Method and system for consistent, repeatable, and safe cryospray treatment of airway tissue

Inventors

Mulcahey, Thomas • Davidson, Marc • Hanley, Brian M. • Sheets, Ellen • Fan, Wei Li

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

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

A cryosurgery/cryospray system performs lumen-specific, patient-specific airway treatment using user-entered patient information and a treatment location. The system sets a treatment duration/dose automatically and stops the cryospray when targets are achieved, including conditions based on measured rate of change, temperature threshold, and time termination conditions.

The system includes cryogen tank pressure control using one or more adjustable pressure valves disposed between a cryogen tank and a cryogen delivery device. A controller receives an indication of a target pressure, measures cryogen tank pressure during operation, determines whether the measured pressure matches the target pressure, determines a current rate of change of pressure of the cryogen tank, and adjusts a control signal based on the pressure measurement, the target pressure, the current rate of change, and a pressure history.

A cryospray test mode and normal mode control workflow is disclosed in which the system measures cooling power of the cryospray delivery device and determines a current rate of change of cryogen tank pressure. The controller adjusts the adjustable pressure valve based on the measured cooling power, the current rate of change, a pressure history, and a pressure set point, and re-tests until a desired cooling power is achieved. When cooling power matches a target cooling power, the system records the cryogen tank pressure and uses the recorded pressure as a target pressure during a future operation.

Claims Coverage

The provided independent claims cover three main inventive aspects: cryogen tank pressure adjustment to match a target pressure using measured pressure, rate of change, and pressure history; cryospray operation with a test mode that measures cooling power and iteratively adjusts pressure until a desired cooling power is achieved; and recording and reuse of the matched tank pressure for future operations. Across the independent claims, the inventive features include adjustable pressure valves responsive to control signals and controller logic using rate-of-change and pressure set point/history.

Taken together, the independent claims define cryospray and cryosurgery control logic that uses adjustable pressure valves and controller feedback based on target pressure or target cooling power, with explicit use of measured pressure or cooling power, a current rate of change of pressure, and pressure history or pressure set point. One claim includes iterative re-testing in a test mode until desired cooling power is achieved, and another includes recording the matched tank pressure for reuse as a target pressure in future operations.

Stated Advantages

Documented Applications