# US 5,045,056 A · Method and device for thermal ablation of hollow body organs > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 5,045,056 A - Document ID: US5045056A - Status: Granted - Kind: A - Application number: 07/407,839 - Filed: 1989-09-15 - Granted: 1991-09-03 - Earliest claimed: 1989-09-15 - Inventors: Robert S. Behl - Web page: https://patentgrep.com/patent/US5045056A ## CPC - A61B 18/082: {Probes or electrodes therefor} - A61B 18/28: for heating a thermal probe or absorber - A61B 2017/22054: {with two balloons} - A61B 2018/00095: {high, i.e. heat conducting} - A61B 2018/046: {in liquid form} - A61B 2090/3933: {Liquid markers} - A61B 2090/3962: {palpable} - A61B 2218/002: Irrigation - A61F 2007/0298: {with a section for heating and a section for cooling} - A61M 3/0279: {Cannula; Nozzles; Tips; their connection means} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) - 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)} ## Abstract Hollow body organs, such as the gallbladder, may be ablated by introducing a substantially unheated thermally conductive medium to the interior of the organ. The thermally conductive medium is then heated to a temperature sufficient to necrose the endothelial lining or mucous membrane of the organ. After the lining or membrane has necrosed, the interior of the organ will fibrose over time and the organ will eventually be resorbed by the body. A catheter useful in performing the ablation method comprises an elongate member having a heating element at its distal tip. The catheter will include at least oen lumen for delivering the thermally conductive medium to the interior of the hollow body organ, and the heating means is used to raise the temperature of the thermally conductive medium after it has been delivered. Optionally, the catheter may include one or more inflatable balloons which facilitate sealing of the hollow body organ to inhibit leakage of the thermally conductive medium during the treatment process. ## Claims ### Claim 1 A method for ablating a hollow body organ, said method comprising: introducing into the hollow body organ a substantially unheated thermally conductive medium, wherein said medium is generally unconstrained so that it is in direct contact with the interior of the hollow body organ; and heating the thermally conductive medium within the hollow body organ to a temperature and for a time sufficient to destroy the lining of said organ, whereby said organ will subsequently fibrose and be resorbed over time. ### Claim 2 (depends on 1) A method as in claim 1, wherein the thermally conductive medium is heated to a temperature in the range from about 60.degree. to 120.degree. C. ### Claim 3 (depends on 2) A method as in claim 2, wherein the temperature is maintained within said range for a period of time in the range from about 1 to 60 minutes. ### Claim 4 (depends on 3) A method as in claim 3, wherein heating of the thermally conductive medium is stopped after said period of time. ### Claim 5 (depends on 4) A method as in claim 4, wherein the thermally conductive medium is allowed to remain in said hollow body organ after the heating is stopped. ### Claim 6 (depends on 4) A method as in claim 4, wherein the thermally conductive medium is aspirated from said hollow body organ after the heating is stopped. ### Claim 7 (depends on 1) A method as in claim 1, wherein at least one drainage path from the hollow body organ is blocked to inhibit loss of the thermally conductive medium prior to heating said medium. ### Claim 8 (depends on 7) A method as in claim 7, wherein the hollow body organ is a gallbladder and the cystic duct is blocked to inhibit loss of fluid. ### Claim 9 (depends on 7) A method as in claim 7, wherein the hollow body organ is a blood vessel having a lumen, wherein the lumen is blocked in an upstream and a downstream location to inhibit loss of fluid from a region therebetween. ### Claim 10 (depends on 1) A method as in claim 1, wherein the thermally conductive medium is convectively heated. ### Claim 11 (depends on 1) A method as in claim 1, wherein the thermally conductive medium is radiantly heated. ### Claim 12 (depends on 1) A method as in claim 1, wherein the thermally conductive medium is selected from the group consisting of water, saline, contrast medium, and physiological irrigating solution. ### Claim 13 A method for ablating a hollow body organ, said method comprising: percutaneously introducing a catheter into the interior of said hollow body organ, said catheter having proximal and distal ends and including a heating means at or near its distal end; introducing a substantially