Method and system for consistent, repeatable, and safe cryospray treatment of airway tissue
Inventors
Maners, Wendelin • Sheets, Ellen • Cordero, Rafael • Davidson, Marc • Fan, Wei Li • Sherrill, David • Hanley, Brian M. • Sarli, Amy • Griffin, Stephen • Hawkes, Heather V.
Assignees
Alfred M Rankin Jr Trust • Benmike Investment Co LLC • Bhcm Csa Medical LLC • Brown David P Mr • Charles G Brown Inc • Chv Iii LP • Claiborne R Rankin Revocable Trust U/a/d 6/22/71 • Cowell Ensign • Dyer Mark V • Ellis Michael A • Evergreen Ventures Ltd • First Analysis Private Equity Fund V A LP • First Analysis Private Equity Fund V C LP • First Analysis Private Equity Fund V LP • G Russell Lincoln Revocable Trust Dtd 10/31/2007 • Guide Medical Ventures LLC • H&b Investment Partnership • Inkley E Dale • INTERSOUTH PARTNERS VII LP • Kroneberger G Brian Jr • Lincoln G Russell • Mahoney James J Jr • Mary T Von Herrmann Family Trust • Medtech Investments LLC • Melita Tom • Mwk Trust Miriam Winder Kelly Tte • Peck Steven E • Schwarz Richard T • Smith Nathaniel T • Sv Life Sciences Fund V Strategic Partners LP • Sv Life Sciences Fund VIP • Sycamore Fund 1 LLC • SYMARK LLC • Timothy T Weglicki Restated Recovable Trust U/a Dtd 9 13 2022 Amended And Restated During Lifetime Of Timothy T Weglicki AS • Victorie G Rankin Trust • William E Conway Uta Dated 12/12/80 Amended AS
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Publication Number
US-11963709-B2
Publication Date
2024-04-23
Expiration Date
Abstract
A method and system for automated and semi-automated predictable, consistent, safe, effective, and lumen-specific and patient-specific cryospray treatment of airway tissue in which treatment duration is automatically set by the system following entry of patient information and treatment location information into the system by the user, and treatment spray is automatically stopped by the system when the automatically selected treatment duration has been achieved as determined by the system.
Core Innovation
The invention relates to reducing mucous production in an airway of a patient using an automated cryospray-based procedure coordinated with bronchial-tree targeting. It advances a flexible endoscope through an airway passage and inserts a flexible cryospray catheter through a working channel toward target tissue in a bronchial tree of a respiratory tract, where the target tissue includes goblet cells or mucosal tissue and the cryospray is configured to generate a primarily regenerative response.
The invention provides a patient-specific, lumen-specific cryospray delivery concept in which user entry of patient and treatment location/lumen diameter sets treatment duration, and the system automatically stops spray when the selected dose duration is reached. Metered cryospray is targeted to a specified annular ablation region associated with cryonecrosis depth, with closed-loop monitoring and automated termination based on temperature thresholds, temperature rate-of-change, and time limits.
A radial cryospray delivery catheter is described that delivers a radially and axially uniform annular ablation pattern without catheter rotation by using a circumferential two-row arrangement with multiple ports per row. Thermally controlled cryogen valves or a manifold and optional gas egress are described, and an adjunct bronchoscope sheath or sleeve with external markings is used to measure and space successive doses to avoid overlap.
Claims Coverage
The provided portion contains three independent method claims. Across these claims, the main inventive theme is automatically supplying a calculated metered cryospray through a flexible endoscope and flexible catheter to bronchial-tree target tissue, configured to generate a primarily regenerative response, with mucous-production reduction or goblet-cell-count reduction outcomes tied to goblet cells or mucosal tissue.
Automatically supplying metered cryospray configured for primarily regenerative response
Calculating a metered amount of cryospray configured to generate a primarily regenerative response when applied to the target tissue in the bronchial tree of the respiratory tract and automatically supplying the metered amount of cryospray through the catheter.
Flexible endoscope advancement and working-channel catheter insertion toward bronchial-tree target tissue
Advancing a flexible endoscope through an airway passage and inserting a flexible cryospray catheter through a working channel of the endoscope and toward a target tissue of a bronchial tree of a respiratory tract.
Target tissue comprises goblet cells for reducing mucous production
Reducing mucous production in an airway of a patient wherein the target tissue comprises goblet cells.
Target tissue comprises mucosal tissue and radial apertures in the catheter
Reducing mucous production in an airway of a patient wherein the target tissue comprises mucosal tissue and the catheter has at least one radial aperture.
Remodeling target tissue to reduce goblet cell count
Remodeling the target tissue to reduce a goblet cell count of the target tissue, after automatically supplying the metered amount of cryospray through the catheter.
The independent claims cover methods that advance a flexible endoscope and insert a flexible catheter to bronchial-tree target tissue, calculate and automatically supply a metered cryospray configured to generate a primarily regenerative response, and achieve mucous-production reduction or goblet-cell-count reduction by remodeling or targeting goblet-cell/mucosal tissue, with an additional feature in one independent claim requiring radial apertures in the catheter.
Stated Advantages
Generate a primarily regenerative response.
Reduce mucous production in an airway of a patient.
Reduce a goblet cell count of the target tissue.
Documented Applications
Reducing mucous production in an airway of a patient by delivering metered cryospray to target tissue in a bronchial tree, where the target tissue comprises goblet cells or mucosal tissue and the cryospray is configured to generate a primarily regenerative response.
Reducing over-proliferating goblet cells in an airway of a patient by automatically supplying metered cryospray and remodeling the target tissue to reduce a goblet cell count.
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