Hyoid bone laryngeal suspension system for the treatment of sleep-disordered breathing

Abstract

The present invention provides a hyoid-laryngeal suspension device and system for treating sleep disordered breathing (SDB). The device includes a first fastener, the size and structure of which are set to anchor to the patient's hyoid bone or thyroid cartilage, and a second fastener, the size and structure of which are set to anchor to the patient's sternum, clavicle or ribs. One end of a static member or elastic member is connected to the first fastener, and the opposite end is connected to the second fastener. The elastic member has sufficient elasticity to dynamically elevate the pharynx and / or larynx to allow speaking and swallowing. The static member has sufficient tension to maintain appropriate pharyngeal wall tension while still allowing sufficient movement of the hyoid bone and thyroid cartilage to achieve speaking and swallowing functions.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 013,678, filed April 22, 2020, the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] The present invention relates to systems and devices for hyolaryngeal suspension to treat sleep-disordered breathing. Background Art

[0004] Sleep-disordered breathing (SDB) occurs when there are multiple episodes of partial or complete cessation of breathing throughout the night. Obstructive sleep apnea (OSA) is a type of SDB that involves cessation or significant reduction of airflow during periods of respiratory distress. This is the most common form of SDB and is characterized by recurrent upper airway collapse during sleep, leading to repeated pauses in breathing followed by oxygen desaturation or neural arousals. The pathophysiology of OSA can involve factors such as craniofacial anatomy, airway collapsibility, and neuromuscular control of upper airway dilator muscles. Electromyographic studies have shown that the tone and phasic activity of pharyngeal airway dilator muscles, such as the genioglossus, decrease from wakefulness to non-rapid eye movement to rapid eye movement.

[0005] Continuous positive airway pressure (CPAP) therapy is the first-line treatment for OSA. CPAP therapy utilizes a machine designed to deliver a constant-pressure airflow (typically consisting of a flow generator, tube, and mask) to keep the airway of OSA patients continuously open. However, the success of CPAP therapy is limited by reported compliance rates ranging from 50% to 70%. For patients with obstructive sleep apnea (OSA) who cannot tolerate positive airway pressure, hypoglossal nerve stimulation (HNS) has now been identified as an effective treatment. This therapy widens the pharyngeal airway by protruding and stiffening the tongue muscles. However, only a small percentage of OSA patients have anatomy suitable for hypoglossal nerve stimulation therapy, as many patients continue to suffer from airway collapse even with stimulation of the hypoglossal nerve musculature.

[0006] Several systems are currently approved for static anchoring of the hyoid bone to the posterior aspect of the mandible, but these systems provide static suspension and may cause swallowing problems, for example, because they restrict the upward and posterior elevation of the hyoid bone and the rest of the larynx to protect the airway from food boluses and liquids. These systems widen the airway by applying anterior traction on the hyoid bone, reducing collapse of the tongue base and providing localized stiffening of the pharyngeal soft tissues at the level of the tongue base, further reducing collapse. These systems are less effective at stiffening the airway at the level of the oropharynx or velopharynx. Summary of the Invention

[0007] The present invention provides a hyoid-laryngeal suspension device and system for treating sleep disordered breathing (SDB). In one embodiment, the size and configuration of the first fastener are set to anchor to the patient's hyoid bone or thyroid cartilage, and the size and configuration of the second fastener are set to anchor to the patient's sternum, clavicle or rib. One end of the static member or elastic member is connected to the first fastener and the opposite end is connected to the second fastener. The elastic member has sufficient elasticity to allow the pharynx and / or larynx to be dynamically lifted to permit speech and swallowing. The static member has sufficient tension to maintain appropriate pharyngeal wall tension while still allowing sufficient movement of the hyoid bone and thyroid cartilage to achieve speech and swallowing functions. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Figure 1 A schematic diagram of a system of the present invention implanted in a patient according to one embodiment of the present invention;

[0009] Figure 2 is a block diagram of a neuromodulation system according to one embodiment of the present invention;

[0010] Figure 3 FIG. 4 is a block diagram of a neuromodulation system according to an embodiment of the present invention. DETAILED DESCRIPTION

[0011] As used herein for the elements described, unless otherwise stated, the terms "one", "an" and "the" include at least one or more elements / elements described including combinations thereof. In addition, unless otherwise stated, the terms "or" and "and" refer to "and / or" and combinations thereof. It is understood that when an element is referred to as "on another element", "above another element", "attached to another element", "connected to another element", "coupled to another element", "in contact with another element", "connected to another element", etc., it can be directly "on another element", "above another element", "attached to another element", "connected to another element", "coupled to another element", "in contact with another element" or "connected to another element", and there can also be intermediate elements. On the contrary, when an element is referred to as "directly above another element", "directly on another element", "directly attached to another element", "directly connected to another element", "directly coupled to another element", "directly in contact with another element" or "directly connected to another element directly", there is no intermediate element. An element arranged to be "adjacent" to another element can have a part that overlaps with an adjacent element or a part that is located below an adjacent element. By "substantially / essentially" is meant that the shape, configuration, or orientation of an element need not have a mathematically precise shape, configuration, or orientation, but may have a general or approximate shape, configuration, or orientation that is recognized by a person skilled in the art as having the described shape, configuration, or orientation. The terms "inferior" and "superior" refer to the posture of a human in a standard anatomical posture. The systems and devices disclosed herein are for medical purposes, and therefore their components are sterile. As used herein, "patient" includes mammals, such as humans.

