territory responds differently to implantable stimulation of upper airway patency-related tissues.

[0214] With this in mind, the velum (soft palate parameter 3664 denotes obstructions taking place in the level of the region of the velum (soft palate), as illustrated in association with FIG. 12F. FIG. 12E is a diagram including a side view schematically representing at least some anatomical features of the upper airway, as well as different sites or levels at which obstruction may occur. By determining a site or location of upper airway collapse, some example arrangements may determine whether to stimulate a hypoglossal nerve, via an IHM-innervating nerve (including which portions thereof to stimulate), and / or via other non-hypoglossal nerves which contribute to upper airway patency, and / or combinations of these nerves including unilateral and bilateral options.

[0215] As shown in FIG. 12E, a diagram 3540 provides a side sectional view (cross hatching omitted for illustrative clarity) of a head-and-neck region 3542 of a patient. In particular, an upper airway portion 3550 extends from the mouth region 3544 to a neck portion 3553. The upper airway portion 3550 includes a velum (soft palate) region 3560, an oropharynx region 3562, and an epiglottis region 3564. The velum (soft palate) region 3560 includes an area extending below sinus 3561 , and including the soft palate 3560, approximately to the point at which tip 3548 of the soft palate 3546 meets a portion of tongue 3547 at the back of the mouth region 3544. The oropharynx region 3562 extends approximately from the tip of the soft palate 3546 (when in a closed position) along the base 3552 of the tongue 3547 until reaching approximately the tip region of the epiglottis 3554. The epiglottis-larynx region 3562extends approximately from the tip of the epiglottis 3554 downwardly to a point above the esophagus 3557.

[0216] As will be understood from FIG. 12E, each of these respective regions 3560, 3562, 3564 within the upper airway correspond to the respective velum parameter 3664, oropharynx parameter 3666, and epiglottis parameter 3668, respectively of FIG. 12F.

[0217] FIG. 12E further illustrates relative location of the hyoid bone 3563 and thyroid cartilage 3565, as illustrated by dashed lines and with the arrows illustrating the direction of the movement of thyroid cartilage 3565, and optionally, the hyoid bone 3563, in response to stimulation of (e.g., electrical stimulation at) the target location of the IHM-related tissue, in accordance with some examples of the present disclosure. The thyroid cartilage 3565 is connected to pharyngeal muscles connected to the pharyngeal walls (such as oropharynx walls) and pulling the thyroid cartilage 3565 down effectively causes the pharyngeal walls (e.g., oropharynx walls) to displace and / or redistribute tissue (e.g., at least adipose tissue) in at least the oropharynx portion 3562 to reduce extraluminal tissue pressure, which may increase and / or maintain patency of the at least the oropharynx portion of the upper airway 3550. For example, the thyroid cartilage 3565 may be connected to the inferior pharyngeal constrictor muscle, the stylopharyngeus muscle, and the thyrohyoid muscle.

[0218] As shown, the hyoid bone 3563 relates to the base 3552 of the tongue 3547 (e.g., genioglossus muscle). In some examples, pulling the hyoid bone 3563 inferiorly, as shown by the arrow, may pull on the middle pharyngeal constrictor muscle which effectively increases upper airway patency. In some examples, stimulating an infrahyoid strap muscle directly and / or via stimulating an infrahyoidmuscle (IHM)-innervating nerve may cause this action on the hyoid bone.

[0219] In some examples, moving the hyoid bone 3563 inferiorly may elongate (e.g., stretch, tug) at least one pharyngeal constrictor muscle, such as the middle constrictor muscle(s). For example, the middle pharyngeal constrictor muscle may attach to the hyoid bone 3563 and depression of the hyoid bone 3563 may causethe middle pharyngeal constrictor muscle to elongate (e.g., stretch) and increase airway patency in at least the oropharynx portion 3562. In some examples, elongating (e.g., stretching) the at least one pharyngeal constrictor muscle may stiffen the upper airway (e.g., increases pharyngeal muscle tone) and reduce collapsibil ity of the upper airway. In some examples, the hyoid bone 3563 may not move in a purely superior-inferior orientation. As such, as used herein, the hyoid bone 3563 being moved inferiorly may include moving generally inferiorly. For example, the patency of upper airway 3550 may increase wall stiffness (at least partially defined by pharyngeal muscles) become stiffened / stretched and / or to move in an orientation (e.g., superior-inferior, anterior-posterior, and / or medial-lateral), with such stiffening and / or movement acting to increase patency of the oropharynx portion.

[0220] In some examples, and as described above, stimulating the at least one IHM-innervating nerve or at least one IHM at or near a target location may cause a physiological response due to contraction of at least one IHM (e.g., infrahyoid strap muscle). The physiological response may include at least one of the thyroid cartilage 3565 moving inferiorly and the hyoid bone 3563 moving inferiorly (as described above), and which causes a physiological effect for treating SDB that occurs remotely from the stimulation location and / or remotely from the physiological response, e.g., movement of the thyroid cartilage 3565 and / or movement of the thyroid cartilage 3565 and hyoid bone 3563 as described above. In some examples, the physiological effect comprises opening at least the oropharynx portion and / or stiffening of a pharyngeal wall of the patient (which at least partially forms a lumen of the oropharynx portion), which occurs remotely from the physiological response (i.e., remote from the stimulation location) of moving at least the thyroid cartilage inferiorly.

[0221] Accordingly, in some examples, the physiological effect occurs a distance away from the stimulation applied at the target location and / or from the physiological response caused by the stimulation. For example, the thyroid cartilage 3565 moving inferiorly (and, optionally, the hyoid bone 3563 moving inferiorly) in response tostimulation of the IHM-innervating nerve and / or the at least one IHM may occur a distance away from the physiological effect for treating the SDB (which occurs in or near the oropharynx portion 3562). The distance away may be a multiple of a diameter of the upper airway 3550 of the patient. For example, the physiological effect may comprise stiffening of a pharyngeal wall (e.g., at least in the oropharynx portion 3562) of the patient which occurs remotely from the thyroid cartilage movement action (e.g., near to reference numeral 3565).

