# US 12,004,775 B2 · Coronary sinus-anchored sheath for delivery of his bundle pacing lead > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,004,775 B2 - Document ID: US12004775B2 - Status: Granted - Kind: B2 - Application number: 17/071,847 - Filed: 2020-10-15 - Published: 2021-03-25 - Granted: 2024-06-11 - Earliest claimed: 2017-03-08 - Assignees: Pacesetter, Inc. - Applicants: Pacesetter, Inc. - Inventors: Wenwen Li; Gene A. Bornzin; Didier Theret; Luke C. McSpadden; Nima Badie - Web page: https://patentgrep.com/patent/US12004775B2 ## CPC - A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)} - A61B 5/321: Accessories or supplementary instruments therefor, e.g. cord hangers - A61M 25/007: {Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked} - A61M 25/0147: {with movable mechanical means, e.g. pull wires} - A61N 1/37205: {Microstimulators, e.g. implantable through a cannula} - A61M 25/0102: {Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod} - A61M 2025/0095: {being one or more needles protruding from the distal tip and which are not used for injection nor for electro-stimulation, e.g. for fixation purposes} - A61M 2025/0096: {being laterally outward extensions or tools, e.g. hooks or fibres} - A61N 1/0563: {specially adapted for defibrillation or cardioversion} - A61N 1/0573: {chacterised by means penetrating the heart tissue, e.g. helix needle or hook} - A61N 1/3622: {comprising two or more electrodes co-operating with different heart regions} - A61N 1/39622: {Pacing therapy} - A61N 2001/0585: {Coronary sinus electrodes} - 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 Disclosed herein is a catheter for delivering an implantable medical lead to an implantation site near an ostium leading to a proximal region of a coronary sinus. The catheter includes a distal end, a proximal end opposite the distal end, a tubular body extending between the distal and proximal ends, an atraumatic fixation structure defining a distal termination of the distal end, and a lead receiving lumen. The atraumatic fixation structure is configured to enter the ostium and passively pivotally anchor with the proximal region of the coronary sinus. The lead receiving lumen extends along the tubular body from the proximal end to an opening defined in a side of the tubular body near the distal end and proximal the atraumatic fixation structure. ## Claims ### Claim 1 A lead delivery catheter, comprising: a tubular body extending along a longitudinal axis from a proximal end to a distal tip, wherein the distal tip includes an anchor needle having a needle axis coaxial with the longitudinal axis of the tubular body and a needle tip distal to the distal tip to actively pivotally anchor in tissue near an implantation site; an extension that projects outward at an angle to the longitudinal axis and the needle axis, wherein the extension extends from an exterior surface of the tubular body to an exit port, wherein the extension has a cylindrical wall over an extension length; and a lead lumen extending through the tubular body along the longitudinal axis and through the extension to the exit port. ### Claim 2 (depends on 1) The lead delivery catheter of claim 1 further comprising a fixation ring mounted on the tubular body proximal to the distal tip. ### Claim 3 (depends on 2) The lead delivery catheter of claim 2, wherein the fixation ring is mounted on the tubular body between the extension and the distal tip. ### Claim 4 (depends on 2) The lead delivery catheter of claim 2 further comprising a deflection member displaceable distally-proximally to deflect the distal tip laterally. ### Claim 5 (depends on 4) The lead delivery catheter of claim 4, wherein the deflection member is coupled to the fixation ring. ### Claim 6 (depends on 1) The lead delivery catheter of claim 1, wherein the distal tip includes a distally tapering tip. ### Claim 7 A lead delivery system, comprising: a lead delivery catheter including a tubular body extending along a longitudinal axis from a proximal end to a distal tip, wherein the distal tip includes an anchor needle configured to actively pivotally anchor in tissue near an implantation site, an extension that projects outward from an exterior surface of the tubular body to an exit port, wherein the extension has a cylindrical wall over an extension length, and a lead lumen extending through the tubular body along the longitudinal axis and through the extension to the exit port; and a pacing lead configured to advance through the lead lumen and to project laterally through the exit port. ### Claim 8 (depends on 7) The lead delivery system of claim 7 further comprising a fixation ring mounted on the tubular body proximal to the distal tip. ### Claim 9 (depends on 8) The lead delivery system of claim 8, wherein the fixation ring is mounted on the tubular body between the extension and the distal tip. ### Claim 10 (depends on 8) The lead delivery system of claim 8 further comprising a deflection member displaceable distally-proximally to deflect the distal tip laterally. ### Claim 11 (depends on 10) The lead delivery system of claim 10, wherein the deflection member is coupled to the fixation ring. ### Claim 12 (depends on 7) The lead delivery system of claim 7, wherein the distal tip includes a distally tapering tip. ### Claim 13 A method, comprising: anchoring a distal tip of a lead delivery catheter near an implantation site, wherein the lead delivery catheter includes a tubular body extending along a longitudinal axis from a proximal end to the distal tip, an extension that projects outward from an exterior surface of the tubular body, wherein the extension has a cylindrical wall over an extension length, and a lead lumen extending through the tubular body along the longitudinal axis and through the extension to the exit port of the extension; and pivoting the lead delivery catheter to cause the extension to sweep through an arc of rotation about the longitudinal axis such that the exit port is directed to the implantation site; and advancing a pacing lead through the lead lumen and the exit port to the implantation site. ### Claim 14 (depends on 13) The method of claim 13 further comprising deflecting the lead delivery catheter to vary a radius between a distal lead tip of the pacing lead relative to the distal tip of the lead delivery catheter. ### Claim 15 (depends on 13) The method of claim 13 further comprising sensing a location of a His bundle with an electrode of the pacing lead. ### Claim 16 (depends on 15) The method of claim 15 further comprising, upon identifying the location of the His bundle, implanting the pacing lead at the location. ### Claim 17 (depends on 13) The method of claim 13, wherein the distal tip includes a distally tapering tip configured to passively pivotally anchor in an ostium of a coronary sinus near the implantation site. ### Claim 18 (depends on 13) The method of claim 13, wherein the distal tip includes an anchor needle configured to actively pivotally anchor in tissue near the implantation site.