# US 9,039,702 B2 · Devices and methods for forming a fistula > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,039,702 B2 - Document ID: US9039702B2 - Status: Granted - Kind: B2 - Application number: 14/550,747 - Filed: 2014-11-21 - Published: 2015-03-19 - Granted: 2015-05-26 - Earliest claimed: 2010-11-16 - Assignees: TVA Medical, Inc. - Applicants: TVA Medical, Inc. - Inventors: Gary H. Miller; Adam L. Berman; William E. Cohn; Dana R. Mester; Damian A. Jelich - Web page: https://patentgrep.com/patent/US9039702B2 ## CPC - A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)} - A61B 17/320016: {Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes (A61B10/0233, A61B17/29, A61B17/3207 take precedence)} - A61B 17/320725: {with radially expandable cutting or abrading elements (A61B17/32075 takes precedence)} - A61B 18/16: Indifferent or passive electrodes for grounding - A61M 1/3655: {Arterio-venous shunts or fistulae} - A61B 2017/00778: {Operations on blood vessels (A61B2017/22097, A61B2017/320741 take precedence)} - A61B 2017/00876: {magnetic} - A61B 2017/22095: {accessing a blood vessel true lumen from the sub-intimal space} - A61B 2017/320791: {with cutter extending outside the cutting window} - A61B 2018/00083: {low, i.e. electrically insulating} - A61B 2018/00107: {Coatings on the energy applicator} - A61B 2018/00172: {Connectors and adapters therefor} - A61B 2018/00404: {Blood vessels other than those in or around the heart} - A61B 2018/00577: {Ablation} - A61B 2018/00625: {Vaporization} - A61B 2018/1253: {monopolar} - A61B 2018/144: {Wire} - A61B 2090/3925: {ultrasonic} - A61B 2090/3966: {Radiopaque markers visible in an X-ray image} - 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 Described here are devices, systems and methods for forming a fistula between two blood vessels. Generally, the systems may comprise a first catheter which may comprise a fistula-forming element. The fistula-forming element may comprise one or more electrodes, mechanical cutting elements, laser sources, or combinations thereof, and may be used to assist in fistula formation. In some instances, a system may comprise a second catheter, which may comprise a fistula-forming element. One or more of the catheters may comprise one or more markers, magnetic alignment elements, and/or one shape-changing elements. ## Claims ### Claim 1 A method for forming a fistula using a first catheter and a second catheter, wherein the first catheter comprises a catheter body and a shaped lead wire, wherein the lead wire is spring biased toward an extended position in which a distal portion of the lead wire is spaced apart from the catheter body, and the first catheter is configured to hold the lead wire in a compressed configuration within the catheter body and is sized for advancement within a first vessel, and wherein the second catheter comprises a pocket comprising an insulating material for receiving the distal portion of the lead wire and is sized for advancement within a second vessel, comprising: forming a fistula using the first and second catheters. ### Claim 2 (depends on 1) The method of claim 1, wherein forming a fistula comprises advancing the first catheter to a target location within the first vessel and advancing the second catheter to a target location within the second vessel. ### Claim 3 (depends on 2) The method of claim 2, wherein the first catheter is advanced with the lead wire in the compressed configuration, and wherein forming a fistula further comprises moving the lead wire proximally relative to the catheter body to release the distal portion of the lead wire from the compressed configuration. ### Claim 4 (depends on 3) The method of claim 3, further comprising moving the lead wire proximally relative to the catheter body to withdraw the distal portion of the lead wire into the catheter body. ### Claim 5 (depends on 2) The method of claim 2, wherein the first vessel is a vein, and the second vessel is an artery. ### Claim 6 (depends on 2) The method of claim 2, wherein the spring bias of the lead wire causes a portion of the lead wire to press into tissue in the extended position. ### Claim 7 (depends on 2) The method of claim 2, wherein forming a fistula further comprises delivering RF energy through a portion of the lead wire. ### Claim 8 (depends on 7) The method of claim 7, wherein the RF energy vaporizes tissue of the first vessel or second vessel. ### Claim 9 (depends on 7) The method of claim 7, wherein the spring bias of the lead wire causes it to press through the tissue of the first and second vessels and to be received by the pocket of the second catheter. ### Claim 10 (depends on 7) The method of claim 7, wherein the RF energy is delivered in a monopolar configuration. ### Claim 11 (depends on 7) The