unheated thermally conductive medium through the catheter to the interior of said hollow body organ, wherein said medium is generally unconstrained so that it is in direct contact with the interior of the hollow body organ; heating the thermally conductive medium within the hollow body organ using the heating means on the catheter to a temperature sufficient to destroy the lining of said organ, whereby said organ will subsequently fibrose and be resorbed over time. ### Claim 14 (depends on 13) A method as in claim 13, wherein the thermally conductive medium is heated to a temperature in the range from about 60 to 120.degree. C. ### Claim 15 (depends on 14) A method as in claim 14, wherein the temperature is maintained within said range for a period of time in the range from about 1 to 60 minutes. ### Claim 16 (depends on 15) A method as in claim 15, wherein heating of the thermally conductive medium is stopped after said period of time. ### Claim 17 (depends on 16) A method as in claim 16, wherein the thermally conductive medium is allowed to remain in said hollow body organ after the heating is stopped. ### Claim 18 (depends on 16) A method as in claim 16, wherein the thermally conductive medium is aspirated from said hollow body organ after the heating is stopped. ### Claim 19 (depends on 13) A method as in claim 13, further comprising inflating a balloon proximate the distal end of the catheter to block at least one drainage path from the hollow body organ to inhibit loss of the thermally conductive medium prior to heating said medium. ### Claim 20 (depends on 19) A method as in claim 19, wherein the hollow body organ is a gallbladder and the balloon is inflated in the cystic duct ### Claim 21 (depends on 13) A method as in claim 13, further comprising inflating at least two balloons spaced-apart from each other on opposite sides of the heating means proximate the distal end of the catheter to isolate a region within the hollow body organ prior to heating the thermally conductive medium within said region. ### Claim 22 (depends on 21) A method as in claim 21, wherein the hollow body organ is a blood vessel and two balloons are inflated to block upstream and downstream locations within said blood vessel. ### Claim 23 (depends on 13) A method as in claim 13, wherein the heating means is a resistive heating element and the thermally conductive medium is heated by passing current through said resistive heating element. ### Claim 24 (depends on 13) A method as in claim 13, wherein the heating means is a coil and the thermally conductive medium is heated by applying a radiofrequency current thereacross. ### Claim 25 (depends on 13) A method as in claim 13, wherein the heating means is a radiofrequency or a microwave radiation generator and the thermally conductive medium is heated by passing the radiation therethrough. ### Claim 26 (depends on 13) A method as in claim 13, wherein the thermally conductive medium is capable of absorbing radiant energy at preselected wavelengths and the heating means includes an optical waveguide, wherein said medium is heated by supplying radiation within said preselected wavelengths through said optical waveguide. ### Claim 27 (depends on 19) A method as in claim 19, further comprising heating an inflation medium within the balloon to a temperature sufficient to destroy the lining of the hollow body organ in contact with the balloon. ### Claim 28 (depends on 21) A method as in claim 21, further comprising heating an inflation medium within at least one of the balloons to a temperature sufficient to destroy the endothelial lining of the hollow body organ in contact with said at least one balloon. ### Claim 29 (depends on 19) A method as in claim 19, wherein the balloon is inflated with a thermally insulating medium to inhibit conduction of heat from the thermally conductive medium. ### Claim 30 (depends on 21) A method as in claim 21, wherein at least one of the balloons is inflated with a thermally insulating medium to inhibit conduction of heat from the thermally conductive medium. ### Claim 31 A method for thermally ablating a gallbladder, said method comprising the following steps performed in a preselected order: sealing the cystic duct to inhibit leakage from the gallbladder; introducing a substantially unheated thermally conductive medium into the gallbladder; and heating the thermally conductive medium within the gallbladder to a temperature and for a time period sufficient to induce fibrosis of the of the gallbladder. ### Claim 32 (depends on 31) A method as in claim 31, wherein the cystic duct is sealed prior to introducing the unheated