# US 2019/0167429 A1 · Expandable heart valve coaptation device > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2019/0167429 A1 - Document ID: US20190167429A1 - Status: Published application - Kind: A1 - Application number: 16/208,264 - Filed: 2018-12-03 - Published: 2019-06-06 - Earliest claimed: 2017-12-04 - Assignees: Edwards Lifesciences Corporation - Applicants: Edwards Lifesciences Corporation - Inventors: Grant Matthew Stearns; Alexander J. Siegel - Web page: https://patentgrep.com/patent/US20190167429A1 ## CPC - A61F 2/2463: {Implants forming part of the valve leaflets} - A61F 2/2442: {Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve} - A61F 2/2454: {Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses} - A61F 2/2466: {Delivery devices therefor} - A61F 2/246: {Devices for obstructing a leak through a native valve in a closed condition} - A61F 2210/0057: stretchable - A61F 2210/0061: swellable - A61F 2220/0075: sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable - A61F 2220/0091: connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type - A61F 2230/001: Figure-8-shaped, e.g. hourglass-shaped - A61F 2250/0003: having an inflatable pocket filled with fluid, e.g. liquid or gas - 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 In one embodiment, an expandable positioning device for improving the coaptation of heart valve leaflets is provided. The expandable positioning device can include one or more expandable members. A first expandable member extends below a leaflet in order to reposition the leaflet to improve coaptation with another leaflet. A second expandable member extends above a leaflet in order to secure the expandable delivery device at the implantation site. The expandable positioning device can include a neck that is inserted through the leaflet on which the device is implanted. The expandable positioning device can include a coupling member to releasably couple the device to a delivery device. One or more sealing members can be included in the expandable positioning device to maintain a desired level of expansion of the one or more expandable members. ## Claims ### Claim 1 An expandable positioning device for repairing a heart valve, the expandable positioning device comprising: a first expandable member having first and second axial ends and a first interior volume, the first expandable member configured to be implanted in a ventricle of a heart against an inferior surface of a native leaflet of a heart valve and expanded to reposition the native leaflet closer to an opposing native leaflet of the heart valve; and a second expandable member having first and second axial ends and a second interior volume, the second interior volume being fluidly sealed from the first interior volume when the expandable positioning device is implanted in the ventricle of the heart, the first axial end of the second expandable member disposed proximate the second axial end of the first expandable member, the second expandable member configured to be implanted in an atrium of the heart against a superior surface of the native leaflet and expanded to secure the positioning device on the native leaflet. ### Claim 2 (depends on 1) The device of claim 1, wherein a neck portion is defined between the first and second expandable members, has a smaller width than the first and second expandable members, and is configured to be inserted through a heart valve leaflet. ### Claim 3 (depends on 2) The device of claim 2, wherein the neck portion comprises a sealing member configured to prevent fluid communication between the first and second expandable members. ### Claim 4 (depends on 1) The device of claim 1, further comprising a cord coupled to the expandable positioning device and useable to constrain a diameter of the expandable positioning device. ### Claim 5 (depends on 1) The device of claim 1, further comprising a coupling member coupled to the second axial end of the first expandable member, the coupling member configured to be releasably retained by a portion of a delivery device, wherein the coupling member is released from the delivery device after the expandable positioning device has been implanted and expanded. ### Claim 6 (depends on 5) The device of claim 5, wherein the coupling member comprises a sealing member configured to retain fluid within the device. ### Claim 7 (depends on 5) The device of claim 5, in combination with a delivery device, the delivery device comprising a shaft extendable through the coupling member into interior portions of the first and second expandable portions. ### Claim 8 (depends on 1) The device of claim 1, wherein the first expandable member is configured to receive a first inflation fluid, the second expandable member is configured to receive a second inflation fluid, which may be the same as the first inflation fluid, and the first and second members define respective first and second enclosures that are at least substantially impermeable with respect to the respective first and second inflation fluids. ### Claim 9 (depends on 1) The device of claim 1, wherein the first expandable member comprises a mass of an expandable material disposed within the first interior volume. ### Claim 10 (depends on 9) The device of claim 9, wherein the expandable material comprises a hydrogel. ### Claim 11 (depends on 9) The device of claim 9, wherein the first expandable member defines an enclosure made from a mesh material. ### Claim 12 A method for improving coaptation of heart valve leaflets, the method comprising: inserting a guidewire through a first heart valve leaflet; advancing an expandable positioning device over the guidewire such that a first expandable member of the expandable positioning device is disposed against an inferior surface of the first leaflet and a second expandable member of the expandable positioning device is disposed against a superior surface of the first leaflet; expanding the first expandable member to reposition the first leaflet such that coaptation is improved between the first leaflet and a second leaflet; and expanding the second expandable member to secure the expandable positioning device to the first leaflet, wherein an interior volume of the first expandable member is fluidly sealed from an interior volume of the second expandable member after the expandable positioning device is secured to the first leaflet. ### Claim 13 (depends on 12) The method of claim 12, wherein the first and second expandable members are separated by a neck portion of the positioning device that is positioned within an opening in the first leaflet. ### Claim 14 (depends on 13) The method of claim 13, wherein a sealing member is disposed in the neck portion and fluidly seals the first expandable member from the second expandable member after the act of the expanding the first expandable member. ### Claim 15 (depends on 12) The method of claim 12, wherein at least one of first and second expandable members is filled with a liquid or gel that solidifies after expansion. ### Claim 16 (depends on 12) The method of claim 12, further comprising: retracting a shaft through a sealing member at a proximal end of the expandable positioning device; and retracting the shaft through a coupling member of a delivery device, thereby releasing the coupling member from a coupled configuration to a decoupled configuration where the expandable positioning device is released from the delivery device. ### Claim 17 (depends on 12) The method of claim 12, further comprising: after expanding the first expandable member, retracting a shaft proximally through a seal disposed between the first and second expandable members. ### Claim 18 (depends on 17) The method of claim 17, further comprising: after expanding the second expandable member, retracting the shaft through a sealing member at a proximal end of the expandable positioning device; and retracting the shaft through a coupling member of a delivery device, thereby releasing the coupling member from a coupled configuration to a decoupled configuration where the expandable positioning device is released from the delivery device. ### Claim 19 (depends on 12) The method of claim 12, wherein the first expandable member comprises a mass of an expandable material. ### Claim 20 (depends on 1) An assembly, comprising: an elongate delivery catheter comprising at least one lumen; and the device of claim 1.