# US 10,478,594 B2 · Apparatus and methods for delivering devices for reducing left atrial pressure > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,478,594 B2 - Document ID: US10478594B2 - Status: Granted - Kind: B2 - Application number: 15/656,936 - Filed: 2017-07-21 - Published: 2017-11-09 - Granted: 2019-11-19 - Earliest claimed: 2013-05-21 - Assignees: V-Wave Ltd. - Applicants: V-Wave Ltd. - Inventors: Menashe Yacoby; Boaz Harari; Yaacov Nitzan - Web page: https://patentgrep.com/patent/US10478594B2 ## CPC - A61M 25/0102: {Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod} - A61B 17/0057: {Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect (sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009)} - A61B 17/3415: {for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters (A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06)} - A61F 2/2418: {Scaffolds therefor, e.g. support stents} - A61F 2/2436: {Deployment by retracting a sheath} - A61M 27/002: {Implant devices for drainage of body fluids from one part of the body to another (intraocular A61F9/00781; middle ear A61F11/202)} - A61B 2017/00243: {cardiac} - A61B 2017/00526: {Methods of manufacturing} - A61B 2017/00575: {for closure at remote site, e.g. closing atrial septum defects} - A61B 2017/00592: {Elastic or resilient implements} - A61B 2017/00597: {Implements comprising a membrane} - A61B 2017/00601: {Implements entirely comprised between the two sides of the opening} - A61B 2017/00606: {Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening} - A61B 2017/00623: {Introducing or retrieving devices therefor} - A61B 2017/12054: {Details concerning the detachment of the occluding device from the introduction device} - A61M 2025/0034: {characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores} - A61M 2210/125: Heart - 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)} - 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) ## Abstract A device for regulating blood pressure between a patient's left atrium and right atrium, and apparatus for delivery the device, are provided. The delivery apparatus may include one or more latching legs, a release ring, a pull chord, and a catheter wherein the latching legs are configured to engage the device for delivery. The inventive devices may reduce left atrial pressure and left ventricular end diastolic pressure, and may increase cardiac output, increase ejection fraction, relieve pulmonary congestion, and lower pulmonary artery pressure, among other benefits. The inventive devices may be used, for example, to treat subjects having heart failure, pulmonary congestion, or myocardial infarction, among other pathologies. ## Claims ### Claim 1 An apparatus for coupling to an atrial shunt for regulating blood pressure between a patient's left atrium and right atrium, the apparatus comprising: a catheter having a proximal region and a distal region, the distal region sized and shaped to be advanced to the patient's atrial septum; one or more latching legs disposed at the distal region of the catheter, the one or more latching legs having a hook portion and a ramp portion disposed proximal to the hook portion; a ring coupled to the one or more latching legs; an actuator disposed at the proximal region of the catheter, the actuator configured to move the ring between a first position, where the ring contacts a first section of the ramp portion such that the one or more latching legs extend radially outward, and a second position, where the ring contacts a second section of the ramp portion such that the one or more latching legs move radially inward; and a ring base coupled to the ring and the actuator, wherein the actuator causes the ring base to move the ring between the first position and the second position. ### Claim 2 (depends on 1) The apparatus of claim 1, wherein the apparatus is configured to deliver the atrial shunt to the atrial septum of the patient such that a first flared end region of the atrial shunt is disposed in the right atrium in an expanded state, a second flared end region of the atrial shunt is disposed in the left atrium in an expanded state, and a neck region between the first and second flared end regions is positioned at the atrial septum. ### Claim 3 (depends on 1) The apparatus of claim 1, wherein the catheter comprises a lumen extending between the proximal region and the distal region of the catheter. ### Claim 4 (depends on 3) The apparatus of claim 3, wherein the one or more latching legs and the ring are at least partially disposed within the lumen. ### Claim 5 (depends on 1) The apparatus of claim 1, further comprising a sheath, wherein the catheter is configured to be at least partially disposed within the sheath. ### Claim 6 (depends on 5) The apparatus of claim 5, wherein the sheath is configured to receive the atrial shunt in a contracted state. ### Claim 7 (depends on 1) The apparatus of claim 1, further comprising a pull chord coupled to the ring, wherein the actuator is configured to move the pull chord to move the ring between the first position and the second position. ### Claim 8 (depends on 1) The apparatus of claim 1 further comprising a spring coupled to the ring base, the spring configured to bias the ring toward the first position. ### Claim 9 (depends on 8) The apparatus of claim 8, further comprising an annular member disposed proximal to the ring base and configured to maintain the spring between the ring base and the annular member. ### Claim 10 (depends on 1) The apparatus of claim 1, wherein the hook portion of the one or more latching legs hooks outwardly away from a center axis of the catheter. ### Claim 11 An apparatus for coupling to an atrial shunt for regulating blood pressure between a patient's left atrium and right atrium, the apparatus comprising: a catheter having a proximal region and a distal region, the distal region sized and shaped to be