[0012] The present disclosure provides systems and devices for providing downward traction to maintain vertical tension within the airway to prevent airway collapse. Figure 1In one embodiment, a hyoid laryngeal suspension device 10 for treating SDB can include a first fastener 12 sized and configured to be anchored to a patient's hyoid bone 14, and a second fastener 16 sized and configured to be anchored to a patient's sternum, clavicle, or rib 18. The device 10 can also include a static or elastic member 20 having one end 22 connected to the first fastener 12 and an opposite end 24 connected to the second fastener 16. For example, the fastener can be a single fastener or a plurality of fasteners, which can include individual miniature plates, bone or soft tissue screws, suture loops, or a combination thereof. Additionally or alternatively, the hyoid laryngeal suspension device 26 can include a first fastener 28 sized and configured to be anchored to a patient's thyroid cartilage 30, and a second fastener 32 sized and configured to be anchored to a patient's clavicle, sternum, or rib 18. The device 26 may further include a static or resilient member 34 having one end 36 connected to the first fastener 28 and an opposite end 38 connected to the second fastener 32. Additionally or alternatively, the hyoid laryngeal suspension device 40 may include a first fastener 42 sized and configured to be anchored to the patient's mandible 44 (e.g., the posterior portion of the mandible) and a second fastener 46 sized and configured to be anchored to the patient's hyoid bone 14. The device 40 may further include a static or resilient member 48 having one end 50 connected to the first fastener 42 and an opposite end 52 connected to the second fastener 46. Additionally or alternatively, the hyoid laryngeal suspension device 54 may include a first fastener 56 sized and configured to be anchored to the patient's mandible 44 and a second fastener 58 sized and configured to be anchored to the patient's tongue 60. Device 54 may also include a static or resilient member 62 having one end 64 connected to first fastener 56 and an opposite end 66 connected to second fastener 58. The present disclosure also provides systems that may include one or more of devices 10, 26, 40, and 54.

[0013] Any embodiment can include a second independent elastic member attached to the corresponding bone to avoid twisting around a single axis. When attached to the hyoid bone or thyroid cartilage, the elastic member can have enough elasticity to allow the hyoid bone or thyroid cartilage to move downward respectively, and allow the larynx to be dynamically elevated to make speech and swallowing possible. For example, by tying the hyoid bone and / or thyroid cartilage below, the device can maintain or improve the vertical tension in the airway between the larynx and the clavicle. The elastic element can maintain moderate tension at night, which can be measured (titratable) when or after being placed, to prevent the pharynx from becoming too compliant at night. In certain embodiments, the device is directly connected to the hyoid bone or thyroid cartilage to directly tighten the pharynx, without being replaced by tracheal tension. When attached to the tongue, the elastic member can minimize the posterior displacement of the tongue during sleep. For example, the elastic member can be a spring or a filament.

[0014] In some embodiments, a static member attached between the fasteners can restrict movement of the hyoid bone and / or thyroid cartilage to a certain distance away from the lower fastener. The static member can be measured during or after placement to prevent the pharynx from becoming too compliant during the night while still allowing sufficient movement for speech and swallowing.

[0015] In addition to positive airway pressure devices, oral appliances, nerve stimulators (e.g., hypoglossal nerve stimulators), and / or muscle stimulators, the systems and devices used herein can also be used to treat SDB. For example, the system can also include a neuromodulation system comprising at least one electrode configured to deliver an electrical signal to a target site comprising an upper airway muscle or a nerve innervating an upper airway muscle to activate the upper airway muscle; a power source electrically connected to the electrode; and a controller electrically connected to the electrode, the controller being programmed to deliver the electrical signal directly to the target site to stimulate the upper airway muscle or the nerve innervating the upper airway muscle, thereby activating the upper airway muscle to improve SDB, such as Figure 2 and Figure 3 shown.

[0016] Each disclosed aspect and embodiment of the present disclosure may be considered independently or in combination with other aspects, embodiments and variations of the present disclosure. Unless otherwise specified, any steps of the disclosed method are not limited to any specific execution order.

Claims

1. A hyoid-laryngeal suspension system for improving sleep-disordered breathing in patients, comprising: a thyroid cartilage fastener sized and configured to anchor to the patient's thyroid cartilage; an inferior bone fastener sized and configured to anchor to an anatomical bony structure beneath the thyroid cartilage of the patient; as well as an elastic member or a static member disposed between the thyroid cartilage fastener and the inferior bone fastener, the elastic member having sufficient elasticity to allow elevation of the pharynx and / or larynx to permit the patient to speak and swallow; The static member has sufficient tension to maintain pharyngeal wall tension while still allowing movement of the hyoid bone and the thyroid cartilage to permit the patient to speak and swallow.

