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US-20260124062-A1 - DEVICES, SYSTEMS, AND METHODS FOR MANIPULATING NASAL TISSUES

US20260124062A1US 20260124062 A1US20260124062 A1US 20260124062A1US-20260124062-A1

Abstract

Described herein are devices, systems, and methods for applying a tension force to various tissues. The devices may be delivered in a minimally invasive fashion and used to manipulate tissues in the nose, car, and throat. Force may be maintained by the devices for a time period that allows shaping, compression, or approximation of tissues.

Inventors

  • Eric Johnson
  • James R. KINTZING
  • Brandon McCutcheon
  • John Bower

Assignees

  • Spirair, Inc.

Dates

Publication Date
20260507
Application Date
20250610

Claims (20)

  1. 1 .- 30 . (canceled)
  2. 31 . A system for shaping one or more tissues comprising: a cannula comprising a curved distal end and a sharp tip; an elongate tension element comprising a distal anchor and a proximal end, the distal anchor comprising one or more arms; an anchor delivery element coupled to the distal anchor; and an actuator configured to advance the anchor delivery element with the distal anchor coupled thereto through the distal end of the cannula and through the one or more tissues.
  3. 32 . The system of claim 31 , wherein the anchor delivery element is coupled to the one or more arms of the distal anchor.
  4. 33 . The system of claim 31 , wherein a distal end of the one or more arms is beveled.
  5. 34 . The system of claim 31 , wherein the tension element comprises a plurality of proximal anchors between the distal anchor and the proximal end.
  6. 35 . The system of claim 31 , wherein the actuator is configured to translate rotation motion into linear motion.
  7. 36 . The system of claim 31 , wherein the elongate tension element comprises a biodegradable polymer.
  8. 37 . The system of claim 36 , wherein the biodegradable polymer comprises PDO (Poly(dioxanone)).
  9. 38 . The system of claim 36 , wherein the biodegradable polymer is configured to biodegrade over a period of at least about six months.
  10. 39 . The system of claim 31 , wherein the elongate tension element has a tensile strength ranging from about 100 MPa to about 800 MPa.
  11. 40 . The system of claim 31 , wherein the elongate tension element has a rectangular cross-sectional shape.
  12. 41 . The system of claim 31 , wherein the cannula has a non-circular cross-sectional shape.
  13. 42 . The system of claim 31 , further comprising a handle coupled to a proximal end of the cannula.
  14. 43 . The system of claim 42 , wherein the actuator comprises a tab configured to move back and forth with respect to the handle.
  15. 44 . The system of claim 31 , further comprising a needle at the proximal end of the elongate tension element.
  16. 45 . The system of claim 31 , wherein the one or more tissues comprises a nasal septal tissue.
  17. 46 . The system of claim 31 , wherein the one or more tissues comprises a nasal turbinate tissue.
  18. 47 . The system of claim 31 , wherein the one or more tissues comprises a throat tissue or a soft palate.
  19. 48 . A method for shaping one or more tissues comprising: advancing a cannula through the one or more tissues, wherein the cannula comprises a curved distal end and a sharp tip; advancing an anchor delivery element with a distal anchor of an elongate tension element coupled thereto through the distal end of the cannula, wherein the distal anchor comprises one or more arms; advancing the anchor delivery element with the distal anchor coupled thereto through the one or more tissues; tensioning the elongate tension element to a tensioned state; and securing the elongate tension element to the one or more tissues in its tensioned state.