[0222] With further reference to FIG. 12F, in general terms the pattern detection function 3670 enables detecting and determining a particular pattern of an obstruction of the upper airway. In one example, the pattern detection function 3670 includes an antero-posterior parameter 3672, a lateral parameter 3674, anteroposterior-lateral (AP-Lateral) parameter 3675, a concentric parameter 3676, and composite parameter 3678.

[0223] The antero-posterior parameter 3672 of pattern detection function 3670 (FIG. 12F) denotes a collapse of the upper airway that occurs in the antero-posterior orientation, as further illustrated in the diagram 3510 of FIG. 12A. In FIG. 12A, arrows 3511 and 3512 indicate one example direction in which the tissue of the upper airway collapses, resulting in the narrowed air passage 3514. FIG. 12A is also illustrative of a collapse of the upper airway in the soft palate region 3560, whether or not the collapse occurs in an antero-posterior orientation. For example, in some instances, the velum (soft palate) region 3560 exhibits a concentric (e.g., circular) pattern of collapse, as shown in diagram 3520 of FIG. 12B.

[0224] The concentric parameter 3676 of pattern detection function 3670 (FIG. 12F) denotes a collapse of the upper airway that occurs in a concentric orientation, as further illustrated in the diagram 3520 of FIG. 12B. In FIG. 12B, arrows 3522 indicate the direction in which the tissue of the upper airway collapses, resulting in the narrowed air passage 3524.

[0225] The lateral parameter 3674 of pattern detection function 3670 (FIG. 12F) denotes a collapse of the upper airway that occurs in a lateral orientation, as further illustrated in the diagram 3530 of FIG. 12C. In FIG. 12C, arrows 3532 and 3533indicate the direction in which the tissue of the upper airway collapses, resulting in the narrowed air passage 3535.

[0226] The AP lateral parameter 3675 of pattern detection function (FIG. 12F corresponds to the AP lateral collapse pattern schematically represented in FIG. 12D, which comprises a combination of the anterior-posterior pattern (FIG. 12A) and the lateral pattern (FIG. 12C) with arrows 3537A, 3537B, 3537C in FIG. 12D indicating example directions in which the tissue of the upper airway collapses, resulting in the narrowed air passage 3538. The narrowed air passage 3538 may comprise a triangular shape in some examples. In some examples, the AP-lateral collapse pattern at a velum / soft palate (3560 in FIG. 12E) may respond better (e.g., increase patency) to stimulation of an infrahyoid-based patency tissue than a concentric collapse pattern having a similar severity / completeness as the AP-lateral collapse pattern at the soft palate.

[0227] The composite parameter 3678 of pattern detection function 3670 (FIG. 12F) denotes a collapse of the upper airway portion that occurs via a combination of the other mechanisms (lateral, concentric, antero-posterior) or that is otherwise ill- defined from a geometric viewpoint but that results in a functional obstruction of the upper airway portion.

[0228] With further reference to obstruction sorting tool 3660 of FIG. 12F, in general terms the degree detection function or module 3680 indicates a relative degree of collapse or obstruction of the upper airway portion. In some examples, the degree detection function 3680 includes a none parameter 3682, a partial collapse parameter 3684, and a complete collapse parameter 3685. In some examples, the none parameter 3682 may correspond to a collapse of 25 percent or less, while the partial collapse parameter 3684 may correspond to a collapse of between about 25 to 75 percent, and the complete collapse parameter 3685 may correspond to a collapse of greater than 75 percent. In some examples, the at least one respiration parameter sensed from the first target tissue may include respiratory obstruction information, such as neural activity which is indicative of a relative degree of collapse or obstruction of the upper airway.

[0229] It will be understood that various patterns of collapse occur at different levels of the upper airway portion and that the level of the upper airway in which a particular pattern of collapse appears can vary from patient-to-patient.

[0230] In some examples, obstruction sorting tool 3660 comprises a weighting function 3686 and score function 3687. In general terms, the weighting function 3686 assigns a weight to each of the location, pattern, and / or degree parameters (FIG. 12F) as one or more of those respective parameters can contribute more heavily to the patient exhibiting sleep disordered breathing or to being more responsive to implantable stimulation of upper airway patency-related tissue. More particularly, each respective parameter (e.g., antero-posterior 3672, lateral 3674, AP-lateral (combination of antero-posterior and lateral) 3675, concentric 3676, composite 3678) of each respective detection modules (e.g., pattern detection function 3670) is assigned a weight corresponding to whether or not the patient is eligible for receiving implantable stimulation of upper airway patency-related tissue. Accordingly, the presence of or lack of a particular pattern of obstruction (or location or degree) will become part of an overall score (according to score parameter 3687) for an obstruction vector indicative of how likely the patient will respond to therapy via an implantable system to promote upper airway patency .

[0231] FIG. 12G is a diagram (e.g., chart) 3690 schematically representing an index or scoring tool to sort and weigh a location, pattern, and degree of obstruction or patency for a particular patient. Chart 3690 combines information regarding location (3662 in FIG. 12F), pattern (3670 in FIG. 12F), and degree (3680 in FIG. 12F) into a single informational grid or tool by which the obstruction is documented for a particular patient and by which appropriate stimulation settings may be determined and applied according to the various examples of the present disclosure, such as but not limited to those in association with at least FIGS. 1A-12F, 13A-18K.

