Cryospray catheters
Inventors
Fan, Wei Li • Cordero, Rafael • Griffin, Stephen • Shia, Benedict • Babko-Malyi, Sergei • McCartin, Stephen M. • Hanley, Brian M.
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-12048469-B2
Publication Date
2024-07-30
Expiration Date
Abstract
A cryosurgery 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, and a disposable spray kit. Features include optional low cryogen flow setting to reduce the cryogen flow rate by 50%, improved cryogen flow consistency reducing pressure pulses and peaks, 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 novel catheter designs of multilayer and flexible construction providing a variety of spray patterns.
Core Innovation
The invention relates to a cryospray catheter for use with an endoscope that delivers low pressure cryogen spray to a treatment area. The catheter includes a proximal end configured to connect to a cryospray apparatus and an open-ended distal end configured for the output of cryogen spray. The distal end has a blunt tip geometry and a pre-formed curve so that the central axis of the distal end outside of the endoscope during use is co-axial with the central axis of the endoscope, while the catheter is configured to retroflex during delivery.
The catheter is implemented with a multilayer construction and tube structures intended to support low pressure cryogen spray delivery while maintaining catheter maneuverability during retroflexion. The invention includes endoscope working-channel compatible arrangements, including coaxial alignment with off-center working channels, and multiple lumen output configured for cryogen circulation between proximal and distal ends, including a cryogen input lumen and a cryogen output lumen. The catheter constructions may include a cryogen delivery lumen and a cryogen return lumen.
The invention also provides nozzle and distal output structures for cryogen spray pattern formation and cryogen handling. A formed or molded tip and a nozzle structure can be configured to provide selected spray pattern outputs, including expanded, contracted, dispersed, or diffused patterns. The catheter constructions further include venting and nozzle junction features for cryogen expansion and venting, including vent/egress and cyclone phase-separation/diffuser-type structures, and optional pressure and temperature sensing and remotely actuated elements.
Claims Coverage
The independent claims identified in the provided set are clm-00001, clm-00007, clm-00015, and clm-00017. Across these independent claims, the main inventive features are centered on a low-pressure cryogen spray catheter compatible with an endoscope, using a pre-formed curved and retroflex-capable catheter geometry with coaxial distal alignment, and including multilayer and nozzle, vent, circulation, and interface structures for cryogen delivery and handling.
Multilayer low pressure cryogen spray catheter with coaxial pre-formed curved blunt tip and retroflexing delivery
A catheter for use with an endoscope comprising a multilayer construction for delivering low pressure cryogen spray to a treatment area, wherein the catheter comprises a proximal end configured to connect to a cryospray apparatus, and an open-ended distal end configured for the output of cryogen spray, the distal end having a blunt tip geometry and a pre-formed curve, whereby a central axis of the distal end outside of the endoscope during use is co-axial with a central axis of the endoscope, wherein the catheter is configured to retroflex during delivery of the cryogen spray to the treatment area.
Low pressure cryogen spray catheter with pre-formed curved blunt nozzle and coaxial distal axis retroflexing during delivery
A catheter for delivering low pressure cryogen spray to a treatment area with an endoscope, comprising a proximal end configured to connect to a cryospray delivery apparatus, an open-ended distal end configured for the output of cryogen spray, the distal end comprising a blunt tip geometry, a nozzle and a pre-formed curve, whereby a central axis of the distal end outside of the endoscope during use is co-axial with a central axis of the endoscope, wherein the catheter is configured to retroflex during delivery of the cryogen spray to the treatment area.
Curved low pressure cryogen spray catheter with retroflexing delivery and multiple lumen cryogen circulation
A catheter for delivering low pressure cryogen spray to a treatment area with an endoscope, comprising a proximal end configured to connect to a cryospray apparatus, a pre-formed curve, whereby a central axis of a distal end of the catheter outside of the endoscope during use is co-axial with a central axis of the endoscope, and a multiple lumen output configured for cryogen circulation between the proximal and distal ends, the multiple lumen output comprising a cryogen input lumen and a cryogen output lumen, wherein the catheter is configured to retroflex during delivery of the cryogen spray to the treatment area.
Cryospray catheter with proximal bayonet interface, insulating sheath, different-diameter pre-formed curve distal tube, coaxial distal axis and retroflexing delivery
A cryospray catheter for use with an endoscope comprising a proximal metal interface bayonet configured to connect to a cryospray console; a plastic cover configured to interface with the cryospray console and bayonet; an insulating sheath distributed over a proximal portion of the cryospray catheter; a proximal tube with a first diameter; and a distal tube with a second diameter less than the first diameter and a pre-formed curve, whereby a central axis of the distal tube outside the endoscope during use is co-axial with a central axis of the endoscope, wherein the cryospray catheter is configured to retroflex during delivery of a cryogen spray from the cryospray console through the proximal and distal tubes.
Across the independent claims, the claim coverage focuses on an endoscope-compatible cryospray catheter that delivers low pressure cryogen spray using a pre-formed curved distal portion whose distal axis is co-axial with the endoscope, and that is configured to retroflex during delivery. Additional coverage includes catheter construction features, nozzle and blunt tip structures, multiple lumen cryogen circulation, and cryospray catheter interfaces and tube geometry for retroflexing delivery from a cryospray console.
Stated Advantages
Improved cryogen flow/flow control including an optional low-flow mode reducing flow.
Reduced pressure pulses.
Integrated suction/cryodecompression for venting.
Selectable spray pattern output.
Catheter design supports targeting and maneuverability including retroflexing while maintaining co-axial distal alignment.
Documented Applications
Cryospray delivery to a treatment area with an endoscope.
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