# US 12,245,790 B2 · Method for painless renal denervation using a peri-vascular tissue ablation catheter with support structures > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,245,790 B2 - Document ID: US12245790B2 - Status: Granted - Kind: B2 - Application number: 16/984,690 - Filed: 2020-08-04 - Published: 2021-01-21 - Granted: 2025-03-11 - Earliest claimed: 2012-10-29 - Assignees: Ablative Solutions, Inc. - Applicants: Ablative Solutions, Inc. - Inventors: David R. Fischell; Tim A. Fischell; Robert Ryan Ragland; Darrin James Kent; Andy Edward Denison; Eric Thomas Johnson; Jeff Alan Burke; Christopher Scott Hayden; Robert E. Fischell - Web page: https://patentgrep.com/patent/US12245790B2 ## CPC - A61B 17/3403: {Needle locating or guiding means} - A61B 17/3478: {Endoscopic needles, e.g. for infusion (biopsy needles A61B10/0233; catheters with injection needles A61M25/0067)} - A61B 18/00: Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body (eye surgery A61F9/007; ear surgery A61F11/00) - A61B 18/04: by heating (by applying electromagnetic radiation A61B18/18) - A61B 18/06: caused by chemical reaction {, e.g. moxaburners} - A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)} - A61M 25/0084: {being one or more injection needles} - A61B 2018/00214: {Expandable means emitting energy, e.g. by elements carried thereon} - A61B 2018/00267: {having a basket shaped structure} - A61B 2018/00279: {deployable} - A61B 2018/00404: {Blood vessels other than those in or around the heart} - A61B 2018/00434: {Neural system} - A61B 2018/00511: {Kidney} - A61B 2018/00517: {Urinary bladder or urethra} - A61B 2018/00577: {Ablation} - A61B 2018/046: {in liquid form} - A61B 2018/143: {multiple needles} - A61B 2018/1432: {curved} - A61B 2018/1475: {Electrodes retractable in or deployable from a housing} - A61B 2090/3966: {Radiopaque markers visible in an X-ray image} - A61B 2218/002: Irrigation - A61M 25/10: Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00}) - A61M 2025/0087: {Multiple injection needles protruding laterally from the distal tip} - 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)} ## Abstract An intravascular catheter for peri-vascular or peri-urethral tissue ablation includes multiple needles advanced through supported guide tubes which expand around a central axis to engage the interior surface of the wall of the renal artery or other vessel of a human body allowing the injection an ablative fluid for ablating tissue, or nerve fibers in the outer layer or deep to the outer layer of the vessel, or in prostatic tissue. A method can involve injection/infusion of the ablative fluid over an extended time period of at least 10 seconds or with two injections at two different penetration depths to reduce or eliminate patient pain during ablation. ## Claims ### Claim 1 A transvascular method of minimizing pain during the treatment of extravascular tissue, comprising: providing a catheter having an elongate flexible body, a proximal end, a distal end, and a needle disposed within a lumen of a guide tube; transvascularly positioning the distal end of the catheter at a treatment site; deploying the needle into a vessel wall at a depth of more than 0.5 mm from an inside surface of the vessel wall while maintaining the guide tube against the vessel wall, without the guide tube puncturing the vessel wall; a single injection of an ablative agent with a first flow rate for desensitizing pain nerves by injecting the ablative agent through the needle wherein the ablative fluid spreads out both radially and circumferentially and a second flow rate for ablating sympathetic nerves by injecting the ablative agent through the needle. ### Claim 2 (depends on 1) The transvascular method of claim 1, further comprising deploying at least three needles into the vessel wall. ### Claim 3 (depends on 2) The transvascular method of claim 2, wherein the depth is between 0.5 mm and 4 mm. ### Claim 4 (depends on 3) The transvascular method of claim 3, wherein the depth is preset. ### Claim 5 (depends on 3) The transvascular method of claim 3, wherein desensitizing pain nerves comprises injecting a first volume of the ablative agent at a site. ### Claim 6 (depends on 5) The transvascular method of claim 5, wherein ablating sympathetic nerves comprises injecting a second volume of the ablative agent at the site. ### Claim 7 (depends on 6) The transvascular method of claim 6, wherein the first volume of the ablative agent is injected at the first flow rate, and the second volume of the ablative agent is injected at the second, faster flow rate. ### Claim 8 (depends on 1) The transvascular method of claim 1, wherein the ablative agent is the same agent which is injected continuously in a single infusion. ### Claim 9 (depends on 1) The transvascular method of claim 1, wherein the the ablative agent is ethanol. ### Claim 10 (depends on 1) The transvascular method of claim 1, wherein the first flow rate is injected slower than 4 ml per minute. ### Claim 11 (depends on 1) The transvascular method of claim 1, wherein the first flow rate is injected over a time period more than 30 seconds. ### Claim 12 A transvascular method of minimizing pain during the treatment of extravascular tissue, comprising: providing a catheter having an elongate flexible body, a proximal end, a distal end, and a needle; transvascularly positioning the distal end at a treatment site; deploying the needle into a vessel wall at a depth of more than 0.5 mm from an inside surface of the vessel wall; a single injection of an ablative agent for desensitizing pain nerves by injecting a first volume of the ablative agent through the needle, wherein the first volume is injected in a continuous, slow rate and ablating sympathetic nerves by injecting a second volume of the ablative agent through the needle at a faster rate. ### Claim 13 (depends on 12) The transvascular method of claim 12, further comprising deploying at least three needles into the vessel wall. ### Claim 14 (depends on 12) The transvascular method of claim 12, wherein the first volume is injected in the continuous, slow rate between 1 ml/minute and 4 ml/minute. ### Claim 15 (depends on 12) The transvascular method of claim 12, further comprising a delay between injecting the first volume of the ablative agent and injecting the second volume of the ablative agent is at least 30 seconds. ### Claim 16 A transvascular method of minimizing pain during the treatment of extravascular tissue, comprising: providing a catheter having an elongate flexible body, a proximal end, a distal end, and a needle; transvascularly positioning the distal end of the catheter at a treatment site; deploying the needle into a vessel wall at a depth of more than 0.5 mm from an inside surface of the vessel wall; a single injection of an ablative agent for desensitizing pain nerves by injecting a first volume of the ablative agent through the needle and ablating sympathetic nerves by injecting a second volume of the ablative agent through the needle, wherein the first volume of the ablative agent is injected at a first rate, and the second volume of the ablative agent is injected at a second, faster rate, wherein the second volume of the ablative agent produces a multiplicity of ablation zones that intersect to form an ablative ring around the circumference of the vessel wall. ### Claim 17 (depends on 16) The transvascular method of claim 16, further comprising at least a 5 second delay between injecting the first volume of the ablative agent and injecting the second volume of the ablative agent. ### Claim 18 (depends on 16) The transvascular method of claim 16, wherein the first volume of the ablative agent is injected in a continuous injection rate. ### Claim 19 (depends on 16) The transvascular method of claim 16, wherein the first volume of the ablative agent is injected slower than 4 ml per minute. ### Claim 20 (depends on 16) The transvascular method of claim 16, wherein the ablative agent is ethanol.