[0232] Accordingly, in some examples, the information sensed and collected via at least FIGS. 12F-12G may be used to determine whether to implement stimulation of a hypoglossal nerve, an IHM-innervating nerve (including which single portion or multiple portions thereof to stimulate), via other non-hypoglossal nerves which maycontribute to upper airway patency, and / or combinations of these nerves including unilateral and bilateral options.

[0233] FIGS. 13A-13E are flow diagrams schematically representing example methods 3800a-3800e for wirelessly charging a power element (e.g., 204 of FIGS. 2A-2C or 3B-3D) of an IMD (e.g, 202a-202c of FIGS. 2A-2C or 250b-250d of FIGS. 3B-3D). As illustrated in FIG. 13A at 3802, method 3800a includes charging a power element of an implantable medical device comprising receiving, at a wireless receiver (e.g., 206 of FIGS. 2A-3D) of the implantable medical device from a wireless transmitter (e.g., 222 of FIGS. 2A-2C) of a patient neck cuff (e.g, 220a-220c of FIGS. 2A-2C, 650 of FIG. 5, 1000a-1000d of FIGS. 6A-6D, 1020a-1020b of FIGS. 7A-7B), power to charge the power element. In some examples, the implantable medical device is configured to apply electrical stimulation to an upper airway patency-related tissue of a patient. In some examples, the implantable medical device is configured to sense diagnostic information of the patient.

[0234] In some examples, the wireless transmitter comprises an array (e.g, 510 of FIG. 4B) of coils or coil structures (e.g, 512 of FIG. 4B, 516 of FIG. 4C, or 520a- 520d of FIGS. 4D-4G). In some examples, method 3800a may further include method 3800b of FIG. 13B. As illustrated in FIG. 13B at 3804, method 3800b may include successively pulsing, via the wireless transmitter, each coil structure (e.g, 512 of FIG. 4B) or subset of coil structures of the array of coil structures. At 3806, method 3800b may include measuring, via the wireless receiver, received energy from each coil structure or subset of coil structures in response to the pulsing of the respective coil structure or subset of coil structures. At 3808, method 3800b may include selecting, via the wireless transmitter, the coil structure or subset of coil structures for which the received energy is greatest to charge the power element.

[0235] In some examples, method 3800a may further include method 3800c of FIG. 13C. As illustrated in FIG. 13C at 3810, method 3800c may include successively pulsing, via the wireless transmitter, each coil structure or subset of coil structures of the array of coil structures. At 3812, method 3800c may include measuring, via the wireless transmitter, loading of each coil structure or subset of coil structures inresponse to the pulsing of the respective coil structure or subset of coil structures. At 3814, method 3800c may include selecting, via the wireless transmitter, the coil structure or subset of coil structures for which the loading is greatest to charge the power element.

[0236] In some examples, method 3800a may further include method 3800d of FIG. 13D. As illustrated in FIG. 13D at 3816, method 3800d may include sensing a position, orientation, and / or location of the implantable medical device. At 3818, method 3800d may include selecting, via the wireless transmitter, a coil structure or subset of coil structures based on the sensed position, orientation, and / or location of the implantable medical device to charge the power element. In some examples, method 3800d may further include sensing, via a Received Signal Strength Indicator (RSSI) corresponding to each coil structure of the array of coil structures, a position of the implantable medical device; and selecting, via the wireless transmitter, a coil structure or subset of coil structures based on the sensed position of the implantable medical device to charge the power element. In some examples, method 3800d may further include sensing, via an accelerometer of the implantable medical device, an orientation of the implantable medical device relative to the patient neck cuff; and selecting, via the wireless transmitter, a coil structure or subset of coil structures based on the sensed orientation of the implantable medical device to charge the power element. In some examples, method 3800d may further include triangulating, via a plurality of Bluetooth Low Energy (BLE) transceivers, a location of the implantable medical device; and selecting, via the wireless transmitter, a coil structure of the array of coil structures based on the triangulated location of the implantable medical device to charge the power element.

[0237] In some examples, method 3800a may further include method 3800e of FIG. 13E. As illustrated in FIG. 13E at 3820, method 3800e may include sensing a position, orientation, and / or location of the implantable medical device. At 3822, method 3800e may include adjusting transmit settings (e.g., amplitude and phase) of each coil structure or subset of coil structures based on the sensed position, orientation, and / or location of the implantable medical device. In some examples,method 3800e may further include sensing, via an accelerometer of the implantable medical device, an orientation of the implantable medical device relative to the patient neck cuff; and adjusting transmit settings of each coil structure or subset of coil structures based on the sensed orientation of the implantable medical device.

[0238] The methods 3800a-3800e for selecting a coil structure or subset of coil structures is also applicable to wireless power transfer to an IMD (e.g., 250a of FIG. 3A) without charging a power element. The methods 3800a-3800e may also be used to select more than one coil structure or subset of coil structures to transmit power to more than one IMD (e.g., 687 and 688 of FIG. 5).

[0239] FIG. 14A is a block diagram schematically representing an example control portion 4200. In some examples, control portion 4200 provides one example implementation of a control portion forming a part of, implementing, and / or generally managing stimulation elements, power / control elements (e.g., pulse generators, microstimulators), wireless receivers, wireless transmitters, transceivers, sensors, and related elements, devices, user interfaces, instructions, information, engines, elements, functions, actions, and / or methods, as described throughout examples of the present disclosure in association with FIGS. 1A-13E.