2. The hyoid-laryngeal suspension system according to claim 1, wherein: The lower bone fastener is sized and configured to anchor to the sternum, ribs, or clavicle.

3. The hyoid-laryngeal suspension system according to claim 1, wherein: The thyroid cartilage distraction device provides separate and unique inferior distraction of the thyroid cartilage.

4. The hyoid laryngeal suspension system according to claim 1 , further comprising: Neuromodulatory system, including: at least one electrode configured to deliver an electrical signal to a target site including an upper airway muscle or nerves innervating an upper airway muscle to activate the upper airway muscle; a power source in electrical communication with the electrode; and A controller is electrically connected to the electrodes, and the controller is programmed to directly transmit the electrical signal to the target site to stimulate the upper airway muscles or the nerves innervating the upper airway muscles, thereby activating the upper airway muscles to improve sleep-disordered breathing.

5. The hyoid-laryngeal suspension system according to claim 4, wherein: The nerve is the cervical loop and the muscle is the sternothyroid muscle.

6. The hyoid laryngeal suspension system according to claim 1 , further comprising: a hyoid bone fastener sized and configured to anchor to the patient's hyoid bone; and an elastic member or static member disposed between the thyroid cartilage fastener and the hyoid bone fastener, the elastic member having sufficient elasticity to allow elevation of the pharynx and / or larynx to permit the patient to speak and swallow; the static member having sufficient tension to maintain pharyngeal wall tension while still permitting movement of the hyoid bone and the thyroid cartilage to permit the patient to speak and swallow.

7. The hyoid-laryngeal suspension system according to claim 1 , further comprising: a hyoid bone fastener sized and configured to anchor to the patient's hyoid bone; and a resilient or static member disposed between the hyoid bone fastener and the inferior bone fastener, the inferior bone fastener being sized and configured to anchor to an anatomical bony structure beneath the hyoid bone; The elastic member has sufficient elasticity to allow the pharynx and / or larynx to be elevated to permit the patient to speak and swallow; the static member has sufficient tension to maintain pharyngeal wall tension while still allowing the hyoid bone and the thyroid cartilage to move to permit the patient to speak and swallow.

8. The hyoid-laryngeal suspension system according to claim 4, wherein: The inferior bone fastener is sized and configured to anchor to an anatomical bony structure beneath the hyoid bone. The inferior bone fastener is sized and configured to anchor to a sternum, rib, or clavicle.

9. The hyoid-laryngeal suspension system according to claim 4, wherein: The inferior bone fastener is sized and configured to anchor to the anatomical bony structure beneath the hyoid bone, and is identical to the inferior bone fastener of claim 1 , which is sized to anchor to the anatomical bony structure beneath the thyroid cartilage of the patient.

10. The hyoid laryngeal suspension system according to claim 1, further comprising: a mandibular fastener sized and configured to anchor to the patient's mandible; a hyoid bone fastener sized and configured to anchor to the patient's hyoid bone; as well as a static or elastic member disposed between the mandibular fastener and the hyoid fastener, the elastic member having sufficient elasticity to allow elevation of the pharynx and / or larynx to permit the patient to speak and swallow; the static member having sufficient tension to maintain pharyngeal wall tension while still permitting movement of the hyoid bone and the thyroid cartilage to permit the patient to speak and swallow.

11. The hyoid laryngeal suspension system according to claim 1 , further comprising: a mandibular fastener sized and configured to anchor to the patient's mandible; a tongue fastener sized and configured to anchor to the patient's tongue; as well as A resilient member is disposed between the mandibular fastener and the tongue fastener, the resilient member having sufficient elasticity to allow the tongue to move to permit speaking and swallowing.

12. The hyoid laryngeal suspension system according to claim 1, further comprising: a hyoid bone fastener sized and configured to anchor to the patient's hyoid bone; and an elastic member or a static member disposed between the hyoid bone fastener and the thyroid cartilage fastener, or disposed between the hyoid bone fastener and the inferior bone fastener; a mandibular fastener sized and configured to anchor to the patient's mandible; and an elastic member or a static member disposed between the mandibular fastener and the hyoid fastener; a tongue fastener sized and configured to anchor to the patient's tongue; and elastic or static members disposed between the mandibular fastener and the tongue fastener, wherein all of the elastic members have sufficient elasticity to allow elevation of the pharynx and / or larynx to permit the patient to speak and swallow, and wherein all of the static members have sufficient tension to maintain pharyngeal wall tension while still permitting movement of the hyoid bone and the thyroid cartilage to permit the patient to speak and swallow.

13. The hyoid-laryngeal suspension system according to claim 4, wherein: The nerve is the hypoglossal nerve and the muscle is the genioglossus muscle.

14. The hyoid-laryngeal suspension system according to claim 4, wherein: The nerve is the glossopharyngeal nerve.

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