# US 2010/0168731 A1 · Apparatus, systems, and methods for achieving intravascular, thermally-induced renal neuromodulation > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2010/0168731 A1 - Document ID: US20100168731A1 - Status: Published application - Kind: A1 - Application number: 12/545,648 - Filed: 2009-08-21 - Published: 2010-07-01 - Earliest claimed: 2008-12-31 - Assignees: Ardian, Inc. - Inventors: Andrew Wu; Benjamin J. Clark; Denise Zarins; Erik Thai - Web page: https://patentgrep.com/patent/US20100168731A1 ## CPC - A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)} - A61B 18/1206: {Generators therefor} - A61M 25/0141: {having flexible regions as a result of using materials with different mechanical properties} - A61B 18/02: by cooling, e.g. cryogenic techniques - A61B 18/18: by applying electromagnetic radiation, e.g. microwaves - A61B 18/24: with a catheter (A61B18/26, A61B18/28 take precedence) - A61B 90/39: {Markers, e.g. radio-opaque or breast lesions markers} - A61B 2017/003: {Steerable} - A61B 2018/00172: {Connectors and adapters therefor} - A61B 2018/00404: {Blood vessels other than those in or around the heart} - A61B 2018/00434: {Neural system} - A61B 2018/00511: {Kidney} - A61B 2018/00577: {Ablation} - A61B 2018/00648: {using more than one sensed parameter} - A61B 2018/00791: {Temperature} - A61B 2018/00875: {Resistance or impedance} - A61N 2007/003: {Destruction of nerve tissue} - 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)} - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) ## Abstract Apparatus, systems, and methods for achieving thermally-induced renal neuromodulation by intravascular access are disclosed herein. One aspect of the present application, for example, is directed to apparatuses, systems, and methods that incorporate a treatment device comprising an elongated shaft. The elongated shaft is sized and configured to deliver a thermal element to a renal artery via an intravascular path. Thermally-induced renal neuromodulation may be achieved via direct and/or via indirect application of thermal energy to heat or cool neural fibers that contribute to renal function, or of vascular structures that feed or perfuse the neural fibers. ## Claims ### Claim 1 A catheter apparatus, comprising: an elongated shaft extending along an axis, the elongated shaft comprising a proximal end region and a distal end region, the distal region including a first flexure zone and a second flexure zone adjacent to and extending distally beyond the first flexure zone; a handle coupled to the proximal end region; a thermal element carried by and extending distally beyond the second flexure zone; a flexure control element coupled to the first flexure zone and configured to apply a first force to the first flexure zone to move the first flexure zone of the distal region of the elongated shaft in a radial direction away from the axis; a flexible structure within the second flexure zone that is coupled to the thermal element and configured to allow passive flexure about the axis in response to a second force applied to the thermal element via contact with a tissue surface; a flexure controller carried by the handle and coupled to the flexure control element, wherein the flexure controller is configured to cause the flexure control element to apply the first force to move the first flexure zone; and a connector carried by the handle and configured to connect the thermal element to a thermal energy source; wherein the thermal element is configured to apply treatment to a tissue region adjacent to the tissue surface. ### Claim 2 (depends on 1) The catheter apparatus of claim 1 wherein the first flexure zone is configured to move in a predetermined radial direction in response to the first force applied by the flexure control element. ### Claim 3 (depends on 1) The catheter apparatus of claim 1 wherein the flexure control element comprises a wire coupled to a distal portion of the first flexure zone, and wherein the first force applied to the first flexure zone is a bending or compressive force resulting from actuation of the flexure controller. ### Claim 4 (depends on 1) The catheter apparatus of claim 1, further comprising a sensor adjacent to, on, or within the thermal element, and wherein the sensor is configured to monitor a parameter of at least one of the apparatus and the tissue surface. ### Claim 5 (depends on 4) The catheter apparatus of claim 4 wherein the sensor is at least one of a temperature sensor, impedance sensor, optical sensor, or micro sensor. ### Claim 6 (depends on 4) The catheter apparatus of claim 4, further comprising a feedback control system configured to alter treatment delivered to the tissue surface in response to the monitored parameter. ### Claim 7 (depends on 6) The catheter apparatus of claim 6 wherein the feedback control system comprises an algorithm for controlling output of the thermal energy source. ### Claim 8 (depends on 1) The catheter apparatus of claim 1 wherein the flexure control element and the flexible structure are configured to mutually create, via the first flexure zone and the second flexure zone, a stabilizing force between the thermal element and the tissue surface. ### Claim 9 (depends on 8) The catheter apparatus of claim 8 wherein the stabilizing force causes at least twenty-five percent of the total surface area of the thermal element to contact the tissue surface. ### Claim 10 (depends on 1) The catheter apparatus of claim 1 wherein the thermal element is configured to apply treatment to the tissue region using at least one of radiofrequency energy, microwave energy, ultrasound energy, laser/light energy, thermal fluid, and cryogenic fluid. ### Claim 11 (depends on 1) The catheter apparatus of claim 1 wherein the thermal element comprises an electrode for applying radiofrequency energy to tissue. ### Claim 12 (depends on 1) The catheter apparatus of claim 1, further comprising a radiopaque marker configured to facilitate angiographic visualization of the catheter apparatus. ### Claim 13 (depends on 1) The catheter apparatus of claim 1 wherein the