[0240] In some examples, control portion 4200 includes a controller 4202 and a memory 4210. In general terms, controller 4202 of control portion 4200 comprises at least one processor 4204 and associated memories. The controller 4202 is electrically coupled to, and in communication with, memory 4210 to generate control signals to direct operation of at least some of the stimulation elements, power / control elements (e.g., pulse generators, microstimulators), wireless receivers, wireless transmitters, transceivers, sensors, and related elements, devices, user interfaces, instructions, information, engines, elements, functions, actions, and / or methods, as described throughout examples of the present disclosure. In some examples, these generated control signals include, but are not limited to, employing instructions 4211 and / or information 4212 stored in memory 4210 for at least controlling the charging of a power element (e.g., 204 of FIGS. 3A-3D), controlling a stimulation element (e.g., 256 of FIG. 3C, 1032 of FIG. 8A, 2330 of FIG. 11 A), and / or controlling asensing element (e.g., 258 of FIG. 3D, 1030 of FIG. 8A, 2020 of FIG. 10C). Such control may comprise part of diagnosing and / or directing and managing treatment of sleep disordered breathing such as obstructive sleep apnea, hypopnea, and / or central sleep apnea, with such control also comprising sensing physiologic information including but not limited to electrical brain activity, respiratory information, cardiac information, and / or monitoring sleep disordered breathing, etc.

[0241] In some instances, the controller 4202 or control portion 4200 may sometimes be referred to as being programmed to perform the above-identified actions, functions, etc. such that the controller 4202, control portion 4200 and any associated processors may sometimes be referred to as being a special purpose computer, control portion, controller, or processor. In some examples, at least some of the stored instructions 4211 are implemented as, or may be referred to as, a care engine, a sensing engine, monitoring engine, and / or treatment engine. In some examples, at least some of the stored instructions 4211 and / or information 4212 may form at least part of, and / or, may be referred to as a care engine, sensing engine, monitoring engine, and / or treatment engine.

[0242] In response to or based upon commands received via a user interface (e.g., user interface 4240 in FIG. 15) and / or via machine-readable instructions, controller 4202 generates control signals as described above in accordance with at least some of the examples of the present disclosure. In some examples, controller 4202 is embodied in a general purpose computing device while in some examples, controller 4202 is incorporated into or associated with at least some of the stimulation elements, power / control elements (e.g., pulse generators, microstimulators), wireless receivers, wireless transmitters, transceivers, sensors, and related elements, devices, user interfaces, instructions, information, engines, functions, actions, and / or methods, etc. as described throughout examples of the present disclosure.

[0243] For purposes of this application, in reference to the controller 4202, the term “processor” shall mean a presently developed or future developed processor (or processing resources) that executes machine-readable instructions contained in amemory. In some examples, execution of the machine-readable instructions, such as those provided via memory 4210 of control portion 4200 cause the processor to perform the above-identified actions, such as operating controller 4202 to implement the charging, sensing, monitoring, determining, treatment, etc. as generally described in (or consistent with) at least some examples of the present disclosure. The machine-readable instructions may be loaded in a random access memory (RAM) for execution by the processor from their stored location in a read only memory (ROM), a mass storage device, or some other persistent storage (e.g., non- transitory tangible medium or non-volatile tangible medium), as represented by memory 4210. In some examples, the machine-readable instructions may comprise a sequence of instructions, a processor-executable data model (e.g., machine learning, other), or the like. In some examples, memory 4210 comprises a computer readable tangible medium providing non-volatile storage of the machine-readable instructions executable by a process of controller 4202. In some examples, the computer readable tangible medium may sometimes be referred to as, and / or comprise at least a portion of, a computer program product. In some examples, hard wired circuitry may be used in place of or in combination with machine-readable instructions to implement the functions described. For example, controller 4202 may be embodied as part of at least one application-specific integrated circuit (ASIC), at least one field-programmable gate array (FPGA), and / or the like. In at least some examples, the controller 4202 is not limited to any specific combination of hardware circuitry and machine-readable instructions, nor limited to any particular source for the machine-readable instructions executed by the controller 4202.

[0244] In some examples, control portion 4200 may be entirely implemented within or by a stand-alone device. In some examples, the control portion 4200 may be partially implemented in one of the sensing devices, monitoring devices, stimulation devices, apnea treatment devices (or portions thereof), etc. and partially implemented in a computing resource separate from, and independent of, the apnea treatment devices (or portions thereof) but in communication with the apnea treatment devices (or portions thereof). For instance, in some examples controlportion 4200 may be implemented via a server accessible via the cloud and / or other network pathways. In some examples, the control portion 4200 may be distributed or apportioned among multiple devices or resources such as among a server, an apnea treatment device (or portion thereof), and / or a user interface. In some examples, control portion 4200 includes, and / or is in communication with, a user interface 4240 as shown in FIG. 15.

[0245] Figure 14B is a diagram schematically illustrating at least some example implementations of a control portion 4220 by which the control portion 4200 (FIG. 14A) can be implemented, according to one example of the present disclosure. In some examples, control portion 4220 is entirely implemented within or by a patient neck cuff 4222 (e.g., 117 of FIG. 1 B, 220a-220c of FIGS. 2A-2C, 650 of FIG. 5, 1000a-1000d of FIGS. 6A-6D, 1020a-1020b of FIGS. 7A-7B, 2052 of FIG. 10C or 11 A) or a medical device 4225 (e.g., implantable pulse generator (IPG) assembly in some examples), which has at least some of substantially the same features and attributes as a medical device as previously described throughout the present disclosure. In some examples, control portion 4220 is entirely implemented within or by a remote control 4230 (e.g., a programmer) external to the patient’s body, such as a patient control 4232 and / or a physician control 4234. In some examples, the control portion 4200 is partially implemented in the patient neck cuff 4222 and / or in the medical device 4225 and partially implemented in the remote control 4230 (at least one of patient control 4232 and physician control 4234).