  20. 49 . The method of claim 48 , wherein the anchor delivery element is coupled to the distal anchor via the one or more arms.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. patent application Ser. No. 18/798,512, filed Aug. 8, 2024, which is a continuation of U.S. patent application Ser. No. 18/536,115, filed Dec. 11, 2023, now U.S. Pat. No. 12,083,034, which claims priority to U.S. Provisional Application No. 63/386,874, filed on Dec. 9, 2022, each of which is hereby incorporated by reference in its entirety. FIELD This application generally relates to devices, systems, and methods for applying a tension force to various tissues. The devices may be delivered in a minimally invasive manner and used to manipulate tissues in the nose, ear, and throat. Force may be maintained for a time period that allows shaping, compression, or approximation of tissues. BACKGROUND Nasal septal deviations occur in up to 75% of the population, with far fewer being symptomatic. When symptomatic, a deviated septum may cause nasal airway obstruction which impairs the patient's ability to breath. When symptoms are sufficiently severe the patient may require a septoplasty or septorhinoplasty surgery. Approximately 300,000-600,000 patients require this surgery in the United States every year. While many ENT surgeries have been transitioned to an office-based setting with minimally invasive approaches, septal surgery has fundamentally lagged behind; leaving patients and physicians looking for minimally invasive approaches. Septal surgery is non-trivial. For the patient, it requires a trip to the operating room and general anesthesia. The recovery can also be significant, especially in the case of septorhinoplasty. For the surgeon, operating room (OR) based surgeries can present increased risks and costs while also introducing inefficiencies in the delivery of care. Therefore, both surgeons and patients may be interested in less invasive procedures that can be performed in a lower resource setting. There are currently no minimally-invasive septal correction devices in clinical practice today. Thus, there is a need for new and useful devices and methods for manipulating and reshaping the nasal septal cartilage. New devices and methods for manipulating and reshaping other nasal tissues, as well as tissues of the ear and throat may also be useful. SUMMARY Described herein are devices, systems, and methods for applying a tension force to various tissues. The devices may be delivered in a minimally invasive fashion and used to manipulate tissues in the nose, ear, and throat, as well as other tissues as described elsewhere herein. Force may be maintained for a time period that allows shaping, compression, or approximation of tissues. The devices may include a tension element having a distal anchor that may be inserted in an insertion configuration into or through tissue in one direction, and upon application of force in the opposite direction, may swivel, flex, flare, rotate, expand or pivot about a pivot point of the distal anchor to a deployed configuration to prevent passage of the distal anchor back through the tissue. In some instances, the longitudinal axis of the distal anchor in its deployed configuration is orthogonal to the longitudinal axis of the tension element. Tension may continue to be applied to the tension element and adjusted to the amount desired for the intended application. For example, tension may be adjusted to an amount that alters the shape of nasal tissues (e.g., a nasal septum, a nasal valve). As used herein, the terms “tension element” and “shaping element” are used interchangeably throughout. Other devices for manipulating a tissue in a subject may include a tension element, where the tension element includes an elongate body having a proximal end and a distal end, and a distal anchor at the tension element distal end having a radially expanded configuration after deployment. The distal anchor may include an anchor body having a surface area, an insertion configuration, and a deployed configuration, where the distal anchor in the deployed configuration has a larger surface area for opposing tissue than the distal anchor in the insertion configuration. The tension element may be made from biodegradable or non-biodegradable materials. When the tension element is biodegradable, it may be made from a biodegradable polymer. Exemplary biodegradable polymers include without limitation, LPLA (Poly(L-lactide)), DLPLA (Poly(DL-lactide)), LDLPLA (Poly(DL-lactide-co-L-lactide)), LPLA-HA (Poly(L-lactide) with hydroxylapatite), PGA (Poly(glycolide)), PGA-TMC (Poly(glycolide-co-trimethylene carbonate) or polyglyconate), PDO (Poly(dioxanone)), LPLG (Poly(L-lactide-co-glycolide)), DLPLG (Poly(DL-lactide-co-glycolide), or copolymers or blends thereof. In some variations, the biodegradable polymer comprises a polylactide, a poly(orthoester), a poly(phosphoester), a polyphosphazene, a polyanhydride, a polycaprolactone, a polyurethane, a polycarbonate, chitosan, cyclodextrin, dextran, hyaluronic acid, chondroitin sulfat