advanced to the patient's atrial septum; one or more latching legs disposed at the distal region of the catheter, the one or more latching legs having a hook portion and a ramp portion disposed proximal to the hook portion, the one or more latching legs comprising two latching legs that share a common ramp portion and a third latching leg having a separate ramp portion; a ring coupled to the one or more latching legs; and an actuator disposed at the proximal region of the catheter, the actuator configured to move the ring between a first position, where the ring contacts a first section of the ramp portion such that the one or more latching legs extend radially outward, and a second position, where the ring contacts a second section of the ramp portion such that the one or more latching legs move radially inward. ### Claim 12 (depends on 11) The apparatus of claim 11, further comprising a pull chord coupled to the ring, wherein the actuator is configured to move the pull chord to move the ring between the first position and the second position. ### Claim 13 A method of coupling to an atrial shunt configured for implantation at an atrial septum, the method comprising: advancing a distal region of a catheter of an apparatus to the atrial septum, the apparatus further comprising an actuator at a proximal region of the catheter, one or more latching legs disposed at the distal region of the catheter and having a hook portion and a ramp portion disposed proximal to the hook portion, the one or more latching legs configured to move the atrial shunt longitudinally forward and longitudinally backward through a sheath, and a ring coupled to the one or more latching legs; and actuating the actuator to move the ring between a first position, where the ring contacts a first section of the ramp portion such that the one or more latching legs extend radially outward, and a second position, where the ring contacts a second section of the ramp portion such that the one or more latching legs move radially inward. ### Claim 14 (depends on 13) The method of claim 13, wherein the advancing further comprises advancing the atrial shunt in the sheath, the method further comprising: expanding a second flared end of the atrial shunt from the sheath such that the atrial shunt engages the left side of the atrial septum; and retracting the sheath such that a first flared end of the atrial shunt expands and is disposed in a right atrium. ### Claim 15 (depends on 13) The method of claim 13, wherein the atrial shunt is configured for implantation at an atrial septum of a patient having a heart pathology comprising at least one of heart failure, pulmonary congestion, pulmonary hypertension, or myocardial infarction. ### Claim 16 A method of coupling to an atrial shunt configured for implantation at an atrial septum, the method comprising: advancing a distal region of a catheter of an apparatus to the atrial septum, the apparatus further comprising an actuator at a proximal region of the catheter, one or more latching legs disposed at the distal region of the catheter and having a hook portion and a ramp portion disposed proximal to the hook portion, and a ring coupled to the one or more latching legs; actuating the actuator to move the ring between a first position, where the ring contacts a first section of the ramp portion such that the one or more latching legs extend radially outward, and a second position, where the ring contacts a second section of the ramp portion such that the one or more latching legs move radially inward; and positioning the atrial shunt across a puncture through a fossa ovalis such that a neck region of the atrial shunt is positioned in the puncture, and wherein a first flared end region of the atrial shunt is disposed in a right atrium in an expanded state and a second flared end region is disposed in a left atrium in an expanded state. ### Claim 17 (depends on 16) The method of claim 16, wherein positioning the atrial shunt comprises positioning the atrial shunt across the puncture through the fossa ovalis at a non-perpendicular angle between a center axis of the catheter and an outer wall of the atrial septum. ### Claim 18 (depends on 16) The method of claim 16, wherein positioning the atrial shunt comprises back tenting the fossa ovalis by pulling the apparatus proximally such that the expanded second flared end of the atrial shunt at least partially engages an outer wall of the fossa ovalis. ### Claim 19 A method of coupling to an atrial shunt configured for implantation at an atrial septum, the method comprising: identifying a middle of a fossa ovalis of the atrial septum by pressing a needle against the fossa ovalis to partially tent the fossa ovalis, and puncturing the middle of the fossa ovalis with the needle such that the atrial shunt is deployed away from a limbus, an atrial wall, and a ridge between an inferior vena cava and coronary sinus; advancing a distal region of a catheter of an apparatus to the atrial septum, the apparatus further comprising an actuator at a proximal region of the catheter, one or more latching legs disposed at the distal region of the catheter and having a hook portion and a ramp portion disposed proximal to the hook portion, and a ring coupled to the one or more latching legs; and actuating the actuator to move the ring between a first position, where the ring contacts a first section of the ramp portion such that the one or more latching legs extend radially outward, and a second position, where the ring contacts a second section of the ramp portion such that the one or more latching legs move radially inward. ### Claim 20 (depends on 19) The method of claim 19, wherein actuating the actuator to move the ring between the first position and the second position comprises actuating the actuator to move a pull chord coupled to the ring to move the ring between the first position and the second position.