[0246] FIG. 15 is a block diagram schematically representing user interface 4240, according to one example of the present disclosure. In some examples, the user interface 4240 forms part of and / or is accessible via a device external to the patient and by which the therapy system may be at least partially controlled and / or monitored. The external device which hosts user interface 4240 may be a patient neck cuff (e.g., 117 of FIG. 1 B, 220a-220c of FIGS. 2A-2C, 650 of FIG. 5, 1000a- 1000d of FIGS. 6A-6D, 1020a-1020b of FIGS. 7A-7B, 2052 of FIG. 10C or 11 A), a patient remote (e.g., 4232 in FIG. 14B), a physician remote (e.g., 4234 in FIG. 14B) and / or a clinician portal. In some examples, the user interface 4240 comprises auser interface or other display that provides for the simultaneous display, activation, and / or operation of at least some of the stimulation elements, power / control elements (e.g., pulse generators, microstimulators), wireless receivers, wireless transmitters, transceivers, sensors, and related elements, devices, user interfaces, instructions, information, engines, functions, actions, and / or method, etc., as described in association with FIGS. 1A-13E. In some examples, at least some portions or aspects of the user interface 4240 are provided via a graphical user interface (GUI) and may comprise a display 4244 and input 4242.

[0247] FIG. 16 is a block diagram 4300 which schematically represents some example implementations by which a medical device (IMD) 4310, such as a pulse generator and / or sensing monitor (either or both of which may be implantable in some examples), may communicate wirelessly with external devices outside the patient. As shown in FIG. 16, in some examples, the IMD 4310 may communicate with at least one of a patient app 4330 on a mobile device 4320, a patient remote control 4340, a clinician programmer 4350, a patient management tool 4360, and a patient neck cuff 4370. The patient management tool 4360 may be implemented via a cloud-based portal 4362, the patient app 4330, the patient remote control 4340, and / or the patient neck cuff 4370. Among other types of data, these communication arrangements enable the IMD 4310 to communicate, display, manage, etc. data for wirelessly charging IMD 4310 and / or for patient management as well as to allow for adjustment to control information (e.g., 4212 of FIG. 14A) if / where needed. It will be understood that at least some of the various devices / elements 4320, 4340, 4350, patient management tool 4360, and patient neck cuff 4370 also may communicate with each other, with or without communicating with the medical device 4310.

[0248] FIG. 17 is a block diagram schematically representing an example arrangement 4600, deployable in an example method of (or as an example system for) patient management to facilitate patient care. As shown in FIG. 17, example arrangement 4600 may comprise an array 4602 of computing devices 4610, each of which host a patient app 4612 relating to patient care. The devices 4610 may sometimes be referred to as patient devices, patient computing devices, and the like.The patient app 4612 may provide patient education and / or enable communication with a caregiver, device servicer, device manufacturer, etc. In some examples, the patient app 4612 may communicate patient usage information (and some related therapy metrics) to a clinician device 4650 (e.g., care entity), device servicer, device manufacturer, etc. In some such examples, at least some of the patient devices 4610 may comprise a mobile computing device, such as a mobile phone, tablet, smartwatch, etc. which has a user interface (e.g., 4240 in FIG. 15) to provide for operation of, and display of, the patient app 4612.

[0249] As shown in FIG. 17, in some examples the example arrangement 4600 may comprise an implantable medical device (IMD) 4625. In some examples, the IMD 4625 may be adapted for treating sleep disordered breathing (SDB) and / or other patient conditions. A patient remote control 4620 and / or a patient neck cuff 4622 may communicate with the IMD 4625 via a wireless communication protocol 4729 either directly or indirectly via an intermediary communication element (e.g., antenna, other). In some examples, such wireless communication may take the form of inductive telemetry. The patient neck cuff 4622 and the patient remote 4620 may also communicate directly with each other via a wireless communication protocol 4730, which may be a Bluetooth, Wi-Fi, or other communication protocol. In some examples, the IMD 4625 may comprise an implantable pulse generator (IPG) for generating stimulation therapy signals to be delivered to the patient via a stimulation element (e.g., electrode) within the patient.

[0250] In general terms, in some examples the patient remote control 4620 and / or the patient neck cuff 4622 enables a patient to have limited control over their stimulation therapy, such as turning the stimulation therapy on / off, pause, and / or increasing or decreasing the amplitude of stimulation within a lower and upper limit set by a clinician (and / or device manufacturer, supplier, etc.). In some examples, the patient remote control 4620 and / or the patient neck cuff 4622 also tracks patient usage of these controls to enable a clinician, the patient, and others to learn about the patient’s usage, therapy effectiveness, patient adherence, etc. In some examples, the patient remote control and / or the patient neck cuff also may receivesome information from the IMD 4625 regarding stimulation metrics, sensing metrics, etc. In some examples, the patient neck cuff 4622 may also recharge a power element of the IMD 4625 as previously described herein.

[0251] In some examples, the patient remote control 4620 and / or the patient neck cuff 4622 is in communication with the patient app 4612 such that patient app 4612 on device 4610 may receive the patient usage information from the patient remote control 4620 and / or the patient neck cuff 4622, as well as whatever therapy, sensing, etc. information was communicated from the IMD 4625 to the patient remote control 4620 and / or the patient neck cuff 4622. In some examples, the patient neck cuff 4622 is in communication with the patient app 4612 such that the patient app 4612 on device 4610 may receive and display information from the patient neck cuff 4622, such as a charge indicator (e.g., representative of charge indicator 1062 of FIG. 8B), an IMD link indicator (e.g., representative of IMD link indicator 1068 of FIG. 8B), other indicators, a status of the patient neck cuff, etc. In some examples, the communication between the patient remote control 4620 and / or the patient neck cuff 4622 and the patient app 4612 (on patient device 4610) may occur wirelessly 4728 via a number of wireless communication protocols such as, but not limited to, a Bluetooth wireless communication protocol. In some examples, the communication between patient remote control 4620 and / or patient neck cuff 4622 and patient app 4612 (on patient device 4610) may occur via a wired connection.