method of claim 7, wherein blood within the first or second vessel serves as a conduction medium during delivery of the RF energy. ### Claim 12 (depends on 7) The method of claim 7, wherein forming a fistula further comprises forming a first opening in the first vessel and a second opening in the second vessel, wherein the first opening is larger than the second opening. ### Claim 13 (depends on 1) The method of claim 1, further comprising providing a ground electrode for placement external to a patient. ### Claim 14 (depends on 1) The method of claim 1, wherein the first catheter comprises a first magnet and the second catheter comprises a second magnet. ### Claim 15 (depends on 14) The method of claim 14, further comprising longitudinally and rotationally aligning the first and second magnets. ### Claim 16 (depends on 1) The method of claim 1, wherein in the extended position, a first angled segment of the lead wire extends at a first angle away from the catheter body, and a second angled segment distal to the first angled segment is approximately parallel to a longitudinal axis of the catheter body. ### Claim 17 (depends on 16) The method of claim 16, wherein the second angled segment is separated from the catheter body by a distance of between about 1 mm and about 3 mm. ### Claim 18 (depends on 17) The method of claim 17, wherein the first angle is between about 30 degrees and about 60 degrees. ### Claim 19 (depends on 16) The method of claim 16, wherein an insulating material at least partially covers the first angled segment of the lead wire. ### Claim 20 (depends on 16) The method of claim 16, wherein the catheter body comprises a lumen, and wherein the second angled segment of the lead wire is configured to be at least partially constrained within the lumen when the lead wire is held in the compressed configuration within the catheter body. ### Claim 21 (depends on 1) The method of claim 1, wherein the lead wire is configured to be released from the compressed configuration toward the extended position by moving the lead wire proximally relative to the catheter body. ### Claim 22 (depends on 21) The method of claim 21, wherein the lead wire is configured to be moved from the extended position to the compressed configuration by moving the lead wire proximally relative to the catheter body. ### Claim 23 A system for forming a fistula, comprising: a first catheter comprising a catheter body, a first magnet, and a shaped lead wire, wherein the lead wire comprises a distal portion spring biased away from the catheter body, and wherein the distal portion comprises a first low-profile configuration in which the distal portion is housed within the catheter body; and a second catheter comprising a magnet and a pocket for receiving the distal portion of the lead wire, wherein the pocket comprises an insulating material, wherein the distal portion of the lead wire is spring biased toward an expanded configuration in which a first angled segment extends at a first angle away from the catheter body, and a second angled segment distal to the first angled segment is approximately parallel to a longitudinal axis of the catheter body. ### Claim 24 (depends on 23) The system of claim 23, further comprising a ground electrode pad for placement external to a patient. ### Claim 25 (depends on 23) The system of claim 23, wherein the second angled segment is separated from the catheter body by a distance of between about 1 mm and about 3 mm in the expanded configuration. ### Claim 26 (depends on 23) The system of claim 23, wherein the first angle is between about 30 degrees and about 60 degrees in the expanded configuration. ### Claim 27 (depends on 23) The system of claim 23, wherein an insulating material at least partially covers the first angled segment of the lead wire. ### Claim 28 (depends on 23) The system of claim 23, wherein the catheter body comprises a lumen, and wherein when the lead wire is in the first low-profile configuration, the second angled segment is at least partially constrained within the lumen. ### Claim 29 (depends on 28) The system of claim 28, wherein the lead wire comprises a second low-profile configuration in which the distal portion is housed within the catheter body such that the first angled segment is at least partially constrained within the lumen. ### Claim 30 (depends on 29) The system of claim 29, where the distal portion of the lead wire is configured to move from the first low-profile configuration to the expanded configuration by moving the lead wire proximally relative to the catheter body, and wherein the distal portion of the lead wire is configured to move from the expanded configuration to the second low-profile configuration by moving the lead wire proximally relative to the catheter body.