thermally conductive medium. ### Claim 33 (depends on 31) A method as in claim 31, wherein the unheated thermally conductive medium is introduced at least in part before the cystic duct is sealed. ### Claim 34 (depends on 31) A method as in claim 31, wherein the thermally conductive medium is at least partially heated as it is introduced. ### Claim 35 (depends on 31) A method as in claim 31, wherein the thermally conductive medium is heated to a temperature in the range from about 60 to 120.degree. C. ### Claim 36 (depends on 35) A method as in claim 35, wherein the temperature is maintained within said range for a period of time in the range from about 1 to 60 minutes. ### Claim 37 (depends on 36) A method as in claim 36, wherein heating of the thermally conductive medium is stopped after said period of time. ### Claim 38 (depends on 37) A method as in claim 37, wherein the thermally conductive medium is allowed to remain in said hollow body organ after the heating is stopped. ### Claim 39 (depends on 37) A method as in claim 37, wherein the thermally conductive medium is aspirated from said hollow body organ after the heating is stopped. ### Claim 40 (depends on 31) A method as in claim 31, wherein the thermally conductive medium is convectively heated. ### Claim 41 (depends on 31) A method as in claim 31, wherein the thermally conductive medium is radiantly heated. ### Claim 42 (depends on 31) A method as in claim 31, wherein the thermally conductive medium is selected from the group consisting of water, saline, contrast medium, and physiological irrigating solution. ### Claim 43 A method for thermally ablating a gallbladder, said method comprising: percutaneously introducing a catheter into the interior of the gallbladder, said catheter having proximal and distal ends and including a heating means and an inflation balloon at its distal end; followed by the following steps performed in a preselected order: introducing a substantially unheated thermally conductive medium through the catheter to the interior of the gallbladder; inflating the balloon to seal the cystic duct to inhibit leakage of the thermally conductive medium from the interior of the gallbladder; and heating the thermally conductive medium within the interior of the gallbladder using the heating means on the catheter to a temperature sufficient to destroy the mucosa of the gallbladder, whereby the gallbladder will subsequently fibrose and be resorbed over time. ### Claim 44 (depends on 43) A method as in claim 43, wherein the thermally conductive medium is heated to a temperature in the range from about 60 to 120.degree. C. ### Claim 45 (depends on 44) A method as in claim 44, wherein the temperature is maintained within said range for a period of time in the range from about 1 to 60 minutes. ### Claim 46 (depends on 45) A method as in claim 45, wherein heating of the thermally conductive medium is stopped after said period of time. ### Claim 47 (depends on 46) A method as in claim 46, wherein the thermally conductive medium is allowed to remain in said gallbladder after the heating is stopped. ### Claim 48 (depends on 43) A method as in claim 43, further inflating a second inflatable balloon located on the catheter proximally of the heating means to seal an entry passage formed through the gallbladder to permit introduction of the catheter. ### Claim 49 (depends on 48) A method as in claim 48, wherein the second inflatable balloon is inflated with a thermally insulating medium to protect the liver. ### Claim 50 (depends on 43) A method as in claim 43, wherein the heating means is a resistive heating element and the thermally conductive medium is heated by passing current through said resistive heating element. ### Claim 51 (depends on 43) A method as in claim 43, wherein the heating means is a coil and the thermally conductive medium is heated by applying a radiofrequency current thereacross. ### Claim 52 (depends on 43) A method as in claim 43, wherein the heating means is a microwave generator and the thermally conductive medium is heated by emitting microwave energy therefrom. ### Claim 53 (depends on 43) A method as in claim 43, wherein the thermally conductive medium is capable of absorbing radiation at preselected wavelengths and the heating means includes an optical waveguide, wherein said medium is heated by supplying radiation within said preselected wavelengths through said optical waveguide. ### Claim 54 (depends on 43) A method as in claim 43, further comprising heating an inflation medium within the inflatable balloon to a temperature sufficient to destroy the lining of the hollow body organ.