[0252] As noted here and elsewhere, the patient app 4612 may communicate this information (received from the patient remote control 4620 and / or from the patient neck cuff 4622) to one or more of the clinician devices 4650 via resource 4630 to facilitate patient management according to examples of the present disclosure. In some examples, the patient app 4612 also may obtain some patient information through the patient’s use of the app 4612 which also may be communicated to the clinician devices 4650 separately from, or integrated with, the patient usage information and therapy information from the patient remote control 4620, patient neck cuff 4622, and / or IMD 4625.

[0253] As further shown in FIG. 17, an example IMD 4625 may comprise a stimulation component 4626 and / or sensing component 4627. In some examples, the stimulation component 4626 comprises a stimulation engine to generate a stimulation signal to be applied to a tissue (e.g., nerve, muscle, etc.). In the examples in which the IMD 4625 comprises an implantable pulse generator (IPG), the tissue to be stimulated may comprise tissue to maintain or restore upper airway patency, such as but not limited to a hypoglossal nerve, an IHM-innervating nerve, and / or other upper airway patency-related tissues. In some examples, other nonupper airway respiratory-related tissues (e.g., phrenic nerve, diaphragm muscle) may be stimulated to treat sleep disordered breathing. In some such examples, the stimulation component 4626 also may comprise circuitry for generating and delivering the stimulation signal. In some examples, the stimulation component 4626 of the IMD 4625 also may comprise a stimulation element, such as an electrode through which the stimulation signal may be applied to the target tissue as previously described herein.

[0254] In some examples, the sensing component 4627 comprises a sensing engine to receive a sensing signal obtained relative to a tissue (e.g., muscle, organ, etc.). In the examples in which the IMD 4625 comprises an IPG for treating sleep disordered breathing (SDB), the tissue to be sensed may be related to respiration, oxygenation, cardiac functions, upper airway patency, and the like. In some such examples, the sensing component 4627 also may comprise circuitry for receiving and processing the sensing signal. In some examples, the sensing component 4627 of the IMD 4625 also may comprise a sensing element, such as an electrode or other element through which the sensing signal is obtained as previously described herein.

[0255] In some examples, the stimulation component 4626 and / or sensing component 4627 may be on-board the IMD 4625, which in some examples may comprise a microstimulator. In some examples, at least a portion of the stimulation component 4626 and / or sensing component 4627 may be separate from, and independent of, a housing of the IMD 4625 with one or both components 4626, 4627 being in wired or wireless communication with the IMD 4625.

[0256] As further shown in FIG. 17, the patient devices 4610 may communicate with other devices, entities, etc. via resource 4630 via a wireless communication protocol as represented by directional arrows 4727 and / or a wired communication protocol in some examples. It will be understood that resource 4630 may comprise a computing resource (including stored programming) provided via a third party to help provide and support patient management with the clinician devices 4650 (e.g., clinician entities, care entities) and the patient app 4612. In some examples, resource 4630 may comprise at least a portion or, and / or an example implementation of, the control portion 4200 (FIG. 14A) and user interface 4240 (FIG. 15). In some examples, the third party providing resource 4630 may comprise a device manufacturer, device supplier, or third party contracted by a device manufacturer. The resource 4630 may be hosted via the internet, World Wide Web, and / or other network communication link.

[0257] As further shown in FIG. 17, example arrangement 4600 may comprise an array 4640 of clinician devices 4650, which provide care in some manner to a patient associated with one of the devices 4610. The entities associated with each clinician device 4650 may work together in at least some aspects to help coordinate care for the patient(s). Each entity may provide a particular form of expertise in patient care, such examples in which one entity (associated with a clinician device 4650) may comprise a medical clinic, while another entity (associated with a different clinician device 4650) may comprise a sleep center, and other entities may comprise providers which support patient care in some manner. There may be greater or fewer than the two clinician devices (e.g., care entities) shown in FIG. 17 which form at least part of a care team.

[0258] Each clinician device 4650 comprises a computing resource, such as a workstation or other computing device which may be stationary or mobile, including a user interface (e.g., 4240 in FIG. 15) to support operation and display of a portal 4655 (e.g., a clinician portal). Among other functions and features, the portal 4655 may comprise a patient management app 4660 by which the particular care provider (e.g., medical clinic, sleep center, etc.) may manage patient care among a group ofpatients, for an individual patient, etc. The patient management app 4660 also may enable communication with other entities (e.g., 4650) regarding patient care of the patients associated with devices 4610. In some examples, the clinician devices 4650 may communicate with each other via at least resource 4630 (e.g., network communication link, internet, web, etc.) as represented via indicators 4727.

[0259] In some examples, the example arrangement 4600 may comprise a clinician programmer 4665, which may periodically communicate with the IMD 4625 wirelessly (e.g. , inductive telemetry) to initially configure and / or modify the configured stimulation therapy settings, sensing settings, etc. of the IMD 4625.

[0260] In some examples, the programmer 4665 comprises a user interface, such as but not limited to, a graphical user interface (GUI) to facilitate display and input relative to workflows by which a clinician operates the programmer 4665. It will be further understood that the programmer 4665 may perform tasks or operations (relating to patient care, maintenance) etc. other than programming stimulation- related aspects of the IMD 4625. Moreover, in some examples, the programmer 4665 may comprise a device dedicated solely for the purpose of communicating with, programming, etc. the IMD 4625. Of course, in some examples, the clinician programmer 4665 also may communicate directly with the clinician portal 4655 (such as via patient management app 4660) to update the patient management system / method regarding at least stimulation settings, etc. which were configured in the IMD 4625 per workflows of the clinician programmer 4665.

