Cryosurgery system
Inventors
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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Abstract
An improved cryosurgical system for application of medical-grade liquid nitrogen to a treatment area via a small, low pressure, open tipped catheter. The system includes a console, including a touch panel computer, a cryogen module, a suction module and an electronics module, all packaged in a mobile cart, and a disposable spray kit. Improved features include optional low cryogen flow setting to reduce the cryogen flow rate by 50%, improved cryogen flow consistency reducing pressure pulses and peaks (improved sensors, control systems, and control algorithms), an integrated suction pump for improved consistency and self-checks, specified vent tube areas and corresponding maximum expected pressures during cryospray procedure; optional pressure sensing capability to monitor pressure during a treatment, and improved catheter design.
Core Innovation
The mobile cryosurgical apparatus performs cryogenic spray ablation using a cryogen tank for storing cryogen under pressure and a cryogen pressure measuring device configured to measure the pressure of the cryogen tank. A cryogen pressure maintenance system monitors the tank pressure and controls the pressure of the cryogen in the tank during use. The apparatus also includes a cryogen level measuring device for measuring cryogen level in the tank.
The system integrates a cryogen tank fill system, a catheter attachment apparatus, a catheter pre-cool system for precooling the catheter, and a catheter defrost system for defrosting the catheter. An on-board suction system evacuates gas from a treatment area, and a user-control system enables user control of cryogen flow and suction application via the on-board suction system.
An on-board control system comprising computer readable instructions performs monitoring and adjusting cryogen pressure, controls cryogen tank fill operation, runs pre-procedure system checks, controls catheter pre-cool and defrost, and controls thermal, timing and suction functions at least in part using the user-control system during user treatment of a patient. The cryogen level measuring device is implemented using a three-point cryogen tank support system with an electronic load cell located at one point and electronics that communicate recorded load to the on-board control system.
Claims Coverage
The provided material covers one independent claim with multiple dependent refinements. The inventive coverage centers on a mobile cryosurgical apparatus that integrates cryogen storage, pressure and level measurement, catheter precooling and defrosting, on-board suction, user control, and on-board computer-controlled thermal, timing, suction, fill, and pre-procedure functions.
Mobile cryosurgical spray ablation apparatus with cryogen pressure monitoring and maintenance
A mobile cryosurgical apparatus comprising a cryogen tank for storing cryogen under pressure, a cryogen pressure measuring device configured to measure a pressure of the cryogen tank, and a cryogen pressure maintenance system configured to monitor the pressure via the measuring device and control the pressure of the cryogen in the cryogen tank during use.
Cryogen level measurement using a three-point support and electronic load cell
A cryogen level measuring device configured to measure a cryogen level in the cryogen tank, wherein the cryogen level measuring device comprises a three-point cryogen tank support system, an electronic load cell located at one point of the three point cryogen tank support system configured to determine the load borne by the support at one point, and electronics for communication of the load to the on-board control system.
Catheter precool and defrost integrated with on-board suction and user control
A catheter pre-cool system for precooling the catheter and a catheter defrost system for defrosting the catheter, together with an on-board suction system configured to evacuate gas from a treatment area and a user-control system configured for user-control of cryogen flow and application of suction via the on-board suction system.
On-board computer-controlled thermal, timing and suction functions with pre-procedure checks
An on-board control system comprising a non-transitory computer readable medium containing computer readable instructions for monitoring and adjusting cryogen pressure, controlling a cryogen tank fill operation, running pre-procedure system checks, controlling catheter pre-cool and defrost, and controlling thermal, timing and suction functions at least in part using the user-control system during user treatment of patient.
Electronic solenoid-based pressure build and vent pressure maintenance
Cryogen pressure maintenance using electronic pressure-control components, wherein the cryogen pressure is monitored and maintained using electronic solenoid devices that selectively transfer liquid cryogen between tank portions to increase pressure and vent to decrease pressure under on-board control instructions.
Discrete cryogen delivery at a plurality of user-selected pressures
A user input interface permits the user to select cryogen delivery at a plurality of discrete pressures.
Automatic catheter precooling mode with temperature-based flow blocking
The catheter pre-cool system can be set to automatic by the user and prevents cryogen flow into the catheter until internal cryogen-delivery components reach a specified temperature.
Low-pressure spray catheter with multi-layer construction enabling retroflex without delamination
A cryosurgical catheter for low-pressure spray with an endoscope having a multi-layer construction including extruded polyimide, a layer of braided stainless steel, and a layer of polyether block amide, forming a blunted tip and capable of retroflex during use without delamination.
Cryogen delivery subsystem with dimension-selected delivery dynamics damping
A cryogen delivery subsystem including a tank lance, downstream liquid cryogen valve, a manifold assembly with a manifold vent and a defrost valve supplying warmed cryogen, and a downstream catheter valve, wherein dimensions of the cryogen tank, manifold assembly, manifold vent, and cryosurgery catheter are selected to dampen dynamic response during cryogen delivery.
The inventive coverage centers on controlling cryogenic spray ablation in a mobile system by monitoring and maintaining cryogen tank pressure, measuring cryogen level via a three-point support with an electronic load cell, integrating catheter precooling and defrost with on-board suction and user-controlled cryogen flow and suction, and using on-board computer instructions to run pressure adjustment, tank fill, pre-procedure checks, and thermal, timing, and suction functions. Dependent refinements further specify electronic solenoid pressure control, discrete user-selected delivery pressures, an automatic temperature-based precooling and flow-block behavior, a multi-layer catheter structure enabling retroflex without delamination, and a valve and manifold architecture with dimension selection to damp dynamic response.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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