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US-12622805-B2 - Devices and methods for treating obstructive breathing disorders

US12622805B2US 12622805 B2US12622805 B2US 12622805B2US-12622805-B2

Abstract

Described herein are devices and methods of treating obstructive breathing disorders in a patient. A method may include: attaching an anchor to a dorsal region of a tongue body; applying an external force to the tongue body; and adjusting a magnitude of the external force. In some embodiments, the magnitude of the external force is adjustable across multiple levels based on one or more of: patient comfort, desired therapeutic effect, or patient wake or sleep state. In some embodiments, at least a portion of the external force is directed along an anterior direction. In some embodiments, the external force causes at least one of the following actions: anterior displacement of a portion of the posterior tongue during sleep or reducing posterior displacement of a portion of the tongue during sleep.

Inventors

  • Randall Ow
  • Clarence EMMONS

Assignees

  • Randall Ow
  • Clarence EMMONS

Dates

Publication Date
20260512
Application Date
20230901

Claims (20)

  1. 1 . A method of treating obstructive breathing disorders in a patient, the method comprising: implanting a first implant in a tongue body of a tongue to form an implant tract within the tongue; removing the first implant from the implant tract of the tongue body of the tongue; determining one or more parameters of a procedure; and performing the procedure using the one or more parameters, wherein the procedure comprises: implanting, in the implant tract of the tongue body of the tongue, an implantable member having a tongue anchor; reversibly coupling a flexible elongate member to the implantable member; and applying a force to the flexible elongate member to generate tension on a portion of the tongue body, wherein at least a portion of the force is directed along an anterior direction, and wherein the force causes at least one of the following actions: an anterior displacement of a posterior portion of the tongue during sleep or reducing posterior displacement of a portion of the tongue during sleep.
  2. 2 . The method of claim 1 , wherein the first implant is used to determine the one or more parameters.
  3. 3 . The method of claim 2 , further comprising determining an effect of the first implant.
  4. 4 . The method of claim 3 , further comprising using drug induced sleep endoscopy to determine the effect of the first implant.
  5. 5 . The method of claim 2 , further comprising administering one or more of: a therapy that generates a positive airway pressure and a therapy that affects a portion of the airway.
  6. 6 . The method of claim 2 , further comprising allowing an initial healing period between a placement of the first implant and the implantation of the implantable member.
  7. 7 . The method of claim 2 , wherein the implantable member is connected to a tongue anchor that is physically separated by a distance from a tissue boundary of the tongue body.
  8. 8 . The method of claim 1 , wherein the one or more parameters comprise one or more of: a type of the implantable member, a size of the implantable member, a number of components of the implantable member, a location of placement of the implantable member, a degree of restriction of the tongue, a displacement of the tongue, a direction of the force to be applied to the tongue, or a magnitude of the force to be applied to the tongue.
  9. 9 . The method of claim 1 , wherein the procedure further comprises disposing the flexible elongate member superiorly to a dorsal surface of the tongue.
  10. 10 . The method of claim 1 , wherein the one or more parameters comprise one or more of: a patient tolerability to an implant, resolution of symptoms, a dimension of an implant, a type of implant, an anatomical location of an implant, or a number of implants.
  11. 11 . A method of treating obstructive breathing disorders in a patient, the method comprising: implanting a temporary implant in a tongue body of a tongue during a first procedure; removing the temporary implant from the tongue body of the tongue after post-operative swelling is reduced; performing the first procedure to determine one or more parameters of a second procedure; and performing the second procedure using the one or more parameters determined from the first procedure, wherein the second procedure comprises: implanting, in a region of the tongue body of the tongue, an implantable member having a tongue anchor; reversibly coupling a flexible elongate member to the implantable member; and applying a force to the flexible elongate member to generate tension on a portion of the tongue body, wherein at least a portion of the force is directed along an anterior direction, and wherein the force causes at least one of the following actions: an anterior displacement of a posterior portion of the tongue during sleep or reducing posterior displacement of a portion of the tongue during sleep.
  12. 12 . The method of claim 11 , wherein the one or more parameters comprise one or more of: a type of the implantable member, a size of the implantable member, a number of components of the implantable member, a location of placement of the implantable member, a degree of restriction of the tongue, a displacement of the tongue, a direction of the force to be applied to the tongue, or a magnitude of the force to be applied to the tongue.
  13. 13 . The method of claim 12 , comprising administering one or more of: a therapy that generates a positive airway pressure and a therapy that affects a portion of the airway.