[0261] However, in some examples, the programmer 4665 may comprise a nondedicated device which may be used for purposes (e.g., general communication, general computing, etc.) other than communicating with or, programming the IMD 4625. In some such examples, the programmer 4665 may comprise a consumer device, such as a consumer tablet, smart phone, etc. which is also operable via secure modes / communications / paths to communicate with, program, etc. the IMD 4625.

[0262] A patient neck cuff (e.g. , 180 of FIG. 1 B, 220a-220c of FIGS. 2A-2C, 650 of FIG. 5, 1000a-1000d of FIGS. 6A-6D, and / or 2052 of FIG. 10C and 11 A), a patientneck cuff pillow (e.g., 1020a-1020b of FIGS. 7A-7B), and / or a patient neck sleeve (e.g., 2600 of FIG. 11 F) may take various forms. The various forms of patient neck cuffs, patient neck cuff pillows, and patient neck sleeves may collectively be referred to as patient neck cuff arrangements. A patient neck cuff arrangement may be defined as an object or garment designed (or configured) to be worn or positioned in close contact (e.g., in charging relation to an IMD, such as in direct contact with a patient’s skin proximate an IMD implant location or within 8 centimeters of the IMD implant location) with the neck of a patient, such that a power / control element within the object or garment may wirelessly transmit power to a medical device implanted within the head-and-neck region of the patient.

[0263] FIGS. 18A-18K are diagrams illustrating example patient neck cuff arrangements 5000a-5000k. In some examples, patient neck cuff arrangements 5000a-5000k may comprise at least some of substantially the same features (e.g., sensing, stimulation, power, communication, other), or be an example implementation of, a patient neck cuff 180 of FIG. 1 B, 220a-220c of FIGS. 2A-2C, 650 of FIG. 5, 1000a-1000d of FIGS. 6A-6D, 1020a-1020b of FIGS. 7A-7B, and / or 2052 of FIG. 10C and 11A except that patient neck cuff arrangements 5000a-5000k each includes a different form which rests on or about the shoulders, neck, and / or head of the patient to position the neck cuff arrangement around and / or proximate the neck region of the patient.

[0264] FIG. 18A illustrates an example patient neck cuff arrangement 5000a in the form of a neck wrap 5002 with a front closure 5004 including a fastener or a cinch cord (e.g., 1021 of FIG. 7A). The fastener may include at least one button, snap, zipper, clasp, buckle, and / or hook and loop material to removably secure the patient neck cuff arrangement 5000a around the neck region of a patient. At least a portion of the neck wrap 5002 may include a soft and / or stretchy material that may be placed around the neck of the patient and secured via the front closure 5004, which may also include a soft and / or stretchy material.

[0265] FIG. 18B illustrates an example patient neck cuff arrangement 5000b in the form of a bendable collar 5010 that is secured by pressing a first end 5012 of the collar against the chest and a second end 5014 of the collar against the neck.

[0266] FIG. 18C illustrates an example patient neck cuff arrangement 5000c in the form of a necklace-style device that can be cinched around the neck. Patient neck cuff arrangement 5000c may include at least one element 5020 (e.g., a coil for wireless power transfer, a sensing element, and / or a stimulation element), a cinching element 5022, and a power / control element 5024 electrically connected to the at least one element 5020 via wires embedded in the band 5026.

[0267] FIG. 18D illustrates an example patient neck cuff arrangement 5000d in the form of a shoulder wrap 5030 with neck coverage 5032 and a front closure 5034 including a fastener or a cinch cord (e.g., 1021 of FIG. 7 A). The fastener may include at least one button, snap, zipper, clasp, buckle, and / or hook and loop material to removably secure the patient neck cuff arrangement 5000d on the shoulders and around the neck region of a patient. At least a portion of the shoulder wrap 5030 may include a soft and / or stretchy material that may be placed on the shoulders and around the neck of the patient and secured via the front closure 5034, which may also include a soft and / or stretchy material.

[0268] FIG. 18E illustrates an example patient neck cuff arrangement 5000e in the form of a scarf-style wrap 5040 where a power / control element 5042 may be inserted into the scarf and adjusted around the neck.

[0269] FIG. 18F illustrates an example patient neck cuff arrangement 5000f in the form of a balaclava 5050 that contains a power / control element pocket 5052 (in which a power / control element may be inserted) on or near the neck.

[0270] FIG. 18G illustrates an example patient neck cuff arrangement 5000g in the form of a turtleneck 5060 that contains a power / control element pocket 5062 on or near the neck.

[0271] FIG. 18H illustrates an example patient neck cuff arrangement 5000h in the form of pajamas or a shirt 5070 that contains a power / control element pocket 5072 in the collar 5074.

[0272] FIG. 181 illustrates an example patient neck cuff arrangement 5000i in the form of a wearable blanket or sweatshirt 5070 that contains a power / control element pocket 5072 on or near the neck.

[0273] FIG. 18J illustrates an example patient neck cuff arrangement 5000j in the form of a pillow that can be positioned against the implant site.

[0274] FIG. 18K illustrates an example patient neck cuff arrangement 5000k in the form of a car headrest accessory 5090 that can be positioned in a car seat 5092, such that the car headrest accessory 5090 is in contact with the user’s neck.

[0275] While FIGS. 18A-18K illustrate various example patient neck cuff arrangements, it will be apparent that other similar arrangements may be used, such as, but not limited to, various garments (e.g., sweater, shirt, dress, pajamas, robe, hoodie, neck gaiter, cape, poncho, dickey, kimono, hijab, scarf, shawl, stole, bandana, necktie, etc.) and / or accessories (e.g., necklace, choker, lanyard, neck strap, neck cuff, neck sleeve, neck brace, cervical collar, sports neck guard, motorcycle neck brace, neck cooling wrap, neck sun shield, etc.).

