Invalidity dossier
US 12096973
Systems and methods for therapeutic nasal treatment using handheld device
Current assignee: Aerin Medical Inc.
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Patent summary
Title, assignee, inventors, filing/issue dates, abstract, and a plain-language overview of the claims.
US patent 12096973, titled "Systems and methods for therapeutic nasal treatment using handheld device," was filed on April 26, 2024, and issued on September 24, 2024. The inventor is David Townley. The patent is currently assigned to Neurent Medical Ltd, with a security interest assigned to CLARET EUROPEAN SPECIALTY LENDING COMPANY III, S.A R.L.
Abstract:
The patent describes a method for improving a patient's sleep by treating conditions such as rhinitis, congestion, or rhinorrhea within the sino-nasal cavity. The method involves delivering energy to target sites in the nasal cavity to disrupt neural signals and/or cause local hypoxia in mucus-producing or mucosal engorgement elements. This action aims to reduce mucus production and swelling, thereby alleviating associated symptoms like nasal congestion, coughing, sneezing, and nasal/throat irritation, ultimately improving the patient's nasal breathability and sleep.
Plain-Language Overview of Independent Claims:
Claim 1 (Method Claim): This claim outlines a method to enhance a patient's sleep by addressing nasal issues like rhinitis, congestion, or rhinorrhea. It involves applying energy to specific locations within the patient's nasal passages. This energy works by either interfering with nerve signals or causing a localized oxygen deficiency (hypoxia) in the cells responsible for mucus production and nasal swelling. The goal is to lessen mucus and swelling, reduce symptoms such as congestion, coughing, sneezing, or irritation, and consequently improve the patient's ability to breathe through the nose and sleep soundly.
Claim 10 (System Claim): This claim describes a therapeutic system, specifically a handheld device, designed to improve a patient's sleep by treating rhinitis, congestion, or rhinorrhea. The device features a handle, an elongated body extending from it, and a retractable, expandable end effector (tip). This end effector has two flexible segments. The first segment is shaped to expand and fit around the front part of the middle turbinate in the nose, placing energy-delivery elements in contact with the tissue there. The second segment is designed to expand and position energy-delivery elements in contact with tissue in a cavity located further back, behind the middle turbinate.
Claim 19 (Handheld Device Claim): This claim details a handheld device for delivering energy to a patient's sino-nasal cavity. The device includes an ergonomically designed handle with a comfortable grip, featuring recesses for an operator's fingers for both overhand and underhand gripping. An elongated body extends from the handle, equipped with electrodes along its length to deliver energy to tissue near the inferior turbinate. At the distal end of the elongated body is a retractable and expandable multi-segment end effector with its own electrodes, designed to deliver energy to tissue near the sphenopalatine foramen. The handle incorporates two distinct user-operated mechanisms: one for deploying the end effector (expanding it from its retracted state) and another for controlling the energy output. These controls are positioned to allow simultaneous, one-handed operation during a procedure.
Claim 20 (Method of Treating Rhinosinusitis): This claim describes a method for treating rhinosinusitis using the aforementioned handheld device. The method involves inserting the device's multi-segment end effector into the patient's sino-nasal cavity. The device's elongated body carries a first set of electrodes, while the end effector carries a second set. The end effector is positioned at a first target site near the sphenopalatine foramen. Simultaneously, a portion of the elongated body is positioned at a second, separate target site near the inferior turbinate. Energy is delivered from the first set of electrodes to the inferior turbinate tissue to reduce swelling, and energy is delivered from the second set of electrodes to the first target site to therapeutically modulate specific postganglionic parasympathetic nerves in the nasal mucosa at microforamina of the palatine bone.
Legal Status Notes:
US patent 12096973 is currently active and is part of a patent family with litigation. A US case (1:24-cv-01070) has been filed in the Delaware District Court. Additionally, a PTAB case, IPR2025-01126, was filed but was not instituted due to procedural reasons.
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