  14. 14 . The method of claim 13 , wherein the second procedure further comprises disposing the flexible elongate member superiorly to a dorsal surface of the tongue.
  15. 15 . The method of claim 11 , wherein the temporary implant comprises a suction anchor or tool.
  16. 16 . The method of claim 11 , further comprising removing the temporary implant prior to the implantation of the implantable member.
  17. 17 . The method of claim 11 , wherein the second procedure includes implanting a long-term implant placed for more than one week.
  18. 18 . The method of claim 11 , wherein the implantable member is connected to a tongue anchor that is physically separated by a distance from a tissue boundary of the tongue body.
  19. 19 . The method of claim 11 , wherein the first procedure comprises applying suction with a suction tool.
  20. 20 . The method of claim 11 , wherein the first procedure comprises utilizing a mechanical tool to displace one or more tissues regions of the tongue.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation-in-part of International Patent Application Ser. No. PCT/US2022018650, filed Mar. 3, 2022; and U.S. Nonprovisional patent application Ser. No. 17/191,019, filed Mar. 3, 2021, the contents of each of which are incorporated by reference in their entireties. U.S. Nonprovisional patent application Ser. No. 17/191,019 claims the priority benefit of U.S. Provisional Patent Application Ser. No. 62/984,792, filed Mar. 4, 2020, which is herein incorporated by reference in its entirety. International Patent Application Ser. No. PCT/US2022018650, filed Mar. 3, 2022, also claims the priority benefit of U.S. Provisional Patent Application Ser. No. 63/241,982, filed Sep. 8, 2021, which is herein incorporated by reference in its entirety. INCORPORATION BY REFERENCE All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety, as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference in its entirety. TECHNICAL FIELD This disclosure relates generally to the field of otolaryngology, and more specifically to the field of obstructive breathing disorders. Described herein are devices and methods for treating obstructive breathing disorders. BACKGROUND Sleep apnea is a common disorder affecting more than 15 million adults in the U.S. Patients with sleep apnea experience stopped or shallow breathing when they sleep. The most common type of sleep apnea is obstructive sleep apnea (OSA). The airway of patients with OSA collapses—during sleep. These patients often snore loudly. Since the patient's sleep is interrupted throughout the night, they are often drowsy during daytime. Further, patients with sleep apnea often experience severe fatigue and are very motivated for a solution to their condition. Further, many OSA sufferers have other medical problems such as hypertension, cardiac disease, type 2 diabetes, stroke, and depression because of their OSA. The prevalence of OSA is expected to continue to rise because of the rising obesity rates in the United States. Treatments include lifestyle changes such as weight loss and avoiding alcohol before sleeping, mouthpieces, breathing devices, and continuous positive airway pressure (CPAP). Patients who do not tolerate or are not helped by these methods may be offered surgery on the nose and/or throat. A major limitation of surgery is the inability to directly address the collapsing tongue base. The tongue base is suspected to be the primary site of obstruction, but surgery on the tongue base is limited due to the serious complications that can occur with invasive procedures on the tongue base itself. Complications include tongue paralysis, permanent swallowing changes, loss of taste and life-threatening bleeding and swelling. Less dangerous surgeries include palatoplasty, hyoid suspension, genioglossal advancement and hypoglossal nerve implantation. But these surgeries are invasive, expensive, and cause a substantial and permanent change to the anatomy. Further, the effect of these surgeries cannot be adjusted after the actual procedure. Accordingly, there is a large unmet need for a treatment for sleep apnea, especially OSA, that is minimally invasive, easy to perform and does not cause significant alteration of the patient's anatomy, such that it can be easily reversed or adjusted if needed. SUMMARY One aspect of the present disclosure is directed to a device for treating obstructive breathing disorders in a patient. In some embodiments, the device includes: a suction well having a body having: a tissue contacting region on a first side of the body and adapted for attachment to a region of a tongue, such that at least a portion of the tissue contacting region distorts, on application of a vacuum, to conform to the region of the tongue, a non-tissue contacting region on a second side of the body opposite the first side, a perimeter at an interface between the first side and the second side, and a flap extending at least partially about the perimeter of the body. In any of the preceding embodiments, the flap performs a function selected from the group consisting of: resisting rotation, resisting sliding over a tissue surface, and increasing a vacuum on application of a force to the suction well. Another aspect of the present disclosure is directed to a device for treating obstructive breathing disorders in a patient. In some embodiments, the device includes a suction anchor comprising a body having: a tissue contacting region on a first side of the body and adapted for attachment to a region of a tongue, the tissue contacting region comprising at least one suction well, and a non-tissue contacting region on a second side of the body opposite the first side, a second anchor for attachment to a region of a head of a user; and a connector for connecting the suction anchor to the