[0276] Although specific examples have been illustrated and described herein, a variety of alternate and / or equivalent implementations may be substituted for the specific examples shown and described without departing from the scope of the present disclosure. This application is intended to cover any adaptations or variations of the specific examples discussed herein.

Claims

CLAIMSWhat is claimed is:

1. A patient neck cuff comprising: a housing comprising a band portion connecting a right side portion and a left side portion; and a wireless transmitter within the housing to transmit power to an implantable medical device implanted within a head-and-neck region of a patient.

2. The patient neck cuff of claim 1 , further comprising: a rechargeable battery within the housing, wherein the wireless transmitter is electrically coupled to the rechargeable battery.

3. The patient neck cuff of claim 1 , further comprising: a power source external to the housing and electrically coupled to the wireless transmitter, the power source comprising a battery pack or an AC outlet.

4. The patient neck cuff of claim 1 , further comprising: a coil antenna for inductive or near-field radio frequency wireless power transfer to the implantable medical device.

5. The patient neck cuff of claim 1 , further comprising: an array of coil structures for inductive wireless power transfer to the implantable medical device.

6. The patient neck cuff of claim 5, wherein a relative amplitude and phase of each coil structure of the array of coil structures is controlled independently.

7. The patient neck cuff of claim 6, wherein the relative amplitude and phase of each coil structure is controlled independently to maximize wireless power transfer to the implantable medical device and / or to minimize a specific absorption rate (SAR) by the patient.

8. The patient neck cuff of claim 1 , further comprising: a wireless receiver within the housing to receive communications from the implantable medical device.

9. The patient neck cuff of claim 1 , further comprising: a sensor to sense physiologic information of the patient.

10. The patient neck cuff of claim 9, wherein the sensor comprises at least one electrode configured to contact skin of the patient.11 . The patient neck cuff of claim 9, wherein the sensor comprises a microphone configured to sense respiratory information or snoring of the patient.

12. The patient neck cuff of claim 9, wherein the sensor comprises an impedance sensor.

13. The patient neck cuff of claim 1 , further comprising: a stimulation element configured to apply electrical stimulation to tissues within the head-and-neck region of the patient.

14. The patient neck cuff of claim 13, wherein the stimulation element comprises at least one electrode configured to contact skin of the patient.

15. The patient neck cuff of claim 1 , wherein an inner side of the band portion, an inner side of the right side portion, and / or an inner side of the left side portion comprises a padded and / or conformable material.

16. The patient neck cuff of claim 1 , further comprising: an implantable medical device link indicator.

17. A patient neck cuff comprising: a housing comprising a band portion connecting a right side portion and a left side portion; a rechargeable battery within the housing; and a stimulation element electrically coupled to the rechargeable battery to apply electrical stimulation to tissues within the head-and-neck region of a patient.

18. The patient neck cuff of claim 17, wherein the stimulation element comprises at least one electrode configured to contact skin of the patient.

19. The patient neck cuff of claim 17, further comprising: a plurality of control buttons to control the electrical stimulation including stimulation on / off, pause, and / or increasing or decreasing an amplitude of stimulation.

20. The patient neck cuff of claim 17, further comprising: a sensor to sense physiologic information of the patient.

21. A patient neck cuff comprising: a housing comprising a band portion connecting a right side portion and a left side portion; a rechargeable battery within the housing; anda sensor electrically coupled to the rechargeable battery to sense physiologic information of a patient.

22. The patient neck cuff of claim 21 , wherein the sensor comprises at least one electrode configured to contact skin of the patient.

23. The patient neck cuff of claim 21 , wherein the sensor comprises a microphone configured to sense respiratory information or snoring of the patient.

24. The patient neck cuff of claim 21 , wherein the sensor comprises an impedance sensor.

25. The patient neck cuff of claim 21 , further comprising: a stimulation element configured to apply electrical stimulation to tissues within the head-and-neck region of the patient.

26. A patient neck cuff arrangement comprising: an object or garment configured to be worn or positioned in close contact with a neck of a patient; and a wireless transmitter within the object or garment to transmit power to a medical device implanted within a head-and-neck region of the patient.

27. The patient neck cuff arrangement of claim 26, wherein the object or garment comprises a neck wrap with a front closure.

28. The patient neck cuff arrangement of claim 26, wherein the object or garment comprises a bendable collar that is secured by pressing a first end of the collar against a chest of the patient and a second end of the collar against the neck of the patient.

29. The patient neck cuff arrangement of claim 26, wherein the object or garment comprises a necklace-style device that can be cinched around the neck of the patient.

30. The patient neck cuff arrangement of claim 26, wherein the object or garment comprises a shoulder wrap with neck coverage and a front closure.31 . The patient neck cuff arrangement of claim 26, wherein the object or garment comprises a scarf-style wrap.

32. The patient neck cuff arrangement of claim 26, wherein the object or garment comprises a balaclava.

33. The patient neck cuff arrangement of claim 26, wherein the object or garment comprises a turtleneck.

34. The patient neck cuff arrangement of claim 26, wherein the object or garment comprises pajamas or a shirt.

35. The patient neck cuff arrangement of claim 26, wherein the object or garment comprises a wearable blanket or a sweatshirt.

36. The patient neck cuff arrangement of claim 26, wherein the object or garment comprises a pillow configured to be positioned against an implant site of the medical device.

37. The patient neck cuff arrangement of claim 26, wherein the object or garment comprises a car headrest accessory configured to be positioned in a car seat such that the car headrest accessory is in contact with the neck of the patient.

Images