# US 11,298,174 B2 · Cryogenic ablation system and method > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,298,174 B2 - Document ID: US11298174B2 - Status: Granted - Kind: B2 - Application number: 16/508,165 - Filed: 2019-07-10 - Published: 2019-10-31 - Granted: 2022-04-12 - Earliest claimed: 2008-11-21 - Assignees: PENTAX of America, Inc. - Applicants: Pentax of America, Inc. - Inventors: Richard S. Williams; Peter Garcia-Meza - Web page: https://patentgrep.com/patent/US11298174B2 ## CPC - A61B 18/02: by cooling, e.g. cryogenic techniques - A61M 25/10185: {Valves} - A61M 25/1034: {Joining of shaft and balloon} - A61B 2017/22051: {with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation (A61B2017/22048, A61B2017/3486 take precedence)} - A61B 2018/0022: {Balloons} - A61B 2018/00488: {Esophagus} - A61B 2018/00714: {Temperature} - A61B 2018/0212: {using an instrument inserted into a body lumen, e.g. catheter} - A61B 2018/0262: {using a circulating cryogenic fluid} - A61B 2018/0268: {with restriction of flow} - A61M 2025/1084: {having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands} - A61M 2210/105: Oesophagus - Y10T 29/49826: Assembling or joining - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION ## Abstract A device for treating esophageal target tissue comprises a catheter, a balloon and a refrigerant delivery device. The catheter has a distal portion and a refrigerant delivery lumen. The balloon is mounted to and the refrigerant delivery device is coupled to the distal portion. The refrigerant delivery device comprises a chamber with the refrigerant delivery lumen opening into the chamber, a refrigerant delivery opening fluidly coupled to the balloon interior, and a distribution passageway fluidly coupling the chamber and the refrigerant delivery opening. A refrigerant is deliverable through the refrigerant delivery lumen, into the chamber, through the distribution passageway, through the refrigerant delivery opening and into the balloon interior so to place the balloon into an expanded, cooled state so that the balloon can press against and cool esophageal target tissue. The medical device may include means for sensing a leak in the balloon. ## Claims ### Claim 1 A method for cryogenically treating esophageal target tissue at a target site, the method comprising: positioning a cryogenically-coolable balloon at the target site for cryogenic treatment of the esophageal target tissue, the cryogenically-coolable balloon having an inner surface, and the cryogenically-coolable balloon being made of balloon material having temperature-dependent elastic properties and stretch-resistant properties; and inflating the cryogenically-coolable balloon to a desired size, followed by: cooling the inner surface of the cryogenically-coolable balloon to a temperature that transitions the cryogenically-coolable balloon from having the elastic properties to having the stretch-resistant properties to prevent further expansion of the cryogenically-coolable balloon material while cryogenically treating target tissue at the target site. ### Claim 2 (depends on 1) The method according to claim 1, further including cooling the inner surface of the cryogenically-coolable balloon by delivering a refrigerant into the cryogenically-coolable balloon, wherein the refrigerant is a liquid refrigerant. ### Claim 3 (depends on 1) The method according to claim 1, further including: cooling the inner surface of the cryogenically-coolable balloon by delivering a refrigerant into the cryogenically-coolable balloon interior utilizing a refrigerant delivery device comprising: a flow deflector tube inside the cryogenically-coolable balloon; a circumferentially-extending refrigerant delivery opening formed in the flow deflector tube and fluidly coupled to the cryogenically-coolable balloon interior; and an axially-positionable flow director sleeve at least partially surrounding the flow deflector tube; and positioning the flow director sleeve to cover part or none of the circumferentially-extending refrigerant delivery opening thereby changing how much of the circumferentially-extending refrigerant delivery opening is exposed to adjust a circumferential extent of a spray of a refrigerant through the circumferentially-extending refrigerant delivery opening. ### Claim 4 (depends on 3) The method according to claim 3, wherein the refrigerant delivery opening extends along a path having changing rotary and axial positions. ### Claim 5 (depends on 4) The method according to claim 4, further including using a catheter having a catheter axis to position the cryogenically-coolable balloon at the target site, wherein the refrigerant delivery opening is a full circumference opening extending at an angle to the catheter axis. ### Claim 6 (depends on 5) The method according to claim 5, wherein the flow director sleeve is cylindrical. ### Claim 7 (depends on 3) The method according to claim 3, wherein the refrigerant delivery opening extends along a path having a constant axial position. ### Claim 8 (depends on 7) The method according to claim 7, further including using a catheter having a catheter axis to position the cryogenically-coolable balloon at the target site, wherein the flow director sleeve has first and second edges, the first edge arranged at an angle to the catheter axis. ### Claim 9 (depends on 8) The method according to claim 8, wherein the first edge is arranged at an angle of 45° to the catheter axis. ### Claim 10 A system for cryogenically treating esophageal target tissue at a target site, the system comprising: a cryogenically-coolable balloon configured to be positioned at the target site for cryogenic treatment of the esophageal target tissue, the cryogenically-coolable balloon comprising an inner surface and being made of balloon material having temperature-dependent elastic properties and stretch-resistant properties, wherein the cryogenically-coolable balloon is configured to be: inflated to a desired size, and then; have the inner surface cooled to a temperature that transitions the cryogenically-coolable balloon from having the elastic properties to having the stretch-resistant properties to prevent further expansion of the cryogenically-coolable balloon material while cryogenically treating target tissue at the target site. ### Claim 11 (depends on 10) The system according to claim 10, wherein the inner surface of the cryogenically-coolable balloon is configured to be cooled by delivering a refrigerant into the cryogenically-coolable balloon, and wherein the refrigerant is a liquid refrigerant. ### Claim 12 (depends on 10) The system according to claim 10, further including: a refrigerant delivery device comprising: a flow deflector tube inside the cryogenically-coolable balloon; a circumferentially-extending refrigerant delivery opening formed in the flow deflector tube and fluidly coupled to the cryogenically-coolable balloon interior; and an axially-positionable flow director sleeve at least partially surrounding the flow deflector tube, wherein the inner surface of the cryogenically-coolable balloon is configured to be cooled by a refrigerant that is delivered into the cryogenically-coolable balloon interior using the refrigerant delivery device, and wherein the flow director sleeve is configured to cover part or none of the circumferentially-extending refrigerant delivery opening thereby changing how much of the circumferentially-extending refrigerant delivery opening is exposed to adjust a circumferential extent of a spray of a refrigerant through the circumferentially-extending refrigerant delivery opening. ### Claim 13 (depends on 12) The system according to claim 12, wherein the refrigerant delivery opening extends along a path having changing rotary and axial positions. ### Claim 14 (depends on 13) The system according to claim 13, further including a catheter having a catheter axis configured to position the cryogenically-coolable balloon at the target site, wherein the refrigerant delivery opening is a full circumference opening extending at an angle to the catheter axis. ### Claim 15 (depends on 14) The system according to claim 14, wherein the flow director sleeve is cylindrical. ### Claim 16 (depends on 12) The system according to claim 12, wherein the refrigerant delivery opening extends along a path having a constant axial position. ### Claim 17 (depends on 16) The system according to claim 16, further including a catheter having a catheter axis configured to position the cryogenically-coolable balloon at the target site, and wherein the flow director sleeve includes first and second edges, the first edge arranged at an angle to the catheter axis. ### Claim 18 (depends on 17) The system according to claim 17, wherein the first edge is arranged at an angle of 45° to the catheter axis.