handle comprises a rotating fitting coupled to the elongated shaft and configured to rotate the elongated shaft about the axis without rotating the handle, and wherein the rotating fitting comprises a rotational limiting element configured to prevent rotation of the elongated shaft beyond a predetermined number of revolutions. ### Claim at position 14 14-48. (canceled) ### Claim 49 (depends on 2) The catheter apparatus of claim 2 wherein the first flexure zone comprises an elongated, tubular structure including a spine and a plurality of connecting ribs, and wherein the spine and ribs are positioned to move the first flexure zone in the predetermined radial direction in response to the first force. ### Claim 50 (depends on 7) The catheter apparatus of claim 7 wherein the algorithm comprises instructions for delivering energy to the thermal element according to a predetermined energy delivery profile, and wherein the predetermined energy delivery profile comprises: increasing energy delivery to a predetermined first power level over a first period of time; maintaining energy delivery at the first power level for a second period of time; and increasing energy delivery to a predetermined second power level if a temperature value of a treatment site or of the thermal element is less than a preset threshold temperature following the second period of time. ### Claim 51 (depends on 1) The catheter apparatus of claim 1 wherein the flexible structure comprises a spring-like flexible tubular structure. ### Claim 52 (depends on 1) The catheter apparatus of claim 1 wherein the distal end region of the elongated shaft is configured to be intravascularly delivered to a renal artery of a patient via a guide catheter. ### Claim 53 (depends on 52) The catheter apparatus of claim 52 wherein the guide catheter is an 8 French guide catheter, and wherein the maximum outer dimension of the elongated shaft and the thermal element carried by the elongated shaft is approximately 0.085 inches. ### Claim 54 (depends on 52) The catheter apparatus of claim 52 wherein the guide catheter is a 5 French guide catheter, and wherein the maximum outer dimension of the elongated shaft and the thermal element carried by the elongated shaft is approximately 0.053 inches. ### Claim 55 (depends on 52) The catheter apparatus of claim 52 wherein the guide catheter is a 6 French guide catheter, and wherein the maximum outer dimension of the elongated shaft and the thermal element carried by the elongated shaft is approximately 0.070 inches. ### Claim 56 (depends on 1) The catheter apparatus of claim 1 wherein the thermal element has an outer diameter of from approximately 0.049 inches to 0.051 inches. ### Claim 57 (depends on 1) The catheter apparatus of claim 1 wherein the first flexure zone has a first length and the second flexure zone has a second length less than the first length. ### Claim 58 (depends on 1) The catheter apparatus of claim 1 wherein the second flexure zone has a length of from approximately 5 mm to 20 mm. ### Claim 59 (depends on 1) The catheter apparatus of claim 1 wherein the second flexure zone has a length of approximately 12.5 mm. ### Claim 60 (depends on 1) The catheter apparatus of claim 1 wherein the distal end region of the elongated shaft and the thermal element are sized and configured for intravascular delivery to a renal artery of a human patient. ### Claim 61 (depends on 1) The catheter apparatus of claim 1 wherein the thermal element comprises a single electrode for applying radiofrequency energy to the tissue, and wherein the electrode comprises a generally circular cylinder having a length and a diameter less than the length. ### Claim 62 A medical treatment kit, comprising: an intravascular treatment device including— an elongated shaft extending along an axis, the elongated shaft comprising a proximal end region and a distal end region, the distal end region including a first flexure zone and a second flexure zone adjacent to and extending distally beyond the first flexure zone; a handle coupled to the proximal end region; a treatment element carried by and extending distally beyond the second flexure zone; a flexure control element coupled to the first flexure zone and configured to apply a first force to the first flexure zone to move the first flexure zone of the distal region of the elongated shaft in a radial direction away from the axis; a flexible structure within the second flexure zone that is coupled to the treatment element and configured to allow passive flexure about the axis in response to a second force applied to the treatment element via contact with a tissue surface; and a flexure controller carried by the handle and coupled to the flexure control element, wherein the flexure controller is configured to cause the flexure control element to apply the first force to move the first flexure zone; a cable configured to electrically connect the treatment device to an energy generator; a guide catheter configured to facilitate intravascular delivery of the treatment device into a patient; and instructions for delivering the treatment device into a renal artery of the patient and at least partially denervating a kidney of the patient corresponding to the renal artery to treat the patient for a condition associated with at least one of hypertension, heart failure, kidney disease, chronic renal failure, sympathetic hyperactivity, diabetes, metabolic disorder, insulin resistance, arrhythmia, acute myocardial infarction and cardio-renal syndrome. ### Claim 63 (depends on 62) The medical treatment kit of claim 62, further comprising a dispersive electrode configured to provide a return path for an energy field from the treatment device. ### Claim 64 (depends on 62) The medical treatment kit of claim 62 wherein the cable is integral with the handle of the treatment device. ### Claim 65 (depends on 62) The medical treatment kit of claim 62 wherein the cable and the treatment device are discrete elements configured to be connected to each other, and wherein the cable is configured to be connected to the handle of the treatment device.