US-12616514-B2 - Systems and methods for treating chronic sinusitis

Abstract

The invention generally relates to systems and methods for targeting of specific tissue(s) of interest within a sino-nasal region of a patient, specifically sinus regions (i.e., ostia and sinus cavities), for the treatment of chronic sinusitis conditions.

Inventors

• David Townley

Assignees

• Neurent Medical Limited

Dates

Publication Date

20260505

Application Date

20221103

Claims (13)

1. 1 . A method for treating chronic sinusitis, the method comprising: advancing an end effector, disposed at a distal end of a shaft of a treatment device, within a sino-nasal cavity of a patient; positioning and deploying the end effector relative to one or more target sites associated with at least one of an ostium and cavity of a paranasal sinus, wherein the end effector comprises a first segment comprising a first set of flexible support elements and a second segment comprising a second set of flexible support elements, wherein the first and second segments each have an open-ended circumferential shape when deployed and generally oppose one another in that the first and second segments extend in opposing directions along a longitudinal axis of the shaft; and delivering energy, from a plurality of energy delivery elements provided on the first and second segments, at the one more target to disrupt neural signals to mucus producing and/or mucosal engorgement elements associated with the paranasal sinus.
2. 2 . The method of claim 1 , wherein the paranasal sinus is selected from the group consisting of a frontal sinus, a sphenoidal sinus, a maxillary sinus, and an ethmoidal sinus.
3. 3 . The method of claim 1 , wherein delivering energy results in ablation of targeted tissue at multiple locations to thereby disrupt the multiple neural signals to the mucus producing and/or mucosal engorgement elements.
4. 4 . The method of claim 3 , wherein the ablation is thermal ablation.
5. 5 . The method of claim 3 , wherein the ablation is caused by delivery of radio-frequency energy.
6. 6 . The method of claim 3 , further comprising receiving feedback, prior to, during, and/or after the ablation.
7. 7 . The method of claim 1 , wherein each of the flexible support elements includes one or more energy delivery elements provided thereon.
8. 8 . The method of claim 7 , wherein each of the flexible support elements comprises a plurality of energy delivery elements provided thereon.
9. 9 . The method of claim 7 , wherein the end effector is transformable from a retracted configuration to an expanded configuration.
10. 10 . The method of claim 9 , wherein the one or more flexible support elements comprises shape memory material.
11. 11 . The method of claim 9 , wherein, when in the expanded configuration, the end effector positions the one or more energy delivery elements relative to parasympathetic nerves inverting the paranasal sinus.
12. 12 . The method of claim 11 , wherein the disrupting of neural signals reduces hyperactive mucosal secretions and soft tissue engorgement of the paranasal sinus.
13. 13 . The method of claim 1 , wherein the end effector comprises at least one inflatable member.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to, and the benefit of, U.S. Provisional Application No. 63/275,701, filed Nov. 4, 2021, the content of which is incorporated by reference herein in its entirety. FIELD OF THE INVENTION The invention generally relates systems and methods for treating medical conditions, and, more particularly, to systems and methods for the treatment of a chronic sinusitis condition. BACKGROUND There are various conditions related to the sino-nasal cavity which may impact breathing and other functions of the nose. One of the more common conditions is rhinitis, which is defined as inflammation of the membranes lining the nose. The symptoms of rhinitis include sino-nasal blockage, obstruction, congestion, sino-nasal discharge (e.g., rhinorrhea and/or posterior sino-nasal drip), facial pain, facial pressure, and/or reduction or complete loss of smell and/or taste. Sinusitis is another common condition, which involves an inflammation or swelling of the tissue lining the sinuses, which can lead to subsequent. Rhinitis and sinusitis are frequently associated with one another, as sinusitis is often preceded by rhinitis. Accordingly, the term rhinosinusitis is often used to describe both conditions. Depending on the duration and type of systems, rhinosinusitis can fall within different subtypes, including allergic rhinitis, non-allergic rhinitis, chronic rhinitis, acute rhinitis, recurrent rhinitis, chronic sinusitis, acute sinusitis, recurrent sinusitis, and medical resistant rhinitis and/or sinusitis, in addition to combinations of one or more of the preceding conditions. Chronic sinusitis is one of the more prevalent chronic illnesses affecting persons of all age groups. It is an inflammatory process that involves the paranasal sinuses and persists for twelve weeks or longer. Chronic sinusitis is almost always accompanied by concurrent nasal airway inflammation and is often preceded by rhinitis symptoms. Accordingly, the term chronic rhinosinusitis is sometimes used. Most cases of chronic sinusitis are continuations of unresolved acute sinusitis. However, chronic sinusitis usually manifests differently from acute sinusitis. Symptoms of chronic sinusitis include, but are not limited to, nasal stuffiness, postnasal drip, facial fullness, and general malaise. Chronic sinusitis can be brought on by an infection, growths in the sinuses (nasal polyps), and/or swelling of the lining the sinuses. Current medical therapy for treating chronic sinusitis is generally focused on reestablishing sinus ventilation by opening sinus ostia. Such therapy includes pharmacotherapy (i.e., antibiotics, decongestants, nasal saline sprays, mast cell stabilizers, and expectorants) and/or surgical intervention (i.e., functional endoscopic sinus surgery (FESS)), which may further be followed by use of implants of one form or another (i.e., stents and or balloons). However, current therapy has its drawbacks. For example, pharmaceutical agents prescribed for chronic sinusitis generally need to be taken on a long-term basis, incurring costs and side effects (e.g., sedation, irritation, impairment to taste, sore throat, dry nose, etc.) and often have suboptimal efficacy. Surgical treatment has inherent risks and complications, ranging from bleeding and scarring to the use of general anesthetic, as well as increased recovery time and the potential to damage otherwise healthy tissue resulting in unintended side effects. SUMMARY The invention recognizes that a problem with current aids and surgical procedures for treating chronic sinusitis are either temporary or are not accurate and further fail to adequately treat the underlying cause, thereby failing to adequately address chronic sinusitis symptoms. The invention solves these problems by providing systems and methods for treating chronic sinusitis by providing, among other things, therapeutic modulation of neural structures associated with chronic sinusitis conditions. For example, the present invention includes a treatment device including an end effector for delivering energy to target sites within the nasal cavity, which may include sinus ostia, sinus cavity walls, or a combination of both. The energy delivered to the target site(s) is sufficient to therapeutically treat tissues of interest associated with the sinuses, specifically neural tissue. In particular, energy delivered to the target site(s) may be sufficient to therapeutically modulate or interrupt neural signals associated with parasympathetic nerves that control autonomic function of the sinuses, thereby reducing or completely eliminating hyperactive mucosal secretions and soft tissue engorgement, thereby treating chronic sinusitis or related indications. The treatment device may include various forms of an end effector shaped and/or sized to be positioned within a nasal cavity and relative to target sites associated with the sinuses, including, but